chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEPA, HPV9, TDAP, VARCEL
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: dizziness; loss of consciousness; syncope; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 589444). This spontaneous report was received from a regulatory authority refers to a 14 year old female patient. The patient had no current illnesses. Patient's medical history was reported as none. Patient's other medications was not reported. On 10-AUG-2015, the patient was vaccinated with the first dose of GARDASIL 9 lot # K026247 (dose, frequency and expiration date were not reported) intramuscularly in the left arm for prophylaxis. Other suspect therapies included ADACEL (dose number: 1, vaccinated date: 10-AUG-2015, intramuscularly in the right arm, lot/batch# U4971AA; dose, frequency and expiration date unknown), VARIVAX (dose number: 1, vaccinated date: 10-AUG-2015, intramuscularly in the right arm, lot# K020757; dose, frequency and expiration date unknown) and HAVRIX (dose number: 1, vaccinated date: 10-AUG-2015, intramuscularly in the right arm, lot/batch# 5CK4Y; dose, frequency and expiration date unknown). On 10-AUG-2015, patient said that she felt faint and passed out for less than 1 minute. Blood pressure and pulse were taken and were within normal limits. The patient recoverd quickly and was taken to her physician by her parents as they wanted her to be checked out. The outcome of dizziness, syncope and loss of consciousness was reported as recovered. Causality assessment for the events dizziness, syncope and loss of consciousness with respect to GARDASIL 9 were not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Presyncope
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 # 589521) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to an 11 year old female patient with prophylaxis. The patient's current illnesses, medical history, other medications and prior vaccinations were not reported. On 23-JUL-2015, the patient was vaccinated with first dose of GARDASIL 9 intramuscularly in the right arm, lot # K026246 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included BOOSTRIX (dose number: 1, vaccinated date: 23-JUL-2015, intramuscularly in the left arm, lot # B54KE; dose and expiration date unknown), HAVRIX (dose number: 1, vaccinated date: 23-JUL-2015, intramuscularly in the left arm, lot # 294X9; dose and expiration date unknown) and MENVEO (dose number: 1, vaccinated date: 23-JUL-2015, intramuscularly in the right arm, lot # M14094; dose and expiration date unknown). On 23-JUL-2015, the patient experienced near syncope while she was sitting the lobby. And then the patient was laid down with feet up, fanned her and an ice pack was kept under her neck. The outcome of the event presyncope was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Erythema, Local 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 # 589555) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to an 11 year old male patient with prophylaxis. The patient's current illnesses, medical history, other medications and prior vaccinations were not reported. On 04-AUG-2015, the patient was vaccinated with first dose of GARDASIL 9 intramuscularly in the left arm, lot # K026247 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included BOOSTRIX (dose number: 1, vaccinated date: 04-AUG-2015, intramuscularly in the right arm, lot # NL7K3; dose and expiration date unknown), MENACTRA (dose number: 1, vaccinated date: 04-AUG-2015 intramuscularly in the right arm, lot # U5155BA; dose and expiration date unknown) and HAVRIX (dose number: 1, vaccinated date: 04-AUG-2015, intramuscularly in the right arm, lot # X22P4; dose and expiration date unknown). On 05-AUG-2015, the patient experienced erythema and localized swelling which occurred 24 hours post injection and it was reported that it was not painful, not pruritic and neuromuscular function was normal. On an unknown date, the patient underwent emergency room (ER) visit. The outcome of erythema and local swelling were reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HEPA, HPV9, MNQ
Symptoms: Eye movement disorder, Loss of consciousness, Pallor, Tremor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 589604). This spontaneous report refers to a 17 year old male patient. The patient had no concurrent illnesses and medical history was not reported. Patient came to the office for Hep A, MENACTRA, and, HPV vaccination. He passed out 2 years ago in the office when he received a Tdap vaccination. Patient's dad came prepared with a water bottle and an ice pack and had another nurse assist with the vaccines. On 11-AUG-2015 the patient was vaccinated with GARDASIL 9 lot # K026246 dose 1, intramuscular in the left arm for prophylaxis. On the same day, the patient was vaccinated with MENACTRA, (lot# U5020AA, dose 1, intramuscularly in left arm) and HAVRIX (intramuscularly in the right arm, lot# 3RB2G, dose 1). The patient lie down on the exam table and administrated the vaccines at the same time. The patient was alert and talking during the vaccinations. He stated that he felt fine and he sat up about 2 minutes later and drank water. He then dropped the water bottle and his eyes rolled back into his head and he "shook" a little bit for about 2 seconds. On 11-AUG-2015, the patient experienced pallor, eye movement disorder and loss of consciousness. Patient's father, the other nurse helped lay him back down on the exam table. Patient was alert and oriented and was joking slightly and was engaged in conversation. He was very pale. We put an ice pack on his head, neck and chest. Patient was instructed to take deep breaths and relax. He continued to lay down for about 15 minutes, engaging in conversation the whole time. Once he sat up he was pink in color and a few minutes later patient moved to a chair. He sat in the chair for about 15 more minutes and drank 11/2 bottles of water. Patient left with his father and was instructed to call with any concerns. Of note: a VAERS was filled out on him 2 years ago for a very similar incident, as well as for his brother last week. The outcome of pallor, eye movement disorder and loss of consciousness were reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 589737). This spontaneous report refers to a 15 year old female patient. The patient's concurrent illnesses and medical history were not reported. On 12-AUG-2015 the patient was vaccinated with first dose of GARDASIL 9 (lot # L004014) and 2nd dose of VARIVAX (lot# L002217) intramuscularly in the right arm for prophylaxis. On the same day, the patient was vaccinated with ADACEL (lot# U5213BA, dose 2, intramuscularly in left arm), HAVRIX (lot# NK747, dose 2, intramuscularly in right arm) and MENVEO (lot# A15008, dose 2, intramuscularly in left arm). Vaccines were inadvertently administered due to human error. Shot record was pre-stamped for vaccines that had been administered exactly 1 year prior to current visit (12-AUG-2014). Nurse saw the dates and thought it was 12-AUG-2015, and accidentally administered Tdap, Varicella, MCV4, and Hepatitis A. Patient also received HPV9, which was the intended vaccine. After administration, patient's mother asked about the number of shots and that is when the error was realized. Patient's mother asked about possible adverse reactions. Nurse advised her to monitor her daughter for any changes and to inform the Health Department if any occurrence should happen. Patient did not show any signs of reaction, but report is being made in an abundance of caution. No reaction reported. The outcome of extra dose administered was reported as recovered. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Abasia, Asthenia, Blood glucose normal, Hyperhidrosis, Laboratory test
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 589937). This spontaneous report refers to a 17 year old male patient. Information on the patient's concurrent illnesses, medical history and other medications were not reported. On 13-AUG-2015, the patient was vaccinated with GARDASIL 9 lot # L004741, dose 1 via intramuscular route in the left arm for prophylaxis (dosage and expiry date unspecified). On the same day, the patient was also vaccinated with ADACEL lot/batch # U4965AA, dose 2 via intramuscular route in the right arm for prophylaxis (dosage and expiry date unspecified). On 13-AUG-2015, the patient experienced abasia, syncope, presyncope, pallor, asthenia, hyperhidrosis and the patient's blood glucose and neurological examination were normal. The patient became faint. Possible vasovagal. After severaI attempts the patient was not able to sit up or stand without becoming diaphoretic again. The patient was observed for over an hour (60") then with the patient's father's consent paramedics were called to transport the patient to local hospital. Vital signs remained stable, the patient was alert and oriented but was pale, weak and diaphoretic. The patient unable to ambulate. Neuro check was negative. Blood sugar was 104. The patient was given juice prior to injection/vaccination and then the following second experienced a near syncope episode. The patient was transport to hospital, observed, probable Iab tests were performed and hydration was possibly given. The report from the ER was not received but the patient's father called and stated that the patient was sent home and was doing well. The outcome of abasia, syncope, presyncope, asthenia, pallor, neurological examination normal, hyperhidrosis and blood glucose normal was reported as recovered. The causality assessment for the events abasia, syncope, presyncope, asthenia, pallor, neurological examination normal, hyperhidrosis and blood glucose normal 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: 17.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Neurological examination normal, Pallor, Presyncope, 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 # 589937). This spontaneous report refers to a 17 year old male patient. Information on the patient's concurrent illnesses, medical history and other medications were not reported. On 13-AUG-2015, the patient was vaccinated with GARDASIL 9 lot # L004741, dose 1 via intramuscular route in the left arm for prophylaxis (dosage and expiry date unspecified). On the same day, the patient was also vaccinated with ADACEL lot/batch # U4965AA, dose 2 via intramuscular route in the right arm for prophylaxis (dosage and expiry date unspecified). On 13-AUG-2015, the patient experienced abasia, syncope, presyncope, pallor, asthenia, hyperhidrosis and the patient's blood glucose and neurological examination were normal. The patient became faint. Possible vasovagal. After severaI attempts the patient was not able to sit up or stand without becoming diaphoretic again. The patient was observed for over an hour (60") then with the patient's father's consent paramedics were called to transport the patient to local hospital. Vital signs remained stable, the patient was alert and oriented but was pale, weak and diaphoretic. The patient unable to ambulate. Neuro check was negative. Blood sugar was 104. The patient was given juice prior to injection/vaccination and then the following second experienced a near syncope episode. The patient was transport to hospital, observed, probable Iab tests were performed and hydration was possibly given. The report from the ER was not received but the patient's father called and stated that the patient was sent home and was doing well. The outcome of abasia, syncope, presyncope, asthenia, pallor, neurological examination normal, hyperhidrosis and blood glucose normal was reported as recovered. The causality assessment for the events abasia, syncope, presyncope, asthenia, pallor, neurological examination normal, hyperhidrosis and blood glucose normal 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.
Sex: F
Vaccine: HPV9, MNQ, VARCEL
Symptoms: 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 # 590244). This spontaneous report refers to a 17 year old female patient. The patient's concurrent illnesses and medical history were reported as none. On 12-AUG-2015 the patient was vaccinated with GARDASIL 9 (lot# 014198, dose 3, intramuscularly in right arm) and VARIVAX (lot# 013066, dose 2, intramuscularly in left arm) for prophylaxis. On the same day, the patient was vaccinated with MENVEO, lot# 15032, dose 2, intramuscularly in left arm. On 13-AUG-2015, the patient experienced injection site erythema, injection site warmth and injection site swelling. The outcome of injection site erythema, injection site warmth and injection site swelling were reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Computerised tomogram head abnormal, Dizziness, Fall, Head injury, 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 # 590399). This spontaneous report refers to a 11 year old female patient. The patient's concurrent illnesses was reported as none. The patient's medical history was not reported. On 12-AUG-2015 the patient was vaccinated with GARDASIL 9 lot # K026247, dose 1, intramuscularly in the right arm for prophylaxis. On the same day, the patient was vaccinated with MENVEO (lot# M15018, dose 1, intramuscularly in right arm) and BOOSTRIX (lot# H5299, dose 1, intramuscularly in left arm). Minutes after receiving GARDASIL 9 the patient followed her mother into the inner waiting room area to receive a copy of her shot record. On 12-AUG-2015, the patient experienced dizziness, pallor, nystagmus, loss of consciousness, headache, head injury and fall. Without warning, she fell backwards hitting her head & losing consciousness. She was immediately placed in Trendelenburg became conscious patient 45-60 sec she remained pale c/o H/A and dizziness. Nystagmus noted. After 15 min she remained pale and not improving. ER strongly recommended. Follow up call to mom on 13-AUG-2015 confirmed a skull fracture on CAT scan (computerized tomogram head abnormal). The outcome of dizziness, computerised tomogram head abnormal, pallor, nystagmus, loss of consciousness, headache, head injury and fall were reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Loss of consciousness, Nystagmus, Pallor, Skull fracture
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 # 590399). This spontaneous report refers to a 11 year old female patient. The patient's concurrent illnesses was reported as none. The patient's medical history was not reported. On 12-AUG-2015 the patient was vaccinated with GARDASIL 9 lot # K026247, dose 1, intramuscularly in the right arm for prophylaxis. On the same day, the patient was vaccinated with MENVEO (lot# M15018, dose 1, intramuscularly in right arm) and BOOSTRIX (lot# H5299, dose 1, intramuscularly in left arm). Minutes after receiving GARDASIL 9 the patient followed her mother into the inner waiting room area to receive a copy of her shot record. On 12-AUG-2015, the patient experienced dizziness, pallor, nystagmus, loss of consciousness, headache, head injury and fall. Without warning, she fell backwards hitting her head & losing consciousness. She was immediately placed in Trendelenburg became conscious patient 45-60 sec she remained pale c/o H/A and dizziness. Nystagmus noted. After 15 min she remained pale and not improving. ER strongly recommended. Follow up call to mom on 13-AUG-2015 confirmed a skull fracture on CAT scan (computerized tomogram head abnormal). The outcome of dizziness, computerised tomogram head abnormal, pallor, nystagmus, loss of consciousness, headache, head injury and fall were reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HEP, HPV9, TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 590404). This spontaneous report refers to a 23 year old female patient. The patient had no concurrent illnesses and medical history was not reported. On 12-AUG-2015 the patient was vaccinated with GARDASIL 9 lot # L014198, intramuscularly in the left arm for prophylaxis. On the same day, the patient was vaccinated with ADACEL (lot# U5235AA, intramuscularly in right arm) and ENGERIX-B (lot# 92M2J, intramuscularly in left arm). On 12-AUG-2015, the patient experienced pain and pyrexia. Temperature was 38.5°C and feel painful all through the body. The patient had emergency visit. The outcome of pain and pyrexia were reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Hypersensitivity, Nausea, 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 # 590779) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 20 year old male patient. The patient's medical history, current illnesses, other medications and prior vaccinations were not reported. On 11-AUG-2015, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # L014198 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 15-AUG-2015, the patient experienced dizzy (dizziness), vomiting, nausea, light headed and PCP (primary care provider) determine to be an allergic reaction (hypersensitivity) and added to allergy list. The outcome of dizziness, vomiting, nausea and hypersensitivity was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Borrelia test, Dizziness, Echocardiogram, Electroencephalogram, 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 # 590830) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 18 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 14-AUG-2015, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # K026247, intramuscularly in the right arm for prophylaxis. On 15-AUG-2015,the patient experienced loss of consciousness, headache, dizziness, red blood cell sedimentation rate normal and underwent Borrelia test, West Nile virus test, nuclear magnetic resonance imaging brain, electroencephalogram and echocardiogram which required ER (Emergency room) visit. It was also reported that the patient had dizziness, headaches, and an episode of unconsciousness 1 day post vaccination. The patient had possible absence seizures with it. The patient continued to be dizzy and had headaches since then. Lab data revealed a normal ESR (erythrocyte sedimentation rate) and currently MRI (magnetic resonance imaging ) Brain, EEG (Electroencephalogram), Echo, Lyme and West Nile titers are being carried out. Further investigation was carried out with labs and imaging and no treatment was done. The outcome of Borrelia test, West Nile virus test, red blood cell sedimentation rate normal, nuclear magnetic resonance imaging brain, loss of consciousness, headache, electroencephalogram, echocardiogram and dizziness were 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
Symptoms: Loss of consciousness, Nuclear magnetic resonance imaging brain, Red blood cell sedimentation rate normal, West Nile virus test
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 590830) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 18 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 14-AUG-2015, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # K026247, intramuscularly in the right arm for prophylaxis. On 15-AUG-2015,the patient experienced loss of consciousness, headache, dizziness, red blood cell sedimentation rate normal and underwent Borrelia test, West Nile virus test, nuclear magnetic resonance imaging brain, electroencephalogram and echocardiogram which required ER (Emergency room) visit. It was also reported that the patient had dizziness, headaches, and an episode of unconsciousness 1 day post vaccination. The patient had possible absence seizures with it. The patient continued to be dizzy and had headaches since then. Lab data revealed a normal ESR (erythrocyte sedimentation rate) and currently MRI (magnetic resonance imaging ) Brain, EEG (Electroencephalogram), Echo, Lyme and West Nile titers are being carried out. Further investigation was carried out with labs and imaging and no treatment was done. The outcome of Borrelia test, West Nile virus test, red blood cell sedimentation rate normal, nuclear magnetic resonance imaging brain, loss of consciousness, headache, electroencephalogram, echocardiogram and dizziness were 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, MNQ, TDAP
Symptoms: 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 # 590837). This spontaneous report refers to a 11 year old male patient. Information on the patient's concurrent illnesses, medical history and other medications were not reported. On 12-AUG-2015, the patient was vaccinated with GARDASIL 9 lot # L001312, intramuscularly in the right arm for prophylaxis. On the same day, the patient was also vaccinated with BOOSTRIX lot # XE2DJ, intramuscularly in the left arm and MENACTRA lot # U5026AA, intramuscularly in the left arm for prophylaxis. On 14-AUG-2015, the patient developed symptoms of redness and swelling on the injection site. No fever and area is hot to touch. The outcome of injection site erythema and injection site swelling was reported as recovered. The causality assessment for injection site erythema and injection site swelling 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.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: 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 # 590882). This spontaneous report refers to a 17 year old female patient. The patient had no concurrent conditions. The patient's concomitant medications were not reported. On 19-AUG-2015 the patient was vaccinated with GARDASIL 9 lot # L004741, intramuscular in the right arm for prophylaxis. Other suspect therapies included BOOSTRIX and MENACTRA given intramuscularly in the left arm. On the same day, the patient fainted, he experienced syncope. The outcome of syncope was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Speech disorder
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 # 590993) on 04-APR-2017. This spontaneous report was received from a regulatory authority concerning a 18 year old female patient. Patient had no pertinent medical history and current illnesses. Other medications and prior vaccinations were not reported. On 12-AUG-2015, the patient was vaccinated with GARDASIL 9 lot # L011846, dose number 1, (dose, frequency and lot expiration date were not reported) intramuscularly in the left arm for prophylaxis. On the same day, the patient experienced dizziness not in the first 15minutes but for about 20 minutes after the initial 15 minutes and also experienced difficulty in vocalizing for 10 minutes. The outcome of dizziness and speech disorder was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Unevaluable event
Clinical narrative: Unevaluable event; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 590996). This spontaneous report refers to a 11 year old female patient. The patient's concurrent illnesses were reported as hepatitis, obesity, epistaxis, and hypertriglyceridaemia. Information on patient's medical history, other medications and prior vaccinations were not reported. On 12-AUG-2015, the patient was vaccinated with GARDASIL 9 lot # L006547 via unknown route in the right arm for prophylaxis (dosage and expiry date not reported). On the same day, the patient was also vaccinated with ADACEL batch # U5235AA via unknown route in the left arm and MENACTRA batch # U5068AA via unknown route in the left arm for prophylaxis. On 13-AUG-2015, the patient experienced an unevaluable event. The outcome of the unevaluable event was unknown. The causality assessment for the unevaluable event 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.
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 # 591479). This spontaneous report refers to a 18 year old female patient. Information on the patient's concurrent illnesses, medical history and other medications were not reported. On 15-AUG-2015, the patient was vaccinated with GARDASIL 9 lot # K026247, dose 1, intramuscularly in the left arm for prophylaxis. On 18-AUG-2015, the patient experienced urticaria (hives). The outcome of urticaria was reported as recovered. The causality assessment of urticaria 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.
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Fall, Hyperhidrosis, Posture abnormal, 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 # 591523) on 04-APR-2017. This spontaneous report was received from a regulatory authority refers to a 13 year old female patient. The patient's concomitant therapies was not reported. Patient's medical history included vasovagal syncope and fear of needles. Patient's other medications and current illness were reported as none. On 14-AUG-2014, (also reported as 14-AUG-2015)  the patient was vaccinated with the first dose of GARDASIL 9 lot # K026247 (dose, frequency and expiration date were not provided) intramuscularly in the left arm for prophylaxis. On 14-AUG-2015, Patient felt faint, slumped on to her father's shoulder. No injury from fall. Patient began vomiting and sweating post vaccine administration. Patient was observed in emergency room for hypotension and dehydration and released on 14-AUG-2015. The outcome of dizziness, vomiting, posture abnormal, hyperhidrosis and fall was reported as recovered. Causality assessments for the events dizziness, vomiting, posture abnormal, hyperhidrosis and fall 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: HEPA, HPV9, MNQ, TDAP
Symptoms: Erythema, Hypersensitivity, Injection site hypersensitivity, Injection site reaction, Pruritus
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 591709). This spontaneous report refers to a 11 year old female patient. The patient had no historical and concurrent conditions. No concomitant medications were reported. On 12-AUG-2015 the patient was vaccinated with GARDASIL 9 lot # L006547 dose 1 in the right leg for prophylaxis. Other suspect therapies included BOOSTRIX (dose 1), HAVRIX (dose 2) and MENVEO (dose 1) given on the same day. On 13-AUG-2015 at 12:22 p.m, the patient and mother noticed erythema, swelling, pruritus in the size of quarter. The patient also experienced  injection site reaction and hypersensitivity. On 14-AUG-2015 at 09:08, the patient's mother described the redness had increased to the size of an adult fist. The patient sought medical care at local urgent care (emergency visit) where it was stated that the conditions were allergic reactions to TDAP (left thigh). The outcome of erythema, swelling, pruritus, injection site reaction and hypersensitivity 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: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: 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 # 591709). This spontaneous report refers to a 11 year old female patient. The patient had no historical and concurrent conditions. No concomitant medications were reported. On 12-AUG-2015 the patient was vaccinated with GARDASIL 9 lot # L006547 dose 1 in the right leg for prophylaxis. Other suspect therapies included BOOSTRIX (dose 1), HAVRIX (dose 2) and MENVEO (dose 1) given on the same day. On 13-AUG-2015 at 12:22 p.m, the patient and mother noticed erythema, swelling, pruritus in the size of quarter. The patient also experienced  injection site reaction and hypersensitivity. On 14-AUG-2015 at 09:08, the patient's mother described the redness had increased to the size of an adult fist. The patient sought medical care at local urgent care (emergency visit) where it was stated that the conditions were allergic reactions to TDAP (left thigh). The outcome of erythema, swelling, pruritus, injection site reaction and hypersensitivity was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Pain in extremity, Tenderness
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 # 591840) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 15 year old female patient. The patient's current illness, medical history, prior vaccinations and other medications were not reported. On 02-JUL-2015, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # K026247 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 24-AUG-2015, patient complained of left arm soreness (pain in extremity), tender (tenderness) to touch for 1 month since injection and the patient has 1 cm area of faint erythema and mild thickening and non-tender. On examination no swelling and no full ROM (range of motion) was reported. Treatment to the patient included ibuprofen, stretching and ice. On an unknown date, the patient underwent emergency room (ER) visit. The outcome of erythema, tenderness and pain in extremity was reported as not recovered.  Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site induration
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 591857). This spontaneous report refers to an 11 year old female patient. The patient had no concurrent illnesses and medical history included Osgood-Schlatter's disease. On 18-AUG-2015 the patient was vaccinated with GARDASIL 9 lot # L014198, dose 1, intramuscularly in the right arm for prophylaxis. On the same day, the patient was vaccinated with MENACTRA, (lot# U5082B, dose 1) and ADACEL intramuscularly in the left arm (lot# 05081AA). On 19-AUG-2015, the patient experienced injection site induration. 8x8 cm area of induration of injection site appeared 24 hours post vaccination. No erythema, non-tender. The outcome of injection site induration was unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Eye movement disorder
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 # 592001). This spontaneous report refers to a 13 year old female patient. The patient's concurrent illnesses included depression, abdominal pain and tinnitus. Medical history and concomitant medication were not reported. On 24-AUG-2015 the patient was vaccinated with GARDASIL 9 dose 2 (lot# L01184), intramuscularly in the right arm for prophylaxis. On 24-AUG-2015, the patient experienced asthenia and eye movement disorder. Patient got really quiet, weak and eyes rolling back but responsive and follows commands. Oxygen saturation was 99%, Heart Rate was 78/min, Blood Pressure (BP) was 110/60. Respiratory Rate was 20. BP before vaccination was 108/62. Child was placed in supine position. By 5:30 PM, she was laughing at picture on her phone and talking loudly. At that point she was discharged home. The outcome of asthenia and eye movement disorder were reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Joint crepitation, 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 # 592008). This spontaneous report refers to a 15 year old male patient. No historical and current conditions were reported. Concomitant medications were not reported. On 28-AUG-2015 the patient was vaccinated with GARDASIL 9 lot # L007560 dose 1, intramuscular in the left arm for prophylaxis. On the same day, the patient experienced dizziness and joint crepitation. Patient became lightheaded and knees buckled as he walked across the room. Patient was caught by staff and patient's father and laid onto the exam table. His legs were elevated and a cool, wet cloth laid across his forehead. Overhead was used to page a physician who came and assessed the situation. Patient did not fall onto the floor or hit his head. After 5 minutes patient was feeling much better so his head was elevated. After another 5 minutes he walked to the chair. His blood pressure (BP) and pulse (P) were then taken and were as follows: BP 188/72 and P 78. After a total of 15 minutes patient was feeling much better and left the room. No follow up is needed. The outcome of dizziness and joint crepitation was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Hypotension, Nausea
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 # 592241). This spontaneous report refers to a 16 year old female patient. Information on the patient's concurrent illnesses, medical history and other medications were not reported. Blood pressure (BP) before vaccination was 113/73 (units not reported). On 31-AUG-2015, the patient was vaccinated with GARDASIL 9 lot # L019287, dose 1, intramuscularly in the left arm for prophylaxis. On the same day, the patient experienced dizziness, nausea and hypotension (post vaccination- blood pressure (BP): 90/62 (units not reported)). The outcome of the events dizziness, nausea and hypotension was reported as recovered. The causality assessment of the events dizziness, nausea and hypotension 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.
Sex: F
Vaccine: HPV9
Symptoms: Cough, Lacrimation increased, Nasal congestion
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 # 592408) on 04-APR-2017. This spontaneous report was received from a regulatory authority refers to a 19 year old female patient. The patient's medical history included down syndrome and sulfa allergy. Patient's current illness was reported as none. Patient's other medications and concurrent therapies were not reported. On 24-AUG-2015, the patient was vaccinated with the first dose of GARDASIL 9 lot # L019287 (dose, frequency and expiration date were not reported) intramuscularly in the left arm for prophylaxis. On 24-AUG-2015, the day of administration, patient experienced nasal congestion, watery eyes. The following day (also reported as 26-AUG-2015) the patient had mild cough. The outcome of cough, nasal congestion and lacrimation increased was reported as recovered. Causality assessment for the events cough, nasal congestion and lacrimation increased with respect to GARDASIL 9 was not reported by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Chest discomfort, Eye swelling, Headache, Lip 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 # 592797). This spontaneous report refers to a 11 year old male patient. The patient's medical history included asthma. The patient had no current conditions Other medications included albuterol, Qvar and Flonase. On 25-AUG-2015 the patient was vaccinated with GARDASIL 9 lot # L019286 dose 1, intramuscular in the left arm for prophylaxis. On the same day, the patient experienced chest discomfort, lip swelling, severe headache and eye swelling. The patient was taken to emergency room. The outcome of chest discomfort, lip swelling, headache and eye swelling was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: FLU3, HPV9
Symptoms: Dizziness, Headache, Phonophobia, Somnolence, 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 # 611132) 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 recurrent HSV labialis and body mass index (BMI)> 85 percentile. The patient's concomitant therapies and concurrent illness were not reported. On 13-NOV-2015 the patient was vaccinated with the first dose of GARDASIL 9 lot # L013429, intramuscularly in the left arm for prophylaxis. Other suspect therapies included FLUZONE. On 13-NOV-2015, the patient fainted within 5-8 minutes after intramuscular vaccinations and blood pressure was 116/80 after recovering from fainting spell. The patient had complained of headache, lightheadedness, dizziness, phonophobia and needing to sleep more (somnolence). The symptoms had not occurred during exercise. The outcome of events dizziness, syncope, somnolence, phonophobia and headache 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: F
Vaccine: HPV9
Symptoms: Blood test normal, Chest X-ray normal, Chest pain, Death, Electrocardiogram normal
Clinical narrative: This spontaneous report as received from an unspecified reporter via a company representative refers to a 14 year old female patient. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 04-NOV-2015, the patient was vaccinated with a dose of FLUMIST (dose, strength, route of administration, lot# and expiry date were not reported). On 09-NOV-2015, the patient was vaccinated with a first dose of GARDASIL (manufacturer unknown) (dose, strength, route of administration, lot# and expiry date were not reported). The patient had no illness at time of vaccination. On 12-NOV-2015, reported as "three days after vaccination", patient claimed of chest pain while playing basketball and was taken to Emergency Room. Results of blood work, electrocardiogram (EKG) and chest X-ray were normal. Upper Respiratory Infection was diagnosed on approximately 12-NOV-2015. The patient felt better the next day. On 15-NOV-2015, reported as "three days later (six days after vaccination)", the patient collapsed while talking to friends. The patient died, on an unknown date. The cause of death was not specified. The causality between the events and the suspect vaccines was not reported. Upon internal review, the events of "the patient collapsed" and patient's death were considered to be medically significant. This is one of several reports received from  the same reporter. Follow-up information has been received on 04-APR-2017. This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID: 611452). The patient was vaccinated with GARDASIL (lot # L017407) intramuscularly in the left arm. On 12-NOV-2015, the patient experienced chest pain, resuscitation, syncope and underwent blood test (normal), chest x-ray (normal), electrocardiogram (normal). The patient died on 12-NOV-2015. Cause of death was reported as chest pain, resuscitation, syncope and upper respiratory Infection and it was unknown if an autopsy was performed. The outcome of the events resuscitation, syncope, chest pain, blood test normal, chest X-ray normal, electrocardiogram normal, upper respiratory Infection was not recovered at the time of death. Causality assessment was not reported. Additional information is not expected as no follow up could be obtained from the Agency. Sender's Comments: US-009507513-1606USA006441: US-009507513-1511USA013397: MERCK 1606USA006419: Mfr number.  Reported Cause(s) of Death: Chest pain; Resuscitation; Syncope; Upper respiratory tract infection.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Resuscitation, Syncope, Upper respiratory tract infection
Clinical narrative: This spontaneous report as received from an unspecified reporter via a company representative refers to a 14 year old female patient. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 04-NOV-2015, the patient was vaccinated with a dose of FLUMIST (dose, strength, route of administration, lot# and expiry date were not reported). On 09-NOV-2015, the patient was vaccinated with a first dose of GARDASIL (manufacturer unknown) (dose, strength, route of administration, lot# and expiry date were not reported). The patient had no illness at time of vaccination. On 12-NOV-2015, reported as "three days after vaccination", patient claimed of chest pain while playing basketball and was taken to Emergency Room. Results of blood work, electrocardiogram (EKG) and chest X-ray were normal. Upper Respiratory Infection was diagnosed on approximately 12-NOV-2015. The patient felt better the next day. On 15-NOV-2015, reported as "three days later (six days after vaccination)", the patient collapsed while talking to friends. The patient died, on an unknown date. The cause of death was not specified. The causality between the events and the suspect vaccines was not reported. Upon internal review, the events of "the patient collapsed" and patient's death were considered to be medically significant. This is one of several reports received from  the same reporter. Follow-up information has been received on 04-APR-2017. This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID: 611452). The patient was vaccinated with GARDASIL (lot # L017407) intramuscularly in the left arm. On 12-NOV-2015, the patient experienced chest pain, resuscitation, syncope and underwent blood test (normal), chest x-ray (normal), electrocardiogram (normal). The patient died on 12-NOV-2015. Cause of death was reported as chest pain, resuscitation, syncope and upper respiratory Infection and it was unknown if an autopsy was performed. The outcome of the events resuscitation, syncope, chest pain, blood test normal, chest X-ray normal, electrocardiogram normal, upper respiratory Infection was not recovered at the time of death. Causality assessment was not reported. Additional information is not expected as no follow up could be obtained from the Agency. Sender's Comments: US-009507513-1606USA006441: US-009507513-1511USA013397: MERCK 1606USA006419: Mfr number.  Reported Cause(s) of Death: Chest pain; Resuscitation; Syncope; Upper respiratory tract infection.