chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Areflexia, Dyskinesia, Malaise, Neurological examination, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a physician concerning a 13 year old female patient who was vaccinated with the third dose of GARDASIL vaccine (lot# was not available) on unspecified date and played a "vigorous volleyball" using the same arm where she received the vaccine the following day after receiving the vaccine. There was no concomitant medication. The physician reported that on 06-NOV-2008 the patient experienced "serious malaise after vaccination" and on 17-NOV-2008, the patient brought to the hospital and was admitted for a "couple of days", Lab diagnostics Studies Performed included neurological tests when the patient was in the hospital including MRI. The patient sought medical attention through the physician. At the time of report the patient was recovering. Additional information has been requested.  2/23/09 MR received for DOS 11/15-xxxx with  DX:  S1 distribution sensory neuropathy.  Lower extremity weakness and altered sensation. No D/C information available.  Pt presented with 1 wk hx of weakness and fatigue. Had local reaction to recent HPV vax 11/6/08 with fever.  Pt describes heaviness of extremities and difficulty lifting them. Low grade temp with mild intermittant H/As, numbess in foot and toes and low back pain.  Seen by outpt neurologist and found to be areflexic. Instucted to go to ER with worsening sx.  Presented for eval following an episode of dyspnea which self-resolved.  Neuro exam (+) for loss of sensation on the back and decreased in extremities. DTRs and strength WNL. Abdominal reflexes absent.  Admitting DX:  S1 sensory neuropathy.  LE weakness and altered sensation.  2/26/09 Neurology consult received dated 11/14/08 with DX: Generalized weakness with depressed ankle jerks.  S/P Vaccination.  R/O GBS despite normal NCS/EMG. PE (+) for decreased strength, depressed reflexes in upper extremities and ankles, normal sensation.  Instructed to go to ER for further progression of sx which pt did.  This is in follow-up to report (s) previously submitted on 1/16/2009. Follow up information received on 23-FEB-2009 stated that the patient with no medical history or allergies, reeived the third dose of GARDASIL vaccine (lot # 661768/0652X) into the left deltoid on 06-NOV-2008 at 10:00. The patient experienced severe fatigue, malaise and feeling of weakness. The patient was admitted on a hospital and was hospitalized foe 2 days. Laboratory diagnostic studies included unspecified laboratory procedures and a magnetic resonance image (MRI). It was also reported that per neurology Guillain Barre Syndrome was excluded. The patient gradially recovered on 26-NOV-2008. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Facial palsy
Clinical narrative: Information has been received from a healthcare worker concerning a 20 year old female patient with no pertinent medical history and with allergic reaction to CECLOR who on 28APR-2008 was vaccinated with the first dose of GARDASIL (lot# 655604/0052X), on 30-JUN-2008 was vaccinated with the second dose of GARDASIL (lot# 0152X) and on 10-Nov-2008 she received third dose of GARDASIL (lot# 0250X). Concomitant therapy included YAZ. It was reported that the patient was diagnosed with Bell's palsy after receiving the third dose of GARDASIL. It was reported that the patient had not recovered at the time of the report. The patient sought medical attention with a different physician. Follow up information was received on 15-DEC-2008 from a medical assistant who stated that the patient went to the emergency room. Follow up information was received on 15-DEC-2008 from the medical assistant who stated that on 10-DEC-2008 went to the emergency room and diagnosed Bell's palsy by the physician. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Folliculitis, Injection site rash, Rash
Clinical narrative: Information has been received from a physician concerning a 20 year old female who on 12-DEC-2008 was vaccinated with a second dose of GARDASIL vaccine. Subsequently, the patient developed a rash at injection site. As of approximately 18-DEC-2008, the patient's rash had spread to her face. No reactions were reported after the first dose was given. The patient contacted the physician for medical attention. At the time of this report, 18-DEC-2008, the events persisted. Additional information has been requested. Follow-up information from the physician indicated that the patient was diagnosed with follculitis and her rash was not related to her prior GARDASIL shot. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old female with no medical history of allergies, who on 09-DEC-2008 was vaccinated with a 0.5 mL first dose  of GARDASIL vaccine, intramuscularly. There was no concomitant medication. On 17-DEC-2008 the patient developed widespread achiness and joint pain. The patient consulted her unspecified pediatrician but no treatment was prescribed. There were no laboratory diagnostics studies performed. The patient had not recovered. The sought unspecified medical attention. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 1/15/2009.  Information has been received from a nurse practitioner concerning a 16 year old female with no medical history and allergies, who on 09-DEC-2008 was vaccinated with a 0.5 mL first dose of GARDASIL, intramuscularly.  There was no concomitant medication.  On 17-DEC-2008 the patient developed widespread achiness and joint pain.  The patient consulted her unspecified pediatrician but no treatment was prescribed.  There were no laboratory diagnostics studies performed.  The patient had not recovered.  The patient sought unspecified medical attention.  No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning a 21 year old female with a penicillin allergy and no medical history who on 14-OCT-2008 was vaccinated with a 0.5 mL first dose of GARDASIL (lot # 661046/0546X), intramuscularly in the deltoid.  There was no concomitant medication.  After received the vaccine the patient experienced a rash on her back that lasted for 2.5 weeks.  There were no laboratory studies performed.  Follow up information received on 18-DEC-2008 at 13:00 stated that "the patient was actually in the office about to get the second of GARDASIL and reported that after the first dose she developed a welt in the area of the bra strap at the cup part of the bra". Follow up information received on 16_JAN-2009 stated that the patient complained of a wheal within 2 to 3 hours after her second dose of Gardisil. The rash area was only by her bra strap scan. A third dose of Gardisil was given and the patient had no reaction at all. Her problem was likely related to the garment and not Gardisil.  Additional information indicated the patient's rash had nothing to do with the vaccine. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Underdose
Clinical narrative: Information has been received from a healthcare worker concerning an 18 year old female with no medical history and allergies, who on 18-JUN-2008 was vaccinated with a first dose of GARDASIL.  There was no concomitant medication.  On 18-DEC-2008 the patient received a partial dose of GARDASIL (lot # 661530/0575X), intramuscularly, the patient pulled away saying "ouch, ouch, ouch."  She did not get another dose yet.  The outcome is unknown.  The outcome is unknown.  The patient sought medical attention through an office visit.  Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: No adverse event, Off label use
Clinical narrative: Information has been received from a physician concerning a male patient who on approximately 03-DEC-2008 was vaccinated with 1 dose of GARDASIL vaccine and was referred to his primary physician for completion of the series. No adverse effects were reported.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Fatigue, Pain in extremity, Swelling
Clinical narrative: Information has been received from a 16 year old female patient with no drug reactions/allergies, who on 09-DEC-2008 was vaccinated with the first dose of GARDASIL.  There was no concomitant medication.  On 15-DEC-2008 the patient experienced joint pain, swelling fatigue and pain in her legs.  The patient spoke to the physician,  At the time of reporting, the patient had not recovered.  Additional information has been requested.2/5/09-records received-12/9/08 received 1st Gardasil injection in left deltoid. No C/O illness or fever. Parent on 12/23/08 stated child might have mono.2/4/09 called MD office C/O possible reaction to vaccine, seen by pediatrician with C/O joint pain, fatigue, pain and swelling of legs.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Muscle spasms, Myalgia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female patient with idiopathic thrombocytopenia and no drug reactions/allergies, who on 29-MAY-2008 was vaccinated intramuscularly on her arm with the first 0.5 mL dose of GARDASIL vaccine. On the same day the patient experienced severe muscle pain and spasm in her back and buttocks. There was no concomitant medication. On 28-JUL-2008 was vaccinated intramuscularly on her arm with the second 0.5 mL dose of GARDASIL vaccine and experienced severe muscle pain and spasm in her back and buttocks several hours later. All symptoms resolved within few days after the vaccination. The patient did not seek medical attention. The patient had not received the third dose. Additional information has been requested. Follow up information received from a registered nurse on 26-JAN-2009. It was reported that the 19 year old female patient with idiopathic thrombocytopenia diagnosed since age 2, no problem within childhood or adolescence, no current problems now, on 28-JUL-2008 was vaccinated intramuscularly into the right deltoid with the second 0.5 mL dose of GARDASIL (Lot # 659184/0843X) at approximately 16:00. The patient reported that on 07-AUG-2008 she developed "waves" of sharp muscle spasms in back, buttocks, upper thighs and side of buttocks. The patient stated it started within a few days to a week from injection. The patient described the pains in her muscles as bad, very painful, when it first happened, but they would become less severe as time went on. The patient saw family physician and was given muscle relaxers, and it helped some. The duration of symptoms lasted on approximately off for a month or so. On approximately 28-AUG-2008, the patient recovered. The patient states she had the same symptoms after the first injection on 29-MAY-2008, but did not put it together that it was from vaccine until she received the second injection and symptoms repeated themselves. She was doing OK at this time, but declined to receive the third dose of GARDASIL. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Endoscopy, Headache, Influenza like illness, Nausea
Clinical narrative: Information has been received from a physician concerning a 20 year old female patient who on 17-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine intramuscularly. Concomitant therapy included hormonal contraceptives (unspecified). On 17-JUN-2008 the patient experienced flu like symptoms, fever, stomach ache, stomach pain, nausea, vomiting and headache, she lost 23 pounds after receiving the vaccine. The patient's symptoms went away and came back after the second dose GARDASIL vaccine intramuscularly. The patient's flu like symptoms, fever, stomach pain, nausea, vomiting, headache and weight loss persisted. On unspecified date the patient had an Endoscopy done (results not provided). Additional information has been requested. This is in follow-up to report (s) previously submitted on 1/16/2009. Follow up information has been received for a licensed practical nurse concerning a 20 year old female patient who on 17-Jun-2008 was vaccinated intramusculary with the first 0.5 ml dose of GARDASIL. The nurse is reporting that physician advised the patient not to get the third injection of GARDASIL. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Vaccine positive rechallenge, Vomiting, Weight decreased
Clinical narrative: Information has been received from a physician concerning a 20 year old female patient who on 17-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine intramuscularly. Concomitant therapy included hormonal contraceptives (unspecified). On 17-JUN-2008 the patient experienced flu like symptoms, fever, stomach ache, stomach pain, nausea, vomiting and headache, she lost 23 pounds after receiving the vaccine. The patient's symptoms went away and came back after the second dose GARDASIL vaccine intramuscularly. The patient's flu like symptoms, fever, stomach pain, nausea, vomiting, headache and weight loss persisted. On unspecified date the patient had an Endoscopy done (results not provided). Additional information has been requested. This is in follow-up to report (s) previously submitted on 1/16/2009. Follow up information has been received for a licensed practical nurse concerning a 20 year old female patient who on 17-Jun-2008 was vaccinated intramusculary with the first 0.5 ml dose of GARDASIL. The nurse is reporting that physician advised the patient not to get the third injection of GARDASIL. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dysmenorrhoea, Menorrhagia
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient who on 14-AUG-2008 was vaccinated with the first dose of GARDASIL (lot# 660612/0229X) 0.5 ml intramuscularly.  After receiving the first dose patient experienced bad cramps and heavy bleeding during her menstrual period.  Patient sought unspecified medical attention.  Patient informed physician about this experience when she came back to receive her second dose of GARDASIL 24-NOV-2008.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Colposcopy abnormal, Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: Information has been received from a physician concerning an 18 year old female patient who on 6-DEC-2007 was vaccinated with the first dose of GARDASIL (lot # not provided). On 09-APR-2008 the patient received the second dose of GARDASIL (lot # not provided). A colposcopy done approximately on 3-DEC-2008, "2 weeks ago", showed the patient was high risk HPV. Possible exposure to HPV through her boyfriend. Patient went to the doctor's office. At the time of the report the patient had not yet recovered. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Arthralgia, Fatigue, Headache
Clinical narrative: Information has been received from an office manager at the physician's office, concerning a female patient, who was vaccinated with first, second and third doses of GARDASIL (dose, route, lot # not reported).  The office manager reported that the patient completed her GARDASIL vaccination series a couple of months ago and started experiencing hip pain and headaches.  At the time of the report, the patient had not recovered.  Follow up information was received from the Registered Nurse on 23-DEC-2008 which reported: The patient was vaccinated with three doses of GARDASIL on 19-SEP-2007, 29-NOV-2007 and 03-APR-2008 respectively.  The patient experienced hip pain, headaches, and stomach pain and that were all still ongoing.  The patient also experienced fatigue but that has resolved.  Follow up information has been received from a Registered Nurse on 30-DEC-2008 which reported that the lot number that was administered was: 660387/19670.  The patient was administered the vaccine at her pediatrician's office.  The patient was also administered varicella virus vaccine live (Oka/Merck) (MSD) and hepatitis B virus vaccine rHBsAg (yeast) (MSD) on the same day the patient received her third dose of GARDASIL.  Additional information has been requested. 2/4/09-records received-presented on 11/17/08 with C/O run down, tired. 11/24/08 still very fatigued, dizzzy, occasional. 12/16/08 C/O headache. Possibility treated by another physician prior to presenting on 11/17/08.  2/23/09-records received-office visit 1/20/09-C/O headache, neck in pain for past 3 months. Holter monitor supraventricular ectopic beats noted. 12/30/08 increasing headaces.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Information has been received from a medical assistant concerning a 23 year old female with no medical history, allergies or drug reactions who on 11-JAN-2007 was vaccinated with the first dose of GARDASIL vaccine (lot no. 658488/1264U) 0.5 ml, IM. Concomitant therapy included hormonal contraceptives (unspecified). On an unknown date,  the patient experienced nausea, vomiting and light headedness after getting the first dose of the vaccine.  Subsequently, the patient recovered from nausea, vomiting and light headiness. No laboratory test was performed. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed, Urine human chorionic gonadotropin negative, Vaginitis bacterial
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female patient with seasonal allergy and no known pertinent medical history who on 17-SEP-2008 was vaccinated with first dose of GARDASIL (Lot # 659184/0843X) 0.5ml, intramuscularly. The patient's last menstrual period was 10-NOV-2008. The patient was in the office to received the second dose of GARDASIL and she mentioned she was 10 days late getting her period. The second dose of GARDASIL was not given to the patient. Although the patient's urine HCG test was negative the physician instructed the patient to wait 1 or 2 days to see if she gets her period. If the patient does not get her period she was instructed to call the office to arrange for blood test for pregnancy. On 17-DEC-2008 the patient was treated with Clindesse for bacterial vaginosis. At the time of report on 17-DEC-2008 the patient was not recovered. Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/16/2009. Follow up information has been received on 09-JAN-2009 from a Registered Nurse who reported that the patient was never received GARDASIL. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4, UNK
Symptoms: Chest pain, Pain in extremity
Clinical narrative: Information has been received from a nurse concerning a 129 year old female patient who was vaccinated with the first dose of GARDASIL vaccine (no lot # provided) intramuscularly. "Patient received two other unspecified vaccines in her opposite arm". Subsequently the patient experienced pain underneath her arm and into her chest. Subsequently, the patient recovered from pain underneath arm and pain into her chest. patient sought unspecified medical attention. At the time of the report the patient's symptoms had resolved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient with no known drug reactions or allergies, who in 2008, "a few weeks ago", was vaccinated wit the first and only dose of GARDASIL (no lot # provided).  There was no concomitant medication.  On the same day of the vaccination the patient passed out.  Patient saw the physician.  No lab diagnostic studies were performed.  The patient recovered after a few minutes.  No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning an adolescent female patient who on an unspecified date, was vaccinated with GARDASIL vaccine. The physician reported that the patient experienced injection site pain. The outcome is unknown. This is one of several cases from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Blister, Injection site pain
Clinical narrative: Information has been received from a physician concerning an adolescent female patient who on an unspecified date, was vaccinated with GARDASIL. The physician reported that the patient experienced injection site pain and blisters under eye. the outcome is unknown.  Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal chest pain, Nausea, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 26 year old female who on 25-SEP-2008 was vaccinated with a first dose of GARDISIL vaccine. After the first dose of GARDASIL vaccine she felt pain in the muscles around her chest but they resolved in three days. Concomitant therapy included vitamins (unspecified) and OMEGA-3. On 18-dec-2008 the patient received a second dose of GARDASIL vaccine and later that day called the nurses and stated that she experienced slight nausea, pain in her left arm and pain in the muscles around the chest not her heart. The nurse also reported that she advised the patient after she told her the experience with the second dose to seek further medical attention, but the patient said she would not since it happened with the first dose and it resolved. The nurse at this time is unsure if the patient had recovered. The patient sought medical attention through a call to the nurse. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: Information has been received from a physician concerning a 21 year old female patient with no pertinent medical history and no drug reactions/allergies, who in approximately October 2008, a few months ago (exact date unspecified) was vaccinated with an initial dose of GARDASIL vaccine. There was no concomitant medication. Since receiving the GARDASIL vaccine, coincidently the patient had not had her period the past 2 months. The patient was not pregnant and not in a relationship. The patient had no underlying medical conditions that would explain this as she exercised regularly but not to excess, she was thin but not underweight, and she did not have a medical issue such as PCOS (polycystic ovary syndrome). She had an upcoming appointment with her gynecologist. No other symptoms were present. As of 22-DEC-2008, the patient's outcome was unknown.  Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Behcet's syndrome
Clinical narrative: This is in follow-up to report (s) previously submitted on 1/16/2009. Information has been received from a physician concerning a patient who on an unknown date was vaccinated with a dose of GARDASIL, (site, route and lot no. not reported). The patient experienced bipolar aphthosis. This is one of several reports from the same source. Additional information has been requested. Follow up information was received from the physician was reported that she did not give the vaccine and that she has no information about the shots. This is one of several reports from the same source. No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Hypoaesthesia, Paraesthesia
Clinical narrative: Information has been received from a medical assistant and a physician concerning a 25 year old female patient who in approximately September 2008, was vaccinated with her second dose of GARDASIL (Lot not provided).  Following the vaccination the patient experienced tingling from her elbow to her pinky intermittently (off and on for several months).  As of 19-DEC-2008 the patient's symptoms persisted.  Additional information has been requested. Follow up information received from the physician concerning the female patient (weight 173 pounds, height 68 inches) who in July 2008, was vaccinated with the second dose of GARDASIL (lot # 660387/1967U). In July 2008, the patient experienced numbness in injection arm, joint pain in elbow and joint pain in knuckles and tingling from her elbow to her pinky. As of December 2008 the patient recovered. Additional information is ot expected,
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Hypersensitivity, Injection site swelling, Local swelling, Oedema peripheral, Swelling face
Clinical narrative: Information has been received from a registered nurse concerning of her 22 year old daughter with no known allergies and a history of contact dermatitis who on 15-DEC-2008 was vaccinated with the first dose of GARDASIL (Lot not reported). Concomitant therapy included hormonal contraceptives (unspecified). On 19-DEC-2009 the patient developed what appears to be an allergic reaction. The patient developed swelling of her injection arm that had progressed up her arm to her neck and face. The patient took Benadryl and Hidroxyzine (Unspecified) (left over from a recent bout of contact dermatitis that "got out of hand"). As of 19-DEC-2008 the patient had not recovered. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: This is in follow-up to report (s) previously submitted on 1/16/2009. Information has been received from a registered nurse concerning a 12 year old female patient with no known allergies and sickle cell anemia who 10-JUL-2008 was vaccinated with first dose of GARDASIL. On 18-DEC-2008 the patient was vaccinated with 0.5ml of her second dose of GARDASIL (lot# 66174/0650X) intramuscularly. Concomitant therapy included influenza virus vaccine and pneumococcal 23v polysaccharide vaccine. On the same day, 18-DEC-2008, the patient developed painful local injection site reaction after vaccination. The reaction consisted of warm, tender and swelling around two inches at the injection site. The patient went to the emergency room and later relased. As of 19-DEC-2008, the patient was recovering.Additional information has been requested. Follow up information has been received from a health professional concerning a 12 year old female patient who at the time of vaccination had bilateral otitis media who on 18-DEC-2008 was vaccinated 0.5 ml of her second dose of GARDASIL (Lot # 661764/0650X) intramuscularly. concomtiant vaccines administered on 18-DEC-2008 included FLUZONE (Lot# U2840AA) and PNEUMONVAX 23 (lot # 0090U). On 18-DEC-2008 the patient developed severe pain on left arm, warthm and swelling at the injection site (Size left upper arm 9.5 inches, right upper arm 7.5 inches). The patient was prescribed with oral BENADRYL at the ER. The patient recovered two or three days later on approximately 20-DEC-2008. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Otitis media
Clinical narrative: This is in follow-up to report (s) previously submitted on 1/16/2009. Information has been received from a registered nurse concerning a 12 year old female patient with no known allergies and sickle cell anemia who 10-JUL-2008 was vaccinated with first dose of GARDASIL. On 18-DEC-2008 the patient was vaccinated with 0.5ml of her second dose of GARDASIL (lot# 66174/0650X) intramuscularly. Concomitant therapy included influenza virus vaccine and pneumococcal 23v polysaccharide vaccine. On the same day, 18-DEC-2008, the patient developed painful local injection site reaction after vaccination. The reaction consisted of warm, tender and swelling around two inches at the injection site. The patient went to the emergency room and later relased. As of 19-DEC-2008, the patient was recovering.Additional information has been requested. Follow up information has been received from a health professional concerning a 12 year old female patient who at the time of vaccination had bilateral otitis media who on 18-DEC-2008 was vaccinated 0.5 ml of her second dose of GARDASIL (Lot # 661764/0650X) intramuscularly. concomtiant vaccines administered on 18-DEC-2008 included FLUZONE (Lot# U2840AA) and PNEUMONVAX 23 (lot # 0090U). On 18-DEC-2008 the patient developed severe pain on left arm, warthm and swelling at the injection site (Size left upper arm 9.5 inches, right upper arm 7.5 inches). The patient was prescribed with oral BENADRYL at the ER. The patient recovered two or three days later on approximately 20-DEC-2008. No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Pain, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning her 23 year old daughter who "about one month ago" was vaccinated with the first dose of GARDASIL. After receiving the vaccine the patient developed shooting and burning pain in the arm the injection was given down to fingertips. At the time of reporting it is unknown if the patient recovered. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, CSF test, Electroencephalogram, Hallucination, auditory, Hallucination, visual
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient with no pertinent medical history, no drug reactions/allergies; who on 17-JUL-2008 was vaccinated with the second dose of GARDASIL. There was no concomitant medication. On 05-SEP-2008, about 5 weeks after vaccination, the patient developed hallucinations, both visual and auditory. The patient had also had syncope. The patient was seen in the office and was treated with KEPPRA with no effect. In the beginning of December 2008, the patient had recovered.  Follow up information has been received from a physician on 20-FEB-2009. It was reported that the 15 year old female patient had hallucinations. On approximately February 2009 the patient had recovered.Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Nuclear magnetic resonance imaging, Syncope
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient with no pertinent medical history, no drug reactions/allergies; who on 17-JUL-2008 was vaccinated with the second dose of GARDASIL. There was no concomitant medication. On 05-SEP-2008, about 5 weeks after vaccination, the patient developed hallucinations, both visual and auditory. The patient had also had syncope. The patient was seen in the office and was treated with KEPPRA with no effect. In the beginning of December 2008, the patient had recovered.  Follow up information has been received from a physician on 20-FEB-2009. It was reported that the 15 year old female patient had hallucinations. On approximately February 2009 the patient had recovered.Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration, Injection site pain, Nodule
Clinical narrative: Information has been received from a physician concerning a 25 year old female with no pertinent medical history or allergies who on 21-NOV-2008 was vaccinated intramuscularly in her right deltoid with 0.5 ml third dose of GARDASIL (lot # 660557/0072X). Concomitant therapy included an unspecified birth control medication. On 21-NOV-2008 the patient developed an induration "about the size of a dime" at the injection site of the right deltoid muscle. The area was painful to touch, The physician added that the patient had a similar knot near her vagina. The patient contacted the office via phone. No laboratory or diagnostics test were performed. At the time of this report, as 18-DEC-2008, the events persisted. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Asthma, Fall, Hypotension, Skin laceration, Syncope
Clinical narrative: Information has been received from a licensed practical nurse concerning a 11 year old female patient with no drug/reactions allergies, who on 17-DEC-2008 was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL (Lot # 660555/0279X).  Concomitant therapy included HAVRIX and MENACTRA.  The patient fainted and fell about 5 minutes after receiving GARDASIL vaccine causing a laceration on her chin.  The patient came to immediately.  It was not known what the patient hit when she fainted.  The patient's blood pressure was low.  It took about 30-45 minutes until her blood pressure and color returned to normal.  The patient received stitches for the laceration in an emergency room.  At the time of reporting, the patient was recovering.  Additional information has been requested. Follow up information was received from the nurse via medical record which reported that the patient had asthma. It was reported that the patient was vaccinated with the first dose of GARDASIL (LOT # 660555/0279X) IM, in her left deltoid at 16:10 PM. Concomitant therapy included the second dose of HAVRIX (lot no. AHAVB147AA) given at 4:12 PM in her left deltoid, MENACTRA (lot no. U2632AA) given IM at 4:11 PM in her right deltoid and albuterol (unspecified) taken occasionally. It  was reported that patient fainted at 16:30 and revealed a chin laceration that was cleaned and bandaged. Blood pressure was 78/58 and 102/68 and the patient was give juice and snacks and was under observaction for 40 minutes. The patient was sent to Emergency room for stiches. A physical examination was performed in the ER which was normal. THe patient did not remember the fainting spell. THere was no headache, no  head injury, no sore throat, no cough, and no urinary symptoms. The patient had no illness at the time of vaccination. On 24-DEC-2008, the stiches were removed and the patient subsequently recovered. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia
Clinical narrative: Information has been received from a physician concerning a 14-15 year old female.  On an unknown date, the patient was vaccinated with her first dose of GARDASIL 0.5ml (route and site not reported).  After vaccination, the patient experienced a pain in her hip.  The pain went away and then the patient received her second dose of GARDASIL and the pain in her hip reappeared.  Patient went to physical therapy however she did decline to receive the third dose.  No lot number was provided.  The patient recovered from pain in her hip.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Fungal infection, Injection site pruritus, Injection site rash, Injection site swelling, Rash erythematous
Clinical narrative: Information has been received from a physician concerning an 18 year old female who on 14-AUG-2008 was vaccinated with a second dose of GARDASIL (lot #660393/0067X) in the left arm. "The patient developed a rash at the injection site shortly after receiving the vaccine. The rash was itchy and swollen and continued to spread into fungal infection. The rash was described as a papular erythemic rash". The patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Rash papular
Clinical narrative: Information has been received from a physician concerning an 18 year old female who on 14-AUG-2008 was vaccinated with a second dose of GARDASIL (lot #660393/0067X) in the left arm. "The patient developed a rash at the injection site shortly after receiving the vaccine. The rash was itchy and swollen and continued to spread into fungal infection. The rash was described as a papular erythemic rash". The patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient with no pertinent medical history who in the end of October 2008 was vaccinated with the second dose of GARDASIL vaccine. There was no concomitant medication. The physician reported that patient has been having temporal headaches on right side of her head since 3 days after receiving the HPV vaccine. A computed axial tomography or magnetic resonance
Age: 0.6
Sex: M
Vaccine: HPV4
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a patient's mother concerning her 7 month old son who was vaccinated with a dose of GARDASIL instead of the flu vaccine by mistake. No adverse event reported as a result. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Weight decreased
Clinical narrative: Information has been received from a registered nurse and the patient's mother concerning a 14 year old female patient with no allergies and no pertinent medical history who on 23-MAR-2007 was vaccinated with the first dose of GARDASIL (date also reported as 22-MAR-2007 by the patient's mother), on 23-MAY-2007 the patient received the second dose of GARDASIL the patient's mother reported that in approximately may 2007, the patient experienced severe hair loss. On 24-SEP-2007, the patient was vaccinated with the third dose of GARDASIL. Concomitant therapy included vitamins (unspecified). In July 2008, the patient came into the doctor's office and stated that her hair started to fall out and she had had dramatic weight loss (onset date not reported). The nurse reported that the patient was going to have various test done. As of 30-DEC-2008, the patient had not recovered. Additional information has been requested.  2/9/09 PCP records received. 2/6/08 WCC with Impression:  Well Teenager.  (Some records illegible) Seen 3/27/08 for bradycardia.   OV 4/24/08 with c/o sore throat and H/A.  Throat hyperemic on PE.  Imp: Pharyngitis.  OV 7/7/08 with c/o losing hair x 1 month, facial hair x 1 month, irregular periods with R sided pain, R foot lump, lump on coccyx, and significant weight loss (169 in 2/08 to 146). Sent for labs. Returned 12/31/08 for f/u of hair loss. No dx noted.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner concerning an 18 year old female patient who on 10-OCT-2008 was vaccinated with first dose of GARDASIL  (Lot # number not reported) 0.5ml, intramuscularly in deltoid. On 10-DEC-2008 she received second dose of GARDASIL (lot # number not reported) 0.5ml, intramuscularly in deltoid. After the patient received the vaccine she developed pain at the injection site which radiates down her arm. The pain has impaired mobility and the pain has persisted for the past 19 days. There were not laboratory diagnostics performed. At the time on the report on 29-DEC-2008 the patient was not recovered. The patient sought medical attention in the office. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy, Rash
Clinical narrative: Information has been received from a nurse practitioner concerning a 22 year old female patient with hypothyroidism and no know allergies who on 07-AUG-2008 was vaccinated with the first dose of GARDASIL. On 08-OCT-2008 the patient was vaccinated with 0.5 ml of her second dose of GARDASIL intramuscularly. Concomitant therapy included "thyroid medication". On 08-OCT-2008 the patient developed unilateral rash on the left side of her neck along with inflamed lymph nodes. The rash disappeared 3 weeks later, on approximately 29-OCT-2008. The rash re-occurred on the same area (2008) and again lasted for 3 weeks (recovered , 2008). The patient had not received the third dose. On an unspecified date the patient recovered (2008). Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy test positive, Rash, Rash
Clinical narrative: Information has been received from a medical assistant concerning a 19 year old female patient for the pregnancy Registry for GARDASIL with no known allergies and a history of papanicolaou smear abnormal who on 08-DEC-2008 was vaccinated with 0.5 ml of the first dose of GARDASIL (Lot: 658563/1063U) intramuscularly. There was no concomitant medication. On 09-DEC-2008, the patient broke out in a rash on the chest and both shoulders. The patient's rash disappeared on an unspecified date in December 2008. The patient was seen by the doctor on 29-DEC-2008 and there was no terrace of the rash.  The patient found out that she was pregnant on 23-DEC-2008. The gestation was on to two weeks.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/16/2009. Follow-up information has been received on 22-JAN-2009 from a completed pregnancy questionnaire by a physician, concerning a 19 year old female patient who on 08-DEC-2008 was vaccinated with 0.5 ml of the first dose of GARDASIL (Lot: 658563/1063U) intramuscularly, subsequently, on 23-DEC-2008 the patient found out she was pregnant (The LMP: 07-NOV-2008, EDD: 14-AUG-2009). Additional information expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram normal, Lymphadenopathy, Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received from a medical assistant concerning a 19 year old female patient with no pertinent medical history and a history of an allergic reaction to Amoxil (reaction unspecified), who on 13-JUN-2008 was vaccinated with her first dose of GARDASIL (Lot: 659962/1740U). On 13-AUG-2008 received the second dose of GARDASIL (Lot: 660393/0067X) and 19-DEC-2008 received the third dose of GARDASIL (Lot: 660393/0067X). On 27-NOV-2008 the patient developed swollen lymph nodes on her neck. The patient sought medical attention with her primary physician. MRI and CT scan were negative. As of 29-DEC-2008 the patient's symptoms persisted. Additional information has been requested.  2/5/09 Received GYN vaccine & medical records of 6/13-12/29/2008. FINAL DX: lymphadenopathy Records reveal patient experienced good health on 6/13 1st HPV.  Received call form parent 12/29 about painful neck lymphadenopathy since week of Thanksgiving.  Had seen PCP & tx w/antibiotics.  Improved initially but then recurred.  Had been referred to ENT who had CT/MRI done which revealed benign lymph nodes.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Disturbance in attention, Dizziness, Lymphadenopathy, Malaise
Clinical narrative: Information has been received from a physician concerning a 23 year old female patient with depression, who on an unspecified date, was vaccinated with the first dose of GARDASIL and on approximately 29-NOV-2008 was vaccinated with GARDASIL.  Concomitant therapy included TRAZODONE HC1, CLONAZEPAM, METHYLPHENIDATE and YASMIN.  The physician reported that the patient reported feeling weak, dizzy, tremulous over her entire body and her subclavian lymph node was enlarged on the same side where the vaccine was received.  The physician reported that the patient experienced the same reaction after both doses of the GARDASIL vaccine.  The symptoms were more severe after her 2nd dose.  Exact dates of vaccinations were not available.  It was 4 four weeks post dose 2 and patient still did not "feel herself".  The patient reported she still felt weak and is unable to concentrate.  At the time of the report, the patient had not recovered.  The patient sought medical attention and was seen at the physician's office.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Tremor
Clinical narrative: Information has been received from a physician concerning a 23 year old female patient with depression, who on an unspecified date, was vaccinated with the first dose of GARDASIL and on approximately 29-NOV-2008 was vaccinated with GARDASIL.  Concomitant therapy included TRAZODONE HC1, CLONAZEPAM, METHYLPHENIDATE and YASMIN.  The physician reported that the patient reported feeling weak, dizzy, tremulous over her entire body and her subclavian lymph node was enlarged on the same side where the vaccine was received.  The physician reported that the patient experienced the same reaction after both doses of the GARDASIL vaccine.  The symptoms were more severe after her 2nd dose.  Exact dates of vaccinations were not available.  It was 4 four weeks post dose 2 and patient still did not "feel herself".  The patient reported she still felt weak and is unable to concentrate.  At the time of the report, the patient had not recovered.  The patient sought medical attention and was seen at the physician's office.  Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Injection site irritation
Clinical narrative: Information has been received from a healthcare worker concerning that "many patients complained of burning at the injection site whey they get a dose of GARDASIL vaccine. Follow up information received on 30-DEC-2008 stated that the healthcare worker did not know the names of the other patients. Attempts are being made to obtain additional identifying information to distinguish the individual patients. This one of two  reports from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old female with asthma and no allergies who was vaccinated with the the third dose of GARDASIL (lot # 659182/1757U) on 23-DEC-2008. Concomitant therapy included ALBUTEROL and fluticasone propionate (+) ADVAIR. After the patient received GARDASIL and 5 minutes later she fainted. The patient recovered from faint on 23-DEC-2008. The patient was seen in the office for medical attention. Attempts to obtain more information had been failed. No further information was available.
Sex: U
Vaccine: HPV4
Symptoms: Sexually transmitted disease
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with GARDASIL (dose, site and route not reported) on unspecified date. The patient tested positive for a sexually transmitted disease after received the vaccine. At the time of reporting the outcome was unknown. No further information is available.