chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9
Symptoms: Folliculitis, Pruritus, Rash, Rash morbilliform, Rash papular
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 # 597528). This spontaneous report refers to a 26 year old female patient. The patient's concurrent illnesses was reported as none. The patient's medical history was not reported. On 04-SEP-2015 the patient was vaccinated with GARDASIL 9 lot # K026247, dose 1, intramuscularly in the left arm for prophylaxis. On 05-SEP-2015, the patient experienced folliculitis, pruritus and rash. On 10-SEP-2015 presented with small bumps on legs with itching. Diagnosis with folliculitis and treated with hydroxyzine, betamethasone valerate 0.1% cream and clindamycin phosphate 1% cream from Doctor. On 14-SEP-2015, the patient presents with worsening rash, now small erythematous papules on trunk and extremities morbilliform on upper legs/hips. The patient was treated with ZYRTEC 10 mg, ZANTAC 150 mg, prednisone 20 mg. The outcome of folliculitis, rash papular, rash morbilliform, rash and pruritus 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: FLU3, HPV9, MNQ
Symptoms: Blood pressure increased, Dizziness, 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 # 598073) on 04-APR-2017. This spontaneous report was received from a regulatory authority refers to a 16 year old male patient. The patient's pertinent medical history, current illnesses, lab data and prior vaccinations were not reported. Other medications were reported as tylenol, differin, motrin, miralax, nizoral shampoo, flonase and zyrtec. On 30-SEP-2015, the patient was vaccinated with GARDASIL 9 lot # 007560, intramuscularly (dose number, dose and expiration date unknown) for prophylaxis. Other suspect therapies included FLUARIX (Manufacturer: Glaxosmithkline, vaccinated date: 30-SEP-2015, intramuscular, lot # 9JX2N, dose number, dose and expiration date unknown) and MENACTRA (Manufacturer: Sanofi Pasteur, vaccinated date: 30-SEP-2015, intramuscular, lot # U5155BA, dose number, dose and expiration date unknown). On the same day, the patient experienced increase in blood pressure, headache and dizziness. Patient reported to nurse who checked him that he was feeling lightheaded and had a headache after receiving the GARDASIL 9, MENACTRA, and Influenza vaccines. Headache was 10/10. Vital signs were checked and were initially normal. Patient was assessed by physician and no focal deficits were noted. He was advised to lie down after drinking water and given Tylenol for headache. Upon reassessment patient reported decreased lightheadedness and headache was now 9/10. Vital signs rechecked and blood pressure was elevated, other vital signs stable. Due to symptoms still being present he was advised for further evaluation and assessment in Emergency department. Patient was subsequently seen there and given IV fluids and Reglan and was consulted to Nephrology due to his blood pressure. Examination remained unchanged from initial exam when first assessed after vaccination. 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.
Age: 14.0
Sex: F
Vaccine: HEP, HPV9, MNQ, TDAP, VARCEL
Symptoms: Crying, Headache, Hypoacusis, 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 # 598352) on 04-APR-2017. This spontaneous report was received from a regulatory authority concerning a 14 year old female patient. Information on patient's concomitant therapies, current illnesses, pertinent medical history, lab data and prior vaccinations were not reported. On 02-OCT-2015, the patient was vaccinated with GARDASIL 9 lot # L007560, dose 1, intramuscularly (dose and expiration date unknown) in the right arm for prophylaxis. Other suspect therapies included VARIVAX (dose number: 1, vaccinated date: 02-OCT-2015, subcutaneously in the left arm, lot# L013827; dose and expiration date unknown) ADACEL (dose number: 1, manufacturer: Sanofi Pasteur, vaccinated date: 02-OCT-2015, intramuscularly in the left arm, lot# U5264AA; dose and expiration date unknown), ENGERIX-B (dose number: 3, manufacturer: Glaxosmithkline, vaccinated date: 02-OCT-2015, intramuscularly in the left arm, lot# 237PJ; dose and expiration date unknown) and MENVEO (dose number: 1, manufacturer: Novartis, vaccinated date: 02-OCT-2015, intramuscularly in the right arm, lot# M15017; dose and expiration date unknown) for prophylaxis. On the same day, post vaccination the nurse observed patient (reported as client) crying and complained of a headache, color pale, blood pressure (B/P): 77/44 and pulse: 66. The patient's head was placed between knees and ammonia inhalant was used. Patient on sitting noted that his color was improving, blood pressure (B/P): 121/88 and pulse: 88. Patient began complaining of not hearing and stated blood pressure (B/P): 63/34, pulse: 67 and pale color. Ice was placed at back of the neck and head was placed between the knees. It was observed that patient's color was improving on sitting and Blood pressure (B/P): 104/44 and pulse: 79 was noticed on drinking water and eating lollipop. Patient was placed on oxygen and 911 emergency was called and transported to hospital and was seen in the emergency room. The outcome of all the events were 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: 21.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Headache, Nausea, Pyrexia, Seasonal allergy
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 # 601291) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 21 year old female patient. The patient had no medical history or concurrent conditions. The patient's concomitant therapies, lab data and prior vaccination details were not reported. The patient's other medications included Advil and unspecified birth control medications. On 06-OCT-2015 the patient was vaccinated with GARDASIL 9 (dose number, dose, frequency, route, site, and lot#, lot expiration date were not reported) and diphtheria toxoid, pertussis acellular vaccine (unspecified) and tetanus toxoid (manufacturer unknown) (dose number, dose, frequency, route, site, and lot#, lot expiration date were not reported) for prophylaxis. On 07-OCT-2015, the patient experienced lasting headache, seasonal allergy with hay fever type symptoms, fever and nausea. The outcome of events was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 26.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Pruritus, Rash macular
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 # 602672) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 26 year old female patient. The patient had no medical history or concurrent conditions. The patient's concomitant therapies and prior vaccination details were not reported. The patient's other medications were not known at the time of this report. There was no lab data available at the time of this report. On 14-OCT-2015 the patient was vaccinated with GARDASIL 9 lot # L013429 dose 3, intramuscularly in the left arm and FLUZONE Quadrivlaent (dose number: 4, intramuscularly in the left arm, lot# UI443AB; dose and expiration date unknown) for prophylaxis. On the same day, the patient experienced pruritus and rash macular. There was itching on breasts and arm with red splotches on arms. The outcome of pruritus and rash macular was unknown. 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: FLU4, HPV9
Symptoms: Arthralgia, Fatigue, Muscular weakness
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 # 603290) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 13 year old male patient. The patient's medical history included Kawasaki disease and seasonal allergies. There were no concurrent conditions and other medications at the time of this report. The patient's concomitant therapies were not reported. On 24-SEP-2015 the patient was vaccinated with GARDASIL 9 lot # L007560 dose 1, intramuscularly in the left arm and influenza FLUZONE Quadrivalent (lot # not reported, manufacturer: Sanofi Pasteur), dose 11, intramuscularly in the right arm for prophylaxis. On 28-OCT-2015 the patient experienced arthralgia, muscular weakness and fatigue. The joints started to hurt and there was overall fatigue. The joint pain increased over next several days and there was weakness in the legs as well on few occasions. The patient visited the emergency room. The symptoms have been continuing until the time of this report (i.e 2.5 weeks post vaccination). The outcome of events 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: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Amnesia, Dizziness, Drug screen negative, Full blood count normal, Metabolic function test 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 # 604424) on 04-APR-2017. This spontaneous report was received from a regulatory authority concerning a 16 year old male patient. The patient's historical condition was reported as obesity. Information on patient's concomitant therapies, current illnesses and prior vaccinations were not reported. On 12-OCT-2015, the patient was vaccinated with GARDASIL 9 dose 1, lot # L006542, intramuscularly (dose and expiration date unknown) in the right arm for prophylaxis. Other suspect therapies included MENACTRA (Manufacturer: Sanofi Pasteur, dose number: 2, vaccinated date: 12-OCT-2015, intramuscularly in the left arm, lot # U503AA, dose and expiration date unknown). On the same day, patient complained of dizziness while lying down 10 min after receiving vaccination and had transient memory loss for about 20 minutes and also underwent complete blood count and metabolic function tests for which results were normal but urine drug screen test showed negative results. He remained responsive but would not answer simple questions. He then improved, went home and presented to the Emergency room 10 hours later with memory loss again. The symptoms were resolved later and patient was sent home. The outcome of all the events were 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: 24.0
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 # 604496) on 04-APR-2017. This spontaneous report was received from a regulatory authority concerning a 24 year old female patient. The patient's concomitant therapies, concurrent illness, pertinent medical history and prior vaccinations were not reported. On 21-SEP-2015, the patient was vaccinated with GARDASIL 9 lot # L0118467, dose number 1 (dose, frequency, lot expiration date, route of administration were not reported) in the left arm for prophylaxis. On an unspecified date in 2015, the patient experienced urticaria, hives intermittent starting few days after receiving vaccine. At the time of report, patient stated that her hives were gone. The outcome of the event 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: 11.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Erythema, Local swelling, Skin warm
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 # 604552) on 04-APR-2017. This spontaneous report was received from a regulatory authority refers to a 11 year old male patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and other medications were not reported. On 21-OCT-2015, the patient was vaccinated with the first dose of GARDASIL 9 lot # L014415, via intramuscular route in the right arm for prophylaxis (dosage and expiry date unspecified). Other suspect therapies included FLUZONE QUADRIVALENT batch # UI431AA, dose 6, via intramuscular route in the left arm for prophylaxis (dosage and expiry date unspecified). On 21-OCT-2015, the patient's right arm had a 10 x10 area of erythema, skin warm, local swelling and patient visited emergency room. The outcome of erythema, skin warm and local swelling 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: FLU3, HPV9, MNQ, TDAP
Symptoms: Asthenia, Differential white blood cell count normal, Full blood count normal, Headache, Liver function test 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 # 605447) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old male patient. The patient's medical history included attention deficit hyperactivity disorder and migraine. The patient's concurrent conditions included upper respiratory tract infection symptoms with cough, rhinorrhea and nasal congestion for several days. The patient's concomitant therapies were not reported and other medications included CONCERTA 27 mg, Guanfacine 1 mg orally every bedtime (qhs). On 26-OCT-2015 the patient was vaccinated with GARDASIL 9 lot # L014415 dose 1, intramuscularly (dose and expiration date unknown) in the right arm for prophylaxis. Other suspect therapies included BOOSTRIX (dose number: 1, manufacturer: GlaxoSmithKline,  vaccinated date: 26-OCT-2015, intramuscularly in the left arm, lot# P57ZX; dose and expiration date unknown), MENACTRA (dose number: 1, manufacturer: Sanofi Pasteur, vaccinated date: 26-OCT-2015, intramuscularly in the left arm, lot# U5178AA; dose and expiration date unknown) and FLUARIX (dose number: 1, manufacturer: GlaxoSmithKline, vaccinated date: 26-OCT-2015, intramuscularly in the right arm, lot# 4JY49; dose and expiration date unknown) for prophylaxis. On the same day 30 minutes post vaccination, the patient experienced asthenia with symptoms of weakness and headache. One hour later patient passed out with loss of consciousness for around 5 minutes and followed by frequent vomiting. On the same day, the patient's urine analysis, liver function test, full blood count and differential white blood cell count were normal. The patient visited the emergency room. The outcome of events 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: FLU3, HPV9, MNQ, TDAP
Symptoms: Loss of consciousness, Urine analysis normal, 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 # 605447) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old male patient. The patient's medical history included attention deficit hyperactivity disorder and migraine. The patient's concurrent conditions included upper respiratory tract infection symptoms with cough, rhinorrhea and nasal congestion for several days. The patient's concomitant therapies were not reported and other medications included CONCERTA 27 mg, Guanfacine 1 mg orally every bedtime (qhs). On 26-OCT-2015 the patient was vaccinated with GARDASIL 9 lot # L014415 dose 1, intramuscularly (dose and expiration date unknown) in the right arm for prophylaxis. Other suspect therapies included BOOSTRIX (dose number: 1, manufacturer: GlaxoSmithKline,  vaccinated date: 26-OCT-2015, intramuscularly in the left arm, lot# P57ZX; dose and expiration date unknown), MENACTRA (dose number: 1, manufacturer: Sanofi Pasteur, vaccinated date: 26-OCT-2015, intramuscularly in the left arm, lot# U5178AA; dose and expiration date unknown) and FLUARIX (dose number: 1, manufacturer: GlaxoSmithKline, vaccinated date: 26-OCT-2015, intramuscularly in the right arm, lot# 4JY49; dose and expiration date unknown) for prophylaxis. On the same day 30 minutes post vaccination, the patient experienced asthenia with symptoms of weakness and headache. One hour later patient passed out with loss of consciousness for around 5 minutes and followed by frequent vomiting. On the same day, the patient's urine analysis, liver function test, full blood count and differential white blood cell count were normal. The patient visited the emergency room. The outcome of events 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: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Diarrhoea, Disturbance in attention, Dizziness, Fatigue
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 # 605481) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 15 year old female patient. The patient's medical history included iron deficiency anemia which was resolved. The patient's concomitant therapies were not reported. The patient had no concurrent conditions and other medications included multivitamins. On 22-SEP-2015 the patient was vaccinated with GARDASIL 9 lot # L013429 dose 1 in the left arm (route unknown) for prophylaxis. On the same day immediately post vaccination the patient experienced lightheadedness with dizziness for 23 hours, disturbance in attention, peripheral swelling and immediate post-injection reaction.  On 25-SEP-2015, the patient experienced abdominal pain, headache, fatigue and diarrhea with loose stools.  On 01-OCT-2015 the patient experienced nausea, neck pain with persistent headache and the patient was advised hydration and rest. There was no lab data because labs were ordered but the symptoms of the events resolved as of 12-OCT-2015. The outcome of all the events 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: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Immediate post-injection reaction, Nausea, Neck 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 # 605481) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 15 year old female patient. The patient's medical history included iron deficiency anemia which was resolved. The patient's concomitant therapies were not reported. The patient had no concurrent conditions and other medications included multivitamins. On 22-SEP-2015 the patient was vaccinated with GARDASIL 9 lot # L013429 dose 1 in the left arm (route unknown) for prophylaxis. On the same day immediately post vaccination the patient experienced lightheadedness with dizziness for 23 hours, disturbance in attention, peripheral swelling and immediate post-injection reaction.  On 25-SEP-2015, the patient experienced abdominal pain, headache, fatigue and diarrhea with loose stools.  On 01-OCT-2015 the patient experienced nausea, neck pain with persistent headache and the patient was advised hydration and rest. There was no lab data because labs were ordered but the symptoms of the events resolved as of 12-OCT-2015. The outcome of all the events 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: FLUX, HEPA, HPV9, MNQ
Symptoms: Extra dose administered, Wrong drug administered
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 # 605622) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 13 year old male patient. The patient's medical history included Asperger's syndrome and there were no concurrent conditions at the time of this report. The patient's other medications included Zoloft 100 mg daily. On 28-OCT-2015 the patient was vaccinated with GARDASIL 9 dose 2, influenza virus vaccine (unspecified) (manufacturer unknown) and hepatitis a vaccine, inactivated (manufacturer unknown) dose 1 for prophylaxis. The mother of the patient stated that her son was given MENACTRA on 28-OCT-2015 in error as he had already received the vaccine on 27-MAR-2015. She had requested for a meningitis B vaccine however the office gave him MENACTRA. According to her this represents an overdose of the stated dose of vaccine but the doctor's office did not think it required reporting. However she disagreed as she felt overdose should be considered an adverse event. On 28-OCT-2015, there was an extra dose administration and wrong drug administration. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV9
Symptoms: Dyskinesia, Eye movement disorder, Fall, Loss of consciousness, Malaise
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 # 605623) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 14 year old female patient. The patient's medical history, concurrent conditions, concomitant therapies and other medications were not reported. The patient was instructed by medical assistant to stay sitting for 10 minutes for administration of GARDASIL 9 vaccine. On 16-OCT-2015 the patient was vaccinated with GARDASIL 9 lot # L016428 dose 3, intramuscularly in the right arm (dose, frequency and lot expiration date were not reported) and FLUZONE (manufacturer: Sanofi Pasteur, lot#: UI440AE) (dose number, dose, frequency were not reported) for prophylaxis. Approximately 1 minute post vaccination, patient stated to mom she didn't feel well, was sitting and then fell back onto table and started making jerking movements, eyes rolled back) with loss of consciousness. Blood pressure was 118/68 (units not reported), pulse oximetry: 98 (units not reported), pulse: 72 (units not reported). In approximately 1 minute patient became aware of person place and time, stayed laying for 2 minutes then sitting for 5 minutes and returned to normal. The patient's mother and younger brother were in room during entire incident, medical assistant was called in when patient fell on table, the reporter was called in by medical assistant and was in room until patient stablilized. The reporter discussed in detail that patient fainting and having jerking movement is a known side effect of GARDASIL 9 vaccine. The patient did not have seizure activity (no history of seizures as well). The patient's mother was instructed to make other providers aware of this vaccine reaction that happened this time and be cautious with subsequent flu vaccines as well since likely to be a GARDASIL 9 vaccine reaction but patient did receive FLUZONE vaccine at same time so needs to be aware). This is patient's 3rd HPV vaccine and she has completed the series- had never had reaction to HPV vaccine before. The patient's mother was reassured that this is a known HPV vaccine side effect and the CDC information was printed and given to her for more information. No injuries sustained during this incident. The outcome of events 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: HPV9
Symptoms: Dyskinesia, Fall, Loss of consciousness, Loss of personal independence in daily activities, 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 # 605625) on 04-APR-2017. This spontaneous report was received from a regulatory authority concerning a 12 year old female patient. Information on patient's concomitant therapies, pertinent medical history, current illnesses, lab data and prior vaccinations were not reported. On 27-OCT-2015, the patient was vaccinated with GARDASIL 9 lot # L016428 dose 1, intramuscularly (dose and expiration unknown) in the left arm for prophylaxis. On the same day, the patient stated that her activities of daily living were impaired, loss of consciousness, complication with vaccination, fall and also experienced syncope and dyskinesia. As per medical assistant (MA), post vaccination patient had adverse reactions which included, patient fainted and fell back on the table, she made some jerking movements and then became awake, mother and medical assistant were with patient entire time. Her pulse was 98, heart rate and respirations were within normal limits, blood pressure (B/P): 120/70 while lying down. The patient's AAO X3, says she remembered getting vaccine, then she said she "saw mickey mouse" and woke up lying on the table. Patient tolerated sitting in room for 10 minutes, excused for rest of the school day per mother's request. The reporter stated that they would wait for other vaccines at next PE, reviewed all known side effects of the vaccine with mother, reassured that that was a common and known side effect and gave her HPV information so she could choose if she wants to continue the series. Advised return to clinic (rtc) if any further concerns or symptoms for the rest of the day. The outcome of all the events were 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: HPV9
Symptoms: Vaccination complication
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 # 605625) on 04-APR-2017. This spontaneous report was received from a regulatory authority concerning a 12 year old female patient. Information on patient's concomitant therapies, pertinent medical history, current illnesses, lab data and prior vaccinations were not reported. On 27-OCT-2015, the patient was vaccinated with GARDASIL 9 lot # L016428 dose 1, intramuscularly (dose and expiration unknown) in the left arm for prophylaxis. On the same day, the patient stated that her activities of daily living were impaired, loss of consciousness, complication with vaccination, fall and also experienced syncope and dyskinesia. As per medical assistant (MA), post vaccination patient had adverse reactions which included, patient fainted and fell back on the table, she made some jerking movements and then became awake, mother and medical assistant were with patient entire time. Her pulse was 98, heart rate and respirations were within normal limits, blood pressure (B/P): 120/70 while lying down. The patient's AAO X3, says she remembered getting vaccine, then she said she "saw mickey mouse" and woke up lying on the table. Patient tolerated sitting in room for 10 minutes, excused for rest of the school day per mother's request. The reporter stated that they would wait for other vaccines at next PE, reviewed all known side effects of the vaccine with mother, reassured that that was a common and known side effect and gave her HPV information so she could choose if she wants to continue the series. Advised return to clinic (rtc) if any further concerns or symptoms for the rest of the day. The outcome of all the events were 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: HEPA, HPV9
Symptoms: Abdominal discomfort, Arthralgia, Cold sweat, Fatigue, 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 # 605695) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 19 year old female patient. The patient's medical history included anxiety and no known allergies. Other medications included fluoxetine and myorisan. On 16-OCT-2015, the patient was vaccinated with GARDASIL 9 dose, frequency and lot expiration date were not reported) lot # L014415 dose 3, intramuscularly in the left arm for prophylaxis. Other suspect therapies included HAVRIX (dose number: 1, vaccination date: 16-OCT-2015, intramuscularly in the left arm, lot# Y4R59; dose and expiration date unknown). On 16-OCT-2015, the patient experienced abdominal discomfort, vomiting, pyrexia, pain, headache, fatigue, cold sweat, arthralgia and chills. The outcome of abdominal discomfort, vomiting, pyrexia, pain, headache, fatigue, chills, cold sweat and arthralgia 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: HEPA, HPV9
Symptoms: Pain, 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 # 605695) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 19 year old female patient. The patient's medical history included anxiety and no known allergies. Other medications included fluoxetine and myorisan. On 16-OCT-2015, the patient was vaccinated with GARDASIL 9 dose, frequency and lot expiration date were not reported) lot # L014415 dose 3, intramuscularly in the left arm for prophylaxis. Other suspect therapies included HAVRIX (dose number: 1, vaccination date: 16-OCT-2015, intramuscularly in the left arm, lot# Y4R59; dose and expiration date unknown). On 16-OCT-2015, the patient experienced abdominal discomfort, vomiting, pyrexia, pain, headache, fatigue, cold sweat, arthralgia and chills. The outcome of abdominal discomfort, vomiting, pyrexia, pain, headache, fatigue, chills, cold sweat and arthralgia 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: F
Vaccine: HPV9
Symptoms: Headache, Injection site erythema, Injection site warmth, Muscle tightness, 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 # 605870) on 04-APR-2017. This spontaneous report was received from a regulatory authority concerning a 13 year old female patient. The patient's pertinent medical history, concomitant therapies, lab data, current illnesses and prior vaccinations were not reported. On 27-OCT-2015, the patient was vaccinated with GARDASIL 9 lot # L004014, dose 2, intramuscularly (dose and expiration date unknown) in the left arm for prophylaxis. On 28-OCT-2015, the patient complained of pain with muscular tightness from shoulder to wrist area and headache. Symptoms continue throughout the day on 29-OCT-2015. Client did not go to doctor for medical treatment and returned to health department. Registered nurse (RN) assessed patient. There was no edema noted in the arm. Minimal redness with mild warmth was noted at the injection site. Patient's arm was painful to touch. The outcome of all the events were reported as unknown. 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: 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 # 605870) on 04-APR-2017. This spontaneous report was received from a regulatory authority concerning a 13 year old female patient. The patient's pertinent medical history, concomitant therapies, lab data, current illnesses and prior vaccinations were not reported. On 27-OCT-2015, the patient was vaccinated with GARDASIL 9 lot # L004014, dose 2, intramuscularly (dose and expiration date unknown) in the left arm for prophylaxis. On 28-OCT-2015, the patient complained of pain with muscular tightness from shoulder to wrist area and headache. Symptoms continue throughout the day on 29-OCT-2015. Client did not go to doctor for medical treatment and returned to health department. Registered nurse (RN) assessed patient. There was no edema noted in the arm. Minimal redness with mild warmth was noted at the injection site. Patient's arm was painful to touch. The outcome of all the events were reported as unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 16.0
Sex: M
Vaccine: FLUN4, HPV9
Symptoms: Dizziness, Dyskinesia, Tremor, Xanthopsia
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 # 606396) on 04-APR-2017. This spontaneous report was received from a regulatory authority concerning a 16 year old male patient. The patient's medical history included Juvenile rheumatoid arthritis (JRA), psoriatic arthritis, reflex sympathetic dystrophy and anxiety. The patient's concomitant therapies were not reported and other medications included Enbrel, Meloxicam, Albuterol sulfate and Flovent. Information on patient's current illnesses, lab data and prior vaccinations were not reported. On 14-OCT-2015, the patient was vaccinated with GARDASIL 9 lot # L014415, dose 1, intramuscularly (dose and expiration date unknown) in the left arm for prophylaxis. Other suspect therapies included FLUMIST Quadrivalent (vaccinated date: 14-OCT-2015, Manufacturer: Medimmune, intranasal, lot # FJ2235; dose and expiration date unknown). On the same day, the patient had onset of symptoms which included dizziness, tremors, jerkiness and yellow vision for 30 minutes. The symptoms started within 2 to 12 hours post vaccination. The outcome of all the events were 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: 12.0
Sex: M
Vaccine: FLU3, HPV9
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, 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 # 606629). This spontaneous report refers to a 12 year old male patient. The patient had no known concurrent illnesses. Information on the patient's medical history and other medications were not reported. On 26-OCT-2015, the patient was vaccinated with GARDASIL 9 lot # L028083 dose 1, intramuscular route in the left arm for prophylaxis (dosage unspecified). On the same day, the patient was also vaccinated with FLUZONE batch/lot# U5338AA, dose 1, intramuscular route in the right arm for prophylaxis (dosage unspecified). On 27-OCT-2015, the patient experienced injection site erythema, paraesthesia, pain in extremity, injection site warmth, injection site swelling and injection site pain. The patient's mother called the office and asked if the patient's arm should still be hurting from the vaccine. Per the patient's mother, the right deltoid was swollen the size of a fist, red and hand was tingling. The patient's mother was told to use cool compresses and Tylenol and was asked to be seen if there was no improvement. The patient was seen on 30-OCT-2015 and the area was still red, warm to the touch and painful. The area was swollen the size of a fist with residual marks from the day before. The patient was referred to his allergist for further direction. The outcome of pain in extremity, injection site warmth, injection site swelling, injection site pain, injection site erythema and paraesthesia 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: 12.0
Sex: M
Vaccine: FLU3, HPV9
Symptoms: Paraesthesia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 606629). This spontaneous report refers to a 12 year old male patient. The patient had no known concurrent illnesses. Information on the patient's medical history and other medications were not reported. On 26-OCT-2015, the patient was vaccinated with GARDASIL 9 lot # L028083 dose 1, intramuscular route in the left arm for prophylaxis (dosage unspecified). On the same day, the patient was also vaccinated with FLUZONE batch/lot# U5338AA, dose 1, intramuscular route in the right arm for prophylaxis (dosage unspecified). On 27-OCT-2015, the patient experienced injection site erythema, paraesthesia, pain in extremity, injection site warmth, injection site swelling and injection site pain. The patient's mother called the office and asked if the patient's arm should still be hurting from the vaccine. Per the patient's mother, the right deltoid was swollen the size of a fist, red and hand was tingling. The patient's mother was told to use cool compresses and Tylenol and was asked to be seen if there was no improvement. The patient was seen on 30-OCT-2015 and the area was still red, warm to the touch and painful. The area was swollen the size of a fist with residual marks from the day before. The patient was referred to his allergist for further direction. The outcome of pain in extremity, injection site warmth, injection site swelling, injection site pain, injection site erythema and paraesthesia 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: FLUN4, HPV9, MNQ, TDAP
Symptoms: Abdominal pain lower, Anti-transglutaminase antibody negative, Diarrhoea, Eosinophil percentage increased, Full blood 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 # 606631) on 04-APR-2017. This spontaneous report was received from a regulatory authority concerning a 11 year old male patient. The patient's concomitant therapies, current illnesses, pertinent medical history and prior vaccinations were not reported. On 23-SEP-2015, the patient was vaccinated with GARDASIL 9 lot # L014415, dose 1, intramuscularly (dose and expiration date unknown) in the right arm for prophylaxis. Other suspect therapies included ADACEL (Manufacturer: Sanofi Pasteur, dose number: 1, vaccinated date: 23-SEP-2015, intramuscularly in the right arm, lot # U5241AA; dose and expiration date unknown), MENVEO (Manufacturer: Novartis, dose number: 1, vaccinated date: 23-SEP-2015, intramuscularly in the left arm, lot # M15032; dose and expiration date unknown) and FLUMIST (INTRANASAL (COLD) (Manufacturer: MedImmune, dose number: 3, vaccinated date: 23-SEP-2015, intranasal, lot # FJ2073; dose and expiration date unknown) for prophylaxis. On 11-OCT-2015, the patient experienced lower abdominal pain, diarrhea and headache. On the same day, the patient underwent anti-transglutaminase antibody test which showed negative result, eosinophil percentage was increased, helicobacter test was performed which showed negative results. The lipase, metabolic function test, red blood cell count, red blood cell sedimentation rate, stool analysis and thyroid tests were performed which showed normal results On 16-OCT-2015, Patient was seen in urgent care for right lower quadrant abdominal pain, severe headache, and diarrhea with describing symptoms starting 5 days prior. On the same day, the complete blood cell count (CBC) and Comprehensive metabolic panel (CMP) were done at urgent care visit for which results were normal. Patient was seen on 26-OCT-2015, at Doctor's office for same symptoms where she was referred to pediatric neurology for abdominal pain of unknown etiology. On the same day, stool studies were performed at office visit for which results were normal but negative for enteric pathogens, ova and parasites. Patient's mother called primary care physician (PCP) office on 30-OCT-2015 and still complained of symptoms. EBV panel ordered at that time and was awaiting for neurology referral. The patient was taken to emergency room. Lab data: On 16-OCT-2015, revealed eosionopils-7.6% and RBC- 5.47mill/mm. On an unknown date, H-pylori, lipase, thyroid studies, sedimentation rate, tissue transglutaminase antibody IgA tests were performed for which results were normal. The outcome of all the events were 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.
Sex: M
Vaccine: FLUN4, HPV9, MNQ, TDAP
Symptoms: Headache, Helicobacter test negative, Lipase normal, Metabolic function test normal, Parasite stool test negative
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 # 606631) on 04-APR-2017. This spontaneous report was received from a regulatory authority concerning a 11 year old male patient. The patient's concomitant therapies, current illnesses, pertinent medical history and prior vaccinations were not reported. On 23-SEP-2015, the patient was vaccinated with GARDASIL 9 lot # L014415, dose 1, intramuscularly (dose and expiration date unknown) in the right arm for prophylaxis. Other suspect therapies included ADACEL (Manufacturer: Sanofi Pasteur, dose number: 1, vaccinated date: 23-SEP-2015, intramuscularly in the right arm, lot # U5241AA; dose and expiration date unknown), MENVEO (Manufacturer: Novartis, dose number: 1, vaccinated date: 23-SEP-2015, intramuscularly in the left arm, lot # M15032; dose and expiration date unknown) and FLUMIST (INTRANASAL (COLD) (Manufacturer: MedImmune, dose number: 3, vaccinated date: 23-SEP-2015, intranasal, lot # FJ2073; dose and expiration date unknown) for prophylaxis. On 11-OCT-2015, the patient experienced lower abdominal pain, diarrhea and headache. On the same day, the patient underwent anti-transglutaminase antibody test which showed negative result, eosinophil percentage was increased, helicobacter test was performed which showed negative results. The lipase, metabolic function test, red blood cell count, red blood cell sedimentation rate, stool analysis and thyroid tests were performed which showed normal results On 16-OCT-2015, Patient was seen in urgent care for right lower quadrant abdominal pain, severe headache, and diarrhea with describing symptoms starting 5 days prior. On the same day, the complete blood cell count (CBC) and Comprehensive metabolic panel (CMP) were done at urgent care visit for which results were normal. Patient was seen on 26-OCT-2015, at Doctor's office for same symptoms where she was referred to pediatric neurology for abdominal pain of unknown etiology. On the same day, stool studies were performed at office visit for which results were normal but negative for enteric pathogens, ova and parasites. Patient's mother called primary care physician (PCP) office on 30-OCT-2015 and still complained of symptoms. EBV panel ordered at that time and was awaiting for neurology referral. The patient was taken to emergency room. Lab data: On 16-OCT-2015, revealed eosionopils-7.6% and RBC- 5.47mill/mm. On an unknown date, H-pylori, lipase, thyroid studies, sedimentation rate, tissue transglutaminase antibody IgA tests were performed for which results were normal. The outcome of all the events were 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.
Sex: M
Vaccine: FLUN4, HPV9, MNQ, TDAP
Symptoms: Red blood cell count normal, Red blood cell sedimentation rate normal, Stool analysis normal, Thyroid function test 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 # 606631) on 04-APR-2017. This spontaneous report was received from a regulatory authority concerning a 11 year old male patient. The patient's concomitant therapies, current illnesses, pertinent medical history and prior vaccinations were not reported. On 23-SEP-2015, the patient was vaccinated with GARDASIL 9 lot # L014415, dose 1, intramuscularly (dose and expiration date unknown) in the right arm for prophylaxis. Other suspect therapies included ADACEL (Manufacturer: Sanofi Pasteur, dose number: 1, vaccinated date: 23-SEP-2015, intramuscularly in the right arm, lot # U5241AA; dose and expiration date unknown), MENVEO (Manufacturer: Novartis, dose number: 1, vaccinated date: 23-SEP-2015, intramuscularly in the left arm, lot # M15032; dose and expiration date unknown) and FLUMIST (INTRANASAL (COLD) (Manufacturer: MedImmune, dose number: 3, vaccinated date: 23-SEP-2015, intranasal, lot # FJ2073; dose and expiration date unknown) for prophylaxis. On 11-OCT-2015, the patient experienced lower abdominal pain, diarrhea and headache. On the same day, the patient underwent anti-transglutaminase antibody test which showed negative result, eosinophil percentage was increased, helicobacter test was performed which showed negative results. The lipase, metabolic function test, red blood cell count, red blood cell sedimentation rate, stool analysis and thyroid tests were performed which showed normal results On 16-OCT-2015, Patient was seen in urgent care for right lower quadrant abdominal pain, severe headache, and diarrhea with describing symptoms starting 5 days prior. On the same day, the complete blood cell count (CBC) and Comprehensive metabolic panel (CMP) were done at urgent care visit for which results were normal. Patient was seen on 26-OCT-2015, at Doctor's office for same symptoms where she was referred to pediatric neurology for abdominal pain of unknown etiology. On the same day, stool studies were performed at office visit for which results were normal but negative for enteric pathogens, ova and parasites. Patient's mother called primary care physician (PCP) office on 30-OCT-2015 and still complained of symptoms. EBV panel ordered at that time and was awaiting for neurology referral. The patient was taken to emergency room. Lab data: On 16-OCT-2015, revealed eosionopils-7.6% and RBC- 5.47mill/mm. On an unknown date, H-pylori, lipase, thyroid studies, sedimentation rate, tissue transglutaminase antibody IgA tests were performed for which results were normal. The outcome of all the events were 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.