chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood thyroid stimulating hormone decreased, Body temperature increased, Full blood count normal, Goitre, Headache
Clinical narrative: Information has been received from a physician concerning an 18 year old female with a history of hypothyroidism who on 28-JUL-2009 was vaccinated with the third dose of GARDASIL (LOT # was not provided). On 29-JUL-2009 the patient experienced a fever of 102 degrees F, ache joints and nausea. As of 31-JUL-2009, the patient had a temperature of 100 degrees F, minimal pain in her finger joints and ankles. The physician also mentioned that the patient had a viral illness after receiving a vaccination a few months ago. She was not sure if the vaccine was dose 2 of GARDASIL  or a different vaccine. The patient was recovering from a fever of 102 degrees F, ache joints and nausea. She sought medical attention and was seen in office. Follow up information has been received from a physician concerning the patient with allergies and a history of hypothyroidism and erythema infectiosum who on 13-AUG-2007 was vaccinated with the first dose of GARDASIL (LOT # 658100/0525U). On 04-SEP-2008 the patient was the second dose of GARDASIL (LOT # 660555/0279X). On 29-JUL-2009 the patient received the third dose of GARDASIL (LOT # 661953/1130X). Concomitant therapy included SYNTHROID 75 microgram daily since 2005 for hypothyroidism and eye drops (therapy unspecified) for "allergies". It was also reported that the patient had no known allergies. After the third dose of GARDASIL, the patient subsequently experienced a fever of 102 degrees F, achy joints and nausea. By 01-AUG-2009 the nausea had subsided, by 03-AUG-2009 the fever was gone. On 05-AUG-2009 the patient was seen for a follow-up appointment and had blood drawn. Her rheumatoid factor was negative, her erythrocyte sedimentation rate (sed. rate) was 6, her complete blood cell count (CBC) was normal and her serum antinuclear antibodies test (ANA) was negative. The patient's parvovirus B19 titer was positive for only old disease, no current infection was present, which indicated that the patient had been exposed to Fifth disease (erythema infectiosum) at some point. The achy joint pain was still present up through 11-AUG-2009 and completely gone by 13-AUG-2009. Due to a combination of the blood test results and the patient's clinical presentation, she was not sent for consult with a Rheumatologist. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hyperthyroidism, Nausea, Pain in extremity, Parvovirus B19 test negative, Platelet count normal
Clinical narrative: Information has been received from a physician concerning an 18 year old female with a history of hypothyroidism who on 28-JUL-2009 was vaccinated with the third dose of GARDASIL (LOT # was not provided). On 29-JUL-2009 the patient experienced a fever of 102 degrees F, ache joints and nausea. As of 31-JUL-2009, the patient had a temperature of 100 degrees F, minimal pain in her finger joints and ankles. The physician also mentioned that the patient had a viral illness after receiving a vaccination a few months ago. She was not sure if the vaccine was dose 2 of GARDASIL  or a different vaccine. The patient was recovering from a fever of 102 degrees F, ache joints and nausea. She sought medical attention and was seen in office. Follow up information has been received from a physician concerning the patient with allergies and a history of hypothyroidism and erythema infectiosum who on 13-AUG-2007 was vaccinated with the first dose of GARDASIL (LOT # 658100/0525U). On 04-SEP-2008 the patient was the second dose of GARDASIL (LOT # 660555/0279X). On 29-JUL-2009 the patient received the third dose of GARDASIL (LOT # 661953/1130X). Concomitant therapy included SYNTHROID 75 microgram daily since 2005 for hypothyroidism and eye drops (therapy unspecified) for "allergies". It was also reported that the patient had no known allergies. After the third dose of GARDASIL, the patient subsequently experienced a fever of 102 degrees F, achy joints and nausea. By 01-AUG-2009 the nausea had subsided, by 03-AUG-2009 the fever was gone. On 05-AUG-2009 the patient was seen for a follow-up appointment and had blood drawn. Her rheumatoid factor was negative, her erythrocyte sedimentation rate (sed. rate) was 6, her complete blood cell count (CBC) was normal and her serum antinuclear antibodies test (ANA) was negative. The patient's parvovirus B19 titer was positive for only old disease, no current infection was present, which indicated that the patient had been exposed to Fifth disease (erythema infectiosum) at some point. The achy joint pain was still present up through 11-AUG-2009 and completely gone by 13-AUG-2009. Due to a combination of the blood test results and the patient's clinical presentation, she was not sent for consult with a Rheumatologist. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pyrexia, Reaction to previous exposure to any vaccine, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Thyroxine free normal
Clinical narrative: Information has been received from a physician concerning an 18 year old female with a history of hypothyroidism who on 28-JUL-2009 was vaccinated with the third dose of GARDASIL (LOT # was not provided). On 29-JUL-2009 the patient experienced a fever of 102 degrees F, ache joints and nausea. As of 31-JUL-2009, the patient had a temperature of 100 degrees F, minimal pain in her finger joints and ankles. The physician also mentioned that the patient had a viral illness after receiving a vaccination a few months ago. She was not sure if the vaccine was dose 2 of GARDASIL  or a different vaccine. The patient was recovering from a fever of 102 degrees F, ache joints and nausea. She sought medical attention and was seen in office. Follow up information has been received from a physician concerning the patient with allergies and a history of hypothyroidism and erythema infectiosum who on 13-AUG-2007 was vaccinated with the first dose of GARDASIL (LOT # 658100/0525U). On 04-SEP-2008 the patient was the second dose of GARDASIL (LOT # 660555/0279X). On 29-JUL-2009 the patient received the third dose of GARDASIL (LOT # 661953/1130X). Concomitant therapy included SYNTHROID 75 microgram daily since 2005 for hypothyroidism and eye drops (therapy unspecified) for "allergies". It was also reported that the patient had no known allergies. After the third dose of GARDASIL, the patient subsequently experienced a fever of 102 degrees F, achy joints and nausea. By 01-AUG-2009 the nausea had subsided, by 03-AUG-2009 the fever was gone. On 05-AUG-2009 the patient was seen for a follow-up appointment and had blood drawn. Her rheumatoid factor was negative, her erythrocyte sedimentation rate (sed. rate) was 6, her complete blood cell count (CBC) was normal and her serum antinuclear antibodies test (ANA) was negative. The patient's parvovirus B19 titer was positive for only old disease, no current infection was present, which indicated that the patient had been exposed to Fifth disease (erythema infectiosum) at some point. The achy joint pain was still present up through 11-AUG-2009 and completely gone by 13-AUG-2009. Due to a combination of the blood test results and the patient's clinical presentation, she was not sent for consult with a Rheumatologist. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Vaccination complication, White blood cell count normal
Clinical narrative: Information has been received from a physician concerning an 18 year old female with a history of hypothyroidism who on 28-JUL-2009 was vaccinated with the third dose of GARDASIL (LOT # was not provided). On 29-JUL-2009 the patient experienced a fever of 102 degrees F, ache joints and nausea. As of 31-JUL-2009, the patient had a temperature of 100 degrees F, minimal pain in her finger joints and ankles. The physician also mentioned that the patient had a viral illness after receiving a vaccination a few months ago. She was not sure if the vaccine was dose 2 of GARDASIL  or a different vaccine. The patient was recovering from a fever of 102 degrees F, ache joints and nausea. She sought medical attention and was seen in office. Follow up information has been received from a physician concerning the patient with allergies and a history of hypothyroidism and erythema infectiosum who on 13-AUG-2007 was vaccinated with the first dose of GARDASIL (LOT # 658100/0525U). On 04-SEP-2008 the patient was the second dose of GARDASIL (LOT # 660555/0279X). On 29-JUL-2009 the patient received the third dose of GARDASIL (LOT # 661953/1130X). Concomitant therapy included SYNTHROID 75 microgram daily since 2005 for hypothyroidism and eye drops (therapy unspecified) for "allergies". It was also reported that the patient had no known allergies. After the third dose of GARDASIL, the patient subsequently experienced a fever of 102 degrees F, achy joints and nausea. By 01-AUG-2009 the nausea had subsided, by 03-AUG-2009 the fever was gone. On 05-AUG-2009 the patient was seen for a follow-up appointment and had blood drawn. Her rheumatoid factor was negative, her erythrocyte sedimentation rate (sed. rate) was 6, her complete blood cell count (CBC) was normal and her serum antinuclear antibodies test (ANA) was negative. The patient's parvovirus B19 titer was positive for only old disease, no current infection was present, which indicated that the patient had been exposed to Fifth disease (erythema infectiosum) at some point. The achy joint pain was still present up through 11-AUG-2009 and completely gone by 13-AUG-2009. Due to a combination of the blood test results and the patient's clinical presentation, she was not sent for consult with a Rheumatologist. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Rash erythematous, Rash generalised, Rash vesicular
Clinical narrative: Information has been received from a registered nurse her 19 year old daughter with CECLOR allergy who on 29-JUN-2008 was vaccinated IM with a 0.5 mL first dose of GARDASIL and in December 2008 received the third dose of GARDASIL. Concomitant therapy included unspecified control pills. One or two days after receiving the third dose of GARDASIL, the patient developed a rash which was distributed across her chest and resolved without treatment. On 21-JUL-2009, the patient experienced the onset of a widespread rash on her breast, thigh, legs, buttocks, right arm and left anticubital area. The lesions were red and vesicular. The patient initially self-treated with CALAMIN, BENADRYL, CLARITIN and ZYRTEC. On 27-JUL-2009 the patient was examined in the office and was diagnosed with possible poison ivy. She was given KENALOG injection and prescribed bethamethasone cream (unspecified). The rash initially improved but worsened on 29-JUL-2009. The patient contacted the physician's office by phone and was prescribed a MEDROL dose pack. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Amenorrhoea, Vaccine positive rechallenge
Clinical narrative: Information has been received from a 16 year old female patient concerning herself with no pertinent medical history and no known drug allergies/drug reactions who on 06-MAY-2009 was vaccinated with the first 0.5 mL dose of GARDASIL (Lot # not reported). The patient received her second dose of GARDASIL on 07-JUL-2009. There was no concomitant medication reported. It was reported that the patient experienced stomach pain and not having menstrual period after she got the first and second dose of GARDASIL. The last menstrual period date was on 04-MAY-2009. The patient sought unspecified medical attention. There were no diagnostic laboratory tests performed. The outcome of the patient was not reported. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Infectious mononucleosis, Tonsillectomy, Tonsillitis, Upper respiratory tract infection
Clinical narrative: Information has been received from a physician concerning a 16 year old female with no pertinent medical history nor known drug reactions/allergies who in June 2007 was vaccinated with the first dose of GARDASIL (Lot#657006/0188U). There were no concomitant medications. The physician reported that the patient had not received the second dose of GARDASIL because the patient experienced upper respiratory infection, tonsillitis, mononucleosis, anxiety and tonsillectomy after administration of the first dose of GARDASIL. The patient had sought unknown medical attention. At the time of report the patient's status was recovered. The physician felt that upper respiratory infection, tonsillitis, mononucleosis, anxiety and tonsillectomy were not related to GARDASIL. The patient will continue with the GARDASIL series. No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Injection site pain, Pain, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 23 year old female patient with no pertinent medical history and drug reactions/allergies who was vaccinated with a first 0.5ml dose of GARDASIL (lot#661764/0650X) on 18-DEC-2008, the second dose (lot#659655/0940X) on 23-FEB-2009 and the third dose (lot# 660612/0229X) on 02-JUN-2009. All three doses were administered intramuscularly into her left deltoid. Concomitant therapy included LO/OVRAL. On approximately 20-JUL-2009, the patient's left arm was painful even when she moved her arm, and when she felt around the area, she could feel a lump. The patient has been using comfort measures such as ice pack or warm compress as needed. The nurse reported that the patient had called office and was referred to her primary care physician, which was not in this office, for a follow-up. At the time of the report, the patient did not recover. Follow-up information received from the registered nurse indicated that the female patient received the third dose of GARDASIL (lot#659655/0940X, previously reported as 660612/0229X) intramuscularly into the left deltoid on 02-JUN-2009. The patient stated that on 03-AUG-2009, she developed "bump" in left deltoid at injection site that was sore and painful. The patient was advised to see primary care physician. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: Information has been received from a physician's assistant concerning a 12 year old female who on an unspecified date was vaccinated with her second dose of GARDASIL. Subsequently the patient experienced amenorrhea for a couple months after administration of her second dose of GARDASIL. The patient sought unspecified medical attention. On an unspecified date, the patient recovered from amenorrhea. Follow-up information has been received which reported that a 13 year old (previously reported as 12 year old) female student with "1.5 months without period" at the time of vaccination on 27-OCT-2009 at 16:00 was vaccinated with the first dose of GARDASIL (lot # 663453/0249Y) in the right arm, and on 28-DEC-2009 at 16:00 p.m. was vaccinated with the second dose of GARDASIL (lot # 663453/0249Y) in the right arm. On 15-DEC-2009 the patient experienced amenorrhea. There were no laboratory studies performed. The patient's sister also experienced amenorrhea after vaccination with GARDASIL (MSD WAES # 1001USA01872). Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Injection site pain, Musculoskeletal discomfort
Clinical narrative: Information has been received from a healthcare worker concerning a female patient who in 2009 was vaccinated with three doses of GARDASIL (Lot # not reported). Now, in January 2010, the patient was having joint pain and arm pain. It is unknown if the patient sought medical attention. At the time of the report, the patient  had not recovered. Follow-up information has been received from a healthcare worker concerning the female patient who was vaccinated with GARDASIL. It was reported that the patient was fine. She had some discomfort in her joint and arm where she received the GARDASIL injection that lasted for a few days and subsided without intervention or treatment. The patient was currently recovered and the office felt as though it was "no big deal", as the patient was not even sure if the discomfort was from something she did over the weekend and not even from the injection. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Ultrasound antenatal screen normal, Urinary tract infection, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from the pregnancy Registry for GARDASIL from a licensed practical nurse concerning a 19 year old female patient with no pertinent medical history or no known drug allergies, who on 08-SEP-2009 was vaccinated with the first dose of GARDASIL (Lot number 663453/0249Y) intramuscularly and on 10-NOV-2009 received the second dose of GARDASIL (Lot number 663453/0249Y). There was no concomitant medication. Nurse reported that after receiving 2 doses of GARDASIL is now pregnant. An ultrasound done on 20-JAN-2010 showed the patient was 19 weeks pregnant. The patient went to the emergency room (hospital unknown) on 18-JAN-2010 because of a urinary infection so as routine, the emergency room did a urine check that included a pregnancy test. The urine pregnancy test was positive. The LMP was on approximate 30-AUG-2009 and her EDD on 06-JUN-2010. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a certified medical assistant concerning a female former staff member's daughter who on an unknown dates received three doses of GARDASIL. Subsequently, the patient developed headaches after receiving 3 doses of GARDASIL. The patient did not seek medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Crying, Injected limb mobility decreased, Myalgia, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a nurse concerning a female patient with yeast allergy resulted in hives who was vaccinated with the second dose of GARDASIL (lot number and route of administration not reported). There was no concomitant medication. The patient experienced severe pain in her left deltoid. The pain lasted 3 days and she was unable to raise her arm and she was in tears. She had no problems after the first dose of GARDASIL. The patient went to her physician's office. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed
Clinical narrative: Information has been received from a medical assistant concerning a female who last month, in December 2009, was vaccinated with a dose of GARDASIL (lot number not reported). As of 20-JAN-2010 the patient was 2 weeks late for her menstrual cycle. It was unknown if medical attention was sought. The outcome of the patient was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Vertigo
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with the first 0.5 ml dose of GARDASIL (lot number not reported). Subsequently the patient experienced severe vertigo after vaccination. Unspecified medical attention was sought. It was unknown if lab studies performed. The outcome of the patient was not reported. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Abdominal pain, Abdominal pain upper, Arrhythmia, Dizziness, Fatigue
Clinical narrative: Information has been received from a consumer concerning her daughter a 15 year old patient with a history of dizzy spells during ovulation and no drug reactions/allergies, who in July 2009, was vaccinated with the first dose of GARDASIL (lot number not available). Concomitant therapy included an unspecified acne medication. In July 2009, the patient experienced weight loss, nausea, vomiting, fainting, dizziness, muscle weakness, heart arrhythmia, fatigue, stomach ache, headache and vision problems after receiving GARDASIL. The patient went to the emergency room but was not admitted to the hospital. Unspecified tests were done at the emergency room (results not provided). At the time of the report the patient had not recovered. The patient sought medical attention (physician, pharmacist). Follow up information has been received from the physician who reported that on 28-JUL-2009, prior to receiving GARDASIL the patient had complained of vomiting problems and difficulty sleeping and waking up. On 28-JUL-2009, the patient received the first dose of GARDASIL (lot number 663451/0216Y) and concomitantly received a booster dose of VARIVAX (Merck) (lot number 663323/0645Y). On 11-SEP-2009, the patient went to Urgent Care and complained of abdominal pain, vomiting and possible syncope. The patient had a cardiac work up with a Cardiologist (results not reported). The patient was transferred from the Cardiologist to a Pediatric Cardiologist. The Pediatric Cardiologist discontinued all cardiac medications. On 22-JAN-2010, the patient was seen by the physician. The patient reported to the physician that she had life threatening stomach problems. The physician stated that the patient was not terribly ill with life threatening stomach problems. The patient had a sedimentation rate test which was elevated. The physician stated that the patient had an appointment with a Gastroenterologist. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Headache, Muscular weakness, Nausea, Red blood cell count increased, Syncope
Clinical narrative: Information has been received from a consumer concerning her daughter a 15 year old patient with a history of dizzy spells during ovulation and no drug reactions/allergies, who in July 2009, was vaccinated with the first dose of GARDASIL (lot number not available). Concomitant therapy included an unspecified acne medication. In July 2009, the patient experienced weight loss, nausea, vomiting, fainting, dizziness, muscle weakness, heart arrhythmia, fatigue, stomach ache, headache and vision problems after receiving GARDASIL. The patient went to the emergency room but was not admitted to the hospital. Unspecified tests were done at the emergency room (results not provided). At the time of the report the patient had not recovered. The patient sought medical attention (physician, pharmacist). Follow up information has been received from the physician who reported that on 28-JUL-2009, prior to receiving GARDASIL the patient had complained of vomiting problems and difficulty sleeping and waking up. On 28-JUL-2009, the patient received the first dose of GARDASIL (lot number 663451/0216Y) and concomitantly received a booster dose of VARIVAX (Merck) (lot number 663323/0645Y). On 11-SEP-2009, the patient went to Urgent Care and complained of abdominal pain, vomiting and possible syncope. The patient had a cardiac work up with a Cardiologist (results not reported). The patient was transferred from the Cardiologist to a Pediatric Cardiologist. The Pediatric Cardiologist discontinued all cardiac medications. On 22-JAN-2010, the patient was seen by the physician. The patient reported to the physician that she had life threatening stomach problems. The physician stated that the patient was not terribly ill with life threatening stomach problems. The patient had a sedimentation rate test which was elevated. The physician stated that the patient had an appointment with a Gastroenterologist. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Visual impairment, Vomiting, Weight decreased
Clinical narrative: Information has been received from a consumer concerning her daughter a 15 year old patient with a history of dizzy spells during ovulation and no drug reactions/allergies, who in July 2009, was vaccinated with the first dose of GARDASIL (lot number not available). Concomitant therapy included an unspecified acne medication. In July 2009, the patient experienced weight loss, nausea, vomiting, fainting, dizziness, muscle weakness, heart arrhythmia, fatigue, stomach ache, headache and vision problems after receiving GARDASIL. The patient went to the emergency room but was not admitted to the hospital. Unspecified tests were done at the emergency room (results not provided). At the time of the report the patient had not recovered. The patient sought medical attention (physician, pharmacist). Follow up information has been received from the physician who reported that on 28-JUL-2009, prior to receiving GARDASIL the patient had complained of vomiting problems and difficulty sleeping and waking up. On 28-JUL-2009, the patient received the first dose of GARDASIL (lot number 663451/0216Y) and concomitantly received a booster dose of VARIVAX (Merck) (lot number 663323/0645Y). On 11-SEP-2009, the patient went to Urgent Care and complained of abdominal pain, vomiting and possible syncope. The patient had a cardiac work up with a Cardiologist (results not reported). The patient was transferred from the Cardiologist to a Pediatric Cardiologist. The Pediatric Cardiologist discontinued all cardiac medications. On 22-JAN-2010, the patient was seen by the physician. The patient reported to the physician that she had life threatening stomach problems. The physician stated that the patient was not terribly ill with life threatening stomach problems. The patient had a sedimentation rate test which was elevated. The physician stated that the patient had an appointment with a Gastroenterologist. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient with no pertinent medical history, drug reactions or allergies reported, who "about a year ago", in approximately 2009, was vaccinated with the first dose of GARDASIL (route and lot # unknown). There was no concomitant medication. In approximately 2009, "about a year ago", after the patient received the first dose of GARDASIL she fainted. No lab diagnostic studies performed. The patient did not seek medical attention. The physician reported that the patient recovered after fainting and was able to leave the office that same day. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site atrophy, Injection site discolouration, Injection site erythema, Injection site pain, Injection site streaking
Clinical narrative: Information has been received from a physician concerning a 23 year old female patient with no pertinent medical history who on 23-NOV-2009 was vaccinated in her left deltoid with the first dose of GARDASIL (Lot#0981Y). Concomitant therapy included LOESTRIN FE and PROZAC. The physician reported that after received GARDASIL, on 23-NOV-2009, the patient experienced discoloration at the injection site, a dent at the injection site that was about the size of a thumb and a red streak going down her arm. No lab tests were performed. At the time of the report, the physician stated that the patient had not recovered and that her experience was getting worse. Follow-up information has been received from a physician regarding a female patient with no illness at the time of vaccination, no pre-existing allergies, no birth defects, no medical conditions who on 23-NOV-2009 was intramuscularly vaccinated in her left deltoid with the first dose of GARDASIL (Lot#0981Y) at 16:24. The physician reported that on 23-NOV-2009 at 16:24 the patient experienced swelling and pain at the injection site which resolved and still had 1x1 centimeter area of erythema and indentation in her left arm. No laboratory/diagnostic tests were performed. It was reported that the patient was thin. Follow-up information has been received which reported that the reporter had not seen the patient since the last correspondence. No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 23 year old female patient with no pertinent medical history who on 23-NOV-2009 was vaccinated in her left deltoid with the first dose of GARDASIL (Lot#0981Y). Concomitant therapy included LOESTRIN FE and PROZAC. The physician reported that after received GARDASIL, on 23-NOV-2009, the patient experienced discoloration at the injection site, a dent at the injection site that was about the size of a thumb and a red streak going down her arm. No lab tests were performed. At the time of the report, the physician stated that the patient had not recovered and that her experience was getting worse. Follow-up information has been received from a physician regarding a female patient with no illness at the time of vaccination, no pre-existing allergies, no birth defects, no medical conditions who on 23-NOV-2009 was intramuscularly vaccinated in her left deltoid with the first dose of GARDASIL (Lot#0981Y) at 16:24. The physician reported that on 23-NOV-2009 at 16:24 the patient experienced swelling and pain at the injection site which resolved and still had 1x1 centimeter area of erythema and indentation in her left arm. No laboratory/diagnostic tests were performed. It was reported that the patient was thin. Follow-up information has been received which reported that the reporter had not seen the patient since the last correspondence. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Eczema, Nausea, Rash, Vertigo
Clinical narrative: Information has been received from a licensed practical nurse concerning a 20 year old female patient with environmental allergies who on 10-NOV-2009 was intramuscularly vaccinated with the first dose of GARDASIL (Lot#660612/0229X) 0.5 mL. Concomitant therapy included ORTHO TRI-CYCLEN LO and albuterol inhaler as needed. The licensed practical nurse reported that 7 days after received GARDASIL, on 17-NOV-2009, the patient experienced dizziness, nausea and a rash on her face, neck and arms. In November 2009 the patient sought her family physician and she was diagnosed with vertigo and eczema. On an unspecified date, the patient had recovered. The licensed practical nurse reported that now, on 21-JAN-2010, the patient reported her that she had bumps on her arms, but none were observed during the office visit. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Injection site pain, Nausea, Rash
Clinical narrative: Information has been received from a 24 year old female consumer with penicillin allergy who on 07-JAN-2010 was vaccinated with a first dose of GARDASIL. On 08-JAN-2010 the patient experienced dizziness, nausea, rash between her breast, tenderness and pain at injection site and headache. Therapy with GARDASIL was discontinued. The patient did not seek medical attention. At the time of this report the patient had not recovered. Attempts to obtain additional follow up information have been unsuccessful. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Tenderness
Clinical narrative: Information has been received from a 24 year old female consumer with penicillin allergy who on 07-JAN-2010 was vaccinated with a first dose of GARDASIL. On 08-JAN-2010 the patient experienced dizziness, nausea, rash between her breast, tenderness and pain at injection site and headache. Therapy with GARDASIL was discontinued. The patient did not seek medical attention. At the time of this report the patient had not recovered. Attempts to obtain additional follow up information have been unsuccessful. Additional information is not expected.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Information has been received from a pharmacist concerning a 13 year old male who on 21-JAN-2010 was vaccinated with his first dose of GARDASIL, and it went well except for initial arm pain when the needle penetrated. It did not persist and the reporter did not feel it was an adverse event. The patient did not seek medical attention. At the time of the report, the patient's status was unknown. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with the second 0.5ml dose of GARDASIL. The patient developed hives about 1 day after vaccination. The patient sought unspecified medical attention. The patient recovered on an unspecified date. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Pallor, Presyncope
Clinical narrative: Information has been received from a physician concerning a female patient in her late teens (maybe 18 or so) who in approximately November 2009, "about one and half months ago" was vaccinated with a second dose of GARDASIL. In approximately November 2009, the patient experienced dizziness, became very pale and came close to fainting. This was a new experience for the office. They were planning to finish the series. It was unknown if the patient sought medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning an 18 year old female patient with reaction/allergy to dairy and no pertinent medical history, who on 15-OCT-2009 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot # 663452/0671Y). The same day the patient was vaccinated with a dose of HAVRIX and MENACTRA. The patient fainted 24 hours after the injections. The patient recovered the same day. The patient sought unspecified medical attention. No laboratory diagnostics studies were performed. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Fall, Head injury, Subdural haematoma, Syncope, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician, who was not the treating physician (overheard the treating physician discussing this in a hospital hallway), concerning a female patient who on an unspecified date was vaccinated with a 0.5 mL dose of GARDASIL. It was reported that "in the last two weeks", approximately on 23-DEC-2009, the patient experienced a syncope event after receiving GARDASIL. It was reported that "the office did not keep the patient in the office after receiving GARDASIL to make sure she did not have a syncope event, and the patient left the office and fell backwards on tile flooring, hitting the back of her head, and developed a subdural hematoma from result of the fall". The patient was sent to the Emergency Room for treatment, but it was not known at this time whether the patient required further hospitalization. At the time of the report the outcome of the patient was unknown. All telephone attempts to obtain follow-up information have been unsuccessful. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 year old female with no medical history or drugs allergies, who in October 2009, was vaccinated with a first dose of GARDASIL. In November 2009, less than four weeks after the GARDASIL, she started to lost all her hair. The patient was treated with CLODERM. The patient sought medical attention through an office visit. At the time of this report the patient was recovering and the hair has started to grow back. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Body temperature normal, Dizziness, Heart rate normal, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 26 year old female patient who on 18-DEC-2009 was vaccinated with the first 0.5 ml dose of GARDASIL (lot# 0294Y) IM in the left deltoid. On 18-DEC-2009 after vaccination, the patient experienced pain at injection site, abdominal pain, left shoulder aches and pain, nausea and dizziness. The patient was examined in the Emergency Room on 19-DEC-2009 but was not admitted. She was discharged on the same day. The name of the hospital was not known. At the time of the report, the patient's outcome was unknown. Follow-up information has been received from a health care professional and medical records concerning a 26 year old female patient with no illness at the time of vaccination and no known allergies who on 18-DEC-2009 11:30 A.M. was vaccinated with the first 0.5ml dose of GARDASIL (lot# 0294Y) IM in the left deltoid. There was no concomitant medication. On 18-DEC-2009 the patient experienced pain at the injection site, abdominal pain, nausea and dizziness. On 19-DEC-2009 the patient visited the emergency room with complaint of pain at the vaccine injection site on her arm. There was no erythema or swelling. The physical examine was within normal limits except for tenderness at the left shoulder. The pain assessment showed that the patient had a 10 pain score. The patient had aching of the upper arm with radiation of pain to the left shoulder. The physician's assessment noted local myalgia. The patient was treated with MOTRIN, tablet, 800mg, PO. At the time of the report, the patient recovered on an unspecified date. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal pain, Myalgia, Nausea, Pregnancy test, Tenderness
Clinical narrative: Information has been received from a physician concerning a 26 year old female patient who on 18-DEC-2009 was vaccinated with the first 0.5 ml dose of GARDASIL (lot# 0294Y) IM in the left deltoid. On 18-DEC-2009 after vaccination, the patient experienced pain at injection site, abdominal pain, left shoulder aches and pain, nausea and dizziness. The patient was examined in the Emergency Room on 19-DEC-2009 but was not admitted. She was discharged on the same day. The name of the hospital was not known. At the time of the report, the patient's outcome was unknown. Follow-up information has been received from a health care professional and medical records concerning a 26 year old female patient with no illness at the time of vaccination and no known allergies who on 18-DEC-2009 11:30 A.M. was vaccinated with the first 0.5ml dose of GARDASIL (lot# 0294Y) IM in the left deltoid. There was no concomitant medication. On 18-DEC-2009 the patient experienced pain at the injection site, abdominal pain, nausea and dizziness. On 19-DEC-2009 the patient visited the emergency room with complaint of pain at the vaccine injection site on her arm. There was no erythema or swelling. The physical examine was within normal limits except for tenderness at the left shoulder. The pain assessment showed that the patient had a 10 pain score. The patient had aching of the upper arm with radiation of pain to the left shoulder. The physician's assessment noted local myalgia. The patient was treated with MOTRIN, tablet, 800mg, PO. At the time of the report, the patient recovered on an unspecified date. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a Registered Nurse concerning a 16 year old female patient who on unspecified dates was vaccinated with all 3 doses of GARDASIL. The patient had a PAP test 2 weeks ago; on approximately 04-JAN-2010 that was "positive high risk in the 30's or 40's for HPV types 16 & 18". The girl had been sexually active for awhile but this was her first PAP test. While she did receive 3 dose of GARDASIL the office had a storage issue with their vaccines and they must revaccinate patients. This patient received one of the GARDASIL vaccine that was not stored properly. The patient's outcome was unknown. The patient sought unspecified medical attention. The nurse reported that there was no additional information about the patient. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: Information has been received from a physician concerning a female patient who in approximately 2009 ("approximately 1 year ago"), was vaccinated with GARDASIL series (date vaccines were given was unspecified). The patient developed HPV positive now. The patient was showing as "high risk HPV". At the time of reporting, the patient's HPV positive persisted. The patient sought office visit. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Alopecia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 15 year old female with ZITHROMAX and with no other pertinent medical history who on 03-JUL-2008 was vaccinated with a dose of GARDASIL 0.5 ml IM. Other suspect therapy included a dose of VARIVAX (MSD). In January 2009, the patient experienced hair loss six months after receiving GARDASIL. No labs were performed. The patient mentioned this at a recent office visit unrelated to this. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Syringe issue, Underdose
Clinical narrative: Information has been received from a medical assistant concerning a 22 year old female patient with no pertinent medical history and no known allergies who on 20-MAR-2009 was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot number 661952/1129X). On 21-MAY-2009 the patient was vaccinated IM with the second 0.5 ml dose of GARDASIL (lot number reported as 664608/1312Y, invalid for GARDASIL, but is a valid lot number for PNEUMOVAX 23 (MSD). On 07-JAN-2010 the patient was vaccinated IM with an incomplete dose of GARDASIL (lot number reported as 662968/0229Y, invalid for GARDASIL, but is a valid lot number for VARIVAX (Merck) (MSD) and experienced pain during administration. The medical assistant stated that she encountered some resistance with the plunger of the syringe during administration. When she withdrew the needle less than a 1/4 of the dose spilled at the site of injection. There was no concomitant medication. Unspecified medical attention was sought. There were no lab studies performed. On 07-JAN-2009, the patient had recovered. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient who on 12-JUL-2007 and 16-JUL-2008 was vaccinated with the first and second dose of GARDASIL respectively. On 09-APR-2009 the patient went to see her OBGYN physician and they conducted a Pap smear test and the patient had an abnormal Pap smear and they detected an HPV infection. The physician noted that the patient's mother didn't want her daughter to be vaccinated with the third dose of GARDASIL. There was no lot number available. At the time of report the patient's status was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a consumer concerning his wife with no pertinent medical history who in the beginning of December 2009 was vaccinated with a first 0.5 ml dose of GARDASIL. There was no concomitant medication. In the beginning of December 2009 the patient experienced injection site pain for 3 to 5 days after being vaccinated. Subsequently, the patient recovered from injection site pain. No labs were performed. The patient did not seek any medical attention. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 19 year old female who about two years ago, in approximately 2007 was vaccinated with all three doses of GARDASIL. On an unspecified date, Papanicolaou (PAP) test was performed. Recently, in last two months, approximately November 2009, the patient was diagnosed with "Lsil". At the time of the report, the outcome was reported as not improved. The patient sought unspecified medical attention. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on 14-JAN-2010 was vaccinated with a second dose of GARDASIL. About 20 minutes after receiving GARDASIL, when the patient was at home, she called the office back and reported that she was experiencing lots of dizziness and lots of nausea. The patient was advised to come into the office on 15-JAN-2010 or go to the hospital if she still felt dizzy and nauseous. As of 15-JAN-2010, the patient was still feeling dizziness and nausea and went back to the office. Follow up information was received from an administrator which reported that the physician did not remember who the patient was and did not have any further information. Follow up information was received from the physician which reported that the 16 year old female patient experienced dizziness and nausea after GARDASIL. The symptoms were not immediately started but the physician could not recall when the symptoms started in relation with when the vaccine was administered. No labs were performed. The patient's dizziness and nausea much improved shortly after ("over 24 hours"). No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Extensive swelling of vaccinated limb, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with the first, second and third 0.5 ml dose of GARDASIL. After the third dose of GARDASIL vaccination the patient developed "severe swelling at the injection site and it was the largest injection site reaction she had ever seen". There was no lot number provided. The patient had sought unknown medical attention. At the time of report the patient's status was unknown. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: HPV4
Symptoms: Contusion, Hypoaesthesia, Injection site pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 30 year old female with a history of laser removal genital wart who on 08-JAN-2010 was vaccinated with a first dose of 0.5 mL GARDASIL. There was no concomitant medication. On 08-JAN-2010 the patient experienced pain at the injection site. The patient called the office on 15-JAN-2010 and informed the reporter that her whole arm was numb, left leg was numb and bruising. At the time of the report, the patient had not recovered. Additional information has been requested.