chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: HPV9, PPV, TDAP
Symptoms: Headache, Injection site erythema, 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 (HA #649384) and refers to a 21 year old female patient. No details about current illnesses, medical history, lab data, prior vaccination and other medications were provided. On 18-AUG-2016 the patient was vaccinated with GARDASIL 9, dose 3 for prophylaxis (strength, dosing detail and route unknown). Other suspect therapies included vaccination with ADACEL and PNEUMOVAX. On 18-AUG-2016, patient developed fever in the evening after vaccine was given, which persisted throughout the following 3 days. During that time, she developed headache and increased/spreading redness around the site of vaccination administration. The events required the patient for emergency room visit. The outcome of injection site erythema, pyrexia and headache was reported as recovered/resolved. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Diarrhoea, Feeling cold, Nausea, Pyrexia
Clinical narrative: Information was received on 02-MAY-2017 from an FOI line listing regarding a 15 year old female patient. Medical history and concurrent conditions were not reported. Concomitant medication included cyanocobalamin (VITAMIN B-12). On 21-SEP-2016 the patient was vaccinated with GARDASIL 9 (lot # M011840- dose not specified) intramuscular in left arm. On 22-SEP-2016 the patient developed abdominal pain, diarrhea, feeling cold, nausea, pyrexia and vomiting. The action taken with GARDASIL 9 is not applicable, and the outcome of adverse events was reported as recovered. The causal relationship was not assessed. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Sex: F
Vaccine: HPV9
Symptoms: Vomiting
Clinical narrative: Information was received on 02-MAY-2017 from an FOI line listing regarding a 15 year old female patient. Medical history and concurrent conditions were not reported. Concomitant medication included cyanocobalamin (VITAMIN B-12). On 21-SEP-2016 the patient was vaccinated with GARDASIL 9 (lot # M011840- dose not specified) intramuscular in left arm. On 22-SEP-2016 the patient developed abdominal pain, diarrhea, feeling cold, nausea, pyrexia and vomiting. The action taken with GARDASIL 9 is not applicable, and the outcome of adverse events was reported as recovered. The causal relationship was not assessed. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Bone erosion, Bone marrow oedema, Limb injury, Nuclear magnetic resonance imaging abnormal, Vaccination site injury
Clinical narrative: (L) shoulder injury. MRI showed bone erosion and bone marrow edema suggestive of SIRVA (shoulder injury related to vaccine administration).
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: X-ray
Clinical narrative: (L) shoulder injury. MRI showed bone erosion and bone marrow edema suggestive of SIRVA (shoulder injury related to vaccine administration).
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Blood immunoglobulin A increased, Burning sensation, Costochondritis, Decreased appetite
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA # 670058) under the Freedom of Information Act, concerning a 13 year old female patient. There was no other current illness on her regular checkup. She had only ever had colds, flus, and ear infections maybe 2 times in her entire life. She was diagnosed at age of 8 year old with Ehlers-Danlos syndrome. Other historical condition included hypermobility. There was no information about concomitant medication. On 06-JUL-2015, the patient was vaccinated with GARDASIL 9 (lot # L014415, expiration date not reported but auto-generated via system with 25-JUL-2017) (route and dose number unknown) for prophylaxis. Costal chondritis began in the morning after the first injection in the series. The second shot resulted in lactose intolerance, loss of appetite and serious bleeding and lethargy with period. The third shot resulted in petechial rashes and henoch-schonlein purpura (HSP) and blood immunoglobulin A increased (IGA) in her system. The patient stayed in the hospital for multiple days. And the patient experienced pancreatitis due to medication administered for pain. The patient was still having constant joint pain and low stamina, heavier more painful periods, extended petechial rashes and pustule petechial rashes that bum and were painful. Onset date for all events was reported as 24-MAR-2016. The outcome of the events was not recovered. The causality between the events and GARDASIL 9 was unknown. All events were considered to be serious by the agency. Additional information is not expected because no further information could be obtained from the regulatory authority.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Dysmenorrhoea, Henoch-Schonlein purpura, Lactose intolerance, Lethargy, Menorrhagia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA # 670058) under the Freedom of Information Act, concerning a 13 year old female patient. There was no other current illness on her regular checkup. She had only ever had colds, flus, and ear infections maybe 2 times in her entire life. She was diagnosed at age of 8 year old with Ehlers-Danlos syndrome. Other historical condition included hypermobility. There was no information about concomitant medication. On 06-JUL-2015, the patient was vaccinated with GARDASIL 9 (lot # L014415, expiration date not reported but auto-generated via system with 25-JUL-2017) (route and dose number unknown) for prophylaxis. Costal chondritis began in the morning after the first injection in the series. The second shot resulted in lactose intolerance, loss of appetite and serious bleeding and lethargy with period. The third shot resulted in petechial rashes and henoch-schonlein purpura (HSP) and blood immunoglobulin A increased (IGA) in her system. The patient stayed in the hospital for multiple days. And the patient experienced pancreatitis due to medication administered for pain. The patient was still having constant joint pain and low stamina, heavier more painful periods, extended petechial rashes and pustule petechial rashes that bum and were painful. Onset date for all events was reported as 24-MAR-2016. The outcome of the events was not recovered. The causality between the events and GARDASIL 9 was unknown. All events were considered to be serious by the agency. Additional information is not expected because no further information could be obtained from the regulatory authority.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Pancreatitis, Petechiae, Rash, Rash pustular
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA # 670058) under the Freedom of Information Act, concerning a 13 year old female patient. There was no other current illness on her regular checkup. She had only ever had colds, flus, and ear infections maybe 2 times in her entire life. She was diagnosed at age of 8 year old with Ehlers-Danlos syndrome. Other historical condition included hypermobility. There was no information about concomitant medication. On 06-JUL-2015, the patient was vaccinated with GARDASIL 9 (lot # L014415, expiration date not reported but auto-generated via system with 25-JUL-2017) (route and dose number unknown) for prophylaxis. Costal chondritis began in the morning after the first injection in the series. The second shot resulted in lactose intolerance, loss of appetite and serious bleeding and lethargy with period. The third shot resulted in petechial rashes and henoch-schonlein purpura (HSP) and blood immunoglobulin A increased (IGA) in her system. The patient stayed in the hospital for multiple days. And the patient experienced pancreatitis due to medication administered for pain. The patient was still having constant joint pain and low stamina, heavier more painful periods, extended petechial rashes and pustule petechial rashes that bum and were painful. Onset date for all events was reported as 24-MAR-2016. The outcome of the events was not recovered. The causality between the events and GARDASIL 9 was unknown. All events were considered to be serious by the agency. Additional information is not expected because no further information could be obtained from the regulatory authority.
Sex: M
Vaccine: FLU4, HEP, HEPA, HPV9, IPV, MMR, TDAP, VARCEL
Symptoms: Full blood count, Immune thrombocytopenic purpura, Immunoglobulin therapy, Platelet count decreased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act concerning a 13 year old male patient. The patient's other medications, current illnesses, history and prior vaccinations were not provided. On 21-NOV-2016, the patient was vaccinated with GARDASIL 9 (dose and expiration date unknown, lot # M023169, intramuscular in the right arm), VARIVAX (dose and expiration date unknown, lot #M028546, subcutaneous in the right arm), M-M-R II (dose and expiration date unknown, lot #M007279, subcutaneous in the left arm), BOOSTRIX (dose and expiration date unknown, lot # EC9A9, intramuscular in the left arm), IPOL (dose and expiration date unknown, lot # N1A451M, intramuscular in the right arm), ENGERIX-B (dose and expiration date unknown, lot # FB2X4, intramuscular in the left arm), FLULAVAL (dose and expiration date unknown, lot # E97K2, intramuscular in the left arm) and HAVRIX (dose and expiration date unknown, lot # GP75A, intramuscular in the right arm)  for prophylaxis. On 02-DEC-2016, the patient experienced full blood count, platelet count decreased, immunoglobulin therapy and immune thrombocytopenic purpura. The patient visited emergency room. The patient's platelet count was 1 (unit unknown) and following hospitalization for intravenous immunoglobulin therapy (IVIG) recovered to 17. The outcome of the events was reported as recovery unknown. The agency was considered as the events as life threatening. Additional information is not expected since no further information could be requested from regulatory authority.
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA# 671094). This spontaneous report refers to a 12 year old female patient. The patient did not have current illnesses or medical history. No information regarding the patient's concomitant therapies was provided. On 09-DEC-2016, the patient was vaccinated with a dose of GARDASIL 9 (strength, dose number, route, anatomical location, lot number and expiration date were not provided. On the same date of vaccination, the patient fainted directly after GARDASIL 9 injection (Immediate post-injection reaction). At the time of the report, the outcome of Immediate post-injection reaction and syncope was reported as recovered. The agency did not assess the relatedness between Immediate post-injection reaction and syncope and GARDASIL 9. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Sex: F
Vaccine: HPV9
Symptoms: Swelling face
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 # 671584) concerning a 15 year old female patient with seafood allergy. The patient had no current illness. The patient's historical drugs included ibuprofen, NAPROSYN, Q-PAP and sodium fluoride. On 12-SEP-2016, the patient was vaccinated with the third dose of GARDASIL 9 (lot # reported as M026306) intramuscularly in the right arm. Concomitant medications included omeprazole and ENTOCORT. On 12-SEP-2016, the patient experienced facial swelling. The patient's mom gave her diphenhydramine 50 mg every 6 hours for three days. On an unspecified date, the patient recovered. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Abdominal pain, Lethargy
Clinical narrative: Abdominal pain; Lethargy; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA# 671741). This spontaneous report refers to a 14 year old male patient. The patient did not have current illness or medical history. No information regarding the concomitant therapies was provided. On 29-NOV-2016, the patient was vaccinated in her left arm with the first dose of GARDASIL 9 lot # M031557, intramuscularly (strength and expiration date were not provided) for prophylaxis. Other suspect therapies included FLUZONE lot # U1673AC, intramuscularly (strength and expiration date were not provided) for prophylaxis. On 30-NOV-2016, the patient experienced 24 hours of severe lethargy and abdominal pain. The outcome of abdominal pain and lethargy was reported as recovered. The agency did not assess the relatedness between lethargy and abdominal pain and GARDASIL 9. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Altered state of consciousness, Blood pressure decreased, Dizziness, Fatigue, Muscle contractions involuntary
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report refers to a 15 year old female patient. The patient's medical history included asthma, migraines and irregular periods. No concomitant medications were reported. On 11-JAN-2016, the patient was vaccinated with the third dose of GARDASIL 9, intramuscularly, in right leg, lot # L036301 (expiry date was not provided) for prophylaxis. On 11-JAN-2016, the patient had 2 brief episodes - body stiffened, clenched arms, some shaking. Lasted about 2-3 seconds. Was tired afterwards. BP lower than normal. Felt dizzy. Was monitored laying down for 30 minutes, then sitting for 20 minutes. Vital were taken every 30 minutes. During episodes, she was not responsive to name, or communication. Brief altered level of consciousness. The outcome of the events was reported as recovered on an unknown date. The relatedness between the events and GARDASIL 9 was not provided by the Agency. The Agency assessed this case as non-serious.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Musculoskeletal stiffness, Tremor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report refers to a 15 year old female patient. The patient's medical history included asthma, migraines and irregular periods. No concomitant medications were reported. On 11-JAN-2016, the patient was vaccinated with the third dose of GARDASIL 9, intramuscularly, in right leg, lot # L036301 (expiry date was not provided) for prophylaxis. On 11-JAN-2016, the patient had 2 brief episodes - body stiffened, clenched arms, some shaking. Lasted about 2-3 seconds. Was tired afterwards. BP lower than normal. Felt dizzy. Was monitored laying down for 30 minutes, then sitting for 20 minutes. Vital were taken every 30 minutes. During episodes, she was not responsive to name, or communication. Brief altered level of consciousness. The outcome of the events was reported as recovered on an unknown date. The relatedness between the events and GARDASIL 9 was not provided by the Agency. The Agency assessed this case as non-serious.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Dizziness, Head injury, Headache, Vision blurred, Visual impairment
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA # 671888) under the Freedom of Information Act and concerns a 13 year old female patient. The patient's medical history was reported as entoptic phenomenon; no other drugs; no allergies. The patient's concomitant medications and concurrent conditions were not reported. On 06-DEC-2016, the patient was vaccinated with the third dose of GARDASIL 9 injection, in her right arm by intramuscular route, lot number M016193 (dose, strength, an expiration date were not reported). Other suspect therapies included FLUZONE, in her left arm, by intramuscular route, lot number U1684AB, for prophylaxis. On 07-DEC-2016 at 05:15, while the patient was in the shower, she began to fell lightheaded, dizzy and blurred vision. About 30 seconds she could not see. She also hit her head (right side), and she experienced frontal headache rates 2/10. Negative for nausea and vomiting. 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.
Age: 17.0
Sex: F
Vaccine: HPV9, VARCEL
Symptoms: Loss of consciousness, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (671891) under the Freedom of Information Act, referring to a 17 year old female patient. The patient's medical history included vasovagal syncope prior the vaccination (on an unknown date). The patient's concurrent conditions and concomitant therapies were unknown. On 12-DEC-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # M007764, administered intramuscularly in the right arm (strength and expiration date were unknown) and with the first dose of VARIVAX lot # M024683, administered subcutaneously in the left arm (strength and expiration date were unknown) both vaccines for prophylaxis. On the same date on 12-DEC-2016, approximately 5 minutes after receiving the vaccines, the patient fainted; it was reported that the patient was unconscious for approximately 10 seconds. An Emergency Medical Technician (EMT) was called. Later, the patient slow recovered from the events. The reporter did not assess the relatedness between the loss of consciousness and the syncope with the vaccination with GARDASIL 9 nor with VARIVAX. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site discolouration
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 (HA# 672684). This spontaneous report refers to a 12 year old male patient. The patient's medical history included intermittent asthma, Historical drug included PROAIR and QVAR. The patient did not have current illness. The patient did not take other medications. On 09-JUN-2016, the patient was vaccinated in her left arm with the first dose of GARDASIL 9 lot # M007728, intramuscularly (strength and expiration date were not provided) for prophylaxis. On 12-DEC-2016, during a sibling visit, the patient's mother noted 6 cm of irregular hypopigmentation at the site of vaccine injection. No inflammation or other issue after vaccine was noted. At the time of the report, the outcome of injection site discoloration was reported as not recovered. The reporter did not assess the relatedness between Injection site discoloration and GARDASIL 9. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Fall, Head injury, Pallor, Syncope, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (672903) under the Freedom of Information Act, referring to a 15 year old male patient. The patient did not have medical history, concomitant therapies or concurrent conditions. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (strength, route, lot number and expiration date were not reported) for prophylaxis. Later on 13-DEC-2016 (also reported as "03-DEC-2016"), the patient was vaccinated with the second dose (also reported as "dose 1") of GARDASIL 9 lot #  M018810, administered intramuscularly in the left arm (strength and expiration date were unknown) for prophylaxis. On the same date on 13-DEC-2016, 5 minutes after the vaccine administration, the patient fainted, falling from exam table to floor, hitting head first-neuro check completed, vitals taken, oxygen was near by if needed. It was reported that patient's skin color was pale; the patient also threw up (vomited) few times. Then, they called emergency and while they arrive the patient received a physical examination that showed that the patient was alert and oriented x 3 (A/OX3), also the vitals sings were monitored (results not provided) and the patient suffered a syncope episode. At the time of the report, the outcome of the fall, the head injury, the pallor, the syncope and the vomiting was reported as recovered. The reporter did not assess the relatedness between the fall, the head injury, the pallor, the syncope and the vomiting with the vaccination with GARDASIL 9. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Age: 20.0
Sex: M
Vaccine: FLUC3, HPV9
Symptoms: Dyspnoea, Loss of consciousness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA#673024)  under the Freedom of Information Act (FOI) and refers to a 20 year old male patient.  On 16-DEC-2013, the patient was vaccinated with GARDASIL 9 lot # M023169, intramuscular in the right arm for prophylaxis (dosage schedule, and expiration date were not reported).  Other suspect therapies given on the same date included FLUCELVAX QUADRIVALENT lot # 186867A, intramuscular in the right arm for prophylaxis (dosage schedule, and expiration date were not reported). Patient passed out, momentarily had trouble breathing. Patient recovered, no epinephrine(EPI) or diphenhydramine hydrochloride(BENADRYL) needed.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Pruritus, Skin warm, Swelling, Tenderness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (agency number 674262) under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to an 11 year old female patient with no medical history, concurrent illnesses and concomitant medications. On 19-DEC-2016, the patient was vaccinated at the public health clinic/ hospital with the first dose of GARDASIL 9 injection, lot number L040054, in the right arm, (dose, route of administration and expiration date were not provided) for prophylaxis. On the same date, the patient also received the first dose of BOOSTRIX lot number LZ972 and the first dose of MENACTRA, lot number U5415AA, both administered in the left arm, (formulation, dose, route of administration and expiration date were not provided) for prophylaxis. On 19-DEC-2016, the patient developed red, raised, fevered area that was painful to touch and as stated by the child that sometimes itched. There were no laboratory diagnostic studies reported. The outcome of erythema, tenderness, swelling, skin warm and pruritus was reported as not recovered. The relatedness between the adverse events and suspect therapies was not provided. Additional information is not expected as no follow up could be obtained from the local regulatory authority.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Head injury, Heart rate increased, Hypotension, Loss of consciousness
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 and refers to 16-year-old male patient with no medical history and concurrent illnesses at the time of vaccination. On 26-DEC-2016, the patient was vaccinated with a second dose of GARDASIL 9 in the right arm, unknown route of administration (dose, lot# and expiration date were not reported). The concomitant medications included Myorisan (not otherwise specified) 40 mg (the patient was on fourth month of the therapy), iron supplement and multivitamin. On 26-DEC-2016, the patient experienced lightheadedness/dizziness within seconds after receiving the vaccine. Sat for about 1 min. Then he walked out to waiting room, seeing white fogginess, sat down with 1 min blacked out with eyes open, smacked back of head on wall, convulsed with eyes open and ended up on the floor sitting up convulsing. The patient had higher heart rate, low blood pressure. Nursed rushed out to monitor him and get his number back to normal. The patient was still pale and lightheaded on way home and pale-faced for at least 3 hours afterward. He napped at home friom about 1:35PM. The patient visited the emergency room. The outcome of the events was reported as recovered (on an unknown date). The relatedness between the events and GARDASIL 9 was not reported. Additional information is not expected as no further information can be obtained from the regulatory authority.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Pallor, Seizure, Vision blurred
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 and refers to 16-year-old male patient with no medical history and concurrent illnesses at the time of vaccination. On 26-DEC-2016, the patient was vaccinated with a second dose of GARDASIL 9 in the right arm, unknown route of administration (dose, lot# and expiration date were not reported). The concomitant medications included Myorisan (not otherwise specified) 40 mg (the patient was on fourth month of the therapy), iron supplement and multivitamin. On 26-DEC-2016, the patient experienced lightheadedness/dizziness within seconds after receiving the vaccine. Sat for about 1 min. Then he walked out to waiting room, seeing white fogginess, sat down with 1 min blacked out with eyes open, smacked back of head on wall, convulsed with eyes open and ended up on the floor sitting up convulsing. The patient had higher heart rate, low blood pressure. Nursed rushed out to monitor him and get his number back to normal. The patient was still pale and lightheaded on way home and pale-faced for at least 3 hours afterward. He napped at home friom about 1:35PM. The patient visited the emergency room. The outcome of the events was reported as recovered (on an unknown date). The relatedness between the events and GARDASIL 9 was not reported. Additional information is not expected as no further information can be obtained from the regulatory authority.
Sex: F
Vaccine: FLU3, HPV9, FLU3, HPV9
Symptoms: Erythema, Local reaction, Mass, Purulent discharge, Scab
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 (HA# 678358). This spontaneous report refers to a 12 year old female patient. No information regarding the patient's medical history was provided. The patient did not have current illnesses. On 09-NOV-2016, the patient was vaccinated in her left arm (also reported as: "right deltoid") with the first dose of GARDASIL 9 intramuscularly, lot number M018810 (Strength and expiration date were not provided) for prophylaxis. On 11-NOV-2016 (reported as: "two days later") the patient returned and had a lump and slight redness of the skin which was felt to be a local reaction and did not require treatment. On 09-JAN-2017, the patient returned and reported the mass had drained pus over on 02-JAN-2017 (reported as: "1 week ago") and now was scabbed over. The causal relationship between all adverse events and GARDASIL 9 was not reported. It was reported that the family did not seek medical attention at the time the mass was draining. Additional information is not expected as no further information can be obtained from the local Regulatory Authority.
Age: 20.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Dizziness, Feeling hot, Nausea, Pruritus, 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 (HA# 678496). This spontaneous report refers to a 20 year old female patient. The patient did not have current illness or medical history. On 18-JAN-2017, the patient was vaccinated in her right arm with the first dose of GARDASIL 9 intramuscularly, lot number M003659 (Strength and expiration date were not provided) for prophylaxis. On 18-JAN-2017, the patient experienced dizziness, lightheadedness, itching, nausea and feeling hot. The patient vomited for once. No hives noted. It was reported that other medications included Seasonique, Metformin and Spironolactone. At the time of the report, the outcome of all adverse event was reported as unknown. The causal relationship between all adverse events and GARDASIL 9 was not reported. Additional information is not expected as no further information can be obtained from the local Regulatory Authority.
Age: 17.0
Sex: M
Vaccine: FLU4, HPV9, MENB, MNQ, FLU4, HPV9, MENB, MNQ
Symptoms: Blood test, Body temperature increased, Headache, Hyperventilation, Panic reaction
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (678923) under the Freedom of Information Act, referring to a 17 year old male patient. It was unknown if the patient had medical history, concomitant therapies or concurrent conditions. On 19-JAN-2017, the patient was vaccinated with the first dose of GARDASIL 9 lot # M026306, administered intramuscularly in the left arm (strength and expiration date were not reported) for prophylaxis. On the same date the patient also received the following vaccines: the first dose of FLUZONE lot # reported as UI709AA, administered intramuscularly in the left arm (strength and expiration date were not reported), the first dose of BEXSERO lot # reported as 157501, administered intramuscularly in the right arm (strength and expiration date were not reported) and with the first dose of MENACTRA lot # reported as U5415AA, administered intramuscularly in the right arm (strength and expiration date were not reported) for prophylaxis. On 20-JAN-2017, the patient was admitted to emergency department (ED), with headache, hyperventilation, panic state, body temperature of 97.3 and 100.3 Fahrenheit (F). Blood work was performed (results were not reported) (coded by the agency as "blood test, body temperature increased, headache, hyperventilation and panic reaction"). At the time of the report, the outcome of blood test, body temperature Increased, headache, hyperventilation and panic reaction was unknown. The reporter did not assess the relatedness between blood test, body temperature increased, headache, hyperventilation and panic reaction with the vaccination with GARDASIL 9, FLUZONE, BEXSERO or MENACTRA. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Sex: F
Vaccine: HPV9, MENB, HPV9, MENB
Symptoms: Dizziness, Fatigue, Headache, Injection site erythema, Injection site pruritus
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA# 679234)under the Freedom of Information Act. on 10-MAY-2017 and refers to a 16 year old female patient.  The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 19-JAN-2017 (reported as "Thursday pm"), the patient was vaccinated her first dose of with GARDASIL 9, in the left arm, which had a lot# reported as "M0354S6" (route, expiration date, dose, concentration and indication were not reported).  Other suspect therapies included her first dose BEXSERO in the left arm, which had a lot# of 158401 (route, expiration date, dose, concentration and indication were not reported). On 20-JAN-2017, the patient wok up Friday feeling nauseated and her left arm started swelling itching and was red where she had the vaccine. The redness and swelling spread to 5" x 3" by Saturday along with occipital headache, dizziness, and fatigue. The patient called provider on Saturday evening and then was seen in office on 23-JAN-2017. With normal physical examination (PE), besides 3x5" fading erytherna of left upper arm. Lab data none. Other Medications Current Illnesses None History None Prior Vaccinations At the time of reporting, the patient did not recover from dizziness, nausea, injection site swelling, injection site pruritus, injection site erythema, headache and fatigue. The reporter did not provide a causality assessment between the suspect therapies and the events. Additional information is not expected, as no further information could be obtained from the Agency.
Sex: F
Vaccine: HPV9, MENB, HPV9, MENB
Symptoms: Injection site swelling, Nausea
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA# 679234)under the Freedom of Information Act. on 10-MAY-2017 and refers to a 16 year old female patient.  The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 19-JAN-2017 (reported as "Thursday pm"), the patient was vaccinated her first dose of with GARDASIL 9, in the left arm, which had a lot# reported as "M0354S6" (route, expiration date, dose, concentration and indication were not reported).  Other suspect therapies included her first dose BEXSERO in the left arm, which had a lot# of 158401 (route, expiration date, dose, concentration and indication were not reported). On 20-JAN-2017, the patient wok up Friday feeling nauseated and her left arm started swelling itching and was red where she had the vaccine. The redness and swelling spread to 5" x 3" by Saturday along with occipital headache, dizziness, and fatigue. The patient called provider on Saturday evening and then was seen in office on 23-JAN-2017. With normal physical examination (PE), besides 3x5" fading erytherna of left upper arm. Lab data none. Other Medications Current Illnesses None History None Prior Vaccinations At the time of reporting, the patient did not recover from dizziness, nausea, injection site swelling, injection site pruritus, injection site erythema, headache and fatigue. The reporter did not provide a causality assessment between the suspect therapies and the events. Additional information is not expected, as no further information could be obtained from the Agency.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP, FLU4, HPV9, MNQ, TDAP
Symptoms: Laboratory test, Pruritus generalised, Swelling face
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 (HA # 679505). Information has been received from a consumer (patient's father) referring to an 11 year old male patient. Information regarding history, current conditions and other medications were not reported. On 18-JAN-2017, the patient was vaccinated with 1st dose of GARDASIL 9 (lot # M018810, intramuscular in the left arm) for prophylaxis. Other suspect therapies included ADACEL (lot # U5486AB, intramuscular in the right arm; dose 1), FLUZONE Quadrivalent (lot # UI678AD, intramuscular in the right arm; dose 5) and MENVEO (lot # M16004, intramuscular in the left arm; dose 1). It was reported that at approximately 4:30-4:40pm on 18-JAN-2017 after receiving the vaccines, the patient experienced swelling of the face as well as a general feeling of "itchiness" all over his body. The father reported the patient had no breathing issues or wheezing. Lab work (date unknown) was done in the emergency room, but uncertain of what type. The Agency coded laboratory test, pruritus generalised and swelling face and considered the events to be non-serious. The outcome of the events was reported as recovered. The causality was not reported. Additional information is not expected as no further information can be obtained from the Agency.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Activities of daily living impaired, Fatigue, Vaccination site nodule
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 and refers to a 12 year old male patient. His concurrent conditions included congestion, runny nose, cough and allergies. The patient's medical history included seasonal allergy and food allergy. Past drugs included ZYRTEC and FLONASE. On unknown dates, the patient was vaccinated with dose 1 and dose 2 of GARDASIL 9 (doses, routes, lot numbers and expiration dates unknown) for prophylaxis. On 12-DEC-2016, the patient was vaccinated with GARDASIL 9 (lot # M018810 dose 3, intramuscular in the left arm) (expiration date unknown) for prophylaxis. On 13-DEC-2016, the patient experienced fatigue, noticed a knot in his arm where the vaccine was given and activities of daily living impaired. On 10-JAN-2017, the patient was followed up with but the knot was still present. The patient was told to massage the area and move the arm around more. There was no redness at the injection site. The outcome of fatigue, vaccination site nodule and loss of personal independence in daily activities was reported as not recovered/not resolved. The relatedness of atigue, vaccination site nodule and loss of personal independence in daily activities was unknown. Additional information is not expected, as the case is from agency and we are unable to do follow up.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Fatigue, Loss of personal independence in daily activities, Vaccination site nodule
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 and refers to a 12 year old male patient. His concurrent conditions included congestion, runny nose, cough and allergies. The patient's medical history included seasonal allergy and food allergy. Past drugs included ZYRTEC and FLONASE. On unknown dates, the patient was vaccinated with dose 1 and dose 2 of GARDASIL 9 (doses, routes, lot numbers and expiration dates unknown) for prophylaxis. On 12-DEC-2016, the patient was vaccinated with GARDASIL 9 (lot # M018810 dose 3, intramuscular in the left arm) (expiration date unknown) for prophylaxis. On 13-DEC-2016, the patient experienced fatigue, noticed a knot in his arm where the vaccine was given and activities of daily living impaired. On 10-JAN-2017, the patient was followed up with but the knot was still present. The patient was told to massage the area and move the arm around more. There was no redness at the injection site. The outcome of fatigue, vaccination site nodule and loss of personal independence in daily activities was reported as not recovered/not resolved. The relatedness of atigue, vaccination site nodule and loss of personal independence in daily activities was unknown. Additional information is not expected, as the case is from agency and we are unable to do follow up.
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP, FLU4, HPV9, MNQ, TDAP
Symptoms: Unevaluable event
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act refers to an 11 year old male patient. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (lot # M018810), (route: intramuscular) in the left arm. Other suspect therapies included FLUZONE Quadrivalent, BOOSTRIX and MENVEO. On an unknown date, the patient experienced unevaluable event. The outcome and causality of unevaluable event were unknown. Additional information is not expected because no further information could be obtained from the regulatory authority.
Age: 11.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Dizziness, Pallor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA #681067) under the Freedom of Information Act and concerns a 11 year old female patient. The patient's medical history included cerebral palsy (right hemiparesis). The patient's concurrent conditions and concomitant therapies were not reported. On 27-JAN-2017, the patient was vaccinated with a dose of GARDASIL 9 injection, in her left arm, by intramuscular route, lot number M035486 (strength, dose and expiration date were not reported) for prophylaxis. On the same date, after 15 minutes, the patient felt "dizzy", pale. The patient was layed down for 45 minutes still C/O dizziness, water given no relief. Bloof pressure with range, PEDIALYTE popsicle given after 5 minutes patient stated she was no longer dizzy. Assessed by medical doctor he was ok and he went home in approximately 2017. 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: 16.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, VARCEL, HPV9, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration
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 # 681075) on 10-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 16 year old female patient. The patient did not have any medical history or current illness. On 30-JAN-2017 the patient was vaccinated with GARDASIL 9 lot # M018840, intramuscular in the right arm for prophylaxis. Other suspect therapies included VARIVAX lot # M028546, subcutaneous in the left arm, BOOSTRIX (lot # 43MP2, intramuscularly on left arm) and MENACTRA (lot # U5272AA, intramuscularly on right arm) for prophylaxis. On 30-JAN-2017, the patient experienced injection site erythema and injection site induration. Other medications included Zoloft, propranolol and mineral oil. The outcome of injection site erythema and injection site induration was unknown. The causality was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: FLU4, HPV9, FLU4, HPV9
Symptoms: Pain in extremity, Paraesthesia
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 (HA #681461). Information has been received from a consumer (patient's mother) referring to a male patient of unknown age. The patient's concomitant medication was not reported. The patient's concurrent illness and current illness were reported as "none". Information on prior vaccinations was reported as "Fatigue, slept all day. Influenza (Seasonal) (no brand name). UN-7.00. Patient aches and cramps the whole next day. Influenza (Seasonal)". The reporter said the patient received the 2nd dose of GARDASIL 9 (lot # was reported as M036259, expiration date and route were unknown; left arm) and the 2nd dose of FLUZONE (lot # U1713AA, expiration date and route were unknown; right arm) about 4pm on 25-JAN-2017. At 9pm on the same day, the patient complained that his (R) foot/leg felt like pins and needles and then had pain mostly in thigh. He slept through the night. Pain continued the next day all day in thigh. The patient went to bed and when he woke up, pain was gone. The agency considered the event to be non-serious. The outcome of the events was reported as recovered. The causality was not reported. Additional information is not expected as no further information can be obtained from the Agency.
Age: 16.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Immune thrombocytopenic purpura, Platelet count decreased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report refers to a 16 year old male patient recovering from a relatively mild viral respiratory infection. The patient's concurrent conditions included attention deficit disorder (ADD), allergic rhinitis and possible food allergy. On 30-SEP-2016, the patient was vaccinated with the first dose of GARDASIL 9, intramuscularly in the left arm, lot # L036301 (expiry date was not reported) for prophylaxis. Concomitant therapies included ADDERALL XR. On 12-OCT-2016, the patient experienced immune thrombocytopenic purpura and platelet count decreased which caused his hospitalization (dates unspecified). On an unknown date, the patient's platelet count was <1 (units not provided). The outcome of platelet count decreased and immune thrombocytopenic purpura was reported as recovered on an unknown date. The relatedness between the events and GARDASIL 9 was not provided by the Agency.
Age: 12.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Axillary pain, Erythema, Pain in extremity, Swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA# 683046) under the Freedom of Information Act referring to a 12 year old female patient. The patient did not have any medical history or concurrent conditions. Concomitant medication included cholecalciferol.  On 09-FEB-2017, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly, in the left arm (lot # M024261, expiration date was not provided), for prophylaxis.  On 13-FEB-2017, mother and child stated (L) upper arm became painful and 2cmx2cm area of redness over deltoid area. Child felt pain under (L) upper arm into (L) axilla. Denies any lumps. Stated was slightly swollen. No numbness or tingling. No laboratory data were provided. The causality relationship between the adverse events and GARDASIL 9 was not provided. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Age: 12.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Axillary pain, Injection site erythema, Injection site pain, Swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA# 683046) under the Freedom of Information Act referring to a 12 year old female patient. The patient did not have any medical history or concurrent conditions. Concomitant medication included cholecalciferol.  On 09-FEB-2017, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly, in the left arm (lot # M024261, expiration date was not provided), for prophylaxis.  On 13-FEB-2017, mother and child stated (L) upper arm became painful and 2cmx2cm area of redness over deltoid area. Child felt pain under (L) upper arm into (L) axilla. Denies any lumps. Stated was slightly swollen. No numbness or tingling. No laboratory data were provided. The causality relationship between the adverse events and GARDASIL 9 was not provided. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9, FLU4, HPV9
Symptoms: Urticaria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA# 683520)  under the Freedom of Information Act (FOI) and refers to a 12 year old female patient. On 20-FEB-2017, the patient was vaccinated with the first dose of GARDASIL 9 intramuscular in the right arm, lot # M033583 for prophylaxis (dosage and expiration date were not reported). Other suspect therapies given on the same date, included the first dose of FLUZONE QUADRIVALENT intramuscular in the left arm, lot # UI669AB for prophylaxis (dosage and expiration date were not reported). On 20-FEB-2017, the patient experienced acute urticaria without angioedema, airway compromise, or anaphylaxis. Current illnesses: no. History: no prior Vaccinations.
Age: 24.0
Sex: M
Vaccine: HEPA, TYP, YF
Symptoms: Abnormal loss of weight, Diabetic ketoacidosis
Clinical narrative: Rapid weight loss, resulted in diabetic ketoacidosis.