chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a female (demographics not reported) who on an unspecified date was vaccinated with Gardasil (yeast) (Lot# not provided). Subsequently the patient developed hives. At the time of this report it was unknown if the patient had recovered from the hives. Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2007. Follow up information received stated that the patient developed hives after receiving the second dose of GARDASIL (Lot # not provided) on an unspecified date in approximately January, 2007. The patient was treated in the physicians office with a dose of an unspecified antihistamine. At the time of this report it was not reported if the patient had recovered from the event. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Vaginal haemorrhage
Clinical narrative: Information has been received from two nurses at a physician's office concerning a female (age not reported) who in October 2006 was vaccinated with the first dose of Gardasil (yeast). In October 2006, the patient developed excessive vaginal bleeding (during her period). The patient sought unspecified medical attention. At the time of this report, the patient had recovered from the event (date unknown). Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Blood human chorionic gonadotropin, Drug exposure during pregnancy, Nausea, Vomiting
Clinical narrative: Information has been received from a physician through the pregnancy registry concerning a 15 year old female who on approximately 20-JAN-2007 was vaccinated intramuscularly with 0.5 ml of Gardasil (yeast). On that same day, concomitant therapy included Menactra and Adacel. It was reported that shortly after getting home, the patient developed nausea and vomiting. The patient was seen by the physician and found also to be pregnant. On an unspecified date, the patient underwent a pregnancy test. At the time of this report, the outcome of the events were unknown. Additional information has been requested. 07/08/2008 No further information is expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Hypokinesia, Injection site urticaria, Malaise, Pain in extremity, Pyrexia
Clinical narrative: This is in follow-up to report(s) previously submitted on 2/14/2007; 4/6/2007. Information has been received from a physician concerning an 18 year old female with no past medical history who on 29-DEC-2006 at 10:00 AM was vaccinated with a first dose of GARDASIL (yeast) (lot # 654885/1424F), intramuscularly in the left arm. Concomitant therapy included CRYSELLE and "Flintstones multivitamins." There was no illness at the time of vaccination. On 29-DEC-2006 at 5:00 PM the patient initially developed hives around injection site, but then developed approximately 10 hives over entire body." It was also reported that the patient developed malaise and fever, also had a sore arm such that she felt she couldn't move it for 24 hours. It was also reported that there were no other symptoms reported. There were no relevant diagnostic tests or laboratory date. The patient recovered on 30-DEC-2006. In follow up it was reported that the patient had been given a 2nd dose of GARDASIL with ZYRTEC and BENADRYL administration and had no reaction. Additional information is not expected. This is in follow-up to report(s) previously submitted on 2/14/2007. It was reported that "used 1% hydrocortisone cream but no oral meds, resolved by next day".
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: This is in follow-up to report(s) previously submitted on 2/14/2007; 4/6/2007. Information has been received from a physician concerning an 18 year old female with no past medical history who on 29-DEC-2006 at 10:00 AM was vaccinated with a first dose of GARDASIL (yeast) (lot # 654885/1424F), intramuscularly in the left arm. Concomitant therapy included CRYSELLE and "Flintstones multivitamins." There was no illness at the time of vaccination. On 29-DEC-2006 at 5:00 PM the patient initially developed hives around injection site, but then developed approximately 10 hives over entire body." It was also reported that the patient developed malaise and fever, also had a sore arm such that she felt she couldn't move it for 24 hours. It was also reported that there were no other symptoms reported. There were no relevant diagnostic tests or laboratory date. The patient recovered on 30-DEC-2006. In follow up it was reported that the patient had been given a 2nd dose of GARDASIL with ZYRTEC and BENADRYL administration and had no reaction. Additional information is not expected. This is in follow-up to report(s) previously submitted on 2/14/2007. It was reported that "used 1% hydrocortisone cream but no oral meds, resolved by next day".
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Chest pain, Dyspnoea, Epigastric discomfort, Respiratory disorder
Clinical narrative: Information has been received from the father of an 18 year old female with a penicillin allergy noted as rash and fever. On 16-JAN-2007, the patient was vaccinated intramuscularly in the deltoid, with the first dose of Gardasil (yeast). There were no concomitant medications reported. On 18-JAN-2007, the patient developed epigastric pressure and discomfort. On 19-JAN-2007, the patient was examined by her physician and was prescribed famotidine. On 21-JAN-2007, the patient complained of difficulty and discomfort breathing which worsened on 22-JAN-2007. On 23-JAN-2007, the patient was planning to seek medical attention, at her local school infirmary. At the time of this report, the patient had not recovered from the events. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 2/14/2007. Information has been received from a physician concerning an overweight 18 year old female with a penicillin allergy noted as rash and fever, acne, smoking, a history of an appendectomy and a family history of the mother (age 45) with ovarian cancer (currently undergoing chemotherapy). On 16-JAN-2007, at 6:32 P.M., the patient was vaccinated intramuscularly in the left deltoid, with the first dose 0.5 ml of GARDASIL. Concomitant therapy included topical medications for acne. On the 16-JAN-2007 the patient had a Pap test done with reflex HPV. On 17-JAN-2007 (previously reported as 18-JAN-2007) the patient complained of a week history of a band of abdominal pain across her abdomen which was associated with chest pain. She denied any burning or back wash of food or fluid coming up in her chest, although occasionally she had this chest pain. There were no foods that aggravated her and she followed a healthy diet. The patient had normal bowel movements and her last period was 2 weeks prior. On examination, the patient was in no acute distress; her abdomen was soft, non-tender, nondistended; no hepatosplenomegaly or masses. The physician's impression was abdominal pain/possible mild viral gastritis. The patient was prescribed famotidine (MSD) 20 mg, twice a day. She was to avoid caffeine and acidic foods or large meals before bed. On 21-JAN-2007, the patient complained of difficulty and discomfort breathing which worsened on 22-JAN-2007. On 23-JAN-2007, the patient was planning to seek medical attention, at her local school infirmary. At the time of this report, the patient had not recovered from the events. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix
Clinical narrative: Information has been received from the father of an 18 year old female with a penicillin allergy noted as rash and fever. On 16-JAN-2007, the patient was vaccinated intramuscularly in the deltoid, with the first dose of Gardasil (yeast). There were no concomitant medications reported. On 18-JAN-2007, the patient developed epigastric pressure and discomfort. On 19-JAN-2007, the patient was examined by her physician and was prescribed famotidine. On 21-JAN-2007, the patient complained of difficulty and discomfort breathing which worsened on 22-JAN-2007. On 23-JAN-2007, the patient was planning to seek medical attention, at her local school infirmary. At the time of this report, the patient had not recovered from the events. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 2/14/2007. Information has been received from a physician concerning an overweight 18 year old female with a penicillin allergy noted as rash and fever, acne, smoking, a history of an appendectomy and a family history of the mother (age 45) with ovarian cancer (currently undergoing chemotherapy). On 16-JAN-2007, at 6:32 P.M., the patient was vaccinated intramuscularly in the left deltoid, with the first dose 0.5 ml of GARDASIL. Concomitant therapy included topical medications for acne. On the 16-JAN-2007 the patient had a Pap test done with reflex HPV. On 17-JAN-2007 (previously reported as 18-JAN-2007) the patient complained of a week history of a band of abdominal pain across her abdomen which was associated with chest pain. She denied any burning or back wash of food or fluid coming up in her chest, although occasionally she had this chest pain. There were no foods that aggravated her and she followed a healthy diet. The patient had normal bowel movements and her last period was 2 weeks prior. On examination, the patient was in no acute distress; her abdomen was soft, non-tender, nondistended; no hepatosplenomegaly or masses. The physician's impression was abdominal pain/possible mild viral gastritis. The patient was prescribed famotidine (MSD) 20 mg, twice a day. She was to avoid caffeine and acidic foods or large meals before bed. On 21-JAN-2007, the patient complained of difficulty and discomfort breathing which worsened on 22-JAN-2007. On 23-JAN-2007, the patient was planning to seek medical attention, at her local school infirmary. At the time of this report, the patient had not recovered from the events. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Pruritus
Clinical narrative: Information has been received from a physician concerning a 26 year old female who on 19-JAN-2007 was vaccinated intramuscularly in left arm (upper outer quadrant) with the first dose of GARDASIL vaccine (lot # 655619/1427F). On approximately 21-JAN-2007, "within about three days", the patient reported that both her arms were itchy and red. The patient sought unspecified medical attention. The physician reported that she told the patient to take some BENADRYL to treat the symptoms. The physician reported that she did not plan to re-vaccinate the patient with GARDASIL vaccine. No lot number was provided. At the time of this report, the outcome of the event was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007. Additional information was received from a health professional. Lot number was provided and added to the report. The injection site was more affected that the opposite arm. The outcome was not reported. No additional information is expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pelvic pain
Clinical narrative: Information has been received from a licensed visiting nurse through the pregnancy registry concerning a 18 year old female who became pregnant during the 3-dose of Gardasil (yeast). On 08-NOV-2006, the patient was vaccinated with the first dose of Gardasil (yeast). It was reported that the patient was not pregnant when she received her first dose of Gardasil (yeast). On 18-DEC-2006, the patient developed pelvic pain. The patient was seen in the emergency room. At the time of this report, the outcome of the events were unknown. Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2007.  Initial and follow-up information has been received from a licensed visiting nurse through the pregnancy registry concerning a 18 year old female who became pregnant during the 1-dose series of GARDASIL.  On 08-NOV-2006, the patient was vaccinated with the first dose of GARDASIL.  It was reported that the patient was not pregnant when received her first dose of GARDASIL.  On 11-DEC-2006, the patient developed pelvic pain.  The patient was scan in the emergency room.  At the time of this report, the outcome of the events were unknown.  Follow-up information indicated that the patient vaginally delivered a full-term, healthy, and normal baby on an unspecified date.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Information has been received from a Pharm D healthcare student concerning a female (age not reported) who on an unspecified date was vaccinated with her first dose of Gardasil (yeast). Two weeks post vaccination, the patient developed a full body rash with tiny, erythematous papules. The patient sought unspecified medical attention. The pharmacist stated that the he has no other information, as the nurse had the chart. At the time of this report, the outcome of the event was unknown. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 16 year old female who "about 2 months ago" in approximately. November 2006, was vaccinated, intramuscularly (IM), into the deltoid muscle with the first 0.5 ml, dose of Gardasil (yeast). "About 2 months ago". in approximately, November 2006, on the same day of  injection, the patient developed swelling at the site of injection. The patient reported that the swelling at the injection site subsided (date not reported). The patient sought unspecified medical attention. The patient received the 2nd dose recently without incident. The latter dose was administered (IM) in the thigh. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated with HPV vaccine (yeast). Subsequently, following vaccination, the patient fainted.  The patient fully recovered.  No further details were provided.  Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 2/14/2007. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Pain, Syncope
Clinical narrative: Information has been received from a  physician concerning a female who was vaccinated with a first dose of HPV vaccine (yeast). Subsequently the patient complained of pain and then fainted within minutes of administration. Subsequently, the patient recovered without any additional treatment.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain, Syncope
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a first dose of HPV vaccine (yeast). Subsequently the patient complained of pain and then fainted within minutes of administration. Subsequently, the patient recovered without any additional treatment.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: HIV test, HIV test negative, HIV test positive
Clinical narrative: Information has been received from a health professional concerning a 17 year old female who in November 2006, was vaccinated with a first dose of HPV vaccine (yeast).  In December 2006, the patient tested positive for human immunodeficiency virus (HIV). The HIV test was performed in December 2006 when the patient donated blood.  Unspecified medical attention was sought.  The patient had 2 subsequent HIV tests.  The first test was "equivocal" and the second test was negative.  It was reported that the patient was not sexually active and did not use intravenous (IV) drugs.  At the time of the report, the patient's outcome was unknown.  Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Rash, Urticaria, Urticaria
Clinical narrative: Information has been received from a 36 year old female with sulfonamide allergy and irritable bowel syndrome who on 11-DEC-2006 was vaccinated with a second 0.5 mL of HPV vaccine (yeast). Concomitant therapy included escitalopram oxalate (LEXAPRO). In December 2006, " few days after" receiving the vaccination, the patient broke out in hives and a rash on her chest.  The patient sought unspecified medical attention.  Subsequently, after three weeks, the patient recovered from the hives and rash.  It was reported that the patient did not have a reaction after vaccination with the first dose of HPV VLP vaccine (yeast).  Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2007. Initial and follow-up information has been received from a medical assistant and a 36 year old female with an allergy to sulfonamide and ATROSEPT and irritable bowel syndrome who on 11-DEC-2006 was vaccinated with a second 0.5 mL dose of GARDASIL (lot #654540/0800F). The patient received the first vaccination on 06-OCT-2006 (lot #654540/1162F). Concomitant therapy included LEXAPRO. On 26-DEC-2006, the patient broke out in hives and a rash on her chest. It was reported that the rash and urticaria required an emergency room/doctor visit. Subsequently, in February 2007, the patient recovered from the hives and rash. It was reported that the patient did not have a reaction after vaccination with the first dose of GARDASIL. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Chest discomfort, Hypersensitivity, Lung disorder, Palpitations
Clinical narrative: Information has been received from a nurse practitioner concerning a female who was vaccinated with a 0.5 ml dose of Gardasil (yeast). Subsequently the patient developed an "allergic reaction". Unspecified medical attention was sought. At the time of the report, the patient's outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007.  Initial and follow-up information has been received from a nurse practitioner and a licensed practical nurse concerning a 17 year old female student with asthma and drug hypersensitivity to BEXTRA (gastrointestinal distress) who on 16-JAN-2007, at 16:05, was vaccinated, intramuscularly, into the left deltoid, with a first dose of GARDASIL (lot #655619/1427F).  On 17-JAN-2007 the patient called the physician's office with complaint of "lungs burning" and felt like she had heartburn.  She reported that she felt her heart was racing and had developed blurry vision.  The patient went to urgent care and told by the physician that the events were a possible reaction to GARDASIL.  The patient was advised to take BENADRYL and TYLENOL PM.  It was reported that the patient was resting comfortably after she was seen in urgent care.  On 18-JAN-2007, she had some residual chest tightness.  The patient did not experience shortness of breath or difficulty breathing.  Subsequently, the patient recovered.  No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Vision blurred
Clinical narrative: Information has been received from a nurse practitioner concerning a female who was vaccinated with a 0.5 ml dose of Gardasil (yeast). Subsequently the patient developed an "allergic reaction". Unspecified medical attention was sought. At the time of the report, the patient's outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007.  Initial and follow-up information has been received from a nurse practitioner and a licensed practical nurse concerning a 17 year old female student with asthma and drug hypersensitivity to BEXTRA (gastrointestinal distress) who on 16-JAN-2007, at 16:05, was vaccinated, intramuscularly, into the left deltoid, with a first dose of GARDASIL (lot #655619/1427F).  On 17-JAN-2007 the patient called the physician's office with complaint of "lungs burning" and felt like she had heartburn.  She reported that she felt her heart was racing and had developed blurry vision.  The patient went to urgent care and told by the physician that the events were a possible reaction to GARDASIL.  The patient was advised to take BENADRYL and TYLENOL PM.  It was reported that the patient was resting comfortably after she was seen in urgent care.  On 18-JAN-2007, she had some residual chest tightness.  The patient did not experience shortness of breath or difficulty breathing.  Subsequently, the patient recovered.  No further information is available.
Sex: U
Vaccine: HPV4
Symptoms: Injection site pain, Injection site reaction
Clinical narrative: Information has been received from a licensed practical nurse concerning approximately 14 patients who was vaccinated with Gardasil (yeast). Subsequently the patients experienced injection site reaction including pain. The reactions resolved "after a couple of days". Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a health professional concerning a female patient who was vaccinated IM with a 0.5 ml "recent" dose of HPV vaccine (yeast).  Subsequently the patient called the practice and reported swelling in both arms and she wanted to be seen by the physician.  No further information was provided.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure, Dizziness, Electrocardiogram, Fatigue, Heart rate increased
Clinical narrative: Information has been received from a physician concerning a 20 year old female with a history of collapse of left lung (September 2006 for which she recovered) who on 05-JAN-2007 was vaccinated with a first IM dose of HPV vaccine (yeast). Concomitant therapy on 05-JAN-2007 included a dose of medroxyprogesterone acetate (DEPO-PROVERA). On 05-JAN-2007 the patient experienced dizziness, tiredness, tachycardia and high blood pressure. The patient has been on medroxyprogesterone acetate since July 2006 and has not experienced any of these symptoms. Her pulse rate has been as high as 145 at rest and blood pressure was 138/85 and an EKG showed tachycardia.  Blood work was done and results not provided. She is scheduled to have pulmonary function tests on 07-FEB-2007 and will be seeing a cardiologist "in the future."  The patient's dizziness and tiredness and tachycardia and high blood persisted.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Hypertension, Tachycardia
Clinical narrative: Information has been received from a physician concerning a 20 year old female with a history of collapse of left lung (September 2006 for which she recovered) who on 05-JAN-2007 was vaccinated with a first IM dose of HPV vaccine (yeast). Concomitant therapy on 05-JAN-2007 included a dose of medroxyprogesterone acetate (DEPO-PROVERA). On 05-JAN-2007 the patient experienced dizziness, tiredness, tachycardia and high blood pressure. The patient has been on medroxyprogesterone acetate since July 2006 and has not experienced any of these symptoms. Her pulse rate has been as high as 145 at rest and blood pressure was 138/85 and an EKG showed tachycardia.  Blood work was done and results not provided. She is scheduled to have pulmonary function tests on 07-FEB-2007 and will be seeing a cardiologist "in the future."  The patient's dizziness and tiredness and tachycardia and high blood persisted.  Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Inappropriate schedule of drug administration, Pruritus
Clinical narrative: Information has been received from a physician concerning a 32 year old female with no pertinent medical history or drug reactions/allergies, who on an unspecified date was vaccinated with Gardasil (yeast) (0.5 ml). There was no concomitant medication. Subsequently, 30 minutes after vaccination, the patient developed redness and itchiness on the palms of her hands, soles of her feet, and in  a "band around her waist". The patient also developed "8 red spots on the left side of her truck". The redness, itchiness, and red spots lasted for approximately 5 days and then disappeared. It was reported that nothing occurred at the injection site. Unspecified medical attention was sought. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007.  Initial and follow-up information has been received from a physician concerning a 32 year old female with no pertinent medical history or drug reactions/allergies, who on 11-Dec-2006 was vaccinated intramuscularly with the first dose of GARDASIL (0.5 ml) (Lot # 653735/0688F).  There was no concomitant medication and no illness at time of vaccination.  Subsequently, approximately 15 minutes after vaccination, on 11-DEC-2006, the patient developed erythema and pruritus on the palms of her hands, soles of her feet, and an erythmatous band around her waist.  It was also reported that the patient also developed "8 red spots on the left side of her trunk".  The redness, itchiness, and red spots lasted for approximately 5 days and then disappeared.  It was reported that nothing occurred at the injection site.  No further information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with the first dose of Gardasil (yeast) (0.5 ml). Subsequently, following vaccination, the patient lost consciousness. It was reported that the patient regained consciousness after a "couple of minutes". Unspecified medical attention was sought. Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2007. Conflicting follow-up from the physician's office manager stated that the office had no knowledge of a patient with a reaction to GARDASIL. No further information is expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Heart rate increased
Clinical narrative: Information has been received from a nurse practitioner concerning a 14 year old female with no pertinent medical history and no history of drug reactions/allergies in January 2007 was vaccinated with the first dose of Gardasil (yeast) (Lot # not reported) 0.5 ml injection. There was no concomitant medication. In January 2007, the evening she received her first dose of Gardasil (yeast), she experienced rapid heart beat. Medical attention was sought. She had the same experience 24 hours later. The patient has not had another experience since then. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a registered nurse concerning a couple of females with unspecified pertinent medical history and unspecified drug reactions/allergies who on an unspecified date were vaccinated with first dose of Gardasil (yeast) (lot # not reported), 0.5 ml, IM. Concomitant therapy was not specified. On an unspecified date, the patients experienced tingling in their fingers of the arm being injected while getting the injection. The tingling resolved within a couple of minutes of receiving the shot. Medical attention was sought. At the time of reporting, the patients had recovered. The patients plan on getting was sought. At the time of reporting, the patients had recovered. The patients plan on getting their second and third doses of Gardasil (yeast). Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007.  Information has been received from a registered nurse concerning a couple of females with unspecified pertinent medical history and unspecified drug reactions/allergies who on an unspecified date were vaccinated with first dose of GARDASIL (lot # not reported), 0.5 ml, IM.  Concomitant therapy was not specified.  On an unspecified date, the patients experienced tingling in their fingers of the arm being injected while getting the injection.  The tingling resolved within a couple of minutes of receiving the shot.  Medical attention was sought.  At the time of reporting, the patients had recovered.  The patients plan on getting their second and third doses of GARDASIL.  Additional information was received from the registered nurse via telephone who reported that there might be 4 patients but was not sure.  Additional information was received from the registered nurse who reported that the event involved a few girls, number unknown.  The patients complained of hand numbness right after the injection.  No specific patient identifiers were known.  The outcome of the hand numbness was not reported.  No additional information is expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus generalised, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 26 year old female with hypothyroidism and a history of papanicolaou smear abnormal and no history of drug reactions/allergies who on 06-NOV-2006 was vaccinated with first dose of Gardasil (yeast) 0.5 ml IM. On 18-JAN-2007, the patient was vaccinated with a second dose of Gardasil (yeast) (lot # not reported). Concomitant therapy included SYNTHROID and LO/OVRAL. On 18-JAN-2007, fourty-five minutes after receiving the second dose, the patient experienced generalized itching. No additional symptoms were noticed. Medical attention was sought. The physician prescribed BENADRYL and the symptoms resolved. The patient fully recovered on 18-JAN-2007. No further information was available at the time of reporting. Additional information has been requested. This is in follow-upinformation has been received from a physician and a nurse concerning a 26 year old female with hypothyroidism and a history of papanicolaou smear abnormal and no history of drug reactions/allergies who on 06-NOV-2006 was vaccinated with first dose of GARDASIL 0.5 ml IM.  On 18-JAN-2007, the patient was vaccinated with a second dose of GARDASIL (lot # not reported).  Concomitant therapy included SYNTHROID and LO/OVRAL.  On 18-JAN-2007, forty-five minutes after receiving the second dose, the patient experienced generalized itching.  No additional symptoms were noticed.  Medical attention was sought.  The physician prescribed BENADRYL and the symptoms resolved.  The patient fully recovered on 18-JAN-2007.  No further information was available at the time of reporting.  In follow-up it was reported, the patient had no reaction after the first dose of GARDASIL.  After the 2nd dose, the patient left the office and later experienced a slight resolved.  The patient had no other allergic symptoms.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccine positive rechallenge, Vertigo
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female with no medical history who in October 2006 or November 2006 was vaccinated with her second dose of HPV VLP vaccine (yeast) (0.5 mg), intramuscularly. There was no concomitant medication. Subsequently, the patient experienced intermittent vertigo 5 days later. The patient was "recently" administered her third dose of HPV VLP vaccine and was "now" experiencing constant vertigo.  It was noted that the patient had a family history of vertigo.  There were no laboratory or diagnostic tests performed.  At the time of the report, the patient had not recovered.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Meningism, Musculoskeletal stiffness
Clinical narrative: Information has been received from a nurse concerning a 17 year old female who at the "end of December" was vaccinated with a second dose of HPV VLP vaccine (yeast) (0.5 ml). Subsequently, the patient experienced meningitis like symptoms and cervical neck stiffening.  Unspecified medical attention was sought.  At the time of the report, th patient was recovering.  Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a laboratory technician concerning a 26 year old female who on 15-JAN-2007 was vaccinated with a first dose of HPV vaccine (yeast). Ten minutes after the vaccination, the patient passed out at the check out for an unspecified time. The patient said that she always passes out after she gets an injection. Unspecified medical attention was sought. On 15-JAN-2007, the patient recovered without incident. No product quality complaint was involved.  Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 2/14/2007. Initial and follow up information has been received from a healthcare provider concerning a 26 year old female with an allergy to sulfa drugs who on 15-JAN-2007, at 8:23 was vaccinated with a first dose of GARDASIL (lot#655617/1447F) in the right deltoid. Ten minutes after the vaccination, the patient passed out at the check out for an unspecified time. The patient said that she always "passes out" after she gets an injection. Unspecified medical attention was sought. On 15-JAN-2007, the patient recovered without incident. No product quality complaint was involved. No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injection site warmth, Mobility decreased, No reaction on previous exposure to drug, Oedema peripheral
Clinical narrative: Information has been received from a registered nurse concerning her 22 year old daughter with no allergies who on 24-JAN-2007 was vaccinated with HPV VLP vaccine (yeast). Concomitant therapy included methylphenidate HCl (RITALIN) and "pregnancy shot" (name unknown). On 24-JAN-2007 the patient immediately "felt her fingers tingle and her arm got hot."  Later that evening her "fingers turned white and blue."  She then went back to the physician who instructed her to "wrap it in warm packs." The patient also took diphenhydramine HCl (BENADRYL).  The nurse stated that her daughter's arm was getting better, but she still had trouble picking up her arm to her shoulder area.  At the time of the report, the patient was recovering.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007.  Information has been received from a registered nurse concerning her 22 year old "healthy" daughter with no medical history and no allergies who on 24-JAN-2007 was vaccinated with GARDASIL.  Concomitant therapy included RITALIN and "pregnancy shot"(name unknown).  There was no illness at the time of vaccination.  On 24-JAN-2007 the patient immediately "felt her fingers tingle and her arm got hot."  Later that evening her "fingers turned white and blue."  She then went back to the physician who instructed her to "wrap it in warm packs."  The patient also took BENADRYL.  The nurse stated that her daughter's arm was getting better, but she still had trouble picking up her arm to her shoulder area.  Follow-up information reported that the patient stated that "her arm stung became hot at time of injection, tingled down to her fingers", same arm shot given in deltoid.  Later hand and fingers (that arm) swollen, white across knuckles.  She put warm packs on it at home, next day felt better difficult to left arm above shoulder height.  The patient recovered 2-3 days later.  It was noted that the patient had no adverse events following previous vaccinations.  Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia, Skin discolouration, Skin warm
Clinical narrative: Information has been received from a registered nurse concerning her 22 year old daughter with no allergies who on 24-JAN-2007 was vaccinated with HPV VLP vaccine (yeast). Concomitant therapy included methylphenidate HCl (RITALIN) and "pregnancy shot" (name unknown). On 24-JAN-2007 the patient immediately "felt her fingers tingle and her arm got hot."  Later that evening her "fingers turned white and blue."  She then went back to the physician who instructed her to "wrap it in warm packs." The patient also took diphenhydramine HCl (BENADRYL).  The nurse stated that her daughter's arm was getting better, but she still had trouble picking up her arm to her shoulder area.  At the time of the report, the patient was recovering.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007.  Information has been received from a registered nurse concerning her 22 year old "healthy" daughter with no medical history and no allergies who on 24-JAN-2007 was vaccinated with GARDASIL.  Concomitant therapy included RITALIN and "pregnancy shot"(name unknown).  There was no illness at the time of vaccination.  On 24-JAN-2007 the patient immediately "felt her fingers tingle and her arm got hot."  Later that evening her "fingers turned white and blue."  She then went back to the physician who instructed her to "wrap it in warm packs."  The patient also took BENADRYL.  The nurse stated that her daughter's arm was getting better, but she still had trouble picking up her arm to her shoulder area.  Follow-up information reported that the patient stated that "her arm stung became hot at time of injection, tingled down to her fingers", same arm shot given in deltoid.  Later hand and fingers (that arm) swollen, white across knuckles.  She put warm packs on it at home, next day felt better difficult to left arm above shoulder height.  The patient recovered 2-3 days later.  It was noted that the patient had no adverse events following previous vaccinations.  Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Immediate post-injection reaction, Injection site erythema, Injection site nodule, Laboratory test
Clinical narrative: This is in follow-up to report(s) previously submitted on 2/14/2007; 7/6/2007. Information has been received from a nurse concerning a 19 year old female with diabetes and a reaction to ROBITUSSIN who in mid-December 2006, was vaccinated intramuscularly with a second dose of GARDASIL. Concomitant therapy included GLUCOPHAGE. On an unspecified date, the patient developed immediate redness at the injection site and a knot was noticed at the injection site 1 to 2 days post injection. The patient also experienced pain "right after the injection." The patient's mother noted that the pain following the first dose was not as severe as the pain experienced after the second dose. The nurse reported that the patient did not see her family physician and the family physician suspected "nerve damage." It was not specified whether or not the patient had a reaction the first time she was vaccinated with HPV VLP vaccine (yeast). The nurse reported that they were following up with the patient to make sure she was okay. On an unspecified date, magnetic resonance imaging (MRI), blood work and a nerve conduction study were performed (results not provided) to make sure there was no nerve damage. Unspecified medical attention was sought. At the time of this report, the patient was still experiencing pain "some days worse than others". No product quality complaint was involved. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Nerve conduction studies, Nerve injury, Nuclear magnetic resonance imaging, Pain, Similar reaction on previous exposure to drug
Clinical narrative: This is in follow-up to report(s) previously submitted on 2/14/2007; 7/6/2007. Information has been received from a nurse concerning a 19 year old female with diabetes and a reaction to ROBITUSSIN who in mid-December 2006, was vaccinated intramuscularly with a second dose of GARDASIL. Concomitant therapy included GLUCOPHAGE. On an unspecified date, the patient developed immediate redness at the injection site and a knot was noticed at the injection site 1 to 2 days post injection. The patient also experienced pain "right after the injection." The patient's mother noted that the pain following the first dose was not as severe as the pain experienced after the second dose. The nurse reported that the patient did not see her family physician and the family physician suspected "nerve damage." It was not specified whether or not the patient had a reaction the first time she was vaccinated with HPV VLP vaccine (yeast). The nurse reported that they were following up with the patient to make sure she was okay. On an unspecified date, magnetic resonance imaging (MRI), blood work and a nerve conduction study were performed (results not provided) to make sure there was no nerve damage. Unspecified medical attention was sought. At the time of this report, the patient was still experiencing pain "some days worse than others". No product quality complaint was involved. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Syncope
Clinical narrative: Information has been received from a physician concerning his 15 year old daughter who on 03-JAN-2007 was vaccinated with a first dose of HPV VLP vaccine (yeast). On 03-JAN-2007 the patient fainted and experienced soreness at the injection site. Unspecified medical attention was sought.  Subsequently, the patient recovered. No product quality complaint was involved.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Hyperhidrosis, Pallor, Paraesthesia, Syncope
Clinical narrative: Information has been received from a physician concerning a female patient who in "the week of 22-JAN-2007" was vaccinated IM with a 0.5 ml dose of HPV VLP vaccine (yeast). After vaccination, the patient fainted.  Unspecified medical attention was sought.  Subsequently, the patient recovered.  No product quality complaint was involved.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2007. Information has been received from a registered nurse concerning a 15 year old female patient who on 23-FEB-2007, at 3:35PM, (previously reported as approximately 22-JAN-2007) was vaccinated IM, left arm, with a 0.5 ml of GARDASIL (lot # 653735/0688F). That same day, the patient was leaving the office when she complained of dizziness; she was extremely pallor, perspiring and had tingling in both hands and subsequently fainted. The patient's blood pressure was 110/70 mmHg, pulse 116bpm, and her oxygen saturation was 98%. The patient was given oxygen and she stayed at the office for 45 minutes. Subsequently, the patients symptoms subsided and the patient recovered. No product quality complaint was involved. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Hyperhidrosis, Oxygen supplementation, Pallor, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a female patient who in "the week of 22-JAN-2007" was vaccinated IM with a 0.5 ml dose of HPV VLP vaccine (yeast). After vaccination, the patient fainted.  Unspecified medical attention was sought.  Subsequently, the patient recovered.  No product quality complaint was involved.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2007. Information has been received from a registered nurse concerning a 15 year old female patient who on 23-FEB-2007, at 3:35PM, (previously reported as approximately 22-JAN-2007) was vaccinated IM, left arm, with a 0.5 ml of GARDASIL (lot # 653735/0688F). That same day, the patient was leaving the office when she complained of dizziness; she was extremely pallor, perspiring and had tingling in both hands and subsequently fainted. The patient's blood pressure was 110/70 mmHg, pulse 116bpm, and her oxygen saturation was 98%. The patient was given oxygen and she stayed at the office for 45 minutes. Subsequently, the patients symptoms subsided and the patient recovered. No product quality complaint was involved. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Mass, Tenderness
Clinical narrative: Information has been received from a 25 year old female office manager who on 13-DEC-2006 was vaccinated with a first 0.5 mL dose of GARDASIL vaccine. On 13-DEC-2006, the patient developed a small bump under the skin that was tender after receiving the vaccination.  The patient sought unspecified medical attention. At the time of this report, the patient's small, tender bump under the skin persisted.  No product quality complaint was involved.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Pharyngeal hypoaesthesia, Throat tightness
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old female with an allergy to amoxicillin (AUGMENTIN) who on 29-NOV-2006 was vaccinated IM, into the deltoid, with a first dose of HPV VLP vaccine (yeast) (lot # 654540/0800F). Concomitant therapy included ORTHO EVRA. Approximately 1 minute after the vaccination, the patient reported that her "throat felt constricted."  Subsequently, the patient recovered after 5 minutes.  On 25-JAN-2007 the patient was vaccinated with a second dose of dose of HPV VLP vaccine (yeast). Five seconds after the vaccination, the patient experienced "numbness in the throat" that lasted a short duration. The patient reported that she developed an intense headache 30 minutes after the vaccination that lasted until she went to bed. On 26-JAN-2007, the patient recovered from the headache.  Unspecified medical attention was sought.  There were no laboratory or diagnostic tests performed.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007.  Initial and follow-up information has been received from a registered nurse concerning a 20 year old female with an allergy to AUGMENTIN who on 29-NOV-2006 was vaccinated intramucularly, into the deltoid, with a first dose of GARDASIL (lot # 654540/0800F).  Concomitant therapy included ORTHO EVRA.  Within 1 minute after the vaccination, the patient felt "tightness in throat" and lightheadedness.  Subsequently, the patient recovered after 5 minutes.  On 25-JAN-2007 the patient was vaccinated, intramuscularly with a second dose of GARDASIL (lot #654540/0800F).  As the vaccine was administered the patient experienced "momentary numbness at the throat area of neck" that lasted a few seconds.  Twenty minutes after the vaccination, while the patient was on the road, she called the physician's office to report she had developed an intense frontal headache.  There were no visual problems and it was not interrupting her ability to function.  The headache that lasted until she went to bed.  On 26-JAN-2007, the patient recovered from the headache.  There were no laboratory or diagnostic tests performed.  Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a registered nurse through a Merck Pregnancy Registry concerning a 23 year old female with allergies to sulfamethoxazole (+) trimethoprim (BACTRIM) and nitrofurantoin (MACROBID) high blood pressure but no current blood pressure medication. Rhesus antibodies (RH) negative, and a history of cervical dysplasia, urinary tract infections and Caesarian (C) section for first child, year 2006, who on 25-AUG-2006 was vaccinated with HPV vaccine (yeast). The nurse reported that the patient was scheduled for a leep procedure, due to cervical dysplasia on 20-SEP-2006 and before the procedure a blood serum pregnancy test was taken, and result was positive for pregnancy. Additional information has been requested.