chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of administration of expired FluMist has been received from a nurse concerning a seven-year-old male.  Neither medical history nor concomitant medications were provided.  The patient received FluMist on 14-Mar-2008.  The FluMist had expired on 10-Mar-2008.  The reporter stated that she received 100 doses of FluMist from the Vaccines For Children Program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008.  The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients.  The patient had no adverse events at the time the report was received, neither as of 18-Apr-2008 when the office was contacted for follow-up information.  The event has resolved.  It was not reported whether or not FluMist was re-administered.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  Follow-up information received 18-Apr-2008 and incorporated into the narrative: no adverse event occurred.  This case is linked to the following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006659; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of administration of expired FluMist has been received from a nurse concerning a five-year old male. Neither medical history nor concomitant medications were provided. The patient received FluMist on 14-Mar-2008. The FluMist had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FluMist from the Vaccines For Children Program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. The patient had no adverse events at the time the report was received, neither as of 18-Apr-2008 when the office was contacted for follow-up information. The event has resolved. It was not reported whether or not FluMist was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow-up information received 18-Apr-2008 and incorporated into the narrative: no adverse event occurred. This case is linked to the following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006659; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of administration of expired FluMist has been received from a nurse concerning a five-year old male. Neither medical history nor concomitant medications were provided. The patient received FluMist on 14-Mar-2008. The FluMist had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FluMist from the Vaccines For Children Program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 26 patients. The patient had no adverse events at the time the report was received, neither as of 18-Apr-2008 when the office was contacted for follow-up information. The event has resolved. It was not reported whether or not FluMist was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow-up information received 18-Apr-2008 and incorporated into the narrative: no adverse event occurred. This case is linked to the following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006659; MEDI-0006683; MEDI-0006684.
Age: 11.0
Sex: M
Vaccine: FLUN3
Symptoms: Anaphylactic reaction, Eye swelling, Heart rate increased, Oxygen saturation normal, Sneezing
Clinical narrative: A serious, spontaneous case of anaphylactic reaction, throat tightness, swollen eyes, hives, wheezing and sneezing has been received from a nurse in an 11-year-old male. Drug and medical history indicated the child was in his sixth year of receiving a series of allergy shots for cat, dog, birch, maple, oak, ragweed, duct, mite and mold. The child has had mild reactions to the allergy shots in the past. It was reported the child had no allergy to eggs but is allergic to sulfa drugs. He has had frequent ear infections and has ADHD. The patient received FluMist intranasally as well as allergy shots at approximately the same time on 24-Oct-2007. The reporter indicated that twenty minutes after administration the child had an anaphylactic reaction including tightness of the throat, swollen eyes, hives, wheezing and sneezing. The child was administered epinephrine and Benadryl; 20 minutes after the treatment his oxygen saturation was 99% and heart rate 105, his chest was clear and the hives resolved. He was transported to the ER where he was observed and released later the same day. The reporter indicated the events resolved the same day. No further information is available on FluMist dosing. The reporter indicated the child's physician and his allergist both thought the reaction was due to FluMist. The reporting source of this case is spontaneous, thus the sponsor's thus the sponsor's comment is not applicable.
Age: 11.0
Sex: M
Vaccine: FLUN3
Symptoms: Throat tightness, Urticaria, Wheezing
Clinical narrative: A serious, spontaneous case of anaphylactic reaction, throat tightness, swollen eyes, hives, wheezing and sneezing has been received from a nurse in an 11-year-old male. Drug and medical history indicated the child was in his sixth year of receiving a series of allergy shots for cat, dog, birch, maple, oak, ragweed, duct, mite and mold. The child has had mild reactions to the allergy shots in the past. It was reported the child had no allergy to eggs but is allergic to sulfa drugs. He has had frequent ear infections and has ADHD. The patient received FluMist intranasally as well as allergy shots at approximately the same time on 24-Oct-2007. The reporter indicated that twenty minutes after administration the child had an anaphylactic reaction including tightness of the throat, swollen eyes, hives, wheezing and sneezing. The child was administered epinephrine and Benadryl; 20 minutes after the treatment his oxygen saturation was 99% and heart rate 105, his chest was clear and the hives resolved. He was transported to the ER where he was observed and released later the same day. The reporter indicated the events resolved the same day. No further information is available on FluMist dosing. The reporter indicated the child's physician and his allergist both thought the reaction was due to FluMist. The reporting source of this case is spontaneous, thus the sponsor's thus the sponsor's comment is not applicable.
Age: 9.0
Sex: M
Vaccine: FLUN3, VARCEL
Symptoms: Anaphylactic reaction, Dyspnoea, Face oedema, Livedo reticularis, Wheezing
Clinical narrative: A serious life-threatening report has been received from a nurse concerning a nine-year-old male experiencing an anaphylaxis reaction. No medical or drug history has been reported for the patient. The patient received both FLUMIST and VARIVAX vaccinations on 30-Oct-2007. Within five minutes of receiving the FLUMIST and VARIVAX vaccines, the patient experienced an anaphylaxis reaction described as wheezing, shortness of breath, facial edema and facial mottling. He was transported to the hospital. No additional information regarding treatment or outcome was available at the time of this report. Additional dosing of FLUMIST was not reported. The reporter did not provide a causality assessment. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Asthma, Hypoxia, Influenza, Influenza serology positive, Wheezing
Clinical narrative: A serious report of hypoxia, exacerbation of asthma, and positive for influenza A and B has been received from a physician concerning an eight- year-old male. The patient had a medical history of asthma and was seen in the physician's office on 20-NOV-2007, for a wheezing episode that occurred on 27-Nov-2007. No concomitant medications were reported. The patient received FLUMIST on 28-Nov-2007. On 06-Dec-2007, the patient was hospitalized with hypoxia and exacerbation of asthma. On 09-Dec-2007, the physician tested the patient for influenza and a nasopharynx wash was positive for influenza types A and B. The patient currently remains in the hospital. No outcome for the events was provided by the reporter. The patient did not experience a rechallenge while receiving the suspect product. The reporter provided no causality assessment for the events. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pain, Rash
Clinical narrative: Information has been received from a physician concerning a 14 year old female with no pertinent medical history and no history of drug reactions or allergies who on 08-JUL-2008 was vaccinated with the first dose of GARDASIL vaccine. There was no concomitant medication. Subsequently, the patient had nausea and aches overnight and then developed a bilateral rash from her knees down to her feet. The physician stated there was no fever and the rash was fading on the day of the report. It was unspecified if the patient sought medical attention. Additional information has been requested. 10/08/08 This is in follow-up to report(s) previously submitted on 8/14/2008. Information has been received from a physician concerning a 14 year old female with no pertinent medical history and no history of drug reactions or allergies who on 08-JUL-2008 was vaccinated with the first dose of GARDASIL (lot#: 659964/1978U) into the arm. There was no concomitant medication. Subsequently, within 24 hours of the vaccination, the patient had nausea and aches overnight and then developed a bilateral rash from her knees to her feet. The physician stated there was no fever and the rash was fading on the day of the report. The symptoms cleared within the next 24 hours and the patient recovered. The patient didn't seek medical attention. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Eye swelling
Clinical narrative: Right and left eyes are severly swollen.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Culture throat, Full blood count, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: HIGH FEVER 102.0 THE FOLLOWING DAY AFTER VACCINATION AND REDNESS WITH SWELLING ON RIGHT ARM WHERE VARICELLA WAS ADMINISTERED..
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: White blood cell count increased
Clinical narrative: HIGH FEVER 102.0 THE FOLLOWING DAY AFTER VACCINATION AND REDNESS WITH SWELLING ON RIGHT ARM WHERE VARICELLA WAS ADMINISTERED..
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Ataxia, Fall
Clinical narrative: ACUTE ONSET OF ATAXIA 08/13/2008. PATIENT AFEBRILE, NO INTERCURRENT ILLNESS, ACTING WELL IN ALL OTHER RESPECTS. NO HISTORY OF TRAUMA. PATIENT UNABLE TO KEEP BALANCE,UNABLE TO TAKE STEPS WITHOUT FALLING. SYMPTOMS PEAKED IN THE A.M. OF 08/15/2008, AFTER WHICH SHE WAS SEEN BY HER PRIMARY PEDIATRICIAN. AT THE TIME OF EVALUATION SHE WAS AFEBRILE, ALERT AND ACTIVE. SHE WAS ABLE TO TAKE A FEW STEPS BEFORE REELING AND FALLING, OCCASIONALLY LOSING BALANCE WHILE STANDING. PARENTS REPORTED THAT THIS EXAM WAS IMPROVED FROM EARLIER IN THE DAY. HER PHYSICAL EXAM WAS OTHERWISE WITHIN NORMAL LIMITS, INCLUDING NORMAL AND NON-FOCAL NEUROLOGIC EXAM. CRANIAL NERVES II-XII WERE GROSSKY INTACT, DEEP TENDON REFLEXES WERE PRESENT AND SYMMETRICAL THROUGHOUT UPPER AND LOWER EXTREMITIES, TONE WAS NORMAL-NO WEAKNESS IDENTIFIED, TOES WERE DOWNGOING, AND BEHAVIOR/INTERACTION/MENTAL STATUS WAS APPROPRIATE FOR AGE AND BASELINE FOR HER.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Arthropod bite, Headache, Rash
Clinical narrative: Headache rash on the legs - insect bites look like to MD though pt denies bug bites
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Back pain, Nausea, Pollakiuria, Thirst
Clinical narrative: Employee states within 1-2hrs of of injection, increased need to urinate (every 20 min since shot), pain in back on both sides (kidney area). Today also has nausea and increased thirst. No symptoms before shot of any problems. Temp 98.8 degrees
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information was also received from a nurse at this practice concerning a different patient who fainted after receiving GARDASIL vaccine (lot # not provided). No additional information was available. This is one of two reports from the same source (WAES# 0807USA03710) Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, HPV4, MNQ
Symptoms: Borrelia burgdorferi serology positive, Fatigue, Hypoaesthesia, Immunology test, Muscular weakness
Clinical narrative: Information has been received from a 15 year old female patient who reported in September 2007, was vaccinated with the first dose of GARDASIL vaccine (yeast). She reported she received her first dose of HPV vaccine and shortly afterward her hands became numb. A couple of months later her legs and feet became so numb that she could not walk. She decided not to receive the 2nd and 3rd doses". Therapy with human papillomavirus was discontinued. Subsequently, the patient recovered from hands became numb and legs and feet became so numb in the "last week". The patient sought medical attention, several physicians. The laboratory diagnostics studies performed were MRI, unspecified blood test (results not reported). Additional information has been requested.  12/12/2008 Reviewed PCP medical records of 9/5/2007- FINAL DX: borreliosis, fatigue, reflex sympathetic dystrophy Records reveal patient experienced general good health on 9/5/07.  RTC 10/26 w/HA, irritability, poor appetite, shaking & generalized aching. Dx w/Lyme's disease.  Tx w/antibiotics.  RTC 1/3/08 w/paresthesia.  ER visits x 2 w/Neuro consults.  Tx w/meds.  Rheumatology consult done 11/2007 & 3/14/08 & being treated w/meds.  RTC 4/17/08 w/continued pain & weakness. Referred to ortho & accupuncture.  RTC 6.20 & was improving slowly w/accunpuncture.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, HPV4, MNQ
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Information has been received from a 15 year old female patient who reported in September 2007, was vaccinated with the first dose of GARDASIL vaccine (yeast). She reported she received her first dose of HPV vaccine and shortly afterward her hands became numb. A couple of months later her legs and feet became so numb that she could not walk. She decided not to receive the 2nd and 3rd doses". Therapy with human papillomavirus was discontinued. Subsequently, the patient recovered from hands became numb and legs and feet became so numb in the "last week". The patient sought medical attention, several physicians. The laboratory diagnostics studies performed were MRI, unspecified blood test (results not reported). Additional information has been requested.  12/12/2008 Reviewed PCP medical records of 9/5/2007- FINAL DX: borreliosis, fatigue, reflex sympathetic dystrophy Records reveal patient experienced general good health on 9/5/07.  RTC 10/26 w/HA, irritability, poor appetite, shaking & generalized aching. Dx w/Lyme's disease.  Tx w/antibiotics.  RTC 1/3/08 w/paresthesia.  ER visits x 2 w/Neuro consults.  Tx w/meds.  Rheumatology consult done 11/2007 & 3/14/08 & being treated w/meds.  RTC 4/17/08 w/continued pain & weakness. Referred to ortho & accupuncture.  RTC 6.20 & was improving slowly w/accunpuncture.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, HPV4, MNQ
Symptoms: Hypoaesthesia, Laboratory test, Nuclear magnetic resonance imaging, Pain in extremity, Paraesthesia
Clinical narrative: Information has been received from a 15 year old female patient who reported in September 2007, was vaccinated with the first dose of GARDASIL vaccine (yeast). She reported she received her first dose of HPV vaccine and shortly afterward her hands became numb. A couple of months later her legs and feet became so numb that she could not walk. She decided not to receive the 2nd and 3rd doses". Therapy with human papillomavirus was discontinued. Subsequently, the patient recovered from hands became numb and legs and feet became so numb in the "last week". The patient sought medical attention, several physicians. The laboratory diagnostics studies performed were MRI, unspecified blood test (results not reported). Additional information has been requested.  12/12/2008 Reviewed PCP medical records of 9/5/2007- FINAL DX: borreliosis, fatigue, reflex sympathetic dystrophy Records reveal patient experienced general good health on 9/5/07.  RTC 10/26 w/HA, irritability, poor appetite, shaking & generalized aching. Dx w/Lyme's disease.  Tx w/antibiotics.  RTC 1/3/08 w/paresthesia.  ER visits x 2 w/Neuro consults.  Tx w/meds.  Rheumatology consult done 11/2007 & 3/14/08 & being treated w/meds.  RTC 4/17/08 w/continued pain & weakness. Referred to ortho & accupuncture.  RTC 6.20 & was improving slowly w/accunpuncture.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, HPV4, MNQ
Symptoms: Abasia, Blood test, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a 15 year old female patient who reported in September 2007, was vaccinated with the first dose of GARDASIL vaccine (yeast). She reported she received her first dose of HPV vaccine and shortly afterward her hands became numb. A couple of months later her legs and feet became so numb that she could not walk. She decided not to receive the 2nd and 3rd doses". Therapy with human papillomavirus was discontinued. Subsequently, the patient recovered from hands became numb and legs and feet became so numb in the "last week". The patient sought medical attention, several physicians. The laboratory diagnostics studies performed were MRI, unspecified blood test (results not reported). Additional information has been requested.  12/12/2008 Reviewed PCP medical records of 9/5/2007- FINAL DX: borreliosis, fatigue, reflex sympathetic dystrophy Records reveal patient experienced general good health on 9/5/07.  RTC 10/26 w/HA, irritability, poor appetite, shaking & generalized aching. Dx w/Lyme's disease.  Tx w/antibiotics.  RTC 1/3/08 w/paresthesia.  ER visits x 2 w/Neuro consults.  Tx w/meds.  Rheumatology consult done 11/2007 & 3/14/08 & being treated w/meds.  RTC 4/17/08 w/continued pain & weakness. Referred to ortho & accupuncture.  RTC 6.20 & was improving slowly w/accunpuncture.
Age: 28.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Alopecia areata, Antiphospholipid antibodies negative, Blood heavy metal normal, Blood testosterone normal, Laboratory test normal
Clinical narrative: This is in follow-up to report(s) previously submitted on 8/14/2008. Information has been received from physician and a 29 year old female consumer with no pertinent medical history, no family history of alopecia, no birth defects and no allergies who on 22-JAN-2007 was vaccinated with the first dose of GARDASIL (lot#654389/0961F) 0.5ml IM in the left deltoid at approximately 1500. On 18-MAY-2008 the patient was vaccinated with the second dose of GARDASIL (lot#657617/0384F) 0.5ml IM in the left deltoid at approximately 15:00.  On 16-JUL-2007 the patient was vaccinated with the third dose of GARDASIL (lot#658222/0927U) 0.5ml IM in left deltoid at approximately 1500. There was no concomitant medication. There was no illness at time of vaccination. By March 2007, the patient experienced severe hair loss after the first dose and the patient's hair began as a small bald spot. There was a patch of hair missing and the area was completely slick. The patient's bald spot was 3-4 cm at top of head which the reporter first saw on 23-MAR-2007. The patient was sent for urgent dermatologist referral. The patient saw a dermatologist who said it was not caused by vaccine but instead from alopecia. After the third dose the patient's entire crown of her head was bald and slick. The bald spot was very large (2-3 bigger than before). The tests performed on the patient which all came up as negative for lupus, thyroid problems and heavy metal. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Thyroid function test normal
Clinical narrative: This is in follow-up to report(s) previously submitted on 8/14/2008. Information has been received from physician and a 29 year old female consumer with no pertinent medical history, no family history of alopecia, no birth defects and no allergies who on 22-JAN-2007 was vaccinated with the first dose of GARDASIL (lot#654389/0961F) 0.5ml IM in the left deltoid at approximately 1500. On 18-MAY-2008 the patient was vaccinated with the second dose of GARDASIL (lot#657617/0384F) 0.5ml IM in the left deltoid at approximately 15:00.  On 16-JUL-2007 the patient was vaccinated with the third dose of GARDASIL (lot#658222/0927U) 0.5ml IM in left deltoid at approximately 1500. There was no concomitant medication. There was no illness at time of vaccination. By March 2007, the patient experienced severe hair loss after the first dose and the patient's hair began as a small bald spot. There was a patch of hair missing and the area was completely slick. The patient's bald spot was 3-4 cm at top of head which the reporter first saw on 23-MAR-2007. The patient was sent for urgent dermatologist referral. The patient saw a dermatologist who said it was not caused by vaccine but instead from alopecia. After the third dose the patient's entire crown of her head was bald and slick. The bald spot was very large (2-3 bigger than before). The tests performed on the patient which all came up as negative for lupus, thyroid problems and heavy metal. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Alopecia, Blood heavy metal normal, Inappropriate schedule of drug administration, Laboratory test normal, Thyroid function test normal
Clinical narrative: This is in follow-up to report(s) previously submitted on 8/14/2008. Information has been received from physician and a 29 year old female consumer with no pertinent medical history, no family history of alopecia, no birth defects and no allergies who on 22-JAN-2007 was vaccinated with the first dose of GARDASIL (lot#654389/0961F) 0.5ml IM in the left deltoid at approximately 1500. On 18-MAY-2008 the patient was vaccinated with the second dose of GARDASIL (lot#657617/0384F) 0.5ml IM in the left deltoid at approximately 15:00.  On 16-JUL-2007 the patient was vaccinated with the third dose of GARDASIL (lot#658222/0927U) 0.5ml IM in left deltoid at approximately 1500. There was no concomitant medication. There was no illness at time of vaccination. By March 2007, the patient experienced severe hair loss after the first dose and the patient's hair began as a small bald spot. There was a patch of hair missing and the area was completely slick. The patient's bald spot was 3-4 cm at top of head which the reporter first saw on 23-MAR-2007. The patient was sent for urgent dermatologist referral. The patient saw a dermatologist who said it was not caused by vaccine but instead from alopecia. After the third dose the patient's entire crown of her head was bald and slick. The bald spot was very large (2-3 bigger than before). The tests performed on the patient which all came up as negative for lupus, thyroid problems and heavy metal. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL, HEPA, HPV4, MNQ, VARCEL
Symptoms: Head injury, Syncope, Tooth fracture
Clinical narrative: This is in follow-up to report(s) previously submitted on 8/14/2008. Information has been received from a registered nurse concerning a female who an unspecified date was vaccinated with a dose of GARDASIL. The nurse reported that the patient "recently fainted some time after receiving GARDASIL". The patient saw the doctor. Additional information has been requested. Follow up information was received from the registered nurse concerning a 17 year old female with no medical history who on 28-MAY-2008 was vaccinated with a first dose of GARDASIL (Lot # 659962/1740U) (also reported as "1740C) 0.5 ml intramuscularly DTP (manufacturer unknown), hepatitis A virus vaccine inactivated, MENACTRA and Varicella virus vaccine live (merck). It was reported that the patient was given multiple vaccines GARDASIL, DTP (unspecified), hepatitis A virus vaccine inactivated, MENACTRA and Varicella virus vaccine (Merck). It was reported that the patient was found on floor screaming. She was holding a piece of tooth with noted laceration near right eye and forehead swollen and red. Patient then was assisted to table. Assessed pupils oriented. Ice pack applied. Blood pressure 126/72 and pulse 70. Patient laid for 15 minutes with mother at side. Forehead/Interal eye pain, right posterior molar with chip and tongue and right cheek with fresh blood. After 15 minutes patient instructed to observe for dizzy/nausea/vomiting or other neurolgoical changes. Also she was informed to see the dentist. The patient recovered on 28-MAY-2008. On 07-AUG-2008, patient was vaccinated with a second dose of GARDASIL (Lot # 659962/1740U) (also reported as "17404") 0.5 ml intramuscularly. No further information is available.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL, HEPA, HPV4, MNQ, VARCEL
Symptoms: Erythema, Eye pain, Screaming, Skin laceration, Swelling
Clinical narrative: This is in follow-up to report(s) previously submitted on 8/14/2008. Information has been received from a registered nurse concerning a female who an unspecified date was vaccinated with a dose of GARDASIL. The nurse reported that the patient "recently fainted some time after receiving GARDASIL". The patient saw the doctor. Additional information has been requested. Follow up information was received from the registered nurse concerning a 17 year old female with no medical history who on 28-MAY-2008 was vaccinated with a first dose of GARDASIL (Lot # 659962/1740U) (also reported as "1740C) 0.5 ml intramuscularly DTP (manufacturer unknown), hepatitis A virus vaccine inactivated, MENACTRA and Varicella virus vaccine live (merck). It was reported that the patient was given multiple vaccines GARDASIL, DTP (unspecified), hepatitis A virus vaccine inactivated, MENACTRA and Varicella virus vaccine (Merck). It was reported that the patient was found on floor screaming. She was holding a piece of tooth with noted laceration near right eye and forehead swollen and red. Patient then was assisted to table. Assessed pupils oriented. Ice pack applied. Blood pressure 126/72 and pulse 70. Patient laid for 15 minutes with mother at side. Forehead/Interal eye pain, right posterior molar with chip and tongue and right cheek with fresh blood. After 15 minutes patient instructed to observe for dizzy/nausea/vomiting or other neurolgoical changes. Also she was informed to see the dentist. The patient recovered on 28-MAY-2008. On 07-AUG-2008, patient was vaccinated with a second dose of GARDASIL (Lot # 659962/1740U) (also reported as "17404") 0.5 ml intramuscularly. No further information is available.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL, HEPA, HPV4, MNQ, VARCEL
Symptoms: Syncope, Tooth injury
Clinical narrative: This is in follow-up to report(s) previously submitted on 8/14/2008. Information has been received from a registered nurse concerning a female who an unspecified date was vaccinated with a dose of GARDASIL. The nurse reported that the patient "recently fainted some time after receiving GARDASIL". The patient saw the doctor. Additional information has been requested. Follow up information was received from the registered nurse concerning a 17 year old female with no medical history who on 28-MAY-2008 was vaccinated with a first dose of GARDASIL (Lot # 659962/1740U) (also reported as "1740C) 0.5 ml intramuscularly DTP (manufacturer unknown), hepatitis A virus vaccine inactivated, MENACTRA and Varicella virus vaccine live (merck). It was reported that the patient was given multiple vaccines GARDASIL, DTP (unspecified), hepatitis A virus vaccine inactivated, MENACTRA and Varicella virus vaccine (Merck). It was reported that the patient was found on floor screaming. She was holding a piece of tooth with noted laceration near right eye and forehead swollen and red. Patient then was assisted to table. Assessed pupils oriented. Ice pack applied. Blood pressure 126/72 and pulse 70. Patient laid for 15 minutes with mother at side. Forehead/Interal eye pain, right posterior molar with chip and tongue and right cheek with fresh blood. After 15 minutes patient instructed to observe for dizzy/nausea/vomiting or other neurolgoical changes. Also she was informed to see the dentist. The patient recovered on 28-MAY-2008. On 07-AUG-2008, patient was vaccinated with a second dose of GARDASIL (Lot # 659962/1740U) (also reported as "17404") 0.5 ml intramuscularly. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Axillary pain, Lethargy, Musculoskeletal chest pain, Pain
Clinical narrative: Information has been received from a nurse midwife concerning a 21 year old female with asthma and no allergies who on 02-APR-2008 was vaccinated with a first dose of GARDASIL (lot number 658100/0525u) (injection site and route not reported). On 18-JUN-2008 the patient was vaccinated with a first dose of GARDASIL (lot number 658100/0525U) 0.5  ml by intramuscular injection in the left arm. Concomitant therapy included DEPO-PROVERA. Subsequently the patient experienced pain in the left axilla and left ribs, and tiredness. The patient sought unspecified medical attention. Subsequently, the patient recovered from the events. Additional information has been requested.  This is in follow-up to report(s) previously submitted on 8/14/2008.  Information has been received from a nurse midwife concerning a 21 year old female with asthma and no allergies who on 02-APR-2008 was vaccinated with a first dose of GARDASIL (lot number 658100/0525U) (injection site and route not reported).  On 18-JUN-2008 the patient was vaccinated with a first dose of GARDASIL (lot number 658100/0525U) 0.5 ml by intramuscular injection in the left arm.  Concomitant therapy included DEPO-PROVERA.  Subsequently the patient experienced pain in the left axilla and left ribs, and tiredness.  The patient sought unspecified medical attention.  Subsequently, the patient recovered from  the events.  Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Axillary pain, Fatigue, Musculoskeletal chest pain
Clinical narrative: Information has been received from a nurse midwife concerning a 21 year old female with asthma and no allergies who on 02-APR-2008 was vaccinated with a first dose of GARDASIL (lot number 658100/0525u) (injection site and route not reported). On 18-JUN-2008 the patient was vaccinated with a first dose of GARDASIL (lot number 658100/0525U) 0.5  ml by intramuscular injection in the left arm. Concomitant therapy included DEPO-PROVERA. Subsequently the patient experienced pain in the left axilla and left ribs, and tiredness. The patient sought unspecified medical attention. Subsequently, the patient recovered from the events. Additional information has been requested.  This is in follow-up to report(s) previously submitted on 8/14/2008.  Information has been received from a nurse midwife concerning a 21 year old female with asthma and no allergies who on 02-APR-2008 was vaccinated with a first dose of GARDASIL (lot number 658100/0525U) (injection site and route not reported).  On 18-JUN-2008 the patient was vaccinated with a first dose of GARDASIL (lot number 658100/0525U) 0.5 ml by intramuscular injection in the left arm.  Concomitant therapy included DEPO-PROVERA.  Subsequently the patient experienced pain in the left axilla and left ribs, and tiredness.  The patient sought unspecified medical attention.  Subsequently, the patient recovered from  the events.  Additional information is not expected.
Age: 0.8
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Started w/ redness & bumps at the site on both legs and then it spread all over the body.  It started on both legs at the same time . (HIVES)
Age: 0.8
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Erythema, Injection site erythema, Injection site rash, Rash generalised, Urticaria
Clinical narrative: Started w/ redness & bumps at the site on both legs and then it spread all over the body.  It started on both legs at the same time . (HIVES)
Age: 20.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, HEPA, HPV4, TDAP
Symptoms: Hypotonia, Pallor
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old female patient with no known allergies or pertinent medical history who on 24-JUN-2008 at 11:00 am was vaccinated intramuscularly in the right arm with a third and last dose of GARDASIL (Lot #660391/0063X). The patient was vaccinated at the same time in the left arm with ADACEL (Lot #C2774AA) and HAVRIX (Lot # AUAVB224BA). There was no illness at the time of vaccination. On 24-JUN-2008, after receiving the third and last vaccine, the patient pale and limp while sitting on exam table. The patient was ok within seconds after lying down, although still pale. BP 118/70, patient checked by the doctor. The patient left the office after 20 minutes and appeared fine. The patient recovered from the pale on 24-JUL-2008. No further information is available.
Age: 20.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, HEPA, HPV4, TDAP
Symptoms: Blood pressure, Hypotonia, Pallor
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old female patient with no known allergies or pertinent medical history who on 24-JUN-2008 at 11:00 am was vaccinated intramuscularly in the right arm with a third and last dose of GARDASIL (Lot #660391/0063X). The patient was vaccinated at the same time in the left arm with ADACEL (Lot #C2774AA) and HAVRIX (Lot # AUAVB224BA). There was no illness at the time of vaccination. On 24-JUN-2008, after receiving the third and last vaccine, the patient pale and limp while sitting on exam table. The patient was ok within seconds after lying down, although still pale. BP 118/70, patient checked by the doctor. The patient left the office after 20 minutes and appeared fine. The patient recovered from the pale on 24-JUL-2008. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Depressed mood, Dizziness, Hypersensitivity, Nausea, Pharyngeal oedema
Clinical narrative: Information has been received from a consumer concerning her daughter, a 15 year old female with a history of syncope vasovagal and no allergies who on 27-JUN-2008 was vaccinated with the first dose of GARDASIL (lot # not reported) injection in left arm.  Concomitant therapy included CLARITIN.  On 27-JUN-2008 the patient experienced throat closed up and sudden severe depression on the day she received vaccine.  The patient was taken to the emergency room but was not admitted to the hospital.  Her throat still did not feel fully recovered and she still occasionally has bouts of sadness.  This is one of several reports from the same source.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Depression, Throat tightness
Clinical narrative: Information has been received from a consumer concerning her daughter, a 15 year old female with a history of syncope vasovagal and no allergies who on 27-JUN-2008 was vaccinated with the first dose of GARDASIL (lot # not reported) injection in left arm.  Concomitant therapy included CLARITIN.  On 27-JUN-2008 the patient experienced throat closed up and sudden severe depression on the day she received vaccine.  The patient was taken to the emergency room but was not admitted to the hospital.  Her throat still did not feel fully recovered and she still occasionally has bouts of sadness.  This is one of several reports from the same source.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash erythematous, Rash generalised, Rash pruritic, Urticaria
Clinical narrative: Information has been received from physician concerning a patient who on approximately 26-MAY-2007 was accidentally exposed to 0.5 ml of GARDASIL (lot# 0151X). The physician reported that a while administering the GARDASIL the prefilled syringe safety device deactivated and syringe leaked onto patient's arm. Conflicting follow-up information was received from a nurse who reported that the patient" was never administered with the prefilled  syringe". No adverse event reported. At the time of this report the patient's outcome was unknown. Follow up information was received which reported that the patient was a 25 year old female with no pre-existing allergies, birth defects or medical conditions who on 07-JUL-2008 at 6 pm was vaccinated with a first dose of GARDASIL in her arm. There was no illness at time of vaccination. On 07-JUL-2008 the patient experienced disseminated welts, erythematous and pruritic which started on lower back then spread to arm, leg with traveling to face started 1 hour after the vaccination (7 pm) and was still spreading 24 hours later. The patient was advised BENADRYL at the onset of rash. The patient stated that it was very little relief and was advised to report to local emergency room for management and evaluation. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Accidental exposure, Medical device complication, Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: Information has been received from physician concerning a patient who on approximately 26-MAY-2007 was accidentally exposed to 0.5 ml of GARDASIL (lot# 0151X). The physician reported that a while administering the GARDASIL the prefilled syringe safety device deactivated and syringe leaked onto patient's arm. Conflicting follow-up information was received from a nurse who reported that the patient" was never administered with the prefilled  syringe". No adverse event reported. At the time of this report the patient's outcome was unknown. Follow up information was received which reported that the patient was a 25 year old female with no pre-existing allergies, birth defects or medical conditions who on 07-JUL-2008 at 6 pm was vaccinated with a first dose of GARDASIL in her arm. There was no illness at time of vaccination. On 07-JUL-2008 the patient experienced disseminated welts, erythematous and pruritic which started on lower back then spread to arm, leg with traveling to face started 1 hour after the vaccination (7 pm) and was still spreading 24 hours later. The patient was advised BENADRYL at the onset of rash. The patient stated that it was very little relief and was advised to report to local emergency room for management and evaluation. Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: HPV4, HPV4, HEP, HEPA, HPV4
Symptoms: Abdominal pain upper, Arthralgia, Blood test normal, Death of companion, Depression
Clinical narrative: Information has been received from a 27 year old male with an allergy to prednisone who about a year ago in 2007 received the complete series of GARDASIL vaccine. Lot # and dates when it was received are not available. Concomitant therapy included hepatitis A virus vaccine (unspecified) and hepatitis B virus vaccine (unspecified) when patient received his first dose of GARDASIL vaccine. Per patient, he passed out every time he received a dose of GARDASIL vaccine and he experienced three times after receiving each dose of GARDASIL. Patient also reported that he had diarrhea, bad neurological problems and arthritic type of pain about a week after receiving the third dose GARDASIL vaccine. Patient noted that he went to the emergency room numerous times last year because of the arthritic pain but he was not admitted to the hospital. It was reported the patient had an MRI done (date and results not provided). No further information provided. The patient's passed out and diarrhea and bad neurological problems and arthritis type of pain persisted. The patient sought medical attention from a neurologist. No further information is available.
Age: 27.0
Sex: M
Vaccine: HPV4, HPV4, HEP, HEPA, HPV4
Symptoms: Diarrhoea, Dizziness, Fatigue, Frequent bowel movements, Fungal infection
Clinical narrative: Information has been received from a 27 year old male with an allergy to prednisone who about a year ago in 2007 received the complete series of GARDASIL vaccine. Lot # and dates when it was received are not available. Concomitant therapy included hepatitis A virus vaccine (unspecified) and hepatitis B virus vaccine (unspecified) when patient received his first dose of GARDASIL vaccine. Per patient, he passed out every time he received a dose of GARDASIL vaccine and he experienced three times after receiving each dose of GARDASIL. Patient also reported that he had diarrhea, bad neurological problems and arthritic type of pain about a week after receiving the third dose GARDASIL vaccine. Patient noted that he went to the emergency room numerous times last year because of the arthritic pain but he was not admitted to the hospital. It was reported the patient had an MRI done (date and results not provided). No further information provided. The patient's passed out and diarrhea and bad neurological problems and arthritis type of pain persisted. The patient sought medical attention from a neurologist. No further information is available.
Age: 27.0
Sex: M
Vaccine: HPV4, HPV4, HEP, HEPA, HPV4
Symptoms: Groin pain, Hyperaesthesia, Infection, Injection site erythema, Mood altered
Clinical narrative: Information has been received from a 27 year old male with an allergy to prednisone who about a year ago in 2007 received the complete series of GARDASIL vaccine. Lot # and dates when it was received are not available. Concomitant therapy included hepatitis A virus vaccine (unspecified) and hepatitis B virus vaccine (unspecified) when patient received his first dose of GARDASIL vaccine. Per patient, he passed out every time he received a dose of GARDASIL vaccine and he experienced three times after receiving each dose of GARDASIL. Patient also reported that he had diarrhea, bad neurological problems and arthritic type of pain about a week after receiving the third dose GARDASIL vaccine. Patient noted that he went to the emergency room numerous times last year because of the arthritic pain but he was not admitted to the hospital. It was reported the patient had an MRI done (date and results not provided). No further information provided. The patient's passed out and diarrhea and bad neurological problems and arthritis type of pain persisted. The patient sought medical attention from a neurologist. No further information is available.
Age: 27.0
Sex: M
Vaccine: HPV4, HPV4, HEP, HEPA, HPV4
Symptoms: Muscle spasms, Muscular weakness, Neck pain, Neurological symptom, Night sweats
Clinical narrative: Information has been received from a 27 year old male with an allergy to prednisone who about a year ago in 2007 received the complete series of GARDASIL vaccine. Lot # and dates when it was received are not available. Concomitant therapy included hepatitis A virus vaccine (unspecified) and hepatitis B virus vaccine (unspecified) when patient received his first dose of GARDASIL vaccine. Per patient, he passed out every time he received a dose of GARDASIL vaccine and he experienced three times after receiving each dose of GARDASIL. Patient also reported that he had diarrhea, bad neurological problems and arthritic type of pain about a week after receiving the third dose GARDASIL vaccine. Patient noted that he went to the emergency room numerous times last year because of the arthritic pain but he was not admitted to the hospital. It was reported the patient had an MRI done (date and results not provided). No further information provided. The patient's passed out and diarrhea and bad neurological problems and arthritis type of pain persisted. The patient sought medical attention from a neurologist. No further information is available.
Age: 27.0
Sex: M
Vaccine: HPV4, HPV4, HEP, HEPA, HPV4
Symptoms: Pain, Red blood cell sedimentation rate normal, Skin exfoliation, Tendon disorder, Tremor
Clinical narrative: Information has been received from a 27 year old male with an allergy to prednisone who about a year ago in 2007 received the complete series of GARDASIL vaccine. Lot # and dates when it was received are not available. Concomitant therapy included hepatitis A virus vaccine (unspecified) and hepatitis B virus vaccine (unspecified) when patient received his first dose of GARDASIL vaccine. Per patient, he passed out every time he received a dose of GARDASIL vaccine and he experienced three times after receiving each dose of GARDASIL. Patient also reported that he had diarrhea, bad neurological problems and arthritic type of pain about a week after receiving the third dose GARDASIL vaccine. Patient noted that he went to the emergency room numerous times last year because of the arthritic pain but he was not admitted to the hospital. It was reported the patient had an MRI done (date and results not provided). No further information provided. The patient's passed out and diarrhea and bad neurological problems and arthritis type of pain persisted. The patient sought medical attention from a neurologist. No further information is available.
Age: 27.0
Sex: M
Vaccine: HPV4, HPV4, HEP, HEPA, HPV4
Symptoms: Arthralgia, Diarrhoea, Loss of consciousness, Nervous system disorder, Vaccine positive rechallenge
Clinical narrative: Information has been received from a 27 year old male with an allergy to prednisone who about a year ago in 2007 received the complete series of GARDASIL vaccine. Lot # and dates when it was received are not available. Concomitant therapy included hepatitis A virus vaccine (unspecified) and hepatitis B virus vaccine (unspecified) when patient received his first dose of GARDASIL vaccine. Per patient, he passed out every time he received a dose of GARDASIL vaccine and he experienced three times after receiving each dose of GARDASIL. Patient also reported that he had diarrhea, bad neurological problems and arthritic type of pain about a week after receiving the third dose GARDASIL vaccine. Patient noted that he went to the emergency room numerous times last year because of the arthritic pain but he was not admitted to the hospital. It was reported the patient had an MRI done (date and results not provided). No further information provided. The patient's passed out and diarrhea and bad neurological problems and arthritis type of pain persisted. The patient sought medical attention from a neurologist. No further information is available.