chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Rash, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse concerning a female patient with no medical history who on 13-APR-2009 and 20-JUL-2009 was vaccinated with her first and second 0.5ml dose of GARDASIL (lot # not provided) respectively. The patient developed a rash on her hands, foot and mouth after getting the first and second dose of vaccination. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Nervous system disorder
Clinical narrative: Information has been received from a physician concerning a female patient who on an unknown date was vaccinated intramuscularly with 0.5 mL of GARDASIL (Lot # was not provided and dose in series was not reported). Subsequently, six months after vaccination, the patient had neurological problems not specified. The physician did not believe the neurological problems were related to GARDASIL. A neurologist who examined the patient after the neurological problems started also said the neurological problems were not related to GARDASIL. The reporter contacted during the telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination/therapy, dose number, lot number, date of event, recovery status. The health care professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination/therapy, dose number, lot number, date of event, recovery status, hospital name. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Information has been received from a certified medical assistant concerning a female patient who on 19-AUG-2009 experienced syncope after receiving a dose of GARDASIL. Unspecified medical attention had been sought. On 19-AUG-2009 the patient had recovered. Follow up information was received from a licensed practical nurse concerning the 20 year old female patient with no illness at the time of vaccination and no pre-existing allergies, birth defects or medical conditions who on 19-AUG-2009 at 11:36 was vaccinated with the first dose of GARDASIL on left arm (lot # 663452/0671Y). Patient passed out after injection was given. Patient stated "this happens all the time with injections". Patient did not eat before she came in for the vaccine. Patient was placed on the bed to lie down and then felt better. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse midwife concerning an 18 year old female patient with no pertinent medical history who approximately in "mid-June", was vaccinated with the first dose of GARDASIL (lot number not reported). On 17-AUG-2009 the patient was vaccinated with the second 0.5 ml dose of GARDASIL (lot number 660618/0572X). There was no concomitant medication. The patient fainted after receiving the second dose of vaccine and recovered a few minutes later. Unspecified medical attention was sought. It was unknown if there were lab studies performed. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache
Clinical narrative: Information has been received from a physician concerning a 17 year old female who was vaccinated with the third dose of GARDASIL on an unspecified date. On 22-MAY-2008 after receiving her third dose the patient had been experiencing headaches. The patient had sought medical attention, saw physician. At the time of report the patient's status was unknown. In follow-up, the physician indicated that on 21-NOV-2007, 22-JAN-2008 and 22-MAY-2008, the 17 year old patient was vaccinated IM with the first dose (Lot# 659055/1522U, left arm), the second dose (lot# 659657/1487U, right arm) and the third dose (lot# 659964/1978U, left arm) of GARDASIL. On 01-JUN-2008, the patient experienced dizzy and headaches. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MEN, VARCEL
Symptoms: Headache, Nausea, Syncope
Clinical narrative: Information has been received from a physician's office staff concerning an approximately 17 year old female who on approximately 05-AUG-2009 (two weeks ago) was vaccinated with her second dose of GARDASIL (Lot # was not provided). Concomitant vaccine therapy included VARIVAX (Merck) and meningococcal vaccine (unspecified) (manufacturers unknown). On approximately 07-AUG-2009 (two days after receiving her second dose) the patient experienced headache and nausea. On 18-AUG-2009 the patient fainted and went to the emergency room but it was unknown if she was admitted to the hospital. The patient's headache and nausea and fainted persisted. The outcome of the events was unknown. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy, Malaise
Clinical narrative: Information has been received from a registered nurse concerning her daughter, a 22 year old female patient who in approximately 2008 (reported as approximately a year and half ago) was vaccinated with the first dose of GARDASIL (lot number, route and site not reported). The nurse reported that the patient was not a patient at the office she worked at. In approximately 2008 (reported as approximately a year and half ago), the patient experienced swelling of the lymph nodes on the left side of her neck and she did not feel really well. Then the patient received the second dose of GARDASIL and after receiving the second dose of GARDASIL, the lymph nodes on her left side of her neck got bigger and were the size of a golf ball. The patient had seen physician to seek medical attention. The nurse reported that the patient has now recovered and was not going to receive the third dose of GARDASIL. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Infectious mononucleosis, Tachycardia
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (lot # was not reported). The physician reported that after receiving the vaccine the patient then experienced tachycardia which was later diagnosed as "mono". The patient sought unspecified medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pain, Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old female who in July 2008 was vaccinated with the first dose of GARDASIL (dose, route, and lot# not reported). The patient experienced vomiting, nausea and body aches after administration of her first dose of GARDASIL. The patient sought unspecified medical attention. No lab diagnostics study was performed. On unspecified date, the patient recovered. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Injection site urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning a 24 year old female patient with no pertinent medical history and no drug reactions/allergies who on 18-AUG-2009 was vaccinated with a first 0.5ml dose of GARDASIL (lot#663454/0672Y) intramuscularly in her right arm. Concomitant therapy included DEPO-PROVERA. On approximately 18-AUG-2009, the patient became dizzy and lightheaded, then developed "hives" on her right arm at the injection site after receiving her first dose of GARDASIL. The patient had sought medical attention by phone call. No laboratory diagnostics study was performed. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Mouth ulceration, Vulval ulceration
Clinical narrative: Information has been received from a physician who reported that a dentist mentioned to him a female patient on an unspecified date was vaccinated with a dose of GARDASIL. On an unspecified date after vaccination the patient had mouth and vulva ulcerations. The outcome was not reported. It was unspecified if the patient sought medical attention. This is one of two reports from the same source. Attempts to verify the existence of an identifiable patient have been unsuccessful. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Antinuclear antibody positive, Arthralgia, Arthritis reactive, Autoimmune disorder, Blood test abnormal
Clinical narrative: Information has been received from a nurse concerning her daughter, a 19 year old female patient with no past medical history or allergies who on 06-SEP-2006 was vaccinated with the first dose of GARDASIL (lot number, route and site not reported). The patient was not taking any medications prior to GARDASIL. The patient received the remaining two doses "at the appropriate scheduled times." About one month after receiving the first dose of GARDASIL, the patient developed pain in her ankle and had difficulty ambulating up and down stairs. She was seen by the family physician who diagnosed her with tendonitis. One month and a half after the first dose, the patient was seen by an orthopedic surgeon and underwent blood tests and a MRI. The nurse stated that the "blood work was erratic for a healthy teenager" and the ANA results were positive. The patient was then referred to rheumatologist, which she was still seeing. The patient was diagnosed with an autoimmune disease and reactive arthritis in her hip, knee and ankle. She was placed on therapies with PLAQUENIL, Vitamins, Fish oil, tramadol, and ibuprofen. The nurse reported that the patient was also seen by a urologist since "she was spilling protein in her urine due to the ibuprofen". The ibuprofen was discontinued. The patient saw an eye specialist every three months to evaluate for possible visual side effects that may occur with the PLAQUENIL and tramadol (no visual side effects reported at this time). The nurse reported that the patient did not require any hospitalization or life saving measures due to this reaction. This reaction was not related to a cancer or an overdose. The nurse stated "This is something that she is going to have for the rest of her life." At the time of the report, the patient did not recover. The health care professional contacted during telephone follow-up could not supply the following information: date of birth, dates of vaccination/therapy, dose number (if applicable), lot number (if applicable), date of event, recovery status, hospital name (if applicable), healthcare provider contact information. Follow up information has been received from a receptionist of a doctor's office who reported that the patient is an 18 year old female (previously reported as 19 year old). Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Gait disturbance
Clinical narrative: Information has been received from a nurse concerning her daughter, a 19 year old female patient with no past medical history or allergies who on 06-SEP-2006 was vaccinated with the first dose of GARDASIL (lot number, route and site not reported). The patient was not taking any medications prior to GARDASIL. The patient received the remaining two doses "at the appropriate scheduled times." About one month after receiving the first dose of GARDASIL, the patient developed pain in her ankle and had difficulty ambulating up and down stairs. She was seen by the family physician who diagnosed her with tendonitis. One month and a half after the first dose, the patient was seen by an orthopedic surgeon and underwent blood tests and a MRI. The nurse stated that the "blood work was erratic for a healthy teenager" and the ANA results were positive. The patient was then referred to rheumatologist, which she was still seeing. The patient was diagnosed with an autoimmune disease and reactive arthritis in her hip, knee and ankle. She was placed on therapies with PLAQUENIL, Vitamins, Fish oil, tramadol, and ibuprofen. The nurse reported that the patient was also seen by a urologist since "she was spilling protein in her urine due to the ibuprofen". The ibuprofen was discontinued. The patient saw an eye specialist every three months to evaluate for possible visual side effects that may occur with the PLAQUENIL and tramadol (no visual side effects reported at this time). The nurse reported that the patient did not require any hospitalization or life saving measures due to this reaction. This reaction was not related to a cancer or an overdose. The nurse stated "This is something that she is going to have for the rest of her life." At the time of the report, the patient did not recover. The health care professional contacted during telephone follow-up could not supply the following information: date of birth, dates of vaccination/therapy, dose number (if applicable), lot number (if applicable), date of event, recovery status, hospital name (if applicable), healthcare provider contact information. Follow up information has been received from a receptionist of a doctor's office who reported that the patient is an 18 year old female (previously reported as 19 year old). Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEP, HEPA, HPV4, VARCEL
Symptoms: Hypotonia, Loss of consciousness, Pallor
Clinical narrative: Information has been received from a physician concerning a 16 year old female student with no pertinent medical history and no known drug allergies who on 24-AUG-2009 was vaccinated IM with the second dose of GARDASIL (Lot# 661766/0652X). The patient also vaccinated with HAVRIX, RECOMBIVAX (Lot#663283/1601X) and VARIVAX (Merck) (Lot#664325/0663Y) on 24-AUG-2009. On 24-AUG-2009 after vaccination the second dose of GARDASIL the patient became pale, limp and started to black out. The patient had sought unknown medical attention via telephone. There were no lab diagnostic studies performed. She was administered oxygen (manufacturer unknown) and fully recovered. Follow-up information received from a physician concerning a 16 year old female patient with no pre-existing allergies, birth defects or medical conditions and with no illness at time of vaccination who was vaccinated with GARDASIL (Lot# 661766/0652X) at right deltoid at 16:12pm on 24-AUG-2009. On 24-AUG-2009 the patient was also vaccinated with HAVRIX (Lot#AHAV113311AA) at left deltoid at 16:11pm, RECOMBIVAX (Lot# 663283/1601X) (thimerosal free) at left deltoid at 16:12pm and VARIVAX (Merck) (Lot # 664325/0663Y) at right LUA at 4:13pm. On 24-AUG-2009 after the vaccines were administered the patient went limp at the arms. Per patient, everything went "black". The patient was sitting at the time, was placed in a lying position with lower extremities elevated. Oxygen mask was administered. All vital signal remained within normal limits, respiratory rate 16, pulse 70-80's, blood pressure 98/64 and pulse oximetry 100%. The patient was observed for 30 minutes, and was discharged home in stable condition. On 25-AUG-2009 the patient was recovered. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a female who was vaccinated with a dose of GARDASIL (lot#, route and site of administration not reported). Subsequently, the patient experienced syncope episodes after vaccination. Unspecified medical attention was sought. On an unspecified date the patient recovered. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a female patient with pertinent medical history reported as none and drug reactions or allergies reported as none who on approximately 13-AUG-2009 was vaccinated with a third dose of GARDASIL (lot # not reported) 0.5ml intramuscularly. There was no concomitant medication. In August 2009, the patient developed swelling and pain at the injection site of the left deltoid area. The patient was seen in the office on 19-AUG-2009. No treatment was prescribed. At the time of the report on 20-AUG-2009 the patient was recovering. There was no laboratories diagnostics studies performed. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Movement disorder
Clinical narrative: Information has been received from a physician concerning a female patient with no pertinent medical history and no drug reactions/allergies who was vaccinated IM with the first 0.5 ml dose of GARDASIL. Right after getting the vaccine the patient experienced seizure like activity. It was unknown if the patient sought medical attention. There were no lab diagnostic studies performed. Within 15 minutes the patient recovered. Upon internal review, seizure like activity was determined to be an other important medical event. On 08-SEP-2009 and 14-SEP-2009, telephone attempts to obtain additional information have been unsuccessful. On 10-SEP-2009 the physician called back to say that she did not report this AE and know nothing of this case, she would speak with her staff to see who it was that reported it. On 14-SEP-2009 the Merck representative stated that the initial reporter was the Office Manager. On 14-SEP-2009 follow-up information received from the Office Manager indicated that on the day the Merck rep came in, it was mentioned in passing that a patient had a seizure like activity event out at the check out window. The patient "sat down for a bit then left the office under her own power". No treatment was necessary. The name of the patient had been forgotten. The health care professional contacted during telephone follow up could not supply the following information: patient name, date of birth, date of vaccination/therapy, lot number, and date of event. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Dizziness
Clinical narrative: Information has been received from a consumer concerning a 22 year old female who on 09-JUL-2009 was vaccinated with a dose of GARDASIL (lot no. not reported). Concomitant therapy included hormonal contraceptives (unspecified). The consumer reported that the patient had not had her period since getting GARDASIL. The consumer also stated that the patient "was a little woozy" after she was vaccinated. The patient's did not have a doctor but she was vaccinated in a local agency. The patient did not seek medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune disorder, Blood immunoglobulin A increased, Skin lesion, Vasculitis
Clinical narrative: Information has been received from a physician concerning a 18 year old patient who on 26-JAN-2009 was vaccinated with the third dose of GARDASIL. On approximately 26-MAY-2009 "four months later" she was sent to a rheumatologist. She developed some sort of autoimmune disease, elevated IGA levels, vasculitis and skin lesions. She was put on steroids and it was still unknown what actually happened. There is some inference that GARDASIL may have a possible connection since it was one of the things she had been on. The patient sought unspecified medical attention. The health professional contacted during telephone follow up could not supply the following information: patient name, date of birth, dates of vaccination, dose number (if applicable), lot number (if applicable), date of event, recovery status, hospital name (if applicable). Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling abnormal, Headache, Hypoaesthesia facial, Hypoaesthesia oral
Clinical narrative: Information has been received from a registered nurse concerning her 13 year old daughter with no pertinent medical history and no known drug allergies, who was vaccinated with the first dose of GARDASIL (0.5ml, IM, lot # unknown) on 31-JUL-2008, the second dose (0.5ml, IM, lot # unknown) on 24-NOV-2008 and the third dose (0.5ml, IM, lot # unknown) on 12-MAR-2009. There was no concomitant medication. On 16-AUG-2009 the patient experienced a headache above her left eye. About 30 to 45 minutes after the start of headache she experienced numbness on the right side of her tongue and face which lasted 1 to 3 hours. Prior to the onset of headache she felt a "little out of it". She was examined in the emergency department on 16-AUG-2009. She was treated with ibuprofen. On 17-AUG-2009 she was examined by a neurologist. Labs and diagnostic tests included CT scan and lab work (results not reported). The patient recovered on 18-AUG-2009. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Lip swelling
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL. There was no concomitant medication. One day after receiving the GARDASIL dose she had some swelling of her lip. No treatment was given, it resolved. The patient sought unspecified medical attention. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Allergy test positive, Chest discomfort, Dyspnoea, Urticaria
Clinical narrative: Information has been received from a physician's assistant concerning a 24 year old female with allergic reaction to sulfa, IMITREX, TB test solution, flu shots, contrast dye, codeine, morphine, MYLANTA and MAALOX who on 01-APR-2008 was vaccinated with the first dose of GARDASIL. On 22-AUG-2009 the patient received the second dose of GARDASIL (lot# 661766/0652X). 10 minutes after the vaccination, the patient experienced hives, shortness of breath and tightness in her chest. She was taken to the ER and received BENADRYL and epinephrine. She recovered within 45 minutes and was released. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient with no medical history and no drug allergies who on an unspecified date was vaccinated with the second 0.5mL dose of GARDASIL intramuscularly. There was no concomitant medication. Twenty-four hours after receiving the vaccine. The patient developed a large bump at the site of injection. No lab diagnostic studies performed. At the time of the report, the patient recovered. Follow-up information has been received from a physician reported that he can not provide any information because he did not know who the patient was and a name was not provided. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, UNK
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a physician's assistant concerning a 13 year old female patient with no medical history and no drug allergies who was vaccinated with the first 0.5mL dose of GARDASIL intramuscularly "last week". Concomitant vaccine administered on the same day included hepatitis virus vaccine (unspecified). The patient experienced syncope immediately after vaccination. There were no lab diagnostic studies performed. The patient recovered within 15 minutes with no additional problems and was able to leave the office. Additional information has been requested. This is one of several reports from the same source.
Age: 14.0
Sex: F
Vaccine: HPV4, UNK
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a physician's assistant concerning a 15 year old female patient with no medical history and no drug allergies who in approximately August 2009, "about a month ago" was vaccinated with the first 0.5mL dose of GARDASIL intramuscularly. Concomitant vaccine administered on the same day included hepatitis virus vaccine (unspecified). The patient experienced syncope immediately after vaccination. There were no lab diagnostic studies performed. The patient recovered within 15 minutes with no additional problem and was able to leave the office. Follow-up information received from a registered nurse indicated a 15 year old student with no illness at time of vaccination but had reported that the patient had stayed up all night and no pre-existing allergies, birth defects, medical conditions who was vaccinated IM with the first dose of GARDASIL (Lot # 662300/0100Y) at left deltoid on 20-AUG-2009. On 20-AUG-2009 the patient had syncope for 3-5 seconds. She was placed in Trendelenburg position on 20-AUG-2009. This is one of several reports from the same source. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (dose, route and lot number not reported). It was reported that the patient experienced hair loss. It was unknown if the patient sought medical attention. The outcome was not reported. This is one of several reports from the same source. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with all 3 doses of GARDASIL (lot#, route and site of administration not reported). The patient was tested positive for HPV. It was unspecified if the patient sought medical attention. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Albumin globulin ratio decreased, Blood thyroid stimulating hormone normal, Epstein-Barr virus test negative, Fatigue
Clinical narrative: Information has been received from a healthcare worker concerning a 17 year old female patient with no medical history or drug allergies/reactions who on an unknown date was vaccinated with the first 0.5 ml dose of GARDASIL intramuscularly. Concomitant therapy included DEPO-PROVERA. The healthcare worker reported that the patient "a few days after she received GARDASIL "developed fatigue, malaise and generalized body pain (more severe in hips and legs). Complete blood counts (CBC), Comprehensive Metabolic Panel (CMP), sedimentation rate, Infectious mononucleosis (IM) test were performed however the result were pending. The patient sought medical attention via an office visit. At the time of the report the patient was recovering. Follow-up information has been received from a healthcare worker and a pharmacy tech reported that the GARDASIL prescription was filled on 14-AUG-2009. But it was unknown where the patient took the GARDASIL to be administered. The health care professional contacted during telephone follow-up could not supply the following information: date of vaccination, lot number, date of event, name of HCP who administered the vaccine. Follow-up information has been received from a healthcare worker and a physician concerning a 17 year old female with no illness at time of vaccination who on 04-SEP-2009 had a doctor visit after receiving her first dose of GARDASIL. It was unknown who and where the patient got the injection. It was reported a few days after the vaccination, the patient experienced pain everywhere, most in the hips and legs. She felt more tired, worn out and slept more. The patient denied new sexual contacts, runny nose or allergies. She had no bites, skin rashes and fevers. The pain in the limb showed no trauma but appeared arthritis in nature. The general examination indicated nothing abnormal was detected. Complete blood cell count (CBC) and comprehensive metabolic panel (CMP) revealed normal values except a low platelet count of 124 and a high albumin/globulin ratio of 2.3. The evaluations for hepatitis and mono screen were negative. The results of thyroid-stimulating hormone test and sedimentation rate were within normal reference range. The physician felt that malaise and fatigue were possibly a vaccination reaction. The follow-up visit would be scheduled one week after as needed. Follow-up information has been received from the healthcare worker who reported that the patient's pre-existing allergies, birth defects and medical conditions were none. The patient experienced abdominal pain, heart palpitations, still ongoing. The patient had had echo performed and labs were still ongoing. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count abnormal, Hepatitis A antibody, Hepatitis B core antigen, Hypersomnia, Malaise
Clinical narrative: Information has been received from a healthcare worker concerning a 17 year old female patient with no medical history or drug allergies/reactions who on an unknown date was vaccinated with the first 0.5 ml dose of GARDASIL intramuscularly. Concomitant therapy included DEPO-PROVERA. The healthcare worker reported that the patient "a few days after she received GARDASIL "developed fatigue, malaise and generalized body pain (more severe in hips and legs). Complete blood counts (CBC), Comprehensive Metabolic Panel (CMP), sedimentation rate, Infectious mononucleosis (IM) test were performed however the result were pending. The patient sought medical attention via an office visit. At the time of the report the patient was recovering. Follow-up information has been received from a healthcare worker and a pharmacy tech reported that the GARDASIL prescription was filled on 14-AUG-2009. But it was unknown where the patient took the GARDASIL to be administered. The health care professional contacted during telephone follow-up could not supply the following information: date of vaccination, lot number, date of event, name of HCP who administered the vaccine. Follow-up information has been received from a healthcare worker and a physician concerning a 17 year old female with no illness at time of vaccination who on 04-SEP-2009 had a doctor visit after receiving her first dose of GARDASIL. It was unknown who and where the patient got the injection. It was reported a few days after the vaccination, the patient experienced pain everywhere, most in the hips and legs. She felt more tired, worn out and slept more. The patient denied new sexual contacts, runny nose or allergies. She had no bites, skin rashes and fevers. The pain in the limb showed no trauma but appeared arthritis in nature. The general examination indicated nothing abnormal was detected. Complete blood cell count (CBC) and comprehensive metabolic panel (CMP) revealed normal values except a low platelet count of 124 and a high albumin/globulin ratio of 2.3. The evaluations for hepatitis and mono screen were negative. The results of thyroid-stimulating hormone test and sedimentation rate were within normal reference range. The physician felt that malaise and fatigue were possibly a vaccination reaction. The follow-up visit would be scheduled one week after as needed. Follow-up information has been received from the healthcare worker who reported that the patient's pre-existing allergies, birth defects and medical conditions were none. The patient experienced abdominal pain, heart palpitations, still ongoing. The patient had had echo performed and labs were still ongoing. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Metabolic function test, Mononucleosis heterophile test negative, Pain, Pain in extremity, Palpitations
Clinical narrative: Information has been received from a healthcare worker concerning a 17 year old female patient with no medical history or drug allergies/reactions who on an unknown date was vaccinated with the first 0.5 ml dose of GARDASIL intramuscularly. Concomitant therapy included DEPO-PROVERA. The healthcare worker reported that the patient "a few days after she received GARDASIL "developed fatigue, malaise and generalized body pain (more severe in hips and legs). Complete blood counts (CBC), Comprehensive Metabolic Panel (CMP), sedimentation rate, Infectious mononucleosis (IM) test were performed however the result were pending. The patient sought medical attention via an office visit. At the time of the report the patient was recovering. Follow-up information has been received from a healthcare worker and a pharmacy tech reported that the GARDASIL prescription was filled on 14-AUG-2009. But it was unknown where the patient took the GARDASIL to be administered. The health care professional contacted during telephone follow-up could not supply the following information: date of vaccination, lot number, date of event, name of HCP who administered the vaccine. Follow-up information has been received from a healthcare worker and a physician concerning a 17 year old female with no illness at time of vaccination who on 04-SEP-2009 had a doctor visit after receiving her first dose of GARDASIL. It was unknown who and where the patient got the injection. It was reported a few days after the vaccination, the patient experienced pain everywhere, most in the hips and legs. She felt more tired, worn out and slept more. The patient denied new sexual contacts, runny nose or allergies. She had no bites, skin rashes and fevers. The pain in the limb showed no trauma but appeared arthritis in nature. The general examination indicated nothing abnormal was detected. Complete blood cell count (CBC) and comprehensive metabolic panel (CMP) revealed normal values except a low platelet count of 124 and a high albumin/globulin ratio of 2.3. The evaluations for hepatitis and mono screen were negative. The results of thyroid-stimulating hormone test and sedimentation rate were within normal reference range. The physician felt that malaise and fatigue were possibly a vaccination reaction. The follow-up visit would be scheduled one week after as needed. Follow-up information has been received from the healthcare worker who reported that the patient's pre-existing allergies, birth defects and medical conditions were none. The patient experienced abdominal pain, heart palpitations, still ongoing. The patient had had echo performed and labs were still ongoing. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Platelet count decreased, Red blood cell sedimentation rate normal
Clinical narrative: Information has been received from a healthcare worker concerning a 17 year old female patient with no medical history or drug allergies/reactions who on an unknown date was vaccinated with the first 0.5 ml dose of GARDASIL intramuscularly. Concomitant therapy included DEPO-PROVERA. The healthcare worker reported that the patient "a few days after she received GARDASIL "developed fatigue, malaise and generalized body pain (more severe in hips and legs). Complete blood counts (CBC), Comprehensive Metabolic Panel (CMP), sedimentation rate, Infectious mononucleosis (IM) test were performed however the result were pending. The patient sought medical attention via an office visit. At the time of the report the patient was recovering. Follow-up information has been received from a healthcare worker and a pharmacy tech reported that the GARDASIL prescription was filled on 14-AUG-2009. But it was unknown where the patient took the GARDASIL to be administered. The health care professional contacted during telephone follow-up could not supply the following information: date of vaccination, lot number, date of event, name of HCP who administered the vaccine. Follow-up information has been received from a healthcare worker and a physician concerning a 17 year old female with no illness at time of vaccination who on 04-SEP-2009 had a doctor visit after receiving her first dose of GARDASIL. It was unknown who and where the patient got the injection. It was reported a few days after the vaccination, the patient experienced pain everywhere, most in the hips and legs. She felt more tired, worn out and slept more. The patient denied new sexual contacts, runny nose or allergies. She had no bites, skin rashes and fevers. The pain in the limb showed no trauma but appeared arthritis in nature. The general examination indicated nothing abnormal was detected. Complete blood cell count (CBC) and comprehensive metabolic panel (CMP) revealed normal values except a low platelet count of 124 and a high albumin/globulin ratio of 2.3. The evaluations for hepatitis and mono screen were negative. The results of thyroid-stimulating hormone test and sedimentation rate were within normal reference range. The physician felt that malaise and fatigue were possibly a vaccination reaction. The follow-up visit would be scheduled one week after as needed. Follow-up information has been received from the healthcare worker who reported that the patient's pre-existing allergies, birth defects and medical conditions were none. The patient experienced abdominal pain, heart palpitations, still ongoing. The patient had had echo performed and labs were still ongoing. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Dizziness, Infectious mononucleosis, Loss of consciousness, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a clinic employee concerning her 18 year daughter who on an unspecified date was vaccinated intramuscularly with the third 0.5mL dose of GARDASIL. Concomitant therapy included DEPO-PROVERA. The clinic employee said that in 2008, her daughter was diagnosed with mononucleosis "a couple months" after getting her third dose of GARDASIL". It was reported that after the mononucleosis "cleared up" the patient started having dizziness, blackouts and vomiting mostly in the morning. The patient sought unspecified medical attention and "blood work" was performed (results not reported). On an unspecified date, the patient recovered. It was noted that there was no adverse event reported after the first 2 doses. Follow-up information was received from the physician that reported that they did not have any record of a patient that had any reaction. Additional information is not expected. This is one of two reports received from the same source.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a clinic employee concerning her 18 year daughter who on an unspecified date was vaccinated intramuscularly with the third 0.5mL dose of GARDASIL. Concomitant therapy included DEPO-PROVERA. The clinic employee said that in 2008, her daughter was diagnosed with mononucleosis "a couple months" after getting her third dose of GARDASIL". It was reported that after the mononucleosis "cleared up" the patient started having dizziness, blackouts and vomiting mostly in the morning. The patient sought unspecified medical attention and "blood work" was performed (results not reported). On an unspecified date, the patient recovered. It was noted that there was no adverse event reported after the first 2 doses. Follow-up information was received from the physician that reported that they did not have any record of a patient that had any reaction. Additional information is not expected. This is one of two reports received from the same source.
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Dizziness, Echocardiogram, Loss of consciousness
Clinical narrative: Information has been received from a consumer concerning her daughter with no pertinent medical medication who was vaccinated IM with the third 0.5ml dose of GARDASIL (lot# not reported). There was no concomitant medication. The reporter said that her daughter started experiencing "periods of dizziness and blackouts" a month after getting her third dose of GARDASIL. This adverse event had "persisted" and happened at least once a day. The patient had had to "come home from work a couple times" because of this adverse event. There was no adverse event after receiving the first 2 doses of GARDASIL. The patient sought unspecified medical attention. A blood test and an echocardiogram were performed and the results were unknown. At the time of the report, the patient had not recovered. The patient's sister experienced mononucleosis, dizziness, blackouts and vomiting after getting her third dose of GARDASIL (MSD, WAES# 0909USA01177). Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dizziness, Nausea, Syncope
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with the first dose of GARDASIL (lot number not reported). Subsequently the patient experienced syncopal after the vaccination. At the time of the report, the outcome of the patient was not reported. Follow-up information has been received from the physician concerning the 18 year old female patient with no pertinent medical history and no known allergies who on 27-AUG-2009 at 11:35 am was vaccinated in the right arm with the first dose of GARDASIL (lot number 655617/1447F). Concomitant vaccination included Hep A vaccine (manufacturer unspecified). On 17-AUG-2009 at 11:35 am, the patient experienced dizziness and nausea lasted for 3-5 minutes. The patient got better without treatment. The patient recovered on the same day. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein increased, Anaemia, Delivery, Drug exposure during pregnancy, Oligohydramnios
Clinical narrative: Initial and follow-up information has been received from a nurse for GARDASIL, a Pregnancy Registry product, concerning a 21 year old female with sickle cell trait and no drug allergies who on 13-JUL-2009 or 17-JUL-2009 was vaccinated with the first dose of GARDASIL (LOT# not reported) from another provider. On 26-AUG-2009 the patient went to another clinic office for her first obstetrical visit. No adverse effects were reported. The pregnancy was confirmed by home pregnancy test on an unspecified date. The patient was currently taking prenatal vitamins. The patient's LMP was 13-JUN-2009. Expected date of delivery was 20-MAR-2010. The patient had an appointment with the nurse on 23-SEP-2009. Follow-up information has been received from the nurse. This was the patient's first pregnancy. The nurse stated that the patient during pregnancy experienced anemia, mild oligohydramnios and Maternal Serum Alpha Fetoprotein (MSAFP) positive. She was treated with prenatal vitamins, PO, daily and ferrous sulfate, PO, TID indication for anemia both from 26-AUG-2009 to 15-MAR-2010. The ultrasound was performed on 15-MAR-2010 revealed "oligo", MSAFP was performed on "25-SEP-2010" revealed it was positive. On 15-MAR-2010, the patient delivered a live female infant, weight 6 pounds 12 ounces, Apgar score 9/10, and 39+ weeks from LMP. The infant was healthy. Follow-up information has been received from the nurse. This was the woman's first pregnancy. The nurse stated that the patient during pregnancy experienced Alpha Fetoprotein (AFP) positive, sickle cell trait positive. She was treated with prenatal vitamins, PO, TID for pregnancy and ferrous sulfate, 325 mg, PO, TID indication for pregnancy both from 26-AUG-2009 to 30-MAR-2010. The ultrasound was performed on 06-NOV-2009 revealed within normal limits (WNL) and "UMC". During pregnancy, the patient had Alpha Fetoprotein (AFP) positive and borderline oligohydramnios. On 15-MAR-2010, the patient delivered a live female infant, weight 6 pounds 12 ounces, length 19 inches, Apgar score 9/10, and 40 weeks from LMP. The infant was healthy. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Pregnancy test positive, Ultrasound scan abnormal
Clinical narrative: Initial and follow-up information has been received from a nurse for GARDASIL, a Pregnancy Registry product, concerning a 21 year old female with sickle cell trait and no drug allergies who on 13-JUL-2009 or 17-JUL-2009 was vaccinated with the first dose of GARDASIL (LOT# not reported) from another provider. On 26-AUG-2009 the patient went to another clinic office for her first obstetrical visit. No adverse effects were reported. The pregnancy was confirmed by home pregnancy test on an unspecified date. The patient was currently taking prenatal vitamins. The patient's LMP was 13-JUN-2009. Expected date of delivery was 20-MAR-2010. The patient had an appointment with the nurse on 23-SEP-2009. Follow-up information has been received from the nurse. This was the patient's first pregnancy. The nurse stated that the patient during pregnancy experienced anemia, mild oligohydramnios and Maternal Serum Alpha Fetoprotein (MSAFP) positive. She was treated with prenatal vitamins, PO, daily and ferrous sulfate, PO, TID indication for anemia both from 26-AUG-2009 to 15-MAR-2010. The ultrasound was performed on 15-MAR-2010 revealed "oligo", MSAFP was performed on "25-SEP-2010" revealed it was positive. On 15-MAR-2010, the patient delivered a live female infant, weight 6 pounds 12 ounces, Apgar score 9/10, and 39+ weeks from LMP. The infant was healthy. Follow-up information has been received from the nurse. This was the woman's first pregnancy. The nurse stated that the patient during pregnancy experienced Alpha Fetoprotein (AFP) positive, sickle cell trait positive. She was treated with prenatal vitamins, PO, TID for pregnancy and ferrous sulfate, 325 mg, PO, TID indication for pregnancy both from 26-AUG-2009 to 30-MAR-2010. The ultrasound was performed on 06-NOV-2009 revealed within normal limits (WNL) and "UMC". During pregnancy, the patient had Alpha Fetoprotein (AFP) positive and borderline oligohydramnios. On 15-MAR-2010, the patient delivered a live female infant, weight 6 pounds 12 ounces, length 19 inches, Apgar score 9/10, and 40 weeks from LMP. The infant was healthy. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Nausea, Swelling
Clinical narrative: Information has been received from a physician as part of a market research focus group concerning a 17 year old female patient who on an unknown date was vaccinated with a first dose of GARDASIL (lot number, route and site not reported). In May 2008, the patient developed swelling, redness and nausea. Therapy with GARDASIL was discontinued. Subsequently, the patient recovered from swelling, redness and nausea on an unknown date. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Autonomic nervous system imbalance, Chest discomfort, Chest pain, Dizziness, Dyspnoea
Clinical narrative: Information has been received from a physician concerning her family member, a 14 year old female with a family history of cardiac problems who on an unspecified date was vaccinated with the second 0.5ml dose of GARDASIL (lot#, route and site of administration not reported). It was reported that about a month after each dose of GARDASIL the patient experienced chest pain and tightness, left arm pain, shortness of breath and dizziness. When she had the same experience after the second dose, the patient went to the emergency room and was diagnosed with dysautonomia. The patient was told that it was due to GARDASIL and was referred to a pediatric cardiologist. Unspecified laboratory diagnostics studies were performed. On an unspecified date the patient had recovered. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning her family member, a 14 year old female with a family history of cardiac problems who on an unspecified date was vaccinated with the second 0.5ml dose of GARDASIL (lot#, route and site of administration not reported). It was reported that about a month after each dose of GARDASIL the patient experienced chest pain and tightness, left arm pain, shortness of breath and dizziness. When she had the same experience after the second dose, the patient went to the emergency room and was diagnosed with dysautonomia. The patient was told that it was due to GARDASIL and was referred to a pediatric cardiologist. Unspecified laboratory diagnostics studies were performed. On an unspecified date the patient had recovered. No further information is available.