chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: PPV, TD
Symptoms: Oedema peripheral, Pain, Pyrexia
Clinical narrative: Very sick with flu-like symptoms for 4-5 days. Symptoms were headache, achiness, malaise, anorexia, temp of 100.2. Cellulitis type redness and swelling in arm where Td injection given (right) for 6 days. Size of lesion was 4-5 inches. Symptomatic treatment, Ibuprofen, heat to arm continuously. I am an RN, so didn't call anyone about it.
Age: 11.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Induration, Oedema peripheral, Skin warm, Tenderness
Clinical narrative: Right arm red, warm, hard to touch, tender, swollen.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Fall, Hyperhidrosis, Hypotension, Muscle twitching, Pallor
Clinical narrative: vasovagal syncope within 4-5 minutes of receiving injection.  Fell from standing position face first to the floor.  "Thankfully", his little sister had already passed out from her vaccination and the nurse and I were helping her on the floor so we broke his fall or it could have been a very serious fall. As with his sister, there were no warning signs before he passed out, no dizziness or nausea or feeling ill, he simply said he saw everything go black and he hit the floor, while he was out his muscles twitched uncontrollably, his blood pressure stayed low for a considerable time after regaining consciousness- 10 minutes after it was at 90/50, he was drenched in sweat and very pale.  He took more than 45 minutes before he could stand up and was shaky for a number of hours afterward.  As with his sister, who received a different injection, I was concerned with the similarities in the two vaccinations--but the doctors refused to consider the vaccinations as having anything to do with it, insisting he passed out because out of sympathy due to watching his sister pass out.  The doctor's office refuses to consider ANYTHING other than my children panicking and not even being aware of it themselves or me being aware of it as their mother.  I know my children and that was NOT the case.   There is something about these vaccines that caused my children to have a very serious reaction and we are just lucky that their falls did not cause serious injury.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Syncope vasovagal, Tremor
Clinical narrative: vasovagal syncope within 4-5 minutes of receiving injection.  Fell from standing position face first to the floor.  "Thankfully", his little sister had already passed out from her vaccination and the nurse and I were helping her on the floor so we broke his fall or it could have been a very serious fall. As with his sister, there were no warning signs before he passed out, no dizziness or nausea or feeling ill, he simply said he saw everything go black and he hit the floor, while he was out his muscles twitched uncontrollably, his blood pressure stayed low for a considerable time after regaining consciousness- 10 minutes after it was at 90/50, he was drenched in sweat and very pale.  He took more than 45 minutes before he could stand up and was shaky for a number of hours afterward.  As with his sister, who received a different injection, I was concerned with the similarities in the two vaccinations--but the doctors refused to consider the vaccinations as having anything to do with it, insisting he passed out because out of sympathy due to watching his sister pass out.  The doctor's office refuses to consider ANYTHING other than my children panicking and not even being aware of it themselves or me being aware of it as their mother.  I know my children and that was NOT the case.   There is something about these vaccines that caused my children to have a very serious reaction and we are just lucky that their falls did not cause serious injury.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Fall, Head injury, Hypotension, Loss of consciousness
Clinical narrative: vasovagal syncope approximately 3 minutes after injection.  No warning signs such as nausea or dizziness beforehand, she explained everything just went "black" slumped off table and I caught her before she hit floor.  She had rapid loss of blood pressure and her muscles were severely twitching in her arms and legs while unconscious for about 10 seconds (it looked similar to a seizure).  Her blood pressure remained low for 10 minutes or so before beginning to climb again, she also had nausea & dizziness after event.  She did hit her head during fall, but it caused only a small bump on the back of her head, and was not serious.  The doctor's refused to consider a link with vaccine, except possibly "nervousness" over getting a shot- which was NOT the case.  Another report will show my son also fainted immediately thereafter at the same time with a different vaccine----I asked if these new vaccines possibly have inactive ingredients that they could possibly have allergies to at the time and was told that he passed out simply because his sister did. (he is 17 and has never passed out)---but the reports of vasovagal syncope show a higher incidence among these 2 vaccines...and perhaps there is a link with a particular ingredient?  Or with a certain bloodtype? There is something about these vaccines that caused my children to have a very serious reaction.  The nurse told me that my daughter must have been hyperventalating without me being aware of it, which is totally ridiculous.  Both kids were calm and chatting pleasantly about the day ahead when my daughter suddenly slumped over and passed out.  This was NOT normal and they were NOT children having some sort of panicked reaction.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Muscle twitching, Nausea, Syncope vasovagal
Clinical narrative: vasovagal syncope approximately 3 minutes after injection.  No warning signs such as nausea or dizziness beforehand, she explained everything just went "black" slumped off table and I caught her before she hit floor.  She had rapid loss of blood pressure and her muscles were severely twitching in her arms and legs while unconscious for about 10 seconds (it looked similar to a seizure).  Her blood pressure remained low for 10 minutes or so before beginning to climb again, she also had nausea & dizziness after event.  She did hit her head during fall, but it caused only a small bump on the back of her head, and was not serious.  The doctor's refused to consider a link with vaccine, except possibly "nervousness" over getting a shot- which was NOT the case.  Another report will show my son also fainted immediately thereafter at the same time with a different vaccine----I asked if these new vaccines possibly have inactive ingredients that they could possibly have allergies to at the time and was told that he passed out simply because his sister did. (he is 17 and has never passed out)---but the reports of vasovagal syncope show a higher incidence among these 2 vaccines...and perhaps there is a link with a particular ingredient?  Or with a certain bloodtype? There is something about these vaccines that caused my children to have a very serious reaction.  The nurse told me that my daughter must have been hyperventalating without me being aware of it, which is totally ridiculous.  Both kids were calm and chatting pleasantly about the day ahead when my daughter suddenly slumped over and passed out.  This was NOT normal and they were NOT children having some sort of panicked reaction.
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Convulsion
Clinical narrative: 2 Minutes after vaccine administration pt. had seizure activity, no history of seizure, although she does have a family h/o seizure disorder. Seizure resolved after about 30 seconds
Age: 11.0
Sex: F
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Vaccine given beyond recommended age guideline of 7 years
Age: 11.0
Sex: F
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Rash
Clinical narrative: rash 12hr after shot administered --called md and went in for visit.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Chills, Pain, Pyrexia, Skin warm
Clinical narrative: PER MOM, CHILD HAD FEVER, FELT HOT TO TOUCH,BODY ACHES,WEAKNESS,CHILLS.
Age: 20.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Eschar, Malaise, Rash, Rash papular
Clinical narrative: Post vaccination day 10 patient reported to ED with malaise, and truncal rash. ROS with no HA, fever, URI, or signs of desimination, which resolved by day 12. Escar at day 12 with no appearance of overly robust reaction, forming a well healing escar. Rash was of very mild acne like appearence with approx dozen papules on anterior and posterior trunk. No evidence of erythema multiform like rash, or lesions with central clearing, as well as no vesicles or desquamation. Patient at day 12 with resolution of malaise. Smallpox vaccine manufacture Acambis VV04003A, typhoid ViCPs by Aventis A05222, Anthrax by Miles lot unknown at this time.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Blindness transient, Dizziness, Faecal incontinence, Immediate post-injection reaction, Visual disturbance
Clinical narrative: Patient received her 3rd Gardasil vaccine in her left arm and then immediately following, her Hep A vaccine in her right arm.  Within seconds following the vaccinations patient became lightheaded and dizzy, and said she could not see.  She stated she thought she was blacking out.  She did not lose consciousness.  She had been standing up and was immediately assisted to the exam table to sit down.  Upon sitting down her dizziness and blindness subsided. She was instructed to lie down.  But, patient insisted she had to go to the bathroom right away.  As she was escorted to the BR, she became dizzy again and was unable to see.  She became incontinent of stool as well.  She was assisted to the bathroom and after sitting on the toilet she said she felt better.  She was cleaned up and sat in the bathroom for approx. 10 minutes.  Upon trying to stand, she again became dizzy, so she sat back down.  We stayed in the bathroom approx. 45 minutes until patient felt able to walk with assistance to the car.  During the walk to the car, she continued to feel lightheaded and dizzy, but did not lose consciousness or vision.  Upon arriving home she layed on the sofa for 2-4 hours.  There were no more adverse symptoms.
Age: 4.0
Sex: F
Vaccine: HEPA, IPV, MMR, VARCEL
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: 12CM X 10CM INDURATED RED AREA  TO RIGHT THIGH AT SITE OF DTAP INJECTION. HOT TO TOUCH, DARK RED.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Local reaction, Skin warm, Swelling, Tenderness
Clinical narrative: local redness, swelling, tenderness, warmth
Age: 14.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Fall, Head injury, Hyperhidrosis, Immediate post-injection reaction, Pallor
Clinical narrative: Immunization given and client immediately got pale, diaphoretic, sweaty, and fell to floor. Mother in room and assisted to floor, but had quarter-sized bump to right head area.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Device leakage, Underdose
Clinical narrative: While administering injection, a small amount of serum leaked out of the hub.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: Prescriber ordered "DTaP" vaccination for this patient when "Tdap" is what should have been order.  The nurse administered the "DTaP" as was ordered by the physician.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Patient complained of headaches after receiving vaccine. Mild headache was still present the following morning when she was seen by me. Normal physical examination.
Age: 11.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: area where vaccine was given ( back of right upper arm, subcutaneous) started getting red,tender and warm 24 hrs. after vaccination.  Mom states area is larger today, but less red. 35 mm circular area measured today.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Appendicectomy, Computerised tomogram abnormal
Clinical narrative: Severe abdominal pain followed by appendectomy.  Hepatitis B shot administered at 9:00 am on August 4th, 2008 , abdominal pain after lunch.  Pain subsided then returned by 2:00 pm the following day, August 5th, 2008. 9/2/08-records received for DOS 8/6-8/7/08-DC DX: Acute appendicitis. Laparoscopic appendectomy. Presented to ED with C/O abdominal pain beginning afternoon of day prior. Nausea and vomiting.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Cellulitis, Erythema, Pain in extremity, Skin warm
Clinical narrative: Pt developed pain over Lt arm, hot totouch, no fever or chills.  Erythema and warmth over the L upper arm/deltoid triceps area 8cm by 3cm.  Cellulitis.  Rx Keflex 500mg QID x7days.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, IPV, RVX
Symptoms: Pallor
Clinical narrative: Pallor following administration of 3 shots and one oral vaccine for a total of 7 vaccines at once. Pallor came on within 5 minutes of the injections and resolved over an hour later. Patient vitals were not taken because physician was not present in room when vaccines were given and after nurse gave the shots she promptly told us we could go home and left. No medical professional was on hand to observe the patient for any kind of reaction and parents were not adequately informed on what to look for.
Sex: U
Vaccine: DTAP, IPV
Symptoms: Anaphylactic reaction, Rash generalised
Clinical narrative: This case was reported by a physician and described the occurrence of anaphylaxis in a child subject of unspecified gender who was vaccinated with INFANRIX (GlaxoSmithKline).  Concurrent vaccination included live attenuated oral poliomyelitis vaccine (manufacturer unspecified) given in 2001.  In 2001 the subject received unspecified dose of INFANRIX (unknown).  At an unspecified time after vaccination with INFANRIX, the subject experienced anaphylaxis and generalized rash.  This case was assessed as medically serious by GSK.  At the time of reporting the events were resolved.  The physician considered the events were probably related to vaccination with INFANRIX.  This event was reported as the reporting physician (an allergist) wanted to give BOOSTRIX to this child subject that is allergic to gelatin.  In the course of conversation, the allergist mentioned the events above in response to INFANRIX.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever over 103 -104 for 3 days, ice extremity and Ibuprofen for fever.
Age: 29.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Blood creatine phosphokinase increased, Fatigue, Inappropriate schedule of drug administration, Musculoskeletal stiffness
Clinical narrative: After first injection 10/08 - fatigue, muscle stiffness and weakness. CPK increased to 2000
Age: 10.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Injection site swelling, Pruritus
Clinical narrative: Onset 8/7 - erythema, itching, given Benadryl; 4cm with 2cm raised area centrally at back of deltoid surrounding puncture mark
Age: 0.1
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Screaming, Tachypnoea
Clinical narrative: Screaming and tachypneic starting the day after injection.  Hospitalized for one day.  8/19/08 Reviewed ER medical records of 8/6/2008. FINAL DX: tachypnea/colic vs vaccine reaction Records reveal patient experienced screaming inconsolably & having difficult breathing upon awakening.  Exam in ER was WNL but was admitted for observation.  No further episodes & d/c to home.
Age: 31.0
Sex: M
Vaccine: ANTH, MNQ, TYP
Symptoms: Local reaction
Clinical narrative: Large local reaction - 7-8 cm in diameter approximately 8 hors after injection.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Patient large redded area, warm to touch 8-12-08. No fever, pain, just itches badly Suggested Benadryleream. Will see her Friday 8-15-08.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, VARCEL
Symptoms: Rash generalised, Urticaria
Clinical narrative: 8-8-08 AM woke up in AM with hives/rash on face which progressed to neck and arms. Pt went to an urgent care and got Rx for zyrtec which is not helping. F/U at medical center 8/12/08 now has "bumps on legs".
Age: 8.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: "None"
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Give rotavirus by mistake (patient is 6 months old)
Age: 10.0
Sex: F
Vaccine: HEPA, HPV4, TDAP
Symptoms: Body temperature increased, Contusion, Erythema, Skin warm, Swelling
Clinical narrative: T-100.5.  11.5x13.5cm rounded, raised, pink & warm area.  Smaller 4x5cm bruised area on side reaction area.  Hive like reaction below reaction yesterday.
Age: 10.0
Sex: F
Vaccine: HEPA, HPV4, TDAP
Symptoms: Urticaria
Clinical narrative: T-100.5.  11.5x13.5cm rounded, raised, pink & warm area.  Smaller 4x5cm bruised area on side reaction area.  Hive like reaction below reaction yesterday.
Age: 5.0
Sex: M
Vaccine: HEPA, MNQ, TYP, YF
Symptoms: Rash papular, Rash vesicular
Clinical narrative: Vaccines administered 8/6/08. 8/7/08 developed rash and seen by MD. Rash on back small pimple raised vesicles/papular. No fever. Rash resolved 8/11 (moving to a foreign country 1 yr).
Age: 1.04
Sex: M
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: TDAP given mistakenly for DTAP, dose #4.  Called CDC - advised dose #4 valid, does not need to be repeated - minimal chance of adverse reaction.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Nausea, Tremor
Clinical narrative: Mother called to report that night he received the vaccine.  Hands felt shaky.  Nauseated the following day & has a headache everyday since receiving the vaccine.  No other known details re: headache.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Cold sweat, Dizziness
Clinical narrative: Within 5 minutes of receiving vaccines felt dizzy, clammy.
Age: 14.0
Sex: F
Vaccine: HEPA, TDAP, TYP
Symptoms: Anxiety, Chills, Headache, Tremor
Clinical narrative: Pt c/o anxiousness, trembling, chills, HA 1-1 1/2 hrs after vaccination.  Mother gave her TYLENOL - symptoms resolve within 1 hour.
Age: 17.0
Sex: F
Vaccine: TDAP, YF
Symptoms: Arthralgia, Headache, Malaise, Ocular hyperaemia, Pharyngolaryngeal pain
Clinical narrative: Fever 103.2 degF 4 days after vaccine. Felt unwell, achy joints reddened eyes, sore throat; bad headache (x 1 week). Sore throat started Tuesday. Get dramatically better on Thursdau; Antibiotics - amoxicillin 500mg tid started on Sunday (6-11-08); Well by Friday; No cultures done, PMD not seen
Age: 17.0
Sex: F
Vaccine: TDAP, YF
Symptoms: Pyrexia
Clinical narrative: Fever 103.2 degF 4 days after vaccine. Felt unwell, achy joints reddened eyes, sore throat; bad headache (x 1 week). Sore throat started Tuesday. Get dramatically better on Thursdau; Antibiotics - amoxicillin 500mg tid started on Sunday (6-11-08); Well by Friday; No cultures done, PMD not seen
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Skin discolouration, Skin disorder, Wound secretion
Clinical narrative: Several red-purple spots in the skin of hands and forearm. Some of the spots had a breakdown of the skin with a white-yellow secretion (as referred by the client). Client refers it as painful. Areas affected are below the elbow on both arms.
Age: 15.0
Sex: F
Vaccine: HPV4, MMR, MNQ, TDAP, VARCEL
Symptoms: Decreased appetite, Fatigue, Headache, Muscular weakness, Nausea
Clinical narrative: Pt c/o fatigue, decreased appetite on the evening of 6/17/08.  Woke up at 5:15am on 6/18/08 c/o headache, nausea, weakness in arms, "shocking" sensation on arms & trunk (from neck down to abdomen) - this sensation would come in "waves".  T 98.3 axillary.  All s/s resolved except fatigue.
Age: 15.0
Sex: F
Vaccine: HPV4, MMR, MNQ, TDAP, VARCEL
Symptoms: Paraesthesia
Clinical narrative: Pt c/o fatigue, decreased appetite on the evening of 6/17/08.  Woke up at 5:15am on 6/18/08 c/o headache, nausea, weakness in arms, "shocking" sensation on arms & trunk (from neck down to abdomen) - this sensation would come in "waves".  T 98.3 axillary.  All s/s resolved except fatigue.
Age: 51.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Back pain, Injection site pain, Injection site swelling, Injection site warmth, Muscle spasms
Clinical narrative: R arm hot & swollen down to elbow & around.  Painful to both sides of site.  Back aches & spasms, neck pain.  Getting better little less painful.
Age: 51.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Neck pain
Clinical narrative: R arm hot & swollen down to elbow & around.  Painful to both sides of site.  Back aches & spasms, neck pain.  Getting better little less painful.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Influenza like illness, Pain, Pyrexia, Urticaria
Clinical narrative: Flu like symptoms, low grade fever, body aches, hives in both arms and few hives on torso. Symptoms lasted for 4 days.
Age: 0.23
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Rotavirus test positive
Clinical narrative: #1 ROTATEQ given 7/29/08.  Developed diarrhea multiple times/day which has persisted >2 weeks.  Stool + for rotavirus.
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RVX
Symptoms: Culture throat negative, Rash, Streptococcal identification test negative
Clinical narrative: Rash developed 1/2 hr - 1 1/2 hrs after administration.
Sex: M
Vaccine: FLU3
Symptoms: Cough
Clinical narrative: States has a persistent cough since he received the flu shot on 12/11/07.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Flank pain, Influenza like illness, Pyrexia, Rash pustular
Clinical narrative: ZOSTAVAX given 7/2/08.  Pt developed flu like sx, fever, pustules on lt hand, nose, rt thigh & back, and rt flank pain on 7/14/08.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Has erythema, warm to touch and swelling.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Shingles left back,  T-12 distribution noted by parents on 08/06. Acyclovir given PO.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Fatigue, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: 07-14-08, approximately 8.5 cm diameter area, red, indurated, painful, hot to touch at injection site right arm. 07-17-08, red area extends to mid forearm, with edema, less indurated. Using ibuprofen, cool compress and elevation. 7-16-08, sore throat and fatigue. 07-30-08, area resolved.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Oedema peripheral, Pharyngolaryngeal pain
Clinical narrative: 07-14-08, approximately 8.5 cm diameter area, red, indurated, painful, hot to touch at injection site right arm. 07-17-08, red area extends to mid forearm, with edema, less indurated. Using ibuprofen, cool compress and elevation. 7-16-08, sore throat and fatigue. 07-30-08, area resolved.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site swelling, Pain, Pruritus
Clinical narrative: Pain, itching, redness.  Diffuse swelling around injection site - improving with use of Odal Medrol dose pack, rest, elevation and ice.
Age: 9.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Hypersensitivity, Local reaction
Clinical narrative: Localized allergic reaction (left arm) (doubt cellulitis) due to varicella.
Age: 17.0
Sex: M
Vaccine: HEPA
Symptoms: Hyperhidrosis, Nervousness, Pallor
Clinical narrative: Pallor, Diaphoresis, Shaking
Age: 14.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pruritus, Pyrexia, Rash maculo-papular
Clinical narrative: Macular/Papular rash (began flesh color and then turned red; started 30 hours after injections. Fever 102deg, itching (no pustules). lasted about 1 week saw local physician - thought not related; treated with Aveeno bath
Age: 35.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site pain, Injection site swelling, Vomiting
Clinical narrative: Spoke with donor on 08-13-08, donor stated that she vomited approximately 8 oz the night of injection. Donor also states she has pain at injection site with swelling.
Age: 1.3
Sex: M
Vaccine: HEP
Symptoms: Erythema, Swelling
Clinical narrative: Patient had redness and swelling to right thigh, soft, no drainage. Pt had no limping, was playful.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red, swollen, warm to the touch.  Approximate size, golf ball size.
Age: 17.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain upper, Chills, Headache, Lethargy, Nausea
Clinical narrative: Headache 2 hours after injection later that evening pt. with nausea, chills, stomach ache, lethargic.  Symptoms lasted 2 days.  Pt. felt better the next day (one day) then symptoms returned again x1 more day.  Pt. advised not to get further vaccine doses.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Encephalopathy, Lumbar puncture abnormal
Clinical narrative: HPV administered on 5/1/08; patient stated above presented to hospital on 5/4/08. Dx - Aseptic meningoencephalitis.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Abasia, Activities of daily living impaired, Aphasia, Computerised tomogram, Convulsion
Clinical narrative: HPV administered on 5/1/08; patient stated above presented to hospital on 5/4/08. Dx - Aseptic meningoencephalitis.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Diagnostic procedure, Encephalopathy, Lumbar puncture, Nuclear magnetic resonance imaging, Pyrexia
Clinical narrative: HPV administered on 5/1/08; patient stated above presented to hospital on 5/4/08. Dx - Aseptic meningoencephalitis.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Scan brain
Clinical narrative: HPV administered on 5/1/08; patient stated above presented to hospital on 5/4/08. Dx - Aseptic meningoencephalitis.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Bacterial culture negative, CSF white blood cell count increased, Encephalitis, Virus culture negative
Clinical narrative: HPV administered on 5/1/08; patient stated above presented to hospital on 5/4/08. Dx - Aseptic meningoencephalitis.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Chest pain, Dyspnoea, Pericardial effusion, Pericarditis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from an agency under the Freedom of Information Act.  A 16 year old female with a medical history of asthma, bronchial asthma, penicillin allergy, peanut allergy and allergy to pertussis vaccine ("screamed for hours"), was vaccinated with the first dose of GARDASIL (Lot #660393/0067X) IM in the left arm on 22-MAY-08.  Concomitant therapies include Ventolin, Zithromax, ibuprofen and prednisone.  On 24-MAY-2008, the patient experienced chest pain and pericarditis.  The patient went to the emergency room and was hospitalized.  On 31-MAY-2008, the patient experienced chest pain and dyspnoea.  On 01-JUN-2008, the patient experienced chest pain, pericardial effusion, and pericarditis on 03-JUN-2008.  The patient went to the emergency room and was hospitalized.  The diagnosis was pericarditis.  The patient presented with chest pain for about 10 days and 2 days after vaccination with GARDASIL.  No further information is available.  The patient's chest pain and pericarditis were considered immediately life threatening.  The originally reported source was not provided.  The VAERS ID is 314559.  A standard lot check investigation was performed.  All in-process quality checks for the lot in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the center and was released.  No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Chest X-ray, Chest pain, Computerised tomogram, Echocardiogram, Laboratory test
Clinical narrative: This report was identified from a line listing obtained on request by the Company from an agency under the Freedom of Information Act.  A 16 year old female with a medical history of asthma, bronchial asthma, penicillin allergy, peanut allergy and allergy to pertussis vaccine ("screamed for hours"), was vaccinated with the first dose of GARDASIL (Lot #660393/0067X) IM in the left arm on 22-MAY-08.  Concomitant therapies include Ventolin, Zithromax, ibuprofen and prednisone.  On 24-MAY-2008, the patient experienced chest pain and pericarditis.  The patient went to the emergency room and was hospitalized.  On 31-MAY-2008, the patient experienced chest pain and dyspnoea.  On 01-JUN-2008, the patient experienced chest pain, pericardial effusion, and pericarditis on 03-JUN-2008.  The patient went to the emergency room and was hospitalized.  The diagnosis was pericarditis.  The patient presented with chest pain for about 10 days and 2 days after vaccination with GARDASIL.  No further information is available.  The patient's chest pain and pericarditis were considered immediately life threatening.  The originally reported source was not provided.  The VAERS ID is 314559.  A standard lot check investigation was performed.  All in-process quality checks for the lot in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the center and was released.  No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Pericarditis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from an agency under the Freedom of Information Act.  A 16 year old female with a medical history of asthma, bronchial asthma, penicillin allergy, peanut allergy and allergy to pertussis vaccine ("screamed for hours"), was vaccinated with the first dose of GARDASIL (Lot #660393/0067X) IM in the left arm on 22-MAY-08.  Concomitant therapies include Ventolin, Zithromax, ibuprofen and prednisone.  On 24-MAY-2008, the patient experienced chest pain and pericarditis.  The patient went to the emergency room and was hospitalized.  On 31-MAY-2008, the patient experienced chest pain and dyspnoea.  On 01-JUN-2008, the patient experienced chest pain, pericardial effusion, and pericarditis on 03-JUN-2008.  The patient went to the emergency room and was hospitalized.  The diagnosis was pericarditis.  The patient presented with chest pain for about 10 days and 2 days after vaccination with GARDASIL.  No further information is available.  The patient's chest pain and pericarditis were considered immediately life threatening.  The originally reported source was not provided.  The VAERS ID is 314559.  A standard lot check investigation was performed.  All in-process quality checks for the lot in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the center and was released.  No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Anion gap increased, Blood creatine phosphokinase increased, Chest pain, Computerised tomogram abnormal, Dyspnoea
Clinical narrative: This report was identified from a line listing obtained on request by the Company from an agency under the Freedom of Information Act.  A 16 year old female with a medical history of asthma, bronchial asthma, penicillin allergy, peanut allergy and allergy to pertussis vaccine ("screamed for hours"), was vaccinated with the first dose of GARDASIL (Lot #660393/0067X) IM in the left arm on 22-MAY-08.  Concomitant therapies include Ventolin, Zithromax, ibuprofen and prednisone.  On 24-MAY-2008, the patient experienced chest pain and pericarditis.  The patient went to the emergency room and was hospitalized.  On 31-MAY-2008, the patient experienced chest pain and dyspnoea.  On 01-JUN-2008, the patient experienced chest pain, pericardial effusion, and pericarditis on 03-JUN-2008.  The patient went to the emergency room and was hospitalized.  The diagnosis was pericarditis.  The patient presented with chest pain for about 10 days and 2 days after vaccination with GARDASIL.  No further information is available.  The patient's chest pain and pericarditis were considered immediately life threatening.  The originally reported source was not provided.  The VAERS ID is 314559.  A standard lot check investigation was performed.  All in-process quality checks for the lot in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the center and was released.  No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Eosinophil percentage decreased, Fibrin D dimer increased, Globulins increased, Pericardial effusion, Pericarditis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from an agency under the Freedom of Information Act.  A 16 year old female with a medical history of asthma, bronchial asthma, penicillin allergy, peanut allergy and allergy to pertussis vaccine ("screamed for hours"), was vaccinated with the first dose of GARDASIL (Lot #660393/0067X) IM in the left arm on 22-MAY-08.  Concomitant therapies include Ventolin, Zithromax, ibuprofen and prednisone.  On 24-MAY-2008, the patient experienced chest pain and pericarditis.  The patient went to the emergency room and was hospitalized.  On 31-MAY-2008, the patient experienced chest pain and dyspnoea.  On 01-JUN-2008, the patient experienced chest pain, pericardial effusion, and pericarditis on 03-JUN-2008.  The patient went to the emergency room and was hospitalized.  The diagnosis was pericarditis.  The patient presented with chest pain for about 10 days and 2 days after vaccination with GARDASIL.  No further information is available.  The patient's chest pain and pericarditis were considered immediately life threatening.  The originally reported source was not provided.  The VAERS ID is 314559.  A standard lot check investigation was performed.  All in-process quality checks for the lot in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the center and was released.  No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Protein total increased, White blood cell count increased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from an agency under the Freedom of Information Act.  A 16 year old female with a medical history of asthma, bronchial asthma, penicillin allergy, peanut allergy and allergy to pertussis vaccine ("screamed for hours"), was vaccinated with the first dose of GARDASIL (Lot #660393/0067X) IM in the left arm on 22-MAY-08.  Concomitant therapies include Ventolin, Zithromax, ibuprofen and prednisone.  On 24-MAY-2008, the patient experienced chest pain and pericarditis.  The patient went to the emergency room and was hospitalized.  On 31-MAY-2008, the patient experienced chest pain and dyspnoea.  On 01-JUN-2008, the patient experienced chest pain, pericardial effusion, and pericarditis on 03-JUN-2008.  The patient went to the emergency room and was hospitalized.  The diagnosis was pericarditis.  The patient presented with chest pain for about 10 days and 2 days after vaccination with GARDASIL.  No further information is available.  The patient's chest pain and pericarditis were considered immediately life threatening.  The originally reported source was not provided.  The VAERS ID is 314559.  A standard lot check investigation was performed.  All in-process quality checks for the lot in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the center and was released.  No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Death
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. on 28-MAY-2008 a 17 year old female with a history of seizures was vaccinated with her first dose of GARDASIL (lot # 658554/0928U) into the left arm. On 12-JUN-2008 she died. The cause of death is unknown. The original reporting source was not provided. The VAERS ID # is 316983. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specification. The lot met the requirements and was released. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Anaemia, Autoimmune disorder, Biopsy muscle abnormal, C-reactive protein increased, Computerised tomogram normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 year old female with no medical history, no known drug allergies and no previous illness was vaccinated intramuscularly into the left arm with a first dose of GARDASIL (Lot # 653735/0688F) on 13-JUL-2007. There was no concomitant therapy. The patient experienced autoimmune myositis, fasciitis, anemia, chronic autoimmune disease. Patient developed symptoms in ipsilateral arm about 3 weeks post vaccination, progressed to severe inflammatory autoimmune disease that has lasted for 1 year and is ongoing. On 09-JUL-2008 office notes received from the Rheumatologist from 07-SEP-2007 to 03-APR-2008 with diagnosis: Myositis/Fasciitis left arm. Patient developed left shoulder pain and decreased range of motion ROM in August 2007 which has persisted. Patient then developed forearm pain and swelling, elbow pain and pain upon extending fingers and wrist. Physical examination (+) for temporomandibular joint pain and inability to fully open mandible, tenderness of the anterior humeral head, upper inner aspect of the arm below the humeral head, and the lateral aspect of the left forearm. Pain upon dorsiflexion of left wrist. Swelling noted on left forearm. Started on prednisolone. Much improved by 11-OCT-2007 with prednisolone taper scheduled. Increased pain with decreased prednisolone. Dose increased and methotrexate started. Episode of inflammation left leg (ankle and shin pain) April 2008. The listing indicated that the events required an ER visit and one or more of the events was considered to be disabling and to be immediately life-threatening. This was originally reported by a physician. The VAERS ID # 318399. A standard lot check investigation was performed. All in-process quality checks for the lot in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements and was released. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fasciitis, Myositis, Red blood cell sedimentation rate increased, Serology normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 year old female with no medical history, no known drug allergies and no previous illness was vaccinated intramuscularly into the left arm with a first dose of GARDASIL (Lot # 653735/0688F) on 13-JUL-2007. There was no concomitant therapy. The patient experienced autoimmune myositis, fasciitis, anemia, chronic autoimmune disease. Patient developed symptoms in ipsilateral arm about 3 weeks post vaccination, progressed to severe inflammatory autoimmune disease that has lasted for 1 year and is ongoing. On 09-JUL-2008 office notes received from the Rheumatologist from 07-SEP-2007 to 03-APR-2008 with diagnosis: Myositis/Fasciitis left arm. Patient developed left shoulder pain and decreased range of motion ROM in August 2007 which has persisted. Patient then developed forearm pain and swelling, elbow pain and pain upon extending fingers and wrist. Physical examination (+) for temporomandibular joint pain and inability to fully open mandible, tenderness of the anterior humeral head, upper inner aspect of the arm below the humeral head, and the lateral aspect of the left forearm. Pain upon dorsiflexion of left wrist. Swelling noted on left forearm. Started on prednisolone. Much improved by 11-OCT-2007 with prednisolone taper scheduled. Increased pain with decreased prednisolone. Dose increased and methotrexate started. Episode of inflammation left leg (ankle and shin pain) April 2008. The listing indicated that the events required an ER visit and one or more of the events was considered to be disabling and to be immediately life-threatening. This was originally reported by a physician. The VAERS ID # 318399. A standard lot check investigation was performed. All in-process quality checks for the lot in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements and was released. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Anaemia, Arthralgia, Autoimmune disorder, Biopsy bone marrow normal, Biopsy muscle abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 year old female with no medical history, no known drug allergies and no previous illness was vaccinated intramuscularly into the left arm with a first dose of GARDASIL (Lot # 653735/0688F) on 13-JUL-2007. There was no concomitant therapy. The patient experienced autoimmune myositis, fasciitis, anemia, chronic autoimmune disease. Patient developed symptoms in ipsilateral arm about 3 weeks post vaccination, progressed to severe inflammatory autoimmune disease that has lasted for 1 year and is ongoing. On 09-JUL-2008 office notes received from the Rheumatologist from 07-SEP-2007 to 03-APR-2008 with diagnosis: Myositis/Fasciitis left arm. Patient developed left shoulder pain and decreased range of motion ROM in August 2007 which has persisted. Patient then developed forearm pain and swelling, elbow pain and pain upon extending fingers and wrist. Physical examination (+) for temporomandibular joint pain and inability to fully open mandible, tenderness of the anterior humeral head, upper inner aspect of the arm below the humeral head, and the lateral aspect of the left forearm. Pain upon dorsiflexion of left wrist. Swelling noted on left forearm. Started on prednisolone. Much improved by 11-OCT-2007 with prednisolone taper scheduled. Increased pain with decreased prednisolone. Dose increased and methotrexate started. Episode of inflammation left leg (ankle and shin pain) April 2008. The listing indicated that the events required an ER visit and one or more of the events was considered to be disabling and to be immediately life-threatening. This was originally reported by a physician. The VAERS ID # 318399. A standard lot check investigation was performed. All in-process quality checks for the lot in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements and was released. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: C-reactive protein increased, Computerised tomogram abnormal, Dyskinesia, Fasciitis, Haematocrit decreased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 year old female with no medical history, no known drug allergies and no previous illness was vaccinated intramuscularly into the left arm with a first dose of GARDASIL (Lot # 653735/0688F) on 13-JUL-2007. There was no concomitant therapy. The patient experienced autoimmune myositis, fasciitis, anemia, chronic autoimmune disease. Patient developed symptoms in ipsilateral arm about 3 weeks post vaccination, progressed to severe inflammatory autoimmune disease that has lasted for 1 year and is ongoing. On 09-JUL-2008 office notes received from the Rheumatologist from 07-SEP-2007 to 03-APR-2008 with diagnosis: Myositis/Fasciitis left arm. Patient developed left shoulder pain and decreased range of motion ROM in August 2007 which has persisted. Patient then developed forearm pain and swelling, elbow pain and pain upon extending fingers and wrist. Physical examination (+) for temporomandibular joint pain and inability to fully open mandible, tenderness of the anterior humeral head, upper inner aspect of the arm below the humeral head, and the lateral aspect of the left forearm. Pain upon dorsiflexion of left wrist. Swelling noted on left forearm. Started on prednisolone. Much improved by 11-OCT-2007 with prednisolone taper scheduled. Increased pain with decreased prednisolone. Dose increased and methotrexate started. Episode of inflammation left leg (ankle and shin pain) April 2008. The listing indicated that the events required an ER visit and one or more of the events was considered to be disabling and to be immediately life-threatening. This was originally reported by a physician. The VAERS ID # 318399. A standard lot check investigation was performed. All in-process quality checks for the lot in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements and was released. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Haemoglobin decreased, Inflammation, Musculoskeletal pain, Myositis, Oedema peripheral
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 year old female with no medical history, no known drug allergies and no previous illness was vaccinated intramuscularly into the left arm with a first dose of GARDASIL (Lot # 653735/0688F) on 13-JUL-2007. There was no concomitant therapy. The patient experienced autoimmune myositis, fasciitis, anemia, chronic autoimmune disease. Patient developed symptoms in ipsilateral arm about 3 weeks post vaccination, progressed to severe inflammatory autoimmune disease that has lasted for 1 year and is ongoing. On 09-JUL-2008 office notes received from the Rheumatologist from 07-SEP-2007 to 03-APR-2008 with diagnosis: Myositis/Fasciitis left arm. Patient developed left shoulder pain and decreased range of motion ROM in August 2007 which has persisted. Patient then developed forearm pain and swelling, elbow pain and pain upon extending fingers and wrist. Physical examination (+) for temporomandibular joint pain and inability to fully open mandible, tenderness of the anterior humeral head, upper inner aspect of the arm below the humeral head, and the lateral aspect of the left forearm. Pain upon dorsiflexion of left wrist. Swelling noted on left forearm. Started on prednisolone. Much improved by 11-OCT-2007 with prednisolone taper scheduled. Increased pain with decreased prednisolone. Dose increased and methotrexate started. Episode of inflammation left leg (ankle and shin pain) April 2008. The listing indicated that the events required an ER visit and one or more of the events was considered to be disabling and to be immediately life-threatening. This was originally reported by a physician. The VAERS ID # 318399. A standard lot check investigation was performed. All in-process quality checks for the lot in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements and was released. No further information is available.