chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Oropharyngeal pain, Rash generalised
Clinical narrative: Information has been received from a licensed practical nurse concerning her 16 year old daughter with DURICET allergy and no pertinent medical history who on 03-AUG-2007 was vaccinated with the first dose of GARDASIL (Lot # 653650/0702F). There was no concomitant medication. Subsequently, sore throat was experienced first followed by the rashes all over her body in August 2007. After rash appeared, strep was ruled out, but the patient was still given (LEVAQUIN) for sore throat. The patient recovered from the sore throat in August 2007, but did not recover from the rash until mid-September 2007. The rashes lasted for 1 month. The patient sought medical attention by contacting physician. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Colposcopy, Incorrect route of drug administration, Papilloma viral infection
Clinical narrative: Information has been received from a female who in 2006 was vaccinated orally with GARDASIL and just recently had been diagnosed with human papillomavirus. The patient was not sure what type but was upset to find out she now had human papillomavirus. The patient experienced colposcopy but the result was unknown. The patient sought unspecified medical attention and outcome was unknown. The patient refused to provide any demographics. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Crying, Headache, Inappropriate schedule of drug administration, Malaise
Clinical narrative: Information has been received from a consumer concerning her 16 year old daughter with lactose intolerance and not other drug reactions or allergies who was vaccinated with the first two doses of GARDASIL "sometime in 2007". After both doses she did not feel well. On approximately 22-APR-2009, "three weeks ago", the patient was vaccinated with the third dose of GARDASIL. There was no concomitant medication. On the night of 09-MAY-2009 the patient started to have a headache and stomach aches. In the past three days her stomach issues and headache have gotten worse, that she came home crying on 12-MAY-2009 because of the pain. As of 13-MAY-2009, "today", the patient was still experienced these symptoms and now she also felt hot to touch but did not have a fever. It was also reported that the patient just got her menstrual cycle and was going on three days of having that . No lab tests were done. The physician was called and unspecified medical attention was sought. The reporter was not sure the experiences the patient was having was from GARDASIL. Additional information has been requested.Records received 7/2/09-on 5/9/09 C/O headache, feeling feverish, stomach ache, tiredness, office note for 5/22/09-seen for C/O sinusitis no further visits.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Skin warm
Clinical narrative: Information has been received from a consumer concerning her 16 year old daughter with lactose intolerance and not other drug reactions or allergies who was vaccinated with the first two doses of GARDASIL "sometime in 2007". After both doses she did not feel well. On approximately 22-APR-2009, "three weeks ago", the patient was vaccinated with the third dose of GARDASIL. There was no concomitant medication. On the night of 09-MAY-2009 the patient started to have a headache and stomach aches. In the past three days her stomach issues and headache have gotten worse, that she came home crying on 12-MAY-2009 because of the pain. As of 13-MAY-2009, "today", the patient was still experienced these symptoms and now she also felt hot to touch but did not have a fever. It was also reported that the patient just got her menstrual cycle and was going on three days of having that . No lab tests were done. The physician was called and unspecified medical attention was sought. The reporter was not sure the experiences the patient was having was from GARDASIL. Additional information has been requested.Records received 7/2/09-on 5/9/09 C/O headache, feeling feverish, stomach ache, tiredness, office note for 5/22/09-seen for C/O sinusitis no further visits.
Age: 15.0
Sex: F
Vaccine: HEP, HPV4, MNQ, TDAP
Symptoms: Hypoaesthesia, Mobility decreased, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a physician, a consumer and a secretary concerning a 15 year old female patient with no history of allergies who on 08-MAY-2009 was vaccinated with the first dose of GARDASIL in her right arm.  Almost immediately the patient felt like that she had no circulation and no blood flow.  She experienced numbness, pain all down the arm and hand, and she had the inability to move and her hand became swollen.  The patient's mother reported that the patient could not use her hand.  There was no rash or itching and no systemic symptoms.  On 11-MAY-2009 the patient went back to see her physician.  The physician stated that it was GARDASIL that was causing the experience and she should not get any more doses of GARDASIL.  The physician did not offer any treatment nor did he do any treatment.  On 14-MAY-2009 the patient's hand was still swollen and had pain, but there was no more pain in her arm.  The patient's mother gave the patient ADVIL 200 mg which seemed to help.  The patient's mother reported that she was going to take the patient back to see the physician.  The outcome for other adverse events was unknown.  Follow up information was received from the physician which reported that on 08-MAY-2009, the patient with no pertinent medical history and no known drug allergy received four different vaccines.  The patient was given GARDASIL (lot # 661766/0652X) and RECOMBIVAX HB (manufacturer unknown, lot # AHBVB663AA) in the right arm, ADACEL (lot #C3032AA) and MENACTRA (lot # U2842AA) in the left arm.  On 11-MAY-2009, the patient came back to the office complaining of right arm pain and swelling.  There was no redness and only minor swelling.  No treatment was given, and cold compresses were suggested.  On 18-MAY-2009, the patient again returned to the office complaining of right arm pain.  The patient was seen by another physician who noted normal findings, but referred the patient to a neurologist.  The physician could not say if the condition was disabling, but did say that the patient was not hospitalized and the event was not life threatening.  At the time of reporting, the outcome was unknown.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Pruritus, Rash pruritic
Clinical narrative: Information has been received from a medical assistant concerning a 21 year old female with no allergies or medical history who was vaccinated intramuscularly, 0.5 ml, with the first dose of GARDASIL (Lot # 661766/0652X) on 23-FEB-2009, and with the second dose of GARDASIL (Lot # 661766/0652X) on 23-APR-2009. There was no concomitant medication. The patient called the physician on 28-APR-2009 and reported that on 25-APR-2009 she developed a rash on her shoulders, back and hands. The patient also reported she felt dizzy but none of the symptoms started until 2 days after getting GARDASIL. The patient reported the rash looked like red dots and were itchy. The physician prescribed (BENADRYL) for the itch. The physician advised the patient not to get the third dose of GARDASIL. The patient sought medical attention by calling office and was recovered. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received form a physician concerning his 33 year old daughter who had been vaccinated with GARDASIL series. During one of the GARDASIL vaccination (unspecified which dose), she developed syncope. She had sought medical attention and had recovered from syncope. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 17 year old female patient who on 27-Feb-2009 was vaccinated with the first dose of GARDASIL IM 0.5ml. On 01-Mar-2009 the patient developed a facial rash. There was no concomitant medication. On approximately 22-Mar-2009, after 2-3 weeks the rash resolved without treatment. The patient mentioned this adverse reaction on 13-May-2009, when she came to the office for her second dose of GARDASIL. No further information provided at the time of reporting. Follow up information has been received from another health professional reported that the 17 year old female patient was vaccinated with the second dose  of GARDASIL (lot#: 661046/0546X) with an expiration of 01-Dec-2010 on 13-May-2009 and it was the only vaccine she received that day. It was confirmed that the patient recovered. No additional information is expected.
Sex: U
Vaccine: HPV4
Symptoms: Complex regional pain syndrome
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with GARDASIL. Subsequently the patient experienced complex regional pain syndrome number 1, that is, regional pain after vaccination. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Injection site reaction
Clinical narrative: Information has been received from a physician concerning a 21 years old female with no pertinent medical history who was vaccinated with GARDASIL (lot#, dose, route and site of administration not reported) by a physician's assistant at the office on 05-MAY-2009 or 07-MAY-2009. The patient experienced headache, dizziness and an injection site reaction several hours after getting the vaccine. The patient was told to take ACETAMINOPHEN (manufacturer unspecified). Subsequently, the patient recovered. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose abnormal, Drug exposure during pregnancy, Glucose tolerance test normal, Ultrasound scan
Clinical narrative: Information has been received from a registered nurse in a physician's office and a registered nurse in a county health department, for the Pregnancy Registry for GARDASIL, concerning a 21 year old female with a history of gestational diabetes with her first child and no drug reactions/ allergies who on 05-Feb-2009 was vaccinated IM with the first 0.5ml dose of GARDASIL (lot# 661954/1496X) in the physician's office. There was no concomitant medication. It was reported that the patient did not have a pregnancy test prior to the vaccination. Subsequently, the patient discovered that she was pregnant. The patient's last menstrual period was 03-Jan-2009, her estimated delivery date is on 10-oct-2009. On 05-Mar-2009, the patient had a prenatal ultrasound performed in the physicians office that reported her estimated date of confinement (EDC) to be 19-Oct-2009. The nurse also reported that along with the prenatal lab work the patient had preformed, she also underwent a 1 hour glucose test that she failed. She then underwent a 3 hour glucose tolerance test that was normal. The patient was referred to a county health department. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Head injury, Loss of consciousness, Nausea, Skull X-ray normal
Clinical narrative: Information has been received from a medical assistant concerning a 26 year old female who on 08-MAY-2009 was vaccinated with her first dose of GARDASIL. Subsequently the patient fainted. The patient has sought medical attention and had recovered. Follow up information has been received from this medical assistant concerning this 26 year old patient who was vaccinated with her first dose of GARDASIL (Lot# 660555/0279X). The patient did not received ant concomitant vaccines at report time. After receiving GARDASIL the patient stool up an fell down and lost consciousness. In the same day the patient regained consciousness. The patient had a "bump" on the right side of her forehead. The patient was nauseous. The patient has a "skull x-ray" which revealed no fracture. An ice-pack was applied to the right side of the patient's head. The physician's office contacted the patient on 09-MAY-2009. The patient stated that she felt fine. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a medical assistant concerning a 26 year old female who on 08-MAY-2009 was vaccinated with her first dose of GARDASIL. Subsequently the patient fainted. The patient has sought medical attention and had recovered. Follow up information has been received from this medical assistant concerning this 26 year old patient who was vaccinated with her first dose of GARDASIL (Lot# 660555/0279X). The patient did not received ant concomitant vaccines at report time. After receiving GARDASIL the patient stool up an fell down and lost consciousness. In the same day the patient regained consciousness. The patient had a "bump" on the right side of her forehead. The patient was nauseous. The patient has a "skull x-ray" which revealed no fracture. An ice-pack was applied to the right side of the patient's head. The physician's office contacted the patient on 09-MAY-2009. The patient stated that she felt fine. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician's assistant who reports an office had several patients faint after receiving GARDASIL. It was unknown exactly how many patients or time frame involved. The outcome of the patients was unknown. Follow up information was received from a office manager who said that their office was aware that "patients might faint when they get their GARDASIL vaccine" and that "patients faint all the time", therefore she was uncertain for the reason of the original report. She explained that details regarding individual patients would have to be discussed with the physician or physician's assistant upon their return. 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.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Injection site pain, Injection site swelling, Injection site warmth, Pregnancy test positive
Clinical narrative: Information has been received from a medical assistant, for GARDASIL, a Pregnancy Registry Product, concerning a 17 year old female who was vaccinated with the first dose of GARDASIL on 02-FEB-2009, the second dose on 04-MAY-2009 IM 0.5 ML right deltoid (lot#: 0151). There was no concomitant medication. On 09-MAY-2009 the patient experienced a warm, swollen and painful injection site reaction and returned to the office on 12-MAY-2009. The patient was instructed to treat the area with cold compresses. On 14-MAY-2009, the patient took a pregnancy test and it was positive. The medical assistant did not have the patient's Last Menstrual Period date or Estimated Delivery Date. Subsequently the patient recovered from the injection site reaction on an unspecified date. The medical assistant did not know the name of the patient's OBGYN physician and no other detail at the time of reporting. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash
Clinical narrative: Information has been received from a nurse concerning a 24 year old female who on 11-MAY-2009 was vaccinated with a 0.5 mL first dose of GARDASIL (lot # 661953/1130x), intramuscularly. The patient developed a rash at the injection site about 6 inched in diameter. No laboratories studies performed. The patient sought unspecified medical attention. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Information has been received from a certified medical assistant concerning a 14 year old female with no pertinent medical history who on 14-May-2009 was vaccinated with the first dose of GARDASIL (lot# 661764/0650X), o.5ml, intramuscular administration. There was no concomitant medication. On 14-May-2009 the patient "passed out" immediately after the vaccination. Subsequently, the patient recovered without requiring treatment and was released to home fully recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Herpes simplex, Herpes simplex serology positive
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient who in 2008 started the series of GARDASIL. Concomitant therapy included (ADVAIR), (CELEXA), (ATIVAN) and hormonal contraceptives (unspecified). It was reported that the patient tested positive for herpes simplex virus after receiving all three doses of GARDASIL vaccine. The patient did not have any symptoms of herpes simplex, but HSV IgG and IgM test showed positive. The patient was seen by the nurse practitioner for medical attention. At the time of reporting the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: Information has been received from a receptionist concerning her daughter who on an unknown date was vaccinated with a dose of GARDASIL (lot no. and route not reported). The receptionist reported the patient experienced HPV after receiving the vaccine. The patient sought unspecified medical attention. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Hot flush, Laboratory test normal
Clinical narrative: Information has been received from a certified medical assistant concerning a 25 year old female patient who on 17-APR-2009 received the first dose of GARDASIL (lot#661531/1311X) IM in her left arm. Concomitant therapy included NASONEX, hormonal contraceptives (unspecified) and ZYRTEC. On 17-APR-2009 the patient experienced hot flashes. The patient sought medical attention through an office visit. The patient's hot flashes persisted. Follow up information was received from a certified medical assistant on 27-MAY-2009. It was reported that the patient "would go ahead with doses #2 and #3." No other information regarding the AE was reported. On 28-MAY-2009, the certified medical assistant reported the following additional details: the patient had an allergy to ALUPENT, dust and pollen; no pertinent medical history; no other vaccines given at the time of the GARDASIL vaccination on 17-APR-2009; exact adverse event onset date was unknown, the patient simply reported at the 18-MAY-2009 office visit that she had been having hot flashes; some routine labs (not specified) drawn that day were all normal; hot flashes coincided with a new work-related stress, but did not go away when the work situation resolved; physician indicated that there was no correlation between the hot flashes and GARDASIL use; patient had to go to the office soon for the second GARDASIL dose; the patient after speaking with a co-worker, was interested in learning her "sugar level" so would see her primary physician. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Wheezing
Clinical narrative: Information has been received from a nurse concerning a female who on an unknown date, was vaccinated IM with the first dose of GARDASIL 0.5mL (lot# not reported). Subsequently the patient experienced wheezing. The patient went to the hospital but it was unspecified if the patient was admitted or not. The patient didn't complete the series of GARDASIL because of this adverse event. Therapy with human papillomavirus vaccine was discontinued. Subsequently, the patient recovered from wheezing. In follow-up, it was reported the events happened in 2008 and the patient's name and details could not be recalled. This is one of several reports from the same source. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Headache
Clinical narrative: Information has been received from a physician concerning a 15 year old female with a history of headaches who on unspecified dates were vaccinated with three doses of GARDASIL. (LOT# were not reported). No other vaccines were given at the time of the GARDASIL doses. It was reported that after each dose, the patient's headaches progressively got worse and required an unspecified medical attention. The patient's outcome was unknown. Follow-up information has been received from a nurse concerning the 15 year old female who was new to their office and was seen for the first time in their office on 18-MAY-2009. The nurse did not have any information regarding the vaccination because it was given elsewhere. The patient was not present with headache at time of the visit. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure increased, Dizziness, Dysarthria
Clinical narrative: Information has been received from a physician and a registered nurse concerning an 18 year old female who on 18-Mar-2009 was vaccinated with the first 0.5ml dose of GARDASIL (659655/0940X, site not reported). There were no concomitant vaccines administered with GARDASIL. The patient experienced slurred speech, elevated blood pressure and felt light headed after receiving GARDASIL. The patient had sought unspecified medical attention. It was unknown if the patient was hospitalized. The patient was not scheduled for a follow-up visit to see the physician and was not going to complete the vaccination series. She recovered after 3 days on approximately 21-Mar-2009. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a nurse practitioner concerning a 25 year old female who on 20-OCT-2008 was vaccinated with the first dose of GARDASIL. The second dose of GARDASIL was given on 04-FEB-2009. The third dose of GARDASIL was given on 16-APR-2009. On 21-APR-2009, the patient was seen by a provider because she presented with a generalized rash. She was treated with (ZYRTEC) and (CALRITIN). At the time of reporting, the outcome was unknown. No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure increased, Chest discomfort, Neck pain
Clinical narrative: Information has been received from a licensed practical nurse concerning her 25 year old female friend who on 18-MAY-2009 was vaccinated with her first IM dose of GARDASIL (lot # not reported), for an unknown reason.  The patient's relevant medical history includes an allergy to penicillin.  She has no relevant concomitant medications or past drug history.  On 18-MAY-2009, she received the first injection of the GARDASIL series in the right deltoid.  On 19-MAY-2009, she began to feel chest pressure, achiness in her neck and a slightly elevated blood pressure.  It is unknown if any relevant laboratory testing was performed.  On 19-MAY-2009, it is unknown if she will continue, receiving the GARDASIL injections, and her chest pressure and the achiness in her neck are subsiding.  It is unknown if her blood pressure remained elevated.  Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Adrenal insufficiency, Laboratory test abnormal
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old female who was vaccinated with the first dose of GARDASIL on 02-Aug-2007, second dose on 02-Oct-2007, and third dose on 20-Mar-2008. The patient did not receive any concomitant vaccinations when the GARDASIL vaccinations were administered. In approximately November 2007, the patient began to have signs and symptoms of Adrenal Insufficiency. The patient had sought medical attention. At the time of reporting, the outcome of adrenal insufficiency was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram normal, Dizziness, Electroencephalogram abnormal, Loss of consciousness, Syncope
Clinical narrative: Information has been received from a physician Assistant and a Licensed Practical Nurse concerning a 16 and half years old female with familial risk factor who was vaccinated with three doses of GARDASIL ON 11-APR-2008, 13-JUN-2008 and 9-JAN-2009. Concomitant therapy included ALASE. The patient had no known drug allergies. On 25-AUG-2008 the patient experienced syncope and was sent to the emergency room (hospital name unknown). At the patient's office visit on 16-JAN-2009 it was reported that on 14-JAN-2009 the patient felt dizzy while driving (with a sibling as passenger), she pulled over then blacked out. On 16-JAN-2009 the patient had CT scan and EEG done and CT scan results were normal but EEG results were abnormal and it showed that she underlying predisposition for seizures. It was known that the patient had a "family history of seizure disorder". The patient was referred to Neurologist. The neurologist did not wish to provide any information on this case. A nurse at the county health department reported that the patient was not in their system. Therefore, lot #'s could not be provided. The patient's experience was not felt to be life-threatening. The patient's status was listed as recovering. The health care professionals contacted during telephone follow up could not supply the following information: lot numbers and hospital name (ER visited 25-AUG-2008). No further information is available at this time.  6/23/09 Neurological consult received DOS 4/02/09. Assessment: seizures, syncope. Patient c/o of an episode consisting of stomach hurting, sweating, feeling hot. Pale and unable to recall subsequent events. Lost conciousness. Also slumped over once while driving and had car wreck. Lightheadedness. Episodes of staring. Myoclonic jerks while sleeping. Sleeps a lot, recent weight gain, distractible. ICD-9 Codes: Spells 780.39, Abnormal EEG 794.02, Syncope 780.2, R/O Epilepsy 345.90   6/29/09 Medical records received DOS 8/07/08 to 4/08/09 Assessment: Cephalgia and Syncope. Patient presents with abdominal and pelvic pain. Menorrhagia. Later "passed out/blacked" out while driving. Plantar warts - cryosurgery, electrosurgery. Syncope, cough, cephalgia, emesis, fever. Nasal congestion and sinus pain. Serous effusion - ears. URI. HPV Dose #1 - 4/11/08, HPV Dose #2 - 6/13/08, HPV Dose #3 - 1/9/09
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphomatoid papulosis
Clinical narrative: Information has been received from a physician concerning a female who was born on 09-Jun-1988 was vaccinated the first dose of GARDASIL (Merck) (LOT # 0210U), 0.5ml, on 23-MAY-2007. On 07-AUG-2007 she got the second dose of GARDASIL (LOT # 655620/0171U). There were no concomitant medications. Subsequently the patient experienced lymphomatoid papulosis after getting the first dose and second dose of GARDASIL. After that the patient sought medical attention. The patient never received the third dose. At the time of the report, the outcome was unknown. A medical assistant reported the patient's mother advised that the patient was undergoing treatment (no further information given) and would not be receiving the third dose. Additional information has been requested.  6/25/09 Medical records received DOS 12/28/07 to 12/24/08. Assessment: Lymphoid papulosis and iron deficiency.  Patient presented with hives on upper extremities. Acne on face. Cellulitis L thigh, lymphadenopathy in groin. Lymphoid papulosis lesions on face, eyelid, legs buttocks. Shotty adenopathy neck. Infection R thigh. Oral contraceptives. Vaccine record: HPV-1 Merck 0210U RA 22.Nov.09  6/29/09 Medical records received 12/28/07 to 12/24/08. Additional information abstracted: Patient presented to oncology center with sweats at night, weight loss, rash and itching. Multiple open weeping papules yellowish in nature, others erythematous and reddish/brown, some are papulopustular. Present on eyelids, neck, arms, back, and posterior portion of legs.  8/24/09 Dermatology consult received. FINAL DX: lymphomatoid papulosis, type C, leaving scars. Records reveal patient experienced widespread & painful nodular lesions, ulcer on left hand, intermittent mouth sores, fatigue, nausea.  Tx w/methotrexate starting 6/08, clobetasol propionate cream & folic acid.  Developed MTX-induced pneumonitis.  MTX d/c'd.  Punch biopsy done when developed scaly patches c/w eczematous dermatitis.  Tx w/PUVA & Oxsoralen starting 12/08 w/good results.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Skin papilloma
Clinical narrative: Information has been received from a Nurse Practitioner concerning a 17-year-old female patient who on 07-AUG-2007 was vaccinated with the first dose of GARDASIL 0.5ml. On 24-JUL-2008 the patient was vaccinated with the second dose of GARDASIL 0.5ml. Two to four weeks after the second after the second dose, the patient experienced developing "hundreds of warts" on her arms legs. Approximately 6 months later the patient recovered. The patient didn't seek medical attention. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Information has been received from a physician concerning an 11 year old female with no illness at time of vaccination or pre-existing, birth defects or medical conditions who on 08-Apr-2009 at 9:00, was vaccinated SQ with the third dose of GARDASIL (lot# 661952/1129X) into her right deltoid. Concomitant vaccine received at the same date included the second dose of VARIVAX (lot #:660566/0792X via SQ into her left deltoid. On 10-Apr-2009 at 09:30, the patient experienced right deltoid red swollen and inflamed to 4 inches wide. The patient was seen by a physician. No relevant lab tests was performed. Subsequently, 7 days after onset, the patient recovered. No information is available.
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: Information has been received from a licensed practical nurse concerning a female who was vaccinated with a dose of GARDASIL. Subsequently, the patient developed swollen lymph nodes after one vaccination with GARDASIL. Nodes haven been swollen for more than one week. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 20 years old female who was vaccinated with GARDASIL three times: 1st dose given on 25-Sep-2007 (Lot# 65439/0742U), 2nd dose given on 27-Nov-2007 (Lot# 655322/1211U), 3rd dose given on 08-Apr-2008 (Lot# 0151X). No other vaccine administered. Concomitant therapy included ORTHO TRI-CYCLEN. On 08-May-2009 the patient had a Pap test done which come back abnormal. The physician reported that the result of the patient's test was that she had a high risk of GARDASIL, but the specific type of GARDASIL had not been determined. The status of the patient was unknown at the report time, and the patient had been outside the country. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Condition aggravated, Syncope
Clinical narrative: Information has been received from representative reported experience as reported by a nurse concerning a female patient who on 18-MAY-2009 was vaccinated with the first dose of GARDASIL (Lot # 661953/1130X), 0.5ml. After receiving the patient fainted. The outcome was unknown. The patient sought medical attention. Later on 27-MAY-2009, C.M.A. provided the following details: a female patient with past history of fainting with blood draw who on 18-MAY-2009 was vaccinated with the first dose of GARDASIL (Lot # 661953/1130X), 0.5ml in the right arm after receiving VAQTA (Lot#663490/1605X) in the left arm. Concomitant therapy is YAZ. After receiving the first dose of GARDASIL (Lot # 661953/1130X) , the patient fainted. When she came to, her B/P was 115/68, she was given something to eat and drink and then fully recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a nurse concerning a female who was vaccinated with a first dose of GARDASIL.  Subsequently the patient experienced arm pain during her first injection.  The patient present status was unknown at the report time.  A call received from the nurse mentioned that she did not remember which patient experienced pain following GARDASIL vaccination as this incident occurred several months ago.  She would try to go back through patient records and identify the patient.  If she can find the patient, she will call back with specific details including patient name, date of birth, vaccination dates/lot numbers, AE onset date, patient outcome and / or status, etc.  This is one of several reports from the same source.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from an office manager concerning a 15 year old female who on 11-NOV-2008 was vaccinated with the first dose of GARDASIL (Lot#661764/0650X), 0.5ml , IM and the second dose(Lot# 661841/0653X) 0.5ml, IM on 10-FEB-2009. The patient had been losing her hair after the third dose of GARDASIL (Lot#662300/0100Y), 0.5ml, IM in her right arm on 11-MAY-2009. Concomitant therapy included DEPO-PROVERA, 150mg, IM in the left arm. Caller was requesting a lot check of this vaccine due to the patient having adverse experience. The patient had sought medical attention. The outcome was unknown. The Lot Check had been initiated. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a Registered Nurse (R.N) concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (Lot # not reported).  It was reported that on an unspecified date the patient fainted after getting the vaccine.  The patient sought unspecified medical attention.  The outcome of the patient was unknown.  Follow up information was received from a Registered Nurse (R.N) who confirmed that there was no patient information to report.  It was reported that the Registered Nurse was not aware of any patient who fainted.  It was reported that she will not be supplying any patient information as she had no knowledge of any specific patient fainting in her practice following vaccination with GARDASIL.  Attempts to verify the existence of an identifiable patient have been unsuccessful.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a medical assistant concerning a 23 year old female with not reported drug reactions/allergies and medical history, who on 10-MAR-2009 was vaccinated IM with 0.5 ml first dose of GARDASIL (lot number: 0074Y). There was no concomitant medication. The medical assistant reported that the patient developed hives on her shoulder and back, after receiving her first and only dose of the GARDASIL vaccine. The patient was recovered "3 days after vaccination" (13-MAR-2009). The patient did not seek medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a teenage female who within the last two years (approximately 2007) was vaccinated IM with a dose of GARDASIL (route in the series and lot number unspecified). The physician reported that the patient "fainted" after getting the vaccine. The outcome of patient was recovered. The patient sought unspecified medical attention. 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. This is one of two reports from the same source. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Oedema peripheral
Clinical narrative: Information has been received from a certified medical assistant concerning a 12 year old female patient with cystic fibrosis, no drug reactions/allergies, who on 13-MAY-2009 was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL (Lot # 661531/1311X).  On 20-MAY-2009, the patient's arm became so swollen after receiving her first and only dose of GARDASIL that she could not lift her arm.  The patient sought unspecified medical attention.  There were no laboratory or diagnostic tests performed.  At the time of reporting, the patient's outcome was unknown.  Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Vaccination site pain, Wrong drug administered
Clinical narrative: Information has been received from a 34 year old patient registered nurse with allergies to IMITREX, COMPAZINE, MACROBID, for the Pregnancy Registry for GARDASIL. The patient stated that on 21-MAY-2009 she was supposed to receive RHOGAM and inadvertently received a first dose of GARDASIL (lot # 1702X). The vaccination was painful. Concomitant medications on the same day included RHOGAM. The nurse stated that the error was immediately recognized that the patient receive GARDASIL instead of RHOGAM, it was a medication error and not product confusion. At the time of reporting, 29 weeks gestation and the pregnancy was normal. Her last menstrual period was 31-OCT-2008 and her EDD was 07-AUG-2009. A follow-up appointment was scheduled with the physician. Additional information has been requested.
Sex: F
Vaccine: HPV4, TTOX
Symptoms: Demyelination, Hypoaesthesia, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Information has been received from a physician concerning a teenage female who within the last year was vaccinated with a dose of GARDASIL vaccine. Concomitant therapy included tetanus toxoid (manufacturer unspecified). Two to three months later the patient she had symptoms of numbness and after MRI demyelinating lesions were discovered. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Menstrual disorder, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a consumer for the pregnancy registry for GARDASIL concerning his 17 year old girlfriend with anemia, irregular menstrual cycle and no known drug allergies/ drug reactions who on 21-Apr-2009 was vaccinated with the first 0.5ml dose of GARDASIL (lot# not reported). There was no concomitant medication reported. It was reported that about two to three weeks after getting the vaccine (approximately on 06-May-2009), the patient went to a clinic and had a urine pregnancy test done, which showed she was pregnant. It was reported that the last menstrual period was on 27-Mar-2009. It was reported that on 18-May-2009 the patient had her menstrual cycle. It was reported that the patient has not seen a physician since received her menstrual cycle on 18-May-2009. It was reported that the consumer was uncertain if his girlfriend was still pregnant or not as she had not seen a physician since the menstrual cycle on 18-May-2009. The estimated delivery date was on 01-Jan-2010. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Menorrhagia
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient who "a couple of months ago" was vaccinated with the first and second dose of GARDASIL vaccine (Lot # not reported). It was reported that the patient experienced heavier menstrual cycle after receiving the first and second dose of GARDASIL vaccine. The patient was seen by the physician. The outcome of the patient was unknown. It was reported that the therapy with GARDASIL was discontinued on an unspecified date. Additional information has been required.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Haemorrhage, Pruritus, Rash
Clinical narrative: Information has been received from a physician concerning a 25 year old female with a history of miscarriage before the vaccination who on 12-MAY-2009 was vaccinated with the first dose of GARDASIL (LOT # 0294Y, 0.5ml, intramuscular administration).  There was no concomitant medication.  The patient developed rash on her both arms and legs one week after the vaccination.  The patient called the office and described the rash as itchy and "bursting" blood vessels.  At the time of reporting the patient was recovering.  Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Electrocardiogram abnormal, Tachycardia
Clinical narrative: Information has been received from a physician concerning an 11 year old female who on 19-MAY-2009 was vaccinated with the second dose of GARDASIL (LOT# 661841/0653X, route and site of administration not reported). The patient experienced dizziness after getting the second dose of GARDASIL and about 4 to 7 hours later she became tachycardia up to 150 that stayed for 2 or 3 days. She received the first dose of GARDASIL (LOT#, route and site of administration not reported 0.5ml) on 19-MAR-2009 with no adverse event. The outcome of dizziness was unknown. Follow up information has been received on 29-MAY-2009. It was reported by the office manager that on 19-MAR-2009 the patient received the first dose of GARDASIL (lot#661952/1129X), VAQTA (lot#662532/1584X), ADACEL (lot#UF452AA) and MENACTRA (lot#42870AT). On 19-MAY-2009 the patient went to the Emergency Room for some unspecified medical attention. In additional follow up the responsible physician stated that the patient was not admitted to the hospital. The patient's EKG revealed Sinus Tachycardia, heart rate 140 to 150. The tachycardia lasted for one day. The patient's dizziness and tachycardia resolved. The patient was referred to cardiologist. The patient had an appointment at the vaccinating physician's office on 26-MAY-2009 and the patient was completely normal. It was reported that the patient was scheduled for the third dose of GARDASIL in 3 and a half months. No further information is available. The patient was treated in the emergency room at hospital.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a mother concerning her daughter who on 31-MAR-2008 was vaccinated with first dose of GARDASIL (Lot # 659180/1758U).  Concomitant therapy included a dose of VARIVAX (Lot # 658287/1173U) (MSD) on 31-MAR-2008 and Acne cream.  Subsequently the patient began to lose hair after her first vaccination.  The patient was vaccinated with the other doses of GARDASIL as follows:  2nd dose (Lot # 656371/0181U) on 24-OCT-2008, and 3rd dose (Lot # 661953/1130X) on 21-MAY-2009.  Other concomitant therapy included influenza virus vaccine (unspecified) on 24-Oct-2008.  The patient didn't seek medical attention.  At the report time, the patient was not recovered.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Premature labour
Clinical narrative: Information has been received from a nurse practitioner for GARDASIL, a Pregnancy Registry product, concerning a 23 year old female with allergies to sulfa, MACROBID and a medical history of Attention Deficit Disorder, depression, anxiety and obesity who on unspecified date was vaccinated with the 1st and 2nd dose of GARDASIL. Concomitant therapy included EFFEXOR and NECON 1/35. The doses were administered at a different facility so the nurse practitioner did not have specific dates or lot numbers. The nurse practitioner  stated that the patient did not document if she received any concomitant vaccines when she received the GARDASIL. Subsequently, after two doses of GARDASIL, the patient became pregnant. Unspecified medical attention had been sought. The patient delivered her baby at 33 weeks on 20-Oct-2008. The patient told the nurse practitioner that the baby was "doing great". Dose 3 has not been administered yet. Dose 3 was due in April 2008 but was never administered. At the time of reporting, the patient status was "fine". Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Headache, Myalgia, No reaction on previous exposure to drug, Urticaria
Clinical narrative: Information has been received from a physician concerning a 15 year old female student with no medical history and no known drug allergy who on 25-FEB-2009 at 13:45 was vaccinated with the first dose of GARDASIL IM into her left deltoid (lot # 660612/0229X). On the same day at 13:45, the patient also received the first dose of ADACEL IM into her right deltoid (lot # C3031AA). There was no illness at the time of vaccination. On 26-FEB-2009 the patient's mother stated that the patient went to bad awake with sore muscles and headache after vaccines. The patient was given ibuprofen and the adverse events had relief. On 30-APR-2009, the patient returned for the second dose and her mother noted that she forgot to mention that the patient had hives on arms and chest after vaccines. The physician advised against the second injection. The patient had had prior ADACEL without reaction. At the time of reporting, the outcome was unknown. The patient did not seek medical attention. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Information has been received from a Certified Medical Assistant (C.M.A.) concerning a 24 year old female patient who on 13-MAR-2009 was vaccinated with the first dose of GARDASIL vaccine (Lot # 661846/1312X) with no incident. On 01-MAY-2009 the patient received the second dose of GARDASIL vaccine (Lot # 658271/0558X). There was no concomitant medication reported. It was reported that "26 days after receiving vaccine", on  27-MAY-2009, the patient developed a red bump at the injection site after receiving GARDASIL vaccine. On 27-MAY-2009 the patient called to the office to report that she has developed a "bump" under the skin at the injection site was painful to the touch. There were no laboratory diagnostic tests performed. The patient has not been seen by the physician for evaluation but was offered a physician's appointment and the patient stated that "she would call back to schedule and appointment to see the physician if the bump under skin at the injection site and the pain to touch persisted". It was reported that the patient had not recovered at the time of the report. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Brachial plexus injury, Condition aggravated, Laboratory test, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a consumer concerning his 16 year old daughter with "brachial plexus" of her right arm which was diagnosed a few years ago, and allergy to viral medications (it caused brachial plexus) who on 01-OCT-2008, 02-DEC-2008 and on 21-APR-2009 was vaccinated with the first, second and third doses (o.5 ml) of GARDASIL (Lot # not reported) respectively. Concomitant medication included "pain medication" (unspecified). It was reported that "after first dose" of GARDASIL the nerve damage on her right arm "flared up". After receiving her second dose of GARDASIL the nerve damage (brachial plexus) occurred on her left arm. It was reported that after receiving her third dose of GARDASIL the nerve pain (brachial plexus) "flare up" on her right arm again. The patient sought unspecified medical attention. There were "numerous laboratory work, MRI" performed (results not provided). It was reported that the patient was recovering at the time of the report. No further information is available.