chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Pain in extremity, Pyrexia, Red blood cell sedimentation rate normal, Viral test negative, Viral titre
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 years old female patient with reflux was vaccinated IM into left arm with lot # (1560AA) dose 3 GARDASIL on 24-FEB-2012. Concomitant medications included dose 1 MENVEO (lot # A10060) vaccinated IM into right arm, dose 2 HAVRIX (lot # AHAVB549BA) vaccinated IM into right arm and omeprazole. On 29-FEB-2012 the patient experienced fever, back pain, neck pain and was treated with NAPROSYN. On 12-MAR-2012 the patient experienced back pain, joint pain, swollen lymph nodes-neck, fatigue. Labs were ordered on 12-MAR-2012. EBV (Epstein-Barr virus) twice, CMV titre (Cytomegalovirus), ANA (Antinuclear antibody), CRP (C-reactive protein), ESR (Red blood cell sedimentation rate), Lyme titre, CMP (Comprehensive Metabolic Panel), all were normal. On 16-MAR-2012 a phone call from parent: patient complained of arm pain and numbness - rheumatologist referral made. The status of the patient was unknown. All adverse events onset date were also reported as 25-FEB-2012. The report was considered to be no condition and non serious. The original reporting source was not provided. The VAERS ID is 452066. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL, HPV4, TDAP, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 year old female with no previous illness and no medical history who on 12-MAR-2012 was vaccinated IM with the first dose of GARDASIL (lot # 670048/0963AA, left leg). Other suspect therapy included VARIVAX (Merck) (lot # 670801/0816AA, third dose, SC, left leg, on 12-MAR-2012). Concomitant therapy included BOOSTRIX (manufacturer: GlaxoSmithKline, lot # AC52B070BA, sixth dose, right leg, on 12-MAR-2012). On 13-MAR-2012 (also reported as 14-MAR-2012) patient presented with left post deltoid area 4 cm x 5 cm cellulitis right varicella vaccine site. Treatment with SEPTRAD 1 tab po BID x 10 day and BENADRYL 25 mg 1 tab po QID. No conditions. At time of the report, the patient's outcome was unknown. No further information is available. The original reporting source was not provided. The VAERS ID # is 452120-1.
Age: 14.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL, HPV4, TDAP, VARCEL
Symptoms: Vaccination site cellulitis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 year old female with no previous illness and no medical history who on 12-MAR-2012 was vaccinated IM with the first dose of GARDASIL (lot # 670048/0963AA, left leg). Other suspect therapy included VARIVAX (Merck) (lot # 670801/0816AA, third dose, SC, left leg, on 12-MAR-2012). Concomitant therapy included BOOSTRIX (manufacturer: GlaxoSmithKline, lot # AC52B070BA, sixth dose, right leg, on 12-MAR-2012). On 13-MAR-2012 (also reported as 14-MAR-2012) patient presented with left post deltoid area 4 cm x 5 cm cellulitis right varicella vaccine site. Treatment with SEPTRAD 1 tab po BID x 10 day and BENADRYL 25 mg 1 tab po QID. No conditions. At time of the report, the patient's outcome was unknown. No further information is available. The original reporting source was not provided. The VAERS ID # is 452120-1.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood glucose normal, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act refers to 13 years old female patient. The patient's medical history included eczema and allergic rhinitis. The patient was vaccinated on the right arm with the third dose of GARDASIL (lot # 671994/1537AA) on 20-MAR-2012. Concomitant medications included loratadine (manufacturer unknown) and FLONASE. On 20-MAR-2012 the patient experienced Syncope. Child fainted briefly within 5 minutes of receiving vaccine. Episode was short lived. Patient was made to lie down on exam table and drank cool liquids. The patient's blood pressure (BP) was 102/64, heart rate (HR) was 98 and finger stick blood sugar was 102. At the time of vaccination, the patient experienced allergic rhinitis. The patient recovered completely within 10-15 minutes. The original reporting source was not provided. Additional information is not expected. The VAERS ID # is 452330-1.
Sex: F
Vaccine: HPV4, FLU3, HPV4, FLU3, HPV4
Symptoms: Arrested labour, Caesarean section, Laboratory test normal, Maternal exposure during pregnancy, Neonatal disorder
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 years old mother who was vaccinated IM with dose 2 GARDASIL (lot# 666931/0337Z) into her left arm and the third dose of FLUZONE (lot#UT445AA) on 16-SEP-2011 at approximately 26 weeks gestational age. The mother delivered normal baby female on 31-DEC-2011 with phocomelia - absent right hand. The infant's APGAR scores are not available. No Emergency room (ER) visit was required. (Mother's case was involved in MAARS# 1207USA012176). The original reporting source was not provided. The VAERS ID# is 452352. No further information is available.
Sex: F
Vaccine: HPV4, FLU3, HPV4, FLU3, HPV4
Symptoms: Ultrasound antenatal screen normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 years old mother who was vaccinated IM with dose 2 GARDASIL (lot# 666931/0337Z) into her left arm and the third dose of FLUZONE (lot#UT445AA) on 16-SEP-2011 at approximately 26 weeks gestational age. The mother delivered normal baby female on 31-DEC-2011 with phocomelia - absent right hand. The infant's APGAR scores are not available. No Emergency room (ER) visit was required. (Mother's case was involved in MAARS# 1207USA012176). The original reporting source was not provided. The VAERS ID# is 452352. No further information is available.
Sex: F
Vaccine: HPV4, FLU3, HPV4, FLU3, HPV4
Symptoms: Foetal disorder, Maternal exposure during pregnancy, Ultrasound antenatal screen
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 years old mother who was vaccinated IM with dose 2 GARDASIL (lot# 666931/0337Z) into her left arm and the third dose of FLUZONE (lot#UT445AA) on 16-SEP-2011 at approximately 26 weeks gestational age. The mother delivered normal baby female on 31-DEC-2011 with phocomelia - absent right hand. The infant's APGAR scores are not available. No Emergency room (ER) visit was required. (Mother's case was involved in MAARS# 1207USA012176). The original reporting source was not provided. The VAERS ID# is 452352. No further information is available.
Sex: F
Vaccine: HPV4, FLU3, HPV4, FLU3, HPV4
Symptoms: Foetal exposure during pregnancy, Limb reduction defect
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 years old mother who was vaccinated IM with dose 2 GARDASIL (lot# 666931/0337Z) into her left arm and the third dose of FLUZONE (lot#UT445AA) on 16-SEP-2011 at approximately 26 weeks gestational age. The mother delivered normal baby female on 31-DEC-2011 with phocomelia - absent right hand. The infant's APGAR scores are not available. No Emergency room (ER) visit was required. (Mother's case was involved in MAARS# 1207USA012176). The original reporting source was not provided. The VAERS ID# is 452352. No further information is available.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Hyperhidrosis, Loss of consciousness, Malaise, Pallor, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 years old male patient with none medical history who on 22-MAR-2012, 11:45 am, was vaccinated with the first dose of GARDASIL (lot # (671006/1291AA, intramuscular on left arm, dose not reported). On the same day the patient was vaccinated with the second dose of VARIVAX (Merck) (Lot#1408AA, SQ on right arm, dose not reported) and the second dose of VAQTA (Lot#672226/1441AA, intramuscular on left arm, dose not reported). Concomitant medications included the first dose of MENACTRA (Lot#U4006AA, left arm intramuscular) and the first dose of BOOSTRIX (Lot#AC52B074CA, right arm intramuscular). On 22-MAR-2012 the patient didn't feel well while in waiting room sat down. Passed out per mom's report. Nurse to front desk where the patient was vomiting, sweating and pale. Vitals taken: blood pressure 120/82, pulse 80, resp 13. Taken back to clinic, given a soda, observed for approx 16 min, was stable and went home. At the time of reporting, the outcome was unknown. Upon internal review, the adverse event "pass out" was determined to be a medical significant. The original reporting source was not provided. The VAERS ID# 452808-1.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pallor, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 years old female patient without medical history and illness at the time of vaccine treated by unspecified route into right arm with the second dose of GARDASIL (lot #: 671994/1537AA) on 23-MAR-2012. On 23-MAR-2012 the patient turned pale, then fainted. The patient then was lay on table and monitored for 30 minutes after injection. Blood pressure taking. There was no other lab performed. At time of the report, the patient's outcome was unknown. No further information is available. The original reporting source was not provided. The VAERS ID # is 452935-1.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Hyperhidrosis, Pallor, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act refers to a 11 years old female patient with no known drug allergies and medical history. The patient was vaccinated in left arm with the first dose of GARDASIL (lot # 670049/1261AA) on 27-MAR-2012). The patient was vaccinated in left arm with the second dose of HAVRIX (lot#AHAVB541AA), in right arm with the first dose of BOOSTRIX (lot#AC52B075AA) and in right arm with the first dose of MENVEO (lot# A10053). On 27-MAR-2012 the patient experienced pallor, syncope and hyperhidrosis. The patient fainted after injection. The patient was sweaty and pale. The adverse events were considered to be non-serious. The patient revived in 15 minutes with feet elevated, ice applied to back of neck and 7-up given. There was no illness at the time of vaccination. It was unknown if the patient sought medical attention. Additional information is not expected. The original reporting source was not provided. The VAERS ID # is 452948-1.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain, Chest pain, Cold sweat, Dizziness, Flushing
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to a 14 years old female patient with no medical history and no pre-existing. The patient's pre-vaccine illness included chest pain and abdominal pain which were lasting 24 hours. The patient was vaccinated IM in left arm with dose 3 GARDASIL (lot # 669308/0636AA) on 28-MAR-2012. No other co-suspects were reported. No concomitant medications were reported. Patient stated she had eaten and had no prior signs or symptoms. Approximately 5 minutes after vaccination of vaccines on 28-MAR-2012, the patient complained of severe headache. Ten minutes later, she complained of nausea, lightheadedness, chest pain and abdominal pain. She appeared flushed and clammy. Vital signs (pulse, temp and blood pressure) were taken and were all normal. Dr. evaluated the patient and asked the patient to remain in the office for 15-20 minutes longer. Patient did state to Dr. that she had chest pain and abdominal pain with the first 2 injections lasting 24 hours. Dr. released the patient to grandfather's were  with mother's knowledge. He was advised to have mother call with an update. Total time spent in the office, after vaccine was given, was approximately 60 minutes. At the time of the report, the patient's outcome was unknown. The original reporting source was not provided. Additional information is not expected.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Nausea
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to a 14 years old female patient with no medical history and no pre-existing. The patient's pre-vaccine illness included chest pain and abdominal pain which were lasting 24 hours. The patient was vaccinated IM in left arm with dose 3 GARDASIL (lot # 669308/0636AA) on 28-MAR-2012. No other co-suspects were reported. No concomitant medications were reported. Patient stated she had eaten and had no prior signs or symptoms. Approximately 5 minutes after vaccination of vaccines on 28-MAR-2012, the patient complained of severe headache. Ten minutes later, she complained of nausea, lightheadedness, chest pain and abdominal pain. She appeared flushed and clammy. Vital signs (pulse, temp and blood pressure) were taken and were all normal. Dr. evaluated the patient and asked the patient to remain in the office for 15-20 minutes longer. Patient did state to Dr. that she had chest pain and abdominal pain with the first 2 injections lasting 24 hours. Dr. released the patient to grandfather's were  with mother's knowledge. He was advised to have mother call with an update. Total time spent in the office, after vaccine was given, was approximately 60 minutes. At the time of the report, the patient's outcome was unknown. The original reporting source was not provided. Additional information is not expected.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain, Chest pain, Cold sweat, Condition aggravated, Dizziness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to a 14 years old female patient with no medical history and no pre-existing. The patient's pre-vaccine illness included chest pain and abdominal pain which were lasting 24 hours. The patient was vaccinated IM in left arm with dose 3 GARDASIL (lot # 669308/0636AA) on 28-MAR-2012. No other co-suspects were reported. No concomitant medications were reported. Patient stated she had eaten and had no prior signs or symptoms. Approximately 5 minutes after vaccination of vaccines on 28-MAR-2012, the patient complained of severe headache. Ten minutes later, she complained of nausea, lightheadedness, chest pain and abdominal pain. She appeared flushed and clammy. Vital signs (pulse, temp and blood pressure) were taken and were all normal. Dr. evaluated the patient and asked the patient to remain in the office for 15-20 minutes longer. Patient did state to Dr. that she had chest pain and abdominal pain with the first 2 injections lasting 24 hours. Dr. released the patient to grandfather's were  with mother's knowledge. He was advised to have mother call with an update. Total time spent in the office, after vaccine was given, was approximately 60 minutes. At the time of the report, the patient's outcome was unknown. The original reporting source was not provided. Additional information is not expected.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Flushing, Headache, Nausea
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to a 14 years old female patient with no medical history and no pre-existing. The patient's pre-vaccine illness included chest pain and abdominal pain which were lasting 24 hours. The patient was vaccinated IM in left arm with dose 3 GARDASIL (lot # 669308/0636AA) on 28-MAR-2012. No other co-suspects were reported. No concomitant medications were reported. Patient stated she had eaten and had no prior signs or symptoms. Approximately 5 minutes after vaccination of vaccines on 28-MAR-2012, the patient complained of severe headache. Ten minutes later, she complained of nausea, lightheadedness, chest pain and abdominal pain. She appeared flushed and clammy. Vital signs (pulse, temp and blood pressure) were taken and were all normal. Dr. evaluated the patient and asked the patient to remain in the office for 15-20 minutes longer. Patient did state to Dr. that she had chest pain and abdominal pain with the first 2 injections lasting 24 hours. Dr. released the patient to grandfather's were  with mother's knowledge. He was advised to have mother call with an update. Total time spent in the office, after vaccine was given, was approximately 60 minutes. At the time of the report, the patient's outcome was unknown. The original reporting source was not provided. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: C-reactive protein normal, Erythema, Full blood count normal, Pain, Red blood cell sedimentation rate normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 11 years old female patient with asthma, eczema, abd. pain, constipation, allergic rhinitis, ear pain. The patient was vaccinated with dose 1 GARDASIL (lot # 672233/1561AA) on the left arm on 15-MAR-2012. No other co-suspects were reported. Concomitant medications included MENACTRA (lot # U4032AA, dose 1, on right arm), ADACEL (lot # U4103AA, dose 1, on right arm), clindamycin, sulfamethoxazole, BACTRIM and prednisone. On 16-MAR-2012 the patient started to develop pain, redness and swelling 1-2 days after. The patient was seen in ED and was started on oral clindamycin. Redness and pain continued and spread downward/distally. Clinda was changed to oral BACTRIM and Prednisone was started 1+ week. Redness spread down to wrist. Symptoms started to improve day 13 and completely resolved by day 17. Laboratory studies performed included CBC/CRP*2 normal. The original reporting source was not provided. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 11 years old female patient with asthma, eczema, abd. pain, constipation, allergic rhinitis, ear pain. The patient was vaccinated with dose 1 GARDASIL (lot # 672233/1561AA) on the left arm on 15-MAR-2012. No other co-suspects were reported. Concomitant medications included MENACTRA (lot # U4032AA, dose 1, on right arm), ADACEL (lot # U4103AA, dose 1, on right arm), clindamycin, sulfamethoxazole, BACTRIM and prednisone. On 16-MAR-2012 the patient started to develop pain, redness and swelling 1-2 days after. The patient was seen in ED and was started on oral clindamycin. Redness and pain continued and spread downward/distally. Clinda was changed to oral BACTRIM and Prednisone was started 1+ week. Redness spread down to wrist. Symptoms started to improve day 13 and completely resolved by day 17. Laboratory studies performed included CBC/CRP*2 normal. The original reporting source was not provided. Additional information is not expected.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Balance disorder, Cold sweat, Dizziness, Headache, Loss of consciousness
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 years old male patient with no medical history and no previous illness who was vaccinated with a dose 1 of GARDASIL of lot # (1726AA), IM, Right arm, and a first dose of VAQTA (Lot # 1416AA), IM, Left arm on 06-APR-2012. Concomitant medications included a first dose of MENACTRA (batch # U3906AA), IM, Left arm. It was reported that on 06-APR-2012 the patient felt light-headed after receiving 3 injections, sat for about 5 minutes with an ice pack and fan running, patient started feeling worse and asked to lie down was moved to next room to recliner but he passed out (medically significant, upon internal review), patient's skin clammy, color pale, patient was lie on floor for another 20 minutes until finally became completely conscious enough to know what was going on. Patient also experienced cold sweat. At the time, the patient left the office (40) minutes after shots were administered, his blood pressure was 90/52, but still appeared a little unsteady and complaint of headache. The outcome of patient's events mentioned above was unknown. It was reported that skin color was pink and patient recovered from passing out. The report was considered non serious with not conditions by the agency. The original reporting source was not provided. The VAERS ID# is 452142-1. Additional information is not expected.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Pallor
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 years old male patient with no medical history and no previous illness who was vaccinated with a dose 1 of GARDASIL of lot # (1726AA), IM, Right arm, and a first dose of VAQTA (Lot # 1416AA), IM, Left arm on 06-APR-2012. Concomitant medications included a first dose of MENACTRA (batch # U3906AA), IM, Left arm. It was reported that on 06-APR-2012 the patient felt light-headed after receiving 3 injections, sat for about 5 minutes with an ice pack and fan running, patient started feeling worse and asked to lie down was moved to next room to recliner but he passed out (medically significant, upon internal review), patient's skin clammy, color pale, patient was lie on floor for another 20 minutes until finally became completely conscious enough to know what was going on. Patient also experienced cold sweat. At the time, the patient left the office (40) minutes after shots were administered, his blood pressure was 90/52, but still appeared a little unsteady and complaint of headache. The outcome of patient's events mentioned above was unknown. It was reported that skin color was pink and patient recovered from passing out. The report was considered non serious with not conditions by the agency. The original reporting source was not provided. The VAERS ID# is 452142-1. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain upper, Chest pain, Computerised tomogram, Decreased appetite, Endoscopy gastrointestinal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to a 12 years old female patient with asthma and ADD. The patient's medical history included back pain, sleeping problems and premature birth. The patient was vaccinated with dose 1 GARDASIL on 07-FEB-2011. No other co-suspects were reported. No concomitant medications were reported. On 01-JUN-2011 the patient experienced abdominal pain, 115 days after onset of therapy, vaginal haemorrhage, tenderness, sleep disorder, sinusitis, road traffic accident, rhinitis allergic, respiratory tract congestion, photophobia, pharyngitis, pallor, pain in extremity, pain, nausea, musculoskeletal pain, mood altered, mental status change, ligament sprain, joint swelling, joint injury, insomnia, hypophagia, hypoaesthesia, headache, hematochezia, feeling of body temperature change, fatigue, enema administration, dysmenorrhoea, dizziness, diarrhoea, decreased appetite, cough, confusional state, condition aggravated, chest pain, burning sensation, back pain, abdominal tenderness and abdominal pain upper. No treatment information was reported. The outcome of abdominal pain, vaginal haemorrhage, tenderness, sleep disorder, sinusitis, road traffic accident, rhinitis allergic, respiratory tract congestion, photophobia, pharyngitis, pallor, pain in extremity, nausea, musculoskeletal pain, mood altered, mental status change, ligament sprain, joint swelling, joint injury, insomnia, hypophagia, hypoaesthesia, headache, hematochezia, feeling of body temperature change, fatigue, enema administration, dysmenorrhoea, dizziness, diarrhoea, decreased appetite, cough, confusional state, condition aggravated, chest pain, burning sensation, back pain, abdominal tenderness and abdominal pain upper is unknown. The outcome of pain was reported as recovering/resolving. The relatedness for abdominal pain, vaginal haemorrhage, tenderness, sleep disorder, sinusitis, road traffic accident, rhinitis allergic, respiratory tract congestion, photophobia, pharyngitis, pallor, pain in extremity, pain, nausea, musculoskeletal pain, mood altered, mental status change, ligament sprain, joint swelling, joint injury, insomnia, hypophagia, hypoaesthesia, headache, hematochezia, feeling of body temperature change, fatigue, enema administration, dysmenorrhoea, dizziness, diarrhoea, decreased appetite, cough, confusional state, condition aggravated, chest pain, burning sensation, back pain, abdominal tenderness and abdominal pain upper is unknown for GARDASIL. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fatigue, Headache, Insomnia, Laboratory test, Mood altered
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to a 12 years old female patient with asthma and ADD. The patient's medical history included back pain, sleeping problems and premature birth. The patient was vaccinated with dose 1 GARDASIL on 07-FEB-2011. No other co-suspects were reported. No concomitant medications were reported. On 01-JUN-2011 the patient experienced abdominal pain, 115 days after onset of therapy, vaginal haemorrhage, tenderness, sleep disorder, sinusitis, road traffic accident, rhinitis allergic, respiratory tract congestion, photophobia, pharyngitis, pallor, pain in extremity, pain, nausea, musculoskeletal pain, mood altered, mental status change, ligament sprain, joint swelling, joint injury, insomnia, hypophagia, hypoaesthesia, headache, hematochezia, feeling of body temperature change, fatigue, enema administration, dysmenorrhoea, dizziness, diarrhoea, decreased appetite, cough, confusional state, condition aggravated, chest pain, burning sensation, back pain, abdominal tenderness and abdominal pain upper. No treatment information was reported. The outcome of abdominal pain, vaginal haemorrhage, tenderness, sleep disorder, sinusitis, road traffic accident, rhinitis allergic, respiratory tract congestion, photophobia, pharyngitis, pallor, pain in extremity, nausea, musculoskeletal pain, mood altered, mental status change, ligament sprain, joint swelling, joint injury, insomnia, hypophagia, hypoaesthesia, headache, hematochezia, feeling of body temperature change, fatigue, enema administration, dysmenorrhoea, dizziness, diarrhoea, decreased appetite, cough, confusional state, condition aggravated, chest pain, burning sensation, back pain, abdominal tenderness and abdominal pain upper is unknown. The outcome of pain was reported as recovering/resolving. The relatedness for abdominal pain, vaginal haemorrhage, tenderness, sleep disorder, sinusitis, road traffic accident, rhinitis allergic, respiratory tract congestion, photophobia, pharyngitis, pallor, pain in extremity, pain, nausea, musculoskeletal pain, mood altered, mental status change, ligament sprain, joint swelling, joint injury, insomnia, hypophagia, hypoaesthesia, headache, hematochezia, feeling of body temperature change, fatigue, enema administration, dysmenorrhoea, dizziness, diarrhoea, decreased appetite, cough, confusional state, condition aggravated, chest pain, burning sensation, back pain, abdominal tenderness and abdominal pain upper is unknown for GARDASIL. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nausea, Pain in extremity, Photophobia, Ultrasound scan, X-ray
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to a 12 years old female patient with asthma and ADD. The patient's medical history included back pain, sleeping problems and premature birth. The patient was vaccinated with dose 1 GARDASIL on 07-FEB-2011. No other co-suspects were reported. No concomitant medications were reported. On 01-JUN-2011 the patient experienced abdominal pain, 115 days after onset of therapy, vaginal haemorrhage, tenderness, sleep disorder, sinusitis, road traffic accident, rhinitis allergic, respiratory tract congestion, photophobia, pharyngitis, pallor, pain in extremity, pain, nausea, musculoskeletal pain, mood altered, mental status change, ligament sprain, joint swelling, joint injury, insomnia, hypophagia, hypoaesthesia, headache, hematochezia, feeling of body temperature change, fatigue, enema administration, dysmenorrhoea, dizziness, diarrhoea, decreased appetite, cough, confusional state, condition aggravated, chest pain, burning sensation, back pain, abdominal tenderness and abdominal pain upper. No treatment information was reported. The outcome of abdominal pain, vaginal haemorrhage, tenderness, sleep disorder, sinusitis, road traffic accident, rhinitis allergic, respiratory tract congestion, photophobia, pharyngitis, pallor, pain in extremity, nausea, musculoskeletal pain, mood altered, mental status change, ligament sprain, joint swelling, joint injury, insomnia, hypophagia, hypoaesthesia, headache, hematochezia, feeling of body temperature change, fatigue, enema administration, dysmenorrhoea, dizziness, diarrhoea, decreased appetite, cough, confusional state, condition aggravated, chest pain, burning sensation, back pain, abdominal tenderness and abdominal pain upper is unknown. The outcome of pain was reported as recovering/resolving. The relatedness for abdominal pain, vaginal haemorrhage, tenderness, sleep disorder, sinusitis, road traffic accident, rhinitis allergic, respiratory tract congestion, photophobia, pharyngitis, pallor, pain in extremity, pain, nausea, musculoskeletal pain, mood altered, mental status change, ligament sprain, joint swelling, joint injury, insomnia, hypophagia, hypoaesthesia, headache, hematochezia, feeling of body temperature change, fatigue, enema administration, dysmenorrhoea, dizziness, diarrhoea, decreased appetite, cough, confusional state, condition aggravated, chest pain, burning sensation, back pain, abdominal tenderness and abdominal pain upper is unknown for GARDASIL. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain, Abdominal pain upper, Abdominal tenderness, Back pain, Burning sensation
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to a 12 years old female patient with asthma and ADD. The patient's medical history included back pain, sleeping problems and premature birth. The patient was vaccinated with dose 1 GARDASIL on 07-FEB-2011. No other co-suspects were reported. No concomitant medications were reported. On 01-JUN-2011 the patient experienced abdominal pain, 115 days after onset of therapy, vaginal haemorrhage, tenderness, sleep disorder, sinusitis, road traffic accident, rhinitis allergic, respiratory tract congestion, photophobia, pharyngitis, pallor, pain in extremity, pain, nausea, musculoskeletal pain, mood altered, mental status change, ligament sprain, joint swelling, joint injury, insomnia, hypophagia, hypoaesthesia, headache, hematochezia, feeling of body temperature change, fatigue, enema administration, dysmenorrhoea, dizziness, diarrhoea, decreased appetite, cough, confusional state, condition aggravated, chest pain, burning sensation, back pain, abdominal tenderness and abdominal pain upper. No treatment information was reported. The outcome of abdominal pain, vaginal haemorrhage, tenderness, sleep disorder, sinusitis, road traffic accident, rhinitis allergic, respiratory tract congestion, photophobia, pharyngitis, pallor, pain in extremity, nausea, musculoskeletal pain, mood altered, mental status change, ligament sprain, joint swelling, joint injury, insomnia, hypophagia, hypoaesthesia, headache, hematochezia, feeling of body temperature change, fatigue, enema administration, dysmenorrhoea, dizziness, diarrhoea, decreased appetite, cough, confusional state, condition aggravated, chest pain, burning sensation, back pain, abdominal tenderness and abdominal pain upper is unknown. The outcome of pain was reported as recovering/resolving. The relatedness for abdominal pain, vaginal haemorrhage, tenderness, sleep disorder, sinusitis, road traffic accident, rhinitis allergic, respiratory tract congestion, photophobia, pharyngitis, pallor, pain in extremity, pain, nausea, musculoskeletal pain, mood altered, mental status change, ligament sprain, joint swelling, joint injury, insomnia, hypophagia, hypoaesthesia, headache, hematochezia, feeling of body temperature change, fatigue, enema administration, dysmenorrhoea, dizziness, diarrhoea, decreased appetite, cough, confusional state, condition aggravated, chest pain, burning sensation, back pain, abdominal tenderness and abdominal pain upper is unknown for GARDASIL. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Chest pain, Computerised tomogram abdomen abnormal, Condition aggravated, Confusional state, Cough
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to a 12 years old female patient with asthma and ADD. The patient's medical history included back pain, sleeping problems and premature birth. The patient was vaccinated with dose 1 GARDASIL on 07-FEB-2011. No other co-suspects were reported. No concomitant medications were reported. On 01-JUN-2011 the patient experienced abdominal pain, 115 days after onset of therapy, vaginal haemorrhage, tenderness, sleep disorder, sinusitis, road traffic accident, rhinitis allergic, respiratory tract congestion, photophobia, pharyngitis, pallor, pain in extremity, pain, nausea, musculoskeletal pain, mood altered, mental status change, ligament sprain, joint swelling, joint injury, insomnia, hypophagia, hypoaesthesia, headache, hematochezia, feeling of body temperature change, fatigue, enema administration, dysmenorrhoea, dizziness, diarrhoea, decreased appetite, cough, confusional state, condition aggravated, chest pain, burning sensation, back pain, abdominal tenderness and abdominal pain upper. No treatment information was reported. The outcome of abdominal pain, vaginal haemorrhage, tenderness, sleep disorder, sinusitis, road traffic accident, rhinitis allergic, respiratory tract congestion, photophobia, pharyngitis, pallor, pain in extremity, nausea, musculoskeletal pain, mood altered, mental status change, ligament sprain, joint swelling, joint injury, insomnia, hypophagia, hypoaesthesia, headache, hematochezia, feeling of body temperature change, fatigue, enema administration, dysmenorrhoea, dizziness, diarrhoea, decreased appetite, cough, confusional state, condition aggravated, chest pain, burning sensation, back pain, abdominal tenderness and abdominal pain upper is unknown. The outcome of pain was reported as recovering/resolving. The relatedness for abdominal pain, vaginal haemorrhage, tenderness, sleep disorder, sinusitis, road traffic accident, rhinitis allergic, respiratory tract congestion, photophobia, pharyngitis, pallor, pain in extremity, pain, nausea, musculoskeletal pain, mood altered, mental status change, ligament sprain, joint swelling, joint injury, insomnia, hypophagia, hypoaesthesia, headache, hematochezia, feeling of body temperature change, fatigue, enema administration, dysmenorrhoea, dizziness, diarrhoea, decreased appetite, cough, confusional state, condition aggravated, chest pain, burning sensation, back pain, abdominal tenderness and abdominal pain upper is unknown for GARDASIL. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Decreased appetite, Diarrhoea, Dizziness, Dysmenorrhoea, Enema administration
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to a 12 years old female patient with asthma and ADD. The patient's medical history included back pain, sleeping problems and premature birth. The patient was vaccinated with dose 1 GARDASIL on 07-FEB-2011. No other co-suspects were reported. No concomitant medications were reported. On 01-JUN-2011 the patient experienced abdominal pain, 115 days after onset of therapy, vaginal haemorrhage, tenderness, sleep disorder, sinusitis, road traffic accident, rhinitis allergic, respiratory tract congestion, photophobia, pharyngitis, pallor, pain in extremity, pain, nausea, musculoskeletal pain, mood altered, mental status change, ligament sprain, joint swelling, joint injury, insomnia, hypophagia, hypoaesthesia, headache, hematochezia, feeling of body temperature change, fatigue, enema administration, dysmenorrhoea, dizziness, diarrhoea, decreased appetite, cough, confusional state, condition aggravated, chest pain, burning sensation, back pain, abdominal tenderness and abdominal pain upper. No treatment information was reported. The outcome of abdominal pain, vaginal haemorrhage, tenderness, sleep disorder, sinusitis, road traffic accident, rhinitis allergic, respiratory tract congestion, photophobia, pharyngitis, pallor, pain in extremity, nausea, musculoskeletal pain, mood altered, mental status change, ligament sprain, joint swelling, joint injury, insomnia, hypophagia, hypoaesthesia, headache, hematochezia, feeling of body temperature change, fatigue, enema administration, dysmenorrhoea, dizziness, diarrhoea, decreased appetite, cough, confusional state, condition aggravated, chest pain, burning sensation, back pain, abdominal tenderness and abdominal pain upper is unknown. The outcome of pain was reported as recovering/resolving. The relatedness for abdominal pain, vaginal haemorrhage, tenderness, sleep disorder, sinusitis, road traffic accident, rhinitis allergic, respiratory tract congestion, photophobia, pharyngitis, pallor, pain in extremity, pain, nausea, musculoskeletal pain, mood altered, mental status change, ligament sprain, joint swelling, joint injury, insomnia, hypophagia, hypoaesthesia, headache, hematochezia, feeling of body temperature change, fatigue, enema administration, dysmenorrhoea, dizziness, diarrhoea, decreased appetite, cough, confusional state, condition aggravated, chest pain, burning sensation, back pain, abdominal tenderness and abdominal pain upper is unknown for GARDASIL. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fatigue, Feeling of body temperature change, Haematochezia, Headache, Hypoaesthesia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to a 12 years old female patient with asthma and ADD. The patient's medical history included back pain, sleeping problems and premature birth. The patient was vaccinated with dose 1 GARDASIL on 07-FEB-2011. No other co-suspects were reported. No concomitant medications were reported. On 01-JUN-2011 the patient experienced abdominal pain, 115 days after onset of therapy, vaginal haemorrhage, tenderness, sleep disorder, sinusitis, road traffic accident, rhinitis allergic, respiratory tract congestion, photophobia, pharyngitis, pallor, pain in extremity, pain, nausea, musculoskeletal pain, mood altered, mental status change, ligament sprain, joint swelling, joint injury, insomnia, hypophagia, hypoaesthesia, headache, hematochezia, feeling of body temperature change, fatigue, enema administration, dysmenorrhoea, dizziness, diarrhoea, decreased appetite, cough, confusional state, condition aggravated, chest pain, burning sensation, back pain, abdominal tenderness and abdominal pain upper. No treatment information was reported. The outcome of abdominal pain, vaginal haemorrhage, tenderness, sleep disorder, sinusitis, road traffic accident, rhinitis allergic, respiratory tract congestion, photophobia, pharyngitis, pallor, pain in extremity, nausea, musculoskeletal pain, mood altered, mental status change, ligament sprain, joint swelling, joint injury, insomnia, hypophagia, hypoaesthesia, headache, hematochezia, feeling of body temperature change, fatigue, enema administration, dysmenorrhoea, dizziness, diarrhoea, decreased appetite, cough, confusional state, condition aggravated, chest pain, burning sensation, back pain, abdominal tenderness and abdominal pain upper is unknown. The outcome of pain was reported as recovering/resolving. The relatedness for abdominal pain, vaginal haemorrhage, tenderness, sleep disorder, sinusitis, road traffic accident, rhinitis allergic, respiratory tract congestion, photophobia, pharyngitis, pallor, pain in extremity, pain, nausea, musculoskeletal pain, mood altered, mental status change, ligament sprain, joint swelling, joint injury, insomnia, hypophagia, hypoaesthesia, headache, hematochezia, feeling of body temperature change, fatigue, enema administration, dysmenorrhoea, dizziness, diarrhoea, decreased appetite, cough, confusional state, condition aggravated, chest pain, burning sensation, back pain, abdominal tenderness and abdominal pain upper is unknown for GARDASIL. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hypophagia, Insomnia, Joint injury, Joint swelling, Ligament sprain
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to a 12 years old female patient with asthma and ADD. The patient's medical history included back pain, sleeping problems and premature birth. The patient was vaccinated with dose 1 GARDASIL on 07-FEB-2011. No other co-suspects were reported. No concomitant medications were reported. On 01-JUN-2011 the patient experienced abdominal pain, 115 days after onset of therapy, vaginal haemorrhage, tenderness, sleep disorder, sinusitis, road traffic accident, rhinitis allergic, respiratory tract congestion, photophobia, pharyngitis, pallor, pain in extremity, pain, nausea, musculoskeletal pain, mood altered, mental status change, ligament sprain, joint swelling, joint injury, insomnia, hypophagia, hypoaesthesia, headache, hematochezia, feeling of body temperature change, fatigue, enema administration, dysmenorrhoea, dizziness, diarrhoea, decreased appetite, cough, confusional state, condition aggravated, chest pain, burning sensation, back pain, abdominal tenderness and abdominal pain upper. No treatment information was reported. The outcome of abdominal pain, vaginal haemorrhage, tenderness, sleep disorder, sinusitis, road traffic accident, rhinitis allergic, respiratory tract congestion, photophobia, pharyngitis, pallor, pain in extremity, nausea, musculoskeletal pain, mood altered, mental status change, ligament sprain, joint swelling, joint injury, insomnia, hypophagia, hypoaesthesia, headache, hematochezia, feeling of body temperature change, fatigue, enema administration, dysmenorrhoea, dizziness, diarrhoea, decreased appetite, cough, confusional state, condition aggravated, chest pain, burning sensation, back pain, abdominal tenderness and abdominal pain upper is unknown. The outcome of pain was reported as recovering/resolving. The relatedness for abdominal pain, vaginal haemorrhage, tenderness, sleep disorder, sinusitis, road traffic accident, rhinitis allergic, respiratory tract congestion, photophobia, pharyngitis, pallor, pain in extremity, pain, nausea, musculoskeletal pain, mood altered, mental status change, ligament sprain, joint swelling, joint injury, insomnia, hypophagia, hypoaesthesia, headache, hematochezia, feeling of body temperature change, fatigue, enema administration, dysmenorrhoea, dizziness, diarrhoea, decreased appetite, cough, confusional state, condition aggravated, chest pain, burning sensation, back pain, abdominal tenderness and abdominal pain upper is unknown for GARDASIL. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Mental status changes, Mood altered, Musculoskeletal pain, Nausea, Pain
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to a 12 years old female patient with asthma and ADD. The patient's medical history included back pain, sleeping problems and premature birth. The patient was vaccinated with dose 1 GARDASIL on 07-FEB-2011. No other co-suspects were reported. No concomitant medications were reported. On 01-JUN-2011 the patient experienced abdominal pain, 115 days after onset of therapy, vaginal haemorrhage, tenderness, sleep disorder, sinusitis, road traffic accident, rhinitis allergic, respiratory tract congestion, photophobia, pharyngitis, pallor, pain in extremity, pain, nausea, musculoskeletal pain, mood altered, mental status change, ligament sprain, joint swelling, joint injury, insomnia, hypophagia, hypoaesthesia, headache, hematochezia, feeling of body temperature change, fatigue, enema administration, dysmenorrhoea, dizziness, diarrhoea, decreased appetite, cough, confusional state, condition aggravated, chest pain, burning sensation, back pain, abdominal tenderness and abdominal pain upper. No treatment information was reported. The outcome of abdominal pain, vaginal haemorrhage, tenderness, sleep disorder, sinusitis, road traffic accident, rhinitis allergic, respiratory tract congestion, photophobia, pharyngitis, pallor, pain in extremity, nausea, musculoskeletal pain, mood altered, mental status change, ligament sprain, joint swelling, joint injury, insomnia, hypophagia, hypoaesthesia, headache, hematochezia, feeling of body temperature change, fatigue, enema administration, dysmenorrhoea, dizziness, diarrhoea, decreased appetite, cough, confusional state, condition aggravated, chest pain, burning sensation, back pain, abdominal tenderness and abdominal pain upper is unknown. The outcome of pain was reported as recovering/resolving. The relatedness for abdominal pain, vaginal haemorrhage, tenderness, sleep disorder, sinusitis, road traffic accident, rhinitis allergic, respiratory tract congestion, photophobia, pharyngitis, pallor, pain in extremity, pain, nausea, musculoskeletal pain, mood altered, mental status change, ligament sprain, joint swelling, joint injury, insomnia, hypophagia, hypoaesthesia, headache, hematochezia, feeling of body temperature change, fatigue, enema administration, dysmenorrhoea, dizziness, diarrhoea, decreased appetite, cough, confusional state, condition aggravated, chest pain, burning sensation, back pain, abdominal tenderness and abdominal pain upper is unknown for GARDASIL. Additional information is not expected.