chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Chills, Headache, Nausea, Pyrexia
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 (VAERS # 677599) on 10-MAY-2017. This spontaneous report as received from the agency refers to a 12 year old male patient. The patient's medical history included functionally bicuspid pulmonary valve. The patient did not have any current illness. On 09-JAN-2017, the patient was vaccinated with GARDASIL 9 (dose: 2.0), intramuscular in the left arm for prophylaxis. On 10-JAN-2017, 2the patient experienced chills, pyrexia, nausea and headache. The outcome of chills, pyrexia, nausea and headache was unknown. The causality was not reported.  Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 9.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, TDAP, VARCEL, FLU4, HEPA, HPV9, TDAP, VARCEL
Symptoms: Fatigue, Pruritus, Urticaria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (Food and Drug Administration) under the Freedom of Information Act (FOI) (Agency # 677724) refers to a 9 years old male. The patient's medical history and concurrent condition included red meat allergy. The patient's historical medication included measles virus vaccine live (unspecified) (+) mumps virus vaccine live (Manufacturer Unknown). There was no other medications and current illness. On 11-JAN-2017 the patient was vaccinated with VARIVAX (lot # M009769, expiry date not reported) subcutaneous in the left arm (dose not reported) for prophylaxis. Other suspect therapies included HAVRIX (Batch # 3R7C4, expiry date not reported), FLUZONE (Batch # U5691AA, expiry date not reported), GARDASIL 9 (lot # M017983, expiry date not reported) and BOOSTRIX (Batch # 3Z27B, expiry date not reported). No concomitant medications was reported. On 11-JAN-2017, after onset of therapy the patient experienced fatigue, urticaria and pruritus. The agency reported that "Client broke out in generalized hives across torso, back, arms and legs, itching 1 minute after vaccines administered. Client was given 25 mg liquid Diphenhydramine orally, hives subsided and client tired 15 minutes later. No respiratory changes noted. Client examined by physician on site, no further treatment". The outcome of fatigue, urticaria and pruritus was reported as recovered/resolved. The agency did not provide the causality assessment for the events. Additional information is not expected since no further information can be obtained from the regulatory authority.
Age: 10.0
Sex: F
Vaccine: FLU4, HPV9, FLU4, HPV9
Symptoms: Injection site erythema, Injection site mass, Injection site rash, Pain in extremity
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA# 678344) under the Freedom of Information Act referring to a 10 year old female patient. The patient did not have any medical history or concomitant medication. There were no illnesses at the time of vaccination. Patient complained of her arm hurting, so we applied an ice pack on 13-JAN-2017. Swelling was significant, but not worrisome. On 14-JAN-2017 at 6pm, we noticed a large raised red patch (rash like) around the injection site. The patch was about as large as a square post-it note. There were three small red patches to the left of the large patch each the size of a quarter. We drew circles around the patches to see if they grew larger. She didn't have a fever, so we iced the area and had her move her arm regularly. Within 12 hours, all the red patches were gone and there was only a small lump at the injection site. This was her third dose of the GARDASIL 9 vaccine. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Age: 10.0
Sex: F
Vaccine: FLU4, HPV9, FLU4, HPV9
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Pain in extremity, Swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA# 678344) under the Freedom of Information Act referring to a 10 year old female patient. The patient did not have any medical history or concomitant medication. There were no illnesses at the time of vaccination. Patient complained of her arm hurting, so we applied an ice pack on 13-JAN-2017. Swelling was significant, but not worrisome. On 14-JAN-2017 at 6pm, we noticed a large raised red patch (rash like) around the injection site. The patch was about as large as a square post-it note. There were three small red patches to the left of the large patch each the size of a quarter. We drew circles around the patches to see if they grew larger. She didn't have a fever, so we iced the area and had her move her arm regularly. Within 12 hours, all the red patches were gone and there was only a small lump at the injection site. This was her third dose of the GARDASIL 9 vaccine. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Age: 14.0
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Asthenia, Syncope, Tremor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (Agency # 678576) under the Freedom of Information Act (FOI) and concerns 14 year old patient of unknown gender. The patient's concurrent conditions included recent concussion on 08-JAN-2017. The patient's medical history was not reported. On 17-JAN-2017 at 15:20, the patient was vaccinated with a dose of GARDASIL 9 injection, in his left arm, by intramuscular route, lot number L037554 (strength, dose and expiration date were not reported) for prophylaxis. The patient's concomitant medications included dexmethylphenidate hydrochloride (FOCALIN XR). On the same date, the patient began to feel shaky in arms and legs, weak and faint. The patient's blood pressure showed 80/52 and did not lose consciousness. In approximately 2017, the patient had recovered from the events with blood pressure within normal limits after lying down, juice and crackers. The causality between the events and the GARDASIL 9 was not reported. Additional information is not expected as no follow-up can be obtained from the agency.
Age: 14.0
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Asthenia, Dizziness, Tremor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (Agency # 678576) under the Freedom of Information Act (FOI) and concerns 14 year old patient of unknown gender. The patient's concurrent conditions included recent concussion on 08-JAN-2017. The patient's medical history was not reported. On 17-JAN-2017 at 15:20, the patient was vaccinated with a dose of GARDASIL 9 injection, in his left arm, by intramuscular route, lot number L037554 (strength, dose and expiration date were not reported) for prophylaxis. The patient's concomitant medications included dexmethylphenidate hydrochloride (FOCALIN XR). On the same date, the patient began to feel shaky in arms and legs, weak and faint. The patient's blood pressure showed 80/52 and did not lose consciousness. In approximately 2017, the patient had recovered from the events with blood pressure within normal limits after lying down, juice and crackers. The causality between the events and the GARDASIL 9 was not reported. Additional information is not expected as no follow-up can be obtained from the agency.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Autoimmune disorder, Immunology test abnormal, Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA# 679655)  under the Freedom of Information Act (FOI) and concern a 15 year old female patient. At first just had small red itchy bumps on arms that would come and go but over the next few weeks the bumps got bigger and would spread throughout her body. Doctor said they were hives and advised them to use ZYRTEC and get blood work to see if it was an allergy. Blood work said she was having an autoimmune response to something she had the first GARDASIL 9 shot, lot# L036301 on 13-JUL-2016  and the second shot on 15-SEP-2016. She noticed the hives on 10-OCT-2016  while she was in class and her arms were itching bad. They treated it with BENADRYL but over the next few weeks it got worse and worse and was covering her whole body and the BENADRYL was not  enough. They went to her primary doctor who send them to an allergist who ordered blood work and found out it was not an allergic reaction it was an autoimmune response. She had been healthy besides the hives so they cannot figure out what triggered her immune system except for one of these immunization shots. Now she had to take an antihistamine two times a day and is always worried she would have a breakout. Lab data: autoimmune test positive. Other Medications: None. Current Illnesses: No illness at time of vaccination. History: No prior vaccinations.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Autoimmune disorder, Immunology test abnormal, Pruritus, Rash erythematous, Rash generalised
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA# 679655)  under the Freedom of Information Act (FOI) and concern a 15 year old female patient. At first just had small red itchy bumps on arms that would come and go but over the next few weeks the bumps got bigger and would spread throughout her body. Doctor said they were hives and advised them to use ZYRTEC and get blood work to see if it was an allergy. Blood work said she was having an autoimmune response to something she had the first GARDASIL 9 shot, lot# L036301 on 13-JUL-2016  and the second shot on 15-SEP-2016. She noticed the hives on 10-OCT-2016  while she was in class and her arms were itching bad. They treated it with BENADRYL but over the next few weeks it got worse and worse and was covering her whole body and the BENADRYL was not  enough. They went to her primary doctor who send them to an allergist who ordered blood work and found out it was not an allergic reaction it was an autoimmune response. She had been healthy besides the hives so they cannot figure out what triggered her immune system except for one of these immunization shots. Now she had to take an antihistamine two times a day and is always worried she would have a breakout. Lab data: autoimmune test positive. Other Medications: None. Current Illnesses: No illness at time of vaccination. History: No prior vaccinations.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Rash pruritic, Urticaria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA# 679655)  under the Freedom of Information Act (FOI) and concern a 15 year old female patient. At first just had small red itchy bumps on arms that would come and go but over the next few weeks the bumps got bigger and would spread throughout her body. Doctor said they were hives and advised them to use ZYRTEC and get blood work to see if it was an allergy. Blood work said she was having an autoimmune response to something she had the first GARDASIL 9 shot, lot# L036301 on 13-JUL-2016  and the second shot on 15-SEP-2016. She noticed the hives on 10-OCT-2016  while she was in class and her arms were itching bad. They treated it with BENADRYL but over the next few weeks it got worse and worse and was covering her whole body and the BENADRYL was not  enough. They went to her primary doctor who send them to an allergist who ordered blood work and found out it was not an allergic reaction it was an autoimmune response. She had been healthy besides the hives so they cannot figure out what triggered her immune system except for one of these immunization shots. Now she had to take an antihistamine two times a day and is always worried she would have a breakout. Lab data: autoimmune test positive. Other Medications: None. Current Illnesses: No illness at time of vaccination. History: No prior vaccinations.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MENB, MNQ, HEPA, HPV9, MENB, MNQ
Symptoms: Dizziness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA# 680722) under the Freedom of Information Act (FOI) and concern a 17 year old male patient. The patient's concurrent conditions included allergy to penicillin per mother. The patient's medical history and concomitant therapies were not reported. On 01-FEB-2017 the patient was vaccinated with GARDASIL 9 injection, in his left arm, by intramuscular route, lot number M021407 (strength, dose and expiration date were not reported) for prophylaxis. Other suspect therapies included MENACTRA, HAVRIX and BEXSERO. On the same date at approximately 13:55, the patient was slightly dizzy after vaccinations. Dizziness completely resolved per patient by 14:08 on 01-FEB-2017. The causality between the event and therapy with GARDASIL 9 was not reported. Additional information is not expected as no follow-up can be obtained from the agency.
Age: 11.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Fall, Mouth injury, Suture insertion
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA # 681079) under the Freedom of Information Act and concerns a 11 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 27-JAN-2017, the patient was vaccinated with a dose of GARDASIL 9 injection, in his right arm, lot number M024261 (strength, dose, route of administration and expiration date were not reported) for prophylaxis. On the same date, after vaccination, the patient fell forward from the exam table causing her to injury her mouth. Stitches were applied by physician and then the patient was sent to her family dentist for further evaluation. In approximately 2017, the patient had recovered from the events. The causality between the events and therapy with GARDASIL 9 was not reported. Additional information is not expected as no follow-up can be obtained from the agency.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Blood culture negative, CSF culture negative, Circumoral oedema, Computerised tomogram head abnormal, Drug hypersensitivity
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (agency #682198 (VAERS ID)) under the Freedom of Information Act and refers to a 13 year old male patient. The patient's historical medications included GARDASIL (no adverse effect) and ibuprofen. Concurrent conditions included peanut allergy and lactose intolerance. At vaccination time, the patient had been having a lumbar strain with musculoskeletal (MSK) symptoms for 2 weeks prior from playing soccer, otherwise in good health. Concomitant medications were not reported. On 03-FEB-2017, the patient was seen for lumbar strain and vaccinated with the second dose of GARDASIL 9 (lot # M031557) intramuscular in the left arm for prophylaxis. It was reported that the patient and his family flew on 04-FEB-2017, when the patient awoke in morning with fever, malaise, and headache. Then after landing, headache returned and had vomiting twice (reported as "x2"), with altered mental status and petechial rash. The patient was admitted to "Medical Center" from 04-FEB-2017 to 07-FEB-2017. The patient had lumbar puncture, started on cefotaxime (reported as "CFTX ")/Vancomycin for presumed meningitis. Then the patient had drug allergy - hives and perioral edema. Treatment was switched to meropenem and linezolid, acyclovir. The patient had mild leukocytosis - cultures, rapid plasma reagin test (RPR), strep cultures (also reported as "group A strep"), cerebrospinal fluid (CSF) and blood cultures all negative. Computerized tomography (CT) showed subtle hypodensities in supratentorial white matter, and magnetic resonance imaging (MRI) was recommended. It was also reported that the patient had treponema test negative and petechiae. The outcome of the events was reported as recovered (date not provided, approximately in February 2017). Causality assessment was not provided by the agency. Additional information is not expected as no further information could be obtained from the agency.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Headache, Leukocytosis, Malaise, Meningitis, Mental status changes
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (agency #682198 (VAERS ID)) under the Freedom of Information Act and refers to a 13 year old male patient. The patient's historical medications included GARDASIL (no adverse effect) and ibuprofen. Concurrent conditions included peanut allergy and lactose intolerance. At vaccination time, the patient had been having a lumbar strain with musculoskeletal (MSK) symptoms for 2 weeks prior from playing soccer, otherwise in good health. Concomitant medications were not reported. On 03-FEB-2017, the patient was seen for lumbar strain and vaccinated with the second dose of GARDASIL 9 (lot # M031557) intramuscular in the left arm for prophylaxis. It was reported that the patient and his family flew on 04-FEB-2017, when the patient awoke in morning with fever, malaise, and headache. Then after landing, headache returned and had vomiting twice (reported as "x2"), with altered mental status and petechial rash. The patient was admitted to "Medical Center" from 04-FEB-2017 to 07-FEB-2017. The patient had lumbar puncture, started on cefotaxime (reported as "CFTX ")/Vancomycin for presumed meningitis. Then the patient had drug allergy - hives and perioral edema. Treatment was switched to meropenem and linezolid, acyclovir. The patient had mild leukocytosis - cultures, rapid plasma reagin test (RPR), strep cultures (also reported as "group A strep"), cerebrospinal fluid (CSF) and blood cultures all negative. Computerized tomography (CT) showed subtle hypodensities in supratentorial white matter, and magnetic resonance imaging (MRI) was recommended. It was also reported that the patient had treponema test negative and petechiae. The outcome of the events was reported as recovered (date not provided, approximately in February 2017). Causality assessment was not provided by the agency. Additional information is not expected as no further information could be obtained from the agency.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Petechiae, Pyrexia, Streptococcus test negative, Treponema test negative, Urticaria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (agency #682198 (VAERS ID)) under the Freedom of Information Act and refers to a 13 year old male patient. The patient's historical medications included GARDASIL (no adverse effect) and ibuprofen. Concurrent conditions included peanut allergy and lactose intolerance. At vaccination time, the patient had been having a lumbar strain with musculoskeletal (MSK) symptoms for 2 weeks prior from playing soccer, otherwise in good health. Concomitant medications were not reported. On 03-FEB-2017, the patient was seen for lumbar strain and vaccinated with the second dose of GARDASIL 9 (lot # M031557) intramuscular in the left arm for prophylaxis. It was reported that the patient and his family flew on 04-FEB-2017, when the patient awoke in morning with fever, malaise, and headache. Then after landing, headache returned and had vomiting twice (reported as "x2"), with altered mental status and petechial rash. The patient was admitted to "Medical Center" from 04-FEB-2017 to 07-FEB-2017. The patient had lumbar puncture, started on cefotaxime (reported as "CFTX ")/Vancomycin for presumed meningitis. Then the patient had drug allergy - hives and perioral edema. Treatment was switched to meropenem and linezolid, acyclovir. The patient had mild leukocytosis - cultures, rapid plasma reagin test (RPR), strep cultures (also reported as "group A strep"), cerebrospinal fluid (CSF) and blood cultures all negative. Computerized tomography (CT) showed subtle hypodensities in supratentorial white matter, and magnetic resonance imaging (MRI) was recommended. It was also reported that the patient had treponema test negative and petechiae. The outcome of the events was reported as recovered (date not provided, approximately in February 2017). Causality assessment was not provided by the agency. Additional information is not expected as no further information could be obtained from the agency.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (agency #682198 (VAERS ID)) under the Freedom of Information Act and refers to a 13 year old male patient. The patient's historical medications included GARDASIL (no adverse effect) and ibuprofen. Concurrent conditions included peanut allergy and lactose intolerance. At vaccination time, the patient had been having a lumbar strain with musculoskeletal (MSK) symptoms for 2 weeks prior from playing soccer, otherwise in good health. Concomitant medications were not reported. On 03-FEB-2017, the patient was seen for lumbar strain and vaccinated with the second dose of GARDASIL 9 (lot # M031557) intramuscular in the left arm for prophylaxis. It was reported that the patient and his family flew on 04-FEB-2017, when the patient awoke in morning with fever, malaise, and headache. Then after landing, headache returned and had vomiting twice (reported as "x2"), with altered mental status and petechial rash. The patient was admitted to "Medical Center" from 04-FEB-2017 to 07-FEB-2017. The patient had lumbar puncture, started on cefotaxime (reported as "CFTX ")/Vancomycin for presumed meningitis. Then the patient had drug allergy - hives and perioral edema. Treatment was switched to meropenem and linezolid, acyclovir. The patient had mild leukocytosis - cultures, rapid plasma reagin test (RPR), strep cultures (also reported as "group A strep"), cerebrospinal fluid (CSF) and blood cultures all negative. Computerized tomography (CT) showed subtle hypodensities in supratentorial white matter, and magnetic resonance imaging (MRI) was recommended. It was also reported that the patient had treponema test negative and petechiae. The outcome of the events was reported as recovered (date not provided, approximately in February 2017). Causality assessment was not provided by the agency. Additional information is not expected as no further information could be obtained from the agency.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Blood culture negative, CSF culture negative, Circumoral oedema, Computerised tomogram head abnormal, Culture negative
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (agency #682198 (VAERS ID)) under the Freedom of Information Act and refers to a 13 year old male patient. The patient's historical medications included GARDASIL (no adverse effect) and ibuprofen. Concurrent conditions included peanut allergy and lactose intolerance. At vaccination time, the patient had been having a lumbar strain with musculoskeletal (MSK) symptoms for 2 weeks prior from playing soccer, otherwise in good health. Concomitant medications were not reported. On 03-FEB-2017, the patient was seen for lumbar strain and vaccinated with the second dose of GARDASIL 9 (lot # M031557) intramuscular in the left arm for prophylaxis. It was reported that the patient and his family flew on 04-FEB-2017, when the patient awoke in morning with fever, malaise, and headache. Then after landing, headache returned and had vomiting twice (reported as "x2"), with altered mental status and petechial rash. The patient was admitted to "Medical Center" from 04-FEB-2017 to 07-FEB-2017. The patient had lumbar puncture, started on cefotaxime (reported as "CFTX ")/Vancomycin for presumed meningitis. Then the patient had drug allergy - hives and perioral edema. Treatment was switched to meropenem and linezolid, acyclovir. The patient had mild leukocytosis - cultures, rapid plasma reagin test (RPR), strep cultures (also reported as "group A strep"), cerebrospinal fluid (CSF) and blood cultures all negative. Computerized tomography (CT) showed subtle hypodensities in supratentorial white matter, and magnetic resonance imaging (MRI) was recommended. It was also reported that the patient had treponema test negative and petechiae. The outcome of the events was reported as recovered (date not provided, approximately in February 2017). Causality assessment was not provided by the agency. Additional information is not expected as no further information could be obtained from the agency.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Drug hypersensitivity, Headache, Leukocytosis, Lumbar puncture, Malaise
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (agency #682198 (VAERS ID)) under the Freedom of Information Act and refers to a 13 year old male patient. The patient's historical medications included GARDASIL (no adverse effect) and ibuprofen. Concurrent conditions included peanut allergy and lactose intolerance. At vaccination time, the patient had been having a lumbar strain with musculoskeletal (MSK) symptoms for 2 weeks prior from playing soccer, otherwise in good health. Concomitant medications were not reported. On 03-FEB-2017, the patient was seen for lumbar strain and vaccinated with the second dose of GARDASIL 9 (lot # M031557) intramuscular in the left arm for prophylaxis. It was reported that the patient and his family flew on 04-FEB-2017, when the patient awoke in morning with fever, malaise, and headache. Then after landing, headache returned and had vomiting twice (reported as "x2"), with altered mental status and petechial rash. The patient was admitted to "Medical Center" from 04-FEB-2017 to 07-FEB-2017. The patient had lumbar puncture, started on cefotaxime (reported as "CFTX ")/Vancomycin for presumed meningitis. Then the patient had drug allergy - hives and perioral edema. Treatment was switched to meropenem and linezolid, acyclovir. The patient had mild leukocytosis - cultures, rapid plasma reagin test (RPR), strep cultures (also reported as "group A strep"), cerebrospinal fluid (CSF) and blood cultures all negative. Computerized tomography (CT) showed subtle hypodensities in supratentorial white matter, and magnetic resonance imaging (MRI) was recommended. It was also reported that the patient had treponema test negative and petechiae. The outcome of the events was reported as recovered (date not provided, approximately in February 2017). Causality assessment was not provided by the agency. Additional information is not expected as no further information could be obtained from the agency.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Meningitis, Mental status changes, Petechiae, Pyrexia, Streptococcus test negative
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (agency #682198 (VAERS ID)) under the Freedom of Information Act and refers to a 13 year old male patient. The patient's historical medications included GARDASIL (no adverse effect) and ibuprofen. Concurrent conditions included peanut allergy and lactose intolerance. At vaccination time, the patient had been having a lumbar strain with musculoskeletal (MSK) symptoms for 2 weeks prior from playing soccer, otherwise in good health. Concomitant medications were not reported. On 03-FEB-2017, the patient was seen for lumbar strain and vaccinated with the second dose of GARDASIL 9 (lot # M031557) intramuscular in the left arm for prophylaxis. It was reported that the patient and his family flew on 04-FEB-2017, when the patient awoke in morning with fever, malaise, and headache. Then after landing, headache returned and had vomiting twice (reported as "x2"), with altered mental status and petechial rash. The patient was admitted to "Medical Center" from 04-FEB-2017 to 07-FEB-2017. The patient had lumbar puncture, started on cefotaxime (reported as "CFTX ")/Vancomycin for presumed meningitis. Then the patient had drug allergy - hives and perioral edema. Treatment was switched to meropenem and linezolid, acyclovir. The patient had mild leukocytosis - cultures, rapid plasma reagin test (RPR), strep cultures (also reported as "group A strep"), cerebrospinal fluid (CSF) and blood cultures all negative. Computerized tomography (CT) showed subtle hypodensities in supratentorial white matter, and magnetic resonance imaging (MRI) was recommended. It was also reported that the patient had treponema test negative and petechiae. The outcome of the events was reported as recovered (date not provided, approximately in February 2017). Causality assessment was not provided by the agency. Additional information is not expected as no further information could be obtained from the agency.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Treponema test negative, Urticaria, Vomiting, White matter lesion
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (agency #682198 (VAERS ID)) under the Freedom of Information Act and refers to a 13 year old male patient. The patient's historical medications included GARDASIL (no adverse effect) and ibuprofen. Concurrent conditions included peanut allergy and lactose intolerance. At vaccination time, the patient had been having a lumbar strain with musculoskeletal (MSK) symptoms for 2 weeks prior from playing soccer, otherwise in good health. Concomitant medications were not reported. On 03-FEB-2017, the patient was seen for lumbar strain and vaccinated with the second dose of GARDASIL 9 (lot # M031557) intramuscular in the left arm for prophylaxis. It was reported that the patient and his family flew on 04-FEB-2017, when the patient awoke in morning with fever, malaise, and headache. Then after landing, headache returned and had vomiting twice (reported as "x2"), with altered mental status and petechial rash. The patient was admitted to "Medical Center" from 04-FEB-2017 to 07-FEB-2017. The patient had lumbar puncture, started on cefotaxime (reported as "CFTX ")/Vancomycin for presumed meningitis. Then the patient had drug allergy - hives and perioral edema. Treatment was switched to meropenem and linezolid, acyclovir. The patient had mild leukocytosis - cultures, rapid plasma reagin test (RPR), strep cultures (also reported as "group A strep"), cerebrospinal fluid (CSF) and blood cultures all negative. Computerized tomography (CT) showed subtle hypodensities in supratentorial white matter, and magnetic resonance imaging (MRI) was recommended. It was also reported that the patient had treponema test negative and petechiae. The outcome of the events was reported as recovered (date not provided, approximately in February 2017). Causality assessment was not provided by the agency. Additional information is not expected as no further information could be obtained from the agency.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, HEPA, HPV9, MNQ
Symptoms: Erythema, Skin warm
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (Agency # 683205) under the Freedom of Information Act (FOI) and concerns a 15 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 08-FEB-2017, the patient was vaccinated with GARDASIL 9 injection, 1 dosing form,  in his right arm, by intramuscular route, lot number M031557 (strength and expiration date were not reported) for prophylaxis. Other suspect therapies included MENACTRA, by intramuscular route, left arm, lot number U5464AA and HAVRIX, 1 dosing form by intramuscular route, right arm, lot number 2T5K4, both for prophylaxis. On 09-FEB-2017,  the patient experienced baseball size redness and warmth to her left arm. At the time of the report, the patient had recovered from the events. The causality between the events and the GARDASIL 9 was not reported. Additional information is not expected as no follow-up can be obtained from the agency.
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP, FLU4, HPV9, MNQ, TDAP
Symptoms: Epistaxis, Full blood count, Immune thrombocytopenic purpura, Immunoglobulin therapy, Petechiae
Clinical narrative: This spontaneous report was received from a line listing obtained on request by the Company from the FDA (VAERS No. 683682) under the Freedom of information Act, referring to a 11 year old male patient. The patient's concurrent conditions included mild cough. The patient had no medical history; and prior vaccinations, concomitant or other medications were unspecified. On 06-FEB-2017, the patient was vaccinated with the first dose of GARDASIL 9 lot # M023169 (expiration date was unspecified), intramuscularly in the left arm for prophylaxis (dose and frequency were unspecified). On the same date, the following other suspect therapies were also administered: the fifth dose of FLUZONE lot# UI713A (expiration date was unspecified), intramuscularly in the right arm; the first dose of MENACTRA lot# U5460BA (expiration date was unspecified), intramuscularly in the left arm, and the first dose of BOOSTRIX lot# LZ972 (expiration date was not reported), intramuscularly in the right arm, all of them for prophylaxis (dose was not reported). On 06-FEB-2017, the patient was seen for well child and vaccines, then, on 13-FEB-2017, returned with petechiae to lower extremities and zero platelets-diagnosed (Complete blood count (CBC): 0-17 (units were unspecified)) (platelet count decreased, immune thrombocytopenic purpura, full blood count) as ITP-treated once with IVIG (immunoglobulin therapy) for nosebleed-requiring ongoing labs and specialty appointments. The patient was hospitalized due to the adverse events. At the time of the report, the outcome of epistaxis, platelet count decreased, petechiae, immunoglobulin therapy, immune thrombocytopenic purpura and full blood count was reported as not recovered. The causality of the aforementioned adverse events with GARDASIL 9 was not provided. Additional information is not expected since no follow up can be obtained from the regulatory authority.
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP, FLU4, HPV9, MNQ, TDAP
Symptoms: Platelet count decreased
Clinical narrative: This spontaneous report was received from a line listing obtained on request by the Company from the FDA (VAERS No. 683682) under the Freedom of information Act, referring to a 11 year old male patient. The patient's concurrent conditions included mild cough. The patient had no medical history; and prior vaccinations, concomitant or other medications were unspecified. On 06-FEB-2017, the patient was vaccinated with the first dose of GARDASIL 9 lot # M023169 (expiration date was unspecified), intramuscularly in the left arm for prophylaxis (dose and frequency were unspecified). On the same date, the following other suspect therapies were also administered: the fifth dose of FLUZONE lot# UI713A (expiration date was unspecified), intramuscularly in the right arm; the first dose of MENACTRA lot# U5460BA (expiration date was unspecified), intramuscularly in the left arm, and the first dose of BOOSTRIX lot# LZ972 (expiration date was not reported), intramuscularly in the right arm, all of them for prophylaxis (dose was not reported). On 06-FEB-2017, the patient was seen for well child and vaccines, then, on 13-FEB-2017, returned with petechiae to lower extremities and zero platelets-diagnosed (Complete blood count (CBC): 0-17 (units were unspecified)) (platelet count decreased, immune thrombocytopenic purpura, full blood count) as ITP-treated once with IVIG (immunoglobulin therapy) for nosebleed-requiring ongoing labs and specialty appointments. The patient was hospitalized due to the adverse events. At the time of the report, the outcome of epistaxis, platelet count decreased, petechiae, immunoglobulin therapy, immune thrombocytopenic purpura and full blood count was reported as not recovered. The causality of the aforementioned adverse events with GARDASIL 9 was not provided. Additional information is not expected since no follow up can be obtained from the regulatory authority.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster, Injection site rash, Pain, Pruritus
Clinical narrative: This spontaneous report was received from a health professional referring to a 43 year old female patient who was retired. Information about concurrent condition and medical history was not provided. Concomitant medication included meloxicam (manufacturer unknown). On 06-APR-2017, at 11:00, the patient was vaccinated with the first dose of ZOSTAVAX (lot# M040623; expiration date and dose not reported) subcutaneously in the left arm for prophylaxis. There was no illness at the time of vaccination. On 07-APR-2017, patient felt itching and burning where the shot was given in, rash was also noted from elbow up. It was also painful at sight of rash. The patient went to urgent care and was diagnosed of shingles and given a prescription for antiviral medication for the event. The outcome of shingles was unknown. The causality between ZOSTAVAX and events was unknown. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: This spontaneous report was received from a health professional referring to a 43 year old female patient who was retired. Information about concurrent condition and medical history was not provided. Concomitant medication included meloxicam (manufacturer unknown). On 06-APR-2017, at 11:00, the patient was vaccinated with the first dose of ZOSTAVAX (lot# M040623; expiration date and dose not reported) subcutaneously in the left arm for prophylaxis. There was no illness at the time of vaccination. On 07-APR-2017, patient felt itching and burning where the shot was given in, rash was also noted from elbow up. It was also painful at sight of rash. The patient went to urgent care and was diagnosed of shingles and given a prescription for antiviral medication for the event. The outcome of shingles was unknown. The causality between ZOSTAVAX and events was unknown. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Arthralgia, Blood glucose increased, Decreased appetite, Fatigue, Injection site mass
Clinical narrative: Muscle pain, joint pain, decreased appetite, plus more..! Elevated random blood glucose reading on 4-19-17 = 188. Random ref. range is 70-140. Prev. readings were = 120 on 9-25-12, 100 on 6-14-13, 130 on 11-6-14, 126 on 1-26-16.
Age: 73.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site pain, Injection site pruritus, Myalgia
Clinical narrative: Muscle pain, joint pain, decreased appetite, plus more..! Elevated random blood glucose reading on 4-19-17 = 188. Random ref. range is 70-140. Prev. readings were = 120 on 9-25-12, 100 on 6-14-13, 130 on 11-6-14, 126 on 1-26-16.
Age: 73.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Arthralgia, Blood glucose normal, Decreased appetite, Myalgia
Clinical narrative: Muscle pain, joint pain, decreased appetite, plus more..! Elevated random blood glucose reading on 4-19-17 = 188. Random ref. range is 70-140. Prev. readings were = 120 on 9-25-12, 100 on 6-14-13, 130 on 11-6-14, 126 on 1-26-16.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Pain, Peripheral swelling
Clinical narrative: This spontaneous report was received from a nurse, concerning a 67 years-old female patient. The patient's concurrent conditions included congestive heart failure, hypertension, coronary artery disease and an implantable cardioverter-defibrillator. The patient's medical history was not provided. Her concomitant medications included baby aspirin (manufacturer unknown), vitamins (unspecified), iron (unspecified), spironolactone (also reported as "IRONACTONE"), potassium (unspecified), lisinopril (manufacturer unknown) (also reported as "LASINAPRILL"), furosemide (LASIX), carvedilol (COREG), gastrointestinal preparations (unspecified) (also reported as "STOOL SOFTNER"), duloxetine hydrochloride (CYMBALTA) (also reported as "SIMBOLTA") and atorvastatin. She did not have drug reactions or allergies. On 02-MAY-2017, the patient was vaccinated with PNEUMOVAX23 with lot # M040804 and expiration date on 20-MAY-2018 (strength, dose and anatomical location were not reported), administered subcutaneously, for prevention of pneumococcal disease. On the same date, the patient experienced swelling in her upper arm around the injection site and it extended down into her forearm. She also experienced an extreme skin irritation that was very painful. The patient sought medical attention and went to her nurse practitioner but no laboratory diagnostics studies were performed. On an unspecified date in approximately May 2017, the patient recovered from the injection site swelling, extensive swelling of vaccinated limb, skin irritation and pain of skin. The causal relationship between the injection site swelling, extensive swelling of vaccinated limb, skin irritation and pain of skin with the PNEUMOVAX23 was not reported. Lot verification was requested as another nurse practitioner's patient experienced the same adverse reactions after receiving a vaccine from the same lot (capture in MARRS # 1705USA003951). No product quality complaint (PQC) was involved. Additional information has been requested.; Sender's Comments: US-009507513-1705USA003951:
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Skin warm
Clinical narrative: This spontaneous report was received from a nurse, concerning a 67 years-old female patient. The patient's concurrent conditions included congestive heart failure, hypertension, coronary artery disease and an implantable cardioverter-defibrillator. The patient's medical history was not provided. Her concomitant medications included baby aspirin (manufacturer unknown), vitamins (unspecified), iron (unspecified), spironolactone (also reported as "IRONACTONE"), potassium (unspecified), lisinopril (manufacturer unknown) (also reported as "LASINAPRILL"), furosemide (LASIX), carvedilol (COREG), gastrointestinal preparations (unspecified) (also reported as "STOOL SOFTNER"), duloxetine hydrochloride (CYMBALTA) (also reported as "SIMBOLTA") and atorvastatin. She did not have drug reactions or allergies. On 02-MAY-2017, the patient was vaccinated with PNEUMOVAX23 with lot # M040804 and expiration date on 20-MAY-2018 (strength, dose and anatomical location were not reported), administered subcutaneously, for prevention of pneumococcal disease. On the same date, the patient experienced swelling in her upper arm around the injection site and it extended down into her forearm. She also experienced an extreme skin irritation that was very painful. The patient sought medical attention and went to her nurse practitioner but no laboratory diagnostics studies were performed. On an unspecified date in approximately May 2017, the patient recovered from the injection site swelling, extensive swelling of vaccinated limb, skin irritation and pain of skin. The causal relationship between the injection site swelling, extensive swelling of vaccinated limb, skin irritation and pain of skin with the PNEUMOVAX23 was not reported. Lot verification was requested as another nurse practitioner's patient experienced the same adverse reactions after receiving a vaccine from the same lot (capture in MARRS # 1705USA003951). No product quality complaint (PQC) was involved. Additional information has been requested.; Sender's Comments: US-009507513-1705USA003951:
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site swelling, Pain of skin, Peripheral swelling, Skin irritation
Clinical narrative: This spontaneous report was received from a nurse, concerning a 67 years-old female patient. The patient's concurrent conditions included congestive heart failure, hypertension, coronary artery disease and an implantable cardioverter-defibrillator. The patient's medical history was not provided. Her concomitant medications included baby aspirin (manufacturer unknown), vitamins (unspecified), iron (unspecified), spironolactone (also reported as "IRONACTONE"), potassium (unspecified), lisinopril (manufacturer unknown) (also reported as "LASINAPRILL"), furosemide (LASIX), carvedilol (COREG), gastrointestinal preparations (unspecified) (also reported as "STOOL SOFTNER"), duloxetine hydrochloride (CYMBALTA) (also reported as "SIMBOLTA") and atorvastatin. She did not have drug reactions or allergies. On 02-MAY-2017, the patient was vaccinated with PNEUMOVAX23 with lot # M040804 and expiration date on 20-MAY-2018 (strength, dose and anatomical location were not reported), administered subcutaneously, for prevention of pneumococcal disease. On the same date, the patient experienced swelling in her upper arm around the injection site and it extended down into her forearm. She also experienced an extreme skin irritation that was very painful. The patient sought medical attention and went to her nurse practitioner but no laboratory diagnostics studies were performed. On an unspecified date in approximately May 2017, the patient recovered from the injection site swelling, extensive swelling of vaccinated limb, skin irritation and pain of skin. The causal relationship between the injection site swelling, extensive swelling of vaccinated limb, skin irritation and pain of skin with the PNEUMOVAX23 was not reported. Lot verification was requested as another nurse practitioner's patient experienced the same adverse reactions after receiving a vaccine from the same lot (capture in MARRS # 1705USA003951). No product quality complaint (PQC) was involved. Additional information has been requested.; Sender's Comments: US-009507513-1705USA003951:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender.     On 06-JAN-2017, 23-JAN-2017, 30-JAN-2017 and on 10-FEB-2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L040054, expiration date: 26-DEC-2017) (dosage and route of administration were not reported) for prophylaxis. From 14-SEP-2016 to 22-MAR-2017, this doses were stored in the temperatures from 47 to 71 degrees of Fahrenheit. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MENB, MMR, MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 17-year-old non-pregnant female patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 04-APR-2017, the patient was administered an expired dose of M-M-R II injected subcutaneously, (lot # L004658 with expiration date at 11-FEB-2017; albumin status, dose and anatomical location were unknown) for prophylaxis, which was reconstituted with sterile diluent (strength, dose, lot # and expiration date were not reported). The reporter verified that administered dose of vaccine was not exposed to any temperature excursions. No adverse effects were reported. There was no product quality complaint (PQC) involved. Additional information has been requested.