chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope vasovagal
Clinical narrative: Information has been received from a newspaper article concerning a 12 year old female who on an unspecified date was vaccinated with a first dose of Gardasil. A few minutes post vaccination, the patient walked about 50 steps then went into what the patient's mother believed to be a seizure. The patient's eyes rolled back in her head, she stiffened up and had clonic jerks. The patient was placed on a stretcher and rushed to the emergency room. The physician's at the emergency room told the patient's mother that the patient experienced vasovagal syncope because "the patient was scared from the shot." Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Loss of consciousness, Malaise
Clinical narrative: Information has been received from a newspaper article concerning a 13 year old female who on 06-NOV-2007 was vaccinated with a dose of Gardasil.  Approximately 6 weeks post vaccination, the patient was tired all the time, had passing out episodes and was not feeling well.  At the time of reporting, the outcome was unknown.  Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect dose administered, Malaise, Syncope
Clinical narrative: Information has been received from a health professional concerning a 20 year old female who on 17-JAN-2008 was vaccinated with a fourth dose of Gardasil (lot # not reported). The reporter reported that the patient almost fainted and was not feeling well. She was not taken to hospital and she felt better. It was reported that patient got a fourth injection of Gardasil. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Asthenia, Diarrhoea, Dizziness
Clinical narrative: Information has been received from a Nurse concerning a 15 year old female with shellfish allergy and drug hypersensitivity to albuterol who on 09-OCT-2007 was vaccinated with the first dose of Gardasil.  On 29-JAN-2008 the patient was vaccinated intramuscularly with 0.5 mL of her second dose of Gardasil (lot # 659653/1448U).  Concomitant therapy included Typhoid vaccine (unspecified) which the patient was given by injection one hour after she received her second dose of Gardasil.  On 30-JAN-2008 the patient experienced abdominal cramps, went to the ER and was discharged.  Subsequently, the patient recovered from the abdominal cramps.  No product complaint was involved.  Additional information has been requested. 02/12/2010 The nurse reported that the patient's nausea started at approximately noon on 29-JAN-2008. It was also reported that the patient developed abdominal pain at 5pm. Diarrhea with abdominal pain in the lower right quandrant lasted from 5 to 10 pm. Morphine was give in the ER at 10pm. The patient remaine din the ER until 2 am on 30-JAN-2008 with no further diarrhea. The patient was discharged to home, weak with more dizziness which lasted for 24 hours. On 31-JAN-2008, the patient was "back to normal". It was reported that the patient called the doctor's office and a call was "put in to Allergist to see if related-"no". There was no illness at the time of vaccination. Follow-up information included mention of an unspecified adverse event patient's sister had following a 0.5 cc dose of DPT. No further information is expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Chest discomfort, Cough, Dizziness, Dyspnoea
Clinical narrative: Information has been received from a nurse practitioner concerning a 14 year old female who on 21-NOV-2007 was vaccinated with the first dose of Gardasil (lot # 658560/1062U). On 22-JAN-2008 the patient was vaccinated intramuscularly with 0.5 mL of a second dose of Gardasil (lot # 659437/1266U). There was no concomitant medication. On 28-JAN-2008 the patient was examined in the Emergency Room. She was experiencing dizziness, numbness in her extremities, tinnitus, shortness of breath, anxiety, chest discomfort and coughing. She was diagnosed as having a panic attack and anxiety. She was not admitted into the hospital and was released on the same day. The nurse practitioner did not know if she was given any medications. No product quality complaint was involved. At the time of this report the outcome of the events was unknown. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Panic attack, Tinnitus
Clinical narrative: Information has been received from a nurse practitioner concerning a 14 year old female who on 21-NOV-2007 was vaccinated with the first dose of Gardasil (lot # 658560/1062U). On 22-JAN-2008 the patient was vaccinated intramuscularly with 0.5 mL of a second dose of Gardasil (lot # 659437/1266U). There was no concomitant medication. On 28-JAN-2008 the patient was examined in the Emergency Room. She was experiencing dizziness, numbness in her extremities, tinnitus, shortness of breath, anxiety, chest discomfort and coughing. She was diagnosed as having a panic attack and anxiety. She was not admitted into the hospital and was released on the same day. The nurse practitioner did not know if she was given any medications. No product quality complaint was involved. At the time of this report the outcome of the events was unknown. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Ocular hyperaemia
Clinical narrative: Information has been received from a nurse concerning a 24 year old female who on 28-NOV-2007 was vaccinated intramuscularly with 0.5 mL of the first dose of Gardasil (lot # 658560/1062U).  Concomitant therapy included ZOLOFT.  The patient told the office later, during another office visit, that on 28-NOV-2007 she experienced eye redness after her first dose of Gardasil.  The symptom lasted for several hours and then resolved on 28-NOV-2007.  There was no product complaint involved.  Unspecified medical attention was sought.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a 14 year old female who in December 2007, was vaccinated with 0.5 mL of her first dose of Gardasil. In December 2007, after the first dose of Gardasil, the patient experienced syncope and was given oxygen. Subsequently, the patient recovered from the syncope. No product quality complaint was involved. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Information has been received from a pharmacist concerning a 13 year old female who on unspecified dates was vaccinated with her first and second dose of Gardasil (lot# unspecified).  Subsequently the patient experienced hand and foot joint pain.  The patient's hand joint pain and foot joint pain persisted.  No other information was available.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site discolouration
Clinical narrative: Information has been received from a health professional concerning three female patients who on approximately 23-JAN-2008 were vaccinated intramuscularly with Gardasil. On 23-JAN-2008 the patient experienced discoloration at the injection site. The discoloration was a lighter skin color where the band aid was in contact with the skin. No further information was provided. The patients sought unspecified medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on unspecified date was vaccinated with first dose of Gardasil given with MENACTRA and passed out. It was noted she has a fear of shots. Unspecified medical attention was sought. Subsequently, the patient recovered. This is one of several reports received from the same source. Additional information has been requested. 07/08/08 Follow-up information indicated request for no further contact. No additional information available.
Age: 16.0
Sex: F
Vaccine: DTAP, HPV4, MNQ
Symptoms: Syncope, Wrong drug administered
Clinical narrative: Information has been received from a medical assistant a 16 year old female who on an unspecified date was vaccinated with a first dose of Gardasil. Concomitant therapy included MENACTRA and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unspecified). Subsequently on an unspecified date the patient fainted after receiving the first dose of Gardasil. Medical attention was sought. On an unspecified date the patient recovered with unspecified therapy. The patient had gone onto receive further doses, however, it is unknown if she had this reaction to the injections. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a 15 or 16 year old female who was vaccinated with a first dose of Gardasil and passed out.  Unspecified medical attention was sought.  Subsequently, the patient recovered from passed out.  This is one of several reports received from the same source.  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 15 or 16 year old female who was vaccinated with a first dose of GARDASIL and passed out.  Unspecified medical attention was sought.  Subsequently, the patient recovered from passed out.  This is one of several reports received from the same source.  Additional information has been requested.  Follow-up information indicated request for no further contact.  No additional information available.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Laboratory test, Menstruation irregular
Clinical narrative: Information has been received from a consumer concerning his 25 year old wife with no pertinent medical history, who on 09-JAN-2008 was vaccinated intramuscularly, "in the arm", with the first dose of Gardasil.  There was no concomitant medication.  The consumer reported that in January 2008, "this past month", after receiving Gardasil, his wife experienced an "irregular menstrual cycle and hasn't had her period."  The patient's amenorrhea and irregular menstrual cycle persisted.  Medical attention was not sought.  Unspecified "blood work" was performed.  No product quality complaint was involved.  No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature normal, Computerised tomogram, Decreased activity, Eye pain, Full blood count normal
Clinical narrative: Information has been received from a nurse concerning a 16 year old female with no pertinent medical history or drug reactions/allergies, who on unspecified dates was vaccinated with the first, second and third doses of Gardasil. There was no concomitant medication. On 01-JAN-2008 the patient experienced prolonged headache "after receiving the third dose of Gardasil." "As of 22-JAN-2008, the headache had not subsided". It was reported that the patient "did not receive the Gardasil at the office." No product quality complaint was involved. Medical attention was sought at the physician. Additional information has been requested. Follow-up received 04/16/2008. The patient complained of severe prolonged headache for 3 weeks following the third dose of Gardisil vaccine on 02-JAN-2008. On 22-JAN-2008 the patient was seen in the office. The patient's body temperature was 97.9 degrees C and the blood pressure measurement was 112/62. The headache was in the eye area and at the top of the head. The patient was not getting headaches in the AM but in themiddle of the day and last til the evening. The headache sometimes resolved with sleep. Acetaminophen hcl (TYLENOL) helps. The patient limits activity. Throbbing and squeezing. The patient has had n o tress, no nausea or vomiting, no visual changes. Hard to concentrate no clumsiness. No fever/URI/cough. Her menses is regular. Eyes hurt but not watery. There is no prior history of headaches.On 30-JAN-2008 the patient stated that her headaches have improved. No product quality complaint was involved. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Pain, White blood cell count increased
Clinical narrative: Information has been received from a nurse concerning a 16 year old female with no pertinent medical history or drug reactions/allergies, who on unspecified dates was vaccinated with the first, second and third doses of Gardasil. There was no concomitant medication. On 01-JAN-2008 the patient experienced prolonged headache "after receiving the third dose of Gardasil." "As of 22-JAN-2008, the headache had not subsided". It was reported that the patient "did not receive the Gardasil at the office." No product quality complaint was involved. Medical attention was sought at the physician. Additional information has been requested. Follow-up received 04/16/2008. The patient complained of severe prolonged headache for 3 weeks following the third dose of Gardisil vaccine on 02-JAN-2008. On 22-JAN-2008 the patient was seen in the office. The patient's body temperature was 97.9 degrees C and the blood pressure measurement was 112/62. The headache was in the eye area and at the top of the head. The patient was not getting headaches in the AM but in themiddle of the day and last til the evening. The headache sometimes resolved with sleep. Acetaminophen hcl (TYLENOL) helps. The patient limits activity. Throbbing and squeezing. The patient has had n o tress, no nausea or vomiting, no visual changes. Hard to concentrate no clumsiness. No fever/URI/cough. Her menses is regular. Eyes hurt but not watery. There is no prior history of headaches.On 30-JAN-2008 the patient stated that her headaches have improved. No product quality complaint was involved. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning an 18 year old female who on 30-JAN-2008 was vaccinated with Gardasil (lot# 659657/1487U). There was no concomitant medication. On 30-JAN_2008 the patient "received her first dose of Gardasil (lot# 659657/1487U) and sat down for a couple of minutes (not 15 minutes as recommended in the guidelines) and when she tried to get up and leave, she fainted. The patient did not eat lunch prior to the vaccine." Unspecified medical attention was sought. Subsequently, the patient recovered from the fainting episode. No product quality complaint was involved. Additional information has been requested. Follow-up received 04/16/2008. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: Information has been received from a physician concerning a female with no known allergies or medical history who in October 2007, was vaccinated with her third dose of Gardasil.  Subsequently the patient had a positive HPV DNA test indicating high risk for human papillomavirus even though she received all three doses.  No further information was available.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Menorrhagia
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with her first dose of Gardasil and began menstruating. Subsequently the patient experienced heavy menstruation. The patient sought unspecified medical treatment at the clinic. Lot number was not available. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 16 year old female with no known allergies or medical history who on 29-JAN -2008 was vaccinated with her first dose of Gardasil and fainted.  Subsequently, the patient recovered from fainting in about five minutes.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Local reaction
Clinical narrative: Information has been received from a nurse concerning a female who in November 2007, was vaccinated with the first dose of Gardasil.  Subsequently, the patient experienced localized reaction at the injection site consisting of redness, warmth, and itching.  Unknown medical attention was sought.  The reaction resolved completely (date unknown).  No product quality complaint was involved.  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 nurse concerning a 19 year old female who with very sensitive to medication, on 19-November 2007, was vaccinated in the left deltoid with the first dose of GARDASIL (lot# 658219/0755U).  On 11-Jan-2008 she received the second dose in the right deltoid (lot# 658219/0755U).  Two hours after the first dose, shot site became red with swelling.  Two weeks after the vaccination the patient experienced nausea and vomiting.  Two weeks after the second vaccination the patient experienced nausea and vomiting.  Unknown medical attention was sought.  The patient was recovered.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Mastitis
Clinical narrative: Information has been received from a physician concerning a female patient who at an unknown date was vaccinated with the second dose of Gardasil. Subsequently the patient experienced mastitis. It was unknown whether or not this patient had this experience was with the first dose. Unknown medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with Gardasil.  Subsequently the patient experienced dizziness.  Subsequently, the patient recovered from the dizziness prior to leaving the office.  This is one of several reports for the same source.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Electrolyte imbalance, Fatigue, Musculoskeletal stiffness, Paraesthesia
Clinical narrative: Information has been received regarding a case in litigation.  On 31-JAN-2007 the mother of a 25 year old female reported that on 25-JAN-2008 her daughter was vaccinated IM with 0.5 mL of the second dose of Gardasil (Lot #659657/1487U).  No concomitant medications were reported.  The patients mother reported that post vaccination on 26-JAN-2008, the patient experienced numbness and tingling in her extremities.  That same day the patient reported that on an unspecified date her physician had her get unspecified blood work for the event.  She reported that all of the blood tests were normal and that her physician was "ruling out paraesthesis".  The patient reported that she did not have any events after her first vaccination with Gardasil (Lot #, dates of vaccination and details were not provided).  On 01-FEB-2008 the patient's father reported "my daughter went to the ER (date not provided) and apparently had a low electrolyte level.  She is stable now, but her condition has not improved much.  My daughter has no other medical conditions".  Later that same day the patient's mother reported that her daughter was experiencing what "she believes is Guillain-Barre syndrome."  She reported that her daughter experienced numbness from her waist down, back tightening, tingling in her fingers and was extremely tired.  She stated "she feels like going to the dentist and coming off anesthesia."  At the time of this report the patient had not recovered from these events.  No further information is available. 9/25/08-records received-for DOS 1/30/08-presented to ED with C/O numbness. Two day history of lower extremity numbness now associated with bilateral hand numbness as well. PE:WNL. Assessment:parestheias.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia oral, Pruritus, Rash generalised, Urticaria
Clinical narrative: Information has been received from a physician concerning a 23 year old female medical assistant with a history of latex allergy and drug hypersensitivity who on 31-JAN-2008 was vaccinated, IM with the 1st dose of GARDASIL (lot# 659653/1448U). There was no concomitant medication. On 31-JAN-2008 a few hours post vaccination she developed a rash all over body, hives, and was itchy. The patient sought unspecified medical attention. At the time of the report she had not recovered from the events. No further information is available. Follow-up received 04/16/2008. The patient also noted her tongue felt itchy, no swelling, and no shortness of breath. 25mg PO Benadryl was given at 1:45pm. The patient was watched for a half hour and the patient stated felling better, less itchy. The patient sought unspecified medical attention. At the time of follow-up, the patient reported recovering on 31-JAN-2008.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site pain, Pain in extremity
Clinical narrative: Information has been received from a health professional concerning a 21 year old white female with a history of acne who on 09-AUG-2007 was vaccinated intramuscularly with the Gardasil. On 10-JAN-2008 the patient was vaccinated intramuscularly with her second dose of Gardasil (lot# 655849/0263U). Concomitant therapy included DENTOMYCIN and topical RETIN-A. The nurse practitioner thinks the patient received a tetanus booster on 10-JAN-2008 at a different anatomic site than Gardasil. On 10-JAN-2008 the patient experienced arm pain after receiving her second dose of Gardasil. The patient experienced pain as she was being injected at the office. The patient continues to have the pain and has difficulty raising her arm. The patient has not recovered. The nurse practitioner expected to examine the patient soon and states the patient was thin with a Body Mass of 19. The patient had no swelling, no bruising and no fever involved. The patient sought medical attention by having her mother call the nurse practitioner. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Pruritus, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning her 25 year old daughter who on 29-JAN-2008 was vaccinated with her first dose of Gardasil.  Concomitant therapy included hormonal contraceptives (unspecified).  On 29-JAN-2008 the patient experienced urticaria, pruritus and redness at injection site.  On 31-Jan-2008, the patient had about 20 to 30 hives mostly on the trunk and waist area.  She also has some hives on her arms and legs.  On 31-Jan-2008, she started taking loratadine (CLARITIN).  The patient sought medical attention "via her mother".  No additional information is available.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Blister
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with her first dose of GARDASIL. On an unspecified date, the patient received her second dose of GARDASIL. The patient developed a blister on her chest all the way up to her neck including her face "1 day after getting the second dose of GARDASIL." The reporter learned of the adverse experience through a colleague who is the treating physician of the patient. The patient sough unspecified medical attention. No additional information was provided. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a physician concerning a 20 year old female who on 15-JAN-2008 was vaccinated intramuscularly with the first dose of Gardasil (655327/1287U).  On 25-JAN-2008 the patient experienced a generalized rash.  The patient went to the physician's office on 28-JAN-2008 and was told to take diphenhydramine hydrochloride (BENADRYL).  Subsequently, the patient recovered from the generalized rash.  No further information was provided.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Chills, Diarrhoea, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a nurse concerning a female patient who was vaccinated IM with 0.5 ml third dose of GARDASIL. Subsequently the patient had been "in bed for 5 days with chills and diarrhea". There were no AE with the fist and second dose of vaccination. Unknown medical attention was sought. The patient's outcome is unknown. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Nasopharyngitis
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with the second dose of Gardasil.  Per the reporter, "a patient experienced a cold after receiving her second dose of Gardasil."  The patient sought unspecified medical attention.  The lot number was not available and no further information was given.  The physician does not want to be contacted.  Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Syncope, Urticaria
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on approximately 31-JAN-2008 was vaccinated with the first dose of Gardasil (lot number not reported). Concomitant therapy included MENACTRA. Subsequently the night of the injection the patient experienced hives. The patient was reported to be recovering. No further information is available. 07/08/08 Information has been received from a physician concerning a 14 year old female with an allergy to cats and SEPTRA, who on 25-Feb-2008 was IM vaccinated with the third dose of GARDASIL (lot number 659653/1448U) in the left deltoid. Original documentation indicated concomitant therapy included MENACTRA, however follow up information did not confirm this. Approximately 4 minutes after the vaccine injection the patient felt faint and fell to the floor hitting right side of her head on the hard floor. It last only a few seconds. Ice was applied to her head and the patient was seen by a physician. She complained of headache. Patient was monitored for 1.75 hours after incident. Patient was sent home with instructions to go to ER if condition worsened. The patient recovered on the same day. No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Vomiting
Clinical narrative: Information has been received from a nurse concerning her 22 year old daughter with a history of crohn's disease who on 30-JAN-2008 was vaccinated with the first dose of GARDASIL (lot number not reported). Concomitant therapy included PENTASA. Subsequently the patient experienced vomiting and nausea. It was reported that the vomiting has resolved but the daughter is still nauseated. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling hot, Injection site pruritus, Sensation of heaviness, Urticaria
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated IM with 0.5 ml dose of Gardasil.  Subsequently the patient experienced red bumps, itching at the injection site 3-4 days after the vaccination.  It was also reported that the patient felt hot and heavy in her arm.  Unspecified medical attention was sought via phone.  At an unknown date the patient was recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on an unspecified date was vaccinated with her first dose of Gardasil (lot # not provided).  Subsequently the next day the patient experienced a rash on both of her arms.  On an unspecified date the patient recovered from the rash.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram, Headache
Clinical narrative: Information has been received from a physician concerning a female who on 27-SEP-2007 was vaccinated with the first dose of GARDASIL. Per the reporter, approximately one to one and an a half months after receiving the first dose of GARDASIL the patient developed a headache that lasted approximately one month. The physician does not believe this adverse experience is related to the vaccine and therefore does not wish to be contacted regarding this event. It is unknown at this time whether or not the patient will receive the second and third doses. No further information was provided. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: Information has been received from a head nurse concerning a 24 year old female who on 17-JUL-2007 was vaccinated with the first dose of Gardasil.  The patient received second dose (date and practice unspecified).  Subsequently the patient was experiencing irregular periods following 2 doses.  The patient came into the office for the third dose.  The patient's irregular periods persisted.  No product quality complaint was involved.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 19-OCT-2007 was vaccinated with the first dose of GARDASIL (655322/1211U). Per the reporter the patient developed a rash on her injection site arm "2 weeks after receiving the first dose of GARDASIL." Subsequently, the rash resolved on its own. On 27-DEC-2007 the patient was vaccinated with the second dose of GARDASIL . Per the reporter, again after a couple of weeks the rash reappeared. On 18-JAN-2008 the patient went to Urgicare and was given 60mg of PROMIFEN (prednisone) (unknown manufacturer). The prednisone therapy lasted until 22-JAN-2008 and the rash was resolved temporarily but returned again on 27-JAN-2008. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with Gardasil.  Subsequently the patient experienced dizziness.  Subsequently, the patient recovered from the dizziness prior to leaving the office.  This is one of several reports from the same source.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness
Clinical narrative: Information has been received from a health professional concerning a female who was vaccinated intramuscularly with the first dose of GARDASIL. Per the reporter the patient experienced flu-like symptoms for 10 days. The patient sought unspecified medical attention. Subsequently, the patient recovered from their flu-like symptoms. No additional information was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a medical assistant concerning a patient (age and gender not reported) who on an unspecified date was vaccinated with a first dose of GARDASIL injection. Subsequently on an unspecified date the patient fainted after receiving GARDASIL. It was unknown if the patient recovered. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Cough, Headache, Malaise, Nausea
Clinical narrative: Information has been received from a health professional concerning a 20 year old female who on 22-JAN-2008 was vaccinated with first dose of GARDASIL. Per the reporter, on 24-JAN-2008 the patient called the office and complained she had a headache, nausea, vomiting and did not feel good. The office recommended that the patient treat the symptoms with over the counter medication and to call back on Monday. Per the reporter, the patient has not called back and calls to the patient's house have gone unanswered. The patient's present status is unknown and no other information is available. Additional information has been requested. Follow-up received 04/16/2008. Information from B Form 15-FEB-2008. The patient's adverse events were reported as a cough, vomiting, slight sore throat and an increased temperature. The patient's status is still unknown.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Oropharyngeal pain, Vomiting
Clinical narrative: Information has been received from a health professional concerning a 20 year old female who on 22-JAN-2008 was vaccinated with first dose of GARDASIL. Per the reporter, on 24-JAN-2008 the patient called the office and complained she had a headache, nausea, vomiting and did not feel good. The office recommended that the patient treat the symptoms with over the counter medication and to call back on Monday. Per the reporter, the patient has not called back and calls to the patient's house have gone unanswered. The patient's present status is unknown and no other information is available. Additional information has been requested. Follow-up received 04/16/2008. Information from B Form 15-FEB-2008. The patient's adverse events were reported as a cough, vomiting, slight sore throat and an increased temperature. The patient's status is still unknown.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a health professional concerning a 13 year old female who in the Fall of 2007 was vaccinated with the first dose of GARDASIL. Per the reporter when she went home she "broke out in rash that lasted about a week or so." Subsequently, the patient recovered from the rash. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure via breast milk, Rash
Clinical narrative: Information has been received from a consumer who on approximately 21-JAN-2008 was vaccinated with a third dose of GARDASIL. The consumer was breast feeding her 1 year old infant. On approximately 26-JAN-2008, "in the last couple of days", the infant developed a rash on it's cheek. At the time of reporting the infant had not recovered. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a 16, 17 or 18 year old patient (high school student) who was vaccinated with a first dose of GARDASIL. Subsequently the patient passed out in the office. It was reported that there was no reaction after the second dose. The patient's twin also was vaccinated with a dose of GARDASIL and passed out (WAES# 0802USA01944). Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Loss of consciousness, Syncope, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 16, 17 or 18 year old patient (high school student) who was vaccinated with a first dose of GARDASIL. Subsequently the patient passed out in the office. It was also reported that after the second dose later in the evening , the patient fainted. The patient's twin was also vaccinated with a dose of GARDASIL and passed out (WAES# 0802USA01476). Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a registered  nurse concerning a 19 year old female with no known allergies and no reported medical history who on 09-JAN-2008 was vaccinated with her first dose of 0.5 ml GARDASIL (Lot #659055/1522U) intramuscularly. On 09-JAN-2008 the patient developed severe pain on both legs. The pain had not been resolved. No other details were reported. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, IPV
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Information has been received from a consumer concerning her 12 month old daughter with a history of "kidney reflex" and a "reaction to the antibiotic SEPTRA" who on 29-NOV-2007 was vaccinated with a first dose of PEDVAXHIB .  Concomitant therapy included antibiotics (unspecified).  On 01-DEC-2007 the patient experienced redness, a huge knot at the injection site, and pain.  It was reported that the pain had gone away but the knot was still located at the injection site.  It was reported that the knot went down but was still there.  The patient sought unspecified medical attention.  No laboratory diagnostics were performed.  At the time of the report, the patient was recovering.  No product quality complaint was involved.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/18/2008.  Initial and follow-up information has been received from a consumer concerning her 12 month old daughter with a history of Grade II Kidney reflux diagnosed at age four months and resolved at 14 months, and a "reaction to the antibiotic SEPTRA" who on 29-NOV-2007 was vaccinated intramuscularly in the right thigh with a third dose PEDVAXHIB (Lot# 657385/0677U).  Concomitant vaccinations included a fourth dose of poliovirus vaccine inactivated (unspecified) (Lot# A02732) administered intramuscularly in the right thigh, a first dose of hepatitis A virus vaccine (unspecified) (Lot# AHAVB214AA) administered intramuscularly in the left thigh, and a second dose of DTaP (Lot# U2993AA).  Concomitant therapy included antibiotics (unspecified) and FURADANTIN.  On 30-NOV-2007, within about 18 hours of the vaccination the patient developed a 4 inch diameter area of erythema (previously reported as redness), a small knot around the vaccination site on the right thigh (previously reported as a huge knot at the injection site), and a fever of 101.  On 01-DEC-2007 the patient experienced pain.  It was reported that the pain has gone away but the knot was still located at the injection site.  It was reported that the knot went down but was still there.  The patient sought unspecified medical attention.  The patient was treated with "antibiotics" antimicrobial (unspecified).  The patient vomitted the doses of antibiotics.  No laboratory diagnostics were performed.  The patient was seen in the office three days later and had recovered.  No product quality complaint was involved.  Additional information is not expected.
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Diarrhoea, Erythema, Feeling hot, Injection site abscess, Lactose intolerance
Clinical narrative: Information has been received from a consumer, concerning her 15 month old (previously reported as 28 month old) male child, who on 16-NOV-2007 was vaccinated with the third dose of PEDVAXHIB (OMPC) (lot # not reported).  Concomitant and secondary suspect vaccine therapy included a dose in the right thigh of VARIVAX (MSD) (lot # not reported) and a dose in the left thigh of DTaP (SP) (lot #UF069AA/U2059BB).  On approximately 17-NOV-2007 ("one or two days after receiving the vaccines"), the patient developed a large knot and welt at the injection site, along with diarrhea and vomiting for "about a week," and a lactose intolerance during which he could not hold down any dairy products.  The child visited the physician twice, and had a "rectal swab" done to evaluate for parasites, with negative results.  On 26-NOV-2007, the child was seen by the physician, with symptoms of vomiting, diarrhea over the weekend and the injection site that was red and warm to the touch.  The physician indicated that the area on the right thigh was firm and rubbery in a half dollar sized area; he felt it was an immunization reaction and not an infection and was improving.  Warm compresses and observation were recommended.  The physician felt the child was suffering from gastroenteritis and advised pedialyte, and to be contacted if the child developed a fever.  On 03-DEC-2007, the mother reported the child had recovered from the events.  Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Rectal examination, Urticaria, Vomiting
Clinical narrative: Information has been received from a consumer, concerning her 15 month old (previously reported as 28 month old) male child, who on 16-NOV-2007 was vaccinated with the third dose of PEDVAXHIB (OMPC) (lot # not reported).  Concomitant and secondary suspect vaccine therapy included a dose in the right thigh of VARIVAX (MSD) (lot # not reported) and a dose in the left thigh of DTaP (SP) (lot #UF069AA/U2059BB).  On approximately 17-NOV-2007 ("one or two days after receiving the vaccines"), the patient developed a large knot and welt at the injection site, along with diarrhea and vomiting for "about a week," and a lactose intolerance during which he could not hold down any dairy products.  The child visited the physician twice, and had a "rectal swab" done to evaluate for parasites, with negative results.  On 26-NOV-2007, the child was seen by the physician, with symptoms of vomiting, diarrhea over the weekend and the injection site that was red and warm to the touch.  The physician indicated that the area on the right thigh was firm and rubbery in a half dollar sized area; he felt it was an immunization reaction and not an infection and was improving.  Warm compresses and observation were recommended.  The physician felt the child was suffering from gastroenteritis and advised pedialyte, and to be contacted if the child developed a fever.  On 03-DEC-2007, the mother reported the child had recovered from the events.  Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Diarrhoea, Injection site mass, Pyrexia, Vomiting
Clinical narrative: Initial and follow up information has been received from a grand mother about her grand son and from a Registered Nurse (R.N.) from the doctor's office concerning a 6 month old white male infant with slight congestion who on 13-OCT-2007 was vaccinated at 10:41 AM, IM into right leg with a second dose of PEDVAXHIB vaccine (OMPC) (lot # 656520/0435U).  Concomitant therapy included PEDIARIX (lot # AC2B126BB) and PREVNAR (lot # B70143C).  The reporter reported that "The night after receiving his PEDVAXHIB vaccine (OMPC) and possibly other vaccinations his grandson had a hard, bump at the injection site, which was the size of a silver dollar.  The patient also experienced diarrhea, vomiting and an on off fever".  In follow up it was reported by the nurse from the physician's office that on 14-OCT-2007 the infant developed a hard bump at the injection site and also had vomiting, diarrhea and fever on and off following the PEDVAXHIB vaccine (OMPC) and possibly other vaccinations.  The patient was recovering.  Additional information is not expected.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Urticaria
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 15 week female with gastrooesophageal reflux disease (GERD) and a history of respiratory syncytial virus infection (RSV) who on 06-SEP-2007 was vaccinated with a first dose of Hib conj vaccine (OMPC) (Lot #654680/0072U).  On 12-DEC-2007, the patient was vaccinated with a second dose of Hib conj vaccine (OMPC) (Lot #656520/0435U) intramuscularly in the thigh. Concomitant suspect vaccination on the same day included ROTATEQ (MSD) given orally.  Other concomitant vaccination on the same day included PREVNAR intramuscularly in the thigh and PEDIARIX intramuscularly in the thigh.  Other concomitant therapy included ZANTAC and unspecified vitamins.  On 13-DEC-2007 the patient experienced urticaria with no respiratory symtoms or edema.  On 13-DEC-2007, the patient was examined in the emergency room.  She was not admitted.  She was released with oral BENADRYL.  There was no laboratory or diagnostic tests performed.  At the time of the report the patient's outcome was unknown.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 02/18/2008. On an unspecified date the patient recovered. Additional information is not expected.
Age: 1.06
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: On 2/13/08, child came to clinic for immunizations.  Nurse noted that child received Varicella vaccine 3 days after receiving MMR vaccine.  Was told by operator at clinic to complete VAERS.  Explained to father that nurse would repeat the Varicella since Varicella given 9/22/07 was too soon after MMR. No reaction. Was given too soon after MMR.
Age: 1.8
Sex: F
Vaccine: HEPA
Symptoms: Body temperature increased
Clinical narrative: Mom states temp 105.3 degrees day after vaccine (HAV) administered & required trip to ER; did not report to HD until months later at an office visit.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure, Dizziness, Heart rate, Hypoxia, Nausea
Clinical narrative: Information has been received from a pharmacist concerning a 21 year old female with migraines and an allergy to VICODIN who on 11-FEB-2008 was vaccinated with her second dose of Gardasil (lot # 654702/0011U). Concomitant therapy included birth control (unspecified). On 11-FEB-2008 the patient was seen in the office and developed nausea, blurred vision, dizziness, tinnitus, lightheadedness and felt like she was going to faint after her second vaccination with Gardasil. Her blood pressure was 84/58 and her pulse was 81. She was slightly hypoxic with an oxygen level of 84. On 11-FEB-2008, she was treated with oxygen and recovered. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Oxygen supplementation, Tinnitus, Vision blurred
Clinical narrative: Information has been received from a pharmacist concerning a 21 year old female with migraines and an allergy to VICODIN who on 11-FEB-2008 was vaccinated with her second dose of Gardasil (lot # 654702/0011U). Concomitant therapy included birth control (unspecified). On 11-FEB-2008 the patient was seen in the office and developed nausea, blurred vision, dizziness, tinnitus, lightheadedness and felt like she was going to faint after her second vaccination with Gardasil. Her blood pressure was 84/58 and her pulse was 81. She was slightly hypoxic with an oxygen level of 84. On 11-FEB-2008, she was treated with oxygen and recovered. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Head injury, Loss of consciousness, Syncope vasovagal
Clinical narrative: Information has been received from a physician concerning a 16 year old female, who on 13-FEB-2008 was vaccinated with a third dose of Gardasil. On 13-FEB-2007, thirty seconds post vaccination, the patient had a "vagal experience", the patient passed out, hit her head and began to experience seizures. The physician reported that they called an ambulance and brought the patient to the emergency room. The patient was discharged that night and was not admitted to the hospital. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Upon internal review seizure was considered to be an other important medical event. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Encephalitis
Clinical narrative: Information has been received from a physician concerning a 23 year old female with no medical history, who in approximately December 2007, was vaccinated with a third dose of GARDASIL. Concomitant therapy "possibly" included hormonal contraceptives (unspecified). Subsequently, post vaccination the patient experienced mild encephalitis. On 04-FEB-2008 the patient was seen in the office for her symptoms. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Upon internal review mild encephalitis was considered to be an other important medical event. Additional information has been requested.