chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Medication error, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning an 18 year old female student with no pre-existing allergies, birth defects or medical conditions, who was vaccinated with a dose of GARDASIL that was stored as low as 31F.  There was no illness at the time of vaccination.  No symptoms reported.  There was no product quality complaint.  Additional information will be provided if available.  This is one of several reports from the same source.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Medication error, No adverse event
Clinical narrative: Information has been received from a health professional concerning a female patient who on 20-AUG-2007 was vaccinated with a first dose of GARDASIL (Lot# 655165/1425F).  On 16-NOV-2007, the patient was vaccinated into the left arm with a second dose of improperly stored GARDASIL (Lot# 655165/1425F).  No adverse symptoms were noted.  At the time of this report, the patient's outcome was unknown.  No product quality complaint was involved.  Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Device malfunction, Underdose
Clinical narrative: This is in follow-up to report(s) previously submitted on 7/8/2008. Information has been received from a health professional concerning a 25 year old, 130 pound female with no illnesses at time of vaccination, and no pre-existing allergies; birth defects or medical conditions, who on 09-APR-2008 was vaccinated with a partial dose of GARDASIL (lot # 655604/0052X) due to a malfunction of the pre-filled syringe. The syringe malfunctioned before the complete dose could be administered.  The patient was subsequently administered a complete dose of GARDASIL at the same office visit. No problems were reported. Patient outcome was not reported. Additional information has been requested. The SR # is 1-3040431198. No additional information is expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Initial information and follow up has been received from a nurse concerning a patient who was vaccinated on an unspecified date with her first dose of GARDASIL (lot# not reported).  The patient received the second dose of GARDASIL (lot# not reported) 7 months after the first dose.  On 07-MAR-2008 the patient received the third dose of GARDASIL (lot# 659180/1758U) (9 1/2 months after the first dose).  Concomitant therapy included MIDRIN and INDOCIN.  The patient's outcome was not reported.  The patient has been notified of need to repeat dose #3.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Device leakage, Injection site irritation, Underdose
Clinical narrative: Information has been received from a nurse practitioner concerning a female who on 03-APR-2008 was vaccinated with a first dose of GARDASIL (lot #655327/1287U).  During administration of the vaccine, the vaccine leaked out of the syringe, ran down the patient's arm and then the patient received partial dose.  The patient also experienced a burning sensation when the vaccine entered her arm.  The nurse practitioner indicated that she put the needle on the syringe properly and she looked at the syringe after vaccination and didn't notice anything unusual.  At the time of the report, the patient's outcome was unknown.  The SR is 1-2829187985.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial and follow up information has been received from a Nurse concerning a 25 year old female who on 27-JUL-2007 was vaccinated with a 1st dose of GARDASIL (lot# not reported).  There was no concomitant medication.  On 20-MAR-2008 the patient was vaccinated with a 2nd dose of GARDASIL (lot# not reported).  The patient sought unspecified medical attention in the office.  The patient did not have any symptoms.  No further information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy induced hypertension, Urine human chorionic gonadotropin
Clinical narrative: Initial and follow up information has been received for the Merck Pregnancy Registry from a registered nurse concerning a 17 year old female with no pertinent medical history or drug reactions/allergies who on 04-OCT-2007 was vaccinated with GARDASIL (lot# 657006/0188U) 0.5 mL IM while pregnant.  There was no concomitant medication.  The patient was approximately 13 weeks pregnant when she received her first dose, but she did not know that she was pregnant at the time.  The patient's date of last menstrual period was 11-JUL-2007.  Gestation was 27 and 1/2 weeks.  Medical attention was sought.  The patient's estimated date of delivery was 16-APR-2008.  The mother experienced pregnancy induced hypertension and was treated with NORVASC.  It was reported that the patient delivered at 38 weeks gestation, a 7lb. 11 oz. healthy baby girl.  On 28-MAY-2008 she was vaccinated with GARDASIL.  At the time of the report the outcome of the pregnancy induced hypertension was unknown.  Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site reaction, Rash papular, Rash pruritic
Clinical narrative: Information has been received from a physician assistant concerning a 20 year old female with unspecified pertinent medical history and no drug reactions/allergies reported, and no concomitant medications who on 20-MAY-2008 was vaccinated with the first dose of GARDASIL, IM to the left arm.  The patient contacted the office on 27-MAY-2008, because of a rash that covered both arms, stomach, and back.  There was also a "mark" at the injection site which was the left arm.  The rash started on the left arm and then spread to the stomach, back and right arm.  The rash is itchy and there are little white bumps everywhere that cannot be seen unless the skin is stretched and can be detected by touch.  No further information is available.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female (age unreported) who on 03-JUN-2008 was vaccinated with a dose of GARDASIL.  The patient reportedly developed syncope after receiving a dose of GARDASIL.  The patient was at the physician's office when she experienced the syncope.  It was reported that the patient recovered on the same day 03-JUN-2008.  No further information was provided.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female who on 11-SEP-2006 was vaccinated with a first dose of GARDASIL.  On 03-JUN-2008 she was vaccinated with a second dose of GARDASIL.  The patient experienced pain at the injection site after injections.  At the time of the report, the outcome of the injection site pain was unknown.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/9/2008. Follow up information was received from a registered nurse concerning a 19 year old female patient with seasonal and cat allergies, who on 03-JUN-2008, at 11:50 am was vaccinated with a second dose of GARDASIL (Lot # 660391/0063X) and with a second dose of HAVRIX (Lot # AHAVB 268AA). The nurse reported that more than one year elapsed between dose 1 and 2 of GARDASIL. No other problems with immunization. There was no illness at the time of vaccination. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a 17 year old female patient with no medical history and an allergy to dust and animal dander, who on 30-APR-2008 was vaccinated intramuscularly in her left deltoid with the first dose of GARDASIL (Lot # 659657/1487U).  Concomitant therapy included hormonal contraceptives (unspecified).  Subsequently, the patient developed swelling at the injection site.  The swelling then changed to a 3 centimeter knot.  The patient sought unspecified medical attention by the physician.  At the time of this report the patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/8/2008.  Initial and follow up information has been received from a licensed practical nurse concerning a 17 year old female patient with no medical history and an allergy to dust and animal dander, who on 30-APR-2008 was vaccinated intramuscularly in her left deltoid with the first dose of GARDASIL (Lot # 659657/1487U).  Concomitant therapy included hormonal contraceptives (unspecified).  On 01-MAY-2008, the patient called the office with complaints of developing swelling at the injection site.  The nurse reported that the swelling then went away.  On 29-MAY-2008, the patient came into the office and was evaluated by the physician for swelling at the initial injection site, almost a month after the initial injection.  The physician treated the patient with an unspecified antibiotic.  At the time of this report the patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a consumer who reported that on 18-MAY-2007 she was vaccinated with the first dose of GARDASIL (lot #, and route not reported).  The consumer reported that on 22-OCT-2007 she was vaccinated with the second dose of GARDASIL (lot #, and route not reported).  She noted that she did not receive the third dose of GARDASIL in January, because she had the flu.  No further information was provided.  Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: Information has been received from a physician concerning a 24 year old female with no specified pertinent medical history or drug allergies, who on 05-JUN-2007 was vaccinated with the first dose of GARDASIL.  The second dose of GARDASIL, was given on 02-AUG-2008.  The third dose of GARDASIL, IM, was given on 03-DEC-2008.  Subsequently the patient developed genital warts.  The patient sought unspecified medical attention and had not recovered at the time of reporting.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Vaccine positive rechallenge
Clinical narrative: Information has been received from a practical nurse concerning a 14 year old female with pertinent medical history and drug reactions/allergies reported as none, who on 20-FEB-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot # 658556/1060U). Following the first dose of GARDASIL vaccine (yeast), the patient experienced difficulty breathing. The second dose of GARDASIL vaccine (yeast), (lot # 660391/0063X), 0.5 ml, IM was given on 03-JUN-2008. The patient also experienced difficulty breathing following this vaccination. These episodes reportedly lasted for less than 5 minutes shortly after receiving each dose. The patient was seen at the physicians office and recovered on the same date of the vaccinations.
Age: 32.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Myalgia
Clinical narrative: Information has been received from a 32 year old female consumer who on an unspecified date was vaccinated with a dose of GARDASIL vaccine (yeast). On 05-MAY-2008, the patient received her second dose of GARDASIL vaccine (yeast), 0.5 ml, IM (lot # not specified). Concomitant therapy included influenza virus vaccine (unspecified), two weeks prior to receiving GARDASIL vaccine (yeast). Subsequently the patient experienced muscle aches and pains. The patient reported that she sought unspecified medical attention and had diagnostic blood work performed. No results were reported. Therapy with GARDASIL vaccine (yeast) was discontinued. At the time of reporting the patient had not recovered. No additional information is expected.
Sex: U
Vaccine: HPV4
Symptoms: Device leakage, Underdose
Clinical narrative: Information has been received from a certified medical assistant concerning a patient (age and gender not reported) who was vaccinated with a dose of GARDASIL (lot #0152X) on an unspecified date. It was reported that the patient received a quarter dose of GARDASIL, the syringe leaked as the patient was being given the vaccination. This is an amended report as the service request number was received.  Additional information has been requested. This is a corrected report as amended.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Lip swelling
Clinical narrative: This is in follow-up to report(s) previously submitted on 7/8/2008. Information has been received from a medical assistant concerning a 17 year old, 60 inch, 94 pound, female with no known pre-existing drug allergies, birth defects, no pertinent medical history and no illness at the time of vaccination who on 03-APR-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast), 0.5 ml, IM. There were no concomitant medications. Subsequently, on the night of 03-JUN-2008 the patient developed swollen lips. She sought medical attention in the office and the swelling resolved on 04-JUN-2008 without any treatment the following night. No other details were provided. Additional information has been requested. No additional information is available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dysmenorrhoea, Metrorrhagia
Clinical narrative: Information has been received from a registered nurse concerning a 22 year old female with sulfonamide allergy and a penicillin allergy who on 18-APR-2008 was vaccinated intramuscularly with the first dose of GARDASIL (lot # 660389/1968U). Concomitant therapy included LEVAQUIN, PREVACID (patient given prescription on 18-APR-2008) and SEASONIQUE. On 18-APR-2008, the patient experienced lightheadedness, dizziness, menstrual-like cramping and spotting. The patient also started LEVAQUIN on that day. On 19-APR-2008, the patient recovered from lightheadedness, dizziness, menstrual-like cramping and spotting. The patient did not seek medical attention. No product quality complaint was involved. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Cough, Dyspnoea, Wheezing
Clinical narrative: Information has been received from a physician concerning a 17 year old female with no known allergies who in the first week of March 2008, was vaccinated intramuscularly with the first dose of GARDASIL vaccine (yeast). Two hours after dose given the patient developed cough, shortness of breath and wheezing. The patient went to emergency room and was given steroids and antibiotic. The patient felt better the next morning (within 24 hours). Subsequently, the patient recovered from cough, shortness of breath and wheezing. It was reported that the patient will most likely not be getting second dose of GARDASIL vaccine (yeast) (also reported as discontinued). It was unknown if the symptoms were related to GARDASIL vaccine (yeast) or not. No product quality complaint was involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Lip swelling, No reaction on previous exposure to drug, Oedema mouth, Oedema peripheral, Pruritus
Clinical narrative: This is in follow-up to report(s) previously submitted on 7/8/2008. Initial and follow up information has been received from a physician and the mother of a 15 year old female (98 lb; height not reported) with attention deficit/hyperactivity disorder, allergies to penicillin, erythromycin, amoxicillin, azithromycin (ZITHROMAX), PHENERGAN with CODEINE, SILVADENE, and PROMETHAZINE with CODEINE), who on 19-FEB-2008 was vaccinated intramuscularly with her first dose of GARDASIL (Lot # 659962/1740U; site not reported). On 18-APR-2008, the patient was vaccinated intramuscularly with her second dose of GARDASIL (Lot # 660387/1967U; site not reported). Concomitant therapy included ADDERALL TABLETS and ORTHO EVRA. It was reported that the therapy with ORTHO EVRA started "concomitantly with the vaccine" (reported as on 18-APR-2008, 20-APR-2008 and 21-APR-2008). On approximately 25-APR-2008 (also reported as 27-APR-2008 and "within one week of the vaccine") the patient developed hives all over her body. The next morning, 26-APR-2008, the patient had swelling in her hands and feet and the patient was treated with ALLEGRA and prednisone (unspecified) (also reported as treatment occurring on 27-APR-2008 in the ER). On 27-APR-2008, the patient developed swelling on her face, mouth and lips. On 27-APR-2008, the patient went to the emergency room for outpatient treatment and received a "steroid shot" (not further specified), BENADRYL and ZANTAC. "The itching persisted for a little while and then all symptoms resolved" (date unspecified). On approximately 27-APR-2008, the patient discontinued therapy with ORTHO EVRA. It was reported that the patient had no adverse effects or problems with the first dose of GARDASIL. The physician suspected that the reactions were related to either GARDASIL or ORTHO EVRA. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Swelling face, Urticaria
Clinical narrative: This is in follow-up to report(s) previously submitted on 7/8/2008. Initial and follow up information has been received from a physician and the mother of a 15 year old female (98 lb; height not reported) with attention deficit/hyperactivity disorder, allergies to penicillin, erythromycin, amoxicillin, azithromycin (ZITHROMAX), PHENERGAN with CODEINE, SILVADENE, and PROMETHAZINE with CODEINE), who on 19-FEB-2008 was vaccinated intramuscularly with her first dose of GARDASIL (Lot # 659962/1740U; site not reported). On 18-APR-2008, the patient was vaccinated intramuscularly with her second dose of GARDASIL (Lot # 660387/1967U; site not reported). Concomitant therapy included ADDERALL TABLETS and ORTHO EVRA. It was reported that the therapy with ORTHO EVRA started "concomitantly with the vaccine" (reported as on 18-APR-2008, 20-APR-2008 and 21-APR-2008). On approximately 25-APR-2008 (also reported as 27-APR-2008 and "within one week of the vaccine") the patient developed hives all over her body. The next morning, 26-APR-2008, the patient had swelling in her hands and feet and the patient was treated with ALLEGRA and prednisone (unspecified) (also reported as treatment occurring on 27-APR-2008 in the ER). On 27-APR-2008, the patient developed swelling on her face, mouth and lips. On 27-APR-2008, the patient went to the emergency room for outpatient treatment and received a "steroid shot" (not further specified), BENADRYL and ZANTAC. "The itching persisted for a little while and then all symptoms resolved" (date unspecified). On approximately 27-APR-2008, the patient discontinued therapy with ORTHO EVRA. It was reported that the patient had no adverse effects or problems with the first dose of GARDASIL. The physician suspected that the reactions were related to either GARDASIL or ORTHO EVRA. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Myalgia
Clinical narrative: Information has been received from a female who was vaccinated with a dose of GARDASIL vaccine (yeast). The patient stated she has experienced fatigue and muscle pain since receiving the vaccination. At the time of the report, the outcome was unknown. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Nasopharyngitis
Clinical narrative: Information has been received from a mother concerning her 19 year old daughter with pollen allergy who in AUG-2007 was vaccinated with a first dose of GARDASIL. Concomitant therapy included allergenic extract. She never received the second dose because when she was scheduled she had a bad cold. The patient did not seek medical attention. At the time of the report, the patient recovered from the bad cold. This one of two reports from the same source. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a nurse for the Pregnancy Registry for GARDASIL vaccine (yeast) concerning a 22 year old female with sulfonamide allergy who on 04-DEC-2007 was vaccinated IM with the first 0.5 ml dose of GARDASIL vaccine (yeast) (Lot # not reported). On an unspecified date the patient was vaccinated with a second dose (Lot # not reported). On 05-JUN-2008, the patient was vaccinated with the third dose of GARDASIL vaccine (yeast) (Lot # not reported) then the office discovered that she was pregnant (LXP: 08-MAY-2008). The office performed a pregnancy test prior to the administration of the vaccine that demonstrated a "weak positive". Then after the vaccination a second pregnancy test was performed that displayed a positive result. No adverse effects reported. Concomitant therapy included hormonal contraceptives (unspecified). Unknown medication attention was sought in the office. The outcome was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Myalgia
Clinical narrative: Information has been received from a female consumer who was vaccinated with the first and second dose of GARDASIL. Patient reported that she experienced muscle pain after receiving the first two doses of GARDASIL and does not plan on receiving the third dose. The outcome was not reported. This case is lost to follow. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea, Syncope
Clinical narrative: Information has been received from an office manager concerning a 14 year old female who on 05-JUN-2008 was vaccinated with GARDASIL (dose and lot# not reported). On 05-JUN-2008, moments after vaccination, the patient felt nauseous lightheaded and fainted. No injuries were reported. Patient was monitored and taken by wheel chair to the car. The patient sought medical attention in the doctor's office. The patient outcome was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Accidental exposure, Device malfunction, No adverse event
Clinical narrative: Information has been received from a registered nurse who reported an ocular exposure with GARDASIL vaccine (lot# not reported) on 05-JUN-2008 caused by a syringe malfunction while administering the vaccine to the patient. This was not a GARDASIL vaccine pre-filled syringe. The nurse is not experiencing any problems with her eyes. Patient outcome was not reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a medical assistant concerning a 15 year old female who on 27-DEC-2007 was vaccinated with GARDASIL vaccine (lot# unspecified). There was no concomitant medication. It was reported that on the same day the PAP test was performed and that the results showed a "lot-grade" abnormality. No other information was available. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: No adverse event
Clinical narrative: Information has been received from a a registered nurse concerning a female who on 19-Feb-2007 and 34-Jul-2007, was vaccinated intramuscularly with 0.5 mL of her first and second doses, respectively, of GARDASIL vaccine (lot#s unspecified). No adverse event reported. At the time of this report, the outcome was unknown. No additional information was provided. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Feeling abnormal, Somnolence
Clinical narrative: Information has been received from a physician concerning a 17 year old female with asthma, hypersensitivity (NOS) and menstrual cramps who on 08-AUG-2006, 19-Oct-2006 and 07-Apr-2007, was vaccinated with first (lot# unspecified), second (lot#653938/0954F) and third (lot#657005/0314U) doses, respectively, of GARDASIL vaccine. Concomitant therapy maybe included LOESTRIN, albuterol and ANAPROX. It was reported by patient's mother that since the third dose the patient sleeps too much, is tired and is "foggy." Unspecified medical attention was sought by calling office. At the time of this report the patient had not recovered. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL vaccine. The physician reported that the patient experienced pruritus and itchiness after receiving GARDASIL vaccine. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/8/2008; 11/3/2008; 11/10/2008. Initial and follow-up information has been received from a physician and a registered nurse concerning a 21 year old female who on 16-NOV-2007 was vaccinated with the first dose of GARDASIL, Lot # 659437/1266U, 0.5 ml, intramuscularly. On 18-JAN-2008, the patient was vaccinated with the second dose of GARDASIL, Lot # 659653/1448U, 0.5 mL, intramuscularly. The physician reported that the patient experienced pruritus and itchiness after receiving GARDASIL. In follow-up information the registered nurse reported that the patient complained of itching (generalized) 2-4 weeks after first injection. It was reported that the patient stated itching occurred more with perspiration or when she got wet. There were no rash or redness detected. It was reported the the patient stated that she was tried BENADRYL and allergy medication but did not help. It was reported that the physician prescribed VISTARIL for a few weeks and disclosed not working. The physician also prescribed METHYLPREDNISOLONE, 4 mg (6 day dose pack). Registered nurse also reported that the patient was pregnant (LMP not reported). It was reported by the registered nurse that since last injection on 19-JAN-2008, patient stated itching has improved. The reporter felt that the generalized itching was other important medical event. Follow-up information was received from the registered nurse who confirmed that the patient was not pregnant at the time of reported adverse event. The registered nurse reported that the patient was still experiencing some itching which appeared to be more noticable and wet. The only medication that the patient was currently taking was a vitamin supplement, METANX, dosage unknown. The patient controlled the itching initially with VISTARIL and never actually took the METHYLPREDNISOLONE. The patient was never and at the time of the report was not incapacitated or disabled but was functioning normally with some persistent itching especially when wet. Follow-up information was received from the physician who confirmed that the patient wasnot pregnant and she had pruritus after receiving the first dose of GARDASIL. No furthere information is available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Feeling abnormal, Lethargy, Nausea
Clinical narrative: Information has been received from a physician assistant concerning a 23 year old female with penicillin allergy and allergic reaction to CECLOR who on 05-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine (LOT# 660387/2967U) 0.5 mL, intramuscularly in left deltoid. There was no concomitant medication. The physician assistant reported that on 05-JUN-2008, the patient experienced dizziness, lethargy, nausea and detached feeling following vaccination. The patient received the GARDASIL vaccine, walked 10 minutes through heat and then about 1 hour after vaccination experienced the dizziness, lethargy, nausea and detached feeling that lasted for 30 minutes. The patient returned to the physician assistant's office and was still experiencing some nausea 3 hours after vaccination. At the time of the report the patient was still recovering. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, No reaction on previous exposure to drug, Paraesthesia
Clinical narrative: Information has been received from a nurse practitioner concerning a 24 year old female with no illness at the time of vaccination, no drug allergies/reactions or pertinent medical history who on 02-OCT-2007 was vaccinated with a first dose GARDASIL vaccine in the left deltoid at 5 PM. On 10-DEC-2007, the patient had a second dose of GARDASIL vaccine (lot # 659441/1446U) in the left deltoid at 5 PM. On 10-APR-2008, the patient had a third dose of GARDASIL vaccine (lot# 659180/1758U) in the left deltoid at 9 AM. There was no concomitant medication. Subsequently, the patient reported tingling and numbness in fingers of both hands for 3 days after each administration of the vaccine. The symptoms resolved spontaneously. The patient was evaluated by her primary care physician after the second dose. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Human papilloma virus test positive, Smear cervix abnormal, Ultrasound scan
Clinical narrative: This is in follow-up to report(s) previously submitted on 7/8/2008; 10/8/2008. Initial and follow up information has been received from a registered nurse through the Merck Pregnancy Registry concerning a 16 year old female with atypical squamous cells of undetermined significance (ASCUS) and human papillomavirus (HPV) positive seen on atypical pap smear with high risk human papillomavirus prior to vaccination on 28-FEB-2008, who on 28-APR-2008 was vaccinated intramuscularly in the left deltoid with GARDASIL vaccine (lot # 660387/1967U). There was no concomitant medication. The nurse reported that the patient is now pregnant and no problems were reported. The reporter also noted that the patient had an ultrasound and a blood pregnancy test (results not reported). The patient's last menstrual period was 07-APR-2008 with an estimated delivery date of 12-JAN-2009. The patient sought medical attention for pregnancy follow up. On 30-MAY-2008, the patient underwent an ultrasound to verify delivery date. Results showed an estimated delivery date of 21-JAN-2009 which differed by 9 days from the LMP which was 07-APR-2008. The nurse reported that on 10-JUN-2008 the patient was treated with MACROBID 100mg BID x 7 days for urinary tract infection. No other information was reported. Follow up information received from a registered nurse who reported that complications during pregnancy included pylonephritis. Medications during pregnancy included MACROBID 100 mg twice a day started on 10-JUN-2008 for seven days also started on 10-NOV-2008 (dose and duration not provided), MACRODANTIN 50 mg daily started on 21-NOV-2008, and TERBUTALIN every four hours started on 07-NOV-2008 for preterm labor. The baby was born 22-DEC-2008, 36 weeks from LMP, female 5 pounds 14 ounces, 18 inches tall. Infant was born normal with no congenital anomalies. Complications include a preterm labor and preterm delivery at 35 6/7 weeks. Additional information considered important in relation to the outcome of this pregnancy include, inadequate weight gain of the patient, smoking and teen pregnancy. Baby was considered small for gestational age. No further information is available.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient who in January 2006, was vaccinated with the first dose of GARDASIL vaccine (lot#, dose and route not reported). On 04-JUN-2008, the patient was vaccinated with the second dose of GARDASIL vaccine (lot# dose and route not reported). No adverse events were reported. No other information was available. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Angiogram normal, Computerised tomogram head, Dizziness, Fatigue, Full blood count normal
Clinical narrative: Information has been received from a physician concerning an 18 year old female with mild hypertension and a history of mildly elevated aspartate aminotransferase and increased cholesterol who on approximately 21-MAY-2008 was vaccinated intramuscularly with GARDASIL vaccine (lot # and dose not reported). Secondary suspect therapy included lisinopril (manufacturer unknown). Two weeks ago approximately 21-MAY-2008 when she received the vaccine, the patient experienced quick fainting episode. She was well for one week. The physician reported that for the past week, the patient has had a persistent frontal headache, dizziness and fatigue that seems worsening. The physician noted that the patient was not previously being treated for the hypertension and that the patient's primary care physician thought that the headache might be due to her hypertension. The patient underwent a head CT and CT angiogram, and labs including thyroid test and CBC for which the results were reported as all being normal. On 03-JUN-2008, the reporting physician started the patient on lisinopril (manufacturer unknown). The patient's headache and dizziness did not change after she was started on lisinopril (manufacturer unknown). Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Syncope, Thyroid function test normal
Clinical narrative: Information has been received from a physician concerning an 18 year old female with mild hypertension and a history of mildly elevated aspartate aminotransferase and increased cholesterol who on approximately 21-MAY-2008 was vaccinated intramuscularly with GARDASIL vaccine (lot # and dose not reported). Secondary suspect therapy included lisinopril (manufacturer unknown). Two weeks ago approximately 21-MAY-2008 when she received the vaccine, the patient experienced quick fainting episode. She was well for one week. The physician reported that for the past week, the patient has had a persistent frontal headache, dizziness and fatigue that seems worsening. The physician noted that the patient was not previously being treated for the hypertension and that the patient's primary care physician thought that the headache might be due to her hypertension. The patient underwent a head CT and CT angiogram, and labs including thyroid test and CBC for which the results were reported as all being normal. On 03-JUN-2008, the reporting physician started the patient on lisinopril (manufacturer unknown). The patient's headache and dizziness did not change after she was started on lisinopril (manufacturer unknown). Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Axillary pain, Hyperhidrosis, Injection site pain, Nausea
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on approximately 02-JUN-2008 was vaccinated in her right deltoid with GARDASIL vaccine (yeast) (lot #, and dose not reported). Concomitant therapy included meningococcal AVYW conj vaccine (dip toxoid) (MENACTRA). The physician reported that the patient experienced excessive pain that radiated to her armpit. That night the patient was sweating, had nausea, and was vomiting. The physician noted that the patient also had a fever of 102 and shooting pain that went across her abdomen. The physician also stated that when the patient came back in the office for a check up she still had a lot of pain at the injection site. Medical attention was sought by the patient. No further information was provided. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on approximately 02-JUN-2008 was vaccinated in her right deltoid with GARDASIL vaccine (yeast) (lot #, and dose not reported). Concomitant therapy included meningococcal AVYW conj vaccine (dip toxoid) (MENACTRA). The physician reported that the patient experienced excessive pain that radiated to her armpit. That night the patient was sweating, had nausea, and was vomiting. The physician noted that the patient also had a fever of 102 and shooting pain that went across her abdomen. The physician also stated that when the patient came back in the office for a check up she still had a lot of pain at the injection site. Medical attention was sought by the patient. No further information was provided. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass
Clinical narrative: Information has been received from a physician assistant concerning a 21 year old female patient with no drug allergies or medical history reported, who on 29-APR-2008 at approximately 16:00 was vaccinated intramuscularly into the left deltoid with the first dose of GARDASIL vaccine (year) (Lot # 659964/1978U). There was no concomitant medication. On 29-APR-2008, (previously reported as approximately 30-APR-2008), within a few days of receiving her initial dose, the patient developed a pea sized lump at the injection site. The mass has not increased or decreased in size or causes any pain or tenderness. The patient just noted mass since injection. At the time of this report the patient had not recovered. No product quality complaint was involved. Additional information has been  requested. This is in follow-up to report (s) previously submitted on 7/8/2008. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: No adverse event
Clinical narrative: Information has been received from a female consumer who on approximately 25-DEC-2007, "around Christmas 2007", was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot no., route and site of administration were not reported). The patient reported that she missed the other two doses of GARDASIL vaccine (yeast) because she could not afford it. No adverse event reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning a multiple patients (no demographics provided) who on unspecified dates were vaccinated with GARDASIL vaccine (yeast) (lot #s unspecified) and had stinging at the injection site. At the time of this report the outcome was unknown. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided when available. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Accidental exposure
Clinical narrative: Information has been received from a nurse practitioner who on 03-APR-2008 was administered a first dose of GARDASIL vaccine (yeast) (lot #655327/1287U) to a patient. During administration of the vaccine, the vaccine leaked out of the syringe and ran down the nurse practitioner's arm and hand. The nurse practitioner indicated that she put the needle on the syringe properly and she looked at the syringe after vaccination and didn't notice anything unusual. At the time of the report, the patient's outcome was unknown. The SR# is 1-2829187985.
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Smear cervix abnormal
Clinical narrative: Information has been received from a female consumer with a history of papanicolaou smear abnormal who was vaccinated with three doses of GARDASIL vaccine (yeast) (lot numbers not reported). The consumer reported that "even after getting three doses of GARDASIL vaccine (yeast) vaccine last year, I still have abnormal PAP smear results". The consumer stated that "she had abnormal pap smear results before getting vaccinated with GARDASIL vaccine (yeast) last year". The consumer reported that "a recent ASCUS pap smear result just taken in MAY 2008 is abnormal too". The patient sought unspecified medical attention. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning his daughter who was vaccinated with a dose of GARDASIL vaccine (yeast) (lot#, dose, site and route not reported). The physician reported that his daughter complained that the injection was painful. The patient's outcome was unknown. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Menstrual disorder
Clinical narrative: Information has been received from a pharmacist concerning a female with a history of liver transplant, salsa allergy and aspirin allergy who began experiencing two menstrual periods each month after receiving two doses of GARDASIL vaccine (yeast) (lot#'s not reported). The patient sought unspecified medical attention in the physician's office. The dates of the GARDASIL vaccine (yeast) injections were not provided and the onset of adverse symptoms was not specified. No other symptoms or treatments were reported and no other information was available. The patient has not recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a registered nurse concerning a female who on 16-AUG-2007 was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot # not reported). On 06-JUN-2008 the patient was vaccinated with a second dose of GARDASIL vaccine (yeast) (lot # not reported). The patient sought unspecified medical attention during the office visit for the second dose. No problems were reported. Patient outcome was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a Nurse Practitioner concerning a female who was vaccinated intramuscularly with a 0.5 mL first dose of GARDASIL vaccine (yeast) (lot # not reported). Subsequently the patient developed severe and prolonged arm pain in the same arm that the vaccine was administered. The pain lasted for a period of two weeks. the patient sought unspecified medical attention by speaking to nurse practitioner. Subsequently, on an unspecified date, the patient recovered from the severe and prolonged arm pain. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a consumer concerning her 13 year old daughter with sickle cell anaemia who on 20-MAY-2008 was vaccinated intramuscularly with a 0.5 mL first dose of GARDASIL vaccine (lot # not reported). The consumer reported that "her daughter has been experiencing hair loss since getting her first dose of GARDASIL vaccine. The patient's hair loss persisted (reportedly began "2 or 3 days after vaccination"). There was no concomitant medication. The patient sought unspecified medical attention. The consumer reported that her daughter "will not be continuing the series." Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: Information has been received from a consumer concerning her 15 year old daughter who in April 2008, was vaccinated IM with the first 0.5 mL dose of GARDASIL vaccine. There was no concomitant medication. The patient felt faint after receiving the vaccine. The patient also fainted after additional blood work was done after she received the vaccine. The patient's mother decided that she will not continue the dosing series. Unknown medical attention was sought. The patient recovered the day after the vaccination. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a pharmacist and a physician concerning a 33 year old female consumer who on 21-MAR-2008 was vaccinated SQ with 0.65ml of zoster vaccine live (Oka/Merck) (lot # 658325/1429U). The patient was to received varicella virus vaccine live (Oka/Merck) (MSD), but zoster vaccine live (Oka/Merck) was dispensed by the pharmacist and administered by the physician. No product confusion identified, the incorrect product was selected in error and the error was never caught. No problems or symptoms reported. Medical attention was sought in the physician's office. The physician called the pharmacist. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Follow-up information from the pharmacist indicated this was a case of human error, that the pharmacist just grabbed the wrong one. She indicated it had nothing to do with the product, the label, the storage or anything else. It was just a mistake. She said the label was placed on it with the patient's name for dispensing, it went thru the pharmacist, the doctor, the patient, and wasn't caught. Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Erythema, Herpes zoster, Pain
Clinical narrative: Information has been received from a consumer concerning her 71 year old sister with no known allergies, high blood pressure and diabetes who in September or October 2007, was vaccinated with a single dose of series of zoster vaccine live (Oka/Merck). Subsequently, around 14-MAR-2008 the patient started to break out in shingles and had a lot of pain. Medical attention was sought. The patient's back hurt so she went to a chiropractor who stated she had red dots on her back.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster ophthalmic
Clinical narrative: Information has been received from a physician concerning a 64 year old female who in approximately January 2008, was vaccinated SC with a dose of zoster vaccine live (Oka/Merck). Two months later, in approximately March 2008, the patient developed zoster opthalmicus. Unspecified medical attention was sought. The patient's zoster opthalmicus persisted. A product complaint was not involved. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a female patient with no history of chickenpox who was vaccinated with a dose of zoster vaccine live (Oka/Merck). Subsequently the patient developed shingles. A product quality complaint was not involved. No further information is available.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blood test, Dizziness, Orthostatic hypotension
Clinical narrative: Information has been received from a 69 year old female with a history of lung cancer, breast cancer, thyroidectomy and a penicillin allergy (rash) who on 13-MAR-2008 was vaccinated with a dose of zoster vaccine live (Oka/Merck). Concomitant therapy included lisinopril (manufacturer unknown), levothyroxine Na, ezetimibe (+) simvastatin (MSD) and various unspecified vitamins. On 13-MAR-2008, after the vaccination, the patient was leaving the physician's office when she became very weak and dizzy and went back into the office. Her blood pressure dropped very low and she was diagnosed with orthostatic hypotension and taken by ambulance to a hospital emergency room. An unspecified blood test was performed. At the time of the report, the patient had not recovered. A product quality complaint was not involved. No further information is available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a Registered Nurse concerning a patient who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck) and subsequently developed shingles. At the time of the report the patient's status was unknown. It was unspecified if medical attention was sought. There was no product quality complaint involved, no additional information was provided. Additional information requested. This is one of several reports from the same source.