chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling, Pain, Weight increased
Clinical narrative: Information has been received from a consumer concerning her daughter (age not reported) with no pertinent medical history, drug reactions/allergies or concomitant medication usage who on 18-JUN-2007 and 15-Aug-2007 was vaccinated (route and site not reported) with the 1st and 2nd dose of the Gardasil (lot # not reported). The patient's mother stated that she picked up the 1st dose of Gardasil from the pharmacy and drove it to the doctor's office in 90F temperature with the air conditioning on and waited for about 1 hour at room temp at the doctor's office for the vaccine to be administered. On 18-JUN-2007, post vaccination, the patient experienced pain immediately after vaccination that lasted up to 2 weeks. The patient was unable to exercise for 1 week post vaccination. The patient stated that the pain was so intense that she felt like crying. The patient developed swelling near injection site, dry skin, dry hair after the 1st dose was administered. The patient also felt very hungry for 1 week after the 1st dose and believed she gained 5 lbs. The patient's mother stated that she picked up the 2nd dose of Gardasil from the pharmacy and stored it in her refrigerator (temp unknown) for 2 days before taking it to the doctor's office. On 15-AUG-2007, post vaccination for the 2nd dose, the patient experienced pain after vaccination that lasted up to 2 weeks. The patient received unspecified medical attention, no diagnostic test were performed. The patient recovered 2 weeks after each vaccination. In follow-up, the vaccination nurse was unable provide no additional information. This is one of several reports from the same source. The reporter stated that the patient had a few friends (number not specified) who received Gardasil and they all complained of pain on the injection arm. One friend still has pain when she gets tapped around the injection area. The friend was injected in June 2007. No additional information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning his twin teenage daughters who were vaccinated IM with a first 0.5 ml dose of GARDASIL. Subsequently the patients fainted after receiving the vaccination. Both girls also received their second dose with no reaction. Medical attention was not sought. The patients were recovered. No product quality complaint was involved. This is one of the multiple reports from the same source. Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/15/2008.  Information has been received from a physician concerning his 17 year old daughter with no allergies who on 06-OCT-2007 at 11:45 was vaccinated IM with a first 0.5 ml dose of GARDASIL.  The patient fainted after receiving the vaccination.  Medical attention was not sought.  On 06-OCT-2007 the patient recovered.  It was reported that after the second dose was administered the patient had a fainting episode later that night.  No product quality complaint was involved.  It was also reported that the patient and her sibling faint if they receive any injection or lab work.  They also faint if they are in the office for an extended period of time.  It has been going on their entire life since age 5.  If one sister was ill and received treatment or lab work the other sister who was not ill will faint.  Their father is also a fainter.  The patient's twin sister also fainted after receiving a dose of GARDASIL (WAES#0712USA02825).  Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug, Syncope
Clinical narrative: Information has been received from a health professional concerning a 15 year old white female who on 16-NOV-2007 was vaccinated with the second dose of Gardasil (lot# 654535/0960F).  Subsequently the patient fainted after the second vaccination.  The patient was fine with the first dose.  Unknown medical attention was sought.  The patient's outcome is unknown.  No product quality complaint was involved.  This is one of the multiple reports from the same source.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a health professional concerning a 17 year old white female who on 26-NOV-2007 was vaccinated with Gardasil (lot# 659437/1266U).  Subsequently the patient fainted after the vaccination.  Unknown medical attention was sought.  The patient's outcome is unknown.  No product quality complaint was involved.  This is one of the multiple reports from the same source.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a health professional concerning a 15 year old white female who on 27-NOV-2007 was vaccinated with the second dose of Gardasil (lot# 657736/0389U).  Subsequently the patient fainted after the vaccination.  She was fine with the first dose.  Unknown medical attention was sought.  The patient's outcome is unknown. No product quality complaint was involved.  This is one of the multiple reports from the same source.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a Physician's Assistant concerning a 14 year old female who on an unspecified date was vaccinated with a first dose of Gardasil (lot# unknown) 0.5mL injection.  On an unspecified date, within a minute after receiving the first dose of Gardasil fainted.  Medical attention was sought.  Subsequently, on an unspecified date the patient recovered from fainting.  No further information was provided.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Angiopathy, Loss of consciousness, Neoplasm, Nuclear magnetic resonance imaging abnormal, Pain in extremity
Clinical narrative: Information has been received from a consumer concerning her 14 year old daughter with asthma, sulfonamide allergy and an allergy to codeine who on 12-OCT-2007, was vaccinated IM with a second dose of Gardasil.  Concomitant therapy given on 16-OCT-2007, included MENACTRA, hepatitis A virus vaccine (unspecified), Varivax (MSD) and allergy shots that she continually receives.  On 12-OCT-2007, the patient passed out at home when they returned home from the physician's office. Unspecified medical attention was sought.  It was also reported that in November 2007, her daughter had also experienced pain in her arm and had gone to her primary physician where they ran a test (magnetic resonance imaging (MRI)) that determined she had a tumor on her left arm and had abnormal blood vessels.  At the time of this report, the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Injection site pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a female patient who on 26-JUL-2007, was vaccinated with a first dose of Gardasil. On an unknown date, the patient received a third dose of the vaccine only 7 weeks after her second dose. The patient also experienced injection site pain. At the time of this report, the patient recovered from injection site pain. No product quality complaint was involved. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Rash generalised, Rash papular, Streptococcal identification test negative
Clinical narrative: Information has been received from a licensed practical nurse concerning a 13 year old female who on 14-DEC-2007 was vaccinated with her second dose of Gardasil (Lot #1062U/658560).  There was no concomitant medication.  On 14-DEC-2007 the patient developed a rash over her entire body.  The rash was described as "red tiny dots".  By the next day the rash was bright red and "looked as if the skin was on fire".  The patient also developed pruritis.  The patient started taking BENADRYL but symptoms had not improved.  The patient was seen in the physician's office and a Strep test was done with negative results.  The first dose of Gardasil (Lot #0929U/658282) was administered on 05-OCT-2007 intramuscularly.  The patient did not experience any adverse events after the first dose of Gardasil.  No further information is available.  In a follow up the physician was contacted and he described a patient with diffuse, pruritic, papular rash characterized by some umbilication 24 hours after receiving the second dose of Gardasil (Lot #1062U/658560) and was still present 4 days later.  A consultation with a dermatologist was suggested as possible being helpful in determining the etiology of the rash.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Nausea, Oral herpes, Oral mucosal blistering, Pharyngolaryngeal pain
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female with a penicillin allergy who on 13-DEC-2007 was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil (Lot #658560/1062U). There was no concomitant medication. On 14-DEC-2007 the patient developed oral herpes. She initially experienced a fever and then later developed blister-like lesions in the inside of her mouth. She also experienced a sore throat and nausea. She was treated with acyclovir. There was no laboratory or diagnostic tests performed. The patient was in for an office visit. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female with a penicillin allergy who on 13-DEC-2007 was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil (Lot #658560/1062U). There was no concomitant medication. On 14-DEC-2007 the patient developed oral herpes. She initially experienced a fever and then later developed blister-like lesions in the inside of her mouth. She also experienced a sore throat and nausea. She was treated with acyclovir. There was no laboratory or diagnostic tests performed. The patient was in for an office visit. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Folliculitis, Furuncle, Incisional drainage, Injection site erythema
Clinical narrative: Information has been received from a registered nurse, concerning her 18 year old daughter with hypersensitivity to para-amino benzoic acid (PABA) in sunblock, who at the end of November 2007, was vaccinated IM in the right buttock, with a dose of GARDASIL (lot # not reported). Concomitant therapy included ethinyl estradiol/norethindrone acetate (LOESTRIN). In December 2007 (two weeks after vaccination), her daughter, who regularly shaved her genital area, developed folliculitis of the genital area. In addition, she developed a boil at the injection site, on the right buttock that became hard, painful and red. The nurse contacted her daughter's physician, who referred her to a surgeon. The surgeon lanced the area, and prescribed trimethoprim/sulfamethoxazole (BACTRIM) as treatment. The wound continued to drain, but was less painful. A lab test was performed fro methicillin-resistant Staphylococcus aureus test (MRSA) (results not yet available). At the time of this report, the nurse reported her daughter was recovering from the events. The nurse reported her daughter had never before developed folliculitis and questioned a  relationship to GARDASIL. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Injection site pain, Methicillin-resistant staphylococcal aureus test
Clinical narrative: Information has been received from a registered nurse, concerning her 18 year old daughter with hypersensitivity to para-amino benzoic acid (PABA) in sunblock, who at the end of November 2007, was vaccinated IM in the right buttock, with a dose of GARDASIL (lot # not reported). Concomitant therapy included ethinyl estradiol/norethindrone acetate (LOESTRIN). In December 2007 (two weeks after vaccination), her daughter, who regularly shaved her genital area, developed folliculitis of the genital area. In addition, she developed a boil at the injection site, on the right buttock that became hard, painful and red. The nurse contacted her daughter's physician, who referred her to a surgeon. The surgeon lanced the area, and prescribed trimethoprim/sulfamethoxazole (BACTRIM) as treatment. The wound continued to drain, but was less painful. A lab test was performed fro methicillin-resistant Staphylococcus aureus test (MRSA) (results not yet available). At the time of this report, the nurse reported her daughter was recovering from the events. The nurse reported her daughter had never before developed folliculitis and questioned a  relationship to GARDASIL. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy, Ultrasound scan
Clinical narrative: Information has been received from a physician concerning his 20 year old daughter, who, on an unspecified date, was vaccinated with a dose of Gardasil. Subsequently, within a week after receiving the vaccination the patient developed a swollen mass/lymph node under the armpit, on the arm where the vaccination was administered. The physician believed that it could be "axillary mass adenopathy." The patient was seen by her primary doctor and was also going to be seen by a surgeon. An ultrasound was performed (no results provided). At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Urticaria
Clinical narrative: Information has been received from a medical assistant concerning a 25 year old female with no pertinent medical history and a penicillin allergy who on 16-OCT-2007 was vaccinated intramuscularly in the left deltoid muscle with the 1st dose of Gardasil (lot#658560/1062U).  Concomitant therapy included AMBIEN as needed.  On 20-Dec-2007, the reporter stated that the patient developed hives 2 weeks ago (exact date not reported).  For treatment the patient was taking unspecified steroid.  Lab diagnostic test (blood work) was performed, results pending.  At the time of this report, the patient was recovering.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Vaccine positive rechallenge
Clinical narrative: Information has been received from a health professional concerning a female who was vaccinated with a first dose of Gardasil.  Subsequently the patient experienced anxiety.  On an unspecified date she received a second dose of Gardasil.  The anxiety reappeared after reintroduction of the vaccine.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a nurse concerning a 14 year old female who was vaccinated with Gardasil and passed out.  The patients outcome was not reported.  No further information was provided.  Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Erythema, Injected limb mobility decreased, Injection site pain, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a patient who in October 2007, was vaccinated with a dose of GARDASIL. Subsequently the patient has a sore arm with some minor redness and swelling. It was minor but continued to have pain at the site and had limited range of motion of the arm due to the pain. At the time of the report the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Tic, Tremor
Clinical narrative: Information has been received from an office manager concerning a female patient (age not reported) who on an unspecified date was vaccinated with Gardasil (lot number unknown) injection.  On an unspecified date, within days after receiving Gardasil the patient experienced a neurological tick/tremor in the arm in which the patient received Gardasil.  Medical attention was sought.  There was no further adverse event information.  No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Lip swelling, Oedema peripheral, Pruritus
Clinical narrative: Information has been received from a 21 year old female who on 12-OCT-2007 was vaccinated with a first dose of Gardasil (Lot # not reported).  Concomitant therapy included venlafaxine HC1 (EFFEXOR).  The patient reported that on 13-OCT-2007, the day after her vaccination with Gardasil, her fingers and lips were swollen and itchy.  The patient reported that she recovered on 14-OCT-2007.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Dyspnoea, Hypersensitivity, Hypoaesthesia oral
Clinical narrative: Information has been received from a health professional via a representative concerning a 13 year old female who on 06-OCT-2007 was vaccinated with a first dose of Gardasil (lot# unknown).  There was no adverse experience reported.  On 21-DEC-2007 the patient was vaccinated with a second dose of Gardasil.  The patient remained in the practice for 15 minutes and after feeling fine left the practice.  The parents called back a little while after that the patient was feeling her mouth was numb, her tongue was numb, started a bit of anxiety and felt shortness of breath.  The patient returned to the practice and received an injection of steroids and BENADRYL and the symptoms resolved in 15 minutes.  The patient received no other vaccines or medications were administered at the time of Gardasil.  The patient did not have any of the pharyngeal swelling or numbness, just in her tongue and mouth.  The physician felt this was an allergic reaction that did in fact get resolved when treatment was administered.  The patient is currently doing well according to the healthcare professional.  Additional information has been requested. Follow-up received 04/16/2008. On 21-DEC-2007 the patient was vaccinated with a second dose of GARDASIL (lot # 659437/1266U) IM in the right deltoid. The parents called back a little while after that the patient was feeling her mouth and tongue became numb and tingling, started a bit of anixiety and felt slight short of breath; no wheezing. The patient returned to the practice and received an injection of methylprednisolone acetate (DEPO MEDROL) 40mg IM with complete resolution of symptoms in 15 minutes. The pulse oximetry was 97%. Prednisone and diphenhydramine hcl (BENADRYL) was given at home. Additional information is not expected.
Sex: U
Vaccine: HPV4, VARCEL
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a patient (age and gender unknown), who, on an unspecified date, was vaccinated with a dose of Gardasil. Concomitant suspect vaccinated with a dose of Gardasil. Concomitant suspect vaccinations included Varivax (MSD). Subsequently, the evening after the administration of the vaccines the patient was vomiting. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: DTAP, HPV4, MNQ
Symptoms: Injection site vesicles, Syncope, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse concerning a 17 year old female with no pertinent medical history and a penicillin allergy who on 12-JUN-2007 was vaccinated intramuscularly (site not reported) with the 1st dose of Gardasil (lot #657737/0522U).  The patient was concomitantly vaccinated with MENACTRA and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown).  On 12-JUN-2007, post vaccination, the patient fainted in the office and was caught by her father before she fell to the floor.  The patient woke up on her own and went home.  On a unspecified date the patient was vaccinated intramuscularly (site not reported) with the 2nd dose of Gardasil (lot #657868/0523U).  When the patient received the 2nd dose of Gardasil she fainted again in the office.  The patient also had blisters around injection site.  The patient did receive unspecified medical attention, no diagnostic labs were performed.  At the time of this report the patient had recovered.  The patient did not receive the 3rd dose of Gardasil.  Additional information has been requested. 04/07/2008 Initial and follow up information has been received from a nurse concerning a 17 year old female student with no pertinent medical history and a penicillin allergy who on 12-JUN-2007 was vaccinated intramuscularly (site not reported) with the 1st dose of GARDASIL (lot#657737/0522U). The patient was concomitantly vaccinated with MENACTRA and DTaP (manufacturer unknown). On 12-JUN-2007, post vaccination, the patient fainted in the office and was caught by her father before she fell to the floor. The patient woke up on her own and went home. In follow up it was reported that on 23-AUG-2007, the patient received her second dose of GARDASIL intramuscularly into left deltoid (lot#657868/0523U). On 23-AUG-2007 when the patient received the 2nd dose of GARDASIL she fainted again in the office and it was reported that she also had blisters around injection site. The patient did receive unspecified medical attention, no diagnostic labs were performed. At the time of this report the patient had recovered. The patient did not receive the 3rd dose of GARDASIL. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure, Syncope
Clinical narrative: Information has been received from a licensed practical nurse concerning a 16 year old white female with no pertinent medical history or drug reactions/allergies or illness at the time of vaccination on 19-DEC-2007 was vaccinated with GARDASIL (lot# 659439/1267U) IM in the left deltoid at 9:35 AM. There was no concomitant medication. On 19-DEC-2007 at 9:40AM, the patient was very apprehensive about receiving the vaccination. Approximately 5 minutes later (child was sitting in the chair) child had a syncope episode lasting 2 - 5 seconds. There was no LOC (loss of consciousness). The patient was lifted by the mother onto the exam table and was in a supine position with legs elevated with a cold pack on legs and and neck. The blood pressure measurement was 102/64. The patient was continued to be monitored for 15 to 20 minutes. On 19-DEC-2007, the patient recovered. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure, Hypotension, Nausea, Skin warm
Clinical narrative: Initial and follow-up information has been received from a physician and nurse concerning a 17 year old female who on 01-NOV-2007 was vaccinated with a first dose of Gardasil (lot# unknown) injection.  On 27-DEC-2007, the patient was vaccinated with a second dose of Gardasil (lot# 659439/1267U) 0.5 mL injection.  On 27-DEC-2007 the patient experienced low blood pressure.  The patient's blood pressure dropped from 110 to 80 (also reported as 80/60), her skin was "hot" to the touch and she felt nauseated.  Medical attention was sought.  The patient went home after the recovery on 27-DEC-2007.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a consumer concerning her daughter's friend (age and gender not reported) who was vaccinated (date, route, and site not reported) Gardasil (lot# not reported) and complained of pain on the injection arm. The friend still has pain when she gets tapped around the injection area. The friend was vaccinated in June 2007 (exact date not reported). It was not reported if the friend sought medical attention or if diagnostic lab test were performed. No additional information is expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Anorexia, Laboratory test, Musculoskeletal stiffness, Photophobia, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her 15 year old daughter with no drug reaction/allergies and no concomitant medication usage who in approximately October 2007, was vaccinated intramuscularly (site not reported) with the 1st 0.5ml dose of Gardasil (lot # not reported).  Three days post vaccination (date not specified), the patient experienced a high fever, a stiff neck, loss of appetite and her eyes were sensitive to light.  The patient was taken to the emergency room but was not admitted.  Lab diagnostic tests were performed and the emergency room diagnosed the patient with a urinary tract infection.  Subsequently, the patient "fully recovered five days later".  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Urinary tract infection
Clinical narrative: Information has been received from a consumer concerning her 15 year old daughter with no drug reaction/allergies and no concomitant medication usage who in approximately October 2007, was vaccinated intramuscularly (site not reported) with the 1st 0.5ml dose of Gardasil (lot # not reported).  Three days post vaccination (date not specified), the patient experienced a high fever, a stiff neck, loss of appetite and her eyes were sensitive to light.  The patient was taken to the emergency room but was not admitted.  Lab diagnostic tests were performed and the emergency room diagnosed the patient with a urinary tract infection.  Subsequently, the patient "fully recovered five days later".  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain
Clinical narrative: Information has been received from a health professional concerning a female patient who on 04-MAY-2007 and in October 2007, was vaccinated with first dose and second dose of GARDASIL, respectively. Subsequently, the patient experienced abdominal pain. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested. 04/07/2008 Follow up information stated that there were no adverse symptoms. The office manager stated she called to ask about dosing at the time the patient sought treatment for an unrelated medical condition. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: Information has been received from a mother concerning her daughter who was vaccinated with two doses of Gardasil.  The mother reported that after the second dose of vaccine the patient developed an "adverse event."  The patient sought unspecified medical attention.  At the time of this report, the patient's adverse event persisted.  No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a laboratory technician concerning a 23 year old female who was vaccinated her second dose of Gardasil 23 days after the first dose and developed a rash. No further information is available. Additional information has been requested. 04/07/2008 Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Hypoaesthesia, Nuclear magnetic resonance imaging, Paraesthesia, Urticaria
Clinical narrative: Information has been received from a consumer concerning her daughter, a 17 year old female with a history of drug hypersensitivity to amoxicillin and sulfates, who on approximately 01-AUG-2007 was intramuscularly vaccinated with her second dose of Gardasil.  On 15-AUG-2007 the patient experienced hives, numbness in arms and legs, tingling in arms and legs and headaches.  The patient sought unspecified medical treatment in the ER where an MRI was performed.  Therapy was reported as discontinued as of "October 2007".  The patient's hives, numbness and tingling in arms and legs, and headaches have not improved.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Information has been received from a health professional concerning a 13 year old female who was vaccinated with the second dose of Gardasil.  5 minutes following the administration of the second dose of Gardasil, the patient experienced a syncopal episode.  The patient sought unspecified medical attention.  Subsequently, the patient recovered from the syncopal episode.  The reporter felt that syncopal episode were not related to therapy with Gardasil.  No further information was available.  Additional information has been requested.2/10/2010. This is a follow-up to report (#) previously concerning a 13 year old feeale with a history of scoliosis wha on 26-Sep-2007 was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). On 28-Dec-2007 the patient was vaccinated intramuscularly in the left arm with the second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). (659439/1267u). 5 minutes following of the second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The patient experienced a syncopal episode. The patient sought unspecified medical attention. Subsquently, the patient recovered from the syncopal episode. The reporter felt that syncopal episode were not related to therapy with HPV rL1 6 11 16 1N VLP vaccine (yeast). No further information was available. Follow-up AE information 03-Jan-2008: Per the reporter the patient had a syncopal episode 5 to 10 minutes after the second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) on 28-Dec-2007. The patient lost consciousness (undetermined time frame) with no reports at any injury. There was no other information to report. Follow up information was received from the doctor on 29-JAN-2008. The patient passed out. MD saw patient lying on the ground. Alert and oriented. P approx. 100. no X. clear to auscultation (CTA) null. The patient was assisted to chair. given water. She felt better and left before being checked again. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Chest X-ray, Computerised tomogram head, Electrocardiogram normal, Full blood count normal, Hypoaesthesia
Clinical narrative: Information has been received from a certified medical assistant concerning a 23 year old white female with a penicillin allergy who on 28-NOV-2007 at 4:00 pm, was vaccinated IM into the left deltoid with a second dose of Gardasil (Lot# 659135/1265U).  On 29-NOV-2007, the patient experienced fever of 102 and rash on abdomen and leg.  On 30-NOV-2007, the patient went to the emergency room for left sided numbness and weakness of upper and lower extremities.  It was reported that the patient was discharged from the ER that same day after her symptoms improved spontaneously and her initial workup was unremarkable.  On 30-NOV-2007, laboratory diagnostic studies performed included a CT (non-contrast) of the brain that was reported to be within normal limits, a complete blood count and basic metabolic panel that was within normal limits, a chest X-ray PAL and an EKG that were within normal limits.  On 04-DEC-2007, the patient was seen by the physician.  It was reported that her symptoms had improved but they were still ongoing.  Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Metabolic function test normal, Muscular weakness, Pyrexia, Rash
Clinical narrative: Information has been received from a certified medical assistant concerning a 23 year old white female with a penicillin allergy who on 28-NOV-2007 at 4:00 pm, was vaccinated IM into the left deltoid with a second dose of Gardasil (Lot# 659135/1265U).  On 29-NOV-2007, the patient experienced fever of 102 and rash on abdomen and leg.  On 30-NOV-2007, the patient went to the emergency room for left sided numbness and weakness of upper and lower extremities.  It was reported that the patient was discharged from the ER that same day after her symptoms improved spontaneously and her initial workup was unremarkable.  On 30-NOV-2007, laboratory diagnostic studies performed included a CT (non-contrast) of the brain that was reported to be within normal limits, a complete blood count and basic metabolic panel that was within normal limits, a chest X-ray PAL and an EKG that were within normal limits.  On 04-DEC-2007, the patient was seen by the physician.  It was reported that her symptoms had improved but they were still ongoing.  Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a nurse concerning a female in her early 20's who on an unspecified date was vaccinated with a second dose of Gardasil. Subsequently, after the second dose, the patient reported that she experienced tingling all over her body but not necessarily at the injection site (not itching exactly). There was no intervention needed, non-serious, and no follow-up was needed. Patient was not pregnant. The outcome of the tingling was not reported. Subsequently, the patient did finish the series. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse concerning a 22 year old black female classroom assistant, who on 28-AUG-2007 at 13:50 was vaccinated intramuscularly in the left deltoid with a first dose of GARDASIL (Lot# 658554/0928U). On 28-AUG-2007 at 14:00 the patient developed bumps on her face, the rash radiated to her neck and right flank area. It was reported that the patient was at camp a few days before the injection and did not recall any problems. The rash was worse on the second day. The patient's primary care physician treated her with cortisone. The patient recovered in approximately 1 week on an unspecified date. The patient was advised by her primary care physician to see a dermatologist. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose normal, Blood pressure, Bronchitis, Chest X-ray normal, Culture urine
Clinical narrative: Information has been received from a certified medical assistant concerning a 21 year old white female nonsmoker with a history of depression, no significant social history, no sexual activity, and no drug allergies, who on 20-NOV-2007 at 09:30 was vaccinated intramuscularly in the left deltoid with a second dose of Gardasil (Lot #659439/1267U).  Concomitant therapy included sertraline HC1 (ZOLOFT), alprazolam (XANAX), and ethinyl estradiol (+) etonogestrel (NUVARING).  On 20-NOV-2007 at 09:45 (also reported as about 10 minutes post vaccination) the patient felt lightheaded and nearly had a syncopal episode while sitting in the chair.  The patient never fell out of the chair and there was no injury.  The patient was "slow to come to" and felt fatigued.  The patient had a head cold followed by a cough and chest congestion that had developed over the past week.  The patient had no fever, chest pain, abdominal pain, shortness of breath.  The patient was taken to the emergency room where she was treated with normal saline 1000cc, 500cc/hour.  Laboratory diagnostics were performed (results located in laboratory section).  The patient was diagnosed with being near syncope and bronchitis.  It was reported that the patient was feeling better and was discharged to home.  The patient's condition was stable.  The patient was advised to follow up with physician.  On 20-NOV-2007 the patient recovered from the near syncopal episode, fatigue, and lightheaded/dizziness.  The outcome of bronchitis was unknown.  Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Full blood count, Heart rate normal, Laboratory test
Clinical narrative: Information has been received from a certified medical assistant concerning a 21 year old white female nonsmoker with a history of depression, no significant social history, no sexual activity, and no drug allergies, who on 20-NOV-2007 at 09:30 was vaccinated intramuscularly in the left deltoid with a second dose of Gardasil (Lot #659439/1267U).  Concomitant therapy included sertraline HC1 (ZOLOFT), alprazolam (XANAX), and ethinyl estradiol (+) etonogestrel (NUVARING).  On 20-NOV-2007 at 09:45 (also reported as about 10 minutes post vaccination) the patient felt lightheaded and nearly had a syncopal episode while sitting in the chair.  The patient never fell out of the chair and there was no injury.  The patient was "slow to come to" and felt fatigued.  The patient had a head cold followed by a cough and chest congestion that had developed over the past week.  The patient had no fever, chest pain, abdominal pain, shortness of breath.  The patient was taken to the emergency room where she was treated with normal saline 1000cc, 500cc/hour.  Laboratory diagnostics were performed (results located in laboratory section).  The patient was diagnosed with being near syncope and bronchitis.  It was reported that the patient was feeling better and was discharged to home.  The patient's condition was stable.  The patient was advised to follow up with physician.  On 20-NOV-2007 the patient recovered from the near syncopal episode, fatigue, and lightheaded/dizziness.  The outcome of bronchitis was unknown.  Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Oxygen saturation normal, Presyncope, Respiratory rate, Urine human chorionic gonadotropin
Clinical narrative: Information has been received from a certified medical assistant concerning a 21 year old white female nonsmoker with a history of depression, no significant social history, no sexual activity, and no drug allergies, who on 20-NOV-2007 at 09:30 was vaccinated intramuscularly in the left deltoid with a second dose of Gardasil (Lot #659439/1267U).  Concomitant therapy included sertraline HC1 (ZOLOFT), alprazolam (XANAX), and ethinyl estradiol (+) etonogestrel (NUVARING).  On 20-NOV-2007 at 09:45 (also reported as about 10 minutes post vaccination) the patient felt lightheaded and nearly had a syncopal episode while sitting in the chair.  The patient never fell out of the chair and there was no injury.  The patient was "slow to come to" and felt fatigued.  The patient had a head cold followed by a cough and chest congestion that had developed over the past week.  The patient had no fever, chest pain, abdominal pain, shortness of breath.  The patient was taken to the emergency room where she was treated with normal saline 1000cc, 500cc/hour.  Laboratory diagnostics were performed (results located in laboratory section).  The patient was diagnosed with being near syncope and bronchitis.  It was reported that the patient was feeling better and was discharged to home.  The patient's condition was stable.  The patient was advised to follow up with physician.  On 20-NOV-2007 the patient recovered from the near syncopal episode, fatigue, and lightheaded/dizziness.  The outcome of bronchitis was unknown.  Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Device failure, Medical device complication, Pain, Stress
Clinical narrative: Information has been received from a physician concerning an Gardasil (lot# 655327/1287U) pre-filled syringe. The physician reported that the pre-filled syringe's safety mechanism failed to activate. The physician feels this increased stress and pain for the patient. The physician states she fully depressed the plunger and it failed. The SR# is 1-2166964843. No further information is available.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Medication error
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female who on 11-OCT-2007, was vaccinated with a dose of Gardasil (possible lot#'s 0523U, 1425F, 0515U) that was improperly stored reaching 32 degrees F on 4 occasions 10/02/2007, 10/03/2007, 10/09/2007 and 10/11/2007. No problems were noted. It was unknown whether medical attention was sought. There was no product quality complaint. This is one of several reports from the same source.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Medication error, No adverse reaction
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female who on 12-OCT-2007, was vaccinated with a dose of Gardasil (possible lot#'s 0523U, 1425F, 0515U) that was improperly stored reaching 32 degrees F on 4 occasions 10/02/2007, 10/03/2007, 10/09/2007 and 10/11/2007.  No problems were reported.  It was unknown whether medical attention was sought.  There was no product quality complaint.  This is one of several reports from the same source.
Age: 13.0
Sex: U
Vaccine: HPV4
Symptoms: Medication error, No adverse reaction
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female who on 12-OCT-2007, was vaccinated with a dose of Gardasil (possible lot#'s 0523U, 1425F, 0515U) that was improperly stored reaching 32 degrees F on 4 occasions 10/02/2007, 10/03/2007, 10/09/2007 and 10/11/2007. No problems were reported. It was unknown whether medical attention was sought. There was no product quality complaint. This is one of several reports from the same source.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Medication error, No adverse reaction
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female who on 15-OCT-2007, was vaccinated with a dose of Gardasil (possible lot#'s 0523U, 1425F, 0515U) that was improperly stored reaching 32 degrees F on 4 occasions 10/02/2007, 10/03/2007, 10/09/2007 and 10/11/2007. No problems were reported.  It was unknown whether medical attention was sought.  There was no product quality complaint.  This is one of several reports from the same source.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Medication error, No adverse reaction
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female who on 15-OCT-2007, was vaccinated with a dose of GARDASIL (possible lot#'s 0523U, 1425F, 0515U) that was improperly stored reaching 32 degrees F on 4 occasions 10/02/2007, 10/03/2007, 10/09/2007 and 10/11/2007. No problems were reported. It was unknown whether medical attention was sought. There was no product quality complaint. This is one of several reports from the same source.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Medication error, No adverse reaction
Clinical narrative: Information has been received from a registered nurse concerning a 22 year old female who on 15-OCT-2007, was vaccinated with a dose of Gardasil (possible lot#'s 0523U, 1425F, 0515U) that was improperly stored reaching 32 degrees F on 4 occasions 10/02/2007, 10/03/2007, 10/09/2007 and 10/11/2007.  No problems were reported.  It was unknown whether medical attention was sought.  There was no product quality complaint.  This is one of several reports from the same source.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Medication error, No adverse reaction
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female who on 17-OCT-2007, was vaccinated with a dose of Gardasil (possible lot#'s 0523U, 1425F, 0515U) that was improperly stored reaching 32 degrees F on 4 occasions 10/02/2007, 10/03/2007, 10/09/2007 and 10/11/2007.  No problems were reported.  It was unknown whether medical attention was sought.  There was no product quality complaint.  This is one of several reports from the same source.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Medication error, No adverse reaction
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female who on 17-OCT-2007, was vaccinated with a dose of GARDASIL (possible lot#'s 0523U, 1425F, 0515U) that was improperly stored reaching 32 degrees F on 4 occasions 10/02/2007, 10/03/2007, 10/09/2007 and 10/11/2007. No problems were reported. It was unknown whether medical attention was sought. There was no product quality complaint. This is one of several reports from the same source.
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with 0.5 ml of Gardasil via injection.  The patient developed severe vomiting after receiving the vaccination.  Lot number was not provided.  The physician stated that the patient was hospitalized, but did not know for how many days.  No further information was provided.  As of 13-DEC-2007 the patient was recovering.  Additional information has been requested. Follow up information has been received on 22-FEB-2008. The nurse reported that the physician has no further adverse event information to provided. No further information is expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Medication error, No adverse reaction
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female who on 18-OCT-2007, was vaccinated with a dose of GARDASIL (possible lot#'s 0523U, 1425F, 0515U) that was improperly stored reaching 32 degrees F on 4 occasions 10/02/2007, 10/03/2007, 10/09/2007 and 10/11/2007. No problems were reported. It was unknown whether medical attention was sought. There was no product quality complaint. This is one of several reports from the same source.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Medication error, No adverse reaction
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female who on 18-OCT-2007, was vaccinated with a dose of Gardasil (possible lot #'s 0523U, 1425F, 0515U) that was improperly stored reaching 32 degrees F on 4 occasions 10/02/2007, 10/03/2007, 10/09/2007 and 10/11/2007.  No problems were reported.  It was unknown whether medical attention was sought.  There was no product quality complaint.  This is one of several reports from the same source.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Medication error, No adverse reaction
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female who on 18-OCT-2007, was vaccinated with a dose of GARDASIL (possible lot#'s 0523U, 1425F, 0515U) that was improperly stored reaching 32 degrees F on 4 occasions 10/02/2007, 10/03/2007, 10/09/2007 and 10/11/2007. No problems were reported. It was unknown whether medical attention was sought. There was no product quality complaint. This is one of several reports from the same source.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Medication error, No adverse reaction
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old female who on 18-OCT-2007, was vaccinated with a dose of Gardasil (possible lot#'s 0523U, 1425F, 0515U) that was improperly stored reaching 32 degrees F on 4 occasions 10/02/2007, 10/03/2007, 10/09/2007 and 10/11/2007. No problems were reported. It was unknown whether medical attention was sought. There was no product quality complaint. This is one of several reports from the same source.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Medication error, No adverse reaction
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female who on 18-OCT-2007, was vaccinated with a dose of Gardasil (possible lot #'s 0523U, 1425F, 0515U) that was improperly stored reaching 32 degrees F on 4 occasions 10/02/2007, 10/03/2007, 10/09/2007 and 10/11/2007.  No problems were reported.  It was unknown whether medical attention was sought.  There was no product quality complaint.  This is one of several reports from the same source.