chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Rash
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female with no medical history or allergies who on 21-MAY-2010 and 03-AUG-2010 was vaccinated IM with the first and second doses of GARDASIL (lot# 666163/0664Z), 0.5 mL into right arm, respectively. There was no concomitant therapy. On approximately 03-AUG-2010 the patient developed rash and large areas of erythema, over upper extremities of her body, left orbit, neck, abdomen and back. No lab diagnostics studies were performed. The patient was being treated with prednisone. The patient's rash and erythema persisted. The patient sought unspecified medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Asthenia, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Information has been received from a medical assistant concerning a 16 year old female patient with no drug reaction or allergies and no pertinent medical history who on 17-AUG-2010 was vaccinated IM with her first 0.5 ml dose of GARDASIL (lot # 663454/0672Y). Concomitant therapy included YAZ, CELEXA, and SEROQUEL. On 22-AUG-2010 (reported as "5 days after vaccination") the patient developed an enlarged lymph node in her groin. The patient complained of increase pain and noticed 0.5 cm lump on her left side of the groin. No lab diagnostics studies were performed. The patient recovered on 05-SEP-2010. The patient sought unspecified medical attention. Follow-up information has been received from the physician indicating that the patient was vaccinated with a second dose of GARDASIL on 12-NOV-2010 and on 14-NOV-2010 had nausea, headache, tired, weak, and not feeling well. Patient was seen at the doctor office on 15-NOV-2010 with those complaints. Blood count profile labs were taken and were okay, except for white blood cell count was low. Patient was treated symptomatically. On physician follow up call 17-NOV-2010, patient was feeling better. However, another call to physician on 22-NOV-2010 and patient was weak and tired. Follow up information has been received from the physician indicating that the patient with no illness at time of vaccination who on 12-NOV-2010 received the second dose of GARDASIL (lot # 666929/0331Z). No other medications were included. On 13-NOV-2010 (previously reported as "on 14-NOV-2010") she had sore arm, nausea, headache, extreme weakness, diarrhoea, dizziness one day after the second dose vaccination. The patient was treated symptomatically. The patient felt better, but not normal after 2 days. At the time of reporting, the patient's outcome was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Groin pain, Headache, Lymphadenopathy, Malaise, Nausea
Clinical narrative: Information has been received from a medical assistant concerning a 16 year old female patient with no drug reaction or allergies and no pertinent medical history who on 17-AUG-2010 was vaccinated IM with her first 0.5 ml dose of GARDASIL (lot # 663454/0672Y). Concomitant therapy included YAZ, CELEXA, and SEROQUEL. On 22-AUG-2010 (reported as "5 days after vaccination") the patient developed an enlarged lymph node in her groin. The patient complained of increase pain and noticed 0.5 cm lump on her left side of the groin. No lab diagnostics studies were performed. The patient recovered on 05-SEP-2010. The patient sought unspecified medical attention. Follow-up information has been received from the physician indicating that the patient was vaccinated with a second dose of GARDASIL on 12-NOV-2010 and on 14-NOV-2010 had nausea, headache, tired, weak, and not feeling well. Patient was seen at the doctor office on 15-NOV-2010 with those complaints. Blood count profile labs were taken and were okay, except for white blood cell count was low. Patient was treated symptomatically. On physician follow up call 17-NOV-2010, patient was feeling better. However, another call to physician on 22-NOV-2010 and patient was weak and tired. Follow up information has been received from the physician indicating that the patient with no illness at time of vaccination who on 12-NOV-2010 received the second dose of GARDASIL (lot # 666929/0331Z). No other medications were included. On 13-NOV-2010 (previously reported as "on 14-NOV-2010") she had sore arm, nausea, headache, extreme weakness, diarrhoea, dizziness one day after the second dose vaccination. The patient was treated symptomatically. The patient felt better, but not normal after 2 days. At the time of reporting, the patient's outcome was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, White blood cell count decreased
Clinical narrative: Information has been received from a medical assistant concerning a 16 year old female patient with no drug reaction or allergies and no pertinent medical history who on 17-AUG-2010 was vaccinated IM with her first 0.5 ml dose of GARDASIL (lot # 663454/0672Y). Concomitant therapy included YAZ, CELEXA, and SEROQUEL. On 22-AUG-2010 (reported as "5 days after vaccination") the patient developed an enlarged lymph node in her groin. The patient complained of increase pain and noticed 0.5 cm lump on her left side of the groin. No lab diagnostics studies were performed. The patient recovered on 05-SEP-2010. The patient sought unspecified medical attention. Follow-up information has been received from the physician indicating that the patient was vaccinated with a second dose of GARDASIL on 12-NOV-2010 and on 14-NOV-2010 had nausea, headache, tired, weak, and not feeling well. Patient was seen at the doctor office on 15-NOV-2010 with those complaints. Blood count profile labs were taken and were okay, except for white blood cell count was low. Patient was treated symptomatically. On physician follow up call 17-NOV-2010, patient was feeling better. However, another call to physician on 22-NOV-2010 and patient was weak and tired. Follow up information has been received from the physician indicating that the patient with no illness at time of vaccination who on 12-NOV-2010 received the second dose of GARDASIL (lot # 666929/0331Z). No other medications were included. On 13-NOV-2010 (previously reported as "on 14-NOV-2010") she had sore arm, nausea, headache, extreme weakness, diarrhoea, dizziness one day after the second dose vaccination. The patient was treated symptomatically. The patient felt better, but not normal after 2 days. At the time of reporting, the patient's outcome was unknown. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with GARDASIL (lot # not reported). Subsequently the patient experienced warmth, tenderness and swelling at the local injection site. The outcome of the events was not reported. The patient sought unspecified medical attention. Follow up information has been received from a medical assistant concerning a 25 year old female who on 19-AUG-2010 2:46PM was vaccinated intramuscularly into right deltoid with GARDASIL (lot # 0787Z). Concomitant therapy included ADACEL. On 21-AUG-2010 5:06PM the patient experienced warmth, tenderness, swelling and redness at the local injection site. On unknown date, the patient recovered from warmth, tenderness, swelling and redness at the local injection site. The patient required emergency room/doctor visit. No further information is available.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Abdominal pain upper, Dyskinesia, Musculoskeletal stiffness, Posture abnormal, Syncope
Clinical narrative: Information has been received from a physician and a licensed practical nurse concerning a 14 year old female patient with no history of fainting and had clean health history, who on 01-SEP-2010 was vaccinated with a first dose of GARDASIL (lot # 666931/0337Z) in an unspecified arm. Concomitant therapy included a dose of HAVRIX, (Lot number AHAVB453BA) at the other arm on the same day with GARDASIL vaccination . The physician further stated that the patient fainted, and experienced movements described as tonic-clonic. The patient was placed on an exam table allowed to rest, and left the practice feeling fine. The nurse stated that about 3 to 6 minutes following the last vaccination the patient stated that her stomach hurt. She slumped over in her chair and she began having jerking movements, her body became stiff. The patient recovered in approximately 10 seconds. The patient was given some candy a "sucker" and cold compresses were applied. The patient's blood pressure was 96/98. Prior to receiving the GARDASIL vaccination, her blood pressure was 107/71. The patient waited in the office for a time (not specified) and had recovered. The patient went home with her mother and older sister. The patient's blood pressure on leaving the physician's office was 103/68. Additional information is not expected. This is a one of several reports received from the same source. The patient's older sister's information was captured in WAES#1009USA00636.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Tonic clonic movements
Clinical narrative: Information has been received from a physician and a licensed practical nurse concerning a 14 year old female patient with no history of fainting and had clean health history, who on 01-SEP-2010 was vaccinated with a first dose of GARDASIL (lot # 666931/0337Z) in an unspecified arm. Concomitant therapy included a dose of HAVRIX, (Lot number AHAVB453BA) at the other arm on the same day with GARDASIL vaccination . The physician further stated that the patient fainted, and experienced movements described as tonic-clonic. The patient was placed on an exam table allowed to rest, and left the practice feeling fine. The nurse stated that about 3 to 6 minutes following the last vaccination the patient stated that her stomach hurt. She slumped over in her chair and she began having jerking movements, her body became stiff. The patient recovered in approximately 10 seconds. The patient was given some candy a "sucker" and cold compresses were applied. The patient's blood pressure was 96/98. Prior to receiving the GARDASIL vaccination, her blood pressure was 107/71. The patient waited in the office for a time (not specified) and had recovered. The patient went home with her mother and older sister. The patient's blood pressure on leaving the physician's office was 103/68. Additional information is not expected. This is a one of several reports received from the same source. The patient's older sister's information was captured in WAES#1009USA00636.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Contusion
Clinical narrative: Information has been received from a representative concerning an "about 20" years old female who on an unknown date was vaccinated with the first dose of GARDASIL (lot # not reported). The patient noticed bruising in her lower extremities. The outcome of bruising in her lower extremities was not reported. The patient sought unspecified medical attention. In follow-up, the physician indicated that the 18 year old (reported as "about 20" in the first version) patient with iodine allergy and mild attention deficient disorder (ADD) who on 12-AUG-2010 was vaccinated IM with the first dose of GARDASIL (lot # 666929/0331Z). In August 2010, the patient experienced bruising in her lower extremities. The outcome of bruising in her lower extremities was not reported. The patient visited the doctor. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: FLUN3, HPV4
Symptoms: Coombs direct test, Herpes zoster, Injection site pain, Injection site rash, Injection site reaction
Clinical narrative: Information has been received from a physician concerning a 13 year old male with hypothyroidism and no drug reactions/allergies and a history of vaccination with VARIVAX (Merck) on 09-SEP-1998 and 09-AUG-2007, who on 11-OCT-2010 was vaccinated with a second dose of GARDASIL (Lot # not reported). Concomitant therapy included SYNTHROID, clonidine and loratadine (MSD). The physician reported that the patient had developed a shingles-like rash and muscle weakness at the injection site after receiving dose 2 of GARDASIL (Lot # not reported). The patient initially started having injection site pain on 12-OCT-2010. On 13-OCT-2010 the patient had developed a rash at the injection site which progressed the following days along with localized muscle weakness. He was prescribed acyclovir by his pediatrician's office. The physician referred the patient to see the specialist in infectious disease. The specialist had done a direct antigen test and was waiting for the result. She reported that the older lesions at the injection site had crusted but the new ones had formed on 17-OCT-2010. The muscle weakness at the injection site was starting to go away. At the time of the report, the patient was recovering. Follow-up information has been received from the physician. The patient had throbbing pain and almost complete paresis of his arm within a few days following the dose 2 of GARDASIL. He was diagnosed with Zoster at C5 and had post-herpetic neuralgia. He did not have natural varicella and had received 2 doses of VARIVAX (Merck). Dates of VARIVAX (Merck) were unknown, but not known to be recent (previously reported on 09-SEP-1999 and 09-AUG-2007). The patient was treated with VALTREX and symptoms of pain and weakness were still persisting as of today (10-NOV-2010). He had physical therapy to treat the weakness. The patient did not undergone any nerve conduction studies but that this would be considered if the symptoms persist for a few more weeks. Follow-up information has been received from a physician concerning the patient. The patient had no illness at time of vaccination. On 11-OCT-2010 the patient received a second dose of GARDASIL (Lot # 666987/1016Z) IM in the left deltoid, and a dose of FLUMIST (Lot # 501036P) intranasally. On 13-OCT-2010 the patient developed swelling and pain in the shoulder area after immunization. He also developed vesiculopapular rash on left shoulder that had spread down the arm on 12-OCT-2010 (2 days post immunization). On 15-OCT-2010 condition was discussed with Infectious Disease. Diagnosis: shingles. The patient has been seen by neurology clinic for post herpetic paresis. At the time of reporting, the patient had not recovered from the events. Follow-up information has been received from the physician. The patient was a male. Besides hypothyroidism, his medical conditions also included precocious puberty, growth failure and poor weight gain. No further information is available.
Age: 13.0
Sex: M
Vaccine: FLUN3, HPV4
Symptoms: Joint swelling, Muscular weakness, Musculoskeletal pain, Pain in extremity, Paresis
Clinical narrative: Information has been received from a physician concerning a 13 year old male with hypothyroidism and no drug reactions/allergies and a history of vaccination with VARIVAX (Merck) on 09-SEP-1998 and 09-AUG-2007, who on 11-OCT-2010 was vaccinated with a second dose of GARDASIL (Lot # not reported). Concomitant therapy included SYNTHROID, clonidine and loratadine (MSD). The physician reported that the patient had developed a shingles-like rash and muscle weakness at the injection site after receiving dose 2 of GARDASIL (Lot # not reported). The patient initially started having injection site pain on 12-OCT-2010. On 13-OCT-2010 the patient had developed a rash at the injection site which progressed the following days along with localized muscle weakness. He was prescribed acyclovir by his pediatrician's office. The physician referred the patient to see the specialist in infectious disease. The specialist had done a direct antigen test and was waiting for the result. She reported that the older lesions at the injection site had crusted but the new ones had formed on 17-OCT-2010. The muscle weakness at the injection site was starting to go away. At the time of the report, the patient was recovering. Follow-up information has been received from the physician. The patient had throbbing pain and almost complete paresis of his arm within a few days following the dose 2 of GARDASIL. He was diagnosed with Zoster at C5 and had post-herpetic neuralgia. He did not have natural varicella and had received 2 doses of VARIVAX (Merck). Dates of VARIVAX (Merck) were unknown, but not known to be recent (previously reported on 09-SEP-1999 and 09-AUG-2007). The patient was treated with VALTREX and symptoms of pain and weakness were still persisting as of today (10-NOV-2010). He had physical therapy to treat the weakness. The patient did not undergone any nerve conduction studies but that this would be considered if the symptoms persist for a few more weeks. Follow-up information has been received from a physician concerning the patient. The patient had no illness at time of vaccination. On 11-OCT-2010 the patient received a second dose of GARDASIL (Lot # 666987/1016Z) IM in the left deltoid, and a dose of FLUMIST (Lot # 501036P) intranasally. On 13-OCT-2010 the patient developed swelling and pain in the shoulder area after immunization. He also developed vesiculopapular rash on left shoulder that had spread down the arm on 12-OCT-2010 (2 days post immunization). On 15-OCT-2010 condition was discussed with Infectious Disease. Diagnosis: shingles. The patient has been seen by neurology clinic for post herpetic paresis. At the time of reporting, the patient had not recovered from the events. Follow-up information has been received from the physician. The patient was a male. Besides hypothyroidism, his medical conditions also included precocious puberty, growth failure and poor weight gain. No further information is available.
Age: 13.0
Sex: M
Vaccine: FLUN3, HPV4
Symptoms: Post herpetic neuralgia, Rash pustular, Scab, Skin lesion
Clinical narrative: Information has been received from a physician concerning a 13 year old male with hypothyroidism and no drug reactions/allergies and a history of vaccination with VARIVAX (Merck) on 09-SEP-1998 and 09-AUG-2007, who on 11-OCT-2010 was vaccinated with a second dose of GARDASIL (Lot # not reported). Concomitant therapy included SYNTHROID, clonidine and loratadine (MSD). The physician reported that the patient had developed a shingles-like rash and muscle weakness at the injection site after receiving dose 2 of GARDASIL (Lot # not reported). The patient initially started having injection site pain on 12-OCT-2010. On 13-OCT-2010 the patient had developed a rash at the injection site which progressed the following days along with localized muscle weakness. He was prescribed acyclovir by his pediatrician's office. The physician referred the patient to see the specialist in infectious disease. The specialist had done a direct antigen test and was waiting for the result. She reported that the older lesions at the injection site had crusted but the new ones had formed on 17-OCT-2010. The muscle weakness at the injection site was starting to go away. At the time of the report, the patient was recovering. Follow-up information has been received from the physician. The patient had throbbing pain and almost complete paresis of his arm within a few days following the dose 2 of GARDASIL. He was diagnosed with Zoster at C5 and had post-herpetic neuralgia. He did not have natural varicella and had received 2 doses of VARIVAX (Merck). Dates of VARIVAX (Merck) were unknown, but not known to be recent (previously reported on 09-SEP-1999 and 09-AUG-2007). The patient was treated with VALTREX and symptoms of pain and weakness were still persisting as of today (10-NOV-2010). He had physical therapy to treat the weakness. The patient did not undergone any nerve conduction studies but that this would be considered if the symptoms persist for a few more weeks. Follow-up information has been received from a physician concerning the patient. The patient had no illness at time of vaccination. On 11-OCT-2010 the patient received a second dose of GARDASIL (Lot # 666987/1016Z) IM in the left deltoid, and a dose of FLUMIST (Lot # 501036P) intranasally. On 13-OCT-2010 the patient developed swelling and pain in the shoulder area after immunization. He also developed vesiculopapular rash on left shoulder that had spread down the arm on 12-OCT-2010 (2 days post immunization). On 15-OCT-2010 condition was discussed with Infectious Disease. Diagnosis: shingles. The patient has been seen by neurology clinic for post herpetic paresis. At the time of reporting, the patient had not recovered from the events. Follow-up information has been received from the physician. The patient was a male. Besides hypothyroidism, his medical conditions also included precocious puberty, growth failure and poor weight gain. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Menorrhagia
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female patient with incontinence, no allergies who on 05-AUG-2010 was vaccinated with a first 0.5 ml dose of GARDASIL (Lot# 0318Z), IM and on 07-DEC-2010 was vaccinated with a second 0.5ml dose of GARDASIL (Lot# 1231Z), IM. There was no concomitant medication. The nurse stated that on 05-AUG-2010 and on 07-DEC-2010 the patient experienced heavy bleeding 24 hours after each dose of GARDASIL. There were no laboratories performed. At the time of the report the patient was recovering from these symptoms. The patient sought unspecified medical attention. This is one of several reports received from the same source. Follow-up information has been received from the registered nurse who reported that the female patient (GU) tanner 4 (not yet normally menstruating) on 06-AUG-2010 was vaccinated with a first 0.5ml dose of GARDASIL (Lot# 1231Z), IM, left deltoid at 19:00, and on 08-DEC-2010 was vaccinated with a second 0.5ml dose of GARDASIL (lot# 1231Z), IM, at 11:00. The patient experienced hematuria at the time of vaccination and also it was reported that the patient was well in the child visits. The registered nurse stated that on 06-AUG-2010 (also reported as 05-AUG-2010 by the registered nurse) the patient was no menstruating and suddenly had an onset of heavy menstrual cycle (24 degrees post injection). On 09-AUG-2010, the patient recovered and she did not require treatment. The nurse also stated that the patient on 08-DEC-2010 (also reported as 07-DEC-2010 by the registered nurse) started a menstrual cycle that included heavy bleeding. No treatment was needed for these events. There were no laboratories diagnostics performed. At the time of the report the patient had recovered on 11-DEC-2010. The patient did not seek medical attention. No further information is available.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Muscular weakness, Nausea, Pain in extremity, Vertigo
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old male patient with unspecified chronic condition, who on 07-DEC-2010 also reported "3 to 4 weeks ago on approximately 21-DEC-2010 by the nurse" was vaccinated with 0.5ml dose of GARDASIL (Lot# not reported), IM. The nurse reported that on 07-DEC-2010 the patient experienced nauseas, lightheaded and the room was spinning. Patient had leg pain and muscle weakness. The patient was instructed to go to the hospital. He was stable and discharged. Follow up information has been received from the registered nurse indicating that the patient "felt dizzy again and was referred to the emergency room". Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPVX, HPV4
Symptoms: Anxiety, Panic attack, Syncope
Clinical narrative: Information has been received from a currently 24 year old female consumer with no drug allergies or pertinent medical history who in August 2007, was vaccinated with the second dose of GARDASIL (lot number not provided). There was no concurrent medication. The consumer reported that in August 2007 (at the age of 21 years old) after receiving the second dose of the vaccine, she fainted in the physician's office. She also began to experience "anxiety, social phobia, tremendous panic attacks and nervous system issues." The consumer reported that she was treated with anti-anxiety medication but that just made it worse so her doctor took her off it. Laboratory tests performed included "regular blood draw" with no results provided. Therapy with GARDASIL was discontinued before receiving the third dose. The consumer reported that she was still experiencing the symptoms mentioned in which she felt "ruined her life". The patient sought unspecified medical attention. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPVX, HPV4
Symptoms: Anxiety, Blood test, Nervous system disorder, Panic attack, Social phobia
Clinical narrative: Information has been received from a currently 24 year old female consumer with no drug allergies or pertinent medical history who in August 2007, was vaccinated with the second dose of GARDASIL (lot number not provided). There was no concurrent medication. The consumer reported that in August 2007 (at the age of 21 years old) after receiving the second dose of the vaccine, she fainted in the physician's office. She also began to experience "anxiety, social phobia, tremendous panic attacks and nervous system issues." The consumer reported that she was treated with anti-anxiety medication but that just made it worse so her doctor took her off it. Laboratory tests performed included "regular blood draw" with no results provided. Therapy with GARDASIL was discontinued before receiving the third dose. The consumer reported that she was still experiencing the symptoms mentioned in which she felt "ruined her life". The patient sought unspecified medical attention. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPVX, HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a currently 24 year old female consumer with no drug allergies or pertinent medical history who in August 2007, was vaccinated with the second dose of GARDASIL (lot number not provided). There was no concurrent medication. The consumer reported that in August 2007 (at the age of 21 years old) after receiving the second dose of the vaccine, she fainted in the physician's office. She also began to experience "anxiety, social phobia, tremendous panic attacks and nervous system issues." The consumer reported that she was treated with anti-anxiety medication but that just made it worse so her doctor took her off it. Laboratory tests performed included "regular blood draw" with no results provided. Therapy with GARDASIL was discontinued before receiving the third dose. The consumer reported that she was still experiencing the symptoms mentioned in which she felt "ruined her life". The patient sought unspecified medical attention. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site rash, Rash
Clinical narrative: Information has been received from a licensed practical nurse concerning a 15 year old female with BENADRYL and NSAIDS allergies and a history of unspecified mood disorder who on 10-JAN-2011 was vaccinated IM with a first dose of GARDASIL (lot # 666931/0337Z, expiration date November 2012). Concomitant therapy included TRILEPTAL. On 10-JAN-2011 the patient returned to the office one hour after receiving GARDASIL with a rash on her neck, chest and around the injection site. The patient was sent to the emergency room where she received a dose of DEPO-MEDROL and was released. On 11-JAN-2011 the patient was full recovered from a rash on her neck, chest and a rash around the injection site. No lab diagnostics studies performed. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a licensed practical nurse concerning a 16 year old female with migraine and no drug allergies who on 10-JAN-2011 was vaccinated IM with GARDASIL (lot # 666931/0337Z expiration date November 2012). Concomitant therapy included DEPO-MEDROL, injection. On 10-JAN-2011 the patient experienced a period of syncope after receiving GARDASIL. The patient was observed for 30 minutes point immunization and released. No treatment was given for the syncope. The patient recovered on 10-JAN-2011. There were no other events to report. No lab diagnostics studies performed. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain upper, Asthenia, Biopsy site unspecified normal, Blood potassium decreased, Colonoscopy
Clinical narrative: Information has been received from a consumer concerning her 19 year old daughter with positive antinuclear antibody (ANA) who in November 2009 was vaccinated with a dose of 0.5ml GARDASIL intramuscular, on 15-DEC-2010 was vaccinated with her 3rd dose of 0.5ml GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). The patient reported that her daughter was so dizzy last week, the daughter said she felt like she was going to faint. On 17-DEC-2010 the patient experienced diarrhea, dizziness, nausea, heartburn and fatigue and no able to function at college. Blood work was performed, result was not provided. When the information was reporting, the patient was not recovered. Follow up information has been received from the physician who mentioned that on 06-NOV-2009 the patient was vaccinated with the first 0.5ml dose of GARDASIL (lot#663454/0672Y) i.m. on left upper arm and the second dose of GARDASIL (662529/1317Y) i.m. on left upper arm on 08-JAN-2010, and the third 0.5ml dose of GARDASIL (lot# 656987/1016Z) i.m. on left upper arm on 15-DEC-2010. The physician mentioned that he did not examine or treat the patient for any side effect of the vaccine. Follow up information has been received from the physician on 05-APR-2011. The physician stated that he would disclose but patient saw another practitioner for all these complaints and they gave us all the information they had. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dehydration, Diarrhoea, Dizziness, Duodenitis, Dyspnoea
Clinical narrative: Information has been received from a consumer concerning her 19 year old daughter with positive antinuclear antibody (ANA) who in November 2009 was vaccinated with a dose of 0.5ml GARDASIL intramuscular, on 15-DEC-2010 was vaccinated with her 3rd dose of 0.5ml GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). The patient reported that her daughter was so dizzy last week, the daughter said she felt like she was going to faint. On 17-DEC-2010 the patient experienced diarrhea, dizziness, nausea, heartburn and fatigue and no able to function at college. Blood work was performed, result was not provided. When the information was reporting, the patient was not recovered. Follow up information has been received from the physician who mentioned that on 06-NOV-2009 the patient was vaccinated with the first 0.5ml dose of GARDASIL (lot#663454/0672Y) i.m. on left upper arm and the second dose of GARDASIL (662529/1317Y) i.m. on left upper arm on 08-JAN-2010, and the third 0.5ml dose of GARDASIL (lot# 656987/1016Z) i.m. on left upper arm on 15-DEC-2010. The physician mentioned that he did not examine or treat the patient for any side effect of the vaccine. Follow up information has been received from the physician on 05-APR-2011. The physician stated that he would disclose but patient saw another practitioner for all these complaints and they gave us all the information they had. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fluid replacement, Gastritis, Oesophagitis, Oesophagogastroduodenoscopy, Pallor
Clinical narrative: Information has been received from a consumer concerning her 19 year old daughter with positive antinuclear antibody (ANA) who in November 2009 was vaccinated with a dose of 0.5ml GARDASIL intramuscular, on 15-DEC-2010 was vaccinated with her 3rd dose of 0.5ml GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). The patient reported that her daughter was so dizzy last week, the daughter said she felt like she was going to faint. On 17-DEC-2010 the patient experienced diarrhea, dizziness, nausea, heartburn and fatigue and no able to function at college. Blood work was performed, result was not provided. When the information was reporting, the patient was not recovered. Follow up information has been received from the physician who mentioned that on 06-NOV-2009 the patient was vaccinated with the first 0.5ml dose of GARDASIL (lot#663454/0672Y) i.m. on left upper arm and the second dose of GARDASIL (662529/1317Y) i.m. on left upper arm on 08-JAN-2010, and the third 0.5ml dose of GARDASIL (lot# 656987/1016Z) i.m. on left upper arm on 15-DEC-2010. The physician mentioned that he did not examine or treat the patient for any side effect of the vaccine. Follow up information has been received from the physician on 05-APR-2011. The physician stated that he would disclose but patient saw another practitioner for all these complaints and they gave us all the information they had. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Peripheral coldness, Protein urine present
Clinical narrative: Information has been received from a consumer concerning her 19 year old daughter with positive antinuclear antibody (ANA) who in November 2009 was vaccinated with a dose of 0.5ml GARDASIL intramuscular, on 15-DEC-2010 was vaccinated with her 3rd dose of 0.5ml GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). The patient reported that her daughter was so dizzy last week, the daughter said she felt like she was going to faint. On 17-DEC-2010 the patient experienced diarrhea, dizziness, nausea, heartburn and fatigue and no able to function at college. Blood work was performed, result was not provided. When the information was reporting, the patient was not recovered. Follow up information has been received from the physician who mentioned that on 06-NOV-2009 the patient was vaccinated with the first 0.5ml dose of GARDASIL (lot#663454/0672Y) i.m. on left upper arm and the second dose of GARDASIL (662529/1317Y) i.m. on left upper arm on 08-JAN-2010, and the third 0.5ml dose of GARDASIL (lot# 656987/1016Z) i.m. on left upper arm on 15-DEC-2010. The physician mentioned that he did not examine or treat the patient for any side effect of the vaccine. Follow up information has been received from the physician on 05-APR-2011. The physician stated that he would disclose but patient saw another practitioner for all these complaints and they gave us all the information they had. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Activities of daily living impaired, Allergy test positive, Antinuclear antibody positive, Blood test, Diarrhoea
Clinical narrative: Information has been received from a consumer concerning her 19 year old daughter with positive antinuclear antibody (ANA) who in November 2009 was vaccinated with a dose of 0.5ml GARDASIL intramuscular, on 15-DEC-2010 was vaccinated with her 3rd dose of 0.5ml GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). The patient reported that her daughter was so dizzy last week, the daughter said she felt like she was going to faint. On 17-DEC-2010 the patient experienced diarrhea, dizziness, nausea, heartburn and fatigue and no able to function at college. Blood work was performed, result was not provided. When the information was reporting, the patient was not recovered. Follow up information has been received from the physician who mentioned that on 06-NOV-2009 the patient was vaccinated with the first 0.5ml dose of GARDASIL (lot#663454/0672Y) i.m. on left upper arm and the second dose of GARDASIL (662529/1317Y) i.m. on left upper arm on 08-JAN-2010, and the third 0.5ml dose of GARDASIL (lot# 656987/1016Z) i.m. on left upper arm on 15-DEC-2010. The physician mentioned that he did not examine or treat the patient for any side effect of the vaccine. Follow up information has been received from the physician on 05-APR-2011. The physician stated that he would disclose but patient saw another practitioner for all these complaints and they gave us all the information they had. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Dyspepsia, Fatigue, Hypersensitivity, Nausea
Clinical narrative: Information has been received from a consumer concerning her 19 year old daughter with positive antinuclear antibody (ANA) who in November 2009 was vaccinated with a dose of 0.5ml GARDASIL intramuscular, on 15-DEC-2010 was vaccinated with her 3rd dose of 0.5ml GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). The patient reported that her daughter was so dizzy last week, the daughter said she felt like she was going to faint. On 17-DEC-2010 the patient experienced diarrhea, dizziness, nausea, heartburn and fatigue and no able to function at college. Blood work was performed, result was not provided. When the information was reporting, the patient was not recovered. Follow up information has been received from the physician who mentioned that on 06-NOV-2009 the patient was vaccinated with the first 0.5ml dose of GARDASIL (lot#663454/0672Y) i.m. on left upper arm and the second dose of GARDASIL (662529/1317Y) i.m. on left upper arm on 08-JAN-2010, and the third 0.5ml dose of GARDASIL (lot# 656987/1016Z) i.m. on left upper arm on 15-DEC-2010. The physician mentioned that he did not examine or treat the patient for any side effect of the vaccine. Follow up information has been received from the physician on 05-APR-2011. The physician stated that he would disclose but patient saw another practitioner for all these complaints and they gave us all the information they had. No further information is available.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Axillary pain, Electrocardiogram normal, Pain in extremity, Sensation of heaviness, Spirometry normal
Clinical narrative: Information has been received from a licensed practical nurse concerning a 14 year old female with no drug reaction/allergies and no pertinent medical history, who on 26-JAN-2011 was IM vaccinated in her left deltoid with a first 0.5 ml dose of GARDASIL (lot # 667165/1167Z). Concomitant therapy included FLUARIX (manufacturer by GSK) in right deltoid on the same day. Post vaccination with GARDASIL, the patient developed sharp left sided pain and weakness in her left arm and left leg. The patient was seen for follow up at the office on Friday 11-FEB-2011, and the left sided pain resolved and was rated a 2 pain level out of 10. However, at the time of the follow up visit, the patient complained of shortness of breath, dizziness and heaviness in her left arm and left leg. The patient was being monitored and was asked to call the office if she was still experiencing any symptoms. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Dizziness, Dyspnoea, Muscular weakness, Pain, Sensation of heaviness
Clinical narrative: Information has been received from a licensed practical nurse concerning a 14 year old female with no drug reaction/allergies and no pertinent medical history, who on 26-JAN-2011 was IM vaccinated in her left deltoid with a first 0.5 ml dose of GARDASIL (lot # 667165/1167Z). Concomitant therapy included FLUARIX (manufacturer by GSK) in right deltoid on the same day. Post vaccination with GARDASIL, the patient developed sharp left sided pain and weakness in her left arm and left leg. The patient was seen for follow up at the office on Friday 11-FEB-2011, and the left sided pain resolved and was rated a 2 pain level out of 10. However, at the time of the follow up visit, the patient complained of shortness of breath, dizziness and heaviness in her left arm and left leg. The patient was being monitored and was asked to call the office if she was still experiencing any symptoms. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram head, Computerised tomogram normal, Dizziness, Face oedema, Headache
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old female with allergic reaction to bee sting and no pertinent medical history who on 10-FEB-2011 was vaccinated with a dose of GARDASIL (lot # 661954/0075Y, expiration date 15-MAR-2011). There was no concomitant medication. On 10-FEB-2011 within 30 minutes after vaccination, the patient experienced numbness and edema on the side of the face. The patient also developed headache, nausea, fever (99 * F), "lightheaded and unable to focus". The patient was treated with BENADRYL and aspirin. The patient's numbness and edema on the side of the face, headache, nausea, fever (99 * F), "lightheaded and unable to focus" persisted. The patient sought medical attention by office visit. Follow up information has been received from the certified registered nurse practitioner concerning the 20 year old female student with bee sting allergy requiring  EPIPEN, asthma and no illness at the time of vaccination who on 10-FEB-2011, at 17:30, was vaccinated with the first dose of GARDASIL into the left deltoid. There was no other concomitant vaccine. 30 minutes post injection (at 18:00), the patient experienced left facial edema. 40 minutes after injection, the patient experienced headache, dizzy and nausea. These adverse events required emergency room/doctor visit. At the time of this report, the patient had not recovered from all the events. CT of head was performed and result was negative. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nausea
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old female with allergic reaction to bee sting and no pertinent medical history who on 10-FEB-2011 was vaccinated with a dose of GARDASIL (lot # 661954/0075Y, expiration date 15-MAR-2011). There was no concomitant medication. On 10-FEB-2011 within 30 minutes after vaccination, the patient experienced numbness and edema on the side of the face. The patient also developed headache, nausea, fever (99 * F), "lightheaded and unable to focus". The patient was treated with BENADRYL and aspirin. The patient's numbness and edema on the side of the face, headache, nausea, fever (99 * F), "lightheaded and unable to focus" persisted. The patient sought medical attention by office visit. Follow up information has been received from the certified registered nurse practitioner concerning the 20 year old female student with bee sting allergy requiring  EPIPEN, asthma and no illness at the time of vaccination who on 10-FEB-2011, at 17:30, was vaccinated with the first dose of GARDASIL into the left deltoid. There was no other concomitant vaccine. 30 minutes post injection (at 18:00), the patient experienced left facial edema. 40 minutes after injection, the patient experienced headache, dizzy and nausea. These adverse events required emergency room/doctor visit. At the time of this report, the patient had not recovered from all the events. CT of head was performed and result was negative. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hypoaesthesia facial, Nausea, Pyrexia, Vision blurred
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old female with allergic reaction to bee sting and no pertinent medical history who on 10-FEB-2011 was vaccinated with a dose of GARDASIL (lot # 661954/0075Y, expiration date 15-MAR-2011). There was no concomitant medication. On 10-FEB-2011 within 30 minutes after vaccination, the patient experienced numbness and edema on the side of the face. The patient also developed headache, nausea, fever (99 * F), "lightheaded and unable to focus". The patient was treated with BENADRYL and aspirin. The patient's numbness and edema on the side of the face, headache, nausea, fever (99 * F), "lightheaded and unable to focus" persisted. The patient sought medical attention by office visit. Follow up information has been received from the certified registered nurse practitioner concerning the 20 year old female student with bee sting allergy requiring  EPIPEN, asthma and no illness at the time of vaccination who on 10-FEB-2011, at 17:30, was vaccinated with the first dose of GARDASIL into the left deltoid. There was no other concomitant vaccine. 30 minutes post injection (at 18:00), the patient experienced left facial edema. 40 minutes after injection, the patient experienced headache, dizzy and nausea. These adverse events required emergency room/doctor visit. At the time of this report, the patient had not recovered from all the events. CT of head was performed and result was negative. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4, FLU3, HPV4
Symptoms: Fluctuance, Injection site induration, Local reaction
Clinical narrative: Information has been received from a physician concerning a patient who was using a vaccine and experienced delayed localized reaction around the HPV injection site. It was unknown if the patient sought medical attention. The representative reported that he thought the product was GARDASIL, but he was not sure. Follow up information received from other health professional concerning a 10 year old female student with no previous reactions to shots with illness at time of vaccination obese, acne, Osgood-Schlatter's disease and patellofemoral stress on 14-FEB-2011 at 15:30 approximately received the first dose of GARDASIL (lot number 666931/0337Z) IM on the right deltoid with public fund at academic. On the same day she received the first dose of FLUZONE (lot number U3776DA) IM on the left deltoid. On the 14-FEB-2011 (also reported 20-FEB-2011) the patient noted swelling a large after injection 6 days after injection, erythema, elevated 9 warm and intermittent purpura with total size of 11.4 cm and 33.4 cm with slighting with a total size of 1 1/4 cm with indurations. The patient required doctor visit. No laboratory data. No further information is available.
Age: 10.0
Sex: F
Vaccine: HPV4, FLU3, HPV4
Symptoms: Erythema, Induration, Purpura, Skin warm, Swelling
Clinical narrative: Information has been received from a physician concerning a patient who was using a vaccine and experienced delayed localized reaction around the HPV injection site. It was unknown if the patient sought medical attention. The representative reported that he thought the product was GARDASIL, but he was not sure. Follow up information received from other health professional concerning a 10 year old female student with no previous reactions to shots with illness at time of vaccination obese, acne, Osgood-Schlatter's disease and patellofemoral stress on 14-FEB-2011 at 15:30 approximately received the first dose of GARDASIL (lot number 666931/0337Z) IM on the right deltoid with public fund at academic. On the same day she received the first dose of FLUZONE (lot number U3776DA) IM on the left deltoid. On the 14-FEB-2011 (also reported 20-FEB-2011) the patient noted swelling a large after injection 6 days after injection, erythema, elevated 9 warm and intermittent purpura with total size of 11.4 cm and 33.4 cm with slighting with a total size of 1 1/4 cm with indurations. The patient required doctor visit. No laboratory data. No further information is available.