chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling hot, Palpitations, Paraesthesia oral, Sensory disturbance
Clinical narrative: Information has been received from a 25 year old female nurse with no drug allergies who in June 2010 and August 2010, was vaccinated IM with the first and the second dose of GARDASIL (lot # not reported). On 08-DEC-2010 her third dose of GARDASIL was given subcutaneously (lot # not reported). Concomitant therapy included vitamins (unspecified) and TRI-SPRINTEC. 30 minutes later (on 08-DEC-2010) the patient felt warm, with a "strange sensation in her left arm, tingling in her mouth and palpitations but on the right side of her chest". All symptoms had since resolved (on 08-DEC-2010). The patient did not seek medical attention. No treatment was given for the events. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: FLUX, HPV4, MNQ, TDAP
Symptoms: Drug exposure during pregnancy, Normal newborn, Premature delivery, Premature rupture of membranes, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a licensed practical nurse for the pregnancy registry for GARDASIL concerning an 18 year old female with no pertinent medical history and no known drug allergies, who on 20-JAN-2009 and 20-MAR-2009 was vaccinated with first dose (dose and route not reported, lot number 661703/0651X) and second dose (dose and route not reported, lot number 661766/0652X) respectively of GARDASIL. The licensed practical nurse reported that the patient was three to four months pregnant when she received the first dose of GARDASIL. The reporter stated "pregnancy is normal to date". Lab test performed included urine pregnancy test. The patient was seen in the office. Follow up information has been received from a licensed practical nurse concerning the patient with a history of varicella and no known drug allergies, who on 20-JAN-2009 was vaccinated intramuscularly (IM) in the left deltoid with first dose of GARDASIL (dose not reported, lot number 661703/0651X). Concomitant therapy included ADACEL (lot number C773AA), MENACTRA (lot number U2734AA) and EMERFLU (lot number U2840AA). Subsequently on 20-MAR-2009, the patient was vaccinated IM with second dose of GARDASIL (lot number 661766/0652X). The licensed practical nurse stated that patient's LMP varied per visit so it cannot be estimated. She suggested contacting the patient's obstetrician to obtain the estimated LMP. Follow up information was received from a health professional which reported that on an unspecified date at 34 weeks of gestation, the patient delivered a normal infant with no congenital anomalies due to premature rupture of membranes. The baby's experienced is captured in WAES 0904USA00268B1. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning a female patient with no pertinent medical history or drug reactions or allergies, who on an unspecified date was vaccinated with the first 0.5 ml dose of GARDASIL (Lot # and route not reported) and on 06-JAN-2011 was vaccinated with the second dose of GARDASIL (Lot # and route not reported). There was no concomitant medication. The physician reported that the patient complained of pain at the injection site after receiving the first dose. The pain lasted approximately two weeks and each day the pain diminished. When the patient received the second dose reported that the pain level was minimal. The physician reported that on 06-JAN-2011 the patient had recovered. No laboratory tests were performed. The patient sought unspecified medical attention. No further information is available.
Age: 42.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Maternal exposure during pregnancy, No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 42 year old female with asthma, glucose intolerance, elevated blood sugar and allergic reaction to Quinolone antibiotics who on 06-JAN-2011 was inadvertently intramuscularly vaccinated with a first 0.5ml dose of GARDASIL (Lot #: 1560Z, expiration date: 28-APR-2013), a Pregnancy Registry Product. At that time, the patient stated her last menstrual period was 17-NOV-2010. Concomitant therapy included PULMICORT, RHINOCORT, VENTOLIN and BENADRYL. The patient was in the office for a routine OB/GYN visit for her pregnancy, and she was supposed to receive the flu vaccine. However, GARDASIL was administered by another physician instead. No adverse effects reported. The patient sought an unspecified medical attention. Blood tests were performed but no results reported. The patient's last menstrual period was reported as 17-NOV-2010. The estimated delivery date would be 24-AUG-2011. Follow up information was obtained stating that this was a case of wrong product grabbing off the shelf by mistake. There was no product confusion involved. Additional information is not expected.
Sex: F
Vaccine: FLUX, HPV4, MNQ, TDAP
Symptoms: Drug exposure during pregnancy, Premature delivery, Premature rupture of membranes
Clinical narrative: Information has been received from a licensed practical nurse concerning a newborn infant whose 18 year old mother with a history of varicella who on 20-JAN-2009 was vaccinated intramuscularly (IM) in the left deltoid with first dose of GARDASIL (dose not reported, lot number 661703/0651X). Concomitant therapy included ADACEL (lot number C773AA), MENACTRA (lot number U2734AA) and EMERFLU (lot number U2840AA). Subsequently on 20-MAR-2009, the patient was vaccinated IM with second dose of GARDASIL (lot number 661766/0652X). It was reported that on an unspecified date at 34 weeks of gestation, the patient delivered a normal infant with no congenital anomalies due to premature rupture of membranes. The mother's experience is captured in WAES 0904USA00268. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Maternal exposure during pregnancy, Nausea, Normal newborn, Pregnancy test positive, Vomiting
Clinical narrative: Information has been received from a consumer concerning her 19 year old daughter, for GARDASIL, a pregnancy Registry product, who with no pertinent medical history and drug reactions/allergies in November 2008, was vaccinated with the first dose of GARDASIL. In January 2009 the patient was vaccinated with the second dose of GARDASIL. There were no concomitant medication. The patient sought unspecified medical attention. In January 2009 (about 12 weeks ago), the patient performed a pregnancy test which showed pregnant. The patient's LMP (last menstrual period) was 05-JAN-2009 and her EDD was 12-OCT-2009. Follow-up information was received on 15-SEP-2010. The mother of the patient reported that her daughter's pregnancy was complicated only by "lots of nausea- she had hyperemesis". The patient was not hospitalized, but she was treated (not specified). She had a normal vaginal birth on 26-SEP-2009, 37 weeks from her last menstrual period, and delivered a boy who was healthy and normal. The boy was a year old and was "just fine" at the time of reporting. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Muscular weakness, Neck pain
Clinical narrative: Information has been received from a physician assistant concerning a 25 year old female patient with penicillin allergy, no pertinent medical history, who on 27-OCT-2009, was vaccinated IM with the first 0.5 ml dose of GARDASIL (Lot#: 0040Z). On 31-JUL-2010, the patient was vaccinated in the left deltoid with the second dose of GARDASIL (Lot#: not reported). There was no concomitant medication. No lab diagnostics studies were performed. The physician assistant stated that on 01-AUG-2010, the day after the patient received her second of GARDASIL, the patient developed muscle weakness of the left arm. The patient also complained of neck pain. Since the patient lives one hour away from the office, the physician assistant directed the patient to report to a local emergency room if the symptoms got worse. The patient contacted the physician assistant by phone. At the time of the report, the patient's muscle weakness of the left arm and neck pain persisted. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 27-SEP-2006 was vaccinated with the first dose of GARDASIL (Lot #, dose and route not reported). On 06-FEB-2007, the patient returned to the physician's office and was vaccinated with the second dose of GARDASIL (Lot #, dose and route not reported). Follow-up information has been received from the physician who stated the case was a pediatric patient who, received GARDASIL (Lot #, dose and route not reported) and then reported back on an unspecified date "a few weeks later" with several vague complaints. At the time of the report, the patient's outcome was unknown. No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Information has been received from a Registered nurse (R.N.) concerning a 22 year old female with no drug reactions or allergies who on 30-JUN-2010 was vaccinated with a dose of GARDASIL (Lot number 663659/1178Y) (route not reported). The nurse stated that the patient received GARDASIL and had pain at the injection site. The pain improved after a few days and then returned, became tender and progressed until patient complained that the arm was hard to lift. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Arthralgia, Complex regional pain syndrome, Erythema, Full blood count, Joint swelling
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient with no pertinent medical history and no drug reactions/allergies who on 28-JUL-2010, was vaccinated IM in the right deltoid with the first 0.5 ml dose of GARDASIL (Lot#: 663559/1178Y). Concomitant therapy included Tdap in the right upper arm given on the same day at a separate location. The physician reported that on 29-JUL-2010, one day after the administration of her first dose of GARDASIL the patient developed redness, swelling and discomfort of the right hand. The symptoms worsened to include exquisite pain in the right fingertips and palm and the patient was evaluated at local emergency room. A sedimentation rate test was performed, the result was normal and the patient was prescribed a 4 day course of unspecified steroid medication. The patient was then evaluated by an unspecified orthopedist. On an unspecified date, the symptoms initially improved but returned when the course of steroids was completed. On 02-AUG-2010, the patient was seen in the office, the physician ordered a complete blood count, sedimentation rate, and rheumatoid factor. The results were pending. At the time of the report, the patient had not recovered. Follow-up information has been received from a physician concerning the 12 year old female patient with no pre-existing conditions, no birth defects and no medical conditions who on 28-JUL-2010 was vaccinated into the right arm with a dose of GARDASIL (Lot#: 663559/1178Y). Concomitant therapy included vaccination into the right arm with a dose of BOOSTRIX (Lot# AC52B05DA) and into the left arm with a dose of MENACTRA (Lot# U3697AV) both on 28-JUL-2010. No illness at time of vaccination. In the morning of 29-JUL-2010, when the patient woke up, she experienced pain, swelling of right distal arm-wrist, fingertips, palm. Tingling. Redness of fingertips. Orthopedic physician diagnosed Reflex sympathetic dystrophy. The patient's outcome was unknown. A magnetic resonance imaging (MRI) and a X-ray were performed on an unspecified date (no results provided). No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Nuclear magnetic resonance imaging, Oedema peripheral, Pain in extremity, Paraesthesia, Red blood cell sedimentation rate normal
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient with no pertinent medical history and no drug reactions/allergies who on 28-JUL-2010, was vaccinated IM in the right deltoid with the first 0.5 ml dose of GARDASIL (Lot#: 663559/1178Y). Concomitant therapy included Tdap in the right upper arm given on the same day at a separate location. The physician reported that on 29-JUL-2010, one day after the administration of her first dose of GARDASIL the patient developed redness, swelling and discomfort of the right hand. The symptoms worsened to include exquisite pain in the right fingertips and palm and the patient was evaluated at local emergency room. A sedimentation rate test was performed, the result was normal and the patient was prescribed a 4 day course of unspecified steroid medication. The patient was then evaluated by an unspecified orthopedist. On an unspecified date, the symptoms initially improved but returned when the course of steroids was completed. On 02-AUG-2010, the patient was seen in the office, the physician ordered a complete blood count, sedimentation rate, and rheumatoid factor. The results were pending. At the time of the report, the patient had not recovered. Follow-up information has been received from a physician concerning the 12 year old female patient with no pre-existing conditions, no birth defects and no medical conditions who on 28-JUL-2010 was vaccinated into the right arm with a dose of GARDASIL (Lot#: 663559/1178Y). Concomitant therapy included vaccination into the right arm with a dose of BOOSTRIX (Lot# AC52B05DA) and into the left arm with a dose of MENACTRA (Lot# U3697AV) both on 28-JUL-2010. No illness at time of vaccination. In the morning of 29-JUL-2010, when the patient woke up, she experienced pain, swelling of right distal arm-wrist, fingertips, palm. Tingling. Redness of fingertips. Orthopedic physician diagnosed Reflex sympathetic dystrophy. The patient's outcome was unknown. A magnetic resonance imaging (MRI) and a X-ray were performed on an unspecified date (no results provided). No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Rheumatoid factor, X-ray
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient with no pertinent medical history and no drug reactions/allergies who on 28-JUL-2010, was vaccinated IM in the right deltoid with the first 0.5 ml dose of GARDASIL (Lot#: 663559/1178Y). Concomitant therapy included Tdap in the right upper arm given on the same day at a separate location. The physician reported that on 29-JUL-2010, one day after the administration of her first dose of GARDASIL the patient developed redness, swelling and discomfort of the right hand. The symptoms worsened to include exquisite pain in the right fingertips and palm and the patient was evaluated at local emergency room. A sedimentation rate test was performed, the result was normal and the patient was prescribed a 4 day course of unspecified steroid medication. The patient was then evaluated by an unspecified orthopedist. On an unspecified date, the symptoms initially improved but returned when the course of steroids was completed. On 02-AUG-2010, the patient was seen in the office, the physician ordered a complete blood count, sedimentation rate, and rheumatoid factor. The results were pending. At the time of the report, the patient had not recovered. Follow-up information has been received from a physician concerning the 12 year old female patient with no pre-existing conditions, no birth defects and no medical conditions who on 28-JUL-2010 was vaccinated into the right arm with a dose of GARDASIL (Lot#: 663559/1178Y). Concomitant therapy included vaccination into the right arm with a dose of BOOSTRIX (Lot# AC52B05DA) and into the left arm with a dose of MENACTRA (Lot# U3697AV) both on 28-JUL-2010. No illness at time of vaccination. In the morning of 29-JUL-2010, when the patient woke up, she experienced pain, swelling of right distal arm-wrist, fingertips, palm. Tingling. Redness of fingertips. Orthopedic physician diagnosed Reflex sympathetic dystrophy. The patient's outcome was unknown. A magnetic resonance imaging (MRI) and a X-ray were performed on an unspecified date (no results provided). No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site nodule, Injection site pain
Clinical narrative: Information has been received from a health professional concerning an 18 year old female with allergy to CECLOR who on 21-MAY-2010 was vaccinated with the first dose of GARDASIL 0.5ml IM into the right deltoid and on 16-JUL-2010 received the second dose of GARDASIL 0.5ml IM into the right deltoid. Concomitant therapy included LOESTRIN. The nurse reported that on approximately 16-JUL-2010, after the administration of her second dose, the patient developed a "tender knot" at the injection site of the right deltoid. The patient contacted the office by phone on 03-AUG-2010 and was suggested to use warm compresses. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Body temperature, Dizziness, Headache, Oropharyngeal pain
Clinical narrative: Information has been received from a consumer concerning her 16 year old son with no drug allergies and no medical history who on 30-JUL-2010 was vaccinated with the first dose of GARDASIL (lot # not reported). On 10-FEB-2011 the patient was vaccinated with the second dose of 0.5 ml GARDASIL (lot # not reported). Concomitant therapy included TYLENOL and MOTRIN. On 10-FEB-2010 while taking GARDASIL, the patient experienced headache, sore throat, ran a temperature and was dizzy. No treatment was given to the patient. Lab diagnostics studies were not performed. Vaccination with GARDASIL continued. At the time of reporting, the patient did not recover from the adverse events. The patient did not seek medical attention. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4, TDAP, TTOX
Symptoms: Pain
Clinical narrative: Information has been received from a 25 year old female nurse who on an unspecified date was vaccinated with a dose GARDASIL (lot #, number of prior dose, injection route and site not provided). Concomitant vaccination included tetanus toxoid and Tdap on the same day. The nurse mentioned that she experienced pain when she was administered GARDASIL. Outcome of the event was not reported. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 15 year old female who was vaccinated with a dose of GARDASIL on an unspecified date. Concomitant therapy included MENACTRA, (manufacturer unspecified) and Tdap (manufacturer unspecified). On an unspecified date, the patient experienced syncope. There were no labs or diagnostic tests performed. The patient received unspecified medical attention. The patient recovered from syncope on an unspecified date. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea, Pain
Clinical narrative: Information has been received from a physician concerning a 13 year old female patient who on unspecified date was vaccinated with the second dose of GARDASIL (lot number not provided). On an unspecified date, "after receiving her second GARDASIL dose ", the patient developed shooting pain, nausea and dizziness a few days after getting the GARDASIL. At the time of this report, the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram, Hypoaesthesia, Migraine, Vaccine positive rechallenge
Clinical narrative: Information has been received from physician assistant concerning a 16 year old female patient who on unspecified date was vaccinated with 0.5 ml 3 doses of GARDASIL (lot#'s not reported). The three shots were given over the course of the year. Concomitant therapy included DEPO-PROVERA at the time of the first dose. That medication was discontinued before the second dose was given. The patient was taking an unspecified birth control medication at the time of the second dose and that was discontinued before the third shot. The patient was not taking other medication at the time of the third dose. It was reported that about a week after each dose of GARDASIL, the patient complained of severe migraine and numbness in her right arm. The patient was sent to the emergency room and was told she had complex migraines. The patient was not admitted to the hospital. The adverse event went away after a couple hours and there were no residual symptoms. The patient had not had any migraines since the one after the third shot. Each time "the numbness in her arm was the aura before the migraine, and both the numbness and the migraines resolved within a couple hours". The patient had a CT scan performed (results not provided) and was treated with a standard migraine medication. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 22 year old female, who on an unspecified date was vaccinated with the first 0.5ml dose of GARDASIL (Lot # unknown) and at the end of March was vaccinated with the second 0.5 ml dose. The nurse reported that the patient developed a rash at the injection side as well as a high fever. She reported that the symptoms resolved on their own with no immediate medical attention. The patient did not seek medical attention. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a consumer concerning her 14 year old daughter who on 29-JUL-2010, was vaccinated with a dose of GARDASIL. There was no concomitant medication. It was reported that on 29-JUL-2010, 20 minutes after receiving GARDASIL, the patient fainted. The patient recovered five minutes after fainting. Follow-up information has been received from a consumer concerning her daughter with no known drugs reactions or allergies and no illness at the time of vaccination who on 29-JUL-2010, was vaccinated with a first dose of GARDASIL (Lot number 662559/1178Y) into her right deltoid. On 29-JUL-2010 she fainted in car after shot. On 29-JUL-2010 she recovered from fainted. The patient did not seek medical attention. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a Licensed Practical Nurse (L.P.N) concerning a 17 year old female with allergy to CECLOR with no pertinent medical history, who on 03-SEP-2009 was vaccinated with a first does of GARDASIL (Lot number not reported), IM. There was no concomitant medication. On 27-JUL-2010, the patient received the second IM dose of GARDASIL (Lot number 666121/0597Z) (Expiration date: 13-AUG-2012) and on 30-JUL-2010 "several days after receiving the second dose" she fainted. No laboratory studies were performed. On 30-JUL-2010 the patient had recovered from fainted. The patient sought unspecified medical attention. Follow up information has been received from the Licensed Practical Nurse who reported that the patient's grandmother stated that on 30-JUL-2010 three days after vaccination, the patient had a fainting spell. It was reported that the patient recovered consciousness quickly. The Licensed Practical Nurse stated that the grandmother's patient did not take the patient to the doctor. The Licensed Practical Nurse advised and reinforce her to take the patient to evaluation. The patient did not seek medical attention. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Folliculitis, Pain of skin, Rash pruritic
Clinical narrative: Information has been received from a nurse concerning a 17 year old female patient who on 19-JUL-2010 was vaccinated IM with the first ml dose of GARDASIL (lot # 665266/1378Y, exp date 09-JUL-2010). Concomitant therapy included LOESTRIN FE 1/20. The nurse reported that 4 days later, on 23-JUL-2010 the patient developed a hive type rash on the scalp which was painful and itchy. On 28-JUL-2010 the patient went to an unspecified primary care physician and was diagnosed with folliculitis. The patient was put on KEFLEX and hydrocortisone cream. The patient still had "bumps" but not as much. At the time of the report, the patient was recovering and had scheduled an appointment with the Primary care physician. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 22 year old female patient with no pertinent medical history and no allergies who on 27-JUL-2010 was vaccinated intramuscularly with the first dose of GARDASIL (lot # 666118/1539Y). There was no concomitant medication. Subsequently, the patient developed an injection site reaction. The patient developed pain and swelling at the site than continued to persist. Unspecified medical attention was sought via phone call. There were no laboratory diagnostics studies performed. The patient's pain at the site and swelling at the injection site persisted. Additional information has been received from the registered nurse indicated the reaction was "0.25 cm area of edema at injection site" and the symptoms were resolving. The patient was fine. Follow up information has been received from the registered nurse concerning the 22 year old female patient with no pre-existing allergies, birth defects or medical conditions who on 27-JUL-2010 was vaccinated IM in the left deltoid with the first dose of GARDASIL (lot number 666118/1539Y). On 27-JUL-2010 the patient experienced swelling, redness and pain at injection site. Follow up information has been received from the registered nurse indicated that the patient recovered within one week of symptoms. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a concerning a female patient who on 07-JAN-2011 was vaccinated subcutaneously with a first dose of GARDASIL (lot # not provided). No adverse effect was reported. It was unknown if the patient sought medical attention. At the time of reporting, the patient's status was not provided. Follow-up information received by the licensed visiting nurse indicated that the patient was a 20 year old female student with no known allergies and no illness at time of vaccination, who on 07-JAN-2011 11:10 AM was vaccinated subcutaneously on left upper arm with a first dose of GARDASIL (lot # 666118/1539Y). In the afternoon of 07-JAN-2011, the patient experienced sore arm at injection site which lasted for approximately 48 hours. No lab diagnostic studies were performed. At the time of reporting, the patient had recovered. The recovery date was reported as 07-JAN-2011. It was reported that the patient did not require emergency room/doctor visit. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Chest pain, Dizziness, Headache, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 22 year old female patient with no pertinent medical history and no allergies who on 02-AUG-2010, "yesterday", was vaccinated with the second 0.5 ml dose of GARDASIL IM into her left arm (lot # 666929/0331Z). There was no concomitant medication. On 03-AUG-2010, the patient called the doctor office to state that she experienced fever, headache, chest pain, dizziness and felt weak. Treatment was oral BENADRYL. No lab diagnostics studies were performed. At the time of reporting, the patient's fever, headache, chest pain, dizziness and felt weak persisted. The patient sought unspecified medical attention. Follow up information was received from the licensed practical nurse who reported that on 02-AUG-2010, the patient with no known drug allergies and no illness in for routine exam at time of vaccination experienced headache, "temperature", chest pain, dizziness and weakness. On 04-AUG-2010, the patient recovered from these adverse events. The patient did not seek medical attention. Additional information is not expected.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Blood creatine phosphokinase normal, Computerised tomogram abnormal, Full blood count normal, Gynaecomastia, Muscle swelling
Clinical narrative: Information has been received from a physician concerning a 16 year old male who on 18-OCT-2010 was vaccinated with the first dose of GARDASIL, 0.5ml, IM, unspecified arm. There was no concomitant medication, medical history, drug reactions or allergies. On 21-DEC-2010 the patient was seen at the office with right side gynecomastia, and right side swelling and tenderness of muscles in the chest and back. On the same date, 21-DEC-2010 the second dose of GARDASIL was administered in the left arm. At the time of report, the patient's symptoms were persisting; he was treated with ibuprofen as needed. Physician states many laboratory tests performed such as CBC, Chest CT, CPK, and all with normal results except for gynecomastia. Follow up information has been received from the physician and stated that after further examination, the patient was provisionally diagnosed of gynaecomastia. He referred to endocrinologist from whom he had not received consult report. Additional information is not expected.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Myalgia
Clinical narrative: Information has been received from a physician concerning a 16 year old male who on 18-OCT-2010 was vaccinated with the first dose of GARDASIL, 0.5ml, IM, unspecified arm. There was no concomitant medication, medical history, drug reactions or allergies. On 21-DEC-2010 the patient was seen at the office with right side gynecomastia, and right side swelling and tenderness of muscles in the chest and back. On the same date, 21-DEC-2010 the second dose of GARDASIL was administered in the left arm. At the time of report, the patient's symptoms were persisting; he was treated with ibuprofen as needed. Physician states many laboratory tests performed such as CBC, Chest CT, CPK, and all with normal results except for gynecomastia. Follow up information has been received from the physician and stated that after further examination, the patient was provisionally diagnosed of gynaecomastia. He referred to endocrinologist from whom he had not received consult report. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure increased, Cyanosis, Hypoaesthesia, Peripheral coldness
Clinical narrative: Information has been received from a nurse concerning a female who on an unknown date, was vaccinated with a dose of GARDASIL. Subsequently the patient's injection site arm became very cold to touch. The patient went to the doctor's office to seek medical attention. At the time of this time, the outcome was unknown. Follow up information has been received from the registered nurse concerning the 11 year old female patient with sore throat at time of vaccination and no pre-existing allergies, birth defects and medical conditions who on 20-JAN-2010 at 12:36 was vaccinated in the deltoid with the first dose of GARDASIL (lot number 662529/1317Y). On 20-JAN-2010 at 13:30 the patient came back to office after immunization complaining of coldness in extremity. Patient's arm had darken bluish color and blood pressure was elevated. Patient also had numbness. Patient was examined by a physician and sent home and instructed to call for worsening symptoms. There was no lab diagnostic test performed. The patient recovered on 20-JAN-2010. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Expired drug administered, Vaccination site pain
Clinical narrative: Information has been received from a consumer concerning her 21 year old daughter with no known drug allergies and no medical history who on 10-JAN-2011 was vaccinated with her first dose of GARDASIL which was expired (lot # and expiration date unknown) at a health center. There was no concomitant medication. The patient felt faint after receiving the vaccine and the vaccination was painful. The patient was in observation. Lab diagnostics studies were not performed. The patient had sought unspecified medical attention. At the time of reporting, the outcome was unknown. No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: Information has been received from a nurse practitioner concerning a 22 year old female who in approximately 2006, "3 or 4 years ago" complete the series of 3 dose GARDASIL (therapy dose, route and site unknown) at her pediatrician's office. "Recently", in "a last month" (in July 2010) the patient had been tested positive for oncogenic type of HPV infection (pap came back ASCUS). The patient sought unspecified medical attention. At the time of this report, the patient's outcome was unknown. Follow up information has been received from the nurse practitioner. The nurse reported that the patient did not have a PAP with an ASCUS result, but had a "swab for sexually transmitted disease (STD)" only. The result of that test was positive for high risk HPV (type unspecified). The nurse also stated that the patient was a virgin when she completed the vaccine series. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a female who on 06-JAN-2011 was vaccinated IM (also reported as submuscularly) with a 0.5 ml dose of GARDASIL (lot # not provided). "In the past few days", the patient experienced swelling, redness and pain at injection site for GARDASIL. Therapy with GARDASIL was reported as not to be reintroduced. Patient did not seek medical attention. At the time of reporting, patient's status was not provided. Follow-up information was received and it was reported that the patient had recovered by the time of reporting. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Migraine, Vomiting
Clinical narrative: Information has been received from an office medical assistant concerning an approximately 14 year old female who "sometime last year 2009", in 2009, was vaccinated with a first dose of GARDASIL (lot # not reported). It was reported that the patient after receiving the first dose of series of GARDASIL, sometime last year 2009, the patient experienced migraines, dizziness and vomiting for two days and then they went away. The patient sought unspecified medical attention. The AEs improved on therapy. On an unspecified date the patient recovered. The patient was not going to receive second or third dose of GARDASIL. Follow up information was received from office medical assistant who was told by the patient's mother concerning this 13 year old (previously reported as approximately 14 year old) female with no illness at the time of the vaccination and no known drug allergies who on 17-DEC-2008 (previously reported as sometime last year 2009) was vaccinated with a dose of GARDASIL at another office. After the vaccination was given the following 24 hours, on approximately 18-DEC-2008, the patient had vomiting, dizziness and bad migraines. At the time of the report, the patient recovered from the symptoms. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: Information has been received from a medical assistant concerning an 11 year old female with allergy to penicillin and sulfa who on 06-JUL-2010, was vaccinated with a 0.5 ml IM dose of GARDASIL. On 06-JUL-2010, five minutes post injection, the patient experienced feeling lightheaded, nauseous and faint. The patient was seen by the physician who instructed her to lie down and after ten minutes the patient was released to home. The patient stated she felt better. On 06-JUL-2010, the patient recovered from feeling lightheaded, nauseous and faint. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: Information has been received from a nurse concerning an around 14 or 15 year old female patient who a few month ago, on an unspecified date was vaccinated with a second dose of GARDASIL (Lot # unknown). The nurse reported that after the patient received the second dose of GARDASIL started experiencing syncope episodes that persisted for a few months. According to the nurse, the patient was still experiencing dizziness and lightheadedness. The outcome of the syncopes is unclear. At the time of the report, the patient had not recovered from dizziness and lightheadedness. The patient sought unspecified medical attention. This is one of several reports received from the same source. No further information is available.
Age: 13.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Axillary mass, Axillary pain, Lymphadenopathy, Swelling, Tenderness
Clinical narrative: Information has been received from a nurse concerning a 13 year old male who on 03-AUG-2010 was vaccinated with GARDASIL (lot # not reported) on her left arm and MENACTRA on unspecified arm. On 06-AUG-2010 the patient's parent called into the office and stated that sometime after receiving GARDASIL on 03-AUG-2010 the patient experienced swelling of the lymph node under her left and right arms, but there was more swelling under the left arm than the right arm. Unspecified medical attention was sought. At the time of the report, the outcome of the event was unknown. Follow-up information has been received from a certified medical assistant (previously reported as a nurse) concerning a 13 year old male with no illness and pre-existing medical conditions who on 03-AUG-2010 was vaccinated IM in the left deltoid with the first dose of GARDASIL (lot # 666929/0331Z) and IM in the left deltoid with the first dose of MENACTRA. On 04-AUG-2010, the patient developed pain in both in axilla post receiving vaccine. Pain was developed approximately 24 hours post injection. Noted 3 "quarter sized" swollen, tender lumps under left arm approximated 48 hours post vaccine. Pain and swelling improved over following 2 days and were gone by 07-AUG-2010. No fever, fatigue, rash, headache. There were no diagnostic tests performed. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Smear cervix
Clinical narrative: Information has been received from a nurse practitioner (N.P.) concerning a current 29 year old female patient who "5 years ago" when she was approximately 24 year old was given GARDASIL series to treat the patient for genital warts. Nurse practitioner reported that genital warts had returned in approximately June 2010 "a couple of weeks ago". The patient sought unspecified medical attention. Pap smear was performed with no results provided. At the time of the report, the patient had not recovered from genital warts. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Hypoaesthesia, Muscle twitching
Clinical narrative: Information has been received from a consumer concerning her 14 year old daughter who on 28-JUN-2010 was vaccinated with the third dose of GARDASIL (lot number unknown). The consumer reported that on 28-JUN-2010 her daughter had experienced headache, numb sensation in her fingers and twitching after receiving her third dose of GARDASIL. The patient sought unspecified medical attention. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: FLU3, HPV4, VARCEL
Symptoms: Loss of consciousness, Tonic clonic movements
Clinical narrative: Initial and follow up information has been received from a physician assistant concerning a 10 year old female patient with no concurrent conditions and medical history who on 12-JAN-2011 was vaccinated with the first dose of GARDASIL (lot #662404/0312Y) in the left arm, secondary suspected therapy included a dose of VARIVAX (lot #666817/0002Z) in the right arm. Concomitant therapy included a dose of FLUZONE, also in the right arm. On 12-JAN-2011 the patient experienced passed out and tonic clonic movements, subsequently recovered within 5-10 seconds after the episode. It was unknown if the patient sought medical attention. There did not seem to be any environmental factors involved, and patient had eaten. The physician assistant could not confirm if patient had a seizure. No treated required. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a nurse concerning a female who on an unspecified date was vaccinated IM with a first 0.5 ml dose of GARDASIL (lot # not provided). Subsequently the patient experienced "breaking out in hives" after receiving her first dose of GARDASIL. The healthcare professionals said they had decided not to continue the series of treatment for the patient. The patient sought unspecified medical attention. At the time of reporting, the patient's status was not provided. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a female patient who in November 2007, an unspecified date and in July 2008 were vaccinated with the first, second and third 0.5 ml doses of GARDASIL intramuscularly respectively. The patient had received all 3 doses of GARDASIL, afterwards, on an unspecified date, she had an abnormal pap smear and tested for oncogenic HPV. She also experienced High grade cervical dysplasia. The patient sought unspecified medical attention and had unspecified treatment. At the time of the report the patient's status was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Musculoskeletal pain
Clinical narrative: Information has been received from a physician concerning a patient who "2 months ago" (approximately on 06-NOV-2010) was vaccinated with GARDASIL and developed a sore shoulder following the vaccination in approximately November 2010 (reported as about 2 months ago). When the information was reporting, the patient recovered from sore shoulder. It was unknown if the patient sought medical attention. No further information was available.
Sex: F
Vaccine: HPV4
Symptoms: Chronic fatigue syndrome, Infectious mononucleosis
Clinical narrative: This report was received from Lilly and was assigned manufacturer report number US201011004024. A female patient was vaccinated with a dose of GARDASIL (Lot # not provided) on an unspecified date. It was reported that the patient was diagnosed with mononucleosis twice after taking the dose of GARDASIL and also diagnosed with chronic fatigue syndrome. At the time of this report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. This was originally reported by a lawyer. This is one of several reports received from the same source. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Loss of consciousness, Open wound
Clinical narrative: Information has been received from a physician concerning an 18 year old female who in December 2010 (within the last 2 weeks), was vaccinated with her second dose of 0.5ml GARDASIL (route, lot# not reported). The patient fell forward off the exam table 30-60 seconds after receiving the injection, and she lacerated her left eyebrow. The patient was taken to the Emergency Room (ER) by her mother and received 17 stitches. The patient was unconscious for 10-15 seconds after falling off of the table. At the time of report, the patient was recovering and her mother had already scheduled her third injection of GARDASIL. Follow up information has been received from a company representative concerning an 18 year old female who was vaccinated with her second dose of 0.5ml GARDASIL (route, lot# not reported) and fell and split her head open (initially reported as lacerated her left eyebrow). No further information was provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Lyme disease
Clinical narrative: Information has been received from a healthcare worker concerning a female patient who on unspecified dates was vaccinated with a first and second dose of GARDASIL (doses, routes and Lots# not reported). The healthcare worker stated that after received GARDASIL doses, on unspecified date the patient had to be treated for lyme disease (medication unknown). At the time of the report the patient's outcome was unknown. The patient sought medical attention by office visit. Follow-up information was received from the healthcare worker who reported that the patient was awaiting the third dose of GARDASIL and the patient was diagnosed with lyme disease before the third dose of GARDASIL was "administered". There were no adverse reaction after GARDASIL. The healthcare worker stated that they were just concerned as to any data that might be able to lacking . The healthcare worker reported that an immunization was given as a treatment for lyme disease. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a female who on unspecified dates several year ago, was vaccinated with the first, second and third dose of GARDASIL (lot# not reported), 0.5 ml suspension, intramuscularly, respectively at 0, 2 months, 6 months. The doctor reported that the patient recently had a pap smear that showed positive for human papillomavirus type 17 (HPV16). At the time of reporting, the patient was not recovered from the event. The patient was not given treatment for the event. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site dermatitis, Injection site erythema, Injection site rash
Clinical narrative: Information has been received from a physician concerning a 20 year old female patient (also reported as "21 year old" by the physician) with unspecified pre-existing dermatological conditions, who on 10-JAN-2011 was vaccinated with a first 0.5 ml dose of GARDASIL (Lot # not provided) IM. The physician reported that on 10-JAN-2011 the patient experienced a red spot at the injection site and dermatitis. The patient did not seek medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 24 year old female who on an unspecified date was vaccinated IM with the third dose of 0.5ml GARDASIL vaccine (Lot # not reported). On 20-DEC-2010, the patient experienced a "sore arm and it was hurting for about 3 weeks". No treatment was given. The patient did not seek medical attention. Follow-up information was received from the physician who stated that the patient has not had an adverse reaction to GARDASIL. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Clostridial infection
Clinical narrative: Information has been received from a registered nurse concerning a female who had been vaccinated with 2 doses of GARDASIL (Lot# of both doses not reported). It was reported that the patient developed clostridium difficile prior to receiving her third dose of GARDASIL. The patient was being treated for clostridium difficile. The patient sought unspecified medical attention. The nurse also mentioned that the first course of antibiotics (manufacturer unknown) did not work for the patient (MSD, WAES1101USA01980), so the patient was on her second course of antibiotics. Additional information has been requested.