chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Dizziness, Erythema, Eye pain, Headache
Clinical narrative: 08/19/2007 Had severe pain in left arm above, below and at site of injection with in an hour. Took 3 reg ADVIL, used heat on arm and went to bed. On 08/20/2007, awoke with severe pain in left arm from top of shoulder to elbow then into fingertips, intolerable headache, dizziness, fever 100.5, nausea, gagging, very weak and eye pain. Went to urgent care to report reaction with physicians office. Suggested rest, ice and Benadryl. 08/23/2007 Arm becoming more swollen and redness expanding further into the arm. Visited doctor at clinic on 08/23/2007 with reaction measured sizes of 10x10 cm swelling, 4x6 cm redness. Reported this reaction to both clinic and to my regular clinic. Physician advised to continue resting, use ice and drink plenty fluids. Two weeks after Tdap shot regained most of my physical strength with continued pain and weakness in left arm. Pain in left arm muscle continued for another month after doctors visit on 08/23/2007, but eventually subsided as all the swelling in the muscle dissipated.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Muscle swelling, Myalgia, Nausea, Oedema peripheral
Clinical narrative: 08/19/2007 Had severe pain in left arm above, below and at site of injection with in an hour. Took 3 reg ADVIL, used heat on arm and went to bed. On 08/20/2007, awoke with severe pain in left arm from top of shoulder to elbow then into fingertips, intolerable headache, dizziness, fever 100.5, nausea, gagging, very weak and eye pain. Went to urgent care to report reaction with physicians office. Suggested rest, ice and Benadryl. 08/23/2007 Arm becoming more swollen and redness expanding further into the arm. Visited doctor at clinic on 08/23/2007 with reaction measured sizes of 10x10 cm swelling, 4x6 cm redness. Reported this reaction to both clinic and to my regular clinic. Physician advised to continue resting, use ice and drink plenty fluids. Two weeks after Tdap shot regained most of my physical strength with continued pain and weakness in left arm. Pain in left arm muscle continued for another month after doctors visit on 08/23/2007, but eventually subsided as all the swelling in the muscle dissipated.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Pyrexia, Retching
Clinical narrative: 08/19/2007 Had severe pain in left arm above, below and at site of injection with in an hour. Took 3 reg ADVIL, used heat on arm and went to bed. On 08/20/2007, awoke with severe pain in left arm from top of shoulder to elbow then into fingertips, intolerable headache, dizziness, fever 100.5, nausea, gagging, very weak and eye pain. Went to urgent care to report reaction with physicians office. Suggested rest, ice and Benadryl. 08/23/2007 Arm becoming more swollen and redness expanding further into the arm. Visited doctor at clinic on 08/23/2007 with reaction measured sizes of 10x10 cm swelling, 4x6 cm redness. Reported this reaction to both clinic and to my regular clinic. Physician advised to continue resting, use ice and drink plenty fluids. Two weeks after Tdap shot regained most of my physical strength with continued pain and weakness in left arm. Pain in left arm muscle continued for another month after doctors visit on 08/23/2007, but eventually subsided as all the swelling in the muscle dissipated.
Age: 10.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Anger, Fatigue, Pyrexia
Clinical narrative: 1 day post PO oral typhoid:  fever, angry, tired.  "Feels like to shout".
Age: 10.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Pyrexia
Clinical narrative: 1 day post PO oral typhoid:  fever, angry, tired.  "Feels like to shout".
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Cough, Hypersensitivity, Increased upper airway secretion, Nasopharyngitis, Pain
Clinical narrative: Pt recd Hep B #1 reports cold sxs, body aches, runny nose, cough and phlegm, fever within 24 hours of vaccination, sxs lasting until today (02/15/09) with fever only. Pt reports only spring allergy sxs, never in winter.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Pt recd Hep B #1 reports cold sxs, body aches, runny nose, cough and phlegm, fever within 24 hours of vaccination, sxs lasting until today (02/15/09) with fever only. Pt reports only spring allergy sxs, never in winter.
Age: 18.0
Sex: M
Vaccine: FLUN3, HEPA, MNQ, FLUN3, HEPA, MNQ, FLUN3, HEPA, MNQ
Symptoms: Blindness, Headache, Optic neuritis
Clinical narrative: Initial report was received from a physician on 11 February 2008. An 18-year-old male patient with no past medical history, had received an injection of Menactra, lot number U2391BA (route/site not reported), and an injection of Hepatitis A vaccine, lot number U2598 (manufacturer Merck, route/site not reported), and a dose of FluMist, manufacturer Wyeth (lot number not reported), on 07 January 2008 and approximately one to two weeks later, he complained of a headache and began loosing his vision. He was diagnosed by an ophthalmologist as having optic neuritis and began receiving corrective treatment with high dose steroids. At the time of the report, the patient had not recovered from the event. No further information was provided.  02/20/2008 MR received from PCP which included vax record and WCC of 1/7/08. Record is somewhat illegible.  F/U TC 2/12/08 with DX of optic neuritis made by another MD (ophthamologist). 06/04/2008 MR received from ophthamolgist beginning 02/05-28/2008 with DX: Optic Neuritis.  Pt presented with c/o foggy vision, eye pain and H/A which started after immunizations. Swollen nerves noted on exam. Return visit 2/8/08 with worsening vision and H/As. Tx with steroids. Disc edema bilaterally noted on photography of fundus. Improvement noted by 2/28/08.
Age: 18.0
Sex: M
Vaccine: FLUN3, HEPA, MNQ, FLUN3, HEPA, MNQ, FLUN3, HEPA, MNQ
Symptoms: Blindness, Headache, Ophthalmological examination abnormal, Optic neuritis
Clinical narrative: Initial report was received from a physician on 11 February 2008. An 18-year-old male patient with no past medical history, had received an injection of Menactra, lot number U2391BA (route/site not reported), and an injection of Hepatitis A vaccine, lot number U2598 (manufacturer Merck, route/site not reported), and a dose of FluMist, manufacturer Wyeth (lot number not reported), on 07 January 2008 and approximately one to two weeks later, he complained of a headache and began loosing his vision. He was diagnosed by an ophthalmologist as having optic neuritis and began receiving corrective treatment with high dose steroids. At the time of the report, the patient had not recovered from the event. No further information was provided.  02/20/2008 MR received from PCP which included vax record and WCC of 1/7/08. Record is somewhat illegible.  F/U TC 2/12/08 with DX of optic neuritis made by another MD (ophthamologist). 06/04/2008 MR received from ophthamolgist beginning 02/05-28/2008 with DX: Optic Neuritis.  Pt presented with c/o foggy vision, eye pain and H/A which started after immunizations. Swollen nerves noted on exam. Return visit 2/8/08 with worsening vision and H/As. Tx with steroids. Disc edema bilaterally noted on photography of fundus. Improvement noted by 2/28/08.
Age: 18.0
Sex: M
Vaccine: FLUN3, HEPA, MNQ, FLUN3, HEPA, MNQ, FLUN3, HEPA, MNQ
Symptoms: Blindness, Headache, Lumbar puncture, Nuclear magnetic resonance imaging normal, Optic neuritis
Clinical narrative: Initial report was received from a physician on 11 February 2008. An 18-year-old male patient with no past medical history, had received an injection of Menactra, lot number U2391BA (route/site not reported), and an injection of Hepatitis A vaccine, lot number U2598 (manufacturer Merck, route/site not reported), and a dose of FluMist, manufacturer Wyeth (lot number not reported), on 07 January 2008 and approximately one to two weeks later, he complained of a headache and began loosing his vision. He was diagnosed by an ophthalmologist as having optic neuritis and began receiving corrective treatment with high dose steroids. At the time of the report, the patient had not recovered from the event. No further information was provided.  02/20/2008 MR received from PCP which included vax record and WCC of 1/7/08. Record is somewhat illegible.  F/U TC 2/12/08 with DX of optic neuritis made by another MD (ophthamologist). 06/04/2008 MR received from ophthamolgist beginning 02/05-28/2008 with DX: Optic Neuritis.  Pt presented with c/o foggy vision, eye pain and H/A which started after immunizations. Swollen nerves noted on exam. Return visit 2/8/08 with worsening vision and H/As. Tx with steroids. Disc edema bilaterally noted on photography of fundus. Improvement noted by 2/28/08.
Age: 18.0
Sex: M
Vaccine: FLUN3, HEPA, MNQ, FLUN3, HEPA, MNQ, FLUN3, HEPA, MNQ
Symptoms: Vision blurred
Clinical narrative: Initial report was received from a physician on 11 February 2008. An 18-year-old male patient with no past medical history, had received an injection of Menactra, lot number U2391BA (route/site not reported), and an injection of Hepatitis A vaccine, lot number U2598 (manufacturer Merck, route/site not reported), and a dose of FluMist, manufacturer Wyeth (lot number not reported), on 07 January 2008 and approximately one to two weeks later, he complained of a headache and began loosing his vision. He was diagnosed by an ophthalmologist as having optic neuritis and began receiving corrective treatment with high dose steroids. At the time of the report, the patient had not recovered from the event. No further information was provided.  02/20/2008 MR received from PCP which included vax record and WCC of 1/7/08. Record is somewhat illegible.  F/U TC 2/12/08 with DX of optic neuritis made by another MD (ophthamologist). 06/04/2008 MR received from ophthamolgist beginning 02/05-28/2008 with DX: Optic Neuritis.  Pt presented with c/o foggy vision, eye pain and H/A which started after immunizations. Swollen nerves noted on exam. Return visit 2/8/08 with worsening vision and H/As. Tx with steroids. Disc edema bilaterally noted on photography of fundus. Improvement noted by 2/28/08.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Crying
Clinical narrative: Excessive crying greater than 3 hours after immunizations.  Inconsolable.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Irritability, Pyrexia
Clinical narrative: Diarrhea (7 days), fever (1 day), fussiness (7 days).
Age: 38.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Nausea
Clinical narrative: I took the first of four doses on Thurs, Feb 14 at about 5 pm, with no adverse effects.  I took the second of four doses at about 11:30 am on 2/16.  About 4 hours, around 4:00 pm that afternoon I experienced periodic stomach cramps and feeling of mild nausea.  I did not take the third and fourth dose.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Oral herpes
Clinical narrative: Six days after receiving the live zoster vaccine I started to develop a cold sore.  Of course, I can't swear the events are related, but I am not normally prone to cold sores and probably haven't had one in the last twenty years.  I promptly called my doctor and got a prescription for Valtrex which I took and the cold sore, which had already started to blister, seems to be healing nicely.  Just wanted people to know this occurred.
Age: 0.27
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Clinical narrative: Pt was reported dead to us by mom this morning.  She stated death was around 4:00 am.  5/9/08 Autopsy report states COD as sudden unexplained death in infancy.  Autopsy report also states patient was found in prone sleeping position on soft bedding w/soft pillow partially covering mouth/nose.  Had been placed in bassinet on back on a soft pillow.  Patient was large for his age weighing 19.6 lbs. Patient had seen PCP approx 11-12 days prior for ear infection & had finished his antibiotibcs.  No problems noted on day of vaccination or afterward.  PCP had noted that patient was overweight & parents counseled to reduce feeding.
Age: 13.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Induration, Oedema peripheral, Skin warm
Clinical narrative: Mother called in on 2/10/2008 to our office to report a reaction to an immunization.  There was an area on the left arm that was warm and swollen.  The middle was red and hard and the size of a quarter.  Ice helps.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: Received immunization and had a 5 inch diameter red, warm, hard lump; no fever.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, VARCEL
Symptoms: Body temperature increased, Injection site warmth
Clinical narrative: 2/16/2008:Call from family to Hospital Pediatric Nurse line to report a reaction to shots given on 2/15/2008.  One injection site is hot to the touch, increased from penny size to 3 inches across. Onset was "yesterday evening".  Temp 100.8; did not specify which extremity was affected.
Age: 0.18
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Apnoea, CSF test normal, Chest X-ray abnormal, Computerised tomogram normal, Culture negative
Clinical narrative: Patient was seen in our office for his 2 mo well child exam on 2/11/08.  Mom reported 4 days of cough but no fever.  His exam was WNL including normal vital signs (afebrile, RR 40, SaO2 100% RA), and normal lung exam.  He received immunizations as listed below.  Later that day he was noted to be difficult to arouse and have increased work of breathing with retractions, possible eye deviation (no frank seizure activity) and decreased responsiveness.  He was taken to a local emergency department where he was found to have 20-30 second periods of apnea and was intubated and transferred to Hospital.  His laboratory evaluation (CBC, urine, CSF) was all normal and all cultures have been negative to date.  Nasal swabs for influenza, RSV, and pertussis were all negative.  CXR revealed bilateral infiltrates.  He was extubated on 2/15 and in completing 7 days of IV antibiotics for possible pneumonia.  There is concern that an unwitnessed seizure may have precipitated the apneic event and he is undergoing neurologic evaluation at this time.  To date a head CT was done and was normal.  He remains an inpatient in stable condition. 2/27/08-records received for DOS 12/11-12/18/07-DX DX: Seizures. Admitted with apneic spells, intubated, full sepsis workup negative.
Age: 0.18
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Depressed level of consciousness, Dyspnoea, Full blood count normal, Gaze palsy, Intercostal retraction
Clinical narrative: Patient was seen in our office for his 2 mo well child exam on 2/11/08.  Mom reported 4 days of cough but no fever.  His exam was WNL including normal vital signs (afebrile, RR 40, SaO2 100% RA), and normal lung exam.  He received immunizations as listed below.  Later that day he was noted to be difficult to arouse and have increased work of breathing with retractions, possible eye deviation (no frank seizure activity) and decreased responsiveness.  He was taken to a local emergency department where he was found to have 20-30 second periods of apnea and was intubated and transferred to Hospital.  His laboratory evaluation (CBC, urine, CSF) was all normal and all cultures have been negative to date.  Nasal swabs for influenza, RSV, and pertussis were all negative.  CXR revealed bilateral infiltrates.  He was extubated on 2/15 and in completing 7 days of IV antibiotics for possible pneumonia.  There is concern that an unwitnessed seizure may have precipitated the apneic event and he is undergoing neurologic evaluation at this time.  To date a head CT was done and was normal.  He remains an inpatient in stable condition. 2/27/08-records received for DOS 12/11-12/18/07-DX DX: Seizures. Admitted with apneic spells, intubated, full sepsis workup negative.
Age: 0.18
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Intubation, Lung infiltration, Pertussis identification test negative, Urine analysis normal
Clinical narrative: Patient was seen in our office for his 2 mo well child exam on 2/11/08.  Mom reported 4 days of cough but no fever.  His exam was WNL including normal vital signs (afebrile, RR 40, SaO2 100% RA), and normal lung exam.  He received immunizations as listed below.  Later that day he was noted to be difficult to arouse and have increased work of breathing with retractions, possible eye deviation (no frank seizure activity) and decreased responsiveness.  He was taken to a local emergency department where he was found to have 20-30 second periods of apnea and was intubated and transferred to Hospital.  His laboratory evaluation (CBC, urine, CSF) was all normal and all cultures have been negative to date.  Nasal swabs for influenza, RSV, and pertussis were all negative.  CXR revealed bilateral infiltrates.  He was extubated on 2/15 and in completing 7 days of IV antibiotics for possible pneumonia.  There is concern that an unwitnessed seizure may have precipitated the apneic event and he is undergoing neurologic evaluation at this time.  To date a head CT was done and was normal.  He remains an inpatient in stable condition. 2/27/08-records received for DOS 12/11-12/18/07-DX DX: Seizures. Admitted with apneic spells, intubated, full sepsis workup negative.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Diarrhoea, Erythema, Flushing, Hypersensitivity
Clinical narrative: We received from a nurse via the Medical Communication the following information on 12 OCT 2007: A 52-year-old woman, born on 11 MAR 1955, was vaccinated with 0.5 ml Fluvirin, batch-no. 80682, i.m. on 10 OCT 2007. In the evening of vaccination day she began to experience abdominal cramping and loose stools. The following day around lunchtime the patient's face became flush, knees, elbows, forearms and mouth became bright red, she experienced burning sensation around mouth and went to Emergency Room where she was believed to be having an allergic reaction. The reported symptoms, except for burning sensation around the mouth, abdominal cramps and loose stools, are expected after vaccination with Fluvirin. On a case level, the case is considered expected. No change in benefit-risk-ratio. No measures necessary. Addendum: We received from the reporting nurse additional information on 06 FEB 2008: The patient is an employee of a hospital. She went to the Emergency Room for evaluation. She indicated at the time that the only thing different that had occurred was that she received the flu vaccine 24 hours earlier. Later she confirmed that the symptoms related to a virus that she had acquired and there is not relationship to the vaccination with Fluvirin.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Oral discomfort
Clinical narrative: We received from a nurse via the Medical Communication the following information on 12 OCT 2007: A 52-year-old woman, born on 11 MAR 1955, was vaccinated with 0.5 ml Fluvirin, batch-no. 80682, i.m. on 10 OCT 2007. In the evening of vaccination day she began to experience abdominal cramping and loose stools. The following day around lunchtime the patient's face became flush, knees, elbows, forearms and mouth became bright red, she experienced burning sensation around mouth and went to Emergency Room where she was believed to be having an allergic reaction. The reported symptoms, except for burning sensation around the mouth, abdominal cramps and loose stools, are expected after vaccination with Fluvirin. On a case level, the case is considered expected. No change in benefit-risk-ratio. No measures necessary. Addendum: We received from the reporting nurse additional information on 06 FEB 2008: The patient is an employee of a hospital. She went to the Emergency Room for evaluation. She indicated at the time that the only thing different that had occurred was that she received the flu vaccine 24 hours earlier. Later she confirmed that the symptoms related to a virus that she had acquired and there is not relationship to the vaccination with Fluvirin.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Slight swelling, about quarter size erythema area to left arm.  Pt. complain affected area is itchy.
Age: 37.0
Sex: F
Vaccine: SMALL
Symptoms: Axillary pain, Cellulitis, Erythema, Injection site pustule, Skin warm
Clinical narrative: Pt received small pox vaccine 2/6/08; read 2/13/08 major reaction.  On 2/14/08 noted redness, tender warm area approx 3" diameter surrounding pustule, tender L axilla.  Diag: cellulitis L deltoid secondary to smallpox vaccine.  Rx: Levaquin 750 mg one PO qd #5.  Symptoms resolved after 3 days on Levaquin.
Age: 37.0
Sex: F
Vaccine: SMALL
Symptoms: Tenderness
Clinical narrative: Pt received small pox vaccine 2/6/08; read 2/13/08 major reaction.  On 2/14/08 noted redness, tender warm area approx 3" diameter surrounding pustule, tender L axilla.  Diag: cellulitis L deltoid secondary to smallpox vaccine.  Rx: Levaquin 750 mg one PO qd #5.  Symptoms resolved after 3 days on Levaquin.
Age: 1.0
Sex: F
Vaccine: HEP, PNC, VARCEL
Symptoms: Rash
Clinical narrative: Pt present in office on 2/4/08 with rash that had started 2 days prior.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature, Erythema, Skin warm, Tenderness
Clinical narrative: Warm, pink/red tender area.  No fluctuance.  Temp 99.1.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Blood urine present
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 26-JUN-2007 was vaccinated with her first dose of GARDASIL (Lot # 657872/0515U). Concomitant therapy included MENACTRA. On 26-JUN-2007 the patient experienced blood in urine. The patient sought unspecified medical attention. On 27-JUN-2007, the patient recovered from having blood in urine. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2008. Information has been received from a physician concerning a 17 year old female who on 26-JUN-2007 was vaccinated intramuscularly in the right deltoid with her first dose of GARDASIL vaccine (Lot # 657872/0515U). Concomitant therapy included MENACTRA vaccine. On 26-JUN-2007 the patient experienced blood in urine. The blood in the urine continued through out day and night. The urine was pink then turned tea color in the morning, and returned to yellow the next day. The patient sought unspecified medical attention. On 27-JUN-2007 the patient recovered from having blood in urine. No additional information is expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Information has been received from a physician concerning a 22 year old female who on 28-DEC-2007 was vaccinated with a dose of Gardasil (lot# 655327/1287U).  Within 15 minutes, the patient fainted.  It was reported that the patient sat for 15 minutes and when she walked into the waiting room she passed out for about a minute.  An ambulance was called but the patient was not admitted to the hospital.  The patient experienced fainting and passed out.  Unspecified medical attention was sought.  Subsequently, the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4, MMR, VARCEL
Symptoms: Rash generalised
Clinical narrative: Information has been received from a physician concerning a 10 year old female who on 30-SEP-2007 was vaccinated with her 1st dose of Gardasil (Lot# 658558/1061U).  Suspect therapy included MMR II (MSD) (duration and dose not reported).  Subsequently the patient developed a rash all over her body.  The vaccine was discontinued due to the experience from the 30-SEP-2007 vaccination.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2008.  Initial and follow-up information has been received from a physician concerning a 10 year old female with no pre-existing allergies, birth defects, medical conditions or illnesses at the time of vaccination, who on 30-SEP-2007 was vaccinated with her 1st dose of GARDASIL (Lot# 659558/1061U).  Suspect therapy also included MMRII (duration and dose not reported), and VARIVAX (lot # 657997/0844U) subcutaneously to the left deltoid.  The patient developed a rash on the chest that spread to her back.  She was diagnosed with impetigo but the rash continued to spread.  On 05-OCT-2007 she saw a dermatologist who performed a punch biopsy that was "negative" and she was diagnosed with eczema (eczematous dermatitis) with environmental cause.  She had bloodwork performed on 16-OCT-2007 that showed eosinophils at 12.0 M.  It was reported that the patient recovered on an unspecified date.  No additional information is expected.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pharyngeal oedema, Urticaria
Clinical narrative: Information has been received from a licensed practical nurse concerning an 18 year old female with seizure disorder who on 16-JUL-2007 was vaccinated IM with a 0.5 ml first dose of GARDASIL (lot #657868/0523U). Concomitant therapy included DEPAKOTE, SEASONALE and LAMICTAL. Subsequently the patient experienced hives and "throat swelling." Subsequently, the patient recovered. On an unspecified date, the patient was vaccinated with a second dose of GARDASIL. Subsequently the patient experienced hives and "throat swelling." Subsequently, the patient recovered. The patient reported the event at an unrelated office visit. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pharyngeal oedema, Urticaria, Vaccine positive rechallenge
Clinical narrative: Information has been received from a licensed practical nurse concerning an 18 year old female with seizure disorder who on 16-JUL-2007 was vaccinated IM with a 0.5 ml first dose of GARDASIL (lot #657868/0523U). Concomitant therapy included DEPAKOTE, SEASONALE and LAMICTAL. Subsequently the patient experienced hives and "throat swelling." Subsequently, the patient recovered. On an unspecified date, the patient was vaccinated with a second dose of GARDASIL. Subsequently the patient experienced hives and "throat swelling." Subsequently, the patient recovered. The patient reported the event at an unrelated office visit. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: FLUX, HPV4, HPV4, HPV4
Symptoms: Blood test normal, Convulsion, Corrective lens user, Decreased appetite, Diplegia
Clinical narrative: Information has been received from a newspaper article concerning a 16 year old female who on 06-NOV-2007 was vaccinated with a dose of Gardasil. Three weeks post vaccination, the patient woke up to not being able to walk or feel her legs. The patient was taken to the hospital and admitted with guillain barre syndrome. For four days, the patient was paralyzed from the top of her knee down. Details of hospitalization were not reported. Subsequently, the patient was tired all the time with passing out episodes and not feeling well. The patient's mother reported that the patient underwent 2 MRIs and many blood tests. The treating health care workers are stating that it is stress, and the patient was placed on therapy with PROZAC. At the time of this report, the outcome was unknown. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: FLUX, HPV4, HPV4, HPV4
Symptoms: Dizziness, Fatigue, Fatigue, Headache, Hypersomnia
Clinical narrative: Information has been received from a newspaper article concerning a 16 year old female who on 06-NOV-2007 was vaccinated with a dose of Gardasil. Three weeks post vaccination, the patient woke up to not being able to walk or feel her legs. The patient was taken to the hospital and admitted with guillain barre syndrome. For four days, the patient was paralyzed from the top of her knee down. Details of hospitalization were not reported. Subsequently, the patient was tired all the time with passing out episodes and not feeling well. The patient's mother reported that the patient underwent 2 MRIs and many blood tests. The treating health care workers are stating that it is stress, and the patient was placed on therapy with PROZAC. At the time of this report, the outcome was unknown. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: FLUX, HPV4, HPV4, HPV4
Symptoms: Hypophagia, Loss of consciousness, Nuclear magnetic resonance imaging normal, Oral mucosal blistering, Sensation of heaviness
Clinical narrative: Information has been received from a newspaper article concerning a 16 year old female who on 06-NOV-2007 was vaccinated with a dose of Gardasil. Three weeks post vaccination, the patient woke up to not being able to walk or feel her legs. The patient was taken to the hospital and admitted with guillain barre syndrome. For four days, the patient was paralyzed from the top of her knee down. Details of hospitalization were not reported. Subsequently, the patient was tired all the time with passing out episodes and not feeling well. The patient's mother reported that the patient underwent 2 MRIs and many blood tests. The treating health care workers are stating that it is stress, and the patient was placed on therapy with PROZAC. At the time of this report, the outcome was unknown. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: FLUX, HPV4, HPV4, HPV4
Symptoms: Weight decreased
Clinical narrative: Information has been received from a newspaper article concerning a 16 year old female who on 06-NOV-2007 was vaccinated with a dose of Gardasil. Three weeks post vaccination, the patient woke up to not being able to walk or feel her legs. The patient was taken to the hospital and admitted with guillain barre syndrome. For four days, the patient was paralyzed from the top of her knee down. Details of hospitalization were not reported. Subsequently, the patient was tired all the time with passing out episodes and not feeling well. The patient's mother reported that the patient underwent 2 MRIs and many blood tests. The treating health care workers are stating that it is stress, and the patient was placed on therapy with PROZAC. At the time of this report, the outcome was unknown. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: FLUX, HPV4, HPV4, HPV4
Symptoms: Convulsion, Dizziness, Guillain-Barre syndrome, Hyperventilation, Hypoaesthesia
Clinical narrative: Information has been received from a newspaper article concerning a 16 year old female who on 06-NOV-2007 was vaccinated with a dose of Gardasil. Three weeks post vaccination, the patient woke up to not being able to walk or feel her legs. The patient was taken to the hospital and admitted with guillain barre syndrome. For four days, the patient was paralyzed from the top of her knee down. Details of hospitalization were not reported. Subsequently, the patient was tired all the time with passing out episodes and not feeling well. The patient's mother reported that the patient underwent 2 MRIs and many blood tests. The treating health care workers are stating that it is stress, and the patient was placed on therapy with PROZAC. At the time of this report, the outcome was unknown. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: FLUX, HPV4, HPV4, HPV4
Symptoms: Laboratory test, Loss of consciousness, Neurological examination, Oropharyngeal blistering, Syncope
Clinical narrative: Information has been received from a newspaper article concerning a 16 year old female who on 06-NOV-2007 was vaccinated with a dose of Gardasil. Three weeks post vaccination, the patient woke up to not being able to walk or feel her legs. The patient was taken to the hospital and admitted with guillain barre syndrome. For four days, the patient was paralyzed from the top of her knee down. Details of hospitalization were not reported. Subsequently, the patient was tired all the time with passing out episodes and not feeling well. The patient's mother reported that the patient underwent 2 MRIs and many blood tests. The treating health care workers are stating that it is stress, and the patient was placed on therapy with PROZAC. At the time of this report, the outcome was unknown. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: FLUX, HPV4, HPV4, HPV4
Symptoms: Abasia, Blood test, Fatigue, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Information has been received from a newspaper article concerning a 16 year old female who on 06-NOV-2007 was vaccinated with a dose of Gardasil. Three weeks post vaccination, the patient woke up to not being able to walk or feel her legs. The patient was taken to the hospital and admitted with guillain barre syndrome. For four days, the patient was paralyzed from the top of her knee down. Details of hospitalization were not reported. Subsequently, the patient was tired all the time with passing out episodes and not feeling well. The patient's mother reported that the patient underwent 2 MRIs and many blood tests. The treating health care workers are stating that it is stress, and the patient was placed on therapy with PROZAC. At the time of this report, the outcome was unknown. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: FLUX, HPV4, HPV4, HPV4
Symptoms: Laboratory test, Loss of consciousness, Malaise, Nuclear magnetic resonance imaging, Paralysis
Clinical narrative: Information has been received from a newspaper article concerning a 16 year old female who on 06-NOV-2007 was vaccinated with a dose of Gardasil. Three weeks post vaccination, the patient woke up to not being able to walk or feel her legs. The patient was taken to the hospital and admitted with guillain barre syndrome. For four days, the patient was paralyzed from the top of her knee down. Details of hospitalization were not reported. Subsequently, the patient was tired all the time with passing out episodes and not feeling well. The patient's mother reported that the patient underwent 2 MRIs and many blood tests. The treating health care workers are stating that it is stress, and the patient was placed on therapy with PROZAC. At the time of this report, the outcome was unknown. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: FLUX, HPV4, HPV4, HPV4
Symptoms: Stress
Clinical narrative: Information has been received from a newspaper article concerning a 16 year old female who on 06-NOV-2007 was vaccinated with a dose of Gardasil. Three weeks post vaccination, the patient woke up to not being able to walk or feel her legs. The patient was taken to the hospital and admitted with guillain barre syndrome. For four days, the patient was paralyzed from the top of her knee down. Details of hospitalization were not reported. Subsequently, the patient was tired all the time with passing out episodes and not feeling well. The patient's mother reported that the patient underwent 2 MRIs and many blood tests. The treating health care workers are stating that it is stress, and the patient was placed on therapy with PROZAC. At the time of this report, the outcome was unknown. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, FLUX, HPV4, MNQ
Symptoms: Contusion, Immediate post-injection reaction, Injury, Syncope
Clinical narrative: Information has been received from a healthcare professional concerning a 14 year old female who was vaccinated intramuscularly with Gardasil.  Concomitant therapy included influenza virus vaccine (unspecified).  Per the reporter the patient passed out in the 15 minute wait period after receiving the vaccine.  Subsequently, the patient recovered from having passed out in the 15 minute wait period after receiving the vaccine.  No further information was provided and no lot number was given.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2008.  Initial and follow-up information has been received from a healthcare professional concerning a 14 year old female (also reported as 15 year old) who was vaccinated intramuscularly wit her third dose of GARDASIL (Lot #659437/1266U, site and route not reported).  Concomitant therapy included influenza virus vaccine (unspecified), also reported MENACTRA (lot # U2562AA).  Per the reporter the patient passed out in the 15 minute wait period after receiving the vaccine.  The patient hit her head and mouth on the counter when he fainted.  the patient permanent tooth damage form the fall.  Subsequently, the patient recovered from having passed out in the 15 minute wait period after receiving the vaccine.  No further information was provided.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, FLUX, HPV4, MNQ
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a healthcare professional concerning a 14 year old female who was vaccinated intramuscularly with Gardasil.  Concomitant therapy included influenza virus vaccine (unspecified).  Per the reporter the patient passed out in the 15 minute wait period after receiving the vaccine.  Subsequently, the patient recovered from having passed out in the 15 minute wait period after receiving the vaccine.  No further information was provided and no lot number was given.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2008.  Initial and follow-up information has been received from a healthcare professional concerning a 14 year old female (also reported as 15 year old) who was vaccinated intramuscularly wit her third dose of GARDASIL (Lot #659437/1266U, site and route not reported).  Concomitant therapy included influenza virus vaccine (unspecified), also reported MENACTRA (lot # U2562AA).  Per the reporter the patient passed out in the 15 minute wait period after receiving the vaccine.  The patient hit her head and mouth on the counter when he fainted.  the patient permanent tooth damage form the fall.  Subsequently, the patient recovered from having passed out in the 15 minute wait period after receiving the vaccine.  No further information was provided.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Lethargy, Musculoskeletal stiffness, Pyrexia, Rash
Clinical narrative: Initial and follow up information has been received from a licensed practical nurse, concerning an 18 year old white female with drug allergies to cefprozil (CEFZIL) and codeine, who on 26-DEC-2007 was vaccinated IM in the left deltoid, with the first dose of Gardasil (lot # 655327/1287U).  Concomitant medication included YASMIN and SARAFEM.  There was no illness at the time of vaccination.  On 06-JAN-2008, the patient developed a rash.  The patient was referred to an allergist.  By 14-JAN-2008, the patient had developed welts and joint swelling, along with stiffness and lethargy.  The LPN noted that the patient's physician (another facility) diagnosed serum sickness (treatment not specified).  At the time of this report, the outcome of the events was unknown.  Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Urticaria
Clinical narrative: Initial and follow up information has been received from a licensed practical nurse, concerning an 18 year old white female with drug allergies to cefprozil (CEFZIL) and codeine, who on 26-DEC-2007 was vaccinated IM in the left deltoid, with the first dose of Gardasil (lot # 655327/1287U).  Concomitant medication included YASMIN and SARAFEM.  There was no illness at the time of vaccination.  On 06-JAN-2008, the patient developed a rash.  The patient was referred to an allergist.  By 14-JAN-2008, the patient had developed welts and joint swelling, along with stiffness and lethargy.  The LPN noted that the patient's physician (another facility) diagnosed serum sickness (treatment not specified).  At the time of this report, the outcome of the events was unknown.  Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Joint swelling, Lethargy, Musculoskeletal stiffness, Rash, Serum sickness
Clinical narrative: Initial and follow up information has been received from a licensed practical nurse, concerning an 18 year old white female with drug allergies to cefprozil (CEFZIL) and codeine, who on 26-DEC-2007 was vaccinated IM in the left deltoid, with the first dose of Gardasil (lot # 655327/1287U).  Concomitant medication included YASMIN and SARAFEM.  There was no illness at the time of vaccination.  On 06-JAN-2008, the patient developed a rash.  The patient was referred to an allergist.  By 14-JAN-2008, the patient had developed welts and joint swelling, along with stiffness and lethargy.  The LPN noted that the patient's physician (another facility) diagnosed serum sickness (treatment not specified).  At the time of this report, the outcome of the events was unknown.  Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Information has been received from a registered nurse concerning a 25 year old female with no medical history and no drug allergies, who on 01-NOV-2007 was vaccinated intramuscularly with a 0.5mL first dose of Gardasil.  There was no concomitant medication.  Subsequently, three days post vaccination, the patient developed swollen lymph nodes and congestion.  On 11-JAN-2008 the patient was vaccinated with a second dose of Gardasil.  Subsequently, the patient experienced congestion and pain in her left eye.  The patient sought unspecified medical attention.  A sonogram was performed of the patient's lymph nodes.  At the time of the report, the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested. 07/08/08 Initial and follow-up information has been received from a registered nurse concerning a 25 year old female with no medical history and no drug allergies, who on 01-NOV-2007 was vaccinated intramuscularly with a 0.5mL first dose of GARDASIL. There was no concomitant medication. Subsequently, three days post vaccination, the patient developed swollen lymph nodes, congestion, and pain in the axillary area. On 11-JAN-2008 the patient was vaccinated with a second dose of GARDASIL. Subsequently, the patient experienced congestion and pain in her left eye. The patient sought unspecified medical attention. A sonogram was performed of the patient's lymph nodes. The ultrasound showed slight lymphadenopathy. The patient recovered from the axillary pain and slight lymphadenopathy on an unspecified date. No product quality complaint was involved. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Eye pain, Lymphadenopathy, Nasal congestion, Ultrasound scan, Ultrasound scan abnormal
Clinical narrative: Information has been received from a registered nurse concerning a 25 year old female with no medical history and no drug allergies, who on 01-NOV-2007 was vaccinated intramuscularly with a 0.5mL first dose of Gardasil.  There was no concomitant medication.  Subsequently, three days post vaccination, the patient developed swollen lymph nodes and congestion.  On 11-JAN-2008 the patient was vaccinated with a second dose of Gardasil.  Subsequently, the patient experienced congestion and pain in her left eye.  The patient sought unspecified medical attention.  A sonogram was performed of the patient's lymph nodes.  At the time of the report, the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested. 07/08/08 Initial and follow-up information has been received from a registered nurse concerning a 25 year old female with no medical history and no drug allergies, who on 01-NOV-2007 was vaccinated intramuscularly with a 0.5mL first dose of GARDASIL. There was no concomitant medication. Subsequently, three days post vaccination, the patient developed swollen lymph nodes, congestion, and pain in the axillary area. On 11-JAN-2008 the patient was vaccinated with a second dose of GARDASIL. Subsequently, the patient experienced congestion and pain in her left eye. The patient sought unspecified medical attention. A sonogram was performed of the patient's lymph nodes. The ultrasound showed slight lymphadenopathy. The patient recovered from the axillary pain and slight lymphadenopathy on an unspecified date. No product quality complaint was involved. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hypoaesthesia, Influenza like illness, Injection site anaesthesia, Injection site pain, Limb discomfort
Clinical narrative: Information has been received from a consumer concerning her 24 year old daughter with no medical history and allergies to penicillin, sulfonamide and azithromycin who on 18-OCT-2007, was vaccinated IM with a first dose of GARDASIL. On 18-DEC-2007, the patient was vaccinated with a second dose of GARDASIL. There was no concomitant medication. On 18-DEC-2007, after she received the vaccination, the patient experienced soreness and numbness in her arm where the vaccine was given. It was also reported that she felt very achy, as if she was coming down with something and felt very ill. The consumer also mentioned that after her daughter received her first dose of the vaccine she had pain at the injection site. Unspecified medical attention was sought.  No laboratory diagnostic studies were performed. At the time of this report, the patient had not recovered. Follow up information stated that the patient had full range of motion in the arm she received the injection in. No product quality complaint was involved. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain
Clinical narrative: Information has been received from a consumer concerning her 24 year old daughter with no medical history and allergies to penicillin, sulfonamide and azithromycin who on 18-OCT-2007, was vaccinated IM with a first dose of GARDASIL. On 18-DEC-2007, the patient was vaccinated with a second dose of GARDASIL. There was no concomitant medication. On 18-DEC-2007, after she received the vaccination, the patient experienced soreness and numbness in her arm where the vaccine was given. It was also reported that she felt very achy, as if she was coming down with something and felt very ill. The consumer also mentioned that after her daughter received her first dose of the vaccine she had pain at the injection site. Unspecified medical attention was sought.  No laboratory diagnostic studies were performed. At the time of this report, the patient had not recovered. Follow up information stated that the patient had full range of motion in the arm she received the injection in. No product quality complaint was involved. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hypoaesthesia, Injection site pain, Malaise, Pain, Pain in extremity
Clinical narrative: Information has been received from a consumer concerning her 24 year old daughter with no medical history and allergies to penicillin, sulfonamide and azithromycin who on 18-OCT-2007, was vaccinated IM with a first dose of GARDASIL. On 18-DEC-2007, the patient was vaccinated with a second dose of GARDASIL. There was no concomitant medication. On 18-DEC-2007, after she received the vaccination, the patient experienced soreness and numbness in her arm where the vaccine was given. It was also reported that she felt very achy, as if she was coming down with something and felt very ill. The consumer also mentioned that after her daughter received her first dose of the vaccine she had pain at the injection site. Unspecified medical attention was sought.  No laboratory diagnostic studies were performed. At the time of this report, the patient had not recovered. Follow up information stated that the patient had full range of motion in the arm she received the injection in. No product quality complaint was involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, FLU3, HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old white female who on an unspecified date was vaccinated with a first dose of GARDASIL. On 03-DEC-2007, the patient was vaccinated with a second dose of  GARDASIL (lot # 659437/1266U) IM in the left arm. Concomitant therapy included a first dose of FLUZONE also given on 03-DEC-2007 (lot # U2481AA) IM in the left arm. On 03-DEC-2007, the patient experienced dizziness after leaving the office. On 03-DEC-2007, the patient recovered from the dizziness. No further information from the dizziness. No further information is available .