chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Migraine
Clinical narrative: Information has been received from a physician concerning a 15 year old female with asthma and penicillin allergy who on 26-Sep-2006 was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot#not provided). Concomitant therapy included hormonal contraceptives (unspecified). On 07-Nov-2006 the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot#6537361/0868F). That same day the patient experienced a migraine with a "blinded spot in one eye", dizziness and was "seeing stars". She was treated with aspirin. At the time of this report it was unknown if the patient had recovered from the event. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Menstrual disorder
Clinical narrative: Information has been received from a physician concerning an 11 year old female who on 05-Sep-2006 was vaccinated intramuscularly with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). On approximately 05-Sep-2006, the patient noted her menstrual cycle increased from every month to every two weeks. The patient sought unspecified medical attention. At the time of this report, the outcome of the event was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Laceration, Syncope
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on an unspecified date was vaccinated with Gardasil (yeast). It was reported that the patient was sitting on a bench and when the personnel left the room, the patient apparently fainted and ended up falling off bench. It was reported that it was unsure if the patient had broken her nose but there was blood. At the time of this report, the outcome of the events were unknown. The physician feels that the patient "might be anorexic and had not had anything to eat all day hence the fainting". No further information is available.  This is in follow-up to report (s) previously submitted on 12/14/2006.  Initial and follow up information has been received from a physician concerning a 16 year old (previously reported as 14 year old) white female.  On 07-NOV-2006, at 10:02 AM, the patient was vaccinated intramuscularly with the first dose of GARDASIL (Lot # 653735/0688F).  On 07-NOV-2006, at 10:03 AM, the patient was sitting on a bench and when the personnel left the room, the patient fainted and ended up falling off the bench.  It was reported that the patient had hit her nose when she fell and developed a small laceration (previously reported that it was unsure if the patient had broken her nose but there was blood).  The patient came to quickly with no other sequelae.  It was reported that the patient had not eaten breakfast.  On 07-NOV-2006, the patient had recovered from the events.  The physician feels that the patient "might be anorexic and had not had anything to eat all day hence the fainting".  No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Sensation of heaviness
Clinical narrative: Information has been received from a mother of an 11 year old female who on 31 Oct 2006 was vaccinated with Gardasil (yeast) (0.5 ml). On 31 Oct 2006, 30 minutes following vaccination, the patient's arm "felt heavy". Subsequently, the patient recovered from the event 30 minutes later. Medical attention was not sought. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Suprapubic pain
Clinical narrative: Information had been received from a physician concerning a patient who on an unspecified date was vaccinated with the second dose of Gardasil (yeast). Subsequently the patient experienced abdominal pain and suprapubic pain that radiated to the vaginal region. No further details were provided. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 12/14/2006.  Information has been received from a physician concerning a patient who on 24-OCT-2006 was vaccinated intramuscularly with the second dose of GARDASIL (lot # 653937/0637F).  Subseqently on 24-OCT-2006, the patient experienced abdominal pain.  The abdominal pain was described as being located at the umbilicus to genital area.  The abdominal pain spontaneously resolved 3 days after the vaccination.  No further details were provided.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site swelling, Wrong technique in drug usage process
Clinical narrative: Initial and follow up information has been received from a vaccine coordinator concerning a  female (age not reported) who on an unspecified date was vaccinated with 0.5 mL of Gardasil (yeast). Subsequently, the patient experienced pain at the injection site. It was reported that the vaccine hurt the patient more when injected into the arm rather than the upper thigh, hip area. It was reported that the "pain was so great that the patient said they would not finish the series". The patient sought unspecified medical attention. The shot was from a pre-filled safety syringe. The vaccine coordinator thinks "the pain may have something to do with the technique because the shots given from the single dose vials have not experienced as much pain". It was further reported that "she was unsure if the extreme pain was caused by the vaccine, injection site or the technique used with the safety syringes." At the time of this report, the outcome of the events were unknown. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 12/14/2006.  Initial and follow up information has been received from a vaccine coordinator concerning a 26 year old female who on 08-SEP-2006 was vaccinated in the left deltoid with the second 0.5 mL dose of GARDASIL (Lot # 654540/0800F).  On 08-SEP-2006, the injection site area filled up with fluid with tennis ball size swelling per the patient.  It was reported that the duration was "a couple hours".  It was previously reported that the patient had developed pain at the injection site.  It was reported that the vaccine hurt the patient more when injected into the arm rather than the upper thigh, hip area.  It was reported that the "pain was so great that the patient said they would not finish the series".  The shot was from a pre-filled safety syringe.  The vaccine coordinator thinks "the pain may have something to do with the technique because the shots given from the single dose vials have not experienced as much pain".  It was further reported that "she was unsure if the extreme pain was caused by the vaccine, injection site or the technique used with the safety syringes".  The patient stated that this "was not a big deal but preferred the injection in her leg".  At the time of this report, the outcome of the events were unknown.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Urticaria
Clinical narrative: Information has been received from a physician and a nurse concerning a 21 year old female with glaucoma who on 09 Sep 2006 was vaccinated with a first dose of Gardasil (yeast). Concomitant therapy included Xalatan. On 12 Nov 2006, the patient was vaccinated IM, in the right deltoid, with a 0.5 ml second dose of Gardasil (yeast) (lot #653736/0868F). On 12 Nov 2006, 13 hours after the vaccination, the patient developed a rash on both arms. The patient used alcholol on these areas and the rash went away. On approximately 12 Sep 2006, at an unspecified time, the patient developed hives. The hives were itchy and "looked like slap marks all over her body" including her legs, abdomen, back and face. The welts were raised and swollen. The patient was treated with Benadryl. At the time of the report, the patient was recovering from the hives. There were laboratory or diagnostic tests performed. It was reported that the patient had no reactions after the first dose of Gardasil (yeast). Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Drug hypersensitivity, Erythema, Injection site cellulitis, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 11 year old female who on 01-Nov-2006 was vaccinated with a 0.5 ml first dose of Gardasil (yeast) (lot #653938/0954F). On 09 Nov 2006 the patient developed cellulitis in the arm where vaccine was administered. Unspecified medical attention was sought. At the time of the report, the patient was recovering from the cellulitis. Additional information has been requested. This is in follow-up to report9s0 previously submitted on 12/14/2006. Entitle and follow-up information has been received from a physician concerning a 11 year old female student with a cephalosporin allergy who on 01-NOV-2006 was vaccinated with a 0.5 ml first dose of GRDASIL (lot # 653938/0954F). On 09-NOV-2006 the patient developed cellulites in the arm where vaccine was administrated. The patient's arm was red, hot, swollen, painful and tender. The patient sought medical attention. A complete blood cell count and x-ray were performed (results in reported). It was reported that the patient had an allergic reaction to cephalexin "once started." Subsequently, the patient recovered from cellulites. Follow-up information reported the physician considered cellulites to be disabling event. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Skin warm, Tenderness
Clinical narrative: Information has been received from a physician concerning a 11 year old female who on 01-Nov-2006 was vaccinated with a 0.5 ml first dose of Gardasil (yeast) (lot #653938/0954F). On 09 Nov 2006 the patient developed cellulitis in the arm where vaccine was administered. Unspecified medical attention was sought. At the time of the report, the patient was recovering from the cellulitis. Additional information has been requested. This is in follow-up to report9s0 previously submitted on 12/14/2006. Entitle and follow-up information has been received from a physician concerning a 11 year old female student with a cephalosporin allergy who on 01-NOV-2006 was vaccinated with a 0.5 ml first dose of GRDASIL (lot # 653938/0954F). On 09-NOV-2006 the patient developed cellulites in the arm where vaccine was administrated. The patient's arm was red, hot, swollen, painful and tender. The patient sought medical attention. A complete blood cell count and x-ray were performed (results in reported). It was reported that the patient had an allergic reaction to cephalexin "once started." Subsequently, the patient recovered from cellulites. Follow-up information reported the physician considered cellulites to be disabling event. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hyperhidrosis, Incorrect route of drug administration, Nausea
Clinical narrative: Information has been received from a registered nurse concerning her 16 year old daughter who on 13 Nov 2006 was vaccinated with her first dose of Gardasil (yeast). The patient's mother reported that she was vaccinated subcutaneously. Conflicting information was received from the administering licensed practical nurse who reported that she was positive the patient was vaccinated intramusculaurly into the deltoid area and not subcutaneously. On 13 Nov 2006, a few minutes after the vaccine was administered, the patient experienced nausea, dizziness and sweating. Unspecified medical attention was sought. Subsequentely, the patient recovered from nausea, dizzines and sweating in a few minutes. Additional information has been received from a registered nurse. The nurse reported that her fellow nurse gave the dose of Gardasil (yeast) IM instead of subcutaneous. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema, Swelling
Clinical narrative: Information has been received from a nurse practitioner concerning a 19 year old female who on an unspecified date was vaccinated with a 0.5 mL dose of Gardasil (yeast). The patient was experiencing vomiting and diarrhea and had no fever prior to receiving the vaccination. Subsequently, the patient developed swelling of hands and feet and her face got puffy after receiving Gardasil (yeast). The patient sought medical attention and was treated with an unspecified antihistamine. Subsequently, the swelling went away, and the patient was considered recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated IM with a first dose of Gardasil (yeast). Subsequently the patient developed a shooting pain down her arm where she received the injection. Reportedly the physician does not think this is an adverse experience. Subsequently, the patient recovered from shooting pain down her arm in less than a minute. The patient does not want to come back for a second injection. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a female who in October 2006, was vaccinated with the first dose of Gardasil (yeast) (0.5mL). In approximately October 2006, "shortly after the injection", the patient was examined and learned that she developed an abnormal PAP. Unspecified medical attention was sought. No further details were provided. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Decreased appetite, Nausea, Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old female who on 13-NOV-2006 was vaccinated intramuscularly with the first dose of Gardasil (yeast) (Lot # not provided). On 13-NOV-2006 the patient experienced nausea, vomiting and decreased appetite. Unspecified medical attention was sought. At the time of this report it was unknown if the patient had recovered from these events. Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/14/2006. Follow-up information from the nurse practitioner indicated that the patient recovered. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on 08 Nove 2006 was vaccinated intramuscularly with the first dose of Gardasil (yeast) (Lot # not provided). On 09 Nov 2006 it was reported that the patient developed hives. Unspecified medical attention was sought. At the time of this report it was unknown if the patient had recovered. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral, Pruritus, Rash generalised, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 22 year ld white female student with no other medical history, no known allergies or adverse drug reactions reported. On 26 Sep 2006, at 12:300 PM, the patient was vaccinated intramuscularly in the left deltoid with the first dose of Gardasil (yeast) (Lot# 653736/0689F), within 2 hours of the injections the patient developed full body hives, itching and swelling of hands and feet. The patient took Benadryl every 4 hours and the symptoms were gone within 24 hours. At the time of this report, the patient had recovered from the events. Additional information has been requested.  This is in follow-up to report(s) previously submitted on 12/14/2006.  Initial and follow up information has been received from a registered nurse concerning a 23 year old (previously reported as 22 year old) white female student with no other medical history, no known allergies or adverse drug reactions reported.  On 26-SEP-2006, at 3:00 PM, the patient was vaccinated intramuscularly in the left deltoid with the first dose of GARDASIL (Lot # 653736/0689F).  There were no illnesses noted at the time of vaccination.  On 26-SEP-2006, at 4:00 PM, the patient developed a rash over body (previously) reported as full body hives and had itching) and had swelling of hands and feet.  The patient took BENADRYL every 4 hours and the rash was gone within 24 hours.  On 27-SEP-2006, the patient had recovered from the events.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Dizziness, Hyperhidrosis, Nausea, Syncope
Clinical narrative: Information has been received from a consumer who is a company representative concerning her 20 year old daughter who on an unspecified date was vaccinated with the second dose of Gardasil (yeast). The patient's mother reported that the vaccination caused the patient to feel faint, and she experienced nausea with chills and sweating. The patient was kept in the office until she felt better. No further details were provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a practice manager concerning a female patient who on an unspecified date was vaccinated with Gardisal (yeast). Subsequently, following vaccination, the patient experienced syncope. Unspecified medical attention was sought. No further details were provided. At the time of this report, the outcome of the event was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who was "shot phobic" who on an unspecified date was vaccinated with Gardasil (yeast) (0.5ml). Subsequently, following vaccination, the patient fainted. Unspecified medical attention was sought. The patient subsequently recovered. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Pain
Clinical narrative: Information has been received from a registered nurse at an OB/GYN's office concerning a 14 year old female with penicillin allergy who on 13 Nov 2006 was vaccinated intramuscularly in the left deltoid with Gardasil (yeast) (lot #653938/0954F). There was no concomitant medication. On 13 Nov 2006 the patient experienced pain in the vaccinated arm, headache, dizziness, fatigue, weakness and ringing in the ears. The patient sought treatment from her pediatrician. At the time of this report the patient's pain in the arm, headache, dizziness, fatigue, weakness and ringing in the ears persisted. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Tinnitus
Clinical narrative: Information has been received from a registered nurse at an OB/GYN's office concerning a 14 year old female with penicillin allergy who on 13 Nov 2006 was vaccinated intramuscularly in the left deltoid with Gardasil (yeast) (lot #653938/0954F). There was no concomitant medication. On 13 Nov 2006 the patient experienced pain in the vaccinated arm, headache, dizziness, fatigue, weakness and ringing in the ears. The patient sought treatment from her pediatrician. At the time of this report the patient's pain in the arm, headache, dizziness, fatigue, weakness and ringing in the ears persisted. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Influenza like illness
Clinical narrative: Information has been received from a registered nurse at an OB/GYN's office concerning a 14 year old female with penicillin allergy who on 13 Nov 2006 was vaccinated intramuscularly in the left deltoid with Gardasil (yeast) (lot #653938/0954F). There was no concomitant medication. On 13 Nov 2006 the patient experienced pain in the vaccinated arm, headache, dizziness, fatigue, weakness and ringing in the ears. The patient sought treatment from her pediatrician. At the time of this report the patient's pain in the arm, headache, dizziness, fatigue, weakness and ringing in the ears persisted. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Pain
Clinical narrative: Information has been received from a nurse concerning a female who on 13 Nov 2006 was vaccinated with the first dose of Gardasil (yeast). Subsequently on 13 Nov 2006, following vaccination, the patient experienced a headache and flu-like symptoms. The patient did not have a fever. Unspecified medical attention was sought. At the time of this report, the outcome of the events was unknown. Additional information has been requested. 04/06/2007 This is in follow-up to report(s) previously submitted on 12/14/2006. Information has been received from a nurse concerning a 14 year old female with no pertinent medical history or allergies, who on 13-NOV-2006 was vaccinated with the first intramuscular dose of GARDASIL in the left deltoid (lot# 653938/0954F). Subsequently on 13-NOV-2006, following vaccination, the patient experienced a headache, flu-like symptoms, fatigue, dizziness, weakness, and ring in ears. The patient did not have a fever. The patient subsequently recovered on 15-NOV-2006. On 15-JAN-2007, the patient was vaccinated with the second IM dose of GARDASIL in the right deltoid (lot# 655619/1427F). The patient subsequently recovered on 16-Jan-2007. No lab testing was performed. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Tinnitus
Clinical narrative: Information has been received from a nurse concerning a female who on 13 Nov 2006 was vaccinated with the first dose of Gardasil (yeast). Subsequently on 13 Nov 2006, following vaccination, the patient experienced a headache and flu-like symptoms. The patient did not have a fever. Unspecified medical attention was sought. At the time of this report, the outcome of the events was unknown. Additional information has been requested. 04/06/2007 This is in follow-up to report(s) previously submitted on 12/14/2006. Information has been received from a nurse concerning a 14 year old female with no pertinent medical history or allergies, who on 13-NOV-2006 was vaccinated with the first intramuscular dose of GARDASIL in the left deltoid (lot# 653938/0954F). Subsequently on 13-NOV-2006, following vaccination, the patient experienced a headache, flu-like symptoms, fatigue, dizziness, weakness, and ring in ears. The patient did not have a fever. The patient subsequently recovered on 15-NOV-2006. On 15-JAN-2007, the patient was vaccinated with the second IM dose of GARDASIL in the right deltoid (lot# 655619/1427F). The patient subsequently recovered on 16-Jan-2007. No lab testing was performed. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Influenza like illness
Clinical narrative: Information has been received from a nurse concerning a female who on 13 Nov 2006 was vaccinated with the first dose of Gardasil (yeast). Subsequently on 13 Nov 2006, following vaccination, the patient experienced a headache and flu-like symptoms. The patient did not have a fever. Unspecified medical attention was sought. At the time of this report, the outcome of the events was unknown. Additional information has been requested. 04/06/2007 This is in follow-up to report(s) previously submitted on 12/14/2006. Information has been received from a nurse concerning a 14 year old female with no pertinent medical history or allergies, who on 13-NOV-2006 was vaccinated with the first intramuscular dose of GARDASIL in the left deltoid (lot# 653938/0954F). Subsequently on 13-NOV-2006, following vaccination, the patient experienced a headache, flu-like symptoms, fatigue, dizziness, weakness, and ring in ears. The patient did not have a fever. The patient subsequently recovered on 15-NOV-2006. On 15-JAN-2007, the patient was vaccinated with the second IM dose of GARDASIL in the right deltoid (lot# 655619/1427F). The patient subsequently recovered on 16-Jan-2007. No lab testing was performed. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abnormal behaviour, Euphoric mood, Malaise, Nausea
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female with a penicillin allergy and drug hypersensitivity to Zithromax. On 14 Nov 2006, the patient was vaccinated with Gardasil (yeast) ( Lot # 653978/0955F). There were no concomitant medications reported. On 15 Nov 2006, the patient was noted to be very emotional, nauseated, felt dazed and "high". The patient sought unspecified medical attention. No treatment was required. On 16 Nov 2006, the patient had recovered from the events. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia, Sensation of heaviness
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a first 0.5 ml Gardasil (yeast). Subsequently the patient experienced a tingle and heaviness. Unspecified medical attention was sought. After twenty minutes the tingle and heaviness went away. No product quality complaint was involved. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Viral infection
Clinical narrative: Information has been received from a physician concerning a 25 year old female who on an unspecified date was vaccinated with HPV Vaccine. One week later, the patient was noted to have a positive human papilloma virus infection (date unknown). It was reported that the physician dose not know when the vaccine was given or the dose because she did not administer the vaccine in her office. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered from the event. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: Information has been received from a health professional concerning a 20 year old female who on an unspecified date was vaccinated with a dose of HPV Vaccine. Subsequently, the patient experienced three menstrual periods during the next month. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 16 year old female with no known drug allergies who on 08 Nov 2006, at 4:00 PM, was vaccinated IM with the first dose of HPV vaccine. On 09 Nov 2006, the patient developed a drug rash. The patient sought unspecified medical attention. On 14 Nov 2006, the patient was recovered from the drug rash. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Pruritus
Clinical narrative: Information has been received from a nurse practitioner concerning a female (age not reported) who on approximately 01 Nov 2006 was vaccinated with the first dose of HPV vaccine. On approximately 01 Nov 2006, the patient developed total body itching. The patient sought unspecified medical attention. At the time of this report, the outcome of the event was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Nausea, Pyrexia
Clinical narrative: Information has been received from a physician's nurse concerning a 15 year old female who on 27 Sep 2006 was vaccinated intramuscularly with HPV vaccine (lot # 653937/0637F). On 28 Sept 2006 the patient experienced nausea, fever and soreness at the injection site. Unspecified medical attention was sought. At the time of this report, the outcome of the events was unknown.
Sex: F
Vaccine: HPV4
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Information has been received from a nurse concerning a female who on an unspecified date was vaccinated with HPV vaccine. Subsequently, one week later, the patient developed welts on the arm where the shot was administered. Unspecified medical attention was sought. At the time of this report, the outcome of the event was unknown. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Injection site erythema
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old female with no pertinent medical history or drug reactions/allergies who on 14 Nov 2006 was vaccinated intramuscularly with HPV Vaccine. There was no concomitant medications. On 15 Nov 2006, about 24 hours later, the patient developed erythema at the injection site and experienced flu like symptoms. Unspecified medical attention was sought. Subsequently, the patient recovered from the erythema at injection site and flu like symptoms within 72 hours. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram normal, Dysaesthesia, Electromyogram normal, Hypoaesthesia, Hypoaesthesia
Clinical narrative: Information has been received from a nurse concerning a female patient (age not reported) with a nerve compression (NOS) who on an unknown date in October 2006, was vaccinated intramuscularly in the left deltoid with the second dose of HPV Vaccine (date of first dose and Lot # were not provided). On an unknown date in Oct 2006, the patient experienced numbness in her left arm. The patient was referred to a neurologist, because of her history of pinched nerve. At the time of this report it was unknown if the patient had recovered from the event. Additional information has been requested. 04/06/07: This is in follow-up to report (s) previously submitted on 12/14/2006. Initial and follow up information has been received from a nurse and a physician concerning a 24 year old female patient with nerve compression (NOS), cervical pain, chronic anxiety, insomina and leg pain and a history of "localized cervical cancer (diagnoses February, 2006)", lumbar laminectomy and a motor vehicle accident (NOS) who at 10:00 on 30-OCT-2006, was vaccinated intramuscularly in the left deltoid with the second dose of HPV rL1 11 16 18 VLP vaccine (yeast) (Lot#653650/0702P), (date of first dose and Lot # were not provided) no concomitant therapies were reported by the OB/GYN. It was reported that at 10:30 am post-vaccination the patient experienced left upper extremity paresthesias and numbness. The patient was seen for follow up by the OB/GYN for the event on 09-NOV-2006 and was referred to a neurologist, because of her history of a pinched nerve. On 29-NOV-2006 the patient was seen by a neurologist. The patient reported the following concurrent medications at that time: cyclobenzaprine hydrochloride (MSD), metaxalone (Skelaxin), acetaminophen (+) hydrocodone bitartrate (Vicodin), oxycodone, alprazolam (Xanax) and diclofenac. conduction studies and electromyography (EMG) with follow-up somatosensory evoked potential studies of the left arm. The patient was seen by the neurologist for a follow up appointment on 06-DEC-2006. The neurologist noted that "she continued to have insomnia, arm pain, dysesthesias, etc which she dates from her motor vehicle accident." The results of her nerve conduction studies and EMG were normal. Her somatosensory evoked potential studies through the brachial plexus and cervical spinal cord were also normal. The neurologist noted "we cannot find an organic explanation for the patient's arm pain complaint's." The neurologist recommended the "Tincture of time" and symptomatic treatment at a pain center. At the time of this report the patient had not recovered from the event. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Insomnia, Nerve conduction studies normal, Nuclear magnetic resonance imaging normal, Pain in extremity, Paraesthesia
Clinical narrative: Information has been received from a nurse concerning a female patient (age not reported) with a nerve compression (NOS) who on an unknown date in October 2006, was vaccinated intramuscularly in the left deltoid with the second dose of HPV Vaccine (date of first dose and Lot # were not provided). On an unknown date in Oct 2006, the patient experienced numbness in her left arm. The patient was referred to a neurologist, because of her history of pinched nerve. At the time of this report it was unknown if the patient had recovered from the event. Additional information has been requested. 04/06/07: This is in follow-up to report (s) previously submitted on 12/14/2006. Initial and follow up information has been received from a nurse and a physician concerning a 24 year old female patient with nerve compression (NOS), cervical pain, chronic anxiety, insomina and leg pain and a history of "localized cervical cancer (diagnoses February, 2006)", lumbar laminectomy and a motor vehicle accident (NOS) who at 10:00 on 30-OCT-2006, was vaccinated intramuscularly in the left deltoid with the second dose of HPV rL1 11 16 18 VLP vaccine (yeast) (Lot#653650/0702P), (date of first dose and Lot # were not provided) no concomitant therapies were reported by the OB/GYN. It was reported that at 10:30 am post-vaccination the patient experienced left upper extremity paresthesias and numbness. The patient was seen for follow up by the OB/GYN for the event on 09-NOV-2006 and was referred to a neurologist, because of her history of a pinched nerve. On 29-NOV-2006 the patient was seen by a neurologist. The patient reported the following concurrent medications at that time: cyclobenzaprine hydrochloride (MSD), metaxalone (Skelaxin), acetaminophen (+) hydrocodone bitartrate (Vicodin), oxycodone, alprazolam (Xanax) and diclofenac. conduction studies and electromyography (EMG) with follow-up somatosensory evoked potential studies of the left arm. The patient was seen by the neurologist for a follow up appointment on 06-DEC-2006. The neurologist noted that "she continued to have insomnia, arm pain, dysesthesias, etc which she dates from her motor vehicle accident." The results of her nerve conduction studies and EMG were normal. Her somatosensory evoked potential studies through the brachial plexus and cervical spinal cord were also normal. The neurologist noted "we cannot find an organic explanation for the patient's arm pain complaint's." The neurologist recommended the "Tincture of time" and symptomatic treatment at a pain center. At the time of this report the patient had not recovered from the event. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased, Dizziness, Syncope
Clinical narrative: Information has been received from a health professional concerning a female patient with an allergy to amoxicillin and clavulanate potassium who on 08 Nov 2006 at 11:00 AM was vaccinated in the right deltoid with the first dose of HPV vaccine. (Lot #654540/0800F) There was no illnesses at the time of vaccination. On 08 Nov  2006, at 1PM, following vaccination, the patient became lightheaded. Then while walking out of the office, the patient had a syncopal episode. It was reported that there was no detectable seizure activity and the patient was not post ictal. The patient's blood pressure was low, however not documented. The patient subsequently recovered with elevation of her feet and after five minutes, the patient was sent home. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Immediate post-injection reaction, Injection site oedema, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a female who was vaccinated with a first dose of HPV vaccine. It was reported that immediately upon administration of the vaccine, the patient developed excessive swelling near the injection site. Unspecified medical attention was sought. At the time of the report, the patient's outcome was unknown.  This is in follow-up to report(s) previously submitted on 12/14/2006.  Initial and follow-up information has been received from a nurse and a physician concerning a 21 year old white female student with asthma who on 24-NOV-2006, at 12:00 p.m., was vaccinated IM, into the right arm, with a first dose of GARDASIL (lot #654389/0961F) concomitantly with a sixth dose of FLUZONE (lot #U2197AA) IM, into the left arm.  On 24-NOV-2006, at 12:01 p.m., the patient developed immediate swelling at the injection site.  The patient recovered on the same day.  There were no laboratory or diagnostic tests performed.  Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Breast tenderness, Nipple pain
Clinical narrative: Information has been received from a female health professional who was vaccinated with HPV vaccine 0.5ml. Subsequently the patient experienced extremely sore nipples that lasted 4 days. The patient recovered from extremely sore nipples. The health professional plans on receiving the next two vaccine injections. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 12/14/2006.  Initial and follow-up information has been received from a 25 year old female secretary/receptionist who is the patient (previously reported as a female health professional).  On an unspecified date, the patient was vaccinated with a first dose of GARDASIL 0.5 ml.  Subsequently the patient experienced extremely sore nipples and slight breast tenderness, starting the day after injection, and lasting approximately 4 days.  04-JAN-2007 the patient was vaccinated with her second dose of GARDASIL.  On 05-JAN-2007 the patient experienced slight breast tenderness and extremely sore nipples that lasted for approximately 4 days.  The patient plans on receiving the series of vaccine injections.  Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Chest discomfort, Chest pain, Erythema, Hypoaesthesia, Injection site erythema
Clinical narrative: Information has been received from a nurse practitioner concerning an 18 year old female with a history of drug reaction/allergy to VICODIN who on 27 Nov 2006 was vaccinated with first dose of HPV vaccine injection into left arm. Concomitant therapy included influenza virus vaccine (unspecified) injection also administered the same day on 27 Nov 2006 into her left arm, YASMIN, Minocycline. On 28 Nov 2006, the patient experienced tingling, swelling, and redness in her left arm and hand. She also experienced swelling and redness in her right hand thumb, and some soreness in her chest and upper body area. The patient sought medical attention. No diagnostic tests were performed. Additional information was obtained from the nurse practitioner via phone call. The patient was vaccinated with HPV vaccine and a flu vaccine on 27 Nov 2006 in her left arm by her primary care physician. The patient was seen in her clinic less than 24 hours later experiencing swelling and numbness of fingers, and chest wall discomfort. The patient was seen for follow upon 29 Nov 2006 and all symptoms had resolved. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Injection site oedema, Oedema, Pain, Paraesthesia
Clinical narrative: Information has been received from a nurse practitioner concerning an 18 year old female with a history of drug reaction/allergy to VICODIN who on 27 Nov 2006 was vaccinated with first dose of HPV vaccine injection into left arm. Concomitant therapy included influenza virus vaccine (unspecified) injection also administered the same day on 27 Nov 2006 into her left arm, YASMIN, Minocycline. On 28 Nov 2006, the patient experienced tingling, swelling, and redness in her left arm and hand. She also experienced swelling and redness in her right hand thumb, and some soreness in her chest and upper body area. The patient sought medical attention. No diagnostic tests were performed. Additional information was obtained from the nurse practitioner via phone call. The patient was vaccinated with HPV vaccine and a flu vaccine on 27 Nov 2006 in her left arm by her primary care physician. The patient was seen in her clinic less than 24 hours later experiencing swelling and numbness of fingers, and chest wall discomfort. The patient was seen for follow upon 29 Nov 2006 and all symptoms had resolved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female with on approximately 22 Nov 2006 was vaccinated with a 0.5ml dose of HPV vaccine. On 22 Nov 2006 the patient fainted. Unspecified medical attention was sought. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Acne
Clinical narrative: Information has been received from a nurse practitioner concerning an 18 year old female who on 08 Nov 2006 was vaccinated with a 0.5ml dose of HPV vaccine. Within one week the patient developed facial acne. Unspecified medical attention was sought. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise
Clinical narrative: Information has been received from the mother of a 21 year old female with penicillin allergy who in 2006 was vaccinated with HPV vaccine. There was no concomitant medication. The patient's mother stated that following vaccination, her daughter was sick. Unspecified medical attention was sought. At the time of this report, the patient was recovering. No further information is expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Skin papilloma, Viral infection
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old female with vaginal papilloma who in approximately November 2006, was vaccainted with HPV vaccine. Concomitant therapy included trichloroacetic acid. The nurse practitioner reported that the patient was treated wit trichloroacetic acid (strength unspecified) for existing vaginal warts one week after vaccination with HPV vaccine (the warts were existing prior to the vaccination with HPV Vaccine). Three weeks after the trichloroacetic acid treatment, on 28 Nov 2006, the warts appeared raised and very red, which was much different than normal treatment with trichloroacetic acid. Unspecified medical attention was sought. At the time of this report, the patient had not yet recovered. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a nurse practitioner concerning a patient who was vaccinated with a dose of HPV vaccine. Concomitant therapy included birth control pills. Subsequently, the patient experienced a full body rash. At the time of this report, the patient's outcome was unknown. The reporter felt that full body rash was not related to therapy with HPV vaccine. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old female with a penicillin allergy who on 16 Nov 2006 was vaccainted with a first 0.5ml dose of HPV vaccine. Concomitant therapy included LOESTRIM. On 26 Nov 2006 the patient broke out into hives. The patient was treated with a steroid and was doing fine. No product quality complaint was involved. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Face oedema
Clinical narrative: Information has been received from a nurse in a physician's office concerning a 17 year old female who in approximately September 2006, was vaccinated with the second 0.56ml dose of HPV vaccine. On 21 Nov 2006, the patient developed swelling of lips and swelling of face. The patient sought unspecified medical attention. On 22 Nov 2006 within 24 hours, the patient had recovered from the events. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a female patient in her 20's who in November 2006, was vaccinated with a dose of HPV vaccine. Immediately after administration, the patient passed out. Medical attention was sought. Subsequently, the patient recovered. The physician explained that another physician from a different office administered the vaccination to the patient. Additional information has been requested. There was no product quality complaint involved.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: information has been received from a health professional concerning a female patient who was vaccinated with a first dose of HPV Vaccine. Subsequently as the patient was leaving the examination room, the patient fainted. Unspecified medical attention was sought. The patient recovered shortly after fainting. No product quality complaint was involved. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Nasal congestion, Rhinorrhoea
Clinical narrative: Information has been received from a physician's assistant concerning a 38 year old female with seasonal allergy and no pertinent medical history who on 11 Sep 2006 was vaccinated intramuscularly with a 0.5ml dose of HPV vaccine (lot #653650/0702F). Concomitant therapy included COMBIVENT and CLARITIN D. The patient reported that within days after 11 Sep 2006, she had to use her inhaler on and off since then. The patient called the physician's office and reported a runny nose and stuffiness since the vaccination with symptoms that continued. The patient took allergy medicine and inhaler without relief. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. In follow-up it was reported by the physician's assistant that the patient had generalized shortness of breath on 10-NOV-2006. The patient needed to use her inhaler, which she had not needed to do in over two years. The patient reported that she did not get any relief from loratadine (+) pseudoephedrine sulfate. At the time of the report, it was unknown, if the patient recovered.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, High-pitched crying, Malaise, Nausea
Clinical narrative: Information has been received from a nurse concerning a female co worker (age not reported) who on 28 Nov 2006 was vaccinated intramuscularly in the deltoid with the first single dose vial of HPV vaccine. The nurse reported that the patient had an experience during and immediately after being vaccinated. The nurse reported that when the patient was given the shot, she started screaming almost immediately and reported that she did not feel well. The nurse also reported that the patient felt like she was going to pass out and was feeling nauseated. The patient was sent home from work and was now out a second day from work. The patient sought unspecified medical attention. At the time of this report, the outcome of the events were unknown as the patient had not returned to work. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a female patient who was vaccinated with a 0.5ml dose of HPV vaccine. Subsequently, the patient fainted. Unspecified medical attention was sought. A short time after vaccination, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a female patient who was vaccinated with a 0.5 ml dose of HPV vaccine. Subsequently the patient fainted. Unspecified medical attention was sought. a short time after vaccination, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a female patient who was vaccinated with a 0.5 ml dos of HPV vaccine. Subsequently, the patient fainted. Unspecified medical attention was sought. A short time after vaccination, the patient recovered. No product quality complaint was involved. Additional information has been requested.