chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.5
Sex: F
Vaccine: DTAP, FLU3, MMR, DTAP, FLU3, MMR, VARCEL
Symptoms: Culture wound positive, Incisional drainage, Injection site pain, Injection site reaction, Skin lesion
Clinical narrative: Patient received DTaP vaccine 12/18/07 IM left thigh (L2606AA).  Exp. 3/15/09.  Within 1-2 weeks, patient had painful lesion at injection site.  Lesion became fluctuant and was I & D'd 1/22/08 - culture grew Enteropacter agglomerams.  03/11/2008 MR received from PCP for 12/18/07-1/31/2008. Pt seen for WCC on 12/18/07 with cough and congestion x 5 days noted. Vax given. Seen again 1/22/08 with c/o cough, congestion and injection site redness and tenderness at DTaP site. (+) Abscess L thigh-fluctuant.  Improving by 1/31/08 after tx with Zithromax and Bactroban
Age: 1.5
Sex: F
Vaccine: DTAP, FLU3, MMR, DTAP, FLU3, MMR, VARCEL
Symptoms: Culture positive, Enterobacter infection, Injection site abscess
Clinical narrative: Patient received DTaP vaccine 12/18/07 IM left thigh (L2606AA).  Exp. 3/15/09.  Within 1-2 weeks, patient had painful lesion at injection site.  Lesion became fluctuant and was I & D'd 1/22/08 - culture grew Enteropacter agglomerams.  03/11/2008 MR received from PCP for 12/18/07-1/31/2008. Pt seen for WCC on 12/18/07 with cough and congestion x 5 days noted. Vax given. Seen again 1/22/08 with c/o cough, congestion and injection site redness and tenderness at DTaP site. (+) Abscess L thigh-fluctuant.  Improving by 1/31/08 after tx with Zithromax and Bactroban
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Convulsion, Syncope
Clinical narrative: Information has been received from a physician concerning a female approximately 14 or 15 years old with a history of seizures who on an unknown date was vaccinated with a first dose of Gardasil. Subsequently on an unknown date the patient fainted and when she came to she convulsed for about five seconds. The patient did not require any additional emergency intervention. Subsequently, on an unknown date the patient fully recovered. Upon internal review the event of convulsions was considered to be an other important medical event. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Head injury, Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female with asthma, anxiety depression and no known drug reactions/allergies who on 21-Sep-2007 her second vaccination with Gardasil (Lot #658490/0802U).  Concomitant therapy included FLONASE and albuterol.  On 21-Sep-2007 the patient fainted after receiving her second dose of Gardasil.  The patient hit her head on the wall after fainting and was taken by ambulance to the emergency room.  Subsequently, the patient recovered.  It was noted that although the patient suffers from anxiety depression disorder she was not nervous at the time of the injection.  The patient received her third dose Gardasil on 25-Jan-2008 and did not faint afterward.  The registered nurse considered the patient fainted and hit her head on the wall to be other important medical events since the patient was taken by ambulance to the emergency room.  Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Death, Guillain-Barre syndrome, Pneumonia
Clinical narrative: Information has been received from a nurse concerning an 80 year old male patient who on an unspecified date was vaccinated with a dose of Pneumovax 23, (lot # not reported) (manufacturer unknown).  The nurse reported that the patient received the Pneumovax 23 and developed a "Guillain-Barre syndrome" which made him develop pneumonia and the patient died as a result.  She reported that the patient was not treated or vaccinated at that practice and was not sure if it was Pneumovax 23, she said it was a pneumonia shot (manufacturer unknown).  No further information was reported.  Additional information is not expected.
Age: 1.17
Sex: F
Vaccine: DTAP, MM, PNC, VARCEL
Symptoms: Injection site swelling, Injection site warmth, Irritability
Clinical narrative: Mild reaction on the LAT, area appears awollen, no pain showed to touch but felt a little warmth to touch, mother denies temperature, pt fussy just the night of the day vaccines were given.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Dyspnoea
Clinical narrative: Pt. was given her 1st dose of Gardasil at 9:30AM, & at noon she began feeling dyspneic with chest pain.  This gradually resolved without treatment over the next few hours.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Abdominal pain, Dizziness, Gastroenteritis viral, Malaise, Nausea
Clinical narrative: Onset, 01/09/08-nausea, vomiting, dizziness, abdominal pain. Pt. out of school 01/10-01/11/08. Returned to school 1/14/08 but "felt bad". Seen by doctor 1/16/08 and dx as "stomach virus gastroenteritis. Out of school 1/15/08-1/17/08. Mother made report on 1/16/08. Follow up call on 1/18/08 revealed no hx of fever or rash.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Vomiting
Clinical narrative: Onset, 01/09/08-nausea, vomiting, dizziness, abdominal pain. Pt. out of school 01/10-01/11/08. Returned to school 1/14/08 but "felt bad". Seen by doctor 1/16/08 and dx as "stomach virus gastroenteritis. Out of school 1/15/08-1/17/08. Mother made report on 1/16/08. Follow up call on 1/18/08 revealed no hx of fever or rash.
Age: 23.0
Sex: F
Vaccine: HEPAB, VARCEL
Symptoms: Diarrhoea, Dizziness, Hallucination, Headache, Malaise
Clinical narrative: Immediately following immunization patient felt "light headed and dizzy" for 2 hours.  At 4:30 PM she began vomiting every 10- 15 minutes and eventually developed "dry heaves".  Shortly after this she developed a headache.  At approximately 7:30 PM on 01/31/2008 she began having diarrhea and "felt really bad". During the night she began experiencing hallucinations.
Age: 23.0
Sex: F
Vaccine: HEPAB, VARCEL
Symptoms: Retching, Vomiting
Clinical narrative: Immediately following immunization patient felt "light headed and dizzy" for 2 hours.  At 4:30 PM she began vomiting every 10- 15 minutes and eventually developed "dry heaves".  Shortly after this she developed a headache.  At approximately 7:30 PM on 01/31/2008 she began having diarrhea and "felt really bad". During the night she began experiencing hallucinations.
Age: 53.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient still complains of arm soreness after receiving the flu vaccination on 11/2/07.
Age: 53.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Patient still complains of arm soreness after receiving the flu vaccination on 11/2/07.
Age: 2.0
Sex: F
Vaccine: DTAPH, FLU3, HEPA
Symptoms: Injection site erythema
Clinical narrative: Erythema of left thigh at site of injection.  Right thigh without reaction.
Age: 0.56
Sex: F
Vaccine: DTAP, FLU3, HEPA, IPV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Hep A was given to a 6 month old female during her routine well child check.
Age: 1.9
Sex: M
Vaccine: DTAPH
Symptoms: Erythema, Oedema peripheral
Clinical narrative: RED, RAISED SWOLLEN AREA, NON-TENDER ON LEFT UPPER THIGH NO INGUINAL LYMPH NODES FELT. ORDERED PRELONE SYRUP AND TOPICAL HYDROCORTISONE BID.
Age: 11.0
Sex: F
Vaccine: DTAP, FLUN3, HEPA, VARCEL
Symptoms: Diarrhoea, Erythema, Oedema peripheral, Pyrexia
Clinical narrative: Varicella vaccine given in right deltoid.  On the day after the vaccine was given, the patient developed swelling and erythema circumferentially on her right upper arm.  She also had fever and 3 episodes of diarrhea.
Age: 65.0
Sex: F
Vaccine: PPV, VARCEL
Symptoms: Body temperature increased, Chest X-ray, Erythema, Rash macular, Swelling
Clinical narrative: Fever to 103.5.  Localized swelling and redness at injection site.  Macular rash on trunk.
Age: 65.0
Sex: F
Vaccine: PPV, VARCEL
Symptoms: White blood cell count
Clinical narrative: Fever to 103.5.  Localized swelling and redness at injection site.  Macular rash on trunk.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Flushing, Injection site pruritus
Clinical narrative: Patient given vaccine at clinic and within 12 hours itching at injection site right arm and burning right side of face and neck.  Seen by doctor 72 hours later - no vesicles no resp sxs.
Age: 12.0
Sex: F
Vaccine: FLU3, HEPA, HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None reported.  No adverse events.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: No adverse reaction
Clinical narrative: None reported.  No adverse events.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration
Clinical narrative: Induration and erythema.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Fatigue, Headache, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Fever up to 103, headache, tiredness.  Slightly stiff neck day after (3) vaccines were administered.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Flushing, Headache, Skin warm
Clinical narrative: Patient reported was not seen for severe headache and hot face for 3 days.
Age: 14.0
Sex: F
Vaccine: HEP, HEPA, HPV4, TDAP
Symptoms: Dizziness, Immediate post-injection reaction, Muscle twitching, Postictal state, Posturing
Clinical narrative: 1 minute after vaccine administration, patient fell back on exam table eyes open and fixed, unresponsive, hands twitching with decorticate posturing.  Event lasted approximately 20-30 seconds postictal for 3-5 minutes.
Age: 14.0
Sex: F
Vaccine: HEP, HEPA, HPV4, TDAP
Symptoms: Unresponsive to stimuli
Clinical narrative: 1 minute after vaccine administration, patient fell back on exam table eyes open and fixed, unresponsive, hands twitching with decorticate posturing.  Event lasted approximately 20-30 seconds postictal for 3-5 minutes.
Age: 37.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Dyskinesia, Pain in jaw
Clinical narrative: Patient states received vaccines approximately 9 AM 1/31/08.  9 PM noted sore left jaw with difficulty opening mouth.  Still sore today.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Injection site pain
Clinical narrative: Temperature 101.7, pain at injection site.  Advise Tylenol for temperature.  Cool compresses to site.  Call if symptoms change.
Age: 2.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Tdap was given for 4th dose.  DTAP and Tdap on same shelf, close in proximity.  Child behind on vaccines.  2 siblings at once, both behind on vaccinations.
Age: 5.0
Sex: F
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: None.  Behind on immunizations.  Tdap given instead of DTAP by error for 5th dose.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Pruritus, Rash
Clinical narrative: On 1-22-08, broke out in rash on chest - spread to back, arms, legs and hands.  Red raised, flat in middle - brown spot - itchy.  Treated with Calamine Lotion, Benadryl - Going to dermatologist today.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Body temperature increased, Nasopharyngitis
Clinical narrative: Temperature 102.  Cold symptoms.  Advised Tylenol for temperature.  Call if symptoms change.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Body temperature increased
Clinical narrative: Temperature 101.3.  Advised to use Tylenol.  Call if symptoms change.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Body temperature increased
Clinical narrative: T. 100.4 24 hours after imms.  Tylenol advised.  Call if sx. change.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Body temperature increased
Clinical narrative: Temperature 100.4 - fussy.  Advised to use Tylenol for temperature.  Call if changes.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Expired drug administered
Clinical narrative: Engerix B (Hep B vaccine) administered on 1-31-08.  Expiration date 1-25-08.  No ill effects noted.
Age: 8.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Induration, Local reaction, Pruritus, Tenderness
Clinical narrative: Local reaction to posterior left forearm, developed erythema, tenderness, and some itching.  2.5 cm circle indurated at site of injection and total 8 cm of erythema.
Age: 8.0
Sex: M
Vaccine: HEPA
Symptoms: Vomiting
Clinical narrative: Injection was given at approximately 3:30 pm.  Dad reported patient began vomiting approximately 15 minutes after injection and 1 hour later was worsening.  The dad paged the doctor's office and doctor arranged to see patient back at the office at 6 pm.  At that time patient continued to vomit.  The doctor administered IM Phenargan.  By 9 pm patient had ceased vomiting.
Age: 9.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Blister, Feeling hot
Clinical narrative: 2/1/08 - Left arm 3x3 cm bullae, hot, ruptured - yais morning with surrounding small vesicles.  Placed on Keflex 375 mg po 2x daily for 7 days.
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Blindness, Deafness, Memory impairment, Rash
Clinical narrative: Loss of vision, audition; skin rashes; forgot things.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Dizziness occurred within an hour of receiving Shingles Vaccine and continued several hours after.  Slept sitting up and next day was fine.
Age: 1.94
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Disorientation, Injection site swelling, Injection site urticaria
Clinical narrative: Hives and swelling at injection site and mental disorientation.
Age: 33.0
Sex: M
Vaccine: ANTH, HEP, MMRV, UNK, ANTH, HEP, TYP
Symptoms: Cough, Dizziness, Fatigue, Sinus headache, Sinusitis
Clinical narrative: The same day I received the shot I began to feel tired, light headed and fatigued.  The next day I also began to feel sinus pressure and began coughing.  When I returned home on 1/27/08 I took otc medication to relieve my symptoms but got no relief.  On 1/29/08 I went to see my doctor and she prescribed antibiotics believing that I had a sinus infection however, I have now finished that treatment and still have the same symptoms.
Age: 33.0
Sex: M
Vaccine: ANTH, HEP, MMRV, UNK, ANTH, HEP, TYP
Symptoms: Arthralgia, Dizziness, Fatigue, Injection site pain, Injection site pruritus
Clinical narrative: The same day I received the shot I began to feel tired, light headed and fatigued.  The next day I also began to feel sinus pressure and began coughing.  When I returned home on 1/27/08 I took otc medication to relieve my symptoms but got no relief.  On 1/29/08 I went to see my doctor and she prescribed antibiotics believing that I had a sinus infection however, I have now finished that treatment and still have the same symptoms.
Age: 33.0
Sex: M
Vaccine: ANTH, HEP, MMRV, UNK, ANTH, HEP, TYP
Symptoms: Injection site swelling, Malaise, Oedema peripheral, Sinus headache
Clinical narrative: The same day I received the shot I began to feel tired, light headed and fatigued.  The next day I also began to feel sinus pressure and began coughing.  When I returned home on 1/27/08 I took otc medication to relieve my symptoms but got no relief.  On 1/29/08 I went to see my doctor and she prescribed antibiotics believing that I had a sinus infection however, I have now finished that treatment and still have the same symptoms.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Injection site hypersensitivity, Injection site pain, Intubation
Clinical narrative: Immediate sensitivity and soreness at injection site - then within a day or two the tingling and numbness began to move through the upper chest area.  Within a couple more days an upward progression beginning with the feet of tingling, numbness, and finally loss of nerve and muscle ability. He was admitted to Hospital on 11/21 with the diagnosis being Guillain-Barre Syndrome thought secondary to his recent influenza shot.  His symptoms progressed rapidly loss of muscle and nerve function in all parts of his body as well as respiratory failure.  He was immediately placed in ICU and required intubation and mechancial ventilation for 7 days in addition to daily infusions of gammaglobulin.  He was later transferred to InPatient Rehab on 12/3/07 for continued rehabilitation for physical therapy, occupational therapy, Speech and Language Pathology. 4/01/08 Reviewed hospital medical records of 11/21-12/03/2007. FINAL DX: Guillain-Barre syndrome, thought secondary to recent flu shost; HTN; and weakness. Records reveal patient experienced lightheadedness, HA, neck stiffness, weakness & tingling of feet, lower legs & fingers ascending & progressing rapidly over 3 days.  Seen in outlying ER & transferred to higher level of care.  Admitted to ICU.  Continued to deteriorate, developed respiratory failure & was intubated 11/23.  DTRs absent in LEs.  Neuro consult obtained.  Tx w/IVIG & improved  Extubated on 11/27.  Continued to improve w/PT & transferred to inpatient rehab.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Mechanical ventilation, Muscular weakness, Respiratory failure
Clinical narrative: Immediate sensitivity and soreness at injection site - then within a day or two the tingling and numbness began to move through the upper chest area.  Within a couple more days an upward progression beginning with the feet of tingling, numbness, and finally loss of nerve and muscle ability. He was admitted to Hospital on 11/21 with the diagnosis being Guillain-Barre Syndrome thought secondary to his recent influenza shot.  His symptoms progressed rapidly loss of muscle and nerve function in all parts of his body as well as respiratory failure.  He was immediately placed in ICU and required intubation and mechancial ventilation for 7 days in addition to daily infusions of gammaglobulin.  He was later transferred to InPatient Rehab on 12/3/07 for continued rehabilitation for physical therapy, occupational therapy, Speech and Language Pathology. 4/01/08 Reviewed hospital medical records of 11/21-12/03/2007. FINAL DX: Guillain-Barre syndrome, thought secondary to recent flu shost; HTN; and weakness. Records reveal patient experienced lightheadedness, HA, neck stiffness, weakness & tingling of feet, lower legs & fingers ascending & progressing rapidly over 3 days.  Seen in outlying ER & transferred to higher level of care.  Admitted to ICU.  Continued to deteriorate, developed respiratory failure & was intubated 11/23.  DTRs absent in LEs.  Neuro consult obtained.  Tx w/IVIG & improved  Extubated on 11/27.  Continued to improve w/PT & transferred to inpatient rehab.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Diarrhoea, Headache, Injection site erythema
Clinical narrative: Extreme pain 4 hrs at site post injection with redness, 102-103 fevers next 48-72 hrs back pain, joint pains, diarrhea, severe headache not recovered yet, same rxn as 4 years ago but was forced to get flu shot against wishes.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pyrexia, Similar reaction on previous exposure to drug
Clinical narrative: Extreme pain 4 hrs at site post injection with redness, 102-103 fevers next 48-72 hrs back pain, joint pains, diarrhea, severe headache not recovered yet, same rxn as 4 years ago but was forced to get flu shot against wishes.
Age: 28.0
Sex: F
Vaccine: HEP, TYP, YF
Symptoms: Headache
Clinical narrative: 1 hour post vaccine - mild headache.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Bloody discharge, Body temperature increased, Enema administration, Insomnia
Clinical narrative: Vaccine administered 11/15/07 at ~9AM, symtoms of leg pain occurred at ~2-3PM that afternoon.  Patient went to the ER at midnight after not being able to sleep, ER took X-rays and gave painkiller intravenously.  Discharged, and we were instructed to bring her to pediatrician next day.  Pediatrician instructed her to go to Hosptial ER.  Patient was admitted to ER again on 11/16/07.  Toxic (transient) synovitis was diagnosed.  Anti-inflammatory was administered thru IV, and patient was discharged.  At home, patient had a temperature of 102-103, but eventually slept thru the night.  The morning of 11/17/07, patient woke up with a bloody discharge in her pull-up.  We went back to Hospital, and patient was diagnosed with an intussusception.  A therapeutic air enema was adminsitered, and patient had to stay in hospital for observation overnight in case intussusception re-occurred.  Patient had a full recovery.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Intussusception, Pain in extremity, Synovitis, Ultrasound scan, X-ray
Clinical narrative: Vaccine administered 11/15/07 at ~9AM, symtoms of leg pain occurred at ~2-3PM that afternoon.  Patient went to the ER at midnight after not being able to sleep, ER took X-rays and gave painkiller intravenously.  Discharged, and we were instructed to bring her to pediatrician next day.  Pediatrician instructed her to go to Hosptial ER.  Patient was admitted to ER again on 11/16/07.  Toxic (transient) synovitis was diagnosed.  Anti-inflammatory was administered thru IV, and patient was discharged.  At home, patient had a temperature of 102-103, but eventually slept thru the night.  The morning of 11/17/07, patient woke up with a bloody discharge in her pull-up.  We went back to Hospital, and patient was diagnosed with an intussusception.  A therapeutic air enema was adminsitered, and patient had to stay in hospital for observation overnight in case intussusception re-occurred.  Patient had a full recovery.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyspnoea, Stomach discomfort, Tenderness, Tremor
Clinical narrative: Dizziness, shortness of breath, tenderness in arm, felt like fainting, upset stomach, shakiness.
Age: 38.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Presented with left arm redness, swelling and erythema that occurred within the last 24 hours. Evaluated by Physician.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Barium enema, Intussusception
Clinical narrative: Information has been received from a physician concerning an approximately 2 month old male who, "in mid-December 2007", on approximately 15-DEC-2007, was vaccinated with an oral first dose of Rotateq.  "Two weeks after the first dose", in approximately December 2007, the patient was hospitalized for intussusception for one day.  The patient was treated with a barium enema and the intussusception resolved.  No product quality complaint was involved.  No other information was provided.  The reporter considered the patient's intussusception to be an other important medical event and immediately life threatening.  Additional information has been requested.
Sex: F
Vaccine: HEPA, HPV4, VARCEL, HEPA, HPV4, VARCEL
Symptoms: Blood urine present, Chest pain, Chills, Flank pain, Micturition urgency
Clinical narrative: Patient seen for routine well check up on 1-2-08.  Noted urgency, frequency on 1-3-08.  No dysuria, no fever, UA on 1-3-08 plus blood - started Trimetloprim sulfamitloxodole.  Symptoms imprvoved x 48.  Levine cts subsequently none.  However patient developed right flank pain/ua.  RL chest pain, plus chills but no fever.  Admitted to hosp for pain, nausea.  No CT, no UA of kidneys and GB, LFTs wkl, WNC.  Patient much better by 1-11-08.
Sex: F
Vaccine: HEPA, HPV4, VARCEL, HEPA, HPV4, VARCEL
Symptoms: Nausea, Pollakiuria, Urine analysis abnormal, Weight decreased
Clinical narrative: Patient seen for routine well check up on 1-2-08.  Noted urgency, frequency on 1-3-08.  No dysuria, no fever, UA on 1-3-08 plus blood - started Trimetloprim sulfamitloxodole.  Symptoms imprvoved x 48.  Levine cts subsequently none.  However patient developed right flank pain/ua.  RL chest pain, plus chills but no fever.  Admitted to hosp for pain, nausea.  No CT, no UA of kidneys and GB, LFTs wkl, WNC.  Patient much better by 1-11-08.
Sex: F
Vaccine: HEPA, HPV4, VARCEL, HEPA, HPV4, VARCEL
Symptoms: Chest pain, Chills, Flank pain, Micturition urgency, Nausea
Clinical narrative: Patient seen for routine well check up on 1-2-08.  Noted urgency, frequency on 1-3-08.  No dysuria, no fever, UA on 1-3-08 plus blood - started Trimetloprim sulfamitloxodole.  Symptoms imprvoved x 48.  Levine cts subsequently none.  However patient developed right flank pain/ua.  RL chest pain, plus chills but no fever.  Admitted to hosp for pain, nausea.  No CT, no UA of kidneys and GB, LFTs wkl, WNC.  Patient much better by 1-11-08.
Sex: F
Vaccine: HEPA, HPV4, VARCEL, HEPA, HPV4, VARCEL
Symptoms: Pollakiuria
Clinical narrative: Patient seen for routine well check up on 1-2-08.  Noted urgency, frequency on 1-3-08.  No dysuria, no fever, UA on 1-3-08 plus blood - started Trimetloprim sulfamitloxodole.  Symptoms imprvoved x 48.  Levine cts subsequently none.  However patient developed right flank pain/ua.  RL chest pain, plus chills but no fever.  Admitted to hosp for pain, nausea.  No CT, no UA of kidneys and GB, LFTs wkl, WNC.  Patient much better by 1-11-08.
Age: 16.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Convulsion, Mechanical ventilation, Pyrexia, Retching, Status epilepticus
Clinical narrative: History of fever (up to 103), dry heaves for 3 days before hospitilization. Admitted to hospital on 1/21 with continued fever & dry heaves, & on 1/22 developed seizures and status epilepticus, & required mechanical ventilation for approx 24 hours, & developed pneumonia.  02/15/2008 MR received for DOS 1/22-2/1/2008 with D/C Dx: Increased seizure activity.  Aspiration pneumonia. Pt presented to ER with fever, decreased po intake, dry heaves and crying. No seizures noted in admission H&P however pt developed prolonged seizure activity requiring intubation.  Pt was found to have aspiration pneumonia.  Pt was extubated after several days and remained seizure free until 1/31/2007.  Pt developed seizure activity (generalized tonic-clonic) lasting ~3 minutes. Txd with abx and seizure meds adjusted.  Seizure free and afebrile x 48hrs prior to d/c.
Sex: F
Vaccine: HPV4, UNK
Symptoms: Convulsion, Syncope
Clinical narrative: Information has been received from a representative concerning a female (age not reported) who in approximately October 2007, (about 4 months ago) was vaccinated with a first dose of Gardasil (lot# unknown) and had fainted and had a seizure. The patient did receive other shots during that time. The patient had not come in for her second dose of Gardasil. At the time of reporting and the seizure it was reported a physician "had come in". The patient was reported as doing "okay". There is no further information. Upon internal review seizure is considered to be an OME (other medical event). Additional information has been requested.
Sex: F
Vaccine: HPV4, UNK
Symptoms: Convulsion, Syncope
Clinical narrative: Information has been received from a representative concerning a female (age not reported) who on approximately 28-NOV-2007 (reported a "2 months ago") was vaccinated with a second dose of Gardasil (lot# unknown). Subsequently the patient had fainted and had a seizure. It was reported that other shots were administered at this time though none were specified. The patient may or may not come back for the third dose of Gardasil. There was no physician available following the fainting and the seizure unfortunately so the staff stabilized the individual and took her to the ER. There was no further information available. the patient was reported as doing "okay". Upon internal review seizure is considered to be an OME (other medical event). Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical conisation, Colposcopy, Smear cervix abnormal
Clinical narrative: Information has been received from a nurse concerning a 23 year old female patient who in February 2007, was vaccinated IM with a dose of Gardasil (lot# 656049/0187U).  Subsequently the patient was diagnosed with cervical cancer and was hospitalized.  The cold knife cone biopsy was performed on 03-May-2007 and "margins were clear".  The cervix was still intact.  In June 2007 the patient was recovered.  The reporting investigator considered cervical cancer to be disabling.  Upon internal review cervical cancer considered to be an other important medical event.  No product quality complaint was involved.  Additional information has been requested.  4/7/09 Received consultant medical records of 5/23/07-7/28/2008. FINAL DX: adenocarcinoma in situ Records reveal patient dx 3/2006 via LEEP procedure.  Subsequent Pap smear abnormal w/HGSIL, cervical biopsies 2/07.  Cold knife cone procedure in OR on 5/3/07 c/w CIN 2 w/marked changes of HPV infection.  RTC 2/6/08 w/right pelvic pain & fatigue.  Had recent colonoscopy for loose stools which was WNL.  Colposcopy done at that visit was WNL.  Referred to PCP for fatigue.  RTC 7/28/08 w/fatigue, bilateral intermittent ovarian pain & pain w/intercourse.  BCP d/c 7/08. Colposcopy done WNL.  Referred for pelvic US.
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Crying, Dizziness, Facial paresis, Hallucination
Clinical narrative: Information has been received in a newspaper article concerning a female who in late May 2007, was vaccinated with her first dose of Gardasil whilst at school. The patient stated that instantly after the shot she began crying "because the shot itself hurt so much". An hour later, at 10:30 am, the patient felt nauseated, very dizzy and weak. She laid down on a bed in the sick bay. Subsequently, she experienced hallucinations, described by the patient as "The kookaburras were flying out of the picture at one point and attacking me, and I couldn't see most of the rainforest animals and the ones I could see were also coming at me ...". After a few hours had passed, the patient stated that her entire right side had become paralyzed, her hand was clenched in a fist that she couldn't open, she couldn't lift her right leg off the bed and the right side of her face was weak. at 3:30 pm the patient's mother took her to see a physician, who sent her home to rest. Subsequently, the patient's symptoms resolved. After the patient's second and third doses of Gardasil (Date not reported) the patient stated that her "reactions were less serious", with prolonged weakness and dizziness after the second dose and mild weakness and very slight dizziness, after the third dose. Subsequently, the patient's symptoms resolved. The reporter considered that her symptoms were related to administration of Gardasil. Upon internal review, paralysis was considered to be an other important medical event. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Hemiplegia, Hypokinesia, Injection site pain, Muscle rigidity, Nausea
Clinical narrative: Information has been received in a newspaper article concerning a female who in late May 2007, was vaccinated with her first dose of Gardasil whilst at school. The patient stated that instantly after the shot she began crying "because the shot itself hurt so much". An hour later, at 10:30 am, the patient felt nauseated, very dizzy and weak. She laid down on a bed in the sick bay. Subsequently, she experienced hallucinations, described by the patient as "The kookaburras were flying out of the picture at one point and attacking me, and I couldn't see most of the rainforest animals and the ones I could see were also coming at me ...". After a few hours had passed, the patient stated that her entire right side had become paralyzed, her hand was clenched in a fist that she couldn't open, she couldn't lift her right leg off the bed and the right side of her face was weak. at 3:30 pm the patient's mother took her to see a physician, who sent her home to rest. Subsequently, the patient's symptoms resolved. After the patient's second and third doses of Gardasil (Date not reported) the patient stated that her "reactions were less serious", with prolonged weakness and dizziness after the second dose and mild weakness and very slight dizziness, after the third dose. Subsequently, the patient's symptoms resolved. The reporter considered that her symptoms were related to administration of Gardasil. Upon internal review, paralysis was considered to be an other important medical event. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Vaccine positive rechallenge
Clinical narrative: Information has been received in a newspaper article concerning a female who in late May 2007, was vaccinated with her first dose of Gardasil whilst at school. The patient stated that instantly after the shot she began crying "because the shot itself hurt so much". An hour later, at 10:30 am, the patient felt nauseated, very dizzy and weak. She laid down on a bed in the sick bay. Subsequently, she experienced hallucinations, described by the patient as "The kookaburras were flying out of the picture at one point and attacking me, and I couldn't see most of the rainforest animals and the ones I could see were also coming at me ...". After a few hours had passed, the patient stated that her entire right side had become paralyzed, her hand was clenched in a fist that she couldn't open, she couldn't lift her right leg off the bed and the right side of her face was weak. at 3:30 pm the patient's mother took her to see a physician, who sent her home to rest. Subsequently, the patient's symptoms resolved. After the patient's second and third doses of Gardasil (Date not reported) the patient stated that her "reactions were less serious", with prolonged weakness and dizziness after the second dose and mild weakness and very slight dizziness, after the third dose. Subsequently, the patient's symptoms resolved. The reporter considered that her symptoms were related to administration of Gardasil. Upon internal review, paralysis was considered to be an other important medical event. Additional information is not expected.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a physician concerning an approximately 6 month old male with a milk allergy and eczema who on an unspecified date was vaccinated orally with a 2 mL second dose of Rotateq. Within 24 hours of getting the second dose of Rotateq the patient developed bloody stool. Unspecified medical attention was sought, there were no lab studies performed. On an unspecified date the patient recovered. There was no product quality complaint involved. No further information was provided. Additional information from the nurse indicated that the patient was vaccinated with first (lot # 656381/0875U) and second (lot # 657670/0901U) 2 ml doses of Rotateq on 29-AUG-2007 and 31-OCT-2007 respectively. The patient did not go on to receive a third 2 ml dose of Rotateq (lot # 657673/0904U) on 02-JAN-2007. The nurse had no additional information. Additional information from the physician indicated that the patient was not seen for the condition. The information was phoned in only. The patient had only one episode of bloody stool, was afebrile and had no loss of appetite. No treatment was required. The association between the event and the vaccine was unknown. Upon internal review the patient's bloody stool was determined to be an other important medical event. Additional information has been requested.
Age: 0.8
Sex: U
Vaccine: RV5
Symptoms: Rotavirus infection
Clinical narrative: Information has been received from a physician concerning an 8 month old patient who was vaccinated with a "third dose of three doses" of Rotateq.  The physician reported that the patient completed the series of Rotateq and developed rotavirus.  The patient was being admitted to the hospital on 28-Jan-2008.  The dates of the dose of the vaccine were unspecified.  The patient sought medical attention.  The patient's rotavirus persisted.  There was no product quality complaint.  Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: RV5
Symptoms: Abdominal pain, Barium enema, Diarrhoea, Intussusception, Surgery
Clinical narrative: Information has been received from a physician concerning an 18 week old female (also reported as 5 months old and also reported as 2 weeks after the patient was 4 months old) who was vaccinated with Rotateq. It was reported the vaccinations with Rotateq started when the patient was 2 months of age and that the patient received other vaccinations at 4 months of age. The physician reported that the patient received her second dose of Rotateq and within two weeks of getting it, she experienced "severe abdominal cramps and diarrhea". Onset date was reported as 2 weeks after the patient was 4 weeks old. The patient's mother took her straight to the emergency room where the patient was given a barium enema which did not work. The patient was diagnosed with intussusception which had to be surgically reduced. It was unknown if the patient was hospitalized. Subsequently (on an unspecified date), the patient recovered from intussusception. There was no product quality complaint. Intussusception was considered to be an other important medical event. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Infection, Pyrexia
Clinical narrative: Initial and follow up information has been received from a 67 year old male consumer, who in September 2004, was vaccinated with PNEUMOVAX 23.  The patient reported that he developed a fever of 102 to 105 degrees for over a year after the administration of PNEUMOVAX 23 (onset not specified).  The Lot # was not provided.  It was reported that two months prior to vaccination the patient had chemotherapy and after the administration of PNEUMOVAX 23 he had chemotherapy and radiotherapy.  The patient reported that he was hospitalized for almost 3 months (dates not specified).  Follow up information from the consumer indicated that he had been diagnosed with a "rare strain of infection."  He recovered in mid-2006.  No further details were provided.  Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Bronchial disorder, Condition aggravated, Nasopharyngitis, Pneumonia
Clinical narrative: Information has been received from a female consumer concerning her 73 year old husband with a "heart disorder" who on 03-DEC-2007, received a 0.65 ml. intramuscular dose of Zostavax. It was indicated that the patient had a cold at the time of the vaccination. Concomitant therapy included an unspecified medication for his "heart". Additional information from the reporter indicated that on an unspecified date since receiving the vaccine, that the patient developed a cold, and unspecified bronchial problems. The patient developed pneumonia and on 26-JAN-2008 was hospitalized. At the time of this report the patient was still hospitalized. A product quality complaint was not reported. This is one of two reports from the same source. Follow up information has been requested.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Allergy test, Blood test, Urticaria
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  Initial report received on 18 January 2008 from a patient.  A 46-year-old female patient, with a medical history of seasonal allergies, had received a right deltoid, intramuscular injection of Fluzone SV 2007-2008, lot number U 2491AA, on 23 October 2007 in the a.m.  At 6:00 p.m. on the same day, the patient developed hives on her face, lips, and ears.  She was examined by a physician twice and treated with Benadryl and prednisone.  The symptoms resolved but returned when the patient was no longer taking the prednisone.  The patient indicated that egg products may possibly cause similar symptoms.  The patient had unspecified blood testing for allergies, but results were not provided.  At the time of this report, the patient had not recovered.
Age: 34.0
Sex: M
Vaccine: TD, TD
Symptoms: Arthritis, Injection site discomfort, Injection site induration, Injection site pain, Musculoskeletal pain
Clinical narrative: Initial report received on 16 August 2007 from a health care professional. A 34 year old male patient received on 06 August 2007 a dose of Decavac (lot# U1944DA), intramuscular into the left deltoid. On 07 August 2007, one day later, he experienced left shoulder severe pain and inflammation in joint. The patient received "prednisone shots". Relevant diagnostic tests was not available. The patient did not receive any other concomitant vaccination. Concomitant medications included Advil, as needed (PRN). The patient's ongoing illness included a laceration of middle finger. The patient did not have any adverse event following prior vaccination. The patient had not recovered. Follow-up information received on 15 January 2008 from a health care professional. The route and site of administration were reported as intramuscular and shoulder. Per the reporter, the vaccine was administered high, possibly into the shoulder bursa. The patient now has rotator cuff involvement and pain. At the time of this report, the patient had not recovered. Follow-up information was received from the health professional on 17 January 2008. based upon this new information, it was determined that the event meets the seriousness criteria for "Other - medically significant". In light of this new information, the case has been upgraded to serious. The patient received Decavac in the left shoulder, and immediately developed pain and discomfort at the injection site, along with an area of induration approximately the size of a "50-cent piece". An MRI revealed an edematous rotator cuff. Since the, he had been treated with several courses of prednisone, local injections of kenalog into the bursa and muscle tendon, and oral decadron. He also underwent physical therapy. Per the reporter, the patient had experienced increased range of motion and decreased pain after initiating therapy with decadron.
Age: 34.0
Sex: M
Vaccine: TD, TD
Symptoms: Pain in extremity, Rotator cuff syndrome
Clinical narrative: Initial report received on 16 August 2007 from a health care professional. A 34 year old male patient received on 06 August 2007 a dose of Decavac (lot# U1944DA), intramuscular into the left deltoid. On 07 August 2007, one day later, he experienced left shoulder severe pain and inflammation in joint. The patient received "prednisone shots". Relevant diagnostic tests was not available. The patient did not receive any other concomitant vaccination. Concomitant medications included Advil, as needed (PRN). The patient's ongoing illness included a laceration of middle finger. The patient did not have any adverse event following prior vaccination. The patient had not recovered. Follow-up information received on 15 January 2008 from a health care professional. The route and site of administration were reported as intramuscular and shoulder. Per the reporter, the vaccine was administered high, possibly into the shoulder bursa. The patient now has rotator cuff involvement and pain. At the time of this report, the patient had not recovered. Follow-up information was received from the health professional on 17 January 2008. based upon this new information, it was determined that the event meets the seriousness criteria for "Other - medically significant". In light of this new information, the case has been upgraded to serious. The patient received Decavac in the left shoulder, and immediately developed pain and discomfort at the injection site, along with an area of induration approximately the size of a "50-cent piece". An MRI revealed an edematous rotator cuff. Since the, he had been treated with several courses of prednisone, local injections of kenalog into the bursa and muscle tendon, and oral decadron. He also underwent physical therapy. Per the reporter, the patient had experienced increased range of motion and decreased pain after initiating therapy with decadron.
Age: 34.0
Sex: M
Vaccine: TD, TD
Symptoms: Arthritis, Drug administered at inappropriate site, Immediate post-injection reaction, Injected limb mobility decreased, Injection site induration
Clinical narrative: Initial report received on 16 August 2007 from a health care professional. A 34 year old male patient received on 06 August 2007 a dose of Decavac (lot# U1944DA), intramuscular into the left deltoid. On 07 August 2007, one day later, he experienced left shoulder severe pain and inflammation in joint. The patient received "prednisone shots". Relevant diagnostic tests was not available. The patient did not receive any other concomitant vaccination. Concomitant medications included Advil, as needed (PRN). The patient's ongoing illness included a laceration of middle finger. The patient did not have any adverse event following prior vaccination. The patient had not recovered. Follow-up information received on 15 January 2008 from a health care professional. The route and site of administration were reported as intramuscular and shoulder. Per the reporter, the vaccine was administered high, possibly into the shoulder bursa. The patient now has rotator cuff involvement and pain. At the time of this report, the patient had not recovered. Follow-up information was received from the health professional on 17 January 2008. based upon this new information, it was determined that the event meets the seriousness criteria for "Other - medically significant". In light of this new information, the case has been upgraded to serious. The patient received Decavac in the left shoulder, and immediately developed pain and discomfort at the injection site, along with an area of induration approximately the size of a "50-cent piece". An MRI revealed an edematous rotator cuff. Since the, he had been treated with several courses of prednisone, local injections of kenalog into the bursa and muscle tendon, and oral decadron. He also underwent physical therapy. Per the reporter, the patient had experienced increased range of motion and decreased pain after initiating therapy with decadron.
Age: 34.0
Sex: M
Vaccine: TD, TD
Symptoms: Injection site pain, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Oedema, Pain
Clinical narrative: Initial report received on 16 August 2007 from a health care professional. A 34 year old male patient received on 06 August 2007 a dose of Decavac (lot# U1944DA), intramuscular into the left deltoid. On 07 August 2007, one day later, he experienced left shoulder severe pain and inflammation in joint. The patient received "prednisone shots". Relevant diagnostic tests was not available. The patient did not receive any other concomitant vaccination. Concomitant medications included Advil, as needed (PRN). The patient's ongoing illness included a laceration of middle finger. The patient did not have any adverse event following prior vaccination. The patient had not recovered. Follow-up information received on 15 January 2008 from a health care professional. The route and site of administration were reported as intramuscular and shoulder. Per the reporter, the vaccine was administered high, possibly into the shoulder bursa. The patient now has rotator cuff involvement and pain. At the time of this report, the patient had not recovered. Follow-up information was received from the health professional on 17 January 2008. based upon this new information, it was determined that the event meets the seriousness criteria for "Other - medically significant". In light of this new information, the case has been upgraded to serious. The patient received Decavac in the left shoulder, and immediately developed pain and discomfort at the injection site, along with an area of induration approximately the size of a "50-cent piece". An MRI revealed an edematous rotator cuff. Since the, he had been treated with several courses of prednisone, local injections of kenalog into the bursa and muscle tendon, and oral decadron. He also underwent physical therapy. Per the reporter, the patient had experienced increased range of motion and decreased pain after initiating therapy with decadron.