chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Allergy to vaccine, Cough, Headache, Pain, Throat tightness
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 21 years old female patient allergic to yeast in vaccine, allergies to gluten, dairy, beef, pork and latex with a previous illness of small cough was vaccinated with dose 2 of GARDASIL (lot # not reported), right arm on 07-MAY-2012. No other co-suspects were reported. Other medications included "birth control". It was reported that on 07-MAY-2012, the patient experienced throat closing, coughing, vomiting, headaches, body aches..Patient had an allergy to yeast in vaccine. No treatment was reported. The outcome of the events mentioned above was unknown. This report was considered non serious with ER visit by the agency. The original reporting source was not provided. The VAERS ID# is 455244-1. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: 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 21 years old female patient allergic to yeast in vaccine, allergies to gluten, dairy, beef, pork and latex with a previous illness of small cough was vaccinated with dose 2 of GARDASIL (lot # not reported), right arm on 07-MAY-2012. No other co-suspects were reported. Other medications included "birth control". It was reported that on 07-MAY-2012, the patient experienced throat closing, coughing, vomiting, headaches, body aches..Patient had an allergy to yeast in vaccine. No treatment was reported. The outcome of the events mentioned above was unknown. This report was considered non serious with ER visit by the agency. The original reporting source was not provided. The VAERS ID# is 455244-1. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Presyncope
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 12 years old female patient with no previous illness was vaccinated with dose 1 GARDASIL lot # (62193/1524AA), IM on 04-MAY-2012. No other co-suspects were reported. Concomitant medications included a first dose of MENACTRA (Lot # U3831AA(, IM and a first dose of ADACEL (Lot # C3517AA), IM. No other medications reported. It was reported that on 04-MAY-2012 the patient experienced vasovagal event approximately 2 min after administered and came to approximately 2 minutes and went home after 15 minutes. This report was considered non serious with no conditions by the agency. The original reporting source was no provided. The VAERS ID # is 455645-1. Additional information is not expected.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Diarrhoea, Pain in extremity, Rash erythematous, Skin discolouration
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 12 years old male patient with no previous illness, asthma and a medical history of eczema who was vaccinated with a first dose of GARDASIL (Lot # 671991/1537AA), left arm, IM pm 09-MAY-2012. No other co-suspects were reported. Concomitant medications included: a first dose of MENACTRA (Lot # U3779AA), right arm, IM on 09-MAY-2012. Other concomitant therapies included albuterol," HFA and PRN". It was reported that on 11-MAY-2012 the patient's mom reported that the patient complaint of arm soreness after school and that the patient developed red spots "like pimples" with blue/black discoloration, then below raised pink area, slightly larger than half dollar, the patient had loose stool all day. No treatment information was reported. The outcome of the events mentioned above was unknown. This report was considered non serious with no conditions by the agency. The original reporting source was the patient's mother. The VAERS ID # is 455803-1. Additional information is not expected.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Diarrhoea, Pain in extremity, Rash erythematous, Skin discolouration
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 12 years old male patient with no previous illness, asthma and a medical history of eczema who was vaccinated with a first dose of GARDASIL (Lot # 671994/1537AA), Left arm, IM on 09-MAY-2012. No other co-suspects were reported. Concomitant medications included: a first dose of MENACTRA (Lot # U3779AA), Right arm, IM on 09-MAY-2012. Other concomitant therapies included albuterol, "HFA and PRN". It was reported that on 11-MAY-2012 the patient's mom reported that the patient complaint of arm soreness after school and that the patient developed red spots "like pimples" with blue/black discoloration, then below raised pink area, slightly larger than half dollar, the patient had loose stool all day. No treatment information was reported. The outcome of the events mentioned above was unknown. This report was considered non serious with no conditions by the agency. The original reporting source was the patient's mother. The VAERS ID# is 455803-1. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, HPV4, VARCEL
Symptoms: Alanine aminotransferase increased, Anaemia, Arrhythmia, Aspartate aminotransferase increased, Blood insulin increased
Clinical narrative: This report was 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 known pre-existing illness at the time of vaccination. The patient's medical history included high insulin level lab draw (05-APR-2006), high cholesterol levels lab draw (05-MAY-2006) and obesity (31-JUL-2006). The patient was vaccinated intramuscularly in the left arm with lot # (659964/1978U) dose 1 GARDASIL on 01-APR-2008. Other suspect therapies included 2 doses of VARIVAX (Merck) (lot # 659944/1796U) (dose not reported) subcutaneously in the left arm, on 01-APR-2008. Concomitant medications included: hydrocortisone (manufacturer unknown) 1 % cream. On 22-SEP-2009 the patient experienced arrhythmia with exercise. On 16-OCT-2009 the patient experienced chest pain. On 09-MAR-2010 the patient experienced anemia and syncope. On 25-MAR-2010 the patient was referred to the hospital-hematology clinic and was diagnosed with thrombocythemia. Labs were performed on 29-MAR-2010 which resulted in platelet count low, absolute eosinophil low, sedimentation rate high, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) high lab draw, On 02-APR-2010 the patient was diagnosed with thrombocytopenia (onset date reported as 28-SEP-2009). On 05-APR-2010 and abdominal ultrasound was performed and lab results showed elevated liver enzymes. No treatment information was reported. The outcome of the events was unknown. The relatedness for the reported events was not provide for GARDASIL and VARIVAX (Merck). This report was considered non serious by the agency. The original reporting source was not provided. The VAERS ID # is 455930-1. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, HPV4, VARCEL
Symptoms: Chest pain, Eosinophil count decreased, Hepatic enzyme increased, Platelet count decreased, Red blood cell sedimentation rate increased
Clinical narrative: This report was 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 known pre-existing illness at the time of vaccination. The patient's medical history included high insulin level lab draw (05-APR-2006), high cholesterol levels lab draw (05-MAY-2006) and obesity (31-JUL-2006). The patient was vaccinated intramuscularly in the left arm with lot # (659964/1978U) dose 1 GARDASIL on 01-APR-2008. Other suspect therapies included 2 doses of VARIVAX (Merck) (lot # 659944/1796U) (dose not reported) subcutaneously in the left arm, on 01-APR-2008. Concomitant medications included: hydrocortisone (manufacturer unknown) 1 % cream. On 22-SEP-2009 the patient experienced arrhythmia with exercise. On 16-OCT-2009 the patient experienced chest pain. On 09-MAR-2010 the patient experienced anemia and syncope. On 25-MAR-2010 the patient was referred to the hospital-hematology clinic and was diagnosed with thrombocythemia. Labs were performed on 29-MAR-2010 which resulted in platelet count low, absolute eosinophil low, sedimentation rate high, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) high lab draw, On 02-APR-2010 the patient was diagnosed with thrombocytopenia (onset date reported as 28-SEP-2009). On 05-APR-2010 and abdominal ultrasound was performed and lab results showed elevated liver enzymes. No treatment information was reported. The outcome of the events was unknown. The relatedness for the reported events was not provide for GARDASIL and VARIVAX (Merck). This report was considered non serious by the agency. The original reporting source was not provided. The VAERS ID # is 455930-1. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, HPV4, VARCEL
Symptoms: Syncope, Thrombocytopenia, Ultrasound abdomen
Clinical narrative: This report was 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 known pre-existing illness at the time of vaccination. The patient's medical history included high insulin level lab draw (05-APR-2006), high cholesterol levels lab draw (05-MAY-2006) and obesity (31-JUL-2006). The patient was vaccinated intramuscularly in the left arm with lot # (659964/1978U) dose 1 GARDASIL on 01-APR-2008. Other suspect therapies included 2 doses of VARIVAX (Merck) (lot # 659944/1796U) (dose not reported) subcutaneously in the left arm, on 01-APR-2008. Concomitant medications included: hydrocortisone (manufacturer unknown) 1 % cream. On 22-SEP-2009 the patient experienced arrhythmia with exercise. On 16-OCT-2009 the patient experienced chest pain. On 09-MAR-2010 the patient experienced anemia and syncope. On 25-MAR-2010 the patient was referred to the hospital-hematology clinic and was diagnosed with thrombocythemia. Labs were performed on 29-MAR-2010 which resulted in platelet count low, absolute eosinophil low, sedimentation rate high, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) high lab draw, On 02-APR-2010 the patient was diagnosed with thrombocytopenia (onset date reported as 28-SEP-2009). On 05-APR-2010 and abdominal ultrasound was performed and lab results showed elevated liver enzymes. No treatment information was reported. The outcome of the events was unknown. The relatedness for the reported events was not provide for GARDASIL and VARIVAX (Merck). This report was considered non serious by the agency. The original reporting source was not provided. The VAERS ID # is 455930-1. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, HPV4, VARCEL
Symptoms: Alanine aminotransferase increased, Anaemia, Arrhythmia, Aspartate aminotransferase increased, Chest pain
Clinical narrative: This report was 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 known pre-existing illness at the time of vaccination. The patient's medical history included high insulin level lab draw (05-APR-2006), high cholesterol levels lab draw (05-MAY-2006) and obesity (31-JUL-2006). The patient was vaccinated intramuscularly in the left arm with lot # (659964/1978U) dose 1 GARDASIL on 01-APR-2008. Other suspect therapies included 2 doses of VARIVAX (Merck) (lot # 659944/1796U) (dose not reported) subcutaneously in the left arm, on 01-APR-2008. Concomitant medications included: hydrocortisone (manufacturer unknown) 1 % cream. On 22-SEP-2009 the patient experienced arrhythmia with exercise. On 16-OCT-2009 the patient experienced chest pain. On 09-MAR-2010 the patient experienced anemia and syncope. On 25-MAR-2010 the patient was referred to the hospital-hematology clinic and was diagnosed with thrombocythemia. Labs were performed on 29-MAR-2010 which resulted in platelet count low, absolute eosinophil low, sedimentation rate high, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) high lab draw, On 02-APR-2010 the patient was diagnosed with thrombocytopenia (onset date reported as 28-SEP-2009). On 05-APR-2010 and abdominal ultrasound was performed and lab results showed elevated liver enzymes. No treatment information was reported. The outcome of the events was unknown. The relatedness for the reported events was not provide for GARDASIL and VARIVAX (Merck). This report was considered non serious by the agency. The original reporting source was not provided. The VAERS ID # is 455930-1. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, HPV4, VARCEL
Symptoms: Eosinophil count decreased, Fatigue, Hepatic enzyme increased, Idiopathic thrombocytopenic purpura, Platelet count decreased
Clinical narrative: This report was 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 known pre-existing illness at the time of vaccination. The patient's medical history included high insulin level lab draw (05-APR-2006), high cholesterol levels lab draw (05-MAY-2006) and obesity (31-JUL-2006). The patient was vaccinated intramuscularly in the left arm with lot # (659964/1978U) dose 1 GARDASIL on 01-APR-2008. Other suspect therapies included 2 doses of VARIVAX (Merck) (lot # 659944/1796U) (dose not reported) subcutaneously in the left arm, on 01-APR-2008. Concomitant medications included: hydrocortisone (manufacturer unknown) 1 % cream. On 22-SEP-2009 the patient experienced arrhythmia with exercise. On 16-OCT-2009 the patient experienced chest pain. On 09-MAR-2010 the patient experienced anemia and syncope. On 25-MAR-2010 the patient was referred to the hospital-hematology clinic and was diagnosed with thrombocythemia. Labs were performed on 29-MAR-2010 which resulted in platelet count low, absolute eosinophil low, sedimentation rate high, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) high lab draw, On 02-APR-2010 the patient was diagnosed with thrombocytopenia (onset date reported as 28-SEP-2009). On 05-APR-2010 and abdominal ultrasound was performed and lab results showed elevated liver enzymes. No treatment information was reported. The outcome of the events was unknown. The relatedness for the reported events was not provide for GARDASIL and VARIVAX (Merck). This report was considered non serious by the agency. The original reporting source was not provided. The VAERS ID # is 455930-1. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, HPV4, VARCEL
Symptoms: Red blood cell sedimentation rate increased, Syncope, Thrombocytosis, Ultrasound abdomen abnormal
Clinical narrative: This report was 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 known pre-existing illness at the time of vaccination. The patient's medical history included high insulin level lab draw (05-APR-2006), high cholesterol levels lab draw (05-MAY-2006) and obesity (31-JUL-2006). The patient was vaccinated intramuscularly in the left arm with lot # (659964/1978U) dose 1 GARDASIL on 01-APR-2008. Other suspect therapies included 2 doses of VARIVAX (Merck) (lot # 659944/1796U) (dose not reported) subcutaneously in the left arm, on 01-APR-2008. Concomitant medications included: hydrocortisone (manufacturer unknown) 1 % cream. On 22-SEP-2009 the patient experienced arrhythmia with exercise. On 16-OCT-2009 the patient experienced chest pain. On 09-MAR-2010 the patient experienced anemia and syncope. On 25-MAR-2010 the patient was referred to the hospital-hematology clinic and was diagnosed with thrombocythemia. Labs were performed on 29-MAR-2010 which resulted in platelet count low, absolute eosinophil low, sedimentation rate high, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) high lab draw, On 02-APR-2010 the patient was diagnosed with thrombocytopenia (onset date reported as 28-SEP-2009). On 05-APR-2010 and abdominal ultrasound was performed and lab results showed elevated liver enzymes. No treatment information was reported. The outcome of the events was unknown. The relatedness for the reported events was not provide for GARDASIL and VARIVAX (Merck). This report was considered non serious by the agency. The original reporting source was not provided. The VAERS ID # is 455930-1. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, HPV4, VARCEL
Symptoms: Alanine aminotransferase increased, Anaemia, Arrhythmia, Aspartate aminotransferase increased, Blood cholesterol increased
Clinical narrative: This report was 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 known pre-existing illness at the time of vaccination. The patient's medical history included high insulin level lab draw (05-APR-2006), high cholesterol levels lab draw (05-MAY-2006) and obesity (31-JUL-2006). The patient was vaccinated intramuscularly in the left arm with lot # (659964/1978U) dose 1 GARDASIL on 01-APR-2008. Other suspect therapies included 2 doses of VARIVAX (Merck) (lot # 659944/1796U) (dose not reported) subcutaneously in the left arm, on 01-APR-2008. Concomitant medications included: hydrocortisone (manufacturer unknown) 1 % cream. On 22-SEP-2009 the patient experienced arrhythmia with exercise. On 16-OCT-2009 the patient experienced chest pain. On 09-MAR-2010 the patient experienced anemia and syncope. On 25-MAR-2010 the patient was referred to the hospital-hematology clinic and was diagnosed with thrombocythemia. Labs were performed on 29-MAR-2010 which resulted in platelet count low, absolute eosinophil low, sedimentation rate high, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) high lab draw, On 02-APR-2010 the patient was diagnosed with thrombocytopenia (onset date reported as 28-SEP-2009). On 05-APR-2010 and abdominal ultrasound was performed and lab results showed elevated liver enzymes. No treatment information was reported. The outcome of the events was unknown. The relatedness for the reported events was not provide for GARDASIL and VARIVAX (Merck). This report was considered non serious by the agency. The original reporting source was not provided. The VAERS ID # is 455930-1. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, HPV4, VARCEL
Symptoms: Blood insulin increased, Chest pain, Eosinophil count decreased, Hepatic enzyme increased, Platelet count decreased
Clinical narrative: This report was 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 known pre-existing illness at the time of vaccination. The patient's medical history included high insulin level lab draw (05-APR-2006), high cholesterol levels lab draw (05-MAY-2006) and obesity (31-JUL-2006). The patient was vaccinated intramuscularly in the left arm with lot # (659964/1978U) dose 1 GARDASIL on 01-APR-2008. Other suspect therapies included 2 doses of VARIVAX (Merck) (lot # 659944/1796U) (dose not reported) subcutaneously in the left arm, on 01-APR-2008. Concomitant medications included: hydrocortisone (manufacturer unknown) 1 % cream. On 22-SEP-2009 the patient experienced arrhythmia with exercise. On 16-OCT-2009 the patient experienced chest pain. On 09-MAR-2010 the patient experienced anemia and syncope. On 25-MAR-2010 the patient was referred to the hospital-hematology clinic and was diagnosed with thrombocythemia. Labs were performed on 29-MAR-2010 which resulted in platelet count low, absolute eosinophil low, sedimentation rate high, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) high lab draw, On 02-APR-2010 the patient was diagnosed with thrombocytopenia (onset date reported as 28-SEP-2009). On 05-APR-2010 and abdominal ultrasound was performed and lab results showed elevated liver enzymes. No treatment information was reported. The outcome of the events was unknown. The relatedness for the reported events was not provide for GARDASIL and VARIVAX (Merck). This report was considered non serious by the agency. The original reporting source was not provided. The VAERS ID # is 455930-1. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, HPV4, VARCEL
Symptoms: Red blood cell sedimentation rate increased, Syncope, Thrombocytopenia, Ultrasound abdomen
Clinical narrative: This report was 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 known pre-existing illness at the time of vaccination. The patient's medical history included high insulin level lab draw (05-APR-2006), high cholesterol levels lab draw (05-MAY-2006) and obesity (31-JUL-2006). The patient was vaccinated intramuscularly in the left arm with lot # (659964/1978U) dose 1 GARDASIL on 01-APR-2008. Other suspect therapies included 2 doses of VARIVAX (Merck) (lot # 659944/1796U) (dose not reported) subcutaneously in the left arm, on 01-APR-2008. Concomitant medications included: hydrocortisone (manufacturer unknown) 1 % cream. On 22-SEP-2009 the patient experienced arrhythmia with exercise. On 16-OCT-2009 the patient experienced chest pain. On 09-MAR-2010 the patient experienced anemia and syncope. On 25-MAR-2010 the patient was referred to the hospital-hematology clinic and was diagnosed with thrombocythemia. Labs were performed on 29-MAR-2010 which resulted in platelet count low, absolute eosinophil low, sedimentation rate high, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) high lab draw, On 02-APR-2010 the patient was diagnosed with thrombocytopenia (onset date reported as 28-SEP-2009). On 05-APR-2010 and abdominal ultrasound was performed and lab results showed elevated liver enzymes. No treatment information was reported. The outcome of the events was unknown. The relatedness for the reported events was not provide for GARDASIL and VARIVAX (Merck). This report was considered non serious by the agency. The original reporting source was not provided. The VAERS ID # is 455930-1. No further information is available.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: 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, concerning to a 16 years old female patient. The patient's medical history included thrombocytopenia in November-2011 based on full blood count result. The patient was vaccinated intramuscularly on left arm with first dose GARDASIL (lot # 671994/1537AA) on 09-MAY-2012. Other suspect therapies included first dose VARIVAX (Merck) (lot # 1275AA) subcutaneously on right leg on 09-MAY-2012. Concomitant medications included BOOSTRIX (lot # AC52B058BA) intramuscularly on left arm on 09-MAY-2012, MENACTRA (lot # U4024AA) intramuscularly on right arm on 09-MAY-2012, and HAVRIX (lot # AHAVB550AA) intramuscularly on right arm on 09-MAY-2012. On 09-MAY-2012, after receiving 3 vaccines HAVRIX, VARIVAX (Merck) and GARDASIL, the patient experienced dizziness. VARIVAX (Merck) was given first, then HAVRIX was given. The patient was fine and denied any discomfort or dizziness. After administered GARDASIL, less than 2 minutes after injection, the patient experienced dizziness without syncopal episode. The outcome of patient was unknown. The patient visited emergency room. The original reporting source was not provided.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Full blood count abnormal
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, concerning to a 16 years old female patient. The patient's medical history included thrombocytopenia in November-2011 based on full blood count result. The patient was vaccinated intramuscularly on left arm with first dose GARDASIL (lot # 671994/1537AA) on 09-MAY-2012. Other suspect therapies included first dose VARIVAX (Merck) (lot # 1275AA) subcutaneously on right leg on 09-MAY-2012. Concomitant medications included BOOSTRIX (lot # AC52B058BA) intramuscularly on left arm on 09-MAY-2012, MENACTRA (lot # U4024AA) intramuscularly on right arm on 09-MAY-2012, and HAVRIX (lot # AHAVB550AA) intramuscularly on right arm on 09-MAY-2012. On 09-MAY-2012, after receiving 3 vaccines HAVRIX, VARIVAX (Merck) and GARDASIL, the patient experienced dizziness. VARIVAX (Merck) was given first, then HAVRIX was given. The patient was fine and denied any discomfort or dizziness. After administered GARDASIL, less than 2 minutes after injection, the patient experienced dizziness without syncopal episode. The outcome of patient was unknown. The patient visited emergency room. The original reporting source was not provided.
Age: 21.0
Sex: M
Vaccine: HPV4, HPV4, HPV4
Symptoms: Gaze palsy, Syncope, Tremor
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 21 years old male patient with no medical history with a past drug history of vaccination with MENACTRA, who was vaccinated with dose 1 of GARDASIL (Batch # 0420AE), Right arm on 07-JUN-2012. No other co-suspects were reported. It was reported that on 07-JUN-2012, after receiving the vaccine the patient fainted, tremors were noted of bilateral upper and lower extremities with eyes rolling. No Loss of Consciousness. There were no labs performed. The outcome of the events mentioned above was reported as recovered immediately. This report was considered non serious with no conditions by the agency. The original reporting source was not provided. The VAERS ID# is 457273-1. Additional information is not expected.
Age: 21.0
Sex: M
Vaccine: HPV4, HPV4, HPV4
Symptoms: Gaze palsy, Syncope, Tremor
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 21 years old male patient with no medical history with a past drug history of vaccination with MENACTRA, who was vaccinated with dose 1 of GARDASIL (Batch # 0420AE), right arm on 07-JUN-2012. No other co-suspects were reported. It was reported that on 07-JUN-2012, after receiving the patient fainted, tremors were noted of bilateral upper and lower extremities with eyes tolling. No loss of consciousness. There ere no labs performed. The outcome of the events mentioned above was reported as recovered immediately. This report was considered non serious with not conditions by the agency. The original reporting source was not provided. The VAERS ID # is 457273-1. Additional information is not expected.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 years old male patient on 07-JUN-2012 was vaccinated IM with the first dose of GARDASIL (lot # 672232/1495AA) into the left arm. No other co-suspects were reported. No concomitant medications were reported. On 07-JUN-2012, the patient complaining of nausea and dizziness. It was reported that the patient's vital signs remained stable. Pulse was between 75 to 80, blood pressure 132/76 to 148/72. After discharge from clinic, went to emergency room (ER). It was given BENADRYL, prednisone and PEPOD for the treatment of the adverse events. At the time of the report, the patient's outcome was not reported. The patient required an emergency room visit. This report was considered non serious by the agency. The original reporting source was not provided. The VAERS ID # is 457428. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: This report was obtained on request by the Company from the FDA under the reported Freedom of Information Act. A 12 years old female patient with no previous illness and no medical history who was vaccinated with a first dose of GARDASIL lot # (672233/1561AA), left arm, IM (dose not reported). Concomitant therapies included: a frost dose of MENACTRA (Lot # U4098AB), left arm, IM (dose not reported) and a first dose of DTAP (unspecified) (Lot # U4106AA), right arm, IM on 11-JUN-2012. It was reported that on 11-JUN-2012 the patient experienced syncopal episode < 1 minute after HPV vaccine was given. No treatment information was reported. The outcome of syncopal episode < 1 minute after HPV vaccine was given was unknown. This report was considered non serious with not conditions by the agency. The original reporting source was not provided. The VAERS ID # is 457535-1. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Syncope
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 years old female with no previous illness who was vaccinated with a third dose of GARDASIL lot # (671006/1291AA), IM on 18-JUN-2012. No other co-suspects were reported. No concomitant medications were reported. It was reported that on 18-JUN-2012 the patient experienced syncope. There was no labs performed. No treatment information was reported. The outcome of syncope was unknown. This report was considered non serious with not conditions by the agency. The original reporting source was not provided. The VAERS ID # is 457653-1. Additional information is not expected.
Age: 9.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Alopecia
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 9 years old female patient with no previous illness was vaccinated with a dose 1 of GARDASIL (lot # 670050/1229AA), (unknown dose and route) on 10-APR-2012. No other co-suspects were reported. There were no concomitant medications reported. It was reported that on an unspecified date the patient experienced alopecia following GARDASIL vaccination. No treatment information was reported. No labs were performed. Patient was referred to a dermatologic clinic. The outcome of the event mentioned above is unknown. The patient's mother has had long-standing history of alopecia but never sought medical attention. This report was considered non serious with not conditions by the agency. The original reporting source was not provided. The VAERS ID # is 457679-1. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Blister, Erythema, Swelling
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 11 years old male patient on 22-JUN-2012 was vaccinated with the first dose of GARDASIL (lot # 672232/1495AA) into the right arm (route was not reported). No other co-suspects were reported. Concomitant medications given on the same day included the first dose of MENVEO into the right am (route was not reported). On 23-JUN-2012, 1 day after onset of therapy, the patient experienced swelling, redness with large blisters. No treatment information was reported. At the time of the report, the patient's outcome was not reported. This report was considered non serious and no conditions by the agency. The original reporting source was not provided. The VAERS ID# is 458031. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, DTAP, MMR, DTAP, MMR
Symptoms: Flushing, Syncope, Vomiting
Clinical narrative: This spontaneous report as received from a consumer refers to a her 4 years old male son with asthma and allergy to penicillin who on 05-JUL-2012, was vaccinated with one 0.5 ml shot M-M-R II subcutaneously (lot number 671485/1450AA). Co suspect therapy given at the same time was Tetanus and Diphtheria Toxoids, Adsorbed (manufacturer unknown). Concomitant therapy included FLOVENT. The mother's patient reported that on 05-JUL-2012, within minutes after vaccination, her son started coughing and his feet started itching. He eventually collapsed and an ambulance was called. The ambulance was cancelled when the boy "came to", and then he started throwing up. The patient was "in a stare" but was able to answer any questions asked to him. He turned beet red, broke out in a sweat and his movements were jerky and jittery. The mother and grandmother drove the patient back to the clinic, where he was given BENADRYL. The patient saw the nurse soon after the reaction. No lab diagnostics studies were performed. The patient recovered the next day on 06-JUL-2012. The relatedness for patient started coughing, his movements were jerky and jittery, patient broke out in a sweat, patient turned beet red, patient was in a stare, patient started throwing up, patient eventually collapsed and his feet starting itching was unknown for M-M-R II. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, DTAP, MMR, DTAP, MMR
Symptoms: Cough, Dyskinesia, Dyspnoea, Erythema, Feeling cold
Clinical narrative: This spontaneous report as received from a consumer refers to a her 4 years old male son with asthma and allergy to penicillin who on 05-JUL-2012, was vaccinated with one 0.5 ml shot M-M-R II subcutaneously (lot number 671485/1450AA). Co suspect therapy given at the same time was Tetanus and Diphtheria Toxoids, Adsorbed (manufacturer unknown). Concomitant therapy included FLOVENT. The mother's patient reported that on 05-JUL-2012, within minutes after vaccination, her son started coughing and his feet started itching. He eventually collapsed and an ambulance was called. The ambulance was cancelled when the boy "came to", and then he started throwing up. The patient was "in a stare" but was able to answer any questions asked to him. He turned beet red, broke out in a sweat and his movements were jerky and jittery. The mother and grandmother drove the patient back to the clinic, where he was given BENADRYL. The patient saw the nurse soon after the reaction. No lab diagnostics studies were performed. The patient recovered the next day on 06-JUL-2012. The relatedness for patient started coughing, his movements were jerky and jittery, patient broke out in a sweat, patient turned beet red, patient was in a stare, patient started throwing up, patient eventually collapsed and his feet starting itching was unknown for M-M-R II. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, DTAP, MMR, DTAP, MMR
Symptoms: Heart rate increased, Injection site pain, Pruritus, Staring, Syncope
Clinical narrative: This spontaneous report as received from a consumer refers to a her 4 years old male son with asthma and allergy to penicillin who on 05-JUL-2012, was vaccinated with one 0.5 ml shot M-M-R II subcutaneously (lot number 671485/1450AA). Co suspect therapy given at the same time was Tetanus and Diphtheria Toxoids, Adsorbed (manufacturer unknown). Concomitant therapy included FLOVENT. The mother's patient reported that on 05-JUL-2012, within minutes after vaccination, her son started coughing and his feet started itching. He eventually collapsed and an ambulance was called. The ambulance was cancelled when the boy "came to", and then he started throwing up. The patient was "in a stare" but was able to answer any questions asked to him. He turned beet red, broke out in a sweat and his movements were jerky and jittery. The mother and grandmother drove the patient back to the clinic, where he was given BENADRYL. The patient saw the nurse soon after the reaction. No lab diagnostics studies were performed. The patient recovered the next day on 06-JUL-2012. The relatedness for patient started coughing, his movements were jerky and jittery, patient broke out in a sweat, patient turned beet red, patient was in a stare, patient started throwing up, patient eventually collapsed and his feet starting itching was unknown for M-M-R II. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, DTAP, MMR, DTAP, MMR
Symptoms: Tremor, Vomiting
Clinical narrative: This spontaneous report as received from a consumer refers to a her 4 years old male son with asthma and allergy to penicillin who on 05-JUL-2012, was vaccinated with one 0.5 ml shot M-M-R II subcutaneously (lot number 671485/1450AA). Co suspect therapy given at the same time was Tetanus and Diphtheria Toxoids, Adsorbed (manufacturer unknown). Concomitant therapy included FLOVENT. The mother's patient reported that on 05-JUL-2012, within minutes after vaccination, her son started coughing and his feet started itching. He eventually collapsed and an ambulance was called. The ambulance was cancelled when the boy "came to", and then he started throwing up. The patient was "in a stare" but was able to answer any questions asked to him. He turned beet red, broke out in a sweat and his movements were jerky and jittery. The mother and grandmother drove the patient back to the clinic, where he was given BENADRYL. The patient saw the nurse soon after the reaction. No lab diagnostics studies were performed. The patient recovered the next day on 06-JUL-2012. The relatedness for patient started coughing, his movements were jerky and jittery, patient broke out in a sweat, patient turned beet red, patient was in a stare, patient started throwing up, patient eventually collapsed and his feet starting itching was unknown for M-M-R II. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, DTAP, MMR, DTAP, MMR
Symptoms: Cough, Dyskinesia, Erythema, Feeling jittery, Hyperhidrosis
Clinical narrative: This spontaneous report as received from a consumer refers to a her 4 years old male son with asthma and allergy to penicillin who on 05-JUL-2012, was vaccinated with one 0.5 ml shot M-M-R II subcutaneously (lot number 671485/1450AA). Co suspect therapy given at the same time was Tetanus and Diphtheria Toxoids, Adsorbed (manufacturer unknown). Concomitant therapy included FLOVENT. The mother's patient reported that on 05-JUL-2012, within minutes after vaccination, her son started coughing and his feet started itching. He eventually collapsed and an ambulance was called. The ambulance was cancelled when the boy "came to", and then he started throwing up. The patient was "in a stare" but was able to answer any questions asked to him. He turned beet red, broke out in a sweat and his movements were jerky and jittery. The mother and grandmother drove the patient back to the clinic, where he was given BENADRYL. The patient saw the nurse soon after the reaction. No lab diagnostics studies were performed. The patient recovered the next day on 06-JUL-2012. The relatedness for patient started coughing, his movements were jerky and jittery, patient broke out in a sweat, patient turned beet red, patient was in a stare, patient started throwing up, patient eventually collapsed and his feet starting itching was unknown for M-M-R II. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, DTAP, MMR, DTAP, MMR
Symptoms: Pruritus, Staring, Syncope, Vomiting
Clinical narrative: This spontaneous report as received from a consumer refers to a her 4 years old male son with asthma and allergy to penicillin who on 05-JUL-2012, was vaccinated with one 0.5 ml shot M-M-R II subcutaneously (lot number 671485/1450AA). Co suspect therapy given at the same time was Tetanus and Diphtheria Toxoids, Adsorbed (manufacturer unknown). Concomitant therapy included FLOVENT. The mother's patient reported that on 05-JUL-2012, within minutes after vaccination, her son started coughing and his feet started itching. He eventually collapsed and an ambulance was called. The ambulance was cancelled when the boy "came to", and then he started throwing up. The patient was "in a stare" but was able to answer any questions asked to him. He turned beet red, broke out in a sweat and his movements were jerky and jittery. The mother and grandmother drove the patient back to the clinic, where he was given BENADRYL. The patient saw the nurse soon after the reaction. No lab diagnostics studies were performed. The patient recovered the next day on 06-JUL-2012. The relatedness for patient started coughing, his movements were jerky and jittery, patient broke out in a sweat, patient turned beet red, patient was in a stare, patient started throwing up, patient eventually collapsed and his feet starting itching was unknown for M-M-R II. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain upper, Dizziness, Headache, Malaise, Myalgia
Clinical narrative: This spontaneous report as received from a mother's patient refers to a her 12 years old female daughter with no pertinent medical history and no drug reactions or allergies, who on 13-JUL-2012, was vaccinated intramuscularly with the first 0.5 ml dose GARDASIL (lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The patient's mother stated that her daughter on 16-JUL-2012, began experiencing bad headaches, extreme dizziness, muscle aches, pains in stomach and restlessness. The patient's mother stated that she contacted the doctor's office and planned on seeing the doctor soon. No lab diagnostics studies were performed. The patient was told to take ibuprofen and TYLENOL in the meantime. At the time of the report, the patient had not recovered. The patient's mother stated that she did not want her daughter to complete the rest of the series of vaccinations. The relatedness for pains in the stomach, restlessness, muscle pains, extreme dizziness and had headaches was unknown for GARDASIL. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nausea
Clinical narrative: This spontaneous report as received from a mother's patient refers to a her 12 years old female daughter with no pertinent medical history and no drug reactions or allergies, who on 13-JUL-2012, was vaccinated intramuscularly with the first 0.5 ml dose GARDASIL (lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The patient's mother stated that her daughter on 16-JUL-2012, began experiencing bad headaches, extreme dizziness, muscle aches, pains in stomach and restlessness. The patient's mother stated that she contacted the doctor's office and planned on seeing the doctor soon. No lab diagnostics studies were performed. The patient was told to take ibuprofen and TYLENOL in the meantime. At the time of the report, the patient had not recovered. The patient's mother stated that she did not want her daughter to complete the rest of the series of vaccinations. The relatedness for pains in the stomach, restlessness, muscle pains, extreme dizziness and had headaches was unknown for GARDASIL. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain upper, Dizziness, Headache, Myalgia, Restlessness
Clinical narrative: This spontaneous report as received from a mother's patient refers to a her 12 years old female daughter with no pertinent medical history and no drug reactions or allergies, who on 13-JUL-2012, was vaccinated intramuscularly with the first 0.5 ml dose GARDASIL (lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The patient's mother stated that her daughter on 16-JUL-2012, began experiencing bad headaches, extreme dizziness, muscle aches, pains in stomach and restlessness. The patient's mother stated that she contacted the doctor's office and planned on seeing the doctor soon. No lab diagnostics studies were performed. The patient was told to take ibuprofen and TYLENOL in the meantime. At the time of the report, the patient had not recovered. The patient's mother stated that she did not want her daughter to complete the rest of the series of vaccinations. The relatedness for pains in the stomach, restlessness, muscle pains, extreme dizziness and had headaches was unknown for GARDASIL. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 61 years old female patient with none pertinent medical history or drug reaction allergies who on 20-JUL-2012 was vaccinated subcutaneously on the left upper arm with a dose of ZOSTAVAX; Lot 0257AE, expiration date: 15-MAR-2013 (dose not reported). No concomitant medications were reported. The pharmacist reported that the patient went to the pharmacy on 21-JUL-2012 with redness at the injection site of the left upper arm. On 24-JUL-2012, the patient called the pharmacy to report a 3-4 inch red rash around the injection site. The reaction was sore, itchy, swollen, and the redness had extended around to the back of the arm. The patient was referred to her unspecified physician for evaluation. All drop-down fields apply to the patient. At the time of the report, the patient's outcome was unknown. No further information is available. This is one of the several reports from the same source.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Rash erythematous
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 61 years old female patient with none pertinent medical history or drug reaction allergies who on 20-JUL-2012 was vaccinated subcutaneously on the left upper arm with a dose of ZOSTAVAX; Lot 0257AE, expiration date: 15-MAR-2013 (dose not reported). No concomitant medications were reported. The pharmacist reported that the patient went to the pharmacy on 21-JUL-2012 with redness at the injection site of the left upper arm. On 24-JUL-2012, the patient called the pharmacy to report a 3-4 inch red rash around the injection site. The reaction was sore, itchy, swollen, and the redness had extended around to the back of the arm. The patient was referred to her unspecified physician for evaluation. All drop-down fields apply to the patient. At the time of the report, the patient's outcome was unknown. No further information is available. This is one of the several reports from the same source.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Rash erythematous
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 61 years old female patient with none pertinent medical history or drug reaction allergies who on 20-JUL-2012 was vaccinated subcutaneously on the left upper arm with a dose of ZOSTAVAX; Lot 0257AE, expiration date: 15-MAR-2013 (dose not reported). No concomitant medications were reported. The pharmacist reported that the patient went to the pharmacy on 21-JUL-2012 with redness at the injection site of the left upper arm. On 24-JUL-2012, the patient called the pharmacy to report a 3-4 inch red rash around the injection site. The reaction was sore, itchy, swollen, and the redness had extended around to the back of the arm. The patient was referred to her unspecified physician for evaluation. All drop-down fields apply to the patient. At the time of the report, the patient's outcome was unknown. No further information is available. This is one of the several reports from the same source.