chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.18
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: developed fever and rash approx. 10 to 12 days after mmr was giver on Jan. 1, 1998, after rash was gone they developed cough around Feb 11, 1998. Mother took patient to doctor on Feb 16. Dx w/ pharyngitis and told increase heart rate due to infection. Sent home w/ antibiotic. On Feb 17, patient vomiting, mother called doctor, MD orderde suppository over phone. Mother tried suppository for vomiting, did not work. Patient appeared to be getting worse. By 3:00 am Feb 18 mother took patient to ER. Patient died by 4:ooam. Autopsy ordered.  4/17/09 Autopsy report states COD as acute viral myocarditis & manner of death as natural.  Report also states patient had been seen by PCP for cold symptoms on 2/16/1998, dx w/pharyngitis & tx w/antibiotics.  Later that day, began vomiting, called clinic & tx w/suppositories. Coughing & vomiting continued & developed fever on 2/18.  Presented to ER on 2/18/98 w/very labored respirations & fever.  Shortly after arrival, went into cardiopulmonary arrest, resuscitation unsuccessful.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Pain in extremity
Clinical narrative: Appointment at 10:15am, pt. called 9:15pm complaining of right arm pain, not red, no fever, vomiting and stomach ache; ate out.
Age: 1.25
Sex: F
Vaccine: DTAP, MMRV, VARCEL
Symptoms: Herpes zoster, Pain
Clinical narrative: developed Herpes Zoster (C5 distribution) 03/21/2009
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient has a softball sized area at the site of administration. Area is painful, red, swollen, and warm to touch.  Patient does not have a fever or other complaints.
Age: 1.0
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Crying, Decreased appetite, Injection site erythema, Insomnia, Irritability
Clinical narrative: Started fever 6 hours after injection.  Tylenol given.Fussy. Appetite down and remains down.  Awoke whimpering with high fever (10 pm) Temp Rectal 105.1.  Left leg with red area that has increased in size at site of injection.  Still red today, still remains fussy, not sleeping or eating well. Fever persists but not as high.
Age: 1.0
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Pyrexia
Clinical narrative: Started fever 6 hours after injection.  Tylenol given.Fussy. Appetite down and remains down.  Awoke whimpering with high fever (10 pm) Temp Rectal 105.1.  Left leg with red area that has increased in size at site of injection.  Still red today, still remains fussy, not sleeping or eating well. Fever persists but not as high.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Dyspnoea, Rash, Urticaria
Clinical narrative: Patient received #2 VZV, #1 HPV, and #1 Tdap (had 5 previous DTP vaccines) 4-1-09 at the HC. At the OV on 4-1-09 patient also had a viral gastroenteritis, was afebrile.  While away, early AM on 4-4-09 patient developed a rash and SOB, taken to ER and diagnosed with "urticaria". Previous to rash child had been eating Cheetos and red Gatorade.   Returned to the HC 4-9-09 to see Dr. for re-check ER visit.  No symptoms or rash at recheck appointment.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Apnoea, Pulse absent
Clinical narrative: Patient brought in the clinic in the afternoon of April 8, 2009 for check-up and immunization.  He had mild congestion only, vital signs were normal, gaining weight, no previous medical problems.  Patient was given Pentacel, Hep B, Prevnar and Rotateq.  The next day, in AM patient was brought to local ER apneic and pulseless.  Patient pronounced dead at about 11:21AM.  8/17/09 Autopsy Report states Probable cause of death: Undetermined. Manner of death: Undetermined. Report additional notes: Preliminary Autopsy Findings - 1. Normally developed infant with height and weight at the 75th and 50th percentile respectively. 2. Rare thymic and epicardial petechia. 3. Bilateral lungs with small perivascular chronic inflammatory collections. 4. Pulmonary hemorrhage. 5. Microscopic mitral valve hemangioma. 6. Negative toxicological, microbiological, and neuropathology evaluations.  Other Significant Conditions - Co-sleeping with adult(s), new sleep environment, childhood immunizations within 48 hours of death.  4/17/09 Received ER medical records of 4/9/09. FINAL DX: cardiopulmonary arrest Records reveal patient experienced unresponsiveness, asystole, EMS started CPR & unableto intubate.  In ER, remained unresponsive w/fixed pupils, abd distention, pale & possible dependent lividity of back.  Intubated in ER but resuscitation efforts were unsuccessful.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Acute generalised exanthematous pustulosis, Pruritus, Rash generalised, Rash vesicular
Clinical narrative: During 5 week field exercise, patient was administered anthrax and smallpox vaccine, 05MAR09. Patient did follow-up note on 12MAR09 with no problems noted.  ~ 23MAR09, patient's rank collar insignia punctured skin in upper left chest.  Patient developed rash at that site.  Over next 2-3 days, patient developed a generalized pox appearing rash over most of body to include torso, face, extremities, genitalia.  Rash spared palms and soles.  Rash was itchy, but felt different from pain of vaccination site.  Patient presented to medical on 26MAR09.  Rash appeared like chickenpox, but mostly in same stage of development.  Patient had chickenpox between age 4-6.  There was no fever, chills, or systemic symptoms (other than pruritis.)  Medical Officer contacted vaccine manufacturer and MILVAX representatives.  Photos were sent to MILVAX via camera phone.  MILVAX felt that the patient's reaction was non-viral pustulosis.  Afterwards, the patient's rash was treated with benadryl.  It resolved over the next 3 days without complications.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Blood test, Convulsion, Cyanosis, Drooling, Febrile convulsion
Clinical narrative: Child recieved shots at health department- behind schedule.Received 6 vaccines. Around 8 hours later, dad found child having seizure, limp, blue, drooling. Rushed to ER. Pediatricians feels child had febrile seizure. At home 3/17/09 and follow up with MD 3/17/09. Mom says chil received 2 doses of Motrin during the time period and did not seem to have fever. Mother believes child nearly died.  4/14/09 Received ER medical records of 3/16/2009. FINAL DX: new onset first time seizure Records reveal patient experienced found by parent slumping over when sitting in bed, shaking, turned blue then limp & unresponsive for few minutes.  In ER afebrile & back to normal behavior.  D/C to home, no meds, w/PCP f/u.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Hypotonia, Inappropriate schedule of drug administration
Clinical narrative: Child recieved shots at health department- behind schedule.Received 6 vaccines. Around 8 hours later, dad found child having seizure, limp, blue, drooling. Rushed to ER. Pediatricians feels child had febrile seizure. At home 3/17/09 and follow up with MD 3/17/09. Mom says chil received 2 doses of Motrin during the time period and did not seem to have fever. Mother believes child nearly died.  4/14/09 Received ER medical records of 3/16/2009. FINAL DX: new onset first time seizure Records reveal patient experienced found by parent slumping over when sitting in bed, shaking, turned blue then limp & unresponsive for few minutes.  In ER afebrile & back to normal behavior.  D/C to home, no meds, w/PCP f/u.
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Crying, Injection site rash, Irritability
Clinical narrative: Patient bacame cranky cried her developed rash on her lower extrimities.Rash lasted for 1 hour patient consolable 1 n 20 minutes after the administration of the vacccines
Age: 8.0
Sex: F
Vaccine: IPV, TD
Symptoms: Body temperature increased, Injection site erythema, Injection site induration, Injection site swelling, Injection site urticaria
Clinical narrative: About 24 hours after TD was given pt started to run a low grade temp and had swelling of the injection site along with a hive. Mom was told to use cool comprises and benadryl and let us know if not improving. On 4/9/09 mom called office and states it was worse so at that time we had pt come in to office was seen by a FNP-BC in the office who states it was generalized erythema with firmness noted around injection site. Mom was then told to continue the Benadryl and cool comprises. and to call office if it does no improve.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient received Kinrix (DTaP,IPV, MMR & Varicella 04/07/09. He was seen in the office this date due to pain, itching and swelling in left arm for 2 days. He was prescribed Ibuprofen 11/2 tsp every 6 hours for 2 days and was given Benadryl 12.5 mg in the office
Age: 1.9
Sex: F
Vaccine: MEA
Symptoms: Pyrexia, Rash erythematous, Rhinorrhoea
Clinical narrative: Fever up to 102.5, rhinorrhea, and erythematous rash that began on cheeks and spread to neck, trunk then extremities. Further details can be obtained from mother at home number.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Death, Dyspnoea, Respiratory tract congestion, Vomiting
Clinical narrative: Started w/chest congestion/shortness of breath on 3/11/09 PM.  Vomiting, weakness on 3/12/09 PM.  Death occurred 11PM 3/12/09. 4/16/09 Death Cert received from reporter who stated pt died at home.  No Autopsy done.  Cause of Death:  Cardiac Arrest.  Coronary Artery Disease.  COPD
Age: 31.0
Sex: F
Vaccine: HEPA
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Underdose
Clinical narrative: This case was reported by a physician (also the father of the subject) and described the occurrence of vaccine underdose in a 31-year-old pregnant female subject who was vaccinated with HAVRIX (GlaxoSmithKline).  There were no concurrent medications.  On 5 March 2009 the subject received 1st dose of HAVRIX at 1.0 ml (1440 elisa units) in the left arm.  During vaccine administration, the needle was not secured on the prefilled syringe and some of the dose leaked out onto the subject's arm.  The physician was not sure how much of the dose the subject received.  This was considered to be a vaccine underdose and a case of vaccine exposure during pregnancy.  No adverse events were reported.  It was noted that the subject was due in 8 months from the time of reporting.  Follow-up information was received from the reporting physician on 30 March 2009.  It was reported that the vaccine spilled out before the total injection could be made.  Last menstrual period was unknown.  On an unspecified date, the subject had a miscarriage.  This case was assessed as medically serious by GSK.
Age: 16.0
Sex: F
Vaccine: DTAP, HPV4, MNQ
Symptoms: Blood culture negative, Urinary tract infection
Clinical narrative: Pt developed acute abdominal pain - 2 hrs after injection of (1) GARDASIL; (2) MENACTRA, (3) TDAP. Pt was evaluated in ER - diagnosis acute UTI. 48 hrs later admission to hospital. Tx IV's and antibiotics.  6/15/09 Received hospital medical records for 3/27-3/28/2009 & ER records for 3/25/09. FINAL DX: Urinary tract infection, low back pain. Records reveal patient experienced abdominal pain, and fever. Seen in ER for UTI and discharged. Admitted for further evaluation of RLQ abdominal and R flank pain. Lightheadedness, nasal congestion and drainage, nausea and constipation. Costovertebral angle tenderness on the right. Muscle spasms. Neck pain.  7/9/09 ICD-9 codes received: 599.0, Y724.2, YV45.2, 789.00, 780.60
Age: 16.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Oval hyperemic swelling on Rt upper arm at injection site 1"/1'/2"
Age: 22.0
Sex: F
Vaccine: IPV, TDAP
Symptoms: Pharyngeal oedema, Pruritus, Rash generalised, Throat irritation
Clinical narrative: On 3/25/09 at 1030 the pt received the TDAP and IPV in her right arm.  The pt woke at about 2230 with the sensation that her throat was swelling.  The pt had no wheezing or difficulty swallowing.  She noticed a rash on her arms, chest, abdomen and legs.  The rash was non raised, non pruritic, pinkish/red dime to nickel size lesions.  The pt took 3 (three) 25mg BENADRYL tabs and feel asleep within 20 minutes.  At that time her throat felt better.  When she woke in the am the rash had resolved and her throat felt itchy.  The itchy throat sensation resolved later that day.  The pt has had no symptoms since.  Symptoms: Rash, diffuse, Pruritus.
Age: 1.0
Sex: M
Vaccine: HEPA, PNC
Symptoms: Angioedema, Rash, Swelling
Clinical narrative: Swelling and rash reaction with angioedema.
Age: 13.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Dyskinesia, Gaze palsy, Musculoskeletal stiffness, Opisthotonus, Pallor
Clinical narrative: Within a few minutes client turned pale, stiffened body, arched back, arms curled to chest, eyes rolled back, head jerked back and forth. Lowered client to floor elevated and elevated legs. No injury.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Asthenia, Blood glucose normal, Blood pressure decreased, Pallor
Clinical narrative: Paleness, weakness BP prior to event 114/62, S/P 96/58 pulse 60 normal breath sounds.  Blood sugar = 82.
Age: 18.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Fall, Head injury, Loss of consciousness, Muscle twitching
Clinical narrative: 15 minutes after receiving vaccine started to "hum" fell over backwards hit head on floor, unconscious approx 10 seconds -> head twitching
Age: 16.0
Sex: F
Vaccine: HIBV
Symptoms: Wrong drug administered
Clinical narrative: Patient was in office to have meningococcal but was given a HIB injection instead.
Age: 33.0
Sex: M
Vaccine: ANTH, FLUN3, TDAP, TYP
Symptoms: Arthralgia, Body temperature increased, Feeling cold, Headache, Hypoaesthesia
Clinical narrative: Received vaccination on 3/31/09:  TDAP and TYPHOID right arm, FLUMIST and AVA #4 left arm.  On 1 April 09 pt noted a 3" circle of redness and swelling around the AVA injection site.  His pain was a 3-4/10.  He thought he might have a slight fever and that his lymph nodes on the left side of his neck were swollen.  The pt went to MSC on 4/2/09.  His temp was recorded as 100.1.  He continued with redness and swelling around the injection site left arm and complained of generalized joint pain (esp his hips) and a low grade headache.  He was prescribed MOTRIN and TYLENOL #3.  On 4/3/09 his joint pain was improved, but the pain in his left arm was worse as was the redness and swelling.  He was prescribed KEFLEX 500mg qid.  Today the pt's pain level is a 2/10, there is decreased swelling and redness at the site.  The pt states for the last 48 hours he has had intermittent left shoulder pain followed by a "cold numb feeling in his arm and left hand (all digits).  These symptoms can last for several minutes to one hour.  The pt was prescribed PREDNISONE 60mg X5 days with a 10mg taper per day.  On 04/9/09 the pt was reexamined.  He had no more left shoulder pain or left hand numbness.  The left arm swelling was completely resolved as was 90% of the erythema.  Symptoms: Pain, Numbness, Erythema, Edema @ injection site 50-120mm, Pain.
Age: 33.0
Sex: M
Vaccine: ANTH, FLUN3, TDAP, TYP
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling, Lymphadenopathy, Musculoskeletal pain
Clinical narrative: Received vaccination on 3/31/09:  TDAP and TYPHOID right arm, FLUMIST and AVA #4 left arm.  On 1 April 09 pt noted a 3" circle of redness and swelling around the AVA injection site.  His pain was a 3-4/10.  He thought he might have a slight fever and that his lymph nodes on the left side of his neck were swollen.  The pt went to MSC on 4/2/09.  His temp was recorded as 100.1.  He continued with redness and swelling around the injection site left arm and complained of generalized joint pain (esp his hips) and a low grade headache.  He was prescribed MOTRIN and TYLENOL #3.  On 4/3/09 his joint pain was improved, but the pain in his left arm was worse as was the redness and swelling.  He was prescribed KEFLEX 500mg qid.  Today the pt's pain level is a 2/10, there is decreased swelling and redness at the site.  The pt states for the last 48 hours he has had intermittent left shoulder pain followed by a "cold numb feeling in his arm and left hand (all digits).  These symptoms can last for several minutes to one hour.  The pt was prescribed PREDNISONE 60mg X5 days with a 10mg taper per day.  On 04/9/09 the pt was reexamined.  He had no more left shoulder pain or left hand numbness.  The left arm swelling was completely resolved as was 90% of the erythema.  Symptoms: Pain, Numbness, Erythema, Edema @ injection site 50-120mm, Pain.
Age: 33.0
Sex: M
Vaccine: ANTH, FLUN3, TDAP, TYP
Symptoms: Pain, Pain in extremity
Clinical narrative: Received vaccination on 3/31/09:  TDAP and TYPHOID right arm, FLUMIST and AVA #4 left arm.  On 1 April 09 pt noted a 3" circle of redness and swelling around the AVA injection site.  His pain was a 3-4/10.  He thought he might have a slight fever and that his lymph nodes on the left side of his neck were swollen.  The pt went to MSC on 4/2/09.  His temp was recorded as 100.1.  He continued with redness and swelling around the injection site left arm and complained of generalized joint pain (esp his hips) and a low grade headache.  He was prescribed MOTRIN and TYLENOL #3.  On 4/3/09 his joint pain was improved, but the pain in his left arm was worse as was the redness and swelling.  He was prescribed KEFLEX 500mg qid.  Today the pt's pain level is a 2/10, there is decreased swelling and redness at the site.  The pt states for the last 48 hours he has had intermittent left shoulder pain followed by a "cold numb feeling in his arm and left hand (all digits).  These symptoms can last for several minutes to one hour.  The pt was prescribed PREDNISONE 60mg X5 days with a 10mg taper per day.  On 04/9/09 the pt was reexamined.  He had no more left shoulder pain or left hand numbness.  The left arm swelling was completely resolved as was 90% of the erythema.  Symptoms: Pain, Numbness, Erythema, Edema @ injection site 50-120mm, Pain.
Age: 34.0
Sex: F
Vaccine: RAB
Symptoms: Nasopharyngitis, Oropharyngeal pain
Clinical narrative: Patient states she started having cold symptoms and a sore throat starting the day after the immunization.
Age: 34.0
Sex: M
Vaccine: RAB
Symptoms: Fatigue, Muscle tightness
Clinical narrative: Approximately 2 weeks after immunization, he states his muscles felt tight, and he states he felt more fatigued than normal. This lasted about 5 days.
Age: 14.0
Sex: U
Vaccine: HEPA, MNQ, TDAP
Symptoms: Back pain
Clinical narrative: Patient complaining of intermittent sharp mid to low back pain since last night.  Pain occurs when getting up from laying down position and forceful exertion.
Age: 15.0
Sex: F
Vaccine: TD, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 48 hrs after vaccine administered had swelling, redness, tender.  To RTR- 2" by 2" - raised red & swelling to L deltoid- 15mm by 15mm diffuse red.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Nausea, Pain, Pain in extremity
Clinical narrative: Patient came to our clinic on 4/9/09 at 10:05 accompanied by mother. Patient complains of body aces, nausea no vomiting, soreness in bilat. arms and 1cm elevated reddened area noted around injection site.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Injection site haemorrhage
Clinical narrative: Initial information was received on 21 November 2008 from a health care professional.  A cluster of approximately 20 cases of slight bleeding at the site who had received PENTACEL (lot number C3178AB).  The date of vaccination, route and site of administration was not reported.  The reporter noticed that all of the patients who received PENTACEL had slight bleeding which was not excessive, usually just a drop of blood.  The slight bleeding was also noticed at an other clinic.  The recovery status of the patients were not reported.  No further information was reported.  Follow up information was received on 26 January 2009 from a health care professional.  The reporter stated that the patients ages ranged from two to six months.  PENTACEL was reported as a first time dose.  The patients were reported as recovered.  No further information was provided.  List of Documents held by Sender: None.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Hypersomnia, Insomnia
Clinical narrative: Initial report was received on 08 December 2008 from a consumer (patient's mother). A 4-month-old male with a history of being 33 weeks premature at birth and a milk protein intolerance had received a first dose of PENTACEL (lot number C3199AA) intramuscularly in the right thigh, an initial dose of ROTATEQ (manufacturer Merck, lot number 1886U) orally and an initial dose of PREVNAR (manufacturer Wyeth, lot number C68312) intramuscularly in the left thigh on 07 October 2008. The patient's mother reported that on 07 October 2008 the patient slept for 48 hours post vaccination. Then the patient was wide awake for five to six days with periods of up to 12 hours awake at a time. The patient had a doctor's visit (date not reported). The patient's recovery status was unknown at the time of the report. Documents held by sender: None.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Confusional state, Lumbar puncture, Myalgia, Oropharyngeal pain
Clinical narrative: 10/08/07 sore, scratchy throat- 10/09/07 (3:00pm) fever 103, chills, myalgia, confusion
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Throat irritation
Clinical narrative: 10/08/07 sore, scratchy throat- 10/09/07 (3:00pm) fever 103, chills, myalgia, confusion
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain, Activities of daily living impaired, Alopecia, Amnesia, Antinuclear antibody
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, concerning a 16 year old female with no relevant medical history reported, who on 11-NOV-2008 was vaccinated with the first dose of GARDASIL, lot number 660616/0570X, intramuscularly, into the left arm. It was reported that the patient experienced chronic debilitating headaches, chronic diarrhea, severe back and abdominal pain, tingling in hands and feet, numbness in hands and feet, stabbing pain lower legs and feet, inability to stand, inability to walk, difficulty breathing, swollen lips, chest pain in conjunction with neck pain, loss of hair, chronic debilitating fatigue, nausea, vomiting, short term memory loss, inability to concentrate, stares off in the distance for long periods of time. It was reported that the patient started these right after the vaccination and continue to 12-NOV-2008 and had made patient's life as she knew it unmanageable. She could no longer attend school. Numerous trips to her pediatrician, blood test (erythrocyte sedimentation rate), Anti-streptolysin O, free thyroxin index, thyroid stimulating hormone, antinuclear titer, Anti-DS-DNA, EBV AB profile, fluorescent antinuclear antibody, urine tests, stool tests, cardiac enzymes, EKG, chest X-ray, CAT Scan (results not provided). There were a lot of emergency room visits, referred to neurologist and nutritionist. No one knew how to treat her. There was no treatment apparently. The neurological testing was scheduled for the next week. The listing indicated that one or more of the events was considered to be disabling, was considered to be immediately life-threatening. No further information is available. 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 specifications. The lot met the requirements of the Center and was released. The original reporting source was not provided. The VAERS ID # is 340807. No further information is available. This report was filed with the FDA. The VAER number is 340807.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Back pain, Blood thyroid stimulating hormone, Culture stool, Culture urine, Diarrhoea
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, concerning a 16 year old female with no relevant medical history reported, who on 11-NOV-2008 was vaccinated with the first dose of GARDASIL, lot number 660616/0570X, intramuscularly, into the left arm. It was reported that the patient experienced chronic debilitating headaches, chronic diarrhea, severe back and abdominal pain, tingling in hands and feet, numbness in hands and feet, stabbing pain lower legs and feet, inability to stand, inability to walk, difficulty breathing, swollen lips, chest pain in conjunction with neck pain, loss of hair, chronic debilitating fatigue, nausea, vomiting, short term memory loss, inability to concentrate, stares off in the distance for long periods of time. It was reported that the patient started these right after the vaccination and continue to 12-NOV-2008 and had made patient's life as she knew it unmanageable. She could no longer attend school. Numerous trips to her pediatrician, blood test (erythrocyte sedimentation rate), Anti-streptolysin O, free thyroxin index, thyroid stimulating hormone, antinuclear titer, Anti-DS-DNA, EBV AB profile, fluorescent antinuclear antibody, urine tests, stool tests, cardiac enzymes, EKG, chest X-ray, CAT Scan (results not provided). There were a lot of emergency room visits, referred to neurologist and nutritionist. No one knew how to treat her. There was no treatment apparently. The neurological testing was scheduled for the next week. The listing indicated that one or more of the events was considered to be disabling, was considered to be immediately life-threatening. No further information is available. 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 specifications. The lot met the requirements of the Center and was released. The original reporting source was not provided. The VAERS ID # is 340807. No further information is available. This report was filed with the FDA. The VAER number is 340807.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Disturbance in attention, Dyspnoea, Dysstasia, Electrocardiogram, Fatigue
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, concerning a 16 year old female with no relevant medical history reported, who on 11-NOV-2008 was vaccinated with the first dose of GARDASIL, lot number 660616/0570X, intramuscularly, into the left arm. It was reported that the patient experienced chronic debilitating headaches, chronic diarrhea, severe back and abdominal pain, tingling in hands and feet, numbness in hands and feet, stabbing pain lower legs and feet, inability to stand, inability to walk, difficulty breathing, swollen lips, chest pain in conjunction with neck pain, loss of hair, chronic debilitating fatigue, nausea, vomiting, short term memory loss, inability to concentrate, stares off in the distance for long periods of time. It was reported that the patient started these right after the vaccination and continue to 12-NOV-2008 and had made patient's life as she knew it unmanageable. She could no longer attend school. Numerous trips to her pediatrician, blood test (erythrocyte sedimentation rate), Anti-streptolysin O, free thyroxin index, thyroid stimulating hormone, antinuclear titer, Anti-DS-DNA, EBV AB profile, fluorescent antinuclear antibody, urine tests, stool tests, cardiac enzymes, EKG, chest X-ray, CAT Scan (results not provided). There were a lot of emergency room visits, referred to neurologist and nutritionist. No one knew how to treat her. There was no treatment apparently. The neurological testing was scheduled for the next week. The listing indicated that one or more of the events was considered to be disabling, was considered to be immediately life-threatening. No further information is available. 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 specifications. The lot met the requirements of the Center and was released. The original reporting source was not provided. The VAERS ID # is 340807. No further information is available. This report was filed with the FDA. The VAER number is 340807.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Free thyroxine index, Headache, Hypoaesthesia, Lip swelling, Nausea
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, concerning a 16 year old female with no relevant medical history reported, who on 11-NOV-2008 was vaccinated with the first dose of GARDASIL, lot number 660616/0570X, intramuscularly, into the left arm. It was reported that the patient experienced chronic debilitating headaches, chronic diarrhea, severe back and abdominal pain, tingling in hands and feet, numbness in hands and feet, stabbing pain lower legs and feet, inability to stand, inability to walk, difficulty breathing, swollen lips, chest pain in conjunction with neck pain, loss of hair, chronic debilitating fatigue, nausea, vomiting, short term memory loss, inability to concentrate, stares off in the distance for long periods of time. It was reported that the patient started these right after the vaccination and continue to 12-NOV-2008 and had made patient's life as she knew it unmanageable. She could no longer attend school. Numerous trips to her pediatrician, blood test (erythrocyte sedimentation rate), Anti-streptolysin O, free thyroxin index, thyroid stimulating hormone, antinuclear titer, Anti-DS-DNA, EBV AB profile, fluorescent antinuclear antibody, urine tests, stool tests, cardiac enzymes, EKG, chest X-ray, CAT Scan (results not provided). There were a lot of emergency room visits, referred to neurologist and nutritionist. No one knew how to treat her. There was no treatment apparently. The neurological testing was scheduled for the next week. The listing indicated that one or more of the events was considered to be disabling, was considered to be immediately life-threatening. No further information is available. 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 specifications. The lot met the requirements of the Center and was released. The original reporting source was not provided. The VAERS ID # is 340807. No further information is available. This report was filed with the FDA. The VAER number is 340807.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Neck pain, Pain in extremity, Paraesthesia, Staring, Streptococcal identification test
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, concerning a 16 year old female with no relevant medical history reported, who on 11-NOV-2008 was vaccinated with the first dose of GARDASIL, lot number 660616/0570X, intramuscularly, into the left arm. It was reported that the patient experienced chronic debilitating headaches, chronic diarrhea, severe back and abdominal pain, tingling in hands and feet, numbness in hands and feet, stabbing pain lower legs and feet, inability to stand, inability to walk, difficulty breathing, swollen lips, chest pain in conjunction with neck pain, loss of hair, chronic debilitating fatigue, nausea, vomiting, short term memory loss, inability to concentrate, stares off in the distance for long periods of time. It was reported that the patient started these right after the vaccination and continue to 12-NOV-2008 and had made patient's life as she knew it unmanageable. She could no longer attend school. Numerous trips to her pediatrician, blood test (erythrocyte sedimentation rate), Anti-streptolysin O, free thyroxin index, thyroid stimulating hormone, antinuclear titer, Anti-DS-DNA, EBV AB profile, fluorescent antinuclear antibody, urine tests, stool tests, cardiac enzymes, EKG, chest X-ray, CAT Scan (results not provided). There were a lot of emergency room visits, referred to neurologist and nutritionist. No one knew how to treat her. There was no treatment apparently. The neurological testing was scheduled for the next week. The listing indicated that one or more of the events was considered to be disabling, was considered to be immediately life-threatening. No further information is available. 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 specifications. The lot met the requirements of the Center and was released. The original reporting source was not provided. The VAERS ID # is 340807. No further information is available. This report was filed with the FDA. The VAER number is 340807.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Vomiting
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, concerning a 16 year old female with no relevant medical history reported, who on 11-NOV-2008 was vaccinated with the first dose of GARDASIL, lot number 660616/0570X, intramuscularly, into the left arm. It was reported that the patient experienced chronic debilitating headaches, chronic diarrhea, severe back and abdominal pain, tingling in hands and feet, numbness in hands and feet, stabbing pain lower legs and feet, inability to stand, inability to walk, difficulty breathing, swollen lips, chest pain in conjunction with neck pain, loss of hair, chronic debilitating fatigue, nausea, vomiting, short term memory loss, inability to concentrate, stares off in the distance for long periods of time. It was reported that the patient started these right after the vaccination and continue to 12-NOV-2008 and had made patient's life as she knew it unmanageable. She could no longer attend school. Numerous trips to her pediatrician, blood test (erythrocyte sedimentation rate), Anti-streptolysin O, free thyroxin index, thyroid stimulating hormone, antinuclear titer, Anti-DS-DNA, EBV AB profile, fluorescent antinuclear antibody, urine tests, stool tests, cardiac enzymes, EKG, chest X-ray, CAT Scan (results not provided). There were a lot of emergency room visits, referred to neurologist and nutritionist. No one knew how to treat her. There was no treatment apparently. The neurological testing was scheduled for the next week. The listing indicated that one or more of the events was considered to be disabling, was considered to be immediately life-threatening. No further information is available. 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 specifications. The lot met the requirements of the Center and was released. The original reporting source was not provided. The VAERS ID # is 340807. No further information is available. This report was filed with the FDA. The VAER number is 340807.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abasia, Abdominal pain, Activities of daily living impaired, Alopecia, Amnesia
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, concerning a 16 year old female with no relevant medical history reported, who on 11-NOV-2008 was vaccinated with the first dose of GARDASIL, lot number 660616/0570X, intramuscularly, into the left arm. It was reported that the patient experienced chronic debilitating headaches, chronic diarrhea, severe back and abdominal pain, tingling in hands and feet, numbness in hands and feet, stabbing pain lower legs and feet, inability to stand, inability to walk, difficulty breathing, swollen lips, chest pain in conjunction with neck pain, loss of hair, chronic debilitating fatigue, nausea, vomiting, short term memory loss, inability to concentrate, stares off in the distance for long periods of time. It was reported that the patient started these right after the vaccination and continue to 12-NOV-2008 and had made patient's life as she knew it unmanageable. She could no longer attend school. Numerous trips to her pediatrician, blood test (erythrocyte sedimentation rate), Anti-streptolysin O, free thyroxin index, thyroid stimulating hormone, antinuclear titer, Anti-DS-DNA, EBV AB profile, fluorescent antinuclear antibody, urine tests, stool tests, cardiac enzymes, EKG, chest X-ray, CAT Scan (results not provided). There were a lot of emergency room visits, referred to neurologist and nutritionist. No one knew how to treat her. There was no treatment apparently. The neurological testing was scheduled for the next week. The listing indicated that one or more of the events was considered to be disabling, was considered to be immediately life-threatening. No further information is available. 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 specifications. The lot met the requirements of the Center and was released. The original reporting source was not provided. The VAERS ID # is 340807. No further information is available. This report was filed with the FDA. The VAER number is 340807.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Antinuclear antibody, Back pain, Blood thyroid stimulating hormone, Cardiac enzymes, Chest X-ray
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, concerning a 16 year old female with no relevant medical history reported, who on 11-NOV-2008 was vaccinated with the first dose of GARDASIL, lot number 660616/0570X, intramuscularly, into the left arm. It was reported that the patient experienced chronic debilitating headaches, chronic diarrhea, severe back and abdominal pain, tingling in hands and feet, numbness in hands and feet, stabbing pain lower legs and feet, inability to stand, inability to walk, difficulty breathing, swollen lips, chest pain in conjunction with neck pain, loss of hair, chronic debilitating fatigue, nausea, vomiting, short term memory loss, inability to concentrate, stares off in the distance for long periods of time. It was reported that the patient started these right after the vaccination and continue to 12-NOV-2008 and had made patient's life as she knew it unmanageable. She could no longer attend school. Numerous trips to her pediatrician, blood test (erythrocyte sedimentation rate), Anti-streptolysin O, free thyroxin index, thyroid stimulating hormone, antinuclear titer, Anti-DS-DNA, EBV AB profile, fluorescent antinuclear antibody, urine tests, stool tests, cardiac enzymes, EKG, chest X-ray, CAT Scan (results not provided). There were a lot of emergency room visits, referred to neurologist and nutritionist. No one knew how to treat her. There was no treatment apparently. The neurological testing was scheduled for the next week. The listing indicated that one or more of the events was considered to be disabling, was considered to be immediately life-threatening. No further information is available. 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 specifications. The lot met the requirements of the Center and was released. The original reporting source was not provided. The VAERS ID # is 340807. No further information is available. This report was filed with the FDA. The VAER number is 340807.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Chest pain, Computerised tomogram, Diarrhoea, Disturbance in attention, Dyspnoea
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, concerning a 16 year old female with no relevant medical history reported, who on 11-NOV-2008 was vaccinated with the first dose of GARDASIL, lot number 660616/0570X, intramuscularly, into the left arm. It was reported that the patient experienced chronic debilitating headaches, chronic diarrhea, severe back and abdominal pain, tingling in hands and feet, numbness in hands and feet, stabbing pain lower legs and feet, inability to stand, inability to walk, difficulty breathing, swollen lips, chest pain in conjunction with neck pain, loss of hair, chronic debilitating fatigue, nausea, vomiting, short term memory loss, inability to concentrate, stares off in the distance for long periods of time. It was reported that the patient started these right after the vaccination and continue to 12-NOV-2008 and had made patient's life as she knew it unmanageable. She could no longer attend school. Numerous trips to her pediatrician, blood test (erythrocyte sedimentation rate), Anti-streptolysin O, free thyroxin index, thyroid stimulating hormone, antinuclear titer, Anti-DS-DNA, EBV AB profile, fluorescent antinuclear antibody, urine tests, stool tests, cardiac enzymes, EKG, chest X-ray, CAT Scan (results not provided). There were a lot of emergency room visits, referred to neurologist and nutritionist. No one knew how to treat her. There was no treatment apparently. The neurological testing was scheduled for the next week. The listing indicated that one or more of the events was considered to be disabling, was considered to be immediately life-threatening. No further information is available. 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 specifications. The lot met the requirements of the Center and was released. The original reporting source was not provided. The VAERS ID # is 340807. No further information is available. This report was filed with the FDA. The VAER number is 340807.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dysstasia, Electrocardiogram, Epstein-Barr virus antibody, Fatigue, Free thyroxine index
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, concerning a 16 year old female with no relevant medical history reported, who on 11-NOV-2008 was vaccinated with the first dose of GARDASIL, lot number 660616/0570X, intramuscularly, into the left arm. It was reported that the patient experienced chronic debilitating headaches, chronic diarrhea, severe back and abdominal pain, tingling in hands and feet, numbness in hands and feet, stabbing pain lower legs and feet, inability to stand, inability to walk, difficulty breathing, swollen lips, chest pain in conjunction with neck pain, loss of hair, chronic debilitating fatigue, nausea, vomiting, short term memory loss, inability to concentrate, stares off in the distance for long periods of time. It was reported that the patient started these right after the vaccination and continue to 12-NOV-2008 and had made patient's life as she knew it unmanageable. She could no longer attend school. Numerous trips to her pediatrician, blood test (erythrocyte sedimentation rate), Anti-streptolysin O, free thyroxin index, thyroid stimulating hormone, antinuclear titer, Anti-DS-DNA, EBV AB profile, fluorescent antinuclear antibody, urine tests, stool tests, cardiac enzymes, EKG, chest X-ray, CAT Scan (results not provided). There were a lot of emergency room visits, referred to neurologist and nutritionist. No one knew how to treat her. There was no treatment apparently. The neurological testing was scheduled for the next week. The listing indicated that one or more of the events was considered to be disabling, was considered to be immediately life-threatening. No further information is available. 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 specifications. The lot met the requirements of the Center and was released. The original reporting source was not provided. The VAERS ID # is 340807. No further information is available. This report was filed with the FDA. The VAER number is 340807.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Hypoaesthesia, Lip swelling, Nausea, Neck pain
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, concerning a 16 year old female with no relevant medical history reported, who on 11-NOV-2008 was vaccinated with the first dose of GARDASIL, lot number 660616/0570X, intramuscularly, into the left arm. It was reported that the patient experienced chronic debilitating headaches, chronic diarrhea, severe back and abdominal pain, tingling in hands and feet, numbness in hands and feet, stabbing pain lower legs and feet, inability to stand, inability to walk, difficulty breathing, swollen lips, chest pain in conjunction with neck pain, loss of hair, chronic debilitating fatigue, nausea, vomiting, short term memory loss, inability to concentrate, stares off in the distance for long periods of time. It was reported that the patient started these right after the vaccination and continue to 12-NOV-2008 and had made patient's life as she knew it unmanageable. She could no longer attend school. Numerous trips to her pediatrician, blood test (erythrocyte sedimentation rate), Anti-streptolysin O, free thyroxin index, thyroid stimulating hormone, antinuclear titer, Anti-DS-DNA, EBV AB profile, fluorescent antinuclear antibody, urine tests, stool tests, cardiac enzymes, EKG, chest X-ray, CAT Scan (results not provided). There were a lot of emergency room visits, referred to neurologist and nutritionist. No one knew how to treat her. There was no treatment apparently. The neurological testing was scheduled for the next week. The listing indicated that one or more of the events was considered to be disabling, was considered to be immediately life-threatening. No further information is available. 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 specifications. The lot met the requirements of the Center and was released. The original reporting source was not provided. The VAERS ID # is 340807. No further information is available. This report was filed with the FDA. The VAER number is 340807.