chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a female who on 16-JUL-2009 was vaccinated with the second dose of GARDASIL (0.5ml, IM). On 23-JUL-2009 the patient's mother called the office and stated that the patient's arm was sore and she could not lay on it or lift her arm above her head. The office mentioned that it might be the same patient that they had difficulty in giving the injection to (unspecified what kind of difficulty). At the report time the patient had not recovered. Follow-up information was received from a physician concerning a 16 year old female who received the first dose of GARDASIL (lot# 658271/0558X) on 18-MAY-2009. On 16-JUL-2009 the patient received the second dose of GARDASIL (lot# 662518/0087Y). There were no concomitant vaccinations. On 27-JUL-2009 the physician reported that the patient had some pain in the arm. The physician stated that it was unsure if the patient's pain was disabling. The patient's pain was not life-threatening and the patient was not hospitalized. Follow-up information has been received from the physician concerning a 16 year old (reported as 17 year old) female patient with no medical history who on 16-JUL-2009 was vaccinated intramuscularly with the second dose of GARDASIL (lot# 662518/0087Y) in her deltoid. There was no illness at the time of vaccination. On 16-JUL-2009 (previously reported as 23-JUL-2009) the patient experienced pain in her arm, and was unable to raise her arm and slept on side. The physician reported that there was still slight pain but had full range of motion. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: Information has been received from a physician concerning a female who on 22-JUL-2009 was vaccinated with the first 0.5ml dose of GARDASIL (lot# 661703/0651X). On 22-JUL-2009 the patient fainted and experienced dizziness for a while after vaccination. Unspecified medical attention was sought. At the time of reporting the patient's conditions were improved. This is one of several cases from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL, HPV4, TDAP, VARCEL
Symptoms: Excoriation, Loss of consciousness
Clinical narrative: Information has been received from a certified medical assistant concerning an 11 year old female with no pertinent medical history and no allergies who on 23-JUL-2009 was vaccinated IM with the first 0.5ml dose of GARDASIL (lot # 659184/0843X). Concomitant therapy included VARIVAX (Merck) (MSD) and BOOSTRIX. The patient received her first dose of GARDASIL on 23-JUL-2009 and "passed out" while getting into the truck to go home and scraped her hands and knees. The medical assistant mentioned "when her mother got to the truck the girl (the patient or her sister) who was sitting in the truck did not remember getting into the truck". She did not indicate which girl it was. The patient was escorted back into the office and laid back down with the legs up and was given water "since it was really hot yesterday." The patient was discharged from the office to home with her mother and younger sister. No lab diagnostics study was performed. At the time of report, the patient had recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL, HPV4, TDAP, VARCEL
Symptoms: Loss of consciousness, Scratch
Clinical narrative: Information has been received from a certified medical assistant concerning an 11 year old female with no pertinent medical history and no allergies who on 23-JUL-2009 was vaccinated IM with the first 0.5ml dose of GARDASIL (lot # 659184/0843X). Concomitant therapy included VARIVAX (Merck) (MSD) and BOOSTRIX. The patient received her first dose of GARDASIL on 23-JUL-2009 and "passed out" while getting into the truck to go home and scraped her hands and knees. The medical assistant mentioned "when her mother got to the truck the girl (the patient or her sister) who was sitting in the truck did not remember getting into the truck". She did not indicate which girl it was. The patient was escorted back into the office and laid back down with the legs up and was given water "since it was really hot yesterday." The patient was discharged from the office to home with her mother and younger sister. No lab diagnostics study was performed. At the time of report, the patient had recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL, HPV4, TDAP, VARCEL
Symptoms: Excoriation, Loss of consciousness
Clinical narrative: Information has been received from a certified medical assistant concerning an 11 year old female with no pertinent medical history and no allergies who on 23-JUL-2009 was vaccinated IM with the first 0.5ml dose of GARDASIL (lot# 659184/0843X). Concomitant therapy included VARIVAX (Merck) (MSD) and BOOSTRIX. The patient received her first dose of GARDASIL on 23-JUL-2009 and "passed out" while getting into the truck to go home and scraped her hands and knees. The medical assistant mentioned "when her mother got to the truck the girl (the patient or her sister) who was sitting in the truck did not remember getting into the truck". She did not indicate which girl it was. The patient was escorted back into the office and laid back down with the legs up and was given water "since it was really hot yesterday". The patient was discharged home the office to home with her mother and younger sister. No lab diagnostics study was performed. At the time of report, the patient had recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL, HPV4, TDAP, VARCEL
Symptoms: Loss of consciousness, Scratch
Clinical narrative: Information has been received from a certified medical assistant concerning an 11 year old female with no pertinent medical history and no allergies who on 23-JUL-2009 was vaccinated IM with the first 0.5ml dose of GARDASIL (lot# 659184/0843X). Concomitant therapy included VARIVAX (Merck) (MSD) and BOOSTRIX. The patient received her first dose of GARDASIL on 23-JUL-2009 and "passed out" while getting into the truck to go home and scraped her hands and knees. The medical assistant mentioned "when her mother got to the truck the girl (the patient or her sister) who was sitting in the truck did not remember getting into the truck". She did not indicate which girl it was. The patient was escorted back into the office and laid back down with the legs up and was given water "since it was really hot yesterday". The patient was discharged home the office to home with her mother and younger sister. No lab diagnostics study was performed. At the time of report, the patient had recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: DTAP, HPV4, MMR, MNQ
Symptoms: Cough, Dyspnoea, Dyspnoea exertional, No reaction on previous exposure to drug, Upper respiratory tract infection
Clinical narrative: Information has been received from a consumer concerning his 12 year old daughter with no pertinent medical history and no known allergies who on 15-JUL-2009 was vaccinated with the first dose of GARDASIL(lot number not reported). Secondary suspect drug included MMR II (MSD). Concomitant therapy included meningococcal vaccine (unspecified) and diphtheria toxoid (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (VACCIN DTP). On 19-JUL-2009 the patient started experiencing difficulty breathing. Unspecified medical attention was sought. The patient's physician prescribed her prednisone 40 mg (manufacturer unspecified) and the patient had been taking it for 4 days. At the time of the report, the patient was not recovered. Follow-up information has been received from a physician concerning the 12 year old female patient with reactive airway disease usually triggered by respiratory infection who on 15-JUL-2009 at 4:05 PM was vaccinated IM in the left deltoid with the first dose of GARDASIL (lot number 622404/0312Y). Secondary suspect vaccination on the same day at 4:05 PM included a second SQ dose of MMR II (lot number 664363/0554Y) in the right arm. Concomitant vaccinations on the same day at 4:05 PM included a first IM dose of MENACTRA (lot number U2918AA) in the right deltoid and a first IM dose of DTAP (UF471AA) (Sanofi Pasteur) in the left deltoid. There was no illness at the time of vaccination and no adverse event following prior vaccination. On 21-AUG-2009 the patient saw the physician for a 3 day history of cough with a 4 days history of afebrile upper respiratory infection (URI). It was noted by the patient that the shortness of breath (SOB) worsened with physical exertion (PE). The patient's mother started albuterol metered dose inhaler (MDI) 2 days before the office visit. The patient had a physical exam and an arterial blood oxygen saturation test performed with a result of 99%. A respiratory rate measurement was also performed with a result of 16 (unit not provided). The patient stated that she had a decreased voluntary air exchange. The patient was placed on XOPENEX (versus Albuterol) and prednisone for 5 days. On 23-JUL-2009, the patient saw the physician for subjective SOB. The patient vital signs and physical examination were within normal limits. On 25-JUL-2009, the patient recovered. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Vaccine positive rechallenge
Clinical narrative: Information has been received from a  physician concerning a female patient who was vaccinated with the first two doses of GARDASIL. The patient fainted after receiving her first two doses of GARDASIL. The patient sought unknown medical attention. At the time of report the patient's status was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Dizziness, No reaction on previous exposure to drug, Vision blurred
Clinical narrative: Information has been received from a physician concerning a patient who on 22-JUL-2009 was vaccinated with the second dose of GARDASIL (lot# 661703/0651X). On 22-JUL-2009 the patient experienced dizziness and blurry vision after vaccination. It was reported that the patient did not experience any adverse effect on first dose. At the time of reporting the patient's outcome was unknown. This is one of several cases from the same reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Palpitations
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female patient with attention deficit disorder who had been vaccinated with all three doses of GARDASIL, the third 0.5ml dose was given intramuscularly in March 2008. Concomitant therapy included YAZ and ADDERALL TABLETS (manufacturer unspecified). The patient's mother reported that the patient started experiencing heart palpitations. The patient did not seek medical attention. No laboratory diagnostic study was performed. The patient's outcome was unknown. The nurse thought that it might have been her other medication (ADDERALL TABLETS) for attention deficit disorder that caused that. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pyrexia, Rash, Swelling
Clinical narrative: Information has been received from a consumer concerning her granddaughter, a female patient who in 2008 was vaccinated with a first dose of GARDASIL (lot number, route and site not reported). Then the patient started experiencing nausea, fever and swelling (unspecified location). The patient developed rashes 3 to 4 weeks after the vaccination of GARDASIL. The patient went to see 2 physicians and was prescribed with BENADRYL, but her rashes were still there. At the time of report, the patient did not recover. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Malaise
Clinical narrative: Information has been received from a consumer concerning her granddaughter, a female patient who was vaccinated with GARDASIL (lot number, route and site not reported). Subsequently the patient became violently ill. It was unknown if the patient sought medical attention. The patient's outcome was unknown. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Palpitations, Syncope, Tremor
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old female taking birth control and allergy to AMOXICILLIN who on 13-MAY-2009 was vaccinated IM with the first 0.5ml dose of GARDASIL. The nurse reported that the patient was vaccinated IM with the second 0.5ml dose of GARDASIL on 17-JUL-2009 (lot# 658271/0558X). Concomitant therapy included NUVARING. On 17-JUL-2009 the patient experienced syncope post vaccination in the office, but did not fall. The patient was monitored at the office and recovered. The patient's mother called on 20-JUL-2009 stating her daughter was experiencing chest pain, heart racing and shakiness, which started on 19-JUL-2009. The patient was coming in the office for follow upon 27-JUL-2009 and the symptoms persisting. No lab diagnostics study was performed. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Diarrhoea, Fatigue, Nausea, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 22 year old female who was vaccinated IM with the first 0.5ml dose of GARDASIL on 21-JAN-2009. On 21-JUL-2009 the patient was vaccinated IM with the third 0.5ml dose of GARDASIL (Lot#661044/0548X). Concomitant therapy included NUVARING. On 25-JUL-2009 the patient developed a red, widespread, "sunburn-like" rash, fever of 101.9F, nausea, diarrhea and extreme fatigue. The patient also fainted at home on 25-JUL-2009. The patient was seen in the office on 27-JUL-2009 and was referred for evaluation by her unspecified primary care physician. At the time of report the patient's status was not recovered. Follow-up information has been received from a registered nurse who reported that this is 22 year female student. As of 27-JUL-2009 the symptoms persisted and the patient will be going to the emergency room for further evaluation. The nurse practitioner was unsure if the events were related to GARDASIL. At the time of this reporting the outcome was reported as not recovered. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Rash erythematous, Rash generalised, Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a 22 year old female who was vaccinated IM with the first 0.5ml dose of GARDASIL on 21-JAN-2009. On 21-JUL-2009 the patient was vaccinated IM with the third 0.5ml dose of GARDASIL (Lot#661044/0548X). Concomitant therapy included NUVARING. On 25-JUL-2009 the patient developed a red, widespread, "sunburn-like" rash, fever of 101.9F, nausea, diarrhea and extreme fatigue. The patient also fainted at home on 25-JUL-2009. The patient was seen in the office on 27-JUL-2009 and was referred for evaluation by her unspecified primary care physician. At the time of report the patient's status was not recovered. Follow-up information has been received from a registered nurse who reported that this is 22 year female student. As of 27-JUL-2009 the symptoms persisted and the patient will be going to the emergency room for further evaluation. The nurse practitioner was unsure if the events were related to GARDASIL. At the time of this reporting the outcome was reported as not recovered. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a medical assistant concerning a 17 year old female had a negative PAP and was negative for HPV in 2007 who on 02-AUG-2007 was vaccinated with the first dose of GARDASIL. On 11-OCT-2007 the patient was vaccinated with the second dose of GARDASIL and on 04-FEB-2008 the patient was vaccinated with the third dose of GARDASIL. On 21-JUL-2009 a PAP test and HPV test were performed and revealed that the patient was positive for the following HPV types: 16, 18, 31, 35, 39, 45, 51, 52, 56, 58, 59, 68. The patient's recent PAP was negative. The patient had sought medical attention, "test taken in office". At the time of report the patient's status was not recovered. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Asthenia, Chest pain, Dyspnoea, Fatigue
Clinical narrative: Information has been received from a Registered Nurse (R.N) concerning an 18 year old female patient who no pertinent medical history and no known drug allergies/drug reactions who on 22-AUG-2007 was vaccinated with the first dose of GARDASIL (Lot # 658558/1061U). On 09-OCT-2007, the patient was vaccinated with the second dose of GARDASIL (Lot # 660618/0572X). Concomitant therapy included ADVIL. It was reported that "three weeks after the first dose" the patient developed inflammatory polyarthritis. The patient developed joint pain, fatigue, shortness of breath, chest pain, rash, headaches, fever, weakness and muscle aches after receiving a dose of GARDASIL. It was reported that the patient also complained that the injection site was sore for two months aft the second dose of GARDASIL. The patient had not received the third dose. The patient saw the physician. On an unspecified date a rheumatoid factor test was performed and it was positive. It was reported that the patient was recovering at the time of the report. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Injection site pain, Myalgia, Polyarthritis, Pyrexia
Clinical narrative: Information has been received from a Registered Nurse (R.N) concerning an 18 year old female patient who no pertinent medical history and no known drug allergies/drug reactions who on 22-AUG-2007 was vaccinated with the first dose of GARDASIL (Lot # 658558/1061U). On 09-OCT-2007, the patient was vaccinated with the second dose of GARDASIL (Lot # 660618/0572X). Concomitant therapy included ADVIL. It was reported that "three weeks after the first dose" the patient developed inflammatory polyarthritis. The patient developed joint pain, fatigue, shortness of breath, chest pain, rash, headaches, fever, weakness and muscle aches after receiving a dose of GARDASIL. It was reported that the patient also complained that the injection site was sore for two months aft the second dose of GARDASIL. The patient had not received the third dose. The patient saw the physician. On an unspecified date a rheumatoid factor test was performed and it was positive. It was reported that the patient was recovering at the time of the report. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Rheumatoid factor positive
Clinical narrative: Information has been received from a Registered Nurse (R.N) concerning an 18 year old female patient who no pertinent medical history and no known drug allergies/drug reactions who on 22-AUG-2007 was vaccinated with the first dose of GARDASIL (Lot # 658558/1061U). On 09-OCT-2007, the patient was vaccinated with the second dose of GARDASIL (Lot # 660618/0572X). Concomitant therapy included ADVIL. It was reported that "three weeks after the first dose" the patient developed inflammatory polyarthritis. The patient developed joint pain, fatigue, shortness of breath, chest pain, rash, headaches, fever, weakness and muscle aches after receiving a dose of GARDASIL. It was reported that the patient also complained that the injection site was sore for two months aft the second dose of GARDASIL. The patient had not received the third dose. The patient saw the physician. On an unspecified date a rheumatoid factor test was performed and it was positive. It was reported that the patient was recovering at the time of the report. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician and the nurses at the physician's office indicating that the GARDASIL "hurts more". Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Asthenia, Dyskinesia, Injection site pain, Pain in extremity
Clinical narrative: Information has been received from a certified registered nurse practitioner concerning a 16 year old female student with no pre-existing medical history who on 18-JUN-2009 at 11:30 a.m. , was vaccinated intramuscularly with the second dose of GARDASIL (lot# 659054/0315Y) into the left deltoid. There was no concomitant medication. On 25-JUN-2009 one week after the vaccination, the patient experienced a pain from the injection site area down the arm to her wrist. She denied any edema, erythema or fever. She had normal movement and strength to the extremity. There was no illness at the time of vaccination. She visited the doctor for medical attention. No relevant diagnostic tests performed. On 29-JUN-2009 the patient recovered. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a medical assistant concerning a female patient at another physician's office who was vaccinated with a dose of GARDASIL and experienced at the injection site of being hot, swollen and hurt during first couple of days and then the area hardened for 2 weeks. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: Information has been received from a physician concerning a 25 year old female patient with no pertinent medical history and no known drug allergies who on 22-FEB-2007 was vaccinated IM with the first 0.5 ml dose of GARDASIL. The patient on 22-APR-2007 was vaccinated IM with the second 0.5 ml dose of GARADSIL and on 20-NOV-2007 she was vaccinated IM with the third 0.5 ml dose of GARDASIL. Lot numbers were not known. There was no concomitant medication. On 06-JAN-2009, there was a HPV test performed and the patient tested positive for HPV. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Abdominal pain, Activities of daily living impaired, Arthralgia, Back pain, Dizziness
Clinical narrative: Information has been received from a consumer concerning her 11 year old daughter with constipation chronic and no drugs allergies, who on 15-JUN-2009 was vaccinated with a first dose of GARDASIL. The patient's mother reported that her daughter has been having constant joint pain in her back, knees and ankles since about 2.5 weeks ago. The patient also had occasional headaches. She was dizzy about 1-2 days after vaccination. The patient had been treated with MIDOL for pain. The patient had normal blood tests. The patient sought medical attention through an office visit. At the time of this report the patient had not recovered. Follow up information received on 30-JUL-2009 from a licensed practical nurse indicated that on 15-JUN-2009 the patient was vaccinated with a first dose of GARDASIL (lot # 658271/0558X) and concomitantly with a second dose of VARIVAX (Merck) (MSD) (lot # 663817/0488Y), a dose of MENACTRA (lot # U2817AA) and a dose of ADACEL (lot # C3246BA). The patient's mother called the physician's office on 16-JUN-2009 to report that her daughter had abdominal pain and was nauseous. It was documented that the patient's mother was "panicked after seeing the internet". The patient was seeing by the physician on 21-JUL-2009. The physician documented that the patient had malaise and arthralgia. The patient had blood work drawn and the results were normal. The blood work revealed that the patient had a previous mononucleosis infection. On 24-JUL-2009, it was documented in the patient's chart that the patient may need referral to a Rheumatologist. Follow-up information was received from a physician via medical records. The physician reported that the patient is an 11 year old female and on 16-JUN-2009, complained of arthralgias in back, knees and ankles within one day of immunizations. The patient complained of extreme fatigue and significant lower body joint pain which restricted her activity. The patient had full work of labs which were normal. On 21-JUL-2009, Epstein-Barr viral capsid antigen immunoglobulin G antibody test was >8.0, serum Epstein-Barr virus nuclear antigen immunoglobulin G antibody test: >8.0 and Streptozyme was elevated to 1:200. On 31-JUL-2009, Streptozyme was elevated to 1:200 and Anti-DNase B Strep Antibodies were 1:170. The patient improved after Nonsteroidal Anti-Inflammatory Drugs for 2 weeks. There was no illness at time of vaccination. The patient recovered in middle August 2009. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Epstein-Barr virus antibody positive, Fatigue, Headache, Malaise, Nausea
Clinical narrative: Information has been received from a consumer concerning her 11 year old daughter with constipation chronic and no drugs allergies, who on 15-JUN-2009 was vaccinated with a first dose of GARDASIL. The patient's mother reported that her daughter has been having constant joint pain in her back, knees and ankles since about 2.5 weeks ago. The patient also had occasional headaches. She was dizzy about 1-2 days after vaccination. The patient had been treated with MIDOL for pain. The patient had normal blood tests. The patient sought medical attention through an office visit. At the time of this report the patient had not recovered. Follow up information received on 30-JUL-2009 from a licensed practical nurse indicated that on 15-JUN-2009 the patient was vaccinated with a first dose of GARDASIL (lot # 658271/0558X) and concomitantly with a second dose of VARIVAX (Merck) (MSD) (lot # 663817/0488Y), a dose of MENACTRA (lot # U2817AA) and a dose of ADACEL (lot # C3246BA). The patient's mother called the physician's office on 16-JUN-2009 to report that her daughter had abdominal pain and was nauseous. It was documented that the patient's mother was "panicked after seeing the internet". The patient was seeing by the physician on 21-JUL-2009. The physician documented that the patient had malaise and arthralgia. The patient had blood work drawn and the results were normal. The blood work revealed that the patient had a previous mononucleosis infection. On 24-JUL-2009, it was documented in the patient's chart that the patient may need referral to a Rheumatologist. Follow-up information was received from a physician via medical records. The physician reported that the patient is an 11 year old female and on 16-JUN-2009, complained of arthralgias in back, knees and ankles within one day of immunizations. The patient complained of extreme fatigue and significant lower body joint pain which restricted her activity. The patient had full work of labs which were normal. On 21-JUL-2009, Epstein-Barr viral capsid antigen immunoglobulin G antibody test was >8.0, serum Epstein-Barr virus nuclear antigen immunoglobulin G antibody test: >8.0 and Streptozyme was elevated to 1:200. On 31-JUL-2009, Streptozyme was elevated to 1:200 and Anti-DNase B Strep Antibodies were 1:170. The patient improved after Nonsteroidal Anti-Inflammatory Drugs for 2 weeks. There was no illness at time of vaccination. The patient recovered in middle August 2009. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Streptococcus test positive
Clinical narrative: Information has been received from a consumer concerning her 11 year old daughter with constipation chronic and no drugs allergies, who on 15-JUN-2009 was vaccinated with a first dose of GARDASIL. The patient's mother reported that her daughter has been having constant joint pain in her back, knees and ankles since about 2.5 weeks ago. The patient also had occasional headaches. She was dizzy about 1-2 days after vaccination. The patient had been treated with MIDOL for pain. The patient had normal blood tests. The patient sought medical attention through an office visit. At the time of this report the patient had not recovered. Follow up information received on 30-JUL-2009 from a licensed practical nurse indicated that on 15-JUN-2009 the patient was vaccinated with a first dose of GARDASIL (lot # 658271/0558X) and concomitantly with a second dose of VARIVAX (Merck) (MSD) (lot # 663817/0488Y), a dose of MENACTRA (lot # U2817AA) and a dose of ADACEL (lot # C3246BA). The patient's mother called the physician's office on 16-JUN-2009 to report that her daughter had abdominal pain and was nauseous. It was documented that the patient's mother was "panicked after seeing the internet". The patient was seeing by the physician on 21-JUL-2009. The physician documented that the patient had malaise and arthralgia. The patient had blood work drawn and the results were normal. The blood work revealed that the patient had a previous mononucleosis infection. On 24-JUL-2009, it was documented in the patient's chart that the patient may need referral to a Rheumatologist. Follow-up information was received from a physician via medical records. The physician reported that the patient is an 11 year old female and on 16-JUN-2009, complained of arthralgias in back, knees and ankles within one day of immunizations. The patient complained of extreme fatigue and significant lower body joint pain which restricted her activity. The patient had full work of labs which were normal. On 21-JUL-2009, Epstein-Barr viral capsid antigen immunoglobulin G antibody test was >8.0, serum Epstein-Barr virus nuclear antigen immunoglobulin G antibody test: >8.0 and Streptozyme was elevated to 1:200. On 31-JUL-2009, Streptozyme was elevated to 1:200 and Anti-DNase B Strep Antibodies were 1:170. The patient improved after Nonsteroidal Anti-Inflammatory Drugs for 2 weeks. There was no illness at time of vaccination. The patient recovered in middle August 2009. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Myalgia
Clinical narrative: Information has been received from a nurse practitioner concerning a 19 year old female who on 28-NOV-2008 was vaccinated IM with the first 0.5ml dose of GARDASIL. On 12-JUN-2009 the patient was vaccinated IM with the third 0.5ml dose of GARDASIL. Concomitant therapy included unspecified birth control therapy. On 12-JUN-2009 since receiving her third dose the patient had experienced persistent deep muscle pain at the injection site of the right upper arm. The pain was getting worse and had not responded to ibuprofen (manufacturer unknown). The patient contacted the office on 27-JUL-2009 and was scheduled for an evaluation on 28-JUL-2009. At the time of report the patient's status was not recovered. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Nausea, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a 22 year old female patient, for GARDASIL, a Pregnancy Registry product, concerning herself who on 16-JUL-2009 was vaccinated with the first dose of GARDASIL. There was no concomitant medication. Last Sunday, the patient conducted a home urine pregnancy test and it was positive. Patient reported that she went to her gynecologist and they confirmed her pregnancy and she was told that she was 7 weeks pregnant. Lot # was not available. Patient reported that around the time that she got pregnant, she had been experiencing nausea but she was recovering from nausea at the time of reporting. The patient's date of last menstrual period was approximately on 10-JUN-2009 and the estimated delivery date is 17-APR-2010. Information also has been received from a medical assistant reported that the patient on 16-JUL-2009 was vaccinated intramuscular with the first dose of 0.5 ml GARDASIL (lot # 662300/0100Y). The patient called the office on 29-JUL-2009 to report she was pregnant. The patient did not provide a last menstrual period date. No problems reported. Follow up information has been received which reported that the patient's estimated delivery date was March 2010. On an unspecified date in March 2010, the patient had a normal infant with no congenital anomaly. No further information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a nurse concerning a 17 year old female who on 06-JAN-2009 was vaccinated with the first dose of GARDASIL (Lot # 661766/0652X). Subsequently the patient developed rash (location unspecified by nurse). The patient had sought medical attention, saw "nurse or physician". At the time of report the patient's status was unknown. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 23 year old female who was vaccinated with the first dose of GARDASIL on unspecified date. The patient broke out with hives one day after her first vaccination. At the report time the patient had recovered. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Eye disorder, Immediate post-injection reaction, Injection site erythema, Syncope
Clinical narrative: Information has been received from a consumer concerning her 15 year old daughter with a history of acne who in Spring 2008, was vaccinated with her first dose of GARDASIL. Concomitant therapy included tetracycline. After vaccination the patient fainted straight away. The patient also experienced serious issues with her eyes and redness at the injection site. The second and third doses were not administered due to complication from the first dose. The outcome of the patient's fainted straight away, serious issues with her eyes and redness at the injection site was not reported. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Dyspnoea
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 15 year old female who in 2008 (last year) was vaccinated with the first 0.5 mL dose of GARDASIL (Lot # was not provided). Patient experienced anxiety and not able to breathe after getting the first dose of GARDASIL. She did receive second and third dose but didn't experienced any AE. The patient sought unspecified medical attention and recovered from anxiety and not able to breathe. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Asthenia, Dizziness, Headache, Hypothyroidism
Clinical narrative: Information has been received from a consumer concerning her 18 year old daughter with no pertinent medical history who on unknown date was vaccinated with the first dose of GARDASIL (LOT # was not provided). Concomitant therapy included SYNTHROID and MOTRIN. After the first dose the patient experienced hypothyroid. On unknown date the patient was vaccinated with the second dose. The third vaccination was on 28-JUL-2009. After the second and third vaccinations the patient experienced nausea, sinus problems, headache, body stiffness, joint aches, dizziness and weakness. The patient didn't recover from hypothyroid, nausea, sinus problems, headache, body stiffness, joint aches, dizziness and weakness. She sought medical attention and was seen in office. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal stiffness, Nausea, Sinus disorder, Vaccine positive rechallenge
Clinical narrative: Information has been received from a consumer concerning her 18 year old daughter with no pertinent medical history who on unknown date was vaccinated with the first dose of GARDASIL (LOT # was not provided). Concomitant therapy included SYNTHROID and MOTRIN. After the first dose the patient experienced hypothyroid. On unknown date the patient was vaccinated with the second dose. The third vaccination was on 28-JUL-2009. After the second and third vaccinations the patient experienced nausea, sinus problems, headache, body stiffness, joint aches, dizziness and weakness. The patient didn't recover from hypothyroid, nausea, sinus problems, headache, body stiffness, joint aches, dizziness and weakness. She sought medical attention and was seen in office. No further information is available.
Age: 26.0
Sex: F
Vaccine: HEPA, HPV4, TDAP
Symptoms: Incorrect dose administered, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a medical assistant concerning a female patient who on 02-JUL-2007 was vaccinated with the first dose of GARDASIL. The second and third dose of GARDASIL were administered on 26-JUN-2008 and 19-JAN-2009. On 28-JUL-2009, the patient received the fourth dose of GARDASIL. Concomitant therapy included ADACEL, which was administered on the same day but different site. The site of injection for ADACEL was warm to touch and red. The patient had visited the office. At the time of the reporting, the patient had not recovered from injection site warm and red. Follow up information has been received from a physician who reported that the 26 year old female who on 28-JUL-2009 was vaccinated IM with a fourth dose of GARDASIL in the right deltoid at 11:52 a.m. (lot number: 662404/0312Y). Concomitant vaccination included a dose of ADACEL (lot number: UF484BA) IM into the left deltoid and a second dose of hepatitis A virus vaccine (unspecified) (lot number: AHAVB285AB) IM into the left deltoid on the same day (28-JUL-2009) at 11:52 a.m. There was no illness at the time of vaccination. On 29-JUL-2009 (also reported as 2 days after vaccination), the patient developed warmth, redness and swelling at the injection site. The physician reported that by day 3 it started to resolve and the events had not caused further problems. The patient's vaccination history included a dose of ADACEL in 2008. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with the first dose of GARDASIL had a fainting episode. The patient had visited the office. At the time of the report, the patient's outcome was unknown. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 19 year old female patient who on unspecified dates was vaccinated with the first and second dose of GARDASIL and experienced flu like symptoms after each dose. The vaccine administered at her gynecologist's office so no additional information was available at this time. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning an 18 year old female who was vaccinated with GARDASIL (Lot #s not provided). The date for the first and second dose was unspecified and the date for the third dose was 29-JUL-2009. "After getting all the three doses of GARDASIL the patient experienced syncope". It was reported that the syncope was improving. The patient had sought unknown medical attention. At the time of report the patient's status was unknown. This is one of several reports from the same source. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning two female patients who on unknown dates, were vaccinated with a dose of GARDASIL. The nurse reported that the patients fainted after receiving HPV vaccine. It is unknown if the patients sought medical attention. Follow up information received on 20-SEP-2009 from a health care professional indicated that the patient was a 15 year old female student, who on 28-JUL-2009 at 11:57 was vaccinated with a first dose of GARDASIL intramuscularly into the left deltoid. On 28-JUL-2009 at 11:58 the patient was in a sitting position. Gave immunization. About one minute later she saw the patient on the floor. The patient was pulled by legs out of corner of the room. The patient awoke from fainting about one minute later. The physician advised. The patient recovered on 28-JUL-2009. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Antinuclear antibody negative, Arthralgia, Full blood count normal, Nausea, Parvovirus B19 test positive
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, Red blood cell sedimentation rate normal, Rheumatoid factor negative
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: Antinuclear antibody negative, Arthralgia, Blood immunoglobulin G increased, Blood immunoglobulin M, Blood prolactin 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.