chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Electrocardiogram, Eye movement disorder, Fall, Musculoskeletal stiffness
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 # 594250) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old male patient with prophylaxis. The patient's current illnesses, other medications and medical history was not reported. On 08-SEP-2015, the patient was vaccinated with third dose of GARDASIL 9 intramuscularly in the left arm, lot # L000610 (dose, frequency and expiration date were not reported) for prophylaxis. Other suspect therapy included, MENACTRA (dose number 1; vaccinated date: 08-SEP-2015, intramuscularly in the right arm, lot number # U5068AA; (dose and expiration date unknown). After 10-20 seconds of administration of GARDASIL 9 and MENACTRA the patient fell back onto examination table, eyes rolled back and arms/body stiffened. Then the patient recovered within 15 seconds and was not aware of what had occurred and oriented x 3. The patient was placed in Trendelenburg position. The patient vital signs (VS) at 4:15pm, 111/52 HR was 48, at 4:25pm = 108/58 HR was 58, at 4:32 102/57 HR was 54, at 4:50pm, 102/59 HR was 59. The patient ate crackers and drank juice without difficulty. The patient stated that he felt "fine." And walked around clinic before Doctor asked him to leave. The patient had underwent Electrocardiogram (EKG). The patient sat in room for 45 minutes after episode. The outcome of electrocardiogram, musculoskeletal stiffness, fall and eye movement disorder was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: FLU4, HPV9, MNQ
Symptoms: Dyskinesia, Gaze palsy, Hypopnoea, Loss of consciousness, Pallor
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 # 594567) on 04-APR-2017. This spontaneous report was received from a regulatory authority refers to a 11 year old male patient. Information on the patient's other medications and prior vaccinations were not reported. The patient's medical history included decreased vision right eye and vitrectomy. Patient had no current illness. On 28-AUG-2015, the patient was vaccinated with the first dose of GARDASIL 9 lot # K02624, via unknown route, in the right arm for prophylaxis (dosage and expiry date unspecified). Other suspect therapies included FLUZONE QUADRIVALENT batch # U5309BA, dose 13, via unknown route in the left arm for prophylaxis and MENACTRA batch # U4847BA, dose 1, via unknown route in the left arm (dosage and expiry date unspecified). On 28-AUG-2015, 3 minutes post GARDASIL 9 vaccine, the patient fainted and was breathing with shallow breaths along with pale complexion. The patient had 5-8 seconds of mild body jerking with eyes straight ahead. The patient became conscious and talkative 10 seconds later. TILTS table test was done and were normal. The outcome of dyskinesia, tilt table test normal, syncope, pallor and hypopnoea was reported as recovered. Causality for the events were not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: FLU4, HPV9, MNQ
Symptoms: Syncope, Tilt table test
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 594567) on 04-APR-2017. This spontaneous report was received from a regulatory authority refers to a 11 year old male patient. Information on the patient's other medications and prior vaccinations were not reported. The patient's medical history included decreased vision right eye and vitrectomy. Patient had no current illness. On 28-AUG-2015, the patient was vaccinated with the first dose of GARDASIL 9 lot # K02624, via unknown route, in the right arm for prophylaxis (dosage and expiry date unspecified). Other suspect therapies included FLUZONE QUADRIVALENT batch # U5309BA, dose 13, via unknown route in the left arm for prophylaxis and MENACTRA batch # U4847BA, dose 1, via unknown route in the left arm (dosage and expiry date unspecified). On 28-AUG-2015, 3 minutes post GARDASIL 9 vaccine, the patient fainted and was breathing with shallow breaths along with pale complexion. The patient had 5-8 seconds of mild body jerking with eyes straight ahead. The patient became conscious and talkative 10 seconds later. TILTS table test was done and were normal. The outcome of dyskinesia, tilt table test normal, syncope, pallor and hypopnoea was reported as recovered. Causality for the events were not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Headache, Nausea, Pain, 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 # 594591) on 04-APR-2017. This spontaneous report was received from a regulatory authority concerning a 17 year old male patient. The patient's concomitant therapies, concurrent illnesses, pertinent medical history and prior vaccinations were not reported. On 09-SEP-2015, the patient was vaccinated with GARDASIL 9, dose number 2, (lot number and expiry date, dose, frequency were not reported), intramuscularly in the left arm for prophylaxis. On the same day, the patient experienced headache, pyrexia, body pains and nausea. The outcome of all the events were unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
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 # 594594) on 04-APR-2017. This spontaneous prospective pregnancy report was received from a regulatory authority refers to a 18 year old female patient. Information on the patient's medical history, other medications and prior vaccinations were not reported. The patient's concurrent illness included pregnancy. Patient was asked if she was pregnant, she told no, to both MA and DO. On 31-AUG-2015, the patient was vaccinated with the first dose of GARDASIL 9 lot # L000610, via intramuscular route, in the right arm for prophylaxis (dosage and expiry date unspecified). On 31-AUG-2015, patient told the provider that she was 6 weeks pregnant, so patient had an exposure during pregnancy. The LMP and EDD was not known. The pregnancy outcome was unknown. The outcome of the event exposure during pregnancy was reported as recovered. Causality for the event was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
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 # 594769). This spontaneous retrospective pregnancy report refers to a 20 year old female patient. The patient had no concurrent illnesses. The patient's medical history included anxiety, migraines, attention deficit disorder (ADD), irritable bowel syndrome (IBS) and asthma. The patient's other medications included CELEXA, ADVAIR, ADDERALL, BENTYL, allergy medications and PROAIR. The patient was trying to conceive at approximately 07-JUL-2015. On 07-JUL-2015, the patient was vaccinated with GARDASIL 9 lot # K026247 dose 1, intramuscular route in the right arm for prophylaxis and subsequently patient became pregnant with LMP of 20-JUN-2015 and EDD of 26-MAR-2016. On 10-SEP-2015, exposure during pregnancy was reported. This was an early pregnancy exposure reporting. The pregnancy outcome was unknown, however the outcome of the event exposure during pregnancy was reported as recovered. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Product use issue
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 # 594791). This spontaneous report refers to a 11 year old male patient. The patient had no concurrent illnesses, medical history and other medications. Information on the patient's prior vaccinations was not reported. On 10-SEP-2015, the patient was vaccinated with GARDASIL 9 lot # L007560, dose 3, intramuscular route in the right arm for prophylaxis (dosage unspecified). On an unknown date, product use issue was reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Eye pain, Nausea, Pyrexia, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 594835). This spontaneous report refers to a 21 year old male patient. The patient had no concurrent illnesses, medical history and other medications. Information on the patient's prior vaccinations were not reported. On 10-SEP-2015, the patient was vaccinated with GARDASIL 9 batch/lot# K02B247, dose 1, intramuscular route in the left thigh (leg) for prophylaxis (dosage unspecified). On 10-SEP-2015, the patient experienced eye pain(bilateral), vomiting, pyrexia and nausea. No treatment was given. The outcome of eye pain (bilateral), vomiting, pyrexia and nausea was reported as recovered. The causality assessment for the events with respect to GARDASIL 9 was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Body temperature increased, Dizziness, Injection site pain
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 595144) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 25 year old female patient. The patient's current illnesses, medical history, other medications and prior vaccinations were not reported. On 01-SEP-2015, the patient was vaccinated with first dose of GARDASIL 9 (route of administration unknown) in the right arm, lot # L019287 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 02-SEP-2015, the patient had a temperature: 99.7, pulse 105-120, experienced dizzy and pain to left deltoid arm. The patient was treated with TYLENOL and advised for rest. On an unknown date, the patient has underwent emergency room (ER) visit. The outcome of dizziness, injection site pain and body temperature increased was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ
Symptoms: C-reactive protein increased, Erythema, Fibrin D dimer increased, Full blood count, Metabolic function test
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 595178). This spontaneous report refers to a 16 year old male patient. The patient's medical history included coarctation of the aorta, scoliosis and short stature. The patient had no concurrent illnesses and the was on no other medications. Information on the patient's prior vaccinations was not reported. On 19-JUN-2015, the patient was vaccinated with GARDASIL 9 lot # L001312, dose 1, intramuscular route in the left thigh(leg) for prophylaxis (dosage unspecified). On the same day, the patient was also vaccinated with MENACTRA lot/batch# U4846A, dose 2, intramuscular route in the right thigh(leg) for prophylaxis (dosage unspecified). On 29-JUN-2015, the patient experienced erythema, peripheral swelling, pain in extremity (bilateral feet pain), the patient's ultrasound scan was normal, the patient underwent metabolic function test and full blood count and the patient's fibrin D-dimer, red blood cell sedimentation rate and C-reactive protein increased. The patient had no known injury. The patient required emergency room (ER) visit. The ER did complete blood count (CBC), CMP, sedimentation rate, D-dimer, C-reactive protein (CRP). This was all lab work. An ultrasound was also done on the lower extremities and result was normal. The patient had elevated CRP and D-dimer which were indicative of inflammation. The outcome of the events was reported as recovered. The causality assessment for the events with respect to GARDASIL 9 was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Pain in extremity, Peripheral swelling, Red blood cell sedimentation rate increased, Ultrasound scan normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 595178). This spontaneous report refers to a 16 year old male patient. The patient's medical history included coarctation of the aorta, scoliosis and short stature. The patient had no concurrent illnesses and the was on no other medications. Information on the patient's prior vaccinations was not reported. On 19-JUN-2015, the patient was vaccinated with GARDASIL 9 lot # L001312, dose 1, intramuscular route in the left thigh(leg) for prophylaxis (dosage unspecified). On the same day, the patient was also vaccinated with MENACTRA lot/batch# U4846A, dose 2, intramuscular route in the right thigh(leg) for prophylaxis (dosage unspecified). On 29-JUN-2015, the patient experienced erythema, peripheral swelling, pain in extremity (bilateral feet pain), the patient's ultrasound scan was normal, the patient underwent metabolic function test and full blood count and the patient's fibrin D-dimer, red blood cell sedimentation rate and C-reactive protein increased. The patient had no known injury. The patient required emergency room (ER) visit. The ER did complete blood count (CBC), CMP, sedimentation rate, D-dimer, C-reactive protein (CRP). This was all lab work. An ultrasound was also done on the lower extremities and result was normal. The patient had elevated CRP and D-dimer which were indicative of inflammation. The outcome of the events was reported as recovered. The causality assessment for the events with respect to GARDASIL 9 was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Peripheral swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID-595263). This spontaneous report refers to a 11 year old male patient. The patient had no medical history, concurrent conditions and concomitant medications. On 01-SEP-2015 the patient was vaccinated with GARDASIL 9 lot # L019287 dose 1 (unspecified dose and frequency), intramuscular in the right arm for prophylaxis. Other suspect therapies included BOOSTRIX (dose 1 in the left arm) and MENACTRA (dose 1 in the left arm) for prophylaxis. On 02-SEP-2015, symptoms of injection site erythema, peripheral swelling and injection site pain started. On 03-SEP-2015, increase in redness is noted and there was no change in swelling. The outcome of injection site erythema, peripheral swelling and injection site pain was reported as unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Pallor, Syncope, Unresponsive to stimuli
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 595280) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old male patient. The patient's other medications was not reported. Current illnesses include that the patient was at the clinic for well child check and has no illnesses. The patient's has no medical history and also reported that the patient had no allergies, no medication taken and had no previous diagnoses. On 14-SEP-2015, the patient was vaccinated with first dose of GARDASIL 9 intramuscularly in the left arm, lot # 013429 (dose, frequency and lot expiration date were not reported) for prophylaxis. On the same day, immediately after administration of injection of HPV the patient fainted (immediate post-injection reaction) and the patient did not respond for seconds, his face was pale. The patient BP (blood pressure) was 109/68 and pulse was 70. Observed patient and child was able to respond to questions. Oriented to person and place. The outcome of pallor, immediate post-injection reaction and syncope was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Burning sensation, International normalised ratio normal, Papule, Petechiae, Platelet count normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID-595518). This spontaneous report refers to a 24 year old female patient. The patient's medical history included sciatica and human papilloma viral infection. On 10-SEP-2015 the patient was vaccinated with GARDASIL 9 lot # L027282 dose 1 (unspecified dose and frequency), intramuscular in the right arm for prophylaxis. On 12-SEP-2015, the patient experienced burning sensation (to the hands and feet), white blood cell count increased, red blood cell count normal, platelet count normal, petechiae (on bilateral hands), papule (flesh colored on bilateral hands) and international normalised ratio normal. The outcome of the events was unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Red blood cell count normal, White blood cell count increased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID-595518). This spontaneous report refers to a 24 year old female patient. The patient's medical history included sciatica and human papilloma viral infection. On 10-SEP-2015 the patient was vaccinated with GARDASIL 9 lot # L027282 dose 1 (unspecified dose and frequency), intramuscular in the right arm for prophylaxis. On 12-SEP-2015, the patient experienced burning sensation (to the hands and feet), white blood cell count increased, red blood cell count normal, platelet count normal, petechiae (on bilateral hands), papule (flesh colored on bilateral hands) and international normalised ratio normal. The outcome of the events was unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV9, MNQ
Symptoms: Cold sweat, Dizziness, Injection site erythema, Injection site swelling, Pallor
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 # 595622). This spontaneous report refers to a 13 year old male patient. Information on the patient's concurrent illnesses, medical history and other medications were not reported. On 26-AUG-2015, the patient was vaccinated with GARDASIL 9 lot # L007560, dose 1, unknown route in the left arm for prophylaxis (dosage unspecified). On the same day, the patient was also vaccinated with MENVEO batch/lot# M15008, dose 1, unknown route in the right arm and HAVRIX batch/lot# X22P4, dose 1, unknown route in the right arm for prophylaxis (dosage unspecified). On 26-AUG-2015, the patient experienced cold sweat, injection site erythema, pallor, injection site swelling and dizziness. The PHN saw the patient 24 hrs after administration of vaccine. Upper left arm (deltoid) was swollen to the size of a "baseball" and was red. During 15 min, after vaccination the became pale, lightheaded and had clammy skin. The patient's legs were elevated and an ice pack was placed to the head. The patient required emergency room visit. The outcome of cold sweat, injection site erythema, injection site swelling, dizziness and pallor was reported as recovered. The causality assessment for the events with respect to GARDASIL 9 was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: 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 under the Freedom of Information Act (VAERS # 595761). This spontaneous report refers to a 11 year old male patient. The patient's concurrent illnesses were reported as cough and runny nose. The patient had no medical history and other medications. Information on the patient's prior vaccinations were not reported. On 15-SEP-2015, the patient was vaccinated with GARDASIL 9 lot # L007560 dose 1, intramuscular route in the left arm for prophylaxis (dosage unspecified). On the same day, the patient was also vaccinated with MENVEO batch/lot# A15008, dose 1, intramuscular route in the left arm and BOOSTRIX batch/lot# Z7S54, dose 1, intramuscular route in the right arm for prophylaxis (dosage unspecified). On 15-SEP-2015, the patient experienced injection site erythema and injection site pruritus. Injection site erythema and injection site pruritus present on left deltoid area 17cm x 20cm. Injection site erythema and injection site pruritus present on right deltoid area 10cm x 13cm. The patient required emergency room visit. The outcome of injection site erythema and injection site pruritus was unknown. The causality assessment for the events with respect to GARDASIL 9 was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Dizziness, Eye irritation, Headache, Nausea, Oropharyngeal pain
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 595826). This spontaneous report refers to a 14 year old female patient. The patient had no known concurrent illnesses. Information on the patient's medical history, prior vaccinations and other medications were not reported. On 03-SEP-2015, the patient was vaccinated with GARDASIL 9 lot # L019286, intramuscular route in the left arm for prophylaxis (dose number and dosage unspecified). On the same day, the patient was also vaccinated with HAVRIX batch/lot# X224P, intramuscular route in the right arm for prophylaxis (dose number and dosage unspecified). On an unknown date, the patient experienced dizziness, light rash, pyrexia, pallor, oropharyngeal pain, nausea, headache and eye irritation within 48 hrs of vaccination as per the patient's parent. On 09-SEP-2015, the patient experienced seizure. The outcome of dizziness, seizure, rash, pyrexia, pallor, oropharyngeal pain, nausea, headache and eye irritation was reported as recovered. The causality assessment for the events with respect to GARDASIL 9 was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Pallor, Pyrexia, Rash, Seizure
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 # 595826). This spontaneous report refers to a 14 year old female patient. The patient had no known concurrent illnesses. Information on the patient's medical history, prior vaccinations and other medications were not reported. On 03-SEP-2015, the patient was vaccinated with GARDASIL 9 lot # L019286, intramuscular route in the left arm for prophylaxis (dose number and dosage unspecified). On the same day, the patient was also vaccinated with HAVRIX batch/lot# X224P, intramuscular route in the right arm for prophylaxis (dose number and dosage unspecified). On an unknown date, the patient experienced dizziness, light rash, pyrexia, pallor, oropharyngeal pain, nausea, headache and eye irritation within 48 hrs of vaccination as per the patient's parent. On 09-SEP-2015, the patient experienced seizure. The outcome of dizziness, seizure, rash, pyrexia, pallor, oropharyngeal pain, nausea, headache and eye irritation was reported as recovered. The causality assessment for the events with respect to GARDASIL 9 was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Contusion, Petechiae, 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 (VAERS # 595989) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old male patient with prophylaxis. The patient's medical history included rhinitis allergic, bicuspid aortic valve, ichthyosis and Tourette's. The patient had no current illnesses and other medications. On 10-AUG-2015, the patient was vaccinated with first dose of GARDASIL 9 intramuscularly in the left arm, lot # L014198 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 30-AUG-2015, the patient's mother noticed bruising and patient had platelet count decreased and petechiae. On 03-SEP-2015, the patient was taken to emergency room (ER) for petechiae and platelets count was 4,000. On 06-SEP-2015, platelets count was 1000. The patient was placed on high dose of steroids. On 08-SEP-2015, platelet count was 9000. It was followed by hematology at hospital. Appts for repeat blood work. The outcome of contusion, platelet count decreased and petechiae was reported as not recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Disorientation, Drooling, Erythema, Eye movement disorder, Hyperhidrosis
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 # 596098) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to an 11 year old female patient with prophylaxis. The patient's current illnesses, other medications and medical history was not reported. On 16-SEP-2015, the patient was vaccinated with second dose of GARDASIL 9 intramuscularly in the right arm, lot # L006547 (dose, frequency and expiration date were not reported) for prophylaxis. On the same day, the patient appeared fine and talked freely to her sister for 1-2 minutes after receiving injection, while sitting on the examination table. Patient stated she felt fine and moved from examination table to chair approximately 5-10 steps away. Patient continued talking for a short time possibly 1 minute then stated she did not feel well. Patient's head fell back and eyes rolled back, patient was unresponsive to touch or sound. Her face turned red and patient began to drool. Her body became stiff and rigid. With assistance was able to maneuver the patient to a sitting position on the floor. Patient seemed to be awake at this time, however, not talking or oriented. Pupils were dilated. Lowered the patient to a supine position on the floor with both legs lifted patient came to and was quickly oriented. Patient's coloring then became very pale and she became diaphoretic and shaky. Placed a cool moist towel on her forehead and continued to talk to the patient. The patient remained on the floor for approximately 10 minutes then was able to sit up and drink Gatorade and eat crackers. The patient remained in the sitting position on the floor for another 5-7 minutes before standing up. Patient was still shaky but was feeling better. The outcome of disorientation, unresponsive to stimuli, tremor, posture abnormal, pallor, mydriasis, musculoskeletal stiffness, muscle rigidity, malaise, hyperhidrosis, eye movement disorder, erythema and drooling was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Malaise, Muscle rigidity, Musculoskeletal stiffness, Mydriasis, Pallor
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 # 596098) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to an 11 year old female patient with prophylaxis. The patient's current illnesses, other medications and medical history was not reported. On 16-SEP-2015, the patient was vaccinated with second dose of GARDASIL 9 intramuscularly in the right arm, lot # L006547 (dose, frequency and expiration date were not reported) for prophylaxis. On the same day, the patient appeared fine and talked freely to her sister for 1-2 minutes after receiving injection, while sitting on the examination table. Patient stated she felt fine and moved from examination table to chair approximately 5-10 steps away. Patient continued talking for a short time possibly 1 minute then stated she did not feel well. Patient's head fell back and eyes rolled back, patient was unresponsive to touch or sound. Her face turned red and patient began to drool. Her body became stiff and rigid. With assistance was able to maneuver the patient to a sitting position on the floor. Patient seemed to be awake at this time, however, not talking or oriented. Pupils were dilated. Lowered the patient to a supine position on the floor with both legs lifted patient came to and was quickly oriented. Patient's coloring then became very pale and she became diaphoretic and shaky. Placed a cool moist towel on her forehead and continued to talk to the patient. The patient remained on the floor for approximately 10 minutes then was able to sit up and drink Gatorade and eat crackers. The patient remained in the sitting position on the floor for another 5-7 minutes before standing up. Patient was still shaky but was feeling better. The outcome of disorientation, unresponsive to stimuli, tremor, posture abnormal, pallor, mydriasis, musculoskeletal stiffness, muscle rigidity, malaise, hyperhidrosis, eye movement disorder, erythema and drooling was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 596098) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to an 11 year old female patient with prophylaxis. The patient's current illnesses, other medications and medical history was not reported. On 16-SEP-2015, the patient was vaccinated with second dose of GARDASIL 9 intramuscularly in the right arm, lot # L006547 (dose, frequency and expiration date were not reported) for prophylaxis. On the same day, the patient appeared fine and talked freely to her sister for 1-2 minutes after receiving injection, while sitting on the examination table. Patient stated she felt fine and moved from examination table to chair approximately 5-10 steps away. Patient continued talking for a short time possibly 1 minute then stated she did not feel well. Patient's head fell back and eyes rolled back, patient was unresponsive to touch or sound. Her face turned red and patient began to drool. Her body became stiff and rigid. With assistance was able to maneuver the patient to a sitting position on the floor. Patient seemed to be awake at this time, however, not talking or oriented. Pupils were dilated. Lowered the patient to a supine position on the floor with both legs lifted patient came to and was quickly oriented. Patient's coloring then became very pale and she became diaphoretic and shaky. Placed a cool moist towel on her forehead and continued to talk to the patient. The patient remained on the floor for approximately 10 minutes then was able to sit up and drink Gatorade and eat crackers. The patient remained in the sitting position on the floor for another 5-7 minutes before standing up. Patient was still shaky but was feeling better. The outcome of disorientation, unresponsive to stimuli, tremor, posture abnormal, pallor, mydriasis, musculoskeletal stiffness, muscle rigidity, malaise, hyperhidrosis, eye movement disorder, erythema and drooling was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site induration, Injection site swelling, Injection site warmth
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 # 596139) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old male patient with prophylaxis. The patient's other medications, current illnesses, medical history and prior vaccinations were not reported. On 15-SEP-2015, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # L016428 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapy included, MENACTRA (dose number 1; vaccinated date: 15-SEP-2015, intramuscularly in the left arm, lot # U5020AA; dose and expiration date unknown) for prophylaxis. On 16-SEP-2015, the patient experienced redness, swelling (15cm) hard, warm erythematous, ecchymosis noted to upper left arm and injection site haemorrhage. The outcome of injection site erythema, injection site warmth, injection site swelling, injection site induration and injection site haemorrhage were not reported. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
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 # 596224) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 13 year old female patient with prophylaxis. The patient's medical history included Raynaud's disease and medication allergy to fluoxetine. The patient's other medications, current illnesses and prior vaccinations were not reported. On 18-SEP-2015 the patient was vaccinated with third dose of GARDASIL 9 intramuscularly in the left arm, lot # L016528 (dose, frequency and expiration date were not reported) for prophylaxis, and on the same day the patient experienced urticarial shortly after injection. The event urticaria was worsened over the next several hours and then patient was seen in emergency room (ER) on the same day at 22:30. The patient was treated with diphenhydramine and methylprednisolone. The outcome of the event urticarial was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Abscess, Cellulitis, Pain in extremity, Peripheral swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 596530) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 17 year old female patient with prophylaxis. The patient's current illnesses included runny nose, sore throat, headache, nausea, diagnosed with URI (upper respiratory tract infection) and age. The patient's other medications was not reported and the patient had no medical history. On 17-AUG-2015, the patient was vaccinated with first dose of GARDASIL 9 intramuscularly in the left arm, lot # K026247 (dose, frequency and expiration date were not reported) for prophylaxis. Other suspect therapy included, MENACTRA (dose number 2; vaccinated date: 17-AUG-2015, intramuscularly in the left arm, lot number # U5049AA; (dose and expiration date unknown). On 17-AUG-2015, the patient had pain in extremity, sore and swollen arm that persists was seen on this day and was diagnosed with cellulitis and abscess. The patient was prescribed with cephalexin and compresses. The outcome of abscess, peripheral swelling, pain in extremity and cellulitis was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 596577) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 13 year old male patient with prophylaxis. The patient's medical history included sulfa allergy. The patient's other medications and current illnesses were not reported. On 18-SEP-2015, the patient was vaccinated with GARDASIL 9 intramuscularly in the right arm, (dose, frequency, lot number and expiration date were not reported) for prophylaxis and VARIVAX intramuscularly in the right arm, (dose, frequency, lot number and expiration date were not reported) for prophylaxis. Other suspect therapies included ADACEL (vaccinated date: 18-SEP-2015, intramuscularly in the left arm, lot number and dose and expiration date unknown), MENACTRA (vaccinated date: 18-SEP-2015, intramuscularly in the left arm, lot number; dose and expiration date unknown), HAVRIX (vaccinated date: 18-SEP-2015, intramuscularly in the right arm, lot number; dose and expiration date unknown). On 18-SEP-2015, the patient experienced redness, swelling and erythema which developed on left arm only. On 20-SEP-2015, the reaction was managed with BENADRYL but redness had spread down past the elbow of the left arm and across chest. The patient was took to the local emergency room (ER) and given prednisone which cleared the reaction. The outcome of erythema, injection site swelling and injection site erythema was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Myalgia
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 # 596578). This spontaneous report refers to a 14 year old female patient. The patient's medical history included constipation and rhinitis allergic. The patient had no concurrent illnesses and other medications. Information on the patient's prior vaccinations were not reported. On 24-AUG-2015, the patient was vaccinated with GARDASIL 9 lot # L019287 dose 1, intramuscular route in the left arm for prophylaxis (dosage unspecified). On 24-AUG-2015, the patient experienced severe abdominal pain in the night, followed by myalgia in arms and legs for more than 7 days. The outcome of abdominal pain and myalgia was unknown. The causality assessment for the events with respect to GARDASIL 9 was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Altered state of consciousness, Blood glucose normal, Cold sweat, Feeling cold
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 # 596742) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 14 year old male patient with prophylaxis. The patient's current illnesses, other medications and medical history was not reported. On 01-SEP-2015, the patient was vaccinated with first dose of GARDASIL 9 (route of administration: unknown) in the left arm, lot # L011846 (dose, frequency and expiration date were not reported) for prophylaxis. On 02-SEP-2015, 1 day after the GARDASIL 9 administrated, the patient came back to the clinic for blood work, and in the process the patient became cold and clammy and felt almost like passing out and blood glucose was normal. Glucose finger stick done was 100. The outcome of blood glucose normal, depressed level of consciousness and cold sweat was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site discharge, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 596779). This spontaneous report refers to a 11 year old male patient. Information on the patient's concurrent illnesses and medical history were not reported. The patient had no other medications. On 15-SEP-2015, the patient was vaccinated with GARDASIL 9 lot # K016966, dose 1, unknown route in the left arm for prophylaxis (dosage unspecified). On the same day, the patient was also vaccinated with BOOSTRIX batch/lot# 5MG55, dose 1, unknown route in the right arm and MENVEO batch/lot# M14133, dose 1, unknown route in the right arm for prophylaxis (dosage unspecified). On 16-SEP-2015, the patient experienced injection site discharge, injection site warmth, injection site vesicles, injection site swelling, injection site pruritus, injection site pain and injection site erythema. The patient had swelling, redness, blistering with some weeping, warm to touch, some pain and itching at injection site where BOOSTRIX and MENVEO were given. On 16-SEP-2015, the area measured 1 inch by 1 inch and was red and warm to touch. On 17-SEP-2015, area measured 6 inches long by 5 inches wide with blistering and weeping at injection site. Area was cleaned and dressed with TAO, 2x2 gauze and wrapped loosely because of weeping from area. Physician prescribed oral steroids for the patient. Follow up call was made on 18-SEP-2015 and the patient's mother reported that the area was improving. Another follow up call was made on 21-SEP-2015, to the parent and the patient's mother reported that area was completely healed. It was noted in patient's chart that reaction took place and was advised caution with next dose of vaccines. The outcome of injection site discharge, injection site warmth, injection site swelling, injection site pruritus, injection site pain, injection site erythema and injection site vesicles was reported as recovered. The causality assessment for the events with respect to GARDASIL 9 was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site vesicles, Injection site warmth
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 # 596779). This spontaneous report refers to a 11 year old male patient. Information on the patient's concurrent illnesses and medical history were not reported. The patient had no other medications. On 15-SEP-2015, the patient was vaccinated with GARDASIL 9 lot # K016966, dose 1, unknown route in the left arm for prophylaxis (dosage unspecified). On the same day, the patient was also vaccinated with BOOSTRIX batch/lot# 5MG55, dose 1, unknown route in the right arm and MENVEO batch/lot# M14133, dose 1, unknown route in the right arm for prophylaxis (dosage unspecified). On 16-SEP-2015, the patient experienced injection site discharge, injection site warmth, injection site vesicles, injection site swelling, injection site pruritus, injection site pain and injection site erythema. The patient had swelling, redness, blistering with some weeping, warm to touch, some pain and itching at injection site where BOOSTRIX and MENVEO were given. On 16-SEP-2015, the area measured 1 inch by 1 inch and was red and warm to touch. On 17-SEP-2015, area measured 6 inches long by 5 inches wide with blistering and weeping at injection site. Area was cleaned and dressed with TAO, 2x2 gauze and wrapped loosely because of weeping from area. Physician prescribed oral steroids for the patient. Follow up call was made on 18-SEP-2015 and the patient's mother reported that the area was improving. Another follow up call was made on 21-SEP-2015, to the parent and the patient's mother reported that area was completely healed. It was noted in patient's chart that reaction took place and was advised caution with next dose of vaccines. The outcome of injection site discharge, injection site warmth, injection site swelling, injection site pruritus, injection site pain, injection site erythema and injection site vesicles was reported as recovered. The causality assessment for the events with respect to GARDASIL 9 was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Feeling abnormal, Mobility decreased, Pain in extremity
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 # 597195). This spontaneous report refers to a 18 year old female patient. The patient had no known concurrent illnesses and medical history. Information on the patient's prior vaccinations was not reported. The patient's other medications included DEPO PROVERA. On 31-AUG-2015, the patient was vaccinated with GARDASIL 9 lot # L004014, dose 3, intramuscular route in the left arm for prophylaxis (dosage unspecified). On 02-SEP-2015, the patient called the health department and complained of asthenia, pain in extremity, mobility decreased and feeling abnormal. The patient stated that her left arm was very sore to raise or lay on it, the patient felt weak and was not herself. The outcome of the events was unknown. The causality assessment for the events with respect to GARDASIL 9 was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.