chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Pruritus, Rash, Rash generalised
Clinical narrative: Immunized 1/21 morning. Rash to neck 1/22 evening, extending to chest and trunk, very itchy, rash worsened 1/23 to almost entire body, went to ER 1/24 in morning after uncomfortable night
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test abnormal, Bronchitis, Influenza like illness, Joint swelling, Purpura
Clinical narrative: On 1/08/09 Pt. awoke with flu like symptoms, pain in arms and purpura-like rash on legs.  Received prescription for steroid pack (pt. could not be more specific) to be taken for 5 days.  Pt. felt better on 1/09/09 but on 1/10/10 had swelling of wrists and ankles.  Rash remained.  At some point (pt. could not be more specific) he received another prescription for 5 days of steroids.  At some point he saw his physician.  On 1/22/09 he had a blood test (pt. could not be specific as to the type of test) which he states was positive for rheumatoid arthritis.  He was referred to a rheumatologist.  He has not had this appointment as yet.  After seeing his doctor, pt. developed bronchitis and was prescribed a Z-Pack. He is recovering from this illness at present.  2/5/09 Received PCP medical records of 1/12/09. FINAL DX: Purpura Records reveal patient experienced pain in bilateral forearms, raised red itchy rash bilateral thighs, pain in legs & feet x 4 days.  Patient had contacted family member who is MD & was tx w/steroids & NSAIDS w/improvement.  but symptoms recurred when steroids complete accompanied w/swelling of wrists & ankles, bruising of wrists & persistent rash on both legs.  Exam revealed extensive non-blanching purple coalescent macules on legs & grey green bruising on volar aspects of wrists.  Tx w/continued steroids & labs were ordered.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Rheumatoid arthritis
Clinical narrative: On 1/08/09 Pt. awoke with flu like symptoms, pain in arms and purpura-like rash on legs.  Received prescription for steroid pack (pt. could not be more specific) to be taken for 5 days.  Pt. felt better on 1/09/09 but on 1/10/10 had swelling of wrists and ankles.  Rash remained.  At some point (pt. could not be more specific) he received another prescription for 5 days of steroids.  At some point he saw his physician.  On 1/22/09 he had a blood test (pt. could not be specific as to the type of test) which he states was positive for rheumatoid arthritis.  He was referred to a rheumatologist.  He has not had this appointment as yet.  After seeing his doctor, pt. developed bronchitis and was prescribed a Z-Pack. He is recovering from this illness at present.  2/5/09 Received PCP medical records of 1/12/09. FINAL DX: Purpura Records reveal patient experienced pain in bilateral forearms, raised red itchy rash bilateral thighs, pain in legs & feet x 4 days.  Patient had contacted family member who is MD & was tx w/steroids & NSAIDS w/improvement.  but symptoms recurred when steroids complete accompanied w/swelling of wrists & ankles, bruising of wrists & persistent rash on both legs.  Exam revealed extensive non-blanching purple coalescent macules on legs & grey green bruising on volar aspects of wrists.  Tx w/continued steroids & labs were ordered.
Age: 1.7
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Blood culture, Blood glucose increased, Blood sodium decreased, Culture negative, Dyspnoea
Clinical narrative: CLIENT HAS IMMUNIZATIONS ON 1/23/2009.  ON 1/24/2009, PARENTS WOKE UP TO CHILD HAVING DIFFICULTY BREATHING, THEN PARENTS REPORTED STOPPED BREATHING AND THEY HAD TO "BREATHE FOR HER".  MADE GAGGING NOISE. REPORTED SHOOK ALL OVER AND FELT VERY HOT. TAKEN TO ER.  DX- FEVER, FEBRILE SEIZURE, RT OTITIS MEDIA. TX- ROCEPHIN IV, TYLENOL.
Age: 1.7
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Febrile convulsion, Full blood count, Mean cell haemoglobin decreased, Mean cell volume decreased, Metabolic function test
Clinical narrative: CLIENT HAS IMMUNIZATIONS ON 1/23/2009.  ON 1/24/2009, PARENTS WOKE UP TO CHILD HAVING DIFFICULTY BREATHING, THEN PARENTS REPORTED STOPPED BREATHING AND THEY HAD TO "BREATHE FOR HER".  MADE GAGGING NOISE. REPORTED SHOOK ALL OVER AND FELT VERY HOT. TAKEN TO ER.  DX- FEVER, FEBRILE SEIZURE, RT OTITIS MEDIA. TX- ROCEPHIN IV, TYLENOL.
Age: 1.7
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Otitis media, Pyrexia, Respiratory arrest, Retching, Skin warm
Clinical narrative: CLIENT HAS IMMUNIZATIONS ON 1/23/2009.  ON 1/24/2009, PARENTS WOKE UP TO CHILD HAVING DIFFICULTY BREATHING, THEN PARENTS REPORTED STOPPED BREATHING AND THEY HAD TO "BREATHE FOR HER".  MADE GAGGING NOISE. REPORTED SHOOK ALL OVER AND FELT VERY HOT. TAKEN TO ER.  DX- FEVER, FEBRILE SEIZURE, RT OTITIS MEDIA. TX- ROCEPHIN IV, TYLENOL.
Age: 1.7
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Tremor
Clinical narrative: CLIENT HAS IMMUNIZATIONS ON 1/23/2009.  ON 1/24/2009, PARENTS WOKE UP TO CHILD HAVING DIFFICULTY BREATHING, THEN PARENTS REPORTED STOPPED BREATHING AND THEY HAD TO "BREATHE FOR HER".  MADE GAGGING NOISE. REPORTED SHOOK ALL OVER AND FELT VERY HOT. TAKEN TO ER.  DX- FEVER, FEBRILE SEIZURE, RT OTITIS MEDIA. TX- ROCEPHIN IV, TYLENOL.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Fatigue, Injection site pain, Pyrexia
Clinical narrative: Patient experienced soreness at the site where the Pneumovax was given (left deltoid).  Client reports chills, fatigue, and fever of 103 degrees for about 6 hours immediately after immunization was given.  Soreness remains at the site (left arm) over 3 months later.  Client describes it as a "dull" sensation.  Client reports soreness increases when affected arm is used (gardening, chores, etc).  The soreness subsides but never has been completely alleviated since the vaccine was given
Age: 11.0
Sex: M
Vaccine: FLU3, HEPA, MNQ
Symptoms: Pyrexia
Clinical narrative: Father reports fever of 100-103 for 3 days fllowing immmunization. afebrile today in clinic
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Injection site swelling, Rash, Urticaria
Clinical narrative: Five minutes post administration of DTaP and MMR, patient's arm began to swell at injection site.  Patient also developed a hive like rash, redness and swelling from shoulder to elbow.  Patient was given Benadryl 12.5 mg oraly.  No respiratory distress noted.
Age: 24.0
Sex: M
Vaccine: FLU3, HEPAB, PPV
Symptoms: Erythema, Oedema peripheral, Pain
Clinical narrative: right arm swelling, pain & redness 2 days after administration of vaccines
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Erythema, Oedema peripheral
Clinical narrative: Seen in our office on 1/22/09 and reecieved 4 year old boosters. Woke up 1/23/09 with red and swollen left arm.  Diagnosed with cellulitis left arm treated with augmentin.
Age: 6.0
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: One day after administration of Varivax, dose #2, the patient developed a warm, itchy, red area on left thigh (site of injection).  The patient was seen in the clinic today.  A 19cm x 15cm raised, faintly erythematous, warm, indurated patch was seen.  Mildly tender.  Diagnosis was a localized allergic reaction, not accompanied by systemic illness.
Age: 6.0
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Local reaction
Clinical narrative: One day after administration of Varivax, dose #2, the patient developed a warm, itchy, red area on left thigh (site of injection).  The patient was seen in the clinic today.  A 19cm x 15cm raised, faintly erythematous, warm, indurated patch was seen.  Mildly tender.  Diagnosis was a localized allergic reaction, not accompanied by systemic illness.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, VARCEL
Symptoms: Body temperature increased, Cellulitis
Clinical narrative: ACCORDING TO MOTHER, CHILD DEVELOPED CELLULITIS IN THE LEFT ARM WITH A TEMPERATURE OF 104.8 AND NEEDED IV ANTIBIOTICS FOR 2 DAYS. 2/6/09 MR received doe DOS 1/25-26/2009 with D/C Dx:  L Upper Arm Cellulitis. Pt presented with several day hx of fever and edema, erythema and warmth of the L upper arm 1 day after vax.  Seen twice in ER and tx with abx. Now with emesis and T=104'F. Started on IV abx.  Hives 2' to Unasyn. Responded well to Clindamycin.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Movement disorder, Tenderness
Clinical narrative: patient with extremely sore arm limiting movement
Age: 63.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Fever (Tmax 102F 2 days after shingles vaccine administration) and redness, warmth, tenderness at injection site. Fever deffervesced day 3 after injection. Redness persists at this time (day 4).
Age: 19.0
Sex: F
Vaccine: SMALL
Symptoms: Drug exposure during pregnancy
Clinical narrative: Vaccine administered around 11 June 2008 prior to deployment.  Pregnancy diagnosed during deployment.  Pt returned upon dx of pregnancy.  No known adverse events.
Age: 28.0
Sex: F
Vaccine: TYP
Symptoms: Rash, Rash generalised
Clinical narrative: Skin rash all over the body, mostly in the torso regions.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Blood culture negative, Chest X-ray normal, Febrile convulsion, Full blood count normal, Lumbar puncture normal
Clinical narrative: Evening of 7/22/2008 child had a prolinged febrile convulsion. He was admitted to Hospital around midnight 7/22/09. He was observed and did not have anymore convulsions and around 4am at last dose of Ibuprophen did not have a fever.  He was given Ativan to stop seizures and Ketamine to sedate for lumbar puncture. Labs and ct and chest films all normal. He was discharged to home by Dr. on 7/23/2008. Has not had any further febrile seizures. 2/6/09 Received hospital medical records of 7/23-7/23/2008. FINAL DX: prolonged febrile convulsion, resolved; febrile illness, probably viral, improved; emesis probably secondary to meds. Records reveal patient seen by PCP in office on day of admit w/normal exam when immunized.  Sick siblings w/fever.  No prior reactions to vaccines.  Developed fever & generalized tonic clonic convulsion.  Seen in ER & required several doses of meds to resolve seizure.  Admitted overnight for observation.  No further fever or seizure activity noted overnight & d/c to home.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Scan brain
Clinical narrative: Evening of 7/22/2008 child had a prolinged febrile convulsion. He was admitted to Hospital around midnight 7/22/09. He was observed and did not have anymore convulsions and around 4am at last dose of Ibuprophen did not have a fever.  He was given Ativan to stop seizures and Ketamine to sedate for lumbar puncture. Labs and ct and chest films all normal. He was discharged to home by Dr. on 7/23/2008. Has not had any further febrile seizures. 2/6/09 Received hospital medical records of 7/23-7/23/2008. FINAL DX: prolonged febrile convulsion, resolved; febrile illness, probably viral, improved; emesis probably secondary to meds. Records reveal patient seen by PCP in office on day of admit w/normal exam when immunized.  Sick siblings w/fever.  No prior reactions to vaccines.  Developed fever & generalized tonic clonic convulsion.  Seen in ER & required several doses of meds to resolve seizure.  Admitted overnight for observation.  No further fever or seizure activity noted overnight & d/c to home.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dyspnoea, Fatigue, Hypoaesthesia, Injected limb mobility decreased
Clinical narrative: The pain in my upper left arm is something I'v never experienced before.  It isn't like a sore muscle, it is worse.  It is a disabling pain.  For the past 3-4 weeks I have been having trouble raising my left arm.  It aches so bad, most all of the time and has been somewhat tolerable.  Today at work I experienced such deep pain that I thought I would have to leave work.  It was as if a large hole had been blown into my arm.  The pain went all the way into the bone.  I felt short of breath and somewhat dizzy.  The pain is becoming more intense as time goes on.  It actually scares me.  It goes up into my shouldger and down the side and back of my left arm.  Today I noticed my arm was tingling and felt tingly, like it had gone to sleep.  It also seemed like it could becoming numb.  I took 2 Tylenol to alieveate the pain and after awhile it was better.  I wouldn't have thought it was the shingles vaccine but it occured to me that the soreness at the injection site never really left, it has just intensified.   It's really making me miserable.   I can't really remember the date I rec'd the injection.  I was supposed to get it right after Thanksgiving, but it wasn't availble for approx. 1 month after that date.  The injection was administered by a nurse.   Fatigued.  I almost called my dr. office today, but since the Tylenol I took for pain helped, I didn't.  When the pain returned tonight I decided to go online and do some investigating about reactions to vaccines and found this site.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Musculoskeletal pain, Paraesthesia
Clinical narrative: The pain in my upper left arm is something I'v never experienced before.  It isn't like a sore muscle, it is worse.  It is a disabling pain.  For the past 3-4 weeks I have been having trouble raising my left arm.  It aches so bad, most all of the time and has been somewhat tolerable.  Today at work I experienced such deep pain that I thought I would have to leave work.  It was as if a large hole had been blown into my arm.  The pain went all the way into the bone.  I felt short of breath and somewhat dizzy.  The pain is becoming more intense as time goes on.  It actually scares me.  It goes up into my shouldger and down the side and back of my left arm.  Today I noticed my arm was tingling and felt tingly, like it had gone to sleep.  It also seemed like it could becoming numb.  I took 2 Tylenol to alieveate the pain and after awhile it was better.  I wouldn't have thought it was the shingles vaccine but it occured to me that the soreness at the injection site never really left, it has just intensified.   It's really making me miserable.   I can't really remember the date I rec'd the injection.  I was supposed to get it right after Thanksgiving, but it wasn't availble for approx. 1 month after that date.  The injection was administered by a nurse.   Fatigued.  I almost called my dr. office today, but since the Tylenol I took for pain helped, I didn't.  When the pain returned tonight I decided to go online and do some investigating about reactions to vaccines and found this site.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC, RV5
Symptoms: Body temperature increased, Diarrhoea, Eating disorder, Feeding disorder of infancy or early childhood, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of diarrhea in a 6-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) ACTHIB, (non-gsk) PREVNAR, ROTATEQ (non-gsk) and seasonal  (non-gsk) FLUZONE. On 6 January 2009 the subject received 3rd dose of PEDIARIX (.5 ml, unknown, right thigh), 2nd dose of ACTHIB, 3rd dose of PREVENAR, 3rd dose of ROTATEQ, and 1st dose of FLUZONE. On 6 January 2009, within hours of vaccination with PEDIARIX and after an unspecified amount of time within the same day of vaccination with PREVNAR, ACTHIB, FLUZONE and ROTATEQ, the subject experienced diarrhea, infant feeding problems, fever, vomiting and inability to eat. The nurse reported that a subject developed a severe reaction after her third vaccination with PEDIARIX. The subject developed a fever of 101.6, diarrhea, vomiting, eating only once every 24 hours, and unable to eat. These symptoms developed a few hours after the vaccination and are worsening. The subject has been seen by emergency rooms, urgent care centers and doctor's office without any improvement. The nurse stated that the subject also received several other vaccines that same day and she is not sure which was related or if the vaccines are involved in the adverse events. The healthcare professional considered the events were disabling, life threatening and clinically significant (or requiring intervention). At the time of reporting the events were worse.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of diarrhea in a 6-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) ACTHIB, (non-gsk) PREVNAR, ROTATEQ (non-gsk) and seasonal  (non-gsk) FLUZONE. On 6 January 2009 the subject received 3rd dose of PEDIARIX (.5 ml, unknown, right thigh), 2nd dose of ACTHIB, 3rd dose of PREVENAR, 3rd dose of ROTATEQ, and 1st dose of FLUZONE. On 6 January 2009, within hours of vaccination with PEDIARIX and after an unspecified amount of time within the same day of vaccination with PREVNAR, ACTHIB, FLUZONE and ROTATEQ, the subject experienced diarrhea, infant feeding problems, fever, vomiting and inability to eat. The nurse reported that a subject developed a severe reaction after her third vaccination with PEDIARIX. The subject developed a fever of 101.6, diarrhea, vomiting, eating only once every 24 hours, and unable to eat. These symptoms developed a few hours after the vaccination and are worsening. The subject has been seen by emergency rooms, urgent care centers and doctor's office without any improvement. The nurse stated that the subject also received several other vaccines that same day and she is not sure which was related or if the vaccines are involved in the adverse events. The healthcare professional considered the events were disabling, life threatening and clinically significant (or requiring intervention). At the time of reporting the events were worse.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Gait disturbance, Limb discomfort, Musculoskeletal discomfort, Rash
Clinical narrative: Started with lower back progressing into thighs and having difficulty walking a lot of joint pain. Started next day and also had rash on left thigh, continuing to get worse.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Musculoskeletal stiffness, Pain, Pyrexia, Vomiting
Clinical narrative: In the evening after his shot, he developed a fever of 100 degrees. The next day, his fever was 101 degrees, he had a bad headache, a stiff neck, and vomited twice. By 1/28/09, the headache and stiff neck were resolving, but he still felt sore.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Left arm large red, warm, painful area around injection site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: R arm. 15x15 cm. edema, erythema, induration.
Age: 51.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Arthralgia, Joint stiffness, Joint swelling
Clinical narrative: To H.D. 12-23-08 for vaccines to travel Jan 9 or 10th, 2009 awoke with severe pain in "every" joint. Took aspirin, pain gradually decreased. Felt much better by 1/16/09, although finger and toe joints remain stiff, "uncomfortable" as today. Swelling in knee and behind knees and "some swelling in wrist".
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Left deltoid area red, swollen, warm to touch 1-29-09. Child active, alert, good movement with arm. No fever marked redness with pen. Advised mom to give BENADRYL, cool compresses to site, continue TYLENOL and follow up 1-30-09. 8:30am 1/30/09 mom reports redness subsiding today and not nearly as swollen.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pruritus, Varicella
Clinical narrative: Pt. C/O redness some swelling at site.  Noted reddened area about 13 mm in diameter.  Pt. started to feel itchiness on L arm in the evening after receiving vaccine.  Pt.  put ice packs on site to help with swelling.  No other S/S  reported by pt.  Pt. had chickenpox at 10x10 reported very acute case at the time.  Pt. reports site is now smaller.  Pt. told to return to clinic if she gets more red/symptoms worse.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Diarrhoea, Myalgia, Pain
Clinical narrative: C/O diarrhea and aching approximately 2 hrs after Adacel shot given - symptom progressed with severe myalgias lasting approximately 72 hrs.
Age: 48.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site irritation, Injection site warmth
Clinical narrative: The patient received a routine booster shot with Td-170 on Friday, 02/01/2008. Immediately, she felt a burning sensation, and then developed a large red circle around the injection site with a bump. The reddened area was also hot to the touch. 2/25/2008: Multiple attempts to obtain follow- up information on the patient's recovery have been unsuccessful.
Age: 27.0
Sex: M
Vaccine: TD
Symptoms: Cough, Ear pain, Influenza like illness, Injection site erythema, Injection site induration
Clinical narrative: Patient received TD-171 on 01/25/08.  He developed flu-like symptoms, including cough, ear pain, pharyngitis, and muscle aches, and a local reaction at the injection site of redness and induration, with a macule and returned to the doctor on 01/29/08.  The local reaction size was 50 x 75 mm.  The local reaction was not itchy.  Patient had a follow up visit scheduled by "refused to come back".  There will not be any additional attempts to obtain follow up information.
Age: 27.0
Sex: M
Vaccine: TD
Symptoms: Myalgia, Pharyngitis, Rash macular
Clinical narrative: Patient received TD-171 on 01/25/08.  He developed flu-like symptoms, including cough, ear pain, pharyngitis, and muscle aches, and a local reaction at the injection site of redness and induration, with a macule and returned to the doctor on 01/29/08.  The local reaction size was 50 x 75 mm.  The local reaction was not itchy.  Patient had a follow up visit scheduled by "refused to come back".  There will not be any additional attempts to obtain follow up information.
Age: 27.0
Sex: F
Vaccine: TD
Symptoms: Influenza like illness, Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: Patient received TD on 03/12/2008.  Patient came back to the doctor's office on 03/14/08 with flu-like symptoms and redness, tenderness and a nodule at the TD injection site.  Her local reaction size was 1 1/2 X 2 inches.  Patient was told to contact the doctor's office if the reaction got worse.  Follow up information obtained on 04/29/08: Reporter of the event confirmed that the patient recovered.
Age: 65.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Diplopia, Dissociative disorder, Effusion, Electroencephalogram
Clinical narrative: Patient was vaccinated on 02/01/08 and the symptoms of the event started on 02/08/08.  Patient experienced a variety of symptoms over a period of two months including myalgias, arthralgia, pelvic pain, jaw claudication and double vision.  Patient said that she was currently suffering from knee and joint swelling and has difficulty climbing stairs.  Patient was also experiencing night sweats.  Follow up obtained on 04/11/2008:  Patient has a history of chronic Lyme disease.  Patient developed diffuse arthralgia and myalgia approximately one week after receiving TD vaccine.  Several weeks after the onset of these symptoms she noted the onset of pelvic and severe jaw pain, which she described as "bone on bone".  More recently she developed problems with double vision and was undergoing an evaluation by a neurologist.  All of these symptoms have persisted with varying intensities during the past two months.  She was unable to recall if any of these symptoms occurred after she last received a TETANUS vaccination.  Follow up obtained on 05/08/08:  Additional history regarding the chronology of the initial events was obtained in addition to obtaining follow up information since 04/11/08.  On 03/12/08 patient had been seen by a neurologist after experiencing a dissociative episode and diplopia lasting several hours.  Carotid studies, MRA and EEG were unrevealing.  She also underwent pelvic ultrasound which was negative.  Right knee pain and effusion developed approximately 1.5 to 2 months after receiving TD vaccine, and evaluation by a rheumatologist and orthopedic surgeon along with MRI have demonstrated degenerative joint disease and osteoarthritis.  She has been prescribed anti-inflammatory medication for this problem.  All of these symptoms have resolved, with the exception that the right knee pain has persisted.
Age: 65.0
Sex: F
Vaccine: TD
Symptoms: Joint swelling, Myalgia, Night sweats, Nuclear magnetic resonance imaging, Osteoarthritis
Clinical narrative: Patient was vaccinated on 02/01/08 and the symptoms of the event started on 02/08/08.  Patient experienced a variety of symptoms over a period of two months including myalgias, arthralgia, pelvic pain, jaw claudication and double vision.  Patient said that she was currently suffering from knee and joint swelling and has difficulty climbing stairs.  Patient was also experiencing night sweats.  Follow up obtained on 04/11/2008:  Patient has a history of chronic Lyme disease.  Patient developed diffuse arthralgia and myalgia approximately one week after receiving TD vaccine.  Several weeks after the onset of these symptoms she noted the onset of pelvic and severe jaw pain, which she described as "bone on bone".  More recently she developed problems with double vision and was undergoing an evaluation by a neurologist.  All of these symptoms have persisted with varying intensities during the past two months.  She was unable to recall if any of these symptoms occurred after she last received a TETANUS vaccination.  Follow up obtained on 05/08/08:  Additional history regarding the chronology of the initial events was obtained in addition to obtaining follow up information since 04/11/08.  On 03/12/08 patient had been seen by a neurologist after experiencing a dissociative episode and diplopia lasting several hours.  Carotid studies, MRA and EEG were unrevealing.  She also underwent pelvic ultrasound which was negative.  Right knee pain and effusion developed approximately 1.5 to 2 months after receiving TD vaccine, and evaluation by a rheumatologist and orthopedic surgeon along with MRI have demonstrated degenerative joint disease and osteoarthritis.  She has been prescribed anti-inflammatory medication for this problem.  All of these symptoms have resolved, with the exception that the right knee pain has persisted.
Age: 65.0
Sex: F
Vaccine: TD
Symptoms: Pain in jaw, Pelvic pain, Ultrasound pelvis
Clinical narrative: Patient was vaccinated on 02/01/08 and the symptoms of the event started on 02/08/08.  Patient experienced a variety of symptoms over a period of two months including myalgias, arthralgia, pelvic pain, jaw claudication and double vision.  Patient said that she was currently suffering from knee and joint swelling and has difficulty climbing stairs.  Patient was also experiencing night sweats.  Follow up obtained on 04/11/2008:  Patient has a history of chronic Lyme disease.  Patient developed diffuse arthralgia and myalgia approximately one week after receiving TD vaccine.  Several weeks after the onset of these symptoms she noted the onset of pelvic and severe jaw pain, which she described as "bone on bone".  More recently she developed problems with double vision and was undergoing an evaluation by a neurologist.  All of these symptoms have persisted with varying intensities during the past two months.  She was unable to recall if any of these symptoms occurred after she last received a TETANUS vaccination.  Follow up obtained on 05/08/08:  Additional history regarding the chronology of the initial events was obtained in addition to obtaining follow up information since 04/11/08.  On 03/12/08 patient had been seen by a neurologist after experiencing a dissociative episode and diplopia lasting several hours.  Carotid studies, MRA and EEG were unrevealing.  She also underwent pelvic ultrasound which was negative.  Right knee pain and effusion developed approximately 1.5 to 2 months after receiving TD vaccine, and evaluation by a rheumatologist and orthopedic surgeon along with MRI have demonstrated degenerative joint disease and osteoarthritis.  She has been prescribed anti-inflammatory medication for this problem.  All of these symptoms have resolved, with the exception that the right knee pain has persisted.
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Patient experienced a high fever of 101.3F, body aches, chills and headache after receiving TD booster shot.  Called the physician's office and was advised to take MOTRIN.  Follow up on 06/16/08: Patient had a fever for two days.  Patient recovered.
Age: 66.0
Sex: M
Vaccine: TD
Symptoms: Discomfort, Rash
Clinical narrative: Patient received TD vaccine on 6/12/08 as a routine booster.  Later that day, the patient visited his cardiologist for an unrelated reason and was not in respiratory distress.  On 6/13/08 the patient visited his primary care physician for the rash and noted some discomfort associated with the rash.  Patient was given BENADRYL; no other symptoms observed.  Follow up received on 07/31/08: Patient recovered.
Age: 47.0
Sex: M
Vaccine: TD
Symptoms: Cellulitis
Clinical narrative: A male patient received vaccine on 06/04/08 and on 06/08/08 patient went to ER, where he was diagnosed with cellulitis in the area of injection site.  Patient was given KELFEX antibiotics to treat the adverse reaction.  Follow up on 08/13/08: patient recovered.
Age: 23.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: A female patient received vaccine on 06/09/08 and on 06/13/08 she came to doctor's office with symptoms of cellulitis - swelling, redness, warmth and a feeling of a knot at the injection site.  Patient was given antibiotics to treat the adverse reaction.
Age: 37.0
Sex: M
Vaccine: TD
Symptoms: Cellulitis, Chills, Myalgia, Oedema peripheral, Pyrexia
Clinical narrative: A male patient received vaccine on 6/11/08 and 6/13/08 patient come to doctor's office with complaints of fever, chills, muscle aches, along with symptoms diagnosed as cellulitis. Patient's whole left arm was swollen. Patient was given antibiotics to treat the adverse reaction. Follow up on 8/13/08: patient recovered.
Age: 22.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: A female patient received vaccine on 06/11/08 and on 06/18/08 she came to doctor's office with symptoms of cellulitis - swelling, redness and a knot at the injection site.  Patient was already on prophylactic antibiotics for a bite and was prescribed a different antibiotic for the adverse reaction.  Reporter contacted patient and noted that the adverse reaction was resolving.  Follow up on 08/13/08: patient recovered.
Age: 44.0
Sex: M
Vaccine: TD
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: C.K. received TD vaccine on 06/20/08 and started to experience pain on 06/21/08.  C.K. described his reaction as feeling a significant amount of pain at injection site, as well as swelling at injection site.  Follow up received on 08/15/08: Patient described additional symptoms of redness and erythema at injection site, as well as chills and myalgia.  Patient recovered within days from the onset of the adverse event.
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Chills, Injection site pain, Myalgia, Pain
Clinical narrative: Patient received TD vaccine on 06/20/08 and experienced pain at injection site and general achiness on 06/21/08.  Patient took TYLENOL for the adverse reaction.  Follow up on 08/15/08: Patient experienced additional symptoms of chills and myalgia.  Patient completely recovered within a few days from the onset of the reaction.
Age: 47.0
Sex: F
Vaccine: TD
Symptoms: Activities of daily living impaired, Dyspnoea, Injection site erythema, Injection site mass, Injection site nodule
Clinical narrative: Patient received Td injection intradermally, instead of a PPD test, two to three years after receiving her regular Td booster shot.  Patient was suppose to received a PPD skin test and developed a nodule at the injection site.  Doctor gave her a prescription for PREDNISONE and DOXYCYCLINE.  Patient noted to the doctor that after a PPD test she was given literature for a Td immunization instead.  She was sent for chest x-rays and administered another PPD skin test.  Both x-ray and the PPD test turned out to be negative.  An incident report form was filled out at the doctor's office.  Patient is still experiencing symptoms of pain, itchiness, muscle soreness and a feeling of a knot at injection site, a month after injection.  Patient did not experience any reactions to the previous Td injection.  Follow up received on 01/08/09:  Patient stated that she continues having breathing difficulties, although she is not sure if it's from Td vaccination.  She has muscle pain in her chest and arms, she is experiencing more pain in the arm where Td was administered.  The Td administration site looks like a "big mosquito bite", a nodule approximately 1/2inch by 1/2inch in size and very red.  The injection site is not warm to the touch and does not itch.  Pt. said that she just had an MRI to identify the cause of breathing difficulties and is waiting for the results.  Follow up received on 01/15/09:  Patient stated that since the time she was administered Td vaccination intradermally, she has had a persistent non-tender, non-pruritic, erythematous nodule (approximately 0.5 inches in diameter at the injection site.  The nodule has not changed in size for the past two months.  She also notes mild continued muscle soreness and weakness in the affected arm.  She has not received any additional therapies for these symptoms and they are not adversely affecting her ability to work or carry out daily life.
Age: 47.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Injection site pruritus, Muscular weakness, Myalgia, Tuberculin test negative
Clinical narrative: Patient received Td injection intradermally, instead of a PPD test, two to three years after receiving her regular Td booster shot.  Patient was suppose to received a PPD skin test and developed a nodule at the injection site.  Doctor gave her a prescription for PREDNISONE and DOXYCYCLINE.  Patient noted to the doctor that after a PPD test she was given literature for a Td immunization instead.  She was sent for chest x-rays and administered another PPD skin test.  Both x-ray and the PPD test turned out to be negative.  An incident report form was filled out at the doctor's office.  Patient is still experiencing symptoms of pain, itchiness, muscle soreness and a feeling of a knot at injection site, a month after injection.  Patient did not experience any reactions to the previous Td injection.  Follow up received on 01/08/09:  Patient stated that she continues having breathing difficulties, although she is not sure if it's from Td vaccination.  She has muscle pain in her chest and arms, she is experiencing more pain in the arm where Td was administered.  The Td administration site looks like a "big mosquito bite", a nodule approximately 1/2inch by 1/2inch in size and very red.  The injection site is not warm to the touch and does not itch.  Pt. said that she just had an MRI to identify the cause of breathing difficulties and is waiting for the results.  Follow up received on 01/15/09:  Patient stated that since the time she was administered Td vaccination intradermally, she has had a persistent non-tender, non-pruritic, erythematous nodule (approximately 0.5 inches in diameter at the injection site.  The nodule has not changed in size for the past two months.  She also notes mild continued muscle soreness and weakness in the affected arm.  She has not received any additional therapies for these symptoms and they are not adversely affecting her ability to work or carry out daily life.
Age: 47.0
Sex: F
Vaccine: TD
Symptoms: Wrong drug administered, X-ray normal
Clinical narrative: Patient received Td injection intradermally, instead of a PPD test, two to three years after receiving her regular Td booster shot.  Patient was suppose to received a PPD skin test and developed a nodule at the injection site.  Doctor gave her a prescription for PREDNISONE and DOXYCYCLINE.  Patient noted to the doctor that after a PPD test she was given literature for a Td immunization instead.  She was sent for chest x-rays and administered another PPD skin test.  Both x-ray and the PPD test turned out to be negative.  An incident report form was filled out at the doctor's office.  Patient is still experiencing symptoms of pain, itchiness, muscle soreness and a feeling of a knot at injection site, a month after injection.  Patient did not experience any reactions to the previous Td injection.  Follow up received on 01/08/09:  Patient stated that she continues having breathing difficulties, although she is not sure if it's from Td vaccination.  She has muscle pain in her chest and arms, she is experiencing more pain in the arm where Td was administered.  The Td administration site looks like a "big mosquito bite", a nodule approximately 1/2inch by 1/2inch in size and very red.  The injection site is not warm to the touch and does not itch.  Pt. said that she just had an MRI to identify the cause of breathing difficulties and is waiting for the results.  Follow up received on 01/15/09:  Patient stated that since the time she was administered Td vaccination intradermally, she has had a persistent non-tender, non-pruritic, erythematous nodule (approximately 0.5 inches in diameter at the injection site.  The nodule has not changed in size for the past two months.  She also notes mild continued muscle soreness and weakness in the affected arm.  She has not received any additional therapies for these symptoms and they are not adversely affecting her ability to work or carry out daily life.
Age: 18.0
Sex: M
Vaccine: TD
Symptoms: Syncope
Clinical narrative: A male patient came to doctor's office to receive TD and MENACTRA vaccinations for admission to college.  Patient was administered TD IM/left deltoid (lot TD-181) and before doctor administered MENACTRA vaccination, patient fainted.  Patient was fine moments later.
Age: 45.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient was administered TD vaccine on 06/25/08 and developed a local reaction of swelling, warmth and redness at injection site during the same day.  Patient was seen by the doctor and prescribed steroid medication.  During a follow up visit, patient completely recovered.
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient was administered Td vaccine on 7/30/08 and developed a local reaction of swelling, warmth and redness at injection site during the same day. Patient was seen by the doctor and prescribed steroid medication. During a follow up visit, patient completely recovered.
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Injection site erythema, Injection site induration
Clinical narrative: Patient received TD injection on 04/15/08 and developed redness and hardness at the injection site.  Patient was treated for cellulitis with AUGMENTIN for 10 days.  Patient recovered.
Age: 37.0
Sex: F
Vaccine: TD
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration
Clinical narrative: Patient received TD injection on 10/16/07 and developed cellulitis, redness and induration at injection site.  Patient was treated with BACTRIM for 10 days.  Patient recovered.
Age: 31.0
Sex: F
Vaccine: TD
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: On 08/25/08 TD was administered to the patient intradermally, in the left inner forearm, instead of a PPD test.  The patient immediately experienced pain, erythema, swelling and induration at the injection site.  The PPD test was performed correctly in the right arm on the same day.  The patient called the clinic back on 08/29 to report that a nodule had formed and she was experiencing itching and warmth at the injection site.
Age: 31.0
Sex: F
Vaccine: TD
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: On 08/25/08 TD was administered to the patient intradermally, in the left inner forearm, instead of a PPD test.  The patient immediately experienced pain, erythema, swelling and induration at the injection site.  The PPD test was performed correctly in the right arm on the same day.  The patient called the clinic back on 08/29 to report that a nodule had formed and she was experiencing itching and warmth at the injection site.
Age: 81.0
Sex: F
Vaccine: TD
Symptoms: Incorrect route of drug administration, Injection site swelling, Malaise
Clinical narrative: Patient reported not feeling good after Td injection and developed swelling at injection site. Follow up on 10/28/2008: As the patient did not return to the medical office, the reporter considers her recovered. Reporter attributed reaction to an incorrect administration technique. The reporter did not have additional details on the administration of the vaccine, vaccine was administered IM in a deltoid.
Age: 13.0
Sex: F
Vaccine: HPV4, PNC, TD, VARCEL
Symptoms: Headache, Injection site erythema, Wrong technique in drug usage process
Clinical narrative: Patient developed induration and redness at injection site, and a headache. Follow up on 10/28/08: As the patient did not return to the medical office, the reporter considered her recovered.  Reporter attributed reaction to an incorrect administration technique.  The reporter did not have additional details on the administration of the vaccine, vaccine was administered IM in a deltoid.
Age: 71.0
Sex: F
Vaccine: TD
Symptoms: Pityriasis rubra pilaris, Rash, Rash pruritic
Clinical narrative: Patient received TD vaccine, lot TD-183 on 09/24/07 due to a scrape and developed an itchy rash on arms, abdomen, legs, face and scalp couple of days later.  Patient visited ER on 10/03/07 with the rash.  The exact date when the rash started is unknown.  Patient visited dermatologist and was diagnosed with Pityriasis Rubra Pilaris.  Patient is still experiencing a rash a year later.  Follow up on 11/13/08: patient did not go back to the Medical Center and is presumed to be recovered by reporter.
Age: 18.0
Sex: M
Vaccine: TD
Symptoms: Heart rate increased, Hyperhidrosis, Injection site swelling, Migraine, Paraesthesia
Clinical narrative: Fever,  sweating, migraine headache, rapid heart beat, paresthsia in fingers and toes, localized swelling at injection site. Patient was examined by a nurse next day and was given a prescription for MIDRIN. Follow up on 12/18/08: Nurse said that when she saw patient next day , his symptoms dissipated. His arm was only a little swollen around the injection site and all of his other symptoms were completely gone. The nurse has not seen patient since.
Age: 18.0
Sex: M
Vaccine: TD
Symptoms: Pyrexia
Clinical narrative: Fever,  sweating, migraine headache, rapid heart beat, paresthsia in fingers and toes, localized swelling at injection site. Patient was examined by a nurse next day and was given a prescription for MIDRIN. Follow up on 12/18/08: Nurse said that when she saw patient next day , his symptoms dissipated. His arm was only a little swollen around the injection site and all of his other symptoms were completely gone. The nurse has not seen patient since.
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of incorrect route of drug administration in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent vaccination included Salmonella typhi Vi capsular polysaccharide vaccine given on an unspecified date. There were no concurrent medications. On 2 November 2008, between 09:00 and 16:00, the subject received a dose of FLULAVAL 0.5 ml, subcutaneously. This was the incorrect route of drug administration. FLULAVAL should have been administered intramuscularly. Within 12 to 24 following injection of FLULAVAL, the subject experienced injection site pain, redness and swelling. At the time of reporting, the events were improved. In the reporter's opinion, the events were probably related to treatment with FLULAVAL. The reported stated that approximately 200 adults were vaccinated with FLULAVAL via deep subcutaneous injection during a flu clinic. Out of these 200 plus subjects, four females reported local reactions of pain, redness and swelling within 12 to 24 hours of vaccination. One of these subjects was seen by the on-site physician who diagnosed it as a secondary infection and treated with antibiotics and TYLENOL. It was reported that the adverse events were improving, but unknown if they resolved. Linked cases include: A0759176A, A0759183A, A0759189A, and A759190A.
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of incorrect route of drug administration in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent vaccination included Salmonella Vi capsular polysaccharide vaccine given on an unspecified date. There were no concurrent medications. On 2 November 2008, between 09:00 and 16:00, the subject received a dose of FLULAVAL 0.5 ml, subcutaneously. This was the incorrect route of drug administration. FLULAVAL should have been administered intramuscularly. Within 12 to 24 hours following injection of FLULAVAL, the subject experienced injection site pain, redness and swelling. At the time of reporting, the events were improved. In the reporter's opinion, the events were probably related to treatment with FLULAVAL. The reported stated that approximately 200 adults were vaccinated with FLULAVAL via deep subcutaneous injection during a flu clinic. Out of these 200 plus subjects, four females reported local reactions of pain, redness and swelling within 12 to 24 hours of vaccination. One of these subjects was seen by the on-site physician who diagnosed it as a secondary infection and treated it with antibiotics and TYLENOL. It was reported that the adverse events were improving, but unknown if they resolved. Linked cases include: A0759176A, A0759188A, A0759189A, A07159190A
Age: 1.3
Sex: M
Vaccine: FLU3, HEPA, HIBV
Symptoms: Body temperature increased, Inappropriate schedule of drug administration, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of fever in a 15-month-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Previous and/or concurrent vaccination included PEDVAXHIB; Merck; unknown given on 4 November 2008; HAVRIX; GlaxoSmithKline; unknown; unknown given on 4 November 2008. On 4 November 2008 the subject received a dose of FLULAVAL (.5 unknown, unknown, right thigh) and the subject experienced drug use for unapproved indication. At an unspecified time after vaccination with FLULAVAL, the subject experienced fever. The healthcare professional reported that a 15-month-old subject was administered FLULAVAL vaccine on 04 November 2008 in addition to HAVRIX and PEDVAXHIB. She reported that the mother told her the subject had some fever up to 100.3  "off and on" that was treated with over the count TYLENOL. The subject was treated with TYLENOL. At the time of reporting the outcome of the events were unspecified. Follow-up information was received on 17 December 2008, via healthcare professional who reported the events resolved on an unknown date.