chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain in extremity, Pallor, Pharyngitis, Photophobia, Pregnancy test negative
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: Respiratory tract congestion, Rhinitis allergic, Road traffic accident, Sinusitis, Sleep 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. 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: Streptococcus test negative, Tenderness, Ultrasound abdomen abnormal, Urine analysis normal, Vaginal haemorrhage
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: White blood cell count decreased, X-ray limb 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. 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: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Alopecia, Amenorrhoea, Arthralgia, Blood test, Computerised tomogram
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 23 years old female patient with type I diabetes was vaccinated with a third dose of GARDASIL (dose, route and lot number not reported) on 18-DEC-2008. No other co-suspects were reported. Concomitant medications included LANTUS and HUMALOG. It was reported that on 01-MAR-2011 the patient experienced chronic fatigue, muscle aches, irritability, hair loss, insomnia, patient experienced joint pain, severe nausea, weight gain, vomiting and no menstrual period (hospitalization extended hospital stay and disability), 803 days after onset of therapy. The following information was obtained through follow up and or provided by the government on 23-MAY-2012, other correspondence, unremarkable. It was also reported that the package's product recommended that the vaccine should not be given to patients with any illness should be till the illness gone. Type 1 diabetes is irreversible and she should never been given this vaccine. No treatment information was reported. An endoscopy, MRI, CAT scan, ultrasound, x ray gastric emptying test and blood tests were performed (no results provided). The outcome of patient experienced no menstrual period, muscle aches, patient experienced chronic fatigue, severe vomiting, patient experienced joint pain, severe nausea, patient experienced irritability, patient experienced hair loss, patient experienced insomnia and severe weight gain was unknown. This report was considered serious, ER visit, extended hospitalized with ER Visit, permanent disability by the agency. The original reporting was not provided. The VAERS ID# is 453304-1. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Endoscopy, Fatigue, Gastric emptying study, Insomnia, Irritability
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 23 years old female patient with type I diabetes was vaccinated with a third dose of GARDASIL (dose, route and lot number not reported) on 18-DEC-2008. No other co-suspects were reported. Concomitant medications included LANTUS and HUMALOG. It was reported that on 01-MAR-2011 the patient experienced chronic fatigue, muscle aches, irritability, hair loss, insomnia, patient experienced joint pain, severe nausea, weight gain, vomiting and no menstrual period (hospitalization extended hospital stay and disability), 803 days after onset of therapy. The following information was obtained through follow up and or provided by the government on 23-MAY-2012, other correspondence, unremarkable. It was also reported that the package's product recommended that the vaccine should not be given to patients with any illness should be till the illness gone. Type 1 diabetes is irreversible and she should never been given this vaccine. No treatment information was reported. An endoscopy, MRI, CAT scan, ultrasound, x ray gastric emptying test and blood tests were performed (no results provided). The outcome of patient experienced no menstrual period, muscle aches, patient experienced chronic fatigue, severe vomiting, patient experienced joint pain, severe nausea, patient experienced irritability, patient experienced hair loss, patient experienced insomnia and severe weight gain was unknown. This report was considered serious, ER visit, extended hospitalized with ER Visit, permanent disability by the agency. The original reporting was not provided. The VAERS ID# is 453304-1. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Myalgia, Nausea, Nuclear magnetic resonance imaging, Ultrasound scan, Vomiting
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 23 years old female patient with type I diabetes was vaccinated with a third dose of GARDASIL (dose, route and lot number not reported) on 18-DEC-2008. No other co-suspects were reported. Concomitant medications included LANTUS and HUMALOG. It was reported that on 01-MAR-2011 the patient experienced chronic fatigue, muscle aches, irritability, hair loss, insomnia, patient experienced joint pain, severe nausea, weight gain, vomiting and no menstrual period (hospitalization extended hospital stay and disability), 803 days after onset of therapy. The following information was obtained through follow up and or provided by the government on 23-MAY-2012, other correspondence, unremarkable. It was also reported that the package's product recommended that the vaccine should not be given to patients with any illness should be till the illness gone. Type 1 diabetes is irreversible and she should never been given this vaccine. No treatment information was reported. An endoscopy, MRI, CAT scan, ultrasound, x ray gastric emptying test and blood tests were performed (no results provided). The outcome of patient experienced no menstrual period, muscle aches, patient experienced chronic fatigue, severe vomiting, patient experienced joint pain, severe nausea, patient experienced irritability, patient experienced hair loss, patient experienced insomnia and severe weight gain was unknown. This report was considered serious, ER visit, extended hospitalized with ER Visit, permanent disability by the agency. The original reporting was not provided. The VAERS ID# is 453304-1. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Weight increased, X-ray
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 23 years old female patient with type I diabetes was vaccinated with a third dose of GARDASIL (dose, route and lot number not reported) on 18-DEC-2008. No other co-suspects were reported. Concomitant medications included LANTUS and HUMALOG. It was reported that on 01-MAR-2011 the patient experienced chronic fatigue, muscle aches, irritability, hair loss, insomnia, patient experienced joint pain, severe nausea, weight gain, vomiting and no menstrual period (hospitalization extended hospital stay and disability), 803 days after onset of therapy. The following information was obtained through follow up and or provided by the government on 23-MAY-2012, other correspondence, unremarkable. It was also reported that the package's product recommended that the vaccine should not be given to patients with any illness should be till the illness gone. Type 1 diabetes is irreversible and she should never been given this vaccine. No treatment information was reported. An endoscopy, MRI, CAT scan, ultrasound, x ray gastric emptying test and blood tests were performed (no results provided). The outcome of patient experienced no menstrual period, muscle aches, patient experienced chronic fatigue, severe vomiting, patient experienced joint pain, severe nausea, patient experienced irritability, patient experienced hair loss, patient experienced insomnia and severe weight gain was unknown. This report was considered serious, ER visit, extended hospitalized with ER Visit, permanent disability by the agency. The original reporting was not provided. The VAERS ID# is 453304-1. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood glucose normal, Convulsion, Dyskinesia, Gaze palsy, Presyncope
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 12 year old female patient with no medical history and no known allergies who on 10-APR-2012, was vaccinated IM in the left deltoid with the first 0.5 ml dose of GARDASIL (lot# 668819/0477AA, exp 29-JUN-2013). There was no concomitant medication. It was reported that on 10-APR-2012, the patient experienced a post-syncope seizure 30 seconds after receiving GARDASIL. The patient had vasovagal reaction, she fainted and had eyes rolled back. The patient's tongue was protruded, her full body was jerking for 15 seconds and was unresponsive during seizure activity. EMS was notified. The patient's blood pressure was 98/50, heart rate 72, respiratory rate 20, post seizure blood pressure 108/83 and blood glucose 87. At the time of the report, the patient's outcome was unknown. This report was considered non serious with not conditions by the agency. Upon internal review convulsion was considered to be another important medical event. The original reporting source was not provided. The VAERS ID# is 453406-1. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Protrusion tongue, Syncope, Unresponsive to stimuli
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 12 year old female patient with no medical history and no known allergies who on 10-APR-2012, was vaccinated IM in the left deltoid with the first 0.5 ml dose of GARDASIL (lot# 668819/0477AA, exp 29-JUN-2013). There was no concomitant medication. It was reported that on 10-APR-2012, the patient experienced a post-syncope seizure 30 seconds after receiving GARDASIL. The patient had vasovagal reaction, she fainted and had eyes rolled back. The patient's tongue was protruded, her full body was jerking for 15 seconds and was unresponsive during seizure activity. EMS was notified. The patient's blood pressure was 98/50, heart rate 72, respiratory rate 20, post seizure blood pressure 108/83 and blood glucose 87. At the time of the report, the patient's outcome was unknown. This report was considered non serious with not conditions by the agency. Upon internal review convulsion was considered to be another important medical event. The original reporting source was not provided. The VAERS ID# is 453406-1. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Acne, Chest pain, Confusional state, Dyspnoea, Headache
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 24 years old female patient with no medical history or pre-existing illness at the time of vaccination. The patient was vaccinated in the left arm with dose 4 of GARDASIL (lot number, dose and route not reported) on 06-APR-2012. No other co-suspects and no concomitant medications were reported. It was reported that with previous vaccinations of GARDASIL (lot number and dose not reported) on unknown dates, the patient had skin problems, vomiting, sharp pains throughout entire body, breathing problems, increased heartbeat, insomnia and cheat HPV. After the patient received the first vaccine, she began having body pains. The doctor did every test possible but could not find what was causing it. After the second vaccine, the pain got much worse. The night the patient received the third injection, she got a fever of 103.4 and passed out (medically significant upon internal review). The patient was not able to move her body for three days. The sharp pains throughout her entire body became unbearable. There were days when she curled up in a ball and could not move. She started breaking out like she had never seen before. Every inch of her face and chest was covered with acne. The patient got dizzy and threw up at least once a day. She had severe headaches that lead to confusion. Flashing lights caused her to black out. The patient sometimes got an increased heart beat that made her feel like she was going to have a heart attack. She often got severe chest pains and found it hard to breathe. Since the first vaccine the patient had been suffering from insomnia. The only way she could sleep was if she would take a sleep aid. All these symptoms had only gotten worse. The patient felt like her body was shutting down and dying. On an unspecified date the patient sought medical attention. It was stated that there was not explanation within lab data. The outcome of the events was not recovered/not resolved. The relatedness for the reported events was not provided for GARDASIL. This report was considered non serious by the agency. The original reporting source was provided by a consumer. The VAERS ID # is 453723. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Heart rate increased, Insomnia, Loss of consciousness, Mobility decreased, 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 24 years old female patient with no medical history or pre-existing illness at the time of vaccination. The patient was vaccinated in the left arm with dose 4 of GARDASIL (lot number, dose and route not reported) on 06-APR-2012. No other co-suspects and no concomitant medications were reported. It was reported that with previous vaccinations of GARDASIL (lot number and dose not reported) on unknown dates, the patient had skin problems, vomiting, sharp pains throughout entire body, breathing problems, increased heartbeat, insomnia and cheat HPV. After the patient received the first vaccine, she began having body pains. The doctor did every test possible but could not find what was causing it. After the second vaccine, the pain got much worse. The night the patient received the third injection, she got a fever of 103.4 and passed out (medically significant upon internal review). The patient was not able to move her body for three days. The sharp pains throughout her entire body became unbearable. There were days when she curled up in a ball and could not move. She started breaking out like she had never seen before. Every inch of her face and chest was covered with acne. The patient got dizzy and threw up at least once a day. She had severe headaches that lead to confusion. Flashing lights caused her to black out. The patient sometimes got an increased heart beat that made her feel like she was going to have a heart attack. She often got severe chest pains and found it hard to breathe. Since the first vaccine the patient had been suffering from insomnia. The only way she could sleep was if she would take a sleep aid. All these symptoms had only gotten worse. The patient felt like her body was shutting down and dying. On an unspecified date the patient sought medical attention. It was stated that there was not explanation within lab data. The outcome of the events was not recovered/not resolved. The relatedness for the reported events was not provided for GARDASIL. This report was considered non serious by the agency. The original reporting source was provided by a consumer. The VAERS ID # is 453723. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Photopsia, Pyrexia, 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. This spontaneous report as received from a regulatory authority refers to a 24 years old female patient with no medical history or pre-existing illness at the time of vaccination. The patient was vaccinated in the left arm with dose 4 of GARDASIL (lot number, dose and route not reported) on 06-APR-2012. No other co-suspects and no concomitant medications were reported. It was reported that with previous vaccinations of GARDASIL (lot number and dose not reported) on unknown dates, the patient had skin problems, vomiting, sharp pains throughout entire body, breathing problems, increased heartbeat, insomnia and cheat HPV. After the patient received the first vaccine, she began having body pains. The doctor did every test possible but could not find what was causing it. After the second vaccine, the pain got much worse. The night the patient received the third injection, she got a fever of 103.4 and passed out (medically significant upon internal review). The patient was not able to move her body for three days. The sharp pains throughout her entire body became unbearable. There were days when she curled up in a ball and could not move. She started breaking out like she had never seen before. Every inch of her face and chest was covered with acne. The patient got dizzy and threw up at least once a day. She had severe headaches that lead to confusion. Flashing lights caused her to black out. The patient sometimes got an increased heart beat that made her feel like she was going to have a heart attack. She often got severe chest pains and found it hard to breathe. Since the first vaccine the patient had been suffering from insomnia. The only way she could sleep was if she would take a sleep aid. All these symptoms had only gotten worse. The patient felt like her body was shutting down and dying. On an unspecified date the patient sought medical attention. It was stated that there was not explanation within lab data. The outcome of the events was not recovered/not resolved. The relatedness for the reported events was not provided for GARDASIL. This report was considered non serious by the agency. The original reporting source was provided by a consumer. The VAERS ID # is 453723. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Acne, Chest pain, Confusional state, Dizziness, Dyspnoea
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 24 years old female patient with no medical history or pre-existing illness at the time of vaccination. The patient was vaccinated in the left arm with dose 4 of GARDASIL (lot number, dose and route not reported) on 06-APR-2012. No other co-suspects and no concomitant medications were reported. It was reported that with previous vaccinations of GARDASIL (lot number and dose not reported) on unknown dates, the patient had skin problems, vomiting, sharp pains throughout entire body, breathing problems, increased heartbeat, insomnia and cheat HPV. After the patient received the first vaccine, she began having body pains. The doctor did every test possible but could not find what was causing it. After the second vaccine, the pain got much worse. The night the patient received the third injection, she got a fever of 103.4 and passed out (medically significant upon internal review). The patient was not able to move her body for three days. The sharp pains throughout her entire body became unbearable. There were days when she curled up in a ball and could not move. She started breaking out like she had never seen before. Every inch of her face and chest was covered with acne. The patient got dizzy and threw up at least once a day. She had severe headaches that lead to confusion. Flashing lights caused her to black out. The patient sometimes got an increased heart beat that made her feel like she was going to have a heart attack. She often got severe chest pains and found it hard to breathe. Since the first vaccine the patient had been suffering from insomnia. The only way she could sleep was if she would take a sleep aid. All these symptoms had only gotten worse. The patient felt like her body was shutting down and dying. On an unspecified date the patient sought medical attention. It was stated that there was not explanation within lab data. The outcome of the events was not recovered/not resolved. The relatedness for the reported events was not provided for GARDASIL. This report was considered non serious by the agency. The original reporting source was provided by a consumer. The VAERS ID # is 453723. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Feeling abnormal, Headache, Heart rate increased, Insomnia, Laboratory test
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 24 years old female patient with no medical history or pre-existing illness at the time of vaccination. The patient was vaccinated in the left arm with dose 4 of GARDASIL (lot number, dose and route not reported) on 06-APR-2012. No other co-suspects and no concomitant medications were reported. It was reported that with previous vaccinations of GARDASIL (lot number and dose not reported) on unknown dates, the patient had skin problems, vomiting, sharp pains throughout entire body, breathing problems, increased heartbeat, insomnia and cheat HPV. After the patient received the first vaccine, she began having body pains. The doctor did every test possible but could not find what was causing it. After the second vaccine, the pain got much worse. The night the patient received the third injection, she got a fever of 103.4 and passed out (medically significant upon internal review). The patient was not able to move her body for three days. The sharp pains throughout her entire body became unbearable. There were days when she curled up in a ball and could not move. She started breaking out like she had never seen before. Every inch of her face and chest was covered with acne. The patient got dizzy and threw up at least once a day. She had severe headaches that lead to confusion. Flashing lights caused her to black out. The patient sometimes got an increased heart beat that made her feel like she was going to have a heart attack. She often got severe chest pains and found it hard to breathe. Since the first vaccine the patient had been suffering from insomnia. The only way she could sleep was if she would take a sleep aid. All these symptoms had only gotten worse. The patient felt like her body was shutting down and dying. On an unspecified date the patient sought medical attention. It was stated that there was not explanation within lab data. The outcome of the events was not recovered/not resolved. The relatedness for the reported events was not provided for GARDASIL. This report was considered non serious by the agency. The original reporting source was provided by a consumer. The VAERS ID # is 453723. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Loss of consciousness, Mobility decreased, Pain, Photophobia, Photopsia
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 24 years old female patient with no medical history or pre-existing illness at the time of vaccination. The patient was vaccinated in the left arm with dose 4 of GARDASIL (lot number, dose and route not reported) on 06-APR-2012. No other co-suspects and no concomitant medications were reported. It was reported that with previous vaccinations of GARDASIL (lot number and dose not reported) on unknown dates, the patient had skin problems, vomiting, sharp pains throughout entire body, breathing problems, increased heartbeat, insomnia and cheat HPV. After the patient received the first vaccine, she began having body pains. The doctor did every test possible but could not find what was causing it. After the second vaccine, the pain got much worse. The night the patient received the third injection, she got a fever of 103.4 and passed out (medically significant upon internal review). The patient was not able to move her body for three days. The sharp pains throughout her entire body became unbearable. There were days when she curled up in a ball and could not move. She started breaking out like she had never seen before. Every inch of her face and chest was covered with acne. The patient got dizzy and threw up at least once a day. She had severe headaches that lead to confusion. Flashing lights caused her to black out. The patient sometimes got an increased heart beat that made her feel like she was going to have a heart attack. She often got severe chest pains and found it hard to breathe. Since the first vaccine the patient had been suffering from insomnia. The only way she could sleep was if she would take a sleep aid. All these symptoms had only gotten worse. The patient felt like her body was shutting down and dying. On an unspecified date the patient sought medical attention. It was stated that there was not explanation within lab data. The outcome of the events was not recovered/not resolved. The relatedness for the reported events was not provided for GARDASIL. This report was considered non serious by the agency. The original reporting source was provided by a consumer. The VAERS ID # is 453723. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pyrexia, Skin disorder, 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. This spontaneous report as received from a regulatory authority refers to a 24 years old female patient with no medical history or pre-existing illness at the time of vaccination. The patient was vaccinated in the left arm with dose 4 of GARDASIL (lot number, dose and route not reported) on 06-APR-2012. No other co-suspects and no concomitant medications were reported. It was reported that with previous vaccinations of GARDASIL (lot number and dose not reported) on unknown dates, the patient had skin problems, vomiting, sharp pains throughout entire body, breathing problems, increased heartbeat, insomnia and cheat HPV. After the patient received the first vaccine, she began having body pains. The doctor did every test possible but could not find what was causing it. After the second vaccine, the pain got much worse. The night the patient received the third injection, she got a fever of 103.4 and passed out (medically significant upon internal review). The patient was not able to move her body for three days. The sharp pains throughout her entire body became unbearable. There were days when she curled up in a ball and could not move. She started breaking out like she had never seen before. Every inch of her face and chest was covered with acne. The patient got dizzy and threw up at least once a day. She had severe headaches that lead to confusion. Flashing lights caused her to black out. The patient sometimes got an increased heart beat that made her feel like she was going to have a heart attack. She often got severe chest pains and found it hard to breathe. Since the first vaccine the patient had been suffering from insomnia. The only way she could sleep was if she would take a sleep aid. All these symptoms had only gotten worse. The patient felt like her body was shutting down and dying. On an unspecified date the patient sought medical attention. It was stated that there was not explanation within lab data. The outcome of the events was not recovered/not resolved. The relatedness for the reported events was not provided for GARDASIL. This report was considered non serious by the agency. The original reporting source was provided by a consumer. The VAERS ID # is 453723. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Malaise, Syncope, Unresponsive to stimuli
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 20 years old female patient with without illness at the time of vaccine and with allergic to CECLOR as baby treated intramuscularly into left arm with a dose of GARDASIL (lot #:672233/1561AA) on 16-APR-2012. On 16-APR-2012 the patient did not feel well and fainted as she feel to her knees and caught by employees. The patient was unresponsive for a few seconds. At time of the report, the patient's outcome was unknown. No further information is available. The original reporting source was not provide. The VAERS IS # is 453842-1.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site warmth, Oedema peripheral
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 12 years old female patient. The patient was i.m. vaccinated the first dose of GARDASIL (lot number 671463/1359AA) in right arm on 11-APR-2012. Other suspect therapies given on 11-APR-2012 included the second dose of VARIVAX (Merck) (lot number 671029/1065AA) subcutaneously in left arm and the first dose of VAQTA (lot number: 672470/1697AA) intramuscularly in left arm. The concomitant therapy vaccines included the first dose of ADACEL (lot number: C4030AA) intramuscularly in right arm and the first dose of MENACTRA (lot number: U3960AB) intramuscularly in right arm. On afternoon of 12-APR-2012 the patient experienced pain, swelling and redness of right arm. On 13-APR-2012 reported decreased pain. At O.V. on 13-APR-2012 area of warmth, red and induration 7", 4" vertical lateral arm. 5" posterior arm in mid-upper arm (R). Increased redness from 12-APR-2012. Patient was treated with KEFLEX 500 mg TID x 7 days. The outcome was unknown. The patient required ER visit. No further information is available.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 12 years old female patient. The patient was i.m. vaccinated the first dose of GARDASIL (lot number 671463/1359AA) in right arm on 11-APR-2012. Other suspect therapies given on 11-APR-2012 included the second dose of VARIVAX (Merck) (lot number 671029/1065AA) subcutaneously in left arm and the first dose of VAQTA (lot number: 672470/1697AA) intramuscularly in left arm. The concomitant therapy vaccines included the first dose of ADACEL (lot number: C4030AA) intramuscularly in right arm and the first dose of MENACTRA (lot number: U3960AB) intramuscularly in right arm. On afternoon of 12-APR-2012 the patient experienced pain, swelling and redness of right arm. On 13-APR-2012 reported decreased pain. At O.V. on 13-APR-2012 area of warmth, red and induration 7", 4" vertical lateral arm. 5" posterior arm in mid-upper arm (R). Increased redness from 12-APR-2012. Patient was treated with KEFLEX 500 mg TID x 7 days. The outcome was unknown. The patient required ER visit. No further information is available.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Erythema, Feeling hot, Induration, Injection site erythema, Oedema peripheral
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 12 years old female patient. The patient was i.m. vaccinated the first dose of GARDASIL (lot number 671463/1359AA) in right arm on 11-APR-2012. Other suspect therapies given on 11-APR-2012 included the second dose of VARIVAX (Merck) (lot number 671029/1065AA) subcutaneously in left arm and the first dose of VAQTA (lot number: 672470/1697AA) intramuscularly in left arm. The concomitant therapy vaccines included the first dose of ADACEL (lot number: C4030AA) intramuscularly in right arm and the first dose of MENACTRA (lot number: U3960AB) intramuscularly in right arm. On afternoon of 12-APR-2012 the patient experienced pain, swelling and redness of right arm. On 13-APR-2012 reported decreased pain. At O.V. on 13-APR-2012 area of warmth, red and induration 7", 4" vertical lateral arm. 5" posterior arm in mid-upper arm (R). Increased redness from 12-APR-2012. Patient was treated with KEFLEX 500 mg TID x 7 days. The outcome was unknown. The patient required ER visit. No further information is available.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Appendicectomy, Appendicitis
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 with history of obesity and no known allergies was vaccinated into left arm with lot # (672233/1561AA) dose 2 GARDASIL on 16-APR-2012. No other co-suspects were reported. The patient was also vaccinated into left arm with lot # (U4237AA) dose 2 MENACTRA. Appendicitis developed the morning after vaccination requiring appendectomy on 17-APR-2012. The following information was obtained through follow-up and/or by the government on 29-MAY-2012. Hospital records date of service on 17-APR-2012 - 18-APR-2012. Diagnosis: acute non-perforated appendicitis. Concurrent condition: Right Lower Quadrant abdominal pain; diarrhea; headache; nausea; dry heaves. Admitted and underwent laparoscopic appendectomy. Discharge in stable condition to follow up with surgery. Labs/diagnostics: Ultrasound abdomen: findings concerning for acute appendicitis. Urine ketone body: 15 mg/dL (H), White blood cells urine 5-10/hpf (H). White blood cell count 9.6 K/mm3 (N), Neutrophil count 81% (H), Lymphocyte count 12% (L). Tot protein 9.6 g/dL (H), total bilirubin 2.3 mg/dL (H), Aspartate aminotransferase 82 u/l (H), amylase 160 u/L (H). The original reporting source was not provided. The VAERS ID # is 453946-1. Additional information is not expected.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Abdominal pain lower, Amylase increased, Appendicectomy, Appendicitis, Aspartate aminotransferase increased
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 with history of obesity and no known allergies was vaccinated into left arm with lot # (672233/1561AA) dose 2 GARDASIL on 16-APR-2012. No other co-suspects were reported. The patient was also vaccinated into left arm with lot # (U4237AA) dose 2 MENACTRA. Appendicitis developed the morning after vaccination requiring appendectomy on 17-APR-2012. The following information was obtained through follow-up and/or by the government on 29-MAY-2012. Hospital records date of service on 17-APR-2012 - 18-APR-2012. Diagnosis: acute non-perforated appendicitis. Concurrent condition: Right Lower Quadrant abdominal pain; diarrhea; headache; nausea; dry heaves. Admitted and underwent laparoscopic appendectomy. Discharge in stable condition to follow up with surgery. Labs/diagnostics: Ultrasound abdomen: findings concerning for acute appendicitis. Urine ketone body: 15 mg/dL (H), White blood cells urine 5-10/hpf (H). White blood cell count 9.6 K/mm3 (N), Neutrophil count 81% (H), Lymphocyte count 12% (L). Tot protein 9.6 g/dL (H), total bilirubin 2.3 mg/dL (H), Aspartate aminotransferase 82 u/l (H), amylase 160 u/L (H). The original reporting source was not provided. The VAERS ID # is 453946-1. Additional information is not expected.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Blood bilirubin increased, Diarrhoea, Headache, Laparoscopic surgery, Lymphocyte percentage decreased
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 with history of obesity and no known allergies was vaccinated into left arm with lot # (672233/1561AA) dose 2 GARDASIL on 16-APR-2012. No other co-suspects were reported. The patient was also vaccinated into left arm with lot # (U4237AA) dose 2 MENACTRA. Appendicitis developed the morning after vaccination requiring appendectomy on 17-APR-2012. The following information was obtained through follow-up and/or by the government on 29-MAY-2012. Hospital records date of service on 17-APR-2012 - 18-APR-2012. Diagnosis: acute non-perforated appendicitis. Concurrent condition: Right Lower Quadrant abdominal pain; diarrhea; headache; nausea; dry heaves. Admitted and underwent laparoscopic appendectomy. Discharge in stable condition to follow up with surgery. Labs/diagnostics: Ultrasound abdomen: findings concerning for acute appendicitis. Urine ketone body: 15 mg/dL (H), White blood cells urine 5-10/hpf (H). White blood cell count 9.6 K/mm3 (N), Neutrophil count 81% (H), Lymphocyte count 12% (L). Tot protein 9.6 g/dL (H), total bilirubin 2.3 mg/dL (H), Aspartate aminotransferase 82 u/l (H), amylase 160 u/L (H). The original reporting source was not provided. The VAERS ID # is 453946-1. Additional information is not expected.