chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Erythema, 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 # 657199) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old male patient. The patient had no concurrent illnesses and lab data. Information on the patient's prior vaccinations were not reported. The patient's other medications included FLONASE, ZYRTEC. The patient's medical history included seasonal allergies. On 29-SEP-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # L036301 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included MENVEO intramuscularly in the left arm, lot # M15166 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 30-SEP-2016, the patient experienced pain, redness and swelling to left arm. The patient required an emergency room (ER) visit. The outcome of erythema, pain in extremity and peripheral swelling was reported as recovered/resolved. Causality assessment 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: Injection site pruritus; Injection site erythema; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 657379) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old male patient. The patient concurrent illnesses and medical history were not reported. Information on the patient's prior vaccinations, lab data and other medications were not reported. On 30-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # L026602 with expiration date: 19-OCT-2017 (dose and frequency were not reported) for prophylaxis. Other suspect therapies included first dose of MENACTRA lot # U5410AA, Manufacturer: Sanofi Pasteur and BOOSTRIX intramuscularly in the left arm, lot # EC9A9, Manufacturer: GlaxoSmithKline (dose, frequency and lot expiration date were not reported) for prophylaxis. On 01-SEP-2016, the patient experienced injection site pruritus and injection site erythema. The outcome of injection site erythema and injection site pruritus was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 14.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Headache, Nausea, 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 # 657801) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 14 year old male patient. The patient had no concurrent illnesses. Information on the patient's prior vaccinations, lab data, medical history and other medications were not reported. On 26-SEP-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # 19297 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included second dose of FLUZONE Quadrivalent intramuscularly in the left arm, lot # UI657AA, first dose of MENACTRA intramuscularly in the left arm, lot # U5244AA and first dose of ADACEL intramuscularly in the right arm, lot # U4971AA, Manufacturer: Sanofi Pasteur (dose, frequency and lot expiration date were not reported) for prophylaxis. On the same day the patient experienced headache, body aches and nausea for four days. The outcome of headache, nausea and pain was reported as unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Dizziness, Fatigue, 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 # 658302) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 17 year old male patient. Information on patient's medical history, other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 03-OCT-2016, the patient was vaccinated with the second dose of GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # L036301, intramuscularly in the left arm for prophylaxis. Other suspect therapies included BEXSERO (dose number: 1, vaccinated date: 03-OCT-2016, intramuscularly in the right arm, lot# 15C601; dose and expiration date unknown) and MENACTRA (dose number: 2, vaccinated date: 03-OCT-2016, intramuscularly in the left arm, lot# U5228BB; dose and expiration date unknown). On 04-OCT-2016, the patient experienced dizziness, vomiting and fatigue. The outcome of dizziness, vomiting and fatigue were unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: FLU4, HEP, HPV9, IPV, MENB, MMR, TD
Symptoms: Asthenia, 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 # 658311) on 02-MAY-2017. This spontaneous report refers to a 16 year old male patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and the other medications were not reported. On 10-OCT-2016, the patient was vaccinated with GARDASIL 9 lot # M016193 (expiration date: 24-APR-2018) (dose and frequency were not reported), dose 1, intramuscularly in the right arm for prophylaxis. Other suspect therapies included M-M-R II lot # L047133, dose 2, subcutaneously in the right arm, BEXSERO batch/lot # 157601, dose 1, intramuscularly in the right arm, TENIVAC batch/lot # U5411CA, dose 2, intramuscularly in the left arm, IPOL batch/lot # K16941, dose 2, subcutaneously in the left arm, FLUZONE batch/lot # UI669AB, dose 1, intramuscularly in the right arm and ENGERIX-B batch/lot # 754AB, dose 2, intramuscularly in the left arm for prophylaxis. On 10-OCT-2016, the patient became weak and diaphoretic. The patient's BP was 70/40 (units unspecified). The patient was given water and crackers. The patient's BP was checked after 10 minutes and it was 90/50 (units unspecified). The patient then stated that he felt better and stood up slowly. The outcome of asthenia and hyperhidrosis was reported as recovered. The causality assessment 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: Face injury, Fall, 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 (VAERS # 658466) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 11 year old male patient. The patient's concurrent illness and medical history were reported as none. The patient's prior vaccinations, concomitant therapies and other medications were not reported. On 10-OCT-2016, the patient was vaccinated with first dose of GARDASIL 9 lot # M018810, lot expiration date 28-MAY-2018 (dose: not reported) via intramuscular route, in the left arm for prophylaxis. Other suspect therapies which were given on the same day included ADACEL (intramuscularly in the right arm, lot# U5406AA; dose and expiration date were not reported) and MENACTRA (intramuscularly in the right arm, lot# U5463AA; dose and expiration date were not reported) for prophylaxis. The patient received the vaccines in a clinic. On the same day shortly after the injection, the patient fainted and fell on the floor and hit his face. The Doctor assessed the patient and could not find any signs of injury or neurological changes. The patient appeared to be well when he left the clinic. The outcome of the events were reported as recovered. Causality assessment 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
Symptoms: Blood glucose normal, Loss of consciousness
Clinical narrative: This spontaneous report as received from a regulatory authority refers to an 11 year old male patient. The patient's other medications, current illnesses, medical history and prior vaccinations were not reported. On 04-OCT-2016, the patient was vaccinated with second dose of GARDASIL 9 lot # M007728 and expiration date: 26-SEP-2018, intramuscularly in the right arm (dose and frequency unknown) for prophylaxis. On same day the patient reported loss of consciousness (LOC) (<30 seconds) which was observed by patient's mother. The patient's mother assisted him to the floor. The patient had no fever, no injuries, Blood pressure was (BP) was 104/64, pulse: 70, D-stick: 94, tolerated PO, observed for 20 minutes and the patient was fully recovered from the loss of consciousness. Causality assessment 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: Cellulitis, Injection site discharge, Injection site erythema, 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 # 659160) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old male patient. The patient's medical history included atopic dermatitis and allergic rhinitis. Other medications was reported as Zyrtec. Information on patient's medical history and prior vaccinations were not reported. The patient had no concurrent illnesses. On 05-OCT-2016, the patient was vaccinated with the first dose of GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # L036301, intramuscularly in the left arm for prophylaxis. Other suspect therapies included BOOSTRIX (dose number: 1, vaccinated date: 05-OCT-2016, intramuscularly in the right arm, lot# G55BR; dose and expiration date unknown) and MENVEO (dose number: 1, vaccinated date: 05-OCT-2016, intramuscularly in the right arm, lot# M15143; dose and expiration date unknown). On 06-OCT-2016, the patient experienced cellulitis, injection site warmth, injection site swelling, injection site erythema and injection site discharge. Patient was seen at the emergency department (ED) and was told to provide with supportive care. On 07-OCT-2016, the doctor visited the patient and found to have swelling of right upper arm with erythema and warmth and wound in center. Patient was diagnosed with cellulitis and started treatment with clindamycin. The outcome of cellulitis, injection site warmth, injection site swelling, injection site erythema and injection site discharge were unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: U
Vaccine: HEPA, HPV9
Symptoms: Dizziness, Dyskinesia, Musculoskeletal stiffness, Nausea, 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 # 659163) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old patient of unknown gender. Information on patient's medical history, other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 07-OCT-2016, the patient was vaccinated with the third dose of GARDASIL 9 lot # L040054, intramuscularly in the left arm for prophylaxis. Other suspect therapies included HAVRIX (dose number: 2, vaccinated date: 07-OCT-2016, intramuscularly in the right arm, lot# LN749; dose and expiration date unknown). At 9:20 A.M, patient fainted after administration of vaccine. On the same day, the patient experienced dizziness, vision blurred, syncope, pallor, nausea, musculoskeletal stiffness and dyskinesia. Patient had jerking and stiffness of the body which lasted for approximately 1 minute. Patient complained of feeling nauseated, blurred vision and dizziness and skin was pale in color. Cool compress was applied to head and neck and blood pressure was monitored. Patient remained in center until then. The outcome of dizziness, vision blurred, syncope, pallor, nausea, musculoskeletal stiffness and dyskinesia was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: U
Vaccine: HEPA, HPV9
Symptoms: Syncope, 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 (VAERS # 659163) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old patient of unknown gender. Information on patient's medical history, other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 07-OCT-2016, the patient was vaccinated with the third dose of GARDASIL 9 lot # L040054, intramuscularly in the left arm for prophylaxis. Other suspect therapies included HAVRIX (dose number: 2, vaccinated date: 07-OCT-2016, intramuscularly in the right arm, lot# LN749; dose and expiration date unknown). At 9:20 A.M, patient fainted after administration of vaccine. On the same day, the patient experienced dizziness, vision blurred, syncope, pallor, nausea, musculoskeletal stiffness and dyskinesia. Patient had jerking and stiffness of the body which lasted for approximately 1 minute. Patient complained of feeling nauseated, blurred vision and dizziness and skin was pale in color. Cool compress was applied to head and neck and blood pressure was monitored. Patient remained in center until then. The outcome of dizziness, vision blurred, syncope, pallor, nausea, musculoskeletal stiffness and dyskinesia was reported as recovered/resolved. 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
Symptoms: Altered state of consciousness, Fall, Head injury, Headache, 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 (VAERS # 659300) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old male patient. Information on patient's medical history, other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 13-OCT-2016, the patient was vaccinated with the second dose of GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # M011117, intramuscularly in the left arm for prophylaxis. Other suspect therapies included FLUARIX (dose number: 1, vaccinated date: 13-OCT-2016, intramuscularly in the left arm, lot# 53T43; dose and expiration date unknown). On the same day, the patient experienced altered state of consciousness, syncope, head injury and fall. Syncopal episode lasted for approximately 5 minutes after receiving vaccines. Patient fell backwards landing on floor and hit back of  his head. Patient regained consciousness after approximately 30 seconds, no apparent injury was seen. Ice pack was applied to back of his head and legs were elevated, and was provided with juice. Patient complained of headache. Patient's mother planned to take him in to the after hours clinic or call the emergency department to find out if any further care should be given. The outcome of altered state of consciousness, syncope, head injury and fall was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: M
Vaccine: HPV9, IPV, MNQ
Symptoms: Dizziness, Fatigue, Hyperhidrosis, Hypoaesthesia, Immediate post-injection reaction
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 # 659409) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 13 year old male patient. The patient had no medical history and concurrent illness. The patient's other medications were reported as none. The patient's concomitant therapies and prior vaccinations were not reported. On 14-OCT-2016, at 14:45 the patient was vaccinated with first dose of GARDASIL 9 lot # M016193, lot expiration date 24-APR-2018 (dose: not reported) via intramuscular route, in the left arm for prophylaxis. Other suspect therapies which were given on the same day at 14:45 included first dose of MENACTRA (intramuscularly in the right arm, lot# U5260AA; dose and expiration date were not reported) and fourth dose of IPOL (intramuscularly in the right arm, lot# L11301; dose and expiration date were not reported) for prophylaxis. On 14-OCT-2016, immediately after the administration of Gardasil (last vaccine given), the patient got tensed up and went into a vasovagal episode. The patient was lowered to the ground safely and a pillow was placed under his head. Cold wash cloths were given for his forehead and immediately called for help. The Doctor came to evaluate. Shortly after the episode, the patient asked where he was and he stated he was tired, dizzy, sweating, whole body felt numb and felt as though he fell asleep for a quick nap. The Doctor checked his blood pressure, and did a full body examination along with listening for bowel sounds, extremity movement, along with checking for level of consciousness. Once the patient was improving, he was placed in a chair with a pillow behind his head and was given some water and Gatorade. The patient was monitored at least 30 minutes post incident. The Doctor evaluated and then accompanied the patient out to his car. The parents and patient stated that the patient had never experienced those events before, but his siblings and his father had experienced those events before. The outcome of the events were reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: M
Vaccine: HPV9, IPV, MNQ
Symptoms: Presyncope, Tension
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 # 659409) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 13 year old male patient. The patient had no medical history and concurrent illness. The patient's other medications were reported as none. The patient's concomitant therapies and prior vaccinations were not reported. On 14-OCT-2016, at 14:45 the patient was vaccinated with first dose of GARDASIL 9 lot # M016193, lot expiration date 24-APR-2018 (dose: not reported) via intramuscular route, in the left arm for prophylaxis. Other suspect therapies which were given on the same day at 14:45 included first dose of MENACTRA (intramuscularly in the right arm, lot# U5260AA; dose and expiration date were not reported) and fourth dose of IPOL (intramuscularly in the right arm, lot# L11301; dose and expiration date were not reported) for prophylaxis. On 14-OCT-2016, immediately after the administration of Gardasil (last vaccine given), the patient got tensed up and went into a vasovagal episode. The patient was lowered to the ground safely and a pillow was placed under his head. Cold wash cloths were given for his forehead and immediately called for help. The Doctor came to evaluate. Shortly after the episode, the patient asked where he was and he stated he was tired, dizzy, sweating, whole body felt numb and felt as though he fell asleep for a quick nap. The Doctor checked his blood pressure, and did a full body examination along with listening for bowel sounds, extremity movement, along with checking for level of consciousness. Once the patient was improving, he was placed in a chair with a pillow behind his head and was given some water and Gatorade. The patient was monitored at least 30 minutes post incident. The Doctor evaluated and then accompanied the patient out to his car. The parents and patient stated that the patient had never experienced those events before, but his siblings and his father had experienced those events before. The outcome of the events were reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Dyskinesia, Grunting, Hypotension, Immediate post-injection reaction, Posturing
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 # 659432) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 20 year old female patient. The patient's medical history was reported as none. The patient had no concurrent illness. The patient's concomitant therapies, other medications and prior vaccinations were not reported. On 13-OCT-2016, the patient was vaccinated with second dose of GARDASIL 9 lot # M011840 (dose and lot expiration date were not reported) via intramuscular route, in the left arm for prophylaxis. On the same day immediately after vaccination, the patient displayed seizure like activities which lasted for approximately 15 seconds. The seizure like activities included unresponsiveness, posturing with arms tucked up to chest, jerking movements and snorting/grunting respirations. Immediately after the events, the patient was oriented to place, time, self and situation and was neurologically intact. There was no apparent injury sustained and the patient denied of any pain/distress. The patient was able to recall receiving vaccine. She stated that those events had never happened to her before. She also stated that she becomes light-headed with injections/blood draws. Vital signs after the events were within normal limits except for hypotension 81/59 (units not provided). Immediately following the events, the patient's pulse rate was 72 (units not provided), respiratory rate was 18 (units not provided) and temperature was 97.8 (units not provided). The outcome of the events were reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Seizure like phenomena, 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 # 659432) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 20 year old female patient. The patient's medical history was reported as none. The patient had no concurrent illness. The patient's concomitant therapies, other medications and prior vaccinations were not reported. On 13-OCT-2016, the patient was vaccinated with second dose of GARDASIL 9 lot # M011840 (dose and lot expiration date were not reported) via intramuscular route, in the left arm for prophylaxis. On the same day immediately after vaccination, the patient displayed seizure like activities which lasted for approximately 15 seconds. The seizure like activities included unresponsiveness, posturing with arms tucked up to chest, jerking movements and snorting/grunting respirations. Immediately after the events, the patient was oriented to place, time, self and situation and was neurologically intact. There was no apparent injury sustained and the patient denied of any pain/distress. The patient was able to recall receiving vaccine. She stated that those events had never happened to her before. She also stated that she becomes light-headed with injections/blood draws. Vital signs after the events were within normal limits except for hypotension 81/59 (units not provided). Immediately following the events, the patient's pulse rate was 72 (units not provided), respiratory rate was 18 (units not provided) and temperature was 97.8 (units not provided). The outcome of the events were reported as recovered. 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: Dizziness, Pallor, 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 # 660424). This spontaneous report refers to a 13 year old female patient. Information on patient's current illnesses, medical history, other medications and prior vaccinations was not reported. On 11-OCT-2016, the patient was vaccinated with GARDASIL 9 lot # M024261 (expiry date: 30-JUL-2018), dose 1, route: unknown in the left arm for prophylaxis. On the same day, the patient experienced dizziness, fever and she turned pale minutes after vaccination. The outcome of the events was reported as unknown. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Pruritus, Rash macular, 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 # 660425). This spontaneous report refers to a 12 year old male patient. The patient had no current illnesses and information on patient's prior vaccinations was not reported. The patient's medical history included lactose intolerance and other medications included Claritin. On 06-OCT-2016, the patient was vaccinated with GARDASIL 9 lot # M016193 (expiry date: 24-APR-2018), dose 2, route: unknown in the right arm for prophylaxis. On 06-OCT-2016, one and half hour after receiving GARDASIL 9, the patient felt very itchy with blotchy hive like welts on arms, legs and torso. The above events resolved with benadryl. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 20.0
Sex: F
Vaccine: FLU4, HPV9, VARCEL
Symptoms: Dizziness, Injection site discomfort, Injection site erythema, 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 # 660584) on 02-MAY-2017. This spontaneous report refers to a 20 year old female patient. The patient's medical history and lab data were reported as none. The patient's other medications included fluoxetine. The patient had no concurrent illnesses. Information on the patient's prior vaccinations was not reported. On 17-OCT-2016, the patient was vaccinated with GARDASIL 9 intramuscularly in the right arm (dose number 3, lot # M024261 and expiration date: 30-JUL-2018) and VARIVAX subcutaneously in the right arm (dose number 2, lot # M020899 and expiration date :27-APR-2018) for prophylaxis. On the same day, the patient was also vaccinated with FLUARIX QUADRIVALENT (dose number 2, intramuscularly in the left arm, lot # 2317C, manufacturer: GlaxoSmithKline; expiration date was not reported) for prophylaxis. On 17-OCT-2016, the patient complained of discomfort at the injection site, feeling lightheaded and feverish. The injection site was red, hot, itchy and swollen. The outcome of the events 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: 20.0
Sex: F
Vaccine: FLU4, HPV9, VARCEL
Symptoms: Injection site warmth, 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 # 660584) on 02-MAY-2017. This spontaneous report refers to a 20 year old female patient. The patient's medical history and lab data were reported as none. The patient's other medications included fluoxetine. The patient had no concurrent illnesses. Information on the patient's prior vaccinations was not reported. On 17-OCT-2016, the patient was vaccinated with GARDASIL 9 intramuscularly in the right arm (dose number 3, lot # M024261 and expiration date: 30-JUL-2018) and VARIVAX subcutaneously in the right arm (dose number 2, lot # M020899 and expiration date :27-APR-2018) for prophylaxis. On the same day, the patient was also vaccinated with FLUARIX QUADRIVALENT (dose number 2, intramuscularly in the left arm, lot # 2317C, manufacturer: GlaxoSmithKline; expiration date was not reported) for prophylaxis. On 17-OCT-2016, the patient complained of discomfort at the injection site, feeling lightheaded and feverish. The injection site was red, hot, itchy and swollen. The outcome of the events 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: M
Vaccine: FLU4, HPV9, MNQ
Symptoms: Fatigue, Hyperhidrosis, Pallor, 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 (VAERS # 660603) on 02-MAY-2017. This spontaneous report refers to a 17 year old male patient. Information about the patient's concurrent illnesses, medical history, prior vaccinations and other medications were not reported. On 18-OCT-2016, during an appointment with a primary care provider, the patient was vaccinated with GARDASIL 9 lot # M018810 (Expiration date: 28-MAY-2018) dose 1 (unspecified dosage) intramuscularly in the right arm, FLUARIX QUADRIVALENT lot # C54L3 dose 1 (unspecified dosage) intramuscularly in the left arm and MENACTRA lot # U5416AA dose 1 (unspecified dosage) intramuscularly in the left arm, for prophylaxis. The order of vaccination was such that, FLUARIX QUADRIVALENT and MENACTRA was given first. A minute later, he was given GARDASIL 9. On 18-OCT-2016, after receiving the vaccination, the patient was sitting on the couch in the exam room, when he became pale, diaphoretic, experienced fatigue and fainted, approximately 1 minute after receiving GARDASIL 9. The nursing staff and primary care provider responded to the nurse's call for assistance, within seconds. The patient was already starting to say a few words and was still seated on the couch. The patient's father was also present during that time. The patient had not sustained any injuries. During the initial assessment at the time of the fainting episode, the blood pressure was found to be 149/80 and the pulse was 82. Patient was assisted to lie down and his feet was elevated above the heart level. The patient was observed, provided oral fluids and allowed to rest in a supine position. Over the next hour, the patient was able to progress to a sitting position and stand briefly. He was able to drink 2 cans (6 ounces) of apple juice and 3 cups (8 ounces) of water, without any difficulty. The patient was alert and oriented, with normal color and was feeling better. He was still very tired during his discharge to home, with his father. Patient's vital signs were stable with a blood pressure of 118/79 and a pulse of 87. The patient was escorted in a wheelchair by the nurse, to his father's car and was later dismissed to the care of his father. At the time of the patient's discharge from the clinic, the patient's primary care provider was notified of the his stable condition. The emergency response actions taken were discussed with the family members present at the time and also notified about, to the primary care provider. The outcome of the events was reported as recovered. The causality assessment for the events was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: F
Vaccine: FLUX, HPV4, FLUX, HPV9
Symptoms: Injection site erythema, Oedema peripheral, Vaccination 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 # 660753). This spontaneous report refers to a 11 year old female patient. The patient had no current illnesses and medical history. Information on patient's other medications and prior vaccinations was not reported. On 19-OCT-2016, the patient was vaccinated with GARDASIL 9 (lot # not reported), dose 3, intramuscularly in the right arm for prophylaxis. On the same day, the patient was also vaccinated with influenza virus vaccine (seasonal), (dose and lot # not reported) intramuscularly in the right arm. On 20-OCT-2016, the patient had large amount of armpit swelling, redness and induration at the site of vaccine. The outcome of the events was reported as unknown. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 11.0
Sex: F
Vaccine: FLUX, HPV4, FLUX, HPV9
Symptoms: Injection site erythema, Injection site induration, 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 # 660753). This spontaneous report refers to a 11 year old female patient. The patient had no current illnesses and medical history. Information on patient's other medications and prior vaccinations was not reported. On 19-OCT-2016, the patient was vaccinated with GARDASIL 9 (lot # not reported), dose 3, intramuscularly in the right arm for prophylaxis. On the same day, the patient was also vaccinated with influenza virus vaccine (seasonal), (dose and lot # not reported) intramuscularly in the right arm. On 20-OCT-2016, the patient had large amount of armpit swelling, redness and induration at the site of vaccine. The outcome of the events was reported as unknown. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Vaccination 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 # 661058) on 02-MAY-2017. This spontaneous report refers to a 12 year old female patient. Information about the patient's concurrent illnesses, medical history, prior vaccinations and other medications were not reported. On 17-OCT-2016, the patient was vaccinated with GARDASIL 9 lot # M009378 dose 2 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On the same day, the patient was also vaccinated with FLUARIX QUADRIVALENT lot # 2994A dose 4 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On 18-OCT-2016, the patient had a swelling of 1/2 dollar sized bump, at the vaccination site and the patient had no fever. The outcome of vaccination site swelling was reported as recovered. The causality assessment for vaccination site swelling was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Blindness, Echocardiogram normal, Tricuspid valve incompetence
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 # 661205) on 02-MAY-2017. This spontaneous report refers to a 16 year old male patient. Information about the patient's concurrent illnesses, medical history and prior vaccinations were not reported. The patient had no other medications. On 06-SEP-2016, the patient was vaccinated with GARDASIL 9 lot # M017983 (Expiration date: 30-MAY-2018 ) dose 2 (unspecified dosage) via an unknown route, in the left arm and MENACTRA lot # U5416AA dose 2 (unspecified dosage) via an unknown route in the left arm, for prophylaxis. On the same night, the patient had episodes of partial blindness at football practice. The patient was taken to the emergency room and was also diagnosed with mild tricuspid regurgitation. The patient's laboratory data included echocardiogram, which was found to be normal. The outcome of the events was reported as unknown. The causality assessment for the events was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Headache
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 661216) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 15 year old male patient. The patient had no concurrent illnesses and was not under use of any other medications. The patient's medical history included allergy to azithromycin and amoxicillin. On 19-OCT-2016 the patient was vaccinated with GARDASIL 9 dose 2, lot#: M021407, intramuscularly in the left arm for prophylaxis. On 23-OCT-2016, the patient experienced headache which was relieved by taking ibuprofen. The headache returned again on 24-OCT-2016. It was reported that the patient does not typically experience headaches. He plays high school football, and there was no report of blunt force to head. The outcome of headache was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 19.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Rash
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 # 661382) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 19 year old female patient. The patient had no concurrent illnesses or medical history. The patient's other medications included birth control Drospirenoine estradiol 3 mg. On 14-OCT-2016 the patient was vaccinated with GARDASIL 9 lot # M018810, expiration date: 28-MAY-2018, dose 1, intramuscularly in the left arm and FLUARIX QUADRIVALENT lot # 24K44, dose 9, intramuscularly in the right arm for prophylaxis. On 18-OCT-2016, the patient experienced a rash on back that was white and raised but not fluid filled. On the same day the mother told the patient to take a dose of Benadryl and the rash disappeared. It returned then later that evening so the patient's mother had her take another dose of Benadryl. The patient was at school. She let the mother know on 19-OCT-2016 that the rash resolved and on the same day the mother called to report about the event. The patient's mother thought she should report it since the patient had gotten the vaccination and a flu shot. No further diagnosis was made since the patient took Benadryl. The event required an emergency room visit. The outcome of rash was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: 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 # 662251) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old female patient. Information on patient's medical history, other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 26-OCT-2016, the patient was vaccinated with the first dose of GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # M030380, intramuscularly in the right arm for prophylaxis. Other suspect therapies included FLUZONE Quadrivalent (dose number: 5, vaccinated date: 26-OCT-2016, intramuscularly in the left arm, lot# UI678AB; dose and expiration date unknown). On the same day, the patient underwent two seizures back to back. The outcome of seizure was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: FLU4, HPV9, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, 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 # 662646). This spontaneous report refers to a 11 year old female patient. Information on patient's current illnesses, medical history and other medications was not reported. The patient's prior vaccinations included FLUZONE dose 1, on an unknown date at 08:00, which caused cellulitis. On 27-OCT-2016, the patient was vaccinated with GARDASIL 9 batch/lot # M03080, dose 1, route: needle and syringe (not specified further) in the right arm for prophylaxis. On the same day, the patient was vaccinated with FLUZONE QUADRIVALENT batch/lot # UI693AA, dose 5, route: needle and syringe (not specified further) in the left arm and ADACEL batch/lot # U5489AA, dose 1, route: needle and syringe (not specified further) in the left arm. On 29-OCT-2016, the patient experienced swelling, redness, pain and warmth at the injection site. Express care diagnosed cellulitis and patient was given oral prednisone and cephalexin. The outcome of the events was reported as recovered. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
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 # 663552) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old female patient. The patient had no concurrent illnesses and other medications included Cetrizine. The patient's medical history included allergic rhinitis. On 12-OCT-2016 the patient was vaccinated with GARDASIL 9 lot # L036301 dose 2, intramuscularly in the left arm and MENACTRA (manufacturer: Sanofi Pasteur) lot # U5460BA, intramuscularly in the right arm for prophylaxis. On the same day several hours after immunization the patient experienced hives/urticaria of face, arms, legs and trunk. The hives lasted for 1 week as of the day of this report. The event required an emergency room visit. The treatment included Benadryl 25 mg daily and prednisone. The outcome of urticaria was reported as not recovered/not resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: M
Vaccine: HPV9, TDAP, VARCEL
Symptoms: Immediate post-injection reaction, Neck pain, Pain in extremity
Clinical narrative: Immediate post-injection reaction; Neck pain; Pain in extremity; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 663798) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 17 year old male patient. The patient's other medications were unknown. The patient had no concurrent illnesses or medical history. On 02-NOV-2016 the patient was vaccinated with GARDASIL 9 expiration date: 28-MAY-2018, lot # M018810 dose 1, intramuscularly in the left arm, VARIVAX lot # M027344 dose 1, subcutaneously in the left arm and ADACEL (manufacturer: Sanofi Pasteur) lot # U5486AB dose 1, intramuscularly in the right arm for prophylaxis.  On the same day immediately after the vaccination with GARDASIL 9 the patient experienced an immediate post-injection reaction and stated that he had severe pain in the left arm and neck. The patient stayed for 15 minutes with continued pain and then went home with his parent. The patient was encouraged to take Ibuprofen or Tylenol and apply ice pack to arm when home. The outcome of all the events was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site induration, Injection site pain
Clinical narrative: Injection site induration; Injection site pain; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 664518). This spontaneous report refers to a 25 year old female patient. The patient had no current illnesses and medical history. Information on patient's other medications and prior vaccinations was not reported. On 18-OCT-2016, the patient was vaccinated with GARDASIL 9 lot # L040164, intramuscularly in the left arm for prophylaxis. On 18-OCT-2016, the patient reported a hard area approximately in nickel size on the left deltoid and the site was painful to touch. The patient had full range of motion and had no other problems associated with site. The outcome of the events injection site induration and injection site pain was unknown. The causality assessment for the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 14.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Injection site erythema; Injection site warmth; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 664559) on 02-MAY-2017. This spontaneous report refers to a 14 year old female patient. The patient's medical history included Sulfa drugs and the patient had no other medications. Information about the patient's concurrent illnesses and prior vaccinations were not reported. On 18-OCT-2016, the patient was vaccinated with GARDASIL 9 lot # L038503 dose 2 (unspecified dosage) via an unknown route in the left arm for prophylaxis. On the same day, the patient was also vaccinated with MENACTRA lot # U5272AA dose 1 (unspecified dosage) via an unknown route in the right arm for prophylaxis. On 20-OCT-2016, the patient experienced mild erythema and warmth at the injection site, superficially (SC4) with a circumference of 3 cm at the left deltoid, where the patient was vaccinated with GARDASIL 9. The outcome of the events was reported as recovered. The causality assessment for the events was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.