chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Lacrimation increased, Lip swelling, Ocular hyperaemia
Clinical narrative: Vaccine given at 1110 Am, at approx 4PM pt. began experiencing swelling of the lips and then the eyes with reddness and watering of eyes.  Took cetirizine at 10 PM with some relief but lips remain swollen and eyes red.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Fatigue, Pain, Rash, Rash generalised
Clinical narrative: Afternoon of 11/18/08 patient developed fatigue, all-over body aches, diarrhea and rash that covered arms, hands and back.  By 11/21/08 when patient notified health dept., patient reports rash going away and no other symptoms.  Patient reports having taken Benedryl. Patient did not contact doctor.  Advised patient to notify doctor of symptoms, and to seek medical treatment if symptoms worsen or if patient develops wheezing, facial swelling or difficulty breathing.
Age: 11.0
Sex: M
Vaccine: DTAP, HEPA, MNQ, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient received DtaP instead of TdaP, no additional vaccine will need to be given per CDC
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None Noted
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Full blood count, Injection site pain, Laboratory test, Musculoskeletal pain, Nuclear magnetic resonance imaging
Clinical narrative: Patient presented to clinic on 11-17-08 with complaint of left shoulder and arm pain.  States he received a flu shot 11-6-08 and pain began within a few hours of receiving flu shot.  States the pain did not go away and has worsened each day, now extends down lateral arm halfway to elbow.  Patient pointed to spot just below left acromium process and states this is where his pain is and states this is where injection was given.  No redness or needle mark was noted. Chart indicates vaccine given IM in the left deltoid. Evaluation is ongoing as to cause/nature of problem.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Red blood cell sedimentation rate
Clinical narrative: Patient presented to clinic on 11-17-08 with complaint of left shoulder and arm pain.  States he received a flu shot 11-6-08 and pain began within a few hours of receiving flu shot.  States the pain did not go away and has worsened each day, now extends down lateral arm halfway to elbow.  Patient pointed to spot just below left acromium process and states this is where his pain is and states this is where injection was given.  No redness or needle mark was noted. Chart indicates vaccine given IM in the left deltoid. Evaluation is ongoing as to cause/nature of problem.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Audiogram abnormal, Headache, Hypoacusis, Oropharyngeal pain, Rhinitis
Clinical narrative: 3 days after vaccine administer, developed headache, sore throat, rhinitis, tinnitis.  Tinnitis persisted 2 weeks later; audiogram documents diminished hearing as compared to 2006 testing.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Tinnitus
Clinical narrative: 3 days after vaccine administer, developed headache, sore throat, rhinitis, tinnitis.  Tinnitis persisted 2 weeks later; audiogram documents diminished hearing as compared to 2006 testing.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Crying, Injected limb mobility decreased, Injection site pain, Sinusitis
Clinical narrative: Child recieved flu vaccine at 1357 on 111908 per Left deltoid IM.  Mom called CHS office back approximately 45 minutes later indicating the child was crying hard and was unconsoleable, complaining of severe arm pain, and wouldn't move arm.  Mom couldn't see any redness at injection site. RN advised Mom to take child to see her Dr.   Mom had administered 2 doses of Tylenol, prior to calling Community Health Services Office.   Mom took child to see PA at the Clinic and child was diagnosis with a sinus infection and was given antibiotics.   Note Mom reports that she had recieved a flu shot a couple of days ago and experienced tightness in her chest after being given the shot.  RN advised Mom to discuss this with the Dr. and Dr advised the flu be given in Dr's office next year.  Dad of this child also experienced a very stiff sore arm after recieving the flu shot this year.
Age: 8.0
Sex: M
Vaccine: FLUX, HEPA, VARCEL
Symptoms: Oropharyngeal pain, Throat irritation, Urticaria
Clinical narrative: Pt. received Hep. A, varivax, flu shot on 11/18/08.  He complaned of sore, scratchy throat 24 hours after vaccines, on 2nd day had hives all over body.  Still has hives on third day.  Benedryl given as ordered by Dr. office.
Age: 71.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Client given Tdap at 71 years of age, Adacel not licensed for those over 64 years of age.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: swelling with readness and slight induration at the injection site. cold compresses to be applied.analgesics if necessary
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Given Zostavax vaccine at 59 years, package insert/policy indicate vaccine to be given to those 60 years of age and older.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Culture throat, Erythema, Oropharyngeal pain, Pyrexia, Rash generalised
Clinical narrative: Patient returned to office with history of sore throat, fever (102), red cheeks, and fine macular rash all over body.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Rash macular
Clinical narrative: Patient returned to office with history of sore throat, fever (102), red cheeks, and fine macular rash all over body.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Client given Zostavax at 59 years of age and it is not recommended to be given until the age of 60 years.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: edema, erythema, redness at injection site
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: right arm pain for two months now since vaccine given
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Allergy test negative, Malaise, Rash, Swelling
Clinical narrative: About 15 minutes after receipt of immunizations, pt developed swelling and rash of eyes, face, lips. Rash on trunk of body. General sense of "I don't feel good."
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: 6cm X 9cm redness and swelling and warm to touch
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Body temperature increased, Headache, Pain in extremity
Clinical narrative: Temperature 101.4, headache, both arms and legs aching- father called 11/21/2008
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Burning sensation, Pyrexia, Vomiting
Clinical narrative: 12 hours after receiving my 2nd dose of the HepB vacc. I woke up with a severe burning sensation down the injected arm and across my chest and into my abdomen. I also had uncontrollable vomiting and a high fever. I was treated with in the emergency room and released to follow up with my physician.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Chest X-ray, Lobar pneumonia, Pyrexia
Clinical narrative: pt developed lobal pneumonia.  Became ill with fever the day following flumist administration.  Significant pneumonia.  Pt DOES have a history of wheezing w/respiratory infections (not disclosed by parent at time of immunization)
Age: 35.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient said injection site is warm to touch, painful, swollen and red..seemed to be spreading down arm toward elbow.  Also had night sweats for 2 nights so far that required 4x pajama change and a fever of 101.3 Thursday night 11/20/08.  Reported slight shortness of breath when climbing stairs. She said she was ignoring symptoms and hoping that it wasn't really happening...that is why she didn't call until Friday at 3:45pm 11/21/08.
Age: 35.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site warmth, Night sweats, Pyrexia
Clinical narrative: Patient said injection site is warm to touch, painful, swollen and red..seemed to be spreading down arm toward elbow.  Also had night sweats for 2 nights so far that required 4x pajama change and a fever of 101.3 Thursday night 11/20/08.  Reported slight shortness of breath when climbing stairs. She said she was ignoring symptoms and hoping that it wasn't really happening...that is why she didn't call until Friday at 3:45pm 11/21/08.
Age: 12.0
Sex: M
Vaccine: DTP, MNQ
Symptoms: Activities of daily living impaired, Computerised tomogram normal, Electroencephalogram abnormal, Eye movement disorder, Feeling abnormal
Clinical narrative: Reduced concentration and academic performance noted by teachers in school for "gifted" children several weeks after receiving Menactra meningococcal vaccine and DPT vaccine on 7/27/07; reported by teachers to be falling asleep and spacing out in class with occasional eye fluttering noted; for several months c/o difficulty falling asleep and also awakening frequently during nights; had noticeably reduced concentration and increased difficulty understanding instructions and doing school work; CAT Scan and blood work within normal limits but three petit mal seizures were documented in 1/2 hr EEG done in approx. April 2008, but none subsequently noted in followup 72 hr EEG done in August 2008; IQ previously measured above 140 was subsequently measured in testing done in Spring 2008 to be approx. 100.  Performance on ERB tests was significantly below scores on previous ERB tests taken and especially showing deficiencies on writing portion. Was prescribed Depakote ER 250 mg tabs iii qd. for approx. two months and then weaned off.  Recently, no spacing out, falling asleep in class or fluttering eye movements currently reported by teachers of new middle school and academic performance seems to be improving. 1/27/09 Received Neuro consult medical records of 4/18-7/23/2008. FINAL DX: none provided Records reveal patient experienced significant decline in school performance, staring, inattention, argumentativeness, opposition, intermittent tinnitus, & intermittent dilated pupils since 2007 & recent enuresis.  Prior IQ test at age 5=145, current IQ test=106.  Psych testing revealed Aspergers.  EEG revealed probable seizures & tx w/meds. Referred to university neuro dept.    2/2/09 Received Neuropsychology evaluation of 3/12-3/18/2008. FINAL DX: Asperger's disorder; moderate major depression Extensive test results revealed above diagnosis.  Referred to peds neuro, psychiatrist, ST/OT for additioanl evaluaiton.  2/13/09 Received Neuro consult of 7/25-7/28/2008. Records consisted of a 72 hour digitrace EEG which was WNL.
Age: 12.0
Sex: M
Vaccine: DTP, MNQ
Symptoms: Insomnia, Petit mal epilepsy, Sleep disorder, Somnolence
Clinical narrative: Reduced concentration and academic performance noted by teachers in school for "gifted" children several weeks after receiving Menactra meningococcal vaccine and DPT vaccine on 7/27/07; reported by teachers to be falling asleep and spacing out in class with occasional eye fluttering noted; for several months c/o difficulty falling asleep and also awakening frequently during nights; had noticeably reduced concentration and increased difficulty understanding instructions and doing school work; CAT Scan and blood work within normal limits but three petit mal seizures were documented in 1/2 hr EEG done in approx. April 2008, but none subsequently noted in followup 72 hr EEG done in August 2008; IQ previously measured above 140 was subsequently measured in testing done in Spring 2008 to be approx. 100.  Performance on ERB tests was significantly below scores on previous ERB tests taken and especially showing deficiencies on writing portion. Was prescribed Depakote ER 250 mg tabs iii qd. for approx. two months and then weaned off.  Recently, no spacing out, falling asleep in class or fluttering eye movements currently reported by teachers of new middle school and academic performance seems to be improving. 1/27/09 Received Neuro consult medical records of 4/18-7/23/2008. FINAL DX: none provided Records reveal patient experienced significant decline in school performance, staring, inattention, argumentativeness, opposition, intermittent tinnitus, & intermittent dilated pupils since 2007 & recent enuresis.  Prior IQ test at age 5=145, current IQ test=106.  Psych testing revealed Aspergers.  EEG revealed probable seizures & tx w/meds. Referred to university neuro dept.    2/2/09 Received Neuropsychology evaluation of 3/12-3/18/2008. FINAL DX: Asperger's disorder; moderate major depression Extensive test results revealed above diagnosis.  Referred to peds neuro, psychiatrist, ST/OT for additioanl evaluaiton.  2/13/09 Received Neuro consult of 7/25-7/28/2008. Records consisted of a 72 hour digitrace EEG which was WNL.
Age: 0.2
Sex: F
Vaccine: HIBV, PPV
Symptoms: Grand mal convulsion, Pyrexia
Clinical narrative: My daughter had a seizure the morning after her vaccination (approx. 18 hours later).  The seizure was a tonic-clonic seizure that lasted approx. 20-30 seconds.  She had only a low-grade fever of 100.5 F. Took her to urgent care immediately following. She had no other episodes prior or since the administration of the vaccination, has since had a normal EEG.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium enema, Intussusception
Clinical narrative: Pt received Pediarix, Hib, PCV, and rotavirus vaccines on 11/6/08.  On 11/17 he was admitted for intussusception.  He was discharged 11/19 after successful reduction by barium enema.  11/26/2008 MR received for DOS 11/17-19/2008 with D/C DX: Intussusception.  Diarrhea. Pt presented to ER with 5 day hx of diarrhea, irritabily, ear grabbing, fever and decreased appetite and 1 day hx of vomiting everything eaten. En route to ER vomited, turned blue and appeared to have stopped breathing, but quickly recovered. Upon admission appeared dehydrated. initially thought to be AGE. Pt remained lethargic and unable to take po. IS dx by X-ray and US.  Reduced by barium enema with immediate improvement in pt condition.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Bronchiolitis, Haematochezia, Vomiting, X-ray abnormal
Clinical narrative: Baby given rotavirus on 9-12-05, vomiting started 9-15-08 and went to hospital (dx with Bronchiolitis) vomiting continued and seen in office on 9-16-08. Admitted to hospital for observation when symptoms worsened and bloody stool noted - transferred to another hospital 9/17th.  12/5/08 Reviewed hospital medical records of 9/16-9/17/2008. FINAL DX: Intussusception Records reveal patient experienced vomiting, decreased appetite, tiredness, lethargy, dehydration, colicky abdominal pain.  Admitted, had continued vomiting & developed bloody stools.  Transferred to higher level of care.  12/5/08 Reviewed hospital medical records of 9/17-9/18/2008. FINAL DX: Ileocolic intussusception, enema reduced Records reveal patient experienced abdominal distention & tenderness, bloody stools, decreased bowel sounds.  Admitted to PICU & surgery consult done.  Enema reduced IS.  Developed screaming & inconsolable crying 9/18.  Repeat KUB revealed paucity of gas & repeat air enema WNL.  Resolved & fed well.  D/C to home.
Age: 1.1
Sex: F
Vaccine: FLU3, HEP, MMR, PNC
Symptoms: Convulsion
Clinical narrative: Seizure approx. 10 hours after vaccination. Patient remains hospitalized. 11/25/08 MR received for 11/19-21/2008 with DX: Seizure. On the evening of 12 mon vax pt was noted to be staring off into space. R arm began shaking then progressed to R leg and whole body shaking. Lasted 7-10 min.  Difficult to awaken afterward. Temp 99.9'F. Sleepy in ER, otherwise exam WNL.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Rash generalised, Rash maculo-papular
Clinical narrative: Developed papulo-macular rash all over body including scalp scattered after vaccination with PEDIARIX, HIB, PCV, and PO ROTATEQ. Rx: Tylenol and Benadryl cream 2 x.
Age: 59.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Abscess, Gram stain negative, Surgery
Clinical narrative: 11-01-08 Hot red spot 2" with improvement. 11-06-08 NP attempted with success IV antibiotics; sent to doctor/orthopedic doctor then admit to hospital (11-06 - 11-13). Surgery/sterile abscess. Currently wound care and antibiotics. 12/2/08 Reviewed hospital medical records of 11/6-11/11/2008. FINAL DX: left deltoid abscess after pneumovax, s/p I&D. Records reveal patient experienced injection site swelling, erythema, induration & decreased mobility of left arm where he received pneumovax. Seen in clinic & sent to surgeon for aspiration of area.  Admitted for I&D, IV antibiotics.  D/C to home on continued oral antibiotics, insulin & wound clinic f/u for wound vacuum treatment.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Chest pain, Chest tube insertion, Collapse of lung, Computerised tomogram abnormal, Culture throat negative
Clinical narrative: Was given FLUMIST on 11/14 afternoon then few hours later developed fever and vomiting then chest pain diagnosed with left lower lobe pneumonia. Admitted to hospital as out patient for IV fluids. Placed on two antibiotics and pain relievers.  12/5/08 Reviewed ER medical records of 11/17/2008. FINAL DX: vomiting & dehydration; pneumonia Records reveal patient experienced nausea, vomiting, dehydration, dry mouth, sunken eyes, veins flat.  IV had to be started w/difficulty by anesthesia.  Tx w/IVF, antipyretics. Follow-up: This is to update a VAERS report that we submitted for this patient. The VAERS ID # is 333037. Pt was seen in our office on 11/26 for follow up on her pneumonia. She had a repeat chest Xray done at that time that revealed her pneumonia was worse and had progressed into the left upper lung as well as lower. She was admitted into hospital. Cat scan was completed at hospital which revealed the left lung had collapsed and pleural effusion had worsened. Pt was placed on ICU status and on Friday 11/28 had surgery to place two chest tubes in left side and debridement of the pleural cavity. Patient remained in ICU for 5 days. Given IV Vancomycin and Cefotaxime while admitted. Was released home from hospital on 12/4 and continues IV Cefotaxime every 8 hours via home infusion for at least one more week. Will be reevaluated for further IV antibiotics by Dr. in one week. Thank you for your attention in this matter.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Culture urine negative, Debridement, Intensive care, Lobar pneumonia, Pyrexia
Clinical narrative: Was given FLUMIST on 11/14 afternoon then few hours later developed fever and vomiting then chest pain diagnosed with left lower lobe pneumonia. Admitted to hospital as out patient for IV fluids. Placed on two antibiotics and pain relievers.  12/5/08 Reviewed ER medical records of 11/17/2008. FINAL DX: vomiting & dehydration; pneumonia Records reveal patient experienced nausea, vomiting, dehydration, dry mouth, sunken eyes, veins flat.  IV had to be started w/difficulty by anesthesia.  Tx w/IVF, antipyretics. Follow-up: This is to update a VAERS report that we submitted for this patient. The VAERS ID # is 333037. Pt was seen in our office on 11/26 for follow up on her pneumonia. She had a repeat chest Xray done at that time that revealed her pneumonia was worse and had progressed into the left upper lung as well as lower. She was admitted into hospital. Cat scan was completed at hospital which revealed the left lung had collapsed and pleural effusion had worsened. Pt was placed on ICU status and on Friday 11/28 had surgery to place two chest tubes in left side and debridement of the pleural cavity. Patient remained in ICU for 5 days. Given IV Vancomycin and Cefotaxime while admitted. Was released home from hospital on 12/4 and continues IV Cefotaxime every 8 hours via home infusion for at least one more week. Will be reevaluated for further IV antibiotics by Dr. in one week. Thank you for your attention in this matter.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Vomiting
Clinical narrative: Was given FLUMIST on 11/14 afternoon then few hours later developed fever and vomiting then chest pain diagnosed with left lower lobe pneumonia. Admitted to hospital as out patient for IV fluids. Placed on two antibiotics and pain relievers.  12/5/08 Reviewed ER medical records of 11/17/2008. FINAL DX: vomiting & dehydration; pneumonia Records reveal patient experienced nausea, vomiting, dehydration, dry mouth, sunken eyes, veins flat.  IV had to be started w/difficulty by anesthesia.  Tx w/IVF, antipyretics. Follow-up: This is to update a VAERS report that we submitted for this patient. The VAERS ID # is 333037. Pt was seen in our office on 11/26 for follow up on her pneumonia. She had a repeat chest Xray done at that time that revealed her pneumonia was worse and had progressed into the left upper lung as well as lower. She was admitted into hospital. Cat scan was completed at hospital which revealed the left lung had collapsed and pleural effusion had worsened. Pt was placed on ICU status and on Friday 11/28 had surgery to place two chest tubes in left side and debridement of the pleural cavity. Patient remained in ICU for 5 days. Given IV Vancomycin and Cefotaxime while admitted. Was released home from hospital on 12/4 and continues IV Cefotaxime every 8 hours via home infusion for at least one more week. Will be reevaluated for further IV antibiotics by Dr. in one week. Thank you for your attention in this matter.
Age: 1.3
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC
Symptoms: Abasia, Injection site extravasation, Injection site swelling
Clinical narrative: Swollen left thigh with slight drainage. Unable to walk for 5 days.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left arm red and swollen 5 cm in size.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Aura, Fatigue
Clinical narrative: After rec. vaccine at 11:35am, extreme fatigue noted from approx 1:00pm- 9:00pm. At approx 4:30-6:00pm area around left eye a small flashing eura with color outside which did effect vision slightly. Stopped approx 6:00pm.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Inflammation, Local swelling
Clinical narrative: Local swelling & inflammation in entire left shoulder area. Ice & Tylenol.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Injection site extravasation, Oedema peripheral, Pain in extremity
Clinical narrative: After received flu vaccine, it leaked out a little & next day swollen red sore arm.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Dyspnoea, Hypersensitivity, Pharyngeal oedema, Urticaria
Clinical narrative: Pt called the store and reported that she was having allergic reaction including hives, diarrhea, possible swelling in the throat and some difficulty breathing. Pharmacist on duty advised her to go to the ER. Pt did go to walk in clinic but by the and she was seen, symptoms were gone and no treatment was needed or given.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Gave flu shot in left deltoid and child had local reaction to injection. Swelling was 2" from point of entry and redness 9" toward elbow from point of entry. 1 ml PO of Benadryl given and father was instructed to ice and give Tylenol if needed. Discussed with MD. Patient is to return to clinic if symptoms worsen.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling
Clinical narrative: Given MMR and Varicella SQ. Rt thigh had immediate swelling and redness. Ice pack applied. BENADRYL 25 ml given swelling did not persist. Discharged home with instructions.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Muscular weakness, Pain in extremity
Clinical narrative: Within one day patient has extreme muscle weakness and pain both legs and back and lasted > 1 week. CK up. ESR up.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Rash papular
Clinical narrative: < 48 hr after vaccine pt developed intense pruritis and multiple discrete red papules over trunk & extremity.  No relief with BENADRYL.  PREDNISOLONE given.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Diarrhoea, Headache, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Pt reported that 12 hours after receiving vaccines she started with fever HA, vomiting, diarrhea, and swelling and pain at the injection site. Unable to keep solid down. Sx continue today at OV on 11/21/08, but afebrile.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Vomiting
Clinical narrative: Pt reported that 12 hours after receiving vaccines she started with fever HA, vomiting, diarrhea, and swelling and pain at the injection site. Unable to keep solid down. Sx continue today at OV on 11/21/08, but afebrile.
Age: 18.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Feeling abnormal, Feeling hot, Hypoacusis, Immediate post-injection reaction, Nausea
Clinical narrative: 3:15 pm injection. Five minutes later reported blurred vision and feeling strange. Had patient sit down, reported feeling warm and nauseous. She asked for some water, gave a bottle, drank a little but did not feel any better. Did not have breathing difficulty or swallowing. 3:30 pm reported that she was having hearing difficulty.
Age: 18.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Vision blurred
Clinical narrative: 3:15 pm injection. Five minutes later reported blurred vision and feeling strange. Had patient sit down, reported feeling warm and nauseous. She asked for some water, gave a bottle, drank a little but did not feel any better. Did not have breathing difficulty or swallowing. 3:30 pm reported that she was having hearing difficulty.
Age: 18.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blindness transient, Feeling abnormal, Feeling hot, Hearing impaired, Nausea
Clinical narrative: 3:15 pm injection. Five minutes later reported blurred vision and feeling strange. Had patient sit down, reported feeling warm and nauseous. She asked for some water, gave a bottle, drank a little but did not feel any better. Did not have breathing difficulty or swallowing. 3:30 pm reported that she was having hearing difficulty.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling abnormal, Local swelling, Lymphadenopathy
Clinical narrative: Felt bad and swollen neck, glands PSI about 24 hours.
Age: 25.0
Sex: M
Vaccine: FLU3, TDAP, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Swelling and redness of upper extremity.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Headache, Mouth ulceration, Myalgia, Nausea
Clinical narrative: Pt states 48hrs after 1st Hep (9/19/08) felt nauseous & achy but thought it was stress. 48hrs after 2nd Hepatitis B nausea was worse, had severe muscle aches & joint aches, severe headache, ulcers on roof of mouth & tongue felt swollen.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Pain, Swollen tongue, Vaccine positive rechallenge
Clinical narrative: Pt states 48hrs after 1st Hep (9/19/08) felt nauseous & achy but thought it was stress. 48hrs after 2nd Hepatitis B nausea was worse, had severe muscle aches & joint aches, severe headache, ulcers on roof of mouth & tongue felt swollen.
Age: 54.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Chills, Constipation, Hyperhidrosis, Injection site pain, Oedema
Clinical narrative: Fever following vaccine administration sweats, chills, aches. Pain at site and constipation.
Age: 54.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Pyrexia
Clinical narrative: Fever following vaccine administration sweats, chills, aches. Pain at site and constipation.
Age: 0.2
Sex: F
Vaccine: DTAP, RV5
Symptoms: Abdominal X-ray, Blood culture, Blood electrolytes, Culture urine, Full blood count
Clinical narrative: Recurrent vomiting for approximately 6 hours. Requiring ER visit. 1/5/09-records received for DOS 11/21/08-Follow up from ER visit evening prior for C/O bilious abdominal x-ray negative. No vomiting since leaving ER. Presently fussy but easily consolable, abdomen soft, normal bowel sounds no masses. Suspect vomiting secondary to recent rotateq on 11/8/08.
Age: 0.2
Sex: F
Vaccine: DTAP, RV5
Symptoms: Vomiting
Clinical narrative: Recurrent vomiting for approximately 6 hours. Requiring ER visit. 1/5/09-records received for DOS 11/21/08-Follow up from ER visit evening prior for C/O bilious abdominal x-ray negative. No vomiting since leaving ER. Presently fussy but easily consolable, abdomen soft, normal bowel sounds no masses. Suspect vomiting secondary to recent rotateq on 11/8/08.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Received flu shot 10/24/08 in R arm. No discomfort until soreness began on the underside of upper and lower R arm 10/27/08. "Soreness" has been intermittent but still persists.
Age: 56.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Feeling hot, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Fever to 101 degrees, chills, headache, swelling, pain, warmth & redness to injection site in left arm.
Age: 56.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Fever to 101 degrees, chills, headache, swelling, pain, warmth & redness to injection site in left arm.
Age: 29.0
Sex: F
Vaccine: ANTH
Symptoms: Activities of daily living impaired, Cellulitis, Fatigue, Injected limb mobility decreased, Injection site erythema
Clinical narrative: After her 1st anthrax vaccine, pt reports a moderate local reaction (redness, swelling, itching, warmth, and tenderness extending about 3-4" surrounding anthrax vaccine site; small subcutaneous nodule for about 2 weeks; no functional limitations and symptoms resolved after about 4 days). After 2nd anthrax vaccine, pt noted a similar reaction on post-vaccine day 1 (11/8). She self treated with OTC analgesics and antihistamines. On post-vaccine day 2 the affected area extended from just below her left shoulder to her elbow. She self treated with OTC analgesics and BENADRYL, but had difficulty sleeping. The following day (9/10), the area had extended to her forearm and because of the significant swelling, she had "no elbow". She experienced tingling in her fingers and thought that her left arm was weaker than her right; these symptoms resolved as the swelling diminished. She denies swollen or tender axillary lymph nodes. No red streaking of LUE. On 11/10, she was seen at ER and diagnosed as cellulitis; she was treated with 10-day course of Clindamycin. Symptoms began improving the next day and by 9/14, the area had decreased to about 3-4" and continued to gradually resolve. Itching persisted until 11/19. Pea-sized subcutaneous nodule remains. At peak of symptoms (9/10 and 9/11), she was limiting function due to pain - about 50% of normal function. She also reports experiencing significant fatigue following both anthrax vaccines, which has gradually improved and her energy level is now back to about 90% of baseline.
Age: 29.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth, Insomnia
Clinical narrative: After her 1st anthrax vaccine, pt reports a moderate local reaction (redness, swelling, itching, warmth, and tenderness extending about 3-4" surrounding anthrax vaccine site; small subcutaneous nodule for about 2 weeks; no functional limitations and symptoms resolved after about 4 days). After 2nd anthrax vaccine, pt noted a similar reaction on post-vaccine day 1 (11/8). She self treated with OTC analgesics and antihistamines. On post-vaccine day 2 the affected area extended from just below her left shoulder to her elbow. She self treated with OTC analgesics and BENADRYL, but had difficulty sleeping. The following day (9/10), the area had extended to her forearm and because of the significant swelling, she had "no elbow". She experienced tingling in her fingers and thought that her left arm was weaker than her right; these symptoms resolved as the swelling diminished. She denies swollen or tender axillary lymph nodes. No red streaking of LUE. On 11/10, she was seen at ER and diagnosed as cellulitis; she was treated with 10-day course of Clindamycin. Symptoms began improving the next day and by 9/14, the area had decreased to about 3-4" and continued to gradually resolve. Itching persisted until 11/19. Pea-sized subcutaneous nodule remains. At peak of symptoms (9/10 and 9/11), she was limiting function due to pain - about 50% of normal function. She also reports experiencing significant fatigue following both anthrax vaccines, which has gradually improved and her energy level is now back to about 90% of baseline.
Age: 29.0
Sex: F
Vaccine: ANTH
Symptoms: Muscular weakness, Paraesthesia, Subcutaneous nodule, Vaccine positive rechallenge
Clinical narrative: After her 1st anthrax vaccine, pt reports a moderate local reaction (redness, swelling, itching, warmth, and tenderness extending about 3-4" surrounding anthrax vaccine site; small subcutaneous nodule for about 2 weeks; no functional limitations and symptoms resolved after about 4 days). After 2nd anthrax vaccine, pt noted a similar reaction on post-vaccine day 1 (11/8). She self treated with OTC analgesics and antihistamines. On post-vaccine day 2 the affected area extended from just below her left shoulder to her elbow. She self treated with OTC analgesics and BENADRYL, but had difficulty sleeping. The following day (9/10), the area had extended to her forearm and because of the significant swelling, she had "no elbow". She experienced tingling in her fingers and thought that her left arm was weaker than her right; these symptoms resolved as the swelling diminished. She denies swollen or tender axillary lymph nodes. No red streaking of LUE. On 11/10, she was seen at ER and diagnosed as cellulitis; she was treated with 10-day course of Clindamycin. Symptoms began improving the next day and by 9/14, the area had decreased to about 3-4" and continued to gradually resolve. Itching persisted until 11/19. Pea-sized subcutaneous nodule remains. At peak of symptoms (9/10 and 9/11), she was limiting function due to pain - about 50% of normal function. She also reports experiencing significant fatigue following both anthrax vaccines, which has gradually improved and her energy level is now back to about 90% of baseline.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Hot flush, Pruritus, Urticaria
Clinical narrative: 24 hrs. after vaccine MENACTRA, GARADSIL administered pt developed hives itching & hot flashes.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hyperhidrosis, Pallor, Presyncope, Sensation of heaviness
Clinical narrative: Patient left the exam room and after leaving the lobby, felt very dizzy while she was standing by the elevator. Told mother her vision was going "white". Mother supported her upright and called for assistance. RN's from the unit brought her into an exam room and helped her lie down on the exam table. She was reportedly pale and sweaty.RN's checked vital signs; teen was stable. They had MD come to check her. Over course of 10-15' she felt well enough to leave. I called mother later in evening. She said that patient was still a little pale but was much better. mostly embarassed about almsot fainting.She was saying that her arm felt heavy all the way down. She had full motion and pink fingers. Reviewed on-call availability with mother.
Age: 62.0
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Rec'd call from pt states pneumonia vaccine administered at our facility and states had "reaction to shot" 5 days later. Facility offered to see pt who opted to follow up with own Dr. Pt sates she was DX with cellulitis, recd ROCEPHIN drip in outpt care and was given an antibiotic. Pt did not f/up at site of administration. It is unknown if physician who followed up with pt completed a VAERS form.
Age: 5.0
Sex: U
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Cerebrovascular accident
Clinical narrative: Information has been received from a lawyer regarding a case in litigation which was reported in a literature article, title as stated above, concerning a 5 year old patient who on 23-OCT-2003 was vaccinated with Hib conj vaccine (manufacturer unknown). Suspect concomitant therapy included Hib vaccine (manufacturer unknown). Other concomitant therapy included DTaP (manufacturer unknown) and poliovirus vaccine (manufacturer unknown). On an unreported date, the patient experienced a stroke. The patient's physician claimed that information from a study, showed that the inflammation associated with acute infections increased the risk of stroke. The findings from the article provided support for the concept that acute infections are associated with a transient increase in the risk of vascular events. By contrast influenza, tetanus, and pneumococcal vaccinations do not produce a detectable increase in the risk of vascular events. A pediatric neurologist reported that the patient has suffered a prenatal stroke. The neurologist noted that "subtle development of early hand preference during infancy, which was typical of a remote brain stroke that occurs before birth and is in stark contrast to those infants with postnatal acquired brain stroke, due to trauma, infection, etc., that presents with an acute degree of unilateral weakness that is immediately noted by parents and brings the child to medical attention." It was concluded that no contemporaneous evidence existed to support a dramatic change in the patient's condition following his vaccinations and that there was failure to demonstrate that childhood vaccinations could cause a stroke. The patient's physician conceded that the literature he had submitted did not support his theory that vaccines administered to the patient caused his stroke. He stated that the literature supported a "potential mechanism" but that literature involved adults. The patient's physician agreed that the authors of the literature did not reach the conclusions that he was drawing in this case." Upon internal review, the patient's stroke was considered to be an other important medical event. Additional information is not available.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site pain, Laboratory test normal, Pain in extremity
Clinical narrative: Initial and follow-up information has been received from a registered nurse concerning a 69 year old female with no known drug allergy and high cholesterol and a history of angioplasty with LAD coronary artery stent and dementia who on 13-OCT-2008 at 3:00 p.m., was vaccinated with PNEUMOVAX, Lot # 662354/0814X, 0.5 ml, intramuscularly into her right arm and FLUZONE, Lot # U2761AA, intramuscularly into her left arm.  Other concomitant therapy included CRESTOR and PLAVIX.  It was reported by the registered nurse that the patient on 13-OCT-2008, within 6 hours of injection (also reported as 6:00 p.m.), the patient complained of severe pain at upper right arm from the shoulder to the elbow.  At 3:00 a.m. the patient went to emergency room with complaint of 10/10 pain at right arm.  No redness or edema.  On 14-OCT-2008, the patient was admitted on observation from 3:00 - 9:30 a.m. of an unspecified hospital for treatment of the arm pain.  No specific emergency room treatment was reported other than the patient was given one LORTAB for pain and blood was also drawn, reported within normal limits.  The patient was discharged.  On 14-OCT-2008, by 4:00 p.m., the patient's husband reported that she was resting with only a soreness at right arm.  No other symptoms or treatment reported.  On 14-OCT-2008, the patient recovered.  No further information is available.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Laboratory test normal, Pain in extremity
Clinical narrative: Initial and follow-up information has been received from a registered nurse concerning a 69 year old female with no known drug allergy and high cholesterol and a history of angioplasty with LAD coronary artery stent and dementia who on 13-OCT-2008 at 3:00 p.m., was vaccinated with PNEUMOVAX, Lot # 662354/0814X, 0.5 ml, intramuscularly into her right arm and FLUZONE, Lot # U2761AA, intramuscularly into her left arm.  Other concomitant therapy included CRESTOR and PLAVIX.  It was reported by the registered nurse that the patient on 13-OCT-2008, within 6 hours of injection (also reported as 6:00 p.m.), the patient complained of severe pain at upper right arm from the shoulder to the elbow.  At 3:00 a.m. the patient went to emergency room with complaint of 10/10 pain at right arm.  No redness or edema.  On 14-OCT-2008, the patient was admitted on observation from 3:00 - 9:30 a.m. of an unspecified hospital for treatment of the arm pain.  No specific emergency room treatment was reported other than the patient was given one LORTAB for pain and blood was also drawn, reported within normal limits.  The patient was discharged.  On 14-OCT-2008, by 4:00 p.m., the patient's husband reported that she was resting with only a soreness at right arm.  No other symptoms or treatment reported.  On 14-OCT-2008, the patient recovered.  No further information is available.
Age: 3.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Biopsy bone marrow, Blood blister, Blood product transfusion, Epistaxis, Gingival bleeding
Clinical narrative: Initial report received on 14 November 2008 from the patient's parent. A three-year-old male patient, who had no concurrent illnesses, no known allergies, and no past medical history, had received a first dose of FLUZONE SV 2008-2009 on 29 October 2008. The lot number, route and site of administration were not provided. Per the reporter, three days post-vaccination, the patient developed a nose bleed and was evaluated by a physician and diagnosed with idiopathic thrombocytopenia that day. Relevant diagnostic tests included platelet count that was 187,000 on 29 October 2008, and had fallen to a "very low" count on 01 November 2008. It was not reported whether the patient had received any corrective treatment, or if he required any hospitalization. The recovery status of the patient was not reported. Documents held by sender: None
Age: 3.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Idiopathic thrombocytopenic purpura, Petechiae, Platelet count decreased, Purpura
Clinical narrative: Initial report received on 14 November 2008 from the patient's parent. A three-year-old male patient, who had no concurrent illnesses, no known allergies, and no past medical history, had received a first dose of FLUZONE SV 2008-2009 on 29 October 2008. The lot number, route and site of administration were not provided. Per the reporter, three days post-vaccination, the patient developed a nose bleed and was evaluated by a physician and diagnosed with idiopathic thrombocytopenia that day. Relevant diagnostic tests included platelet count that was 187,000 on 29 October 2008, and had fallen to a "very low" count on 01 November 2008. It was not reported whether the patient had received any corrective treatment, or if he required any hospitalization. The recovery status of the patient was not reported. Documents held by sender: None
Age: 3.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Epistaxis, Idiopathic thrombocytopenic purpura, Platelet count decreased
Clinical narrative: Initial report received on 14 November 2008 from the patient's parent. A three-year-old male patient, who had no concurrent illnesses, no known allergies, and no past medical history, had received a first dose of FLUZONE SV 2008-2009 on 29 October 2008. The lot number, route and site of administration were not provided. Per the reporter, three days post-vaccination, the patient developed a nose bleed and was evaluated by a physician and diagnosed with idiopathic thrombocytopenia that day. Relevant diagnostic tests included platelet count that was 187,000 on 29 October 2008, and had fallen to a "very low" count on 01 November 2008. It was not reported whether the patient had received any corrective treatment, or if he required any hospitalization. The recovery status of the patient was not reported. Documents held by sender: None
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Angiogram, Angiogram abnormal, Aortic stenosis, Back pain, Blood pressure increased
Clinical narrative: Information has been received from a physician concerning a 19 year old female patient, with allergic reaction to antibiotics, who on 16-JUL-2007 was vaccinated with a first dose of GARDASIL (lot # 658094/0524U, on 20-SEP-2007 she received the second dose of GARDASIL (lot # 657736/0389U), and on 18-MAR-2008 she received the third dose of GARDASIL (lot # 659964/1978U). The physician reported that the patient experienced "back pain" from the GARDASIL, and on approximately 19-JUL-2007 the patient experienced blood dripping from both eyes (just for one day) and she has been having bad headaches since then. The physician reported that the patient was diagnosed with high blood pressure and an autoimmune disease affecting the large arteries called "TAKAYASU". The physician reported that the patient had been hospitalized for about a week as a result of the condition. Physician recommended Ibuprofen for treatment. The back pain, blood dripping from both eyes, bad headaches, high blood pressure and autoimmune disease affecting the large arteries called "TAKAYASU" were considered immediately life-threatening. On 27-May-2008 a "TB test" was done as a laboratory diagnostic studied (results not provided). The patient had not recovered. According to the physician, the patient has been released from the hospital. The physician is concerned about the "weird" things that she heard are happening to patients around the time of the GARDASIL vaccination. According to the reporting physician, "complications resulting from chronic use of steroids" was considered to be disabling. This is one of two reports from the same source. Additional information has been requested. 1/28/2010 Ongoing treatment of Talemagaen disease.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Coeliac artery stenosis, Headache, Renal artery stenosis, Subclavian artery stenosis, Takayasu's arteritis
Clinical narrative: Information has been received from a physician concerning a 19 year old female patient, with allergic reaction to antibiotics, who on 16-JUL-2007 was vaccinated with a first dose of GARDASIL (lot # 658094/0524U, on 20-SEP-2007 she received the second dose of GARDASIL (lot # 657736/0389U), and on 18-MAR-2008 she received the third dose of GARDASIL (lot # 659964/1978U). The physician reported that the patient experienced "back pain" from the GARDASIL, and on approximately 19-JUL-2007 the patient experienced blood dripping from both eyes (just for one day) and she has been having bad headaches since then. The physician reported that the patient was diagnosed with high blood pressure and an autoimmune disease affecting the large arteries called "TAKAYASU". The physician reported that the patient had been hospitalized for about a week as a result of the condition. Physician recommended Ibuprofen for treatment. The back pain, blood dripping from both eyes, bad headaches, high blood pressure and autoimmune disease affecting the large arteries called "TAKAYASU" were considered immediately life-threatening. On 27-May-2008 a "TB test" was done as a laboratory diagnostic studied (results not provided). The patient had not recovered. According to the physician, the patient has been released from the hospital. The physician is concerned about the "weird" things that she heard are happening to patients around the time of the GARDASIL vaccination. According to the reporting physician, "complications resulting from chronic use of steroids" was considered to be disabling. This is one of two reports from the same source. Additional information has been requested. 1/28/2010 Ongoing treatment of Talemagaen disease.