chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a female patient with a history of shingles who on approximately 15-MAY-2007 was vaccinated SC with a dose of Zostavax (Oka/Merck). On an unspecified date in May 2007, the patient experienced "a little rash on her hand but there was no severe pain." Unspecified medical attention was sought. The patient's rash has cleared and she was doing fine and was considered recovered on an unspecified date in May 2007. A product quality complaint was not involved. Additional information has been requested. 09/24/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a physician concerning a 65 year old female with hypertension, hyperlipidaemia, migraine, allergies to amitriptyline hydrochloride (MSD), MACRODANTIN, DARVOCET, CELEXA, PHENERGAN, atenolol (manufacturer unknown), and LEXAPRO and a history of shingles who on 09-MAR-2007 at 13:00 PM was vaccinated SC in the right deltoid with a first dose of ZOSTAVAX (Oka/Merck) (lot # 656606/0033U). There was no illness at the time of vaccination. On an unspecified date the patient experienced "a little rash on her hand but there was no severe pain". Unspecified medical attention was sought. The patient's rash has cleared and she was doing fine and was considered recovered. A product quality complaint was not involved. Additional information has been received from a registered nurse who reported that the patient broke out in a rash on the hand a few days after administration of the vaccine, on approximately 12-MAR-2007. It was noted to be a shingles-type rash. The symptoms resolved on their own. The patient was considered recovered on 20-MAR-2007. No diagnostic laboratory tests were performed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Paraesthesia
Clinical narrative: Information has been received from a 61 year old female consumer with no known history or allergies who on 18-APR-2007 was vaccinated SC with a dose of Zostavax. There was no concomitant medication. On 25-APR-2007 the patient developed muscle ache and pain in the bicep and tricep of the arm used for the injection. She also had "pringling sensation" in the same arm. Unspecified medical attention was sought. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Headache, Incorrect dose administered
Clinical narrative: Information has been received from a physician concerning a female (age unknown) with thyroid nodule and hypertension who on 24-MAY-2007 was vaccinated with a first dose of Zostavax (lot#652966/0623F) and on 25-May-2007 was vaccinated with another dose of Zostavax (lot#656861/0329U). Concomitant therapy included LIPITOR and ALTACE. The patient was seen by the physician on 24-May-2007 and was given the first injection of Zostavax. The physician wrote in the chart that the patient had received the injection, but the computerized office system was not updated. The patient then was told by a medical assistant to fill the prescription for Zostavax and returned to the office for injection. The patient completed this on 25-May-2007 and received a second injection on 25-May-2007. On approximately 25-MAY-2007 the patient experienced a headache described as "a burning in the head". The nurse mentioned that the patient was seen in the office on 29-May-2007 for a complaint of headache and "a burning in the head" that resolved in 24 hours. The date the headache began was unknown, but it resolved by the time the patient saw the physician on 29-May-2007. The physicians exam was unremarkable and no abnormal findings were noted. Additional information has been requested.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a nurse concerning a patient who was vaccinated with a dose of ZOSTAVAX. Subsequently the patient had a "reaction' when the vaccine was administered to them. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 12 month old female who on 26-APR-2007 who was vaccinated with a dose of Zostavax (lot # 656394/0162U) instead of varicella virus vaccine live. The physician reported that the practice ordered varicella virus vaccine live and zoster vaccine live was sent by the pharmacy. The vaccine was put in the freezer where varicella virus vaccine live is normally kept and the medical assistant administered the vaccine assuming it was varicella virus vaccine live. The medical assistants will now be double checking all medications prior to administration. As of 07-JUN-2007 the patient was fine, there was no fever or rash. There was no product quality complaint involved. This is one of several reports from the same reporter. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 5 year old female who on 10-MAY-2007 was vaccinated with a dose of Zostavax (lot # 656394/0162U) instead of Varivax. The physician reported that the practice ordered Varivax and Zostavax was sent by the pharmacy. The vaccine was put in the freezer where Varicella is normally kept and the medical assistant administered the vaccine assuming it was Varivax. The medical assistants will now be double checking all medications prior to administration. As of 07-JUN-2007 the patient was fine, there was no fever or rash. There was no product quality complaint involved. This is one of several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 4 year old patient who on 26-APRI-2007 was vaccinated with a dose of Zostavax (lot # 656394/0162U) instead of Varivax. The physician reported that the practice ordered Varivax and Zostavax was sent by the pharmacy. The vaccine was put in the freezer where Varivax is normally kept and the medical assistant administered the vaccine assuming it was Varivax. The medical assistants will now be double checking all medications prior to administration. As of 07-JUN-2007 the patient was fine, there was no fever or rash. There was no product quality complaint. This is one of several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning 4 year old male who on 18-MAY-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (lot # 656394/0162U) instead of Varivax (Oka/Merck). The physician reported that the practice ordered Varivax (Oka/Merck) and Zostavax (Oka/Merck) was sent by the pharmacy. The vaccine was put in the freezer where Varivax (Oka/Merck) is normally kept and the medical assistant administered the vaccine assuming it was Varivax (Oka/Merck). The medical assistants will now be double checking all medications prior to administration. As of 07-JUN-2007 the patient was fine, there was no fever or rash. There was no product quality complaint involved. This is one of several reports from the same reporter. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse reaction, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 14 year old male who on 25-MAY-2007 was vaccinated with a dose of Zostavax (lot # 656394/0162U) instead of Varivax. The physician reported that the practice ordered Varivax and Zostavax was sent by the pharmacy. The vaccine was put in the freezer where Varivax is normally kept and the medical assistant administered the vaccine assuming it was Varivax. The medical assistants will now be double checking all medications prior to administration. As of 07-JUN-2007 the patient was fine, there was no fever or rash. There was no product quality complaint involved. This is one of several reports from the same reporter. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Chest X-ray, Rash, Rib fracture
Clinical narrative: Information has been received from a nurse concerning a 72 year old male with high blood pressure who on 23-APR-2007 was vaccinated with a 0.65 ml dose of Zostavax. Concomitant therapy included lisinopril, hydrochlorothiazide and aspirin. The patient developed blister and a rash on his torso on 05-MAY-2005. It was noted that the patient experienced a fractured rib after lifting 150 pounds on 30-APR-2007. A chest x-ray performed (results not provided). The nurse reported that the rash was located in the same area as the fracture. Unspecified medical attention was sought. At the time of report, the patient had recovered. A product quality complaint was not involved. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Skin lesion
Clinical narrative: Information has been received from a physician concerning a 62 year old female who on 29-MAY-2007 was vaccinated with a dose of Zostavax. Since approximately 29-MAY-2007, the patient has been experiencing mild unilateral pain across the abdomen "for about one month." The patient's pain is a 1 to 2 on a scale of 1 to 10. At the time of the report, the patient rated his pain to be about a 3 on a scale of 1 to 10. He had one or two lesions on the abdomen. Unspecified medical attention was sought and he was being treated with an unspecified anti-viral medication. At the time of the report, the patient was not recovered. A product quality complaint was not involved. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician and a nurse concerning a patient who was vaccinated with "a single dose" of Zostavax, SC. Subsequently the patient experienced vesicular rash with a few lesions on the right leg, ten days post vaccination (also reported as 48 hours post vaccination). The physician reported that the rash looked like herpes simplex rash. The symptoms resolved without treatment. There was no product quality complaint. Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/14/2007.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, PNC, VARZOS
Symptoms: Accidental exposure, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old male with no known allergies or pertinent medical history who on 09-MAY-2007 was inadvertently vaccinated SC with a dose of Zostavax (lot # 656606/0033U) instead of MMR. Concomitant vaccination included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown), poliovirus vaccine (manufacturer unknown) and PREVNAR. Unspecified medical attention was sought. The patient had no symptoms or adverse effects. There was no lab tests performed. There was no product quality complaint involved. No further information was provided. Additional information has been requested. This is one of several reports from the same source. Additional information has been received from the registered nurse who stated that the error occurred because the bottles of the vaccines were kept in the same place and they looked similair. It was reported that now they store vaccines separately to prevent the product confusion. The patient did not experience any adverse event. No further information is expected. This is one of several reports from the same source.
Age: 3.0
Sex: M
Vaccine: DTAP, IPV, PNC, VARZOS
Symptoms: No adverse reaction, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old male with no known allergies or pertinent medical history who on 09-MAY-2007 was inadvertently vaccinated SC with a dose of Zostavax (lot # 656606/0033U) instead of MMR. Concomitant vaccination included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown), poliovirus vaccine (manufacturer unknown) and PREVNAR. Unspecified medical attention was sought. The patient had no symptoms or adverse effects. There were no lab tests performed. There was no product quality complaint involved. No further information was provided. Additional information has been requested. This is one of several reports from the same source. This is in follow-up to report (s) previously submitted on 6/14/2007. Additional information has been received from the registered nurse who stated that the error occurred because of the bottles of the vaccines were kept in the same place and they looked similar . It was reported that now they store vaccines seperately to prevent the product confustion. There were no adverse event reported. No fruther information is expected. This is one of several reports form the same source.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Inappropriate schedule of drug administration, Urticaria
Clinical narrative: Information has been received from a health professional concerning a 16 year old white female student (142 lbs., 61.25 in.) who on 19-FEB-2007 was vaccinated with Gardasil. The patient was vaccinated with the second dose of Gardasil on 19-MAR-2007, which was only one month post dose one. The patient had no illness on the day of vaccine administration. On 22-MAR-2007 the patient experienced symptoms of hives and feeling dizzy and sought unspecified medical attention. No laboratory/diagnostic tests were performed. Subsequently, the patient recovered from symptoms of hives and feeling dizzy. Additional information is  expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Injection site pain
Clinical narrative: Initial and follow up information has been received from an office manager in a physician's office, concerning a 16 year old black female patient with no known drug allergies, oral herpes and asthma who on 18-JAN-2007 at approximately 3:30pm, was vaccinated IM in the right gluteal, with the first dose of Gardasil (Lot #654540/1163F). The patient experienced some pain during the administration of the vaccine (previously reported as no symptoms), but subsequently recovered (date unspecified). The patient's mother, who was a nurse, had questioned the office3 about the effectiveness of the vaccine, after she received training of correct Gardasil administration. On 19-MAR-2007, at approximately 3:45pm, the patient received the second dose, IM in the right deltoid, of Gardasil (Lot #654702/0011U), with no problems reported. No further information is expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a registered nurse in a physician's office concerning a 20 year old patient with an allergy to sulfamethoxazole (+) trimethoprim who on 08-MAR-2007 was vaccinated with a first dose of Gardasil (lot # 655618/0186U) in the left deltoid at 11:00 AM. The nurse reported that the patient had received the second dose late (second dose was given on "01-OCT-2007"). No adverse experience is related to this event. No other information was available at the time of reporting. Additional information was received. Conflicting information was received regarding the number of doses of vaccine that the patient had received. The reporter indicated that this was the first dose of vaccine. On 10-MAR-2007, the patient experienced hives. On an unspecified date, the patient recovered. The reporter felt that the hives were serious medical intervention was required (Other Important Medical Event). No additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: Information has been received from a physician concerning a several female patients who were vaccinated with a dose of Gardasil. Subsequently, within ten minutes of vaccine, the patient experienced dizziness and syncope. Subsequently, they regained consciousness after fainting and were "fine". Unspecified medical attention was sought. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Hypersensitivity, Joint swelling, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of Gardasil. A week later the patient experienced swelling of the wrist, ankles and feet with edema and extreme sensitivity. The patient was seen in the ER and was given NAPROSYN. The patient's outcome was unknown. No product quality complaint was involved. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Blood urine present, Laboratory test normal, Ultrasound scan normal
Clinical narrative: Information has been received from a nurse concerning a female with an allergy to aluminum hydroxyphosphate who was vaccinated with Gardasil. The patient developed blood in urine after receiving her second dose. It was unknown if she had any problems after her first dose. An ultrasound and tests to rule out urinary tract infection and kidney infection were performed. The patient did not have a kidney or urinary tract infection. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/14/2007.  Information has been received from a nurse concerning a female with an allergy to aluminum hydroxyphosphate who was vaccinated with Gardasil. The patient developed blood in urine after receiving her second dose. It was unknown if she had any problems after her first dose. An ultrasound and tests to rule out urinary tract infection and kidney infection were performed. The patient did not have a kidney or urinary tract infection. At the time of this report, the patient's outcome was unknown.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash pruritic
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female with pertinent medical history and drug reactions/allergies reported as none who on 25-APR-2007 was vaccinated with the first dose of Gardasil (lot #657621/03857U), 0.5 ml, IM. Concomitant therapy included amoxicillin and hormonal contraceptives (unspecified). On approximately 28-APR-2007 or 29-APR-2007 (nurse was not sure which date), the following weekend, the patient developed an itchy rash. The rash developed first on the patient's arms and then on her legs. The patient sought unspecified medical attention. The patient took BENADRYL for the symptoms. There has been no improvement so the patient will be seeing a dermatologist. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fungal infection, Migraine, Palpitations, Rash, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female with pertinent medical history and drug reactions/allergies reported as none who on 25-APR-2007 was vaccinated with the first dose of Gardasil (lot #657621/03857U), 0.5 ml, IM. Concomitant therapy included amoxicillin and hormonal contraceptives (unspecified). On approximately 28-APR-2007 or 29-APR-2007 (nurse was not sure which date), the following weekend, the patient developed an itchy rash. The rash developed first on the patient's arms and then on her legs. The patient sought unspecified medical attention. The patient took BENADRYL for the symptoms. There has been no improvement so the patient will be seeing a dermatologist. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Information has been received via a company representative, from a 22 year old female nursing assistant, who on 19-APR-2007 was vaccinated IM in the deltoid, with the first dose of Gardasil. The nursing assistant report she experienced pain in her deltoid muscle at the injections site, and pain that was radiating down her arm. At the time of this report, the nursing assistant had not recovered. The patient did not seek medical attention. No further information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Local reaction
Clinical narrative: Information has been received from a nurse practitioner, via a company representative, concerning a female patient who was vaccinated (date unspecified) with a dose, 0.5ml, of Gardasil. Subsequently the patient "developed a localized reaction after getting (Gardasil)." At the time of this report, the patient had recovered from the reaction. The patient sought unspecified medical attention. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Cystitis
Clinical narrative: Information has been received from a consumer concerning her 20 year old daughter with a history of warts on her hands (approximately August 2006), who in February or march 2007, was vaccinated with a first dose of Gardasil, intramuscularly. Approximately two weeks after this dose, the patient developed genital warts. Subsequently, the patient received her second dose of Gardasil, intramuscularly (date not reported). Subsequently, the patient developed a bladder infection. The patient sought unspecified medical attention. The patient's genital warts and bladder infection persisted. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Nausea
Clinical narrative: Information has been received from a female with no known drug allergies who was vaccinated with a 0.5 mL first dose of Gardasil. There was no concomitant medication. Subsequently the patient experienced nausea and pain on injection site after getting the Gardasil. The patient sought unspecified medical attention. Subsequently, the patient recovered from nausea and pain on injection site. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Injection site irritation, Injection site pain
Clinical narrative: Information has been received for a physician's "office staff" concerning a 26 year old female who on 08-FEB-2007 was vaccinated with a 0.5 ml dose of Gardasil (lot 654702/0011U). On 08-FEB-2007 the patient experienced burning and pain in the arm and the injection site, so much so that she could not move her arm. The patient sought unspecified medical attention. Subsequently, the patient recovered from burning and pain in arm an injection site so much so she could not move her arm. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Rash, Swelling face
Clinical narrative: Information has been received from a registered nurse concerning a female who on 01-MAY-2007 was vaccinated with a dose of Gardasil (lot # not provided). It was unknown if the dose was a first dose or if a previous dose had been given. The morning after vaccination, on 02-MAY-2007, the patient woke up with a swollen face and red spots on her legs. The patient sought unspecified medical attention. The Patient's swollen face and red spots on her legs persisted. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Diarrhoea, Hyperhidrosis
Clinical narrative: Information has been received from a physician concerning a 16 year old female relative with no pertinent medical history or drug reactions/allergies, who on 06-APR-2007 was vaccinated with a first dose of Gardasil, 0.5 ml, intramuscularly. Concomitant therapy included (YAZ). On 09-APR-2007 the patient experienced sweats, chills and diarrhea. Since this initial episode the patient experienced three to four similar incidences. All of the incidences have occurred one hour after eating meat. No laboratory tests were performed. The patient's sweats and chills and diarrhea after eating meat have persisted. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a female patient in her 20's who was vaccinated with a dose of Gardasil and experienced mild soreness at the injection site after the vaccination was given. The same source reported that another patient had the same reaction (WAES # 0706USA01310). Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow-up information has been received from a licensed practical nurse concerning a female patient in her early 20's who was vaccinated with a dose of GARDASIL and experienced mild soreness at the injection site after the vaccination was given. The same source reported that another patient had the same reaction (WAES # 0706USA01310). Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hyperhidrosis, Nausea, Pallor, Syncope vasovagal
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old female with no known drug allergies and a history of dizziness, nausea and sweating following blood draws, who on 02-MAY-2007 at 14:45 was vaccinated IM into the left deltoid with a second 0.5 ml dose of Gardasil (lot 655205/1426F). There was no concomitant medication. On 02-MAY-2007 at 14:45, the patient experienced dizziness, paleness, sweating, nausea and ringing in ears. It was noted that the reaction appeared to be a vasovagal response to the injection. The patient sought unspecified medical attention. No diagnostic studies were performed. Within one minute, the patient recovered from the ringing in ears. Within a few minutes the rest of the symptoms resolved. it was also reported that the patient was seen for another reason on 08-MAY-2007. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Tinnitus
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old female with no known drug allergies and a history of dizziness, nausea and sweating following blood draws, who on 02-MAY-2007 at 14:45 was vaccinated IM into the left deltoid with a second 0.5 ml dose of Gardasil (lot 655205/1426F). There was no concomitant medication. On 02-MAY-2007 at 14:45, the patient experienced dizziness, paleness, sweating, nausea and ringing in ears. It was noted that the reaction appeared to be a vasovagal response to the injection. The patient sought unspecified medical attention. No diagnostic studies were performed. Within one minute, the patient recovered from the ringing in ears. Within a few minutes the rest of the symptoms resolved. it was also reported that the patient was seen for another reason on 08-MAY-2007. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Dizziness, Headache, Nausea, Vision blurred
Clinical narrative: Information has been received from a registered nurse (school nurse), via an agency, concerning a 17 year old female student, who at 9:00am on 02-MAY-2007 was vaccinated with a dose of Gardasil. Thirty minutes after the vaccine was administered, the patient experienced nausea, dizziness, headache, stomach ache and blurred vision. The patient reported to the school nurse, who made the call to the agency to question if the symptoms had been previously reported after vaccination with Gardasil. At the time of this report, four and one half hours after receiving the vaccination, the patient had not recovered and was referred to her primary physician. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Initial and follow-up information has been received from a licensed practical nurse (LPN), concerning a 20 year old (previously reported as 24 year old) female patient with no significant medical history, who on 24-APR-2007 was vaccinated IM in the left deltoid, with the first dose of Gardasil (lot # 655617/1447F). On 25-APR-2007, the patient experienced nausea, started vomiting and had diarrhea. The patient's vomiting resolved after 4 days, on approximately, 29-APR-207, the date of recovery for nausea abd diarrhea was reported 01-MAY-2007. The nurse clarified that the evets did not require an office visit or emergency room treatment. No further information is expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a licensed practical nurse (LPN), concerning a female patient who was vaccinated (date and dose unspecified) with the second dose of Gardasil. The nurse reported that the patient experienced nausea for approximately 24 hours after the vaccination was administered, though she had not experienced nausea with the first dose. At the time of this report, the nurse confirmed that the patient had recovered. The patient sought unspecified medical attention. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow up information has been received from a licensed practical nurse (LPN), concerning a 23 year old female, with seasonal allergies and a hypersensitivity to tetracyclines, who on 22-FEB-2007 was vaccinated in the left deltoid, with the second dose of GARDASIL (Lot #654741/0013U). Concomitant therapy included EFFEXOR XR, NUVARING, MSD, CLARITIN, FLONASE and trazodone HCl. There was no illness at the time of vaccination. The nurse reported that t he patient experienced nausea for approximately 24 hours after the vaccination was administered, though she had not experienced nausea with the first dose. At the time of this report, the patient had recovered. Follow up information indicated that the patient experienced dizziness (date of onset not specified), along with the nausea. The date of recovery was noted as 26-APR-2007, although nausea was originally reported with a 24 hour duration. The nurse clarified that the patient did not require a physician's office visit or an ER visit. No further information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with Gardasil. After the third dose the patient's menstrual cycle became irregular. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Bronchospasm
Clinical narrative: Information has been received from a health professional concerning a female who was vaccinated with Gardasil. Subsequently the patient experienced bronchospasm after receiving the first dose of Gardasil. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a physician, via a company representative, concerning an 18 year old female patient, who on 30-JAN-2007 was vaccinated IM, with the first dose of Gardasil, and on 04-APR-2007 with the second dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). On 04-APR-2007, following the vaccination, the patient developed "band-like swelling around her arm at the injection site," which continued for two days and then resolved. On approximately 25-APR-2007, the swelling around her arm returned; the patient had been applying cold compresses to relieve the swelling around her arm returned; the patient had been applying cold compresses to relieve the swelling. On 27-APR-2007, the physician saw the patient and reported there was no visible discoloration or bruising of the arm, though the swelling was still present. At the time of this report, it was unknown if the patient had recovered from the recurrent swelling of her arm. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a health professional, via a company representative, concerning the health professional's 15 year old daughter, who was vaccinated with the first dose (date unspecified), the second dose (date unspecified) and the third dose (date unspecified) of Gardasil. The mother stated that her daughter had arm soreness in the area of the injection site following each vaccination; the arm soreness lasted for approximately one week and then resolved. It was unknown if the patient sought medical attention. No further information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with Gardasil. Following the first injection, the patient developed pain, swelling and redness. She was not hospitalized and has recovered fine. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with a first dose of GARDASIL (lot number unknown). On an unspecified date, one day after the GARDASIL was administered, the patient developed pain, swelling and redness. The patient was not hospitalized and has recovered fine. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Asthma
Clinical narrative: Information has been received from a health care professional concerning her female co-worker, who on 27-APR-2007 was vaccinated with a dose, 0.5ml, IM of Gardasil. On 29-APR-2007, two days after the vaccination, the patient experienced an asthma attack, and visited the emergency room. The patient was not admitted to the hospital, and treatment was not specified. At the time of this report, it was unknown if the patient had recovered from the asthma attack. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from an other health professional concerning a 19 year old female student with no known drug allergies who on 20-OCT-2006 was vaccinated IM with a first 0.5ml dose of Gardasil.  On 15-DEC-2006  in the morning, the patient received a second dose of 0.5 ml IM Gardasil (lot # 653650/0702F, also reported as lot # 653978/0955F) and a second dose of Vaqta (lot # 655090/0651F). Concomitant therapy included hormonal contraceptives (unspecified). On 26-DEC-2006 the patient tested positive for HPV on PAP testing with atypical cells. 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: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Injection site pain
Clinical narrative: Information has been received from a physician via a company representative concerning a 17 year old female patient with an unremarkable medical history and no known drug reactions/allergies who on 17-APR-2007 was vaccinated with Gardasil (Lot #654510/0962F). Concomitant therapy included Menactra and "T-DEP vaccines". On 17-APR-2007 the patient experienced pain at injection site and felt faint right after receiving this initial dose. The patient felt fine upon observation by the health care provider about 20 minutes after receiving the injection. It was noted the patient received her vaccine injection on an empty stomach. Subsequently, the patient recovered from pain at injection site and felt faint right after receiving initial dose. It was also noted the patient will receive future doses of Gardasil. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Information has been received from a female registered nurse with no known drug allergies and no pertinent medical history, who on 29-MAR-2007 was vaccinated with Gardasil (Lot #656051/0244U) vaccine.  There was no concomitant medication.  The nurse reported she noted a pea sized lump at the injection site a day or so post vaccination and that the area continues to be painful.  The nurse reported that she did seek medical attention.  As of 03-MAY-2007, the nurse was recovering.  Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Joint range of motion decreased, No reaction on previous exposure to drug, Pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a 26 year old female patient who on 24-APR-2007 was vaccinated with her third dose of Gardasil. On 24-APR-2007 the patient experienced shooting pains in her arm. In addition, she had no range of motion with her arm. She did not have this experience with the first two doses. As of 03-MAY-2007, the patient's shooting pains in her arm and no range of motion with her arm persisted. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow-up information has been received from a licensed practical nurse concerning a 26 year old female who on 24-APR-2007 was vaccinated with her third dose of GARDASIL. On 24-APR-2007 the patient experienced shooting pains in her arm. In addition, she had no range of motion with her arm. She did not have this experience with the first two doses. As of 03-MAY-2007, the patient's shooting pains in her arm and no range of motion with her arm persisted. Patient did not come in for her evaluation. The licensed practical nurse presumed the problem had resolved. Additional information not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Arrhythmia
Clinical narrative: Information has been received from a physician concerning a 17 year old female who was vaccinated with Gardasil. Subsequently the patient experienced arrhythmia after receiving a dose of Gardasil. It was not known which dose this was in the series. Outcome was unknown. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Hypersensitivity, Immediate post-injection reaction, Injection site erythema, Injection site haematoma
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with Gardasil.  Subsequently the patient experienced severe swelling and redness at the injection site.  Subsequently, the patient recovered.  Additional information has been requested.  03/18/2010 follow up - OEDEMA PERIPHERAL; ERYTHEMA; HYPERSENSITIVITY; SKIN WARM; PAIN IN EXTREMITY; INJECTION SITE BRUISING  This is in follow-up to report (s) previously submitted on 06/14/2007  Initial and follow-up information has been received from a physician concerning a 26 year old white female with no pertinent medical history who on 31-JAN-2007 was vaccinated with a first dose of HPV rL1 6 11 18 VLP vaccine (yeast)  (lot# 654540/1162P) Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO TRI-CYCLES). On 31-Jan-2007. Immediately after the vaccination, the patient developed a severe allergic reaction with erythema. Severe swelling and warmth of the left arm and bruising at the injection site.  There was no dyspnea, wheezing or throat swelling. Ice was applied to the patient's arm. The patient recovered from severe allergic reaction with erythema, severe swelling and warmth of the left arm and bruising at the injection site.  It was reported that the patient's arm remained sore for approximately 1 week.  The second dose of HPV ILI 6 11 16 18 VLP vaccine (yeast) was not given.  No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with Gardasil.  Subsequently the patient experienced severe swelling and redness at the injection site.  Subsequently, the patient recovered.  Additional information has been requested.  03/18/2010 follow up - OEDEMA PERIPHERAL; ERYTHEMA; HYPERSENSITIVITY; SKIN WARM; PAIN IN EXTREMITY; INJECTION SITE BRUISING  This is in follow-up to report (s) previously submitted on 06/14/2007  Initial and follow-up information has been received from a physician concerning a 26 year old white female with no pertinent medical history who on 31-JAN-2007 was vaccinated with a first dose of HPV rL1 6 11 18 VLP vaccine (yeast)  (lot# 654540/1162P) Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO TRI-CYCLES). On 31-Jan-2007. Immediately after the vaccination, the patient developed a severe allergic reaction with erythema. Severe swelling and warmth of the left arm and bruising at the injection site.  There was no dyspnea, wheezing or throat swelling. Ice was applied to the patient's arm. The patient recovered from severe allergic reaction with erythema, severe swelling and warmth of the left arm and bruising at the injection site.  It was reported that the patient's arm remained sore for approximately 1 week.  The second dose of HPV ILI 6 11 16 18 VLP vaccine (yeast) was not given.  No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise, Pyrexia, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old white female nurse's aid who on 20-FEB-2007 was vaccinated with Gardasil (Lot 654702/0011U).  On 20-FEB-2007 the patient experienced malaise, slight fever and vomited x2 later that day.  The patient went to bed and on 21-FEB-2007, she had recovered from malaise, slight fever and vomiting.  On 23-APR-2007, the patient received her second dose of Gardasil (Lot 657622/0388U) and had no adverse effects.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site irritation, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning college-aged females who received Gardasil at her clinic.  The nurse reported that they all experienced pain upon injection as well as burning pain after receiving the vaccination.  The nurse found that the thinner patients experienced more pain.  There was pain resolution by the time the patients left the office or by the following day.  This is one of several reports received from the same source.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Limb immobilisation, Paraesthesia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse practitioner concerning a 24 year old white female who on 26-JAN-2007 at 1:45 PM was vaccinated IM in the deltoid with the first dose of Gardasil (lot # 653736/0014U).  On 26-JAN-2007, at 1:45 PM, during the first injection, the patient complained of tingling and dead arm.  It lasted only a short time and was better the same day.  On 04-APR-2007 at 10:00 AM, the patient was vaccinated IM in the deltoid with the second dose of Gardasil (lot # 657617/0384U).  On 04-APR-2007, at approximately 10:00 AM, with the second injection, the patient experienced the same exact complaints.  The patient recovered on the same day.  No further information is available. The patient recovered on the same day. It was reported that the "patent was fine when she got home". This is a consolidation of two reports concerning the same patient. No further information is available. Follow-up information indicated that WAES#0705USA00161 is a duplicate of WAES # 0705USA01053. Therefore, WAES # 0705USA0016 is being deleted from our files and the reports consolidated into WAES 0705uSA01053.
Age: 31.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea
Clinical narrative: Information has been received from a medical assistant concerning a 31 year old female who on 16-MAR-2007 was vaccinated with Gardasil (Lot #656049/0187U), intramuscular, in the left deltoid.  On 16-MAR-2007 the patient experienced shortness of breath beginning 2 hours after the vaccination.  It lasted a couple hours and then resolved without treatment.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site vesicles
Clinical narrative: Information has been received from a nurse practitioner concerning an 18 year old white female who on 11-APR-2007 at 15:00 was vaccinated, intramuscularly in the right deltoid, with a first 0.5 ml dose of Gardasil (Lot #655324/0089U).  Concomitant therapy included medroxyprogesterone acetate (DEPO-PROVERA) and metronidazole (FLAGYL).  On 11-APR-2007, several hours after the vaccination, the patient developed a blister-like reaction at the injection site and at 15:00 experienced prolonged injection site pain (for three weeks).  At the time of this report the patient's outcome for blister-like reaction at injection site was unknown.  No product quality complaint was involved.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass
Clinical narrative: Information has been received from a health professional concerning a two patients who were vaccinated with Gardasil. Subsequently, the patients developed a lump at the injection site. Subsequently, the patients recovered. Both patients plan to continue the series of injections. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a 22 year old female who on 08-JAN-2007 was vaccinated with Gardasil. On 12-Mar-2007 the patient received her second dose of Gardasil (lot #653938/0954F). On 12-MAR-2007 the patient experienced swelling at the injection site and pain at the injection site. It was reported that she sought unspecified medical attention. The events lasted about two weeks and subsequently she recovered from swelling and pain at the injection site. No further information is available at this time. Additional information has been requested. Initial and follow-up has been received from a licensed visiting nurse concerning a 21 year old female, with no pertinent medical history, who on 08-JAN-2007 was vaccinated with a first dose of GARDASIL vaccine. On 12-MAR-2007 at 9:00, the patient was vaccinated IM in the right deltoid with a
Sex: F
Vaccine: HPV4
Symptoms: Feeling hot, Injection site rash, Vaccine positive rechallenge
Clinical narrative: Information has been received from a health professional concerning a female who was vaccinated, intramuscularly in the arm, with Gardasil. Subsequently, the patient developed a site rash and experienced a warm feeling throughout her body approximately a half hour after receiving the second vaccination. The patient experienced a similar reaction after the first vaccination. Subsequently, the patient recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Haematoma, Immediate post-injection reaction, Pain in extremity
Clinical narrative: Information has been received from a nurse concerning an 18 year old female who on 06-APR-2007 was vaccinated with her second dose of Gardasil. Concomitant therapy included NUVARING. On 06-APR-2007, right after receiving the vaccination, the patient experienced a lot of pain and 2 days later developed a hematoma on her left deltoid arm of 3.5 cm in size. It was reported that the patient sought unspecified medical attention. The patient's pain and hematoma persisted. No further details were provided. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Biopsy
Clinical narrative: Information has been received from a physician concerning a 21 year old female with no known drug reactions or allergies and a history of papilloma viral infection and loop electrosurgical excision procedure (2005) who on 13-APR-2007 was vaccinated with Gardasil.  Concomitant therapy included NUVARING.  On 03-MAY-2007 the patient developed condyloma on her vulva and vagina.  A biopsy of the condyloma was taken (results pending).  The Gardasil was not reintroduced.  Additional information has been requested.