chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Patient presented in office 8/22/2007 with lt upper arm red, swollen and warm to the touch. Size of redness 70mm. Mother reports that it first showed up this am. Patient denies any pain or discomfort. Inst mother to give advil for discomfort and benerdyl for the swelling. Instr to apply cool compress to area.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Injection site erythema, Rash generalised, Scratch
Clinical narrative: The grandmother refers that his mother told her that the boy was scratching his hand and at night a rash appear in all his body and redness in the injection area and ears.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MEN, HEPA, HPV4, MEN, HEPA, HPV4, MNQ
Symptoms: Convulsion, Eye rolling, Syncope
Clinical narrative: My daughter received Meningitis, Hepatitis A, and HPV vaccines. [First injection for each of these for her...I know HPV and one of the others requires booster(s).]  Less than a minute after receiving injections and while still sitting on exam table, my daughter fainted and had short episode of seizure-type activity...shaking and her eyes rolled.  Vital signs monitored and oxygen was administered.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MEN, HEPA, HPV4, MEN, HEPA, HPV4, MNQ
Symptoms: Convulsion, Syncope
Clinical narrative: My daughter received Meningitis, Hepatitis A, and HPV vaccines. [First injection for each of these for her...I know HPV and one of the others requires booster(s).]  Less than a minute after receiving injections and while still sitting on exam table, my daughter fainted and had short episode of seizure-type activity...shaking and her eyes rolled.  Vital signs monitored and oxygen was administered.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MEN, HEPA, HPV4, MEN, HEPA, HPV4, MNQ
Symptoms: Eye rolling, Pallor, Syncope, Tremor
Clinical narrative: My daughter received Meningitis, Hepatitis A, and HPV vaccines. [First injection for each of these for her...I know HPV and one of the others requires booster(s).]  Less than a minute after receiving injections and while still sitting on exam table, my daughter fainted and had short episode of seizure-type activity...shaking and her eyes rolled.  Vital signs monitored and oxygen was administered.
Age: 22.0
Sex: M
Vaccine: ANTH, FLUX
Symptoms: Biopsy lung abnormal, Cough, Culture stool negative, Dyspnoea, Eosinophilia
Clinical narrative: massive headaches beginning in Feb99 which resolved sometime in 1999. Nite sweats beginning in July99 and resolved in Aug99; breathing problems beginning in Aug 99. 12/12/99 admitted to hospital for cough, fever.1/26/2000 admitted to NH for cough dx with eosinophilic pnuemonia 9/17/07-records received for DOS 12/22-12/24/99-admitted with 2 week history of fever, cough most lately with some hemoptysis, 10 pound weight loss. Shortness of breath, lungs clear. Impression:bilateral apical infiltrates, rule out tuberculosis, rule out atypical viral disease
Age: 22.0
Sex: M
Vaccine: ANTH, FLUX
Symptoms: Eosinophilic pneumonia, Headache, Night sweats, Pyrexia
Clinical narrative: massive headaches beginning in Feb99 which resolved sometime in 1999. Nite sweats beginning in July99 and resolved in Aug99; breathing problems beginning in Aug 99. 12/12/99 admitted to hospital for cough, fever.1/26/2000 admitted to NH for cough dx with eosinophilic pnuemonia 9/17/07-records received for DOS 12/22-12/24/99-admitted with 2 week history of fever, cough most lately with some hemoptysis, 10 pound weight loss. Shortness of breath, lungs clear. Impression:bilateral apical infiltrates, rule out tuberculosis, rule out atypical viral disease
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Pyrexia
Clinical narrative: During early morning hours after vaccine given, client had fever of 102 degrees. Also had complaint of headache. Symptoms lasted about 24 hours. Given Ibuprofen by her mother for fever and headache.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Anaphylactic reaction, Face oedema, Swelling face, Urticaria generalised
Clinical narrative: Anaphylactic/ type I/ reaction within 12 hours of vaccine Gardasil generalized urticaria, facial oedema.  10/16/07 Received ER medical records of 8/24/2007 which reveal patient experienced hives, swollen lips & face & itching all over.  Tx w/epi, IV steroids, IV antihistamine.  Improved & d/c to home FINAL DX: angioedema.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Anaphylactoid reaction, Face oedema, Swelling face, Urticaria
Clinical narrative: Anaphylactic/ type I/ reaction within 12 hours of vaccine Gardasil generalized urticaria, facial oedema.  10/16/07 Received ER medical records of 8/24/2007 which reveal patient experienced hives, swollen lips & face & itching all over.  Tx w/epi, IV steroids, IV antihistamine.  Improved & d/c to home FINAL DX: angioedema.
Age: 19.0
Sex: M
Vaccine: HEPAB, MMR, MNQ, TDAP, VARCEL
Symptoms: Blister, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Was seen 18 Aug. c/o itchy rash on his body when he woke up that morning. PE showed papular, erythematous rashes on his trunk and one vesicular lesion. He was vaccinated with Varivax 2 1/2 weeks ago.  9/4/07 Reviewed hospital medical records which reveal patient experienced maculopapular truncal rash, some appeared as crusted vesicles, 3 wks s/p varicella vax.  Also had sore throat, runny nose & HA for approx 1 wk prior to admit.  Admitted 8/18-8/21/07. Placed in resp isolation & tx w/antivirals.  Had chest congestion & sore throat.  ID consult.  Improved & d/c to home. FINAL DX: Truncal rash; acute varicella infection; viral URI.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Erythema, Injection site rash, Oedema peripheral, Skin warm
Clinical narrative: Left leg reddened, swollen, warm to touch 3cm x 5cm, rash around injection site left upper thigh.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Antinuclear antibody positive, Arthralgia, Full blood count, Joint effusion, Joint stiffness
Clinical narrative: Pt received 1st dose of Gardasil 5/21/07. Within 9 days she developed severe bilateral joint pain and stiffness with bilateral elbow effusion. Her ANA was 1:2560. Normal sed rate, RF, CBC, Mild elevation of liver function tests.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Liver function test abnormal, Red blood cell sedimentation rate normal, Rheumatoid factor
Clinical narrative: Pt received 1st dose of Gardasil 5/21/07. Within 9 days she developed severe bilateral joint pain and stiffness with bilateral elbow effusion. Her ANA was 1:2560. Normal sed rate, RF, CBC, Mild elevation of liver function tests.
Age: 12.0
Sex: M
Vaccine: HEP, HEPA, MMR, MNQ, TDAP
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling
Clinical narrative: (L) deltoid 5cm swollen, red slight discomfort (R) deltoid 2 cm swollen slight redness no discomfort
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Patient noted with redness and swelling to left deltoid. Advised to apply cool pack to area and give Tylenol for discomfort.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Eye swelling, Rash
Clinical narrative: Rash on back of neck, right eye swollen, Epinephrine 1:1000 0.5 ml/sc. Treatment: Benadryl 50mg/ml IM. ice pack on right eye.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Migraine
Clinical narrative: Migraine headache 2 hours after Gardasil #2 given
Age: 19.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Urticaria
Clinical narrative: Hives
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Immediate post-injection reaction, Syncope, Throat tightness
Clinical narrative: Client experienced post immunization syncope approximately 3 minutes after vaccines were given. States her throat felt tight and she was dizzy". This appeared to last approximately a few minutes and client returned to pre-vaccine state within 10 - 15 minutes total. VSS B/P 100/60, Pulse ox 99%. No intercostal retractions. EMT called at request of mother. Mother declined taking child to hospital.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Rash
Clinical narrative: Woke up the am following administration of Gardasil and Menactra with rash on left side of torso, no itching, no swelling, no heat, no SOB. Vaccines given at 11am on 8/23/07. Rash appeared a.m. of 8/27 Calamine/ Caladryl lotion applied.
Age: 14.0
Sex: F
Vaccine: HEP, HEPA, HPV4
Symptoms: Computerised tomogram, Electrocardiogram, Fall, Head injury, Syncope
Clinical narrative: Patient was given immunizations while patient was standing up. Shortly afterwards patient fainted and hit her head on the immunization floor. After patient fell, she started to fling her arms around for about 10 seconds. Patient claimed she remembers leaning against the frig and then blacked out. Patient seen by doctor sent to ER.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Immediate post-injection reaction, Nausea, Syncope
Clinical narrative: Injection given (MCV4) one arm < 1 minute Gardasil other arm. In 5 seconds fainted few seconds - eyelids fluttered and then regained consciousness - c/o nausea ++
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Expired drug administered, No adverse effect
Clinical narrative: Vaccine expired 8/5/06 was administered 8/8/06 no adverse effects occurred, discovered on chart review.
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Rash
Clinical narrative: Within 5 minutes, child broke out in rash all over legs and back of neck; rash resolved in approximately 10 minutes; administered 5ml Benadryl.
Age: 0.33
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Injection site pain, Irritability, Pyrexia
Clinical narrative: Marked irritability and crying non stop 4 hours post vaccines fever 102.3 degrees no rash no seizures bilateral thighs both very tender on injection sites.
Age: 20.0
Sex: M
Vaccine: IPV, TD
Symptoms: Pruritus, Rash, Skin lesion, Urticaria
Clinical narrative: 20 y/o basic trainee who developed urticarial eruptions with itching on his arms 2 minutes after receipt of IPV and Td; lesions ranged from penny to quarter size, 3 on right forearm, 1 on left forearm, and one on each elbow. There was no lip, tongue, or facial swelling; no throat tightness, cough, wheezing, or shortness of breath. He was treated with IM Benadryl and oral Loratadine. The eruptions resolved by day 3, and itching resolved completely by day 7. Urticaria Start: 08/10/2007 End: 08/13/2007 Pruritus Start: 08/10/2007 End: 08/17/2007
Age: 18.0
Sex: M
Vaccine: HEPAB, MMR
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticaria with itching 2 hours after receipt of Twinrix and MMR. Urticaria Start: 08/02/2007 End: 08/04/2007 Pruritus Start: 08/02/2007 End: 08/04/2007
Age: 1.34
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Oedema peripheral, Pyrexia, Skin warm, Tenderness
Clinical narrative: Red dot at injection site the following morning increased in redness w/2 large circular areas at injection sites. Swelling in left thigh and low grade fever of around 100 deg. Antibiotic prescription by physician. Pronounced generalized left thigh swelling, warmth - tenderness.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Skin warm
Clinical narrative: Silver dollar size area of redness/ warmth left arm.
Age: 1.1
Sex: F
Vaccine: DTAP, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: High fever 101 - 104 degrees x 3 days with rash. 2 weeks after vaccine whelp like rash with mild fever.
Age: 4.0
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Rash erythematous
Clinical narrative: Red round bump
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Pruritus
Clinical narrative: 3cm diameter pruritic > painful induration, erythema - onset 3 days after vax
Sex: F
Vaccine: PPV
Symptoms: Erythema, Influenza like illness, Pain in extremity, Pyrexia
Clinical narrative: Prescribed 3 day Azithromycin due to flu-like symptoms arm began to ache, by 2am pain increased and had fever also. Pain increased on 8/18 took Tylenol and Benadryl, arm was also red. On 8/19 arm was swollen, red, hot, are affected extended from shoulder to elbow sensitive underneath arm pit. On 8/20 seen by nurse problems started to resolve by then.
Age: 4.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Cellulitis, Injection site cellulitis, Injection site swelling, Oedema peripheral, Tenderness
Clinical narrative: SWOLLEN AND TENDER ON LEFT ARM. PATIENT WAS SEEN BY HOSPITAL ER ON 08/22/2007 FOR REACTION TO VACCINES ON LEFT ARM GIVEN ON 08/21/2007.PT WAS TREATED W/KEFLEX. ON 08/23/2007 PT WAS SEEN BY MEDICAL CLINIC F/U VACCINES REACTION STILL SOME SWELLING AND CELLULITIS ON LEFT ARM SITE ON INJECTIONS. RECOMMANED APPY ICE ON AFFECTED AREA AND CONTINUE ON KEFLEX PRESCRIBE BY ER. F/U W/DR IN 1WK.
Age: 1.0
Sex: M
Vaccine: HIBV, PNC, VARCEL
Symptoms: Pyrexia
Clinical narrative: FEVER OF 102
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site infection
Clinical narrative: Left arm deltoid with injection site infection after MCV4 given.
Age: 5.0
Sex: F
Vaccine: DTAP, HEP, HEPA, IPV, MMR, VARCEL
Symptoms: Dyspnoea, Pruritus
Clinical narrative: Patient started itching, then having trouble breathing about 20 minutes after getting shots.  She was seen in our Urgent CAre which is in the same building.  She was given a breathing treatment Benadryl 25mg IV,and Decadron 4mg IV.  She was then transported by ambulance to Medical Center.
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Erythema multiforme, Rash generalised
Clinical narrative: Developed generalized rash (erythema multiforme)within 10 days of getting immunizations, self limited, no treatment
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Erythema, Malaise, Pain, Pyrexia
Clinical narrative: Ache and fever next day. Chills, 24th ache and cold, arm red and swollen about 2 inch red area, just didn't feel good, feels some better today (24th)
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: Ache and fever next day. Chills, 24th ache and cold, arm red and swollen about 2 inch red area, just didn't feel good, feels some better today (24th)
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Hyperaesthesia, Myalgia, Neck pain, Pain, Tenderness
Clinical narrative: Pt describes the onset of left sided neck pain the day after receiving the injection.  The pain is sharp and is in the area of muscle insertion at the base of the occiput and mastoid process.  Has tenderness to palpation over the SCM tendon insertion superiorly.  Notes that the pain increased with certain head movements.  Not associated with headache, fever, redness, or swelling in the area.  Also noted skin sensitivity over left cheek initially, however this has resolved.  Did not take any pain medication for this.  Has had pain for the past 3 days.
Age: 29.0
Sex: F
Vaccine: TYP
Symptoms: Migraine with aura, Photophobia, Pyrexia, Visual acuity reduced
Clinical narrative: About 40 hrs after 1st pill, migraine with aura. Aura lasted approx. 15 minutes (visual impairment and flashing lights) and migraine pain lasted about 7 hours (with photophobia).  At about 34 hrs after 2nd pill, migraine with aura.  Less severe pain, lasting about 6 hrs.  At about 24 hrs after 3rd pill, migraine with aura.  Pain lasted about 8 hrs.  At about 34 hours after 3rd pill, a second migraine with aura.  Less severe, pain lasting about 4 hours.  At about 30 hrs after 4th pill, migraine with aura.  Took Maxalt -MLT 10 mg migraine pill given to me by my doctor that day.  Symptoms less severe as result, lasting about 4 hrs.  Since the 23rd (10 days after initial dose) I am running a very slight fever, .3 degrees.  I took the vaccine on the 13th, 15th, 17th, 19th of August, 2007.  I have never had a migraine before taking this vaccine.  Since the 21st, two days after the final, I have not had another migraine, though I have had an almost constant minor headache.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth, and swelling at site of injection
Age: 43.0
Sex: F
Vaccine: MM
Symptoms: Musculoskeletal pain, Neck pain, Oedema, Pain
Clinical narrative: right hand edema and pain, right forearm pain, right shoulder and neck pain, edema of supraclavicular region; pt given motrin 800 mg and t#3 prn.  PPD placed as well, Sanofi-Pasteur, lot C2670AA, right forearm.
Age: 4.0
Sex: F
Vaccine: HEP, HEPA, IPV, PNC, VARCEL
Symptoms: Medication error
Clinical narrative: BASICALLY, THIS REPORT I'M WRITTING IS NOT AN ADVERSE EFFECT REPORT, IT IS MORE INFORMATIONAL OF A PREVIOUS MISUNDERSTANDING ABOUT VACCINE TWINRIX AND INDIVIDUAL HEP A & B COMBINED IN ONE SYRINGE AND GIVEN AS A  SINGLE SHOT. I NOW LEARNED THIS SHOULD NEVER BE DONE. NO REACTION REPORTED ON THE DAY OR AFTER THE DAY OF VACCINATION; EVEN TILL TODAY NO REACTION REPORTED TO THE CLINIC. I AM SUBMITTING THIS VAERS FORM MAINLY FOR INFORMATIONAL PURPOSE. I HAD A MISUNDERSTANDING ABOUT TWINRIX(HEP A& B) AND INDIVIDUAL HEP A & B VACCINES WHICH I GAVE TO THE PT AS A SINGLE SHOT. THIS IS THE ONLY ONE TIME THIS MIXED UP HAPPEN AND ONLY WITH THIS PT; AND I  HAVE LEARNED THAT THIS SHOULD NEVER BE DONE, THEREFORE I PROMISE THIS WILL NEVER REPEAT. PT'S MOM WAS INFORMED OF BOTH VACCINE COMBINATION BEFORE THE SHOT WAS GIVEN TO PT AND SHE SEEMED APPRECIATIVE AND SAID IT WILL DEFINETLY CAUSE LESS PAIN TO PT . I FULLY UNDERSTAND AS OF NOW THAT THE TWINRIX IS A DIFFERENT VACCINE AND THE INDIVIDUAL HEP A & HEP B VACCINE SHOULD NEVER EVER BE CONBINED AS A SINGLE SHOT. AGAIN, NO REACTION OR COMPLAINT REPORTED ABOUT THIS EVENT. THANKS
Age: 1.5
Sex: F
Vaccine: DTAP, IPV
Symptoms: Convulsion
Clinical narrative: Generalized seizure lasting approx one minute.  Required no treatment.
Age: 1.1
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Rash morbilliform
Clinical narrative: Morbilliform rash over face? trunk
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: Red spot at injection site - no meds
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema
Clinical narrative: Redness, 1500 mg Rocephin IM administered
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Rash and varicelliform eruption of arms, legs, upper back.
Age: 11.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Pyrexia, Rash pustular
Clinical narrative: Seen at pediatricians office 6-27-07 for fever 102 that morning and redness at injection site -> left deltoid 1" over redness, right deltoid 3" area redness-returned to office 6-28-07 -> right deltoid with 7 cm area at redness with pinpoint pustule in center-incised and cultured drainage-started on Clindamycin
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Contusion, Erythema, Pruritus
Clinical narrative: Bruise appeared 5 days after vaccine - 2 days later arm became itchy and red. Bruise still present 10 days after vaccine.
Age: 10.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Induration, Tenderness
Clinical narrative: Varivax and Hep A given on 8/18/07 right upper arm laterally for Varivax. Itching locally followed by erythema, induration 1" diameter. Redness 4 1/2" x 3 7/8" slightly tender on palpitation. Full range of movement for the arm. Seen on 8/20/07. Advised cold compress and Benadryl PO.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Redness, swelling, no pain at injection site. Redness approximately 3" x 5" plus induration. 1 3/4" (inches) child put on antibiotics.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Eye swelling
Clinical narrative: Eyes swollen no other symptoms. Patient given Benadryl 1 tsp at office start Crapred 15mol/5ml at 2 tsp daily x days. Patient doing well as of 8/22/07 per mother.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Blister, Rash papular, Skin lesion
Clinical narrative: Erythematous papules with small vesicles on face and upper trunk and 12 lesions.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Pain, Pruritus
Clinical narrative: 8/15/07 Left injection site was red. 8-16-07 anterior of left thigh was red. Patient c/o some pain and itching. Not warm to touch. Patient was given Benadryl strips - 2 strips every 4-6.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Swelling, Tenderness
Clinical narrative: Patient received PPV vaccine 8/14/07 2pm patient called to report left arm pain - swelling - warmth. Appointment 8-16-07 with PA - extensive erythema, swelling extending from left elbow to shoulder, tenderness to palpation.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Blood creatinine increased, Blood urea increased, Body temperature increased, Injection site erythema, Injection site warmth
Clinical narrative: <24 hours after vaccine - redness at site with warmth, temp 103, BUN and Cr increase
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Local reaction
Clinical narrative: Local reaction 10 centimeter by 6 centimeter no other symptoms.
Age: 1.6
Sex: M
Vaccine: HEPA
Symptoms: Accidental exposure
Clinical narrative: Child was given inadvertently an adult Hep A instead of a peds. Hep A spoke with CDC immunization hotline. Referred to complete VAERS form.
Age: 1.2
Sex: F
Vaccine: HIBV, MMR
Symptoms: Croup infectious, Febrile convulsion, Full blood count, Pyrexia, White blood cell count normal
Clinical narrative: Patient with previous history of febrile seizures, got MMR as his on 8/13/07. Developed fever on 8/17/07 and had seizure exam 8/14/07 and examine 8/16/07. Patient found to have viral tracheoso (acute croup) after serous febrile seizure disease.
Age: 7.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Received DTaP 8/14/07 right thigh. 8/16/07 c/o of 1/2 dollar size red and swollen thigh. 8/17/07 went to Ed - cellulitis given Keflex 550mg PO right thigh red 4 1/2 x 4" in size.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Welts on face, arms, and abdomen. Patient was given .2 of Epi, she waited in office for 20 minutes and was sent home with Benadryl.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site swelling
Clinical narrative: Received Varicella vaccine on 7-31-07 returned to clinic 8-2-07 measured 30mm x 40mm at site of injection.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Erythema and induration at injection site approximately 30 mm diameter.
Age: 17.0
Sex: F
Vaccine: HEPA, HPVX, MEN, TDAP
Symptoms: Chills, Dizziness, Dyspnoea, Fatigue, Headache
Clinical narrative: The day after receiving the meningococcal vaccine (she also received HPV,Hep A & Tdap at the same time)she woke up not feeling well.  As the day progressed she got a 102.5 fever, chills, headache, whole body ache, difficulty breathing and her hands felt numb at times.  This lasted until the next day.  She felt better the next day but still felt tired, some what achy and dizzy at times.  By the next day she felt normal again.  I gave her ibuprofen, which brought the fever down some and somewhat helped with the aches.  I did not take her in to the doctors office.     She received two shots in the left arm and two in the right (which ones in each, I do not know).  I clicked unkown manufacturer below, because I do not know what was used.
Age: 17.0
Sex: F
Vaccine: HEPA, HPVX, MEN, TDAP
Symptoms: Hypoaesthesia, Malaise, Pain, Pyrexia
Clinical narrative: The day after receiving the meningococcal vaccine (she also received HPV,Hep A & Tdap at the same time)she woke up not feeling well.  As the day progressed she got a 102.5 fever, chills, headache, whole body ache, difficulty breathing and her hands felt numb at times.  This lasted until the next day.  She felt better the next day but still felt tired, some what achy and dizzy at times.  By the next day she felt normal again.  I gave her ibuprofen, which brought the fever down some and somewhat helped with the aches.  I did not take her in to the doctors office.     She received two shots in the left arm and two in the right (which ones in each, I do not know).  I clicked unkown manufacturer below, because I do not know what was used.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Injection site urticaria
Clinical narrative: Hives developed around injection site.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: C-reactive protein normal, Febrile convulsion, Full blood count normal, Metabolic function test normal, Unresponsive to stimuli
Clinical narrative: Patient received a Dtap, IPV, and MMR the afternoon of August 21, 2007.  One the morning of August 22, 2007 he had a fever.  By 8:15 AM he was unresponsive and had seizure activity.  After a full ER workup and evaluation it was determined that he had a febrile seizure due to the previous days vaccinations.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Barium double contrast, Enema administration, Intussusception, X-ray
Clinical narrative: Given Rotateq vaccine on May 1, 2007, developed symptoms of intussusception on May 14, 2007 and then officially diagnosed, treated, and hospitalized for intussusception on May 17, 2007.  0924/2007 Hospital record received for DOS 5/17-18/2007 for DX of Ileocolic Intussusception.  Child presented to ER on 5/17/07 with 3 day hx of abdominal pain, vomiting and bloody stool.  IS reduced by air contrast enema.  PE (+) systolic ejection murmur prior to D/C.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Abdominal pain, Barium double contrast, Cardiac murmur, Haematochezia, Intussusception
Clinical narrative: Given Rotateq vaccine on May 1, 2007, developed symptoms of intussusception on May 14, 2007 and then officially diagnosed, treated, and hospitalized for intussusception on May 17, 2007.  0924/2007 Hospital record received for DOS 5/17-18/2007 for DX of Ileocolic Intussusception.  Child presented to ER on 5/17/07 with 3 day hx of abdominal pain, vomiting and bloody stool.  IS reduced by air contrast enema.  PE (+) systolic ejection murmur prior to D/C.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Urinary system X-ray, Vomiting
Clinical narrative: Given Rotateq vaccine on May 1, 2007, developed symptoms of intussusception on May 14, 2007 and then officially diagnosed, treated, and hospitalized for intussusception on May 17, 2007.  0924/2007 Hospital record received for DOS 5/17-18/2007 for DX of Ileocolic Intussusception.  Child presented to ER on 5/17/07 with 3 day hx of abdominal pain, vomiting and bloody stool.  IS reduced by air contrast enema.  PE (+) systolic ejection murmur prior to D/C.
Age: 29.0
Sex: F
Vaccine: YF
Symptoms: Influenza like illness, Injection site erythema, Injection site pruritus, Injection site swelling, Rhinorrhoea
Clinical narrative: Injection site swell up to 14mm surround area was red and itching. Also had flu-like symptoms (runny nose, sneezing) for 2 days after injection
Age: 29.0
Sex: F
Vaccine: YF
Symptoms: Sneezing
Clinical narrative: Injection site swell up to 14mm surround area was red and itching. Also had flu-like symptoms (runny nose, sneezing) for 2 days after injection
Age: 12.0
Sex: M
Vaccine: MEN, MNQ
Symptoms: Chest discomfort, Headache, Injection site swelling, Lethargy, Palpitations
Clinical narrative: High fever, severe swelling on entire right side of vaccine injection, severe headache, racing heart, heaving chest, lethargic behavior for 3 days
Age: 12.0
Sex: M
Vaccine: MEN, MNQ
Symptoms: Pyrexia
Clinical narrative: High fever, severe swelling on entire right side of vaccine injection, severe headache, racing heart, heaving chest, lethargic behavior for 3 days
Age: 12.0
Sex: M
Vaccine: MEN, MNQ
Symptoms: Auricular swelling, Erythema, Local swelling, Oedema peripheral, Pain
Clinical narrative: High fever, severe swelling on entire right side of vaccine injection, severe headache, racing heart, heaving chest, lethargic behavior for 3 days
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Skin papilloma
Clinical narrative: My daughter began to have facial(flat) warts on her face and chest after the 2nd dose of Gardasil.  There are many warts on her face and chest at least 20 or more.  She has never had this problem before receiving the vaccine.  She was treated for warts by her Doctor and now has been referred to Dermatology.  She has not recovered yet.  She will not receive the 3rd dose.
Age: 18.0
Sex: M
Vaccine: DTAP, MNQ
Symptoms: Blood test, Computerised tomogram, Dyspnoea, Echocardiogram, Heart rate increased
Clinical narrative: Took the vaccine for menningitis on May 29, 2007, since he planned to attend University as a freshman. One week later patient suffered the following symptoms: difficulty breathing, rapid heart rate, aching muscles in his chest, arms and legs and problems with his vision.  We took him to the emergency room at Hospital on two occasions with several doctor visits over the summer months.  He has also received several blood tests (high white blood cell count).  Plans to visit a pulmonary specialist early September.  09/24/2007 MR received for 2 ER visits dated 6/10/2007 and 6/21/2007 for c/o chest pain and palpitations. Additional symptom of dyspnea on 6/21/07 visit, reported as being unable to get a good breath. Discharge DX 6/10/07: Chest wall pain.  Palpitations. Discharge DX 6/21/07 Dyspnea.  10/02/2007 Spoke with parent.  Pt has seen an opthomologist for visual disturbances without definative dx, and seen a pulmonary MD for breathing problems/exacerbation of asthma also without definative dx.  Pt has been referred to 2 other specialists in neurology and pulmonary later in the month.   10/29/2007 MR received for neuro consult of 10/8/2007 for c/o headaches and body weakness onset June 2007. Assessment: Headache follwed meningio vaccine.  Visual disturbances, unspecified DDX-vascular, optic neuritis.  Weakness Fatigue, DDX-SMN, myopathy, polyrad inflamm.  10/29/2007 MR received from pulmonary consult done 10/16/2007 for c/o shortness of breath, chest heaviness, blurred vision, diffuse myalgias, and palpitations since May 2007.  Symptoms have slowly been improving. PE WNL. DX: serum sickness reaction from meningococcal vaccine. 10/31/2007 F/U OV received from Neurology. Workup was negative. Still with vague symptoms.
Age: 18.0
Sex: M
Vaccine: DTAP, MNQ
Symptoms: Inappropriate schedule of drug administration, Myalgia, Ophthalmological examination, Pulmonary function test, Visual disturbance
Clinical narrative: Took the vaccine for menningitis on May 29, 2007, since he planned to attend University as a freshman. One week later patient suffered the following symptoms: difficulty breathing, rapid heart rate, aching muscles in his chest, arms and legs and problems with his vision.  We took him to the emergency room at Hospital on two occasions with several doctor visits over the summer months.  He has also received several blood tests (high white blood cell count).  Plans to visit a pulmonary specialist early September.  09/24/2007 MR received for 2 ER visits dated 6/10/2007 and 6/21/2007 for c/o chest pain and palpitations. Additional symptom of dyspnea on 6/21/07 visit, reported as being unable to get a good breath. Discharge DX 6/10/07: Chest wall pain.  Palpitations. Discharge DX 6/21/07 Dyspnea.  10/02/2007 Spoke with parent.  Pt has seen an opthomologist for visual disturbances without definative dx, and seen a pulmonary MD for breathing problems/exacerbation of asthma also without definative dx.  Pt has been referred to 2 other specialists in neurology and pulmonary later in the month.   10/29/2007 MR received for neuro consult of 10/8/2007 for c/o headaches and body weakness onset June 2007. Assessment: Headache follwed meningio vaccine.  Visual disturbances, unspecified DDX-vascular, optic neuritis.  Weakness Fatigue, DDX-SMN, myopathy, polyrad inflamm.  10/29/2007 MR received from pulmonary consult done 10/16/2007 for c/o shortness of breath, chest heaviness, blurred vision, diffuse myalgias, and palpitations since May 2007.  Symptoms have slowly been improving. PE WNL. DX: serum sickness reaction from meningococcal vaccine. 10/31/2007 F/U OV received from Neurology. Workup was negative. Still with vague symptoms.
Age: 18.0
Sex: M
Vaccine: DTAP, MNQ
Symptoms: White blood cell count increased
Clinical narrative: Took the vaccine for menningitis on May 29, 2007, since he planned to attend University as a freshman. One week later patient suffered the following symptoms: difficulty breathing, rapid heart rate, aching muscles in his chest, arms and legs and problems with his vision.  We took him to the emergency room at Hospital on two occasions with several doctor visits over the summer months.  He has also received several blood tests (high white blood cell count).  Plans to visit a pulmonary specialist early September.  09/24/2007 MR received for 2 ER visits dated 6/10/2007 and 6/21/2007 for c/o chest pain and palpitations. Additional symptom of dyspnea on 6/21/07 visit, reported as being unable to get a good breath. Discharge DX 6/10/07: Chest wall pain.  Palpitations. Discharge DX 6/21/07 Dyspnea.  10/02/2007 Spoke with parent.  Pt has seen an opthomologist for visual disturbances without definative dx, and seen a pulmonary MD for breathing problems/exacerbation of asthma also without definative dx.  Pt has been referred to 2 other specialists in neurology and pulmonary later in the month.   10/29/2007 MR received for neuro consult of 10/8/2007 for c/o headaches and body weakness onset June 2007. Assessment: Headache follwed meningio vaccine.  Visual disturbances, unspecified DDX-vascular, optic neuritis.  Weakness Fatigue, DDX-SMN, myopathy, polyrad inflamm.  10/29/2007 MR received from pulmonary consult done 10/16/2007 for c/o shortness of breath, chest heaviness, blurred vision, diffuse myalgias, and palpitations since May 2007.  Symptoms have slowly been improving. PE WNL. DX: serum sickness reaction from meningococcal vaccine. 10/31/2007 F/U OV received from Neurology. Workup was negative. Still with vague symptoms.
Age: 2.0
Sex: M
Vaccine: MEA
Symptoms: Eye irritation, Pyrexia, Rhinorrhoea
Clinical narrative: Fever, runny nose, eye irritation
Age: 21.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus, Injection site warmth
Clinical narrative: Pt c/o itching and erythema over injection site (left deltoid) x 2 days. Pt has 6x12 area of erythema/edema/warmth.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4
Symptoms: Dizziness, Loss of consciousness, Syncope, Vomiting
Clinical narrative: None stated. 8/29/07-spoke with reporter patient had vomiting and a syncopal episode in office and recovered
Age: 6.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Abdominal pain, Anaphylactic reaction, Dyspnoea, Eyelid oedema, Flushing
Clinical narrative: Five minutes after injection, he developed palpitations, his eyes and neck became flushed, and his mother noted erythema in his sclerae.  The treating physician commented on abdominal cramping.  Blood pressure at that time was 100/60.  He then developed itchy rash to his chest and ears, and a swollen lower lip.  Benadryl was given with no response.  Epinephrine SQ was given and the symptoms then responded immediately.  He was observed with no further problems.
Age: 6.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Lip swelling, Palpitations, Rash pruritic
Clinical narrative: Five minutes after injection, he developed palpitations, his eyes and neck became flushed, and his mother noted erythema in his sclerae.  The treating physician commented on abdominal cramping.  Blood pressure at that time was 100/60.  He then developed itchy rash to his chest and ears, and a swollen lower lip.  Benadryl was given with no response.  Epinephrine SQ was given and the symptoms then responded immediately.  He was observed with no further problems.
Age: 6.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Abdominal pain, Flushing, Lip swelling, Palpitations, Rash pruritic
Clinical narrative: Five minutes after injection, he developed palpitations, his eyes and neck became flushed, and his mother noted erythema in his sclerae.  The treating physician commented on abdominal cramping.  Blood pressure at that time was 100/60.  He then developed itchy rash to his chest and ears, and a swollen lower lip.  Benadryl was given with no response.  Epinephrine SQ was given and the symptoms then responded immediately.  He was observed with no further problems.
Age: 6.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Scleral discolouration
Clinical narrative: Five minutes after injection, he developed palpitations, his eyes and neck became flushed, and his mother noted erythema in his sclerae.  The treating physician commented on abdominal cramping.  Blood pressure at that time was 100/60.  He then developed itchy rash to his chest and ears, and a swollen lower lip.  Benadryl was given with no response.  Epinephrine SQ was given and the symptoms then responded immediately.  He was observed with no further problems.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4
Symptoms: Facial palsy
Clinical narrative: Initial report received from a health care professional in the United States on 16 August 2007. A 13-year-old female had received a left deltoid injection of Menactra, lot number U2278AA, expiration date 09 May 2008, and a left deltoid injection of Gardasil, lot number 0515U on 01 August 2007 and 14 days later developed left sided facial nerve paralysis (Bell's Palsy). The route of administration of both vaccines had not been reported. The patient had no illness at the time of vaccination, no reported medical history and they had not received any concomitant medications. The patient had received a prior dose of Menactra and no prior events had been reported at this time. The date and route/site of administration for Menactra previously received had not been reported. The patient's status had been listed as not recovered at the time of this report. 9/7/07 Reviewed pcp medical records which reveal patient well & healthy on day of vax.  Only concern was for hair loss.  Returned to pcp on 8/15 s/p developed left eye watery & twitchy x 3 days.  Awakened 8/14 & could not smile or squint.  Exam revealed left ptosis w/sluggish light reflex & left side facial paralysis.  Tx w/steroid taper.  PCP discussed case w/neurologist & started on antiviral 8/16.  Noted to have tingling/burning s/s of herpetic outbreak 8/13 but no actual vesicles.  F/U visit on 8/29 revealed smile almost normal but still residual eye involvement.  Exam revealed improved smile but still mildly weak on left.  Eye exam WNL.  Immunization records do not include lot #s.  Does indicate patient received initial meningococcal 8/22/06.   FINAL DX: Bell's Palsy
Age: 5.0
Sex: F
Vaccine: HEPA, IPV
Symptoms: Erythema, Injection site rash, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a 5 year old female with no remarkable medical history who on 02-APR-2007 at 3:20pm was vaccinated with a first 0.5ml intramuscular dose of VAQTA (Lot # "02484:) in the right thigh. Concomitant vaccine administered on the same day included a fifth dose of IPOL. There was no illness at the time of vaccination and no adverse events following prior vaccination. The following day after receiving VAQTA, on 03-APR-2007, the patient developed a large rash at the injection site. The patient was treated with BENADRYL for the reaction. Unspecified medical attention was sought. There was no laboratory or diagnostic tests performed. No further information was provided at the time of this report. No product quality complaint was involved. Additional information has been requested. Follow-up information received from a physician stated that the patient experienced severe redness and swelling of the right thigh from the right anterior superior iliac spine down to the knee. The patient recovered, however, the reporter "can not recall" the date. The event of redness and swelling of the right thigh was determined to be an other important medical event by the investigator.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure increased, Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a 12 year old female who in July 2007, was vaccinated with a first dose of Gardasil. In July 2007, the patient passed out and experienced elevated blood pressure after receiving Gardasil. Subsequently, the patient recovered from passing out and elevated blood pressure. The physician considered passing out and elevated blood pressure as other important medical events due to intervention with intravenous and oxygen administration (not further specified). The patient sought medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Grand mal convulsion, Head injury, Heart rate, Heart rate decreased, Hyperhidrosis
Clinical narrative: Information has been received from a physician concerning a 16 year old female with no known allergies who on 01-AUG-2007 was vaccinated with the first dose of Gardasil (Lot# not provided). No concomitant therapies were reported. The physician reported that within 60 seconds post vaccination the patient had a vasal vagal response, experienced a Tonic clonic Grand mal seizure and hit her head on the office wall. The physician reported that at that time the patient was sweating and her pulse was 43 BPM. The patient laid down and oxygen was administered. The physician reported that the patient was monitored and with 20 minutes her pulse was 68 BPM and she had recovered from the event. The physician considered the event to be disabling and an other important medical event. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope vasovagal, Tonic clonic movements
Clinical narrative: Information has been received from a physician concerning a 16 year old female with no known allergies who on 01-AUG-2007 was vaccinated with the first dose of Gardasil (Lot# not provided). No concomitant therapies were reported. The physician reported that within 60 seconds post vaccination the patient had a vasal vagal response, experienced a Tonic clonic Grand mal seizure and hit her head on the office wall. The physician reported that at that time the patient was sweating and her pulse was 43 BPM. The patient laid down and oxygen was administered. The physician reported that the patient was monitored and with 20 minutes her pulse was 68 BPM and she had recovered from the event. The physician considered the event to be disabling and an other important medical event. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Myelitis transverse, Neuromyelitis optica, Paralysis
Clinical narrative: Initial and follow-up information has been received from a physician concerning an "otherwise healthy" 13 year old female who was vaccinated with her first and second doses of Gardasil. Subsequently the patient experienced what was thought to be transverse myelitis and was hospitalized. She experienced paralysis from the chest down, lesions of the optic nerve, and was diagnosed with "Neuromyelitis Optica (NMO)". The patient was treated with high dose corticosteroids (unspecified) and did not respond. A course of Cytoxan was planned. Duration of hospitalization was not reported. At the time of the report the patient had not recovered. Additional information has been requested.  5/13/08 Reviewed hospital medical records of 8/1-8/24/2007 & 9/25-9/26/2007. FINAL DX: neuromyelitis optica. Records reveal patient experienced sudden onset of bilateral LEs weakness & numbness proceeded by several hours of leg pains, LBP & urinary retention.  Parent w/gastroenteritis several weeks prior.  Patient had malaise at that time but never actually ill.  Admit exam revealed areflexia bilateral LEs, loss of sensation below T12 bilaterally as well as flaccid paraplegia & urinary retention.  Admitted to PICU.  Tx w/IV steroids w/no improvement.  Tx w/plasmapheresis, I/O cath, bowel regime. Neuro, rheum, psych consults done.  Developed decreased sensation up to T8, restarted IV steroids & MRIs repeated.  Tspine MRI revealed traumatic progression of disease up to T4-5.  No improvement w/additional steroids or plasmapheresis.  Tx w/IVIG x 7 days w/no improvement but no worsening.  Transferred to inpatient rehab to be readmitted for rituximab in the next month.  Medical records of 9/25-9/26/07 for rituximab infusion.  Exam revealed loss of motor control of bilateral LEs.  Was to return 10/2 for second treatment & PICC placement.  Patient continued to be home schooled due to her condition.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose abnormal, Computerised tomogram normal, Dizziness, Electrocardiogram abnormal, Haematoma
Clinical narrative: Initial and follow up information has been received from a Registered Nurse (R.N.) concerning a 26 year old female patient who on 14-AUG-2007 was vaccinated with a first dose of Gardasil lot #658222/0927U. Concomitant therapy included ethinyl estradiol (+) Levonorgestrel (SEASONALE). On 14-AUG-2007, within one month of vaccination patient developed injection site soreness, and then passed out for about one minute. She was dizzy and nauseated. She was transported to the Emergency Room via ambulance. In follow up the nurse reported that after patient received her Gardasil injection she turned her back and about 30 seconds later she turned around and the patient's head had dropped down and she was very stiff, not limp but stiff. She passed out. She was taken to the emergency room (ER) where she vomited. She had a computed axial tomography (CAT) scan which was normal, although she had a hematoma on her head. The nurse said that she did not fall while in the office or anytime before hand that she knew about so she was not sure where that came from. She had an electrocardiogram (EKG) which was borderline abnormal, and she was recommended to follow up with her primary care physician about the EKG. The primary care physician was aware of the patient's cardiology problem. The patient's glucose was 126, prothrombin time (PT) 13.0, red blood cell count (RBC) 4.05, everything else was right on the normal border. She was discharged from the ER that same day. Her discharge diagnosis was vasovagal syncope. The nurse's office was not able to contact the patient since then and was not sure if patient had recovered. The nurse reported that she did not know whether the event was from her Gardasil vaccination, since the event occurred about 30 seconds after her vaccination. The reporter indicated that the patient's adverse events injection site soreness, passing out, being dizzy and nauseated were disabling. She also believed transporting patient to the emergency room (ER) via ambulance was an intervention to prevent a serious criteria and it was reported as an other medical event. Additional information has been requested.