chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: PNC13, TDAP, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient's wife called and stated patient has redness and swelling at injection site where given ZOSTAVAX. Could also hear patient on the phone and he confirmed this and stated when asked that he did not have any itching with it.
Age: 0.08
Sex: F
Vaccine: IPV, PNC13
Symptoms: Apnoea, Decreased appetite, Dyskinesia, Lethargy, Pain
Clinical narrative: Lethargy. Absence of muscle control (arms, neck). Pale color. Light breathing stopping at times (had to be woken to start again). Swelling (all body, leg in particular). Extreme pain. Absence of appetite. Leg tremor. Fever. Feeling of absence (looking but not seeing, not recognizing objects or people). Lost Sucking reflex - inability to feed effectively.
Age: 0.08
Sex: F
Vaccine: IPV, PNC13
Symptoms: Pallor, Peripheral swelling, Poor sucking reflex, Pyrexia, Selective eating disorder
Clinical narrative: Lethargy. Absence of muscle control (arms, neck). Pale color. Light breathing stopping at times (had to be woken to start again). Swelling (all body, leg in particular). Extreme pain. Absence of appetite. Leg tremor. Fever. Feeling of absence (looking but not seeing, not recognizing objects or people). Lost Sucking reflex - inability to feed effectively.
Age: 0.08
Sex: F
Vaccine: IPV, PNC13
Symptoms: Swelling, Tremor, Visual impairment
Clinical narrative: Lethargy. Absence of muscle control (arms, neck). Pale color. Light breathing stopping at times (had to be woken to start again). Swelling (all body, leg in particular). Extreme pain. Absence of appetite. Leg tremor. Fever. Feeling of absence (looking but not seeing, not recognizing objects or people). Lost Sucking reflex - inability to feed effectively.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9, MENB, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Left upper extremity with redness and swelling with some tenderness in mid lateral deltoid. Supportive care rendered. 13 yr old here with mother with C/O left arm pain. Child received 4 immunizations at 10am today and later while at school - felt pain in her left arm and called her mother who picked her up - no meds given.
Age: 1.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Gait disturbance, X-ray of pelvis and hip
Clinical narrative: 12mo with limp after vaccination.
Age: 30.0
Sex: F
Vaccine: ANTH
Symptoms: Back pain, Fatigue, Injected limb mobility decreased, Injection site mass, Injection site pain
Clinical narrative: In the few hours following receipt of the Anthrax vaccine, the injection site was very achy and tender. By the evening of May 6, 2017, the pain increased with the slightest movement of my arm (where the injection site was), to the point that I lost full mobility of my arm without unbearable pain. Additionally, any pressure on the arm, (i.e. laying down), was borderline excruciating. The following morning, approximately 5:00am, I woke in considerable pain, radiating from the injection site to my neck and upper back. Also, there is a firm lump at the injection site, and it appears that the muscle itself is raised, as the lump sort of wraps around the top of my arm where the muscle is. Also, throughout the morning, felt extremely fatigued, and generally sick. It felt as if I could fall asleep at any moment if I just closed my eyes. This is my fifth Anthrax vaccination over the course of 7 years, and each time presented similar side effects, albeit the effects were somewhat worse the past two times (6 May 2017 and 11 Jan 2015). It is currently 9:00 AM on 7 May 2017, and I am still experiencing the radiating pain from my arm, up my neck, and across my upper back; I still have very limited mobility of my arm without extreme discomfort, and am still very fatigued with general feelings of malaise.
Age: 30.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site swelling, Limb discomfort, Malaise, Neck pain, Pain
Clinical narrative: In the few hours following receipt of the Anthrax vaccine, the injection site was very achy and tender. By the evening of May 6, 2017, the pain increased with the slightest movement of my arm (where the injection site was), to the point that I lost full mobility of my arm without unbearable pain. Additionally, any pressure on the arm, (i.e. laying down), was borderline excruciating. The following morning, approximately 5:00am, I woke in considerable pain, radiating from the injection site to my neck and upper back. Also, there is a firm lump at the injection site, and it appears that the muscle itself is raised, as the lump sort of wraps around the top of my arm where the muscle is. Also, throughout the morning, felt extremely fatigued, and generally sick. It felt as if I could fall asleep at any moment if I just closed my eyes. This is my fifth Anthrax vaccination over the course of 7 years, and each time presented similar side effects, albeit the effects were somewhat worse the past two times (6 May 2017 and 11 Jan 2015). It is currently 9:00 AM on 7 May 2017, and I am still experiencing the radiating pain from my arm, up my neck, and across my upper back; I still have very limited mobility of my arm without extreme discomfort, and am still very fatigued with general feelings of malaise.
Age: 30.0
Sex: F
Vaccine: ANTH
Symptoms: Somnolence
Clinical narrative: In the few hours following receipt of the Anthrax vaccine, the injection site was very achy and tender. By the evening of May 6, 2017, the pain increased with the slightest movement of my arm (where the injection site was), to the point that I lost full mobility of my arm without unbearable pain. Additionally, any pressure on the arm, (i.e. laying down), was borderline excruciating. The following morning, approximately 5:00am, I woke in considerable pain, radiating from the injection site to my neck and upper back. Also, there is a firm lump at the injection site, and it appears that the muscle itself is raised, as the lump sort of wraps around the top of my arm where the muscle is. Also, throughout the morning, felt extremely fatigued, and generally sick. It felt as if I could fall asleep at any moment if I just closed my eyes. This is my fifth Anthrax vaccination over the course of 7 years, and each time presented similar side effects, albeit the effects were somewhat worse the past two times (6 May 2017 and 11 Jan 2015). It is currently 9:00 AM on 7 May 2017, and I am still experiencing the radiating pain from my arm, up my neck, and across my upper back; I still have very limited mobility of my arm without extreme discomfort, and am still very fatigued with general feelings of malaise.
Age: 2.0
Sex: F
Vaccine: HEP, IPV
Symptoms: Erythema, Peripheral swelling, Rash
Clinical narrative: Swelling of whole thigh bright red looked like rash started covering her swollen thigh it was the size of a grapefruit the redness it was spreading felt like lumps under her skin.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness and warmth around injection site spread around upper arm for next 24 hours, had not spread overnight and reported to pharmacy on morning of 5/6/17, took BENADRYL at bedtime on 5/6/17 and pharmacy followed up on 5/7/17 at 12:30pm and patient reported site was not as red, no longer warm to touch and area had reduced some.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Heat in injected site. Swelling at injected site. Severe pain at injected site. Unable to raise arm.
Age: 60.0
Sex: F
Vaccine: HEPAB
Symptoms: Grip strength decreased, Injection site pain, Myalgia, Pain, Pain in extremity
Clinical narrative: Patient states that her back right shoulder and front right clavicle started hurting badly a few days (Saturday) after the vaccine. On Sunday, the pain spread down her arm. She said her muscles hurt. Patient also began having trouble twisting caps. She is still struggling with her symptoms. She wants us to contact her MD and is not comfortable continuing the series.
Age: 1.67
Sex: M
Vaccine: DTAPHEPBIP, HEPAB
Symptoms: Injection site rash, Injection site warmth, Pyrexia
Clinical narrative: Had a fever first night home, 3rd day 5/5/2017 he developed a rash that was hot to touch around injection site. Ongoing.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient's arm where she received the vaccine was red and warm. Over the course of the next week the redness became worse which led her to return to the pharmacy to report the problem.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Joint stiffness, Lymphadenopathy, Respiratory disorder, Wheezing
Clinical narrative: Joint stiffness and aches, lymph swelling bilaterally in chest/neck. Took BENADRYL and TYLENOL. Started having Resp issues with wheezing, went to Urgent care that night.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Injected limb mobility decreased, Injection site pain, Joint range of motion decreased, Joint stiffness
Clinical narrative: SIRVA (shoulder injury related to vaccine administration): Vaccine was administered high up on the left arm. L. shoulder achieness onset within 30-60 minutes of vaccine administration; within 24hrs of administration pain and stiffness in left shoulder, decreased range of motion (unable to get arm up over head). Symptoms continued to increase over time. Dx: subacromial bursitis, rotator cuff impingement. Treatment to date: steroid injection X2, physical therapy. No prior injuries to the either shoulder, no prior complaints of signs/symptoms in either shoulder. No complaints regarding R. shoulder.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging abnormal, Rotator cuff syndrome, Tendon disorder
Clinical narrative: SIRVA (shoulder injury related to vaccine administration): Vaccine was administered high up on the left arm. L. shoulder achieness onset within 30-60 minutes of vaccine administration; within 24hrs of administration pain and stiffness in left shoulder, decreased range of motion (unable to get arm up over head). Symptoms continued to increase over time. Dx: subacromial bursitis, rotator cuff impingement. Treatment to date: steroid injection X2, physical therapy. No prior injuries to the either shoulder, no prior complaints of signs/symptoms in either shoulder. No complaints regarding R. shoulder.
Age: 31.0
Sex: F
Vaccine: DTAP
Symptoms: Back pain, Chills, Diarrhoea, Headache, Nausea
Clinical narrative: Severe nausea, chills, vomiting, diarrhea, low grade fever, severe lower backache, headache.
Age: 31.0
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia, Vomiting
Clinical narrative: Severe nausea, chills, vomiting, diarrhea, low grade fever, severe lower backache, headache.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: Arm got swollen and redness occurred for two days and patient also experienced pain.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Chest pain, Echocardiogram normal, Electrocardiogram ST segment elevation, 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 ID-645758). This spontaneous report refers to a 17 year old male patient. The patient's medical history included asthma and peanut allergy. Other medications were reported as none. On 26-JUL-2016 the patient was vaccinated with GARDASIL 9 lot # M004116, dose 3 (unspecified dose and frequency), intramuscularly in the right arm, TRUMENBA dose 1 (unspecified dose and frequency), intramuscularly in the left arm and MENACTRA dose 2 (unspecified dose and frequency), intramuscularly in the left arm for prophylaxis. On 27-JUL-2016, the patient experienced fever and chest pain. The patient's myocardial necrosis marker, metabolic function test, full blood count and echocardiogram were normal. Electrocardiogram ST segment elevation was observed at a local urgent care. The patient was hospitalized where his lab work including cardiac enzymes were normal. The patient was discharged home the next day after observation. The outcome of the events were reported as recovered. Causality assessment was not provided. The agency considered the case to be serious as these events led to hospitalization. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Myocardial necrosis marker normal, 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 ID-645758). This spontaneous report refers to a 17 year old male patient. The patient's medical history included asthma and peanut allergy. Other medications were reported as none. On 26-JUL-2016 the patient was vaccinated with GARDASIL 9 lot # M004116, dose 3 (unspecified dose and frequency), intramuscularly in the right arm, TRUMENBA dose 1 (unspecified dose and frequency), intramuscularly in the left arm and MENACTRA dose 2 (unspecified dose and frequency), intramuscularly in the left arm for prophylaxis. On 27-JUL-2016, the patient experienced fever and chest pain. The patient's myocardial necrosis marker, metabolic function test, full blood count and echocardiogram were normal. Electrocardiogram ST segment elevation was observed at a local urgent care. The patient was hospitalized where his lab work including cardiac enzymes were normal. The patient was discharged home the next day after observation. The outcome of the events were reported as recovered. Causality assessment was not provided. The agency considered the case to be serious as these events led to hospitalization. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Acute disseminated encephalomyelitis, CSF white blood cell count increased, Encephalitis, Headache, 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 ID-646239) This spontaneous report refers to a 12 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-JUL-2016 the patient was vaccinated with GARDASIL 9 lot # L043214 (route and site unknown), dose 2 (unspecified dosage regimen) for prophylaxis and VAQTA (lot # M009377, route and site unknown) dose 3 (unspecified dosage regimen) for prophylaxis. On the same day, patient was vaccinated with other suspect therapies included ADACEL (dose 6, route and site unknown) and MENACTRA (dose 1, route and site unknown) for prophylaxis. On 11-JUL-2016, the patient experienced acute disseminated encephalomyelitis, vomiting, optic neuritis, nausea, headache, encephalitis. On 01-AUG-2016, CSF (Cerebrospinal fluid) panel showed increased white blood cells 37 (units not specified). On 02-AUG-2016: MRI (Magnetic resonance imaging) brain- showed acute disseminated encephalomyelitis (ADEM). The patient's nuclear magnetic resonance imaging brain was abnormal and CSF white blood cell count was increased. The patient was taken to emergency room. The patient was treated with methyl prednisone. The outcome of the events were reported as not recovered. Causality assessment was not provided. The agency considered the case to be serious as these events led to hospitalization. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Optic neuritis, 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 ID-646239) This spontaneous report refers to a 12 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-JUL-2016 the patient was vaccinated with GARDASIL 9 lot # L043214 (route and site unknown), dose 2 (unspecified dosage regimen) for prophylaxis and VAQTA (lot # M009377, route and site unknown) dose 3 (unspecified dosage regimen) for prophylaxis. On the same day, patient was vaccinated with other suspect therapies included ADACEL (dose 6, route and site unknown) and MENACTRA (dose 1, route and site unknown) for prophylaxis. On 11-JUL-2016, the patient experienced acute disseminated encephalomyelitis, vomiting, optic neuritis, nausea, headache, encephalitis. On 01-AUG-2016, CSF (Cerebrospinal fluid) panel showed increased white blood cells 37 (units not specified). On 02-AUG-2016: MRI (Magnetic resonance imaging) brain- showed acute disseminated encephalomyelitis (ADEM). The patient's nuclear magnetic resonance imaging brain was abnormal and CSF white blood cell count was increased. The patient was taken to emergency room. The patient was treated with methyl prednisone. The outcome of the events were reported as not recovered. Causality assessment was not provided. The agency considered the case to be serious as these events led to hospitalization. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Arnold-Chiari malformation, Blood potassium decreased, Computerised tomogram, Dizziness, Electroencephalogram
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 # 646453) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 11 year old female patient. The patient's concurrent illness included tired and dizzy. The patient had no medical history. Information on the patient's prior vaccinations was not reported. On 23-SEP-2015 the patient was vaccinated with the first dose of GARDASIL 9 in the arm (route reported as needle and syringe-not specified), lot # L007560 (dose, frequency and lot expiration date were not reported) for prophylaxis. On the same day, other suspect therapies included BOOSTRIX (dose 1, lot#9NA32, route and site unknown) and MENACTRA (dose 1, lot#U5178AA, route and site unknown). On 29-FEB-2016, the patient experienced Arnold-Chiari malformation, blood potassium decreased, dizziness, epilepsy, migraine and underwent nuclear magnetic resonance imaging, laboratory tests and computerized tomogram. Laboratory test included computerised tomogram, MRI's (magnetic resonance imaging), Cat Scans, brain wave test were done. The patient visited emergency room, neurologist, neurosurgeons, but there was no conclusive answer for patient's problem. The doctors cleared the patient to do anything that she felt like doing with adult supervision. So on Sunday 31-JUL-2016, the patient began to run in a track to meet with her mom, coaches, medical staff, etc in attendance, when one of above episodes happened. Until that time, the doctors had not been able to know what had happened to the patient when one of the episodes occurred. The patient's coach informed her mom on Sunday to get these episodes captured on video. The patient was taken to the ER and they found nothing wrong except her blood potassium level was decreased. All her vitals were normal no heat exhaustion, no heat stroke. The videos had been sent to patient's doctors and waiting for an appointments with doctors. The patient's mother had done hours of investigation into all the aspects of possible causes and truly believes that patient had a reaction of taking the HPV virus vaccination. The patient's mother waits and watches for any sign from patient that happens again. The outcome of Arnold-Chiari malformation, blood potassium decreased, computerised tomogram, dizziness, epilepsy, laboratory test, migraine and nuclear magnetic resonance imaging were reported as not recovered. Causality assessment was not reported. The agency considered the case to be serious as these events led to hospitalization and disability. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Epilepsy, Laboratory test, Migraine, Nuclear magnetic resonance imaging
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 # 646453) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 11 year old female patient. The patient's concurrent illness included tired and dizzy. The patient had no medical history. Information on the patient's prior vaccinations was not reported. On 23-SEP-2015 the patient was vaccinated with the first dose of GARDASIL 9 in the arm (route reported as needle and syringe-not specified), lot # L007560 (dose, frequency and lot expiration date were not reported) for prophylaxis. On the same day, other suspect therapies included BOOSTRIX (dose 1, lot#9NA32, route and site unknown) and MENACTRA (dose 1, lot#U5178AA, route and site unknown). On 29-FEB-2016, the patient experienced Arnold-Chiari malformation, blood potassium decreased, dizziness, epilepsy, migraine and underwent nuclear magnetic resonance imaging, laboratory tests and computerized tomogram. Laboratory test included computerised tomogram, MRI's (magnetic resonance imaging), Cat Scans, brain wave test were done. The patient visited emergency room, neurologist, neurosurgeons, but there was no conclusive answer for patient's problem. The doctors cleared the patient to do anything that she felt like doing with adult supervision. So on Sunday 31-JUL-2016, the patient began to run in a track to meet with her mom, coaches, medical staff, etc in attendance, when one of above episodes happened. Until that time, the doctors had not been able to know what had happened to the patient when one of the episodes occurred. The patient's coach informed her mom on Sunday to get these episodes captured on video. The patient was taken to the ER and they found nothing wrong except her blood potassium level was decreased. All her vitals were normal no heat exhaustion, no heat stroke. The videos had been sent to patient's doctors and waiting for an appointments with doctors. The patient's mother had done hours of investigation into all the aspects of possible causes and truly believes that patient had a reaction of taking the HPV virus vaccination. The patient's mother waits and watches for any sign from patient that happens again. The outcome of Arnold-Chiari malformation, blood potassium decreased, computerised tomogram, dizziness, epilepsy, laboratory test, migraine and nuclear magnetic resonance imaging were reported as not recovered. Causality assessment was not reported. The agency considered the case to be serious as these events led to hospitalization and disability. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Body temperature increased, Computerised tomogram normal, Dizziness, Dyspnoea, 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 ID-647183). This spontaneous report refers to a 13 year old male patient. The patient's medical history, concurrent illnesses and concomitant medications were not reported. On 05-AUG-2016 the patient was vaccinated with GARDASIL 9 lot # L037554, dose 3 (unspecified dose, route and frequency) in the left arm for prophylaxis. On the same day, the patient experienced increased body temperature (102), syncope, dyspnea, dizziness and headache. The patient's nuclear magnetic resonance imaging, full blood count and computerized tomogram were normal. The patient required emergency room visit. The outcome of these events were reported as recovered. Causality assessment was not provided. The agency considered the case to be serious as these events led to hospitalization. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Headache, Nuclear magnetic resonance imaging normal, 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 ID-647183). This spontaneous report refers to a 13 year old male patient. The patient's medical history, concurrent illnesses and concomitant medications were not reported. On 05-AUG-2016 the patient was vaccinated with GARDASIL 9 lot # L037554, dose 3 (unspecified dose, route and frequency) in the left arm for prophylaxis. On the same day, the patient experienced increased body temperature (102), syncope, dyspnea, dizziness and headache. The patient's nuclear magnetic resonance imaging, full blood count and computerized tomogram were normal. The patient required emergency room visit. The outcome of these events were reported as recovered. Causality assessment was not provided. The agency considered the case to be serious as these events led to hospitalization. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Deep vein thrombosis, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Ultrasound scan normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 648679) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 22 year old female patient. The patient's medical history included endometriosis and vitamin D deficiency. The patient had no concurrent illnesses. On 28-MAR-2016, patient was vaccinated with GARDASIL 9 lot # L045711, dose 1, intramuscularly in the left arm (dose, frequency and lot expiration date were not reported) for prophylaxis. On the date of vaccination patient's birth control pill was increased from JUNEL 1.5 to SPRINTEC 0.25/35 due to gynaecological concerns of dyspareunia/dysmenorrhea/menorrhagia. The vaccination was stated to be an uncomplicated administration. On 13-APR-2016, the patient experienced pain in extremity and underwent ultrasound scan which was normal, however the nuclear magnetic resonance imaging was abnormal and revealed deep vein thrombosis. The patient was seen in the emergency unit. The patient had continuous bilateral lower extremities pain, left extremity pain greater than right extremity (L>>R). Lab data detailed: Ultrasound of bilateral lower extremities: negative for deep venous thrombosis; MRI of lower extremities: left posterior tibialis deep venous thrombosis. The outcome of all the events were reported as recovered. The agency considered the case to be serious as all these events were life threatening and led to prolonged hospitalization. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Back pain, Computerised tomogram normal, Hypoaesthesia, Mobility decreased, Nuclear magnetic resonance imaging spinal 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 # 653984) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 16 year old female patient. The patient's other medications included ORTHO TRI-CYCLEN. The patient had no concurrent illnesses and no medical history, however reported to have had back pain that summer. On 29-AUG-2016 the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # L036301, dose 1, route: unknown, in the left arm and VAQTA dose number: 2, in the right arm, lot# M022924 route: unknown (dose and lot expiration date not reported) for prophylaxis. On 01-SEP-2016, the patient was playing cello for a few hours and developed sharp back pain without radiation and also had paraesthesia with tingling distal to knee. Patient experienced hypoaesthesia with entire left leg numb to touch and there was decreased mobility as she was not able to move ankle. On the same day the patient underwent pelvic scan, nuclear magnetic resonance imaging of lumbar section spine and computerised tomogram which were normal. Patient was hospitalized for three days, followed by neuro and leg remained numb below knee. Patient was undergoing physical therapy at the time of this report. The outcome of all the events was reported as not recovered/not resolved. Causality assessment was not reported. The agency considered the case to be serious as the events involved hospitalization. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Paraesthesia, Scan normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 653984) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 16 year old female patient. The patient's other medications included ORTHO TRI-CYCLEN. The patient had no concurrent illnesses and no medical history, however reported to have had back pain that summer. On 29-AUG-2016 the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # L036301, dose 1, route: unknown, in the left arm and VAQTA dose number: 2, in the right arm, lot# M022924 route: unknown (dose and lot expiration date not reported) for prophylaxis. On 01-SEP-2016, the patient was playing cello for a few hours and developed sharp back pain without radiation and also had paraesthesia with tingling distal to knee. Patient experienced hypoaesthesia with entire left leg numb to touch and there was decreased mobility as she was not able to move ankle. On the same day the patient underwent pelvic scan, nuclear magnetic resonance imaging of lumbar section spine and computerised tomogram which were normal. Patient was hospitalized for three days, followed by neuro and leg remained numb below knee. Patient was undergoing physical therapy at the time of this report. The outcome of all the events was reported as not recovered/not resolved. Causality assessment was not reported. The agency considered the case to be serious as the events involved hospitalization. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Anaemia, Apnoea, Chills, Decreased appetite, Dizziness
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 # 654994) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old female patient. Information on patient's other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. Historical drug included penicillin. On 19-SEP-2016, the patient was vaccinated with the first dose of GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # L040054, intramuscularly in the left arm for prophylaxis. On 19-SEP-2016, the patient experienced anaemia, apnoea, chills, decreased appetite, dizziness, epistaxis, haemorrhage, head injury, headache, hot flush, hyperhidrosis, hypertension, hypotension, loss of consciousness, pain, pyrexia, skin discoloration, tachycardia, thrombosis, transfusion and urinary tract infection. Blood transfusion was needed to save life. The outcome of events anaemia, apnoea, chills, decreased appetite, dizziness, epistaxis, haemorrhage, head injury, headache, hot flush, hyperhidrosis, hypertension, hypotension, loss of consciousness, pain, pyrexia, skin discoloration, tachycardia, thrombosis, transfusion and urinary tract infection was reported as unknown. The causality assessment was not reported. The agency considered the case to be serious due to life-threatening which led to hospitalization. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Epistaxis, Haemorrhage, Head injury, Headache, Hot flush
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 # 654994) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old female patient. Information on patient's other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. Historical drug included penicillin. On 19-SEP-2016, the patient was vaccinated with the first dose of GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # L040054, intramuscularly in the left arm for prophylaxis. On 19-SEP-2016, the patient experienced anaemia, apnoea, chills, decreased appetite, dizziness, epistaxis, haemorrhage, head injury, headache, hot flush, hyperhidrosis, hypertension, hypotension, loss of consciousness, pain, pyrexia, skin discoloration, tachycardia, thrombosis, transfusion and urinary tract infection. Blood transfusion was needed to save life. The outcome of events anaemia, apnoea, chills, decreased appetite, dizziness, epistaxis, haemorrhage, head injury, headache, hot flush, hyperhidrosis, hypertension, hypotension, loss of consciousness, pain, pyrexia, skin discoloration, tachycardia, thrombosis, transfusion and urinary tract infection was reported as unknown. The causality assessment was not reported. The agency considered the case to be serious due to life-threatening which led to hospitalization. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Hyperhidrosis, Hypertension, Hypotension, Loss of consciousness, 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 # 654994) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old female patient. Information on patient's other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. Historical drug included penicillin. On 19-SEP-2016, the patient was vaccinated with the first dose of GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # L040054, intramuscularly in the left arm for prophylaxis. On 19-SEP-2016, the patient experienced anaemia, apnoea, chills, decreased appetite, dizziness, epistaxis, haemorrhage, head injury, headache, hot flush, hyperhidrosis, hypertension, hypotension, loss of consciousness, pain, pyrexia, skin discoloration, tachycardia, thrombosis, transfusion and urinary tract infection. Blood transfusion was needed to save life. The outcome of events anaemia, apnoea, chills, decreased appetite, dizziness, epistaxis, haemorrhage, head injury, headache, hot flush, hyperhidrosis, hypertension, hypotension, loss of consciousness, pain, pyrexia, skin discoloration, tachycardia, thrombosis, transfusion and urinary tract infection was reported as unknown. The causality assessment was not reported. The agency considered the case to be serious due to life-threatening which led to hospitalization. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Pyrexia, Skin discolouration, Tachycardia, Thrombosis, Transfusion
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 # 654994) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old female patient. Information on patient's other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. Historical drug included penicillin. On 19-SEP-2016, the patient was vaccinated with the first dose of GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # L040054, intramuscularly in the left arm for prophylaxis. On 19-SEP-2016, the patient experienced anaemia, apnoea, chills, decreased appetite, dizziness, epistaxis, haemorrhage, head injury, headache, hot flush, hyperhidrosis, hypertension, hypotension, loss of consciousness, pain, pyrexia, skin discoloration, tachycardia, thrombosis, transfusion and urinary tract infection. Blood transfusion was needed to save life. The outcome of events anaemia, apnoea, chills, decreased appetite, dizziness, epistaxis, haemorrhage, head injury, headache, hot flush, hyperhidrosis, hypertension, hypotension, loss of consciousness, pain, pyrexia, skin discoloration, tachycardia, thrombosis, transfusion and urinary tract infection was reported as unknown. The causality assessment was not reported. The agency considered the case to be serious due to life-threatening which led to hospitalization. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Urinary tract infection
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 # 654994) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old female patient. Information on patient's other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. Historical drug included penicillin. On 19-SEP-2016, the patient was vaccinated with the first dose of GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # L040054, intramuscularly in the left arm for prophylaxis. On 19-SEP-2016, the patient experienced anaemia, apnoea, chills, decreased appetite, dizziness, epistaxis, haemorrhage, head injury, headache, hot flush, hyperhidrosis, hypertension, hypotension, loss of consciousness, pain, pyrexia, skin discoloration, tachycardia, thrombosis, transfusion and urinary tract infection. Blood transfusion was needed to save life. The outcome of events anaemia, apnoea, chills, decreased appetite, dizziness, epistaxis, haemorrhage, head injury, headache, hot flush, hyperhidrosis, hypertension, hypotension, loss of consciousness, pain, pyrexia, skin discoloration, tachycardia, thrombosis, transfusion and urinary tract infection was reported as unknown. The causality assessment was not reported. The agency considered the case to be serious due to life-threatening which led to hospitalization. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Blood pressure decreased, Hypotonia, Loss of consciousness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 655535) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old male patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and other medications (the patient stated that he had lost consciousness when some blood was drawn and he did not mention that during questionnaire was asked if he had ever fainted or had a bad reaction in the past) were not reported. On 08-SEP-2016 the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # L043214 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included BOOSTRIX, MENVEO and HAVRIX. On 08-SEP-2016, the patient became limp and lost consciousness. The patient was made to lay down on table with feet elevated, he responded to name, but quickly lost consciousness again. The patient's blood pressure was decreased but increased as he became more conscious. The outcome of blood pressure decreased, loss of consciousness and hypotonia 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: HPV9, MNQ, TDAP
Symptoms: Contusion, Immune thrombocytopenic purpura, Laboratory test abnormal, Petechiae
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA #656485) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old male patient. The patient had no pertinent medical history, other medications and concurrent illnesses. On 13-SEP-2016, the patient was vaccinated with GARDASIL 9, lot # L036301, dose 1, in the left arm for prophylaxis (dosing details and route unknown). Other suspect therapies included vaccination with MENACTRA (dose number: 1, manufacturer: Sanofi Pasteur, vaccinated date: 13-SEP-2016, route: unknown, in the right arm, lot# U541544; dose and expiration date unknown) and BOOSTRIX (dose number: 1, manufacturer: GlaxoSmithKline, vaccinated date: 13-SEP-2016, route: unknown, in the right arm, lot# L2972; dose and expiration date unknown) for prophylaxis. On 15-SEP-2016, patient had a contusion and at 7 pm, petechiae were noticed on his lower legs and feet and there was heavy bruising on his lower legs. No treatment was provided. On an unknown date an unspecified test was performed which revealed immune thrombocytopenic purpura. It was to be decided further whether it was an acute or chronic condition. The outcome of contusion, petechiae and immune thrombocytopenic purpura was unknown. Causality assessment was not provided. The agency considered the events to be serious due to hospitalization. Additional information is not expected as no follow-up can be requested from local health authority.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Immune thrombocytopenic purpura, Immunoglobulin therapy, Petechiae, Platelet count decreased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 657074) on 02-MAY-2017. This spontaneous report was received from a regulatory authority concerning a 13 year old male patient. The patient's historical conditions were reported as Allergic to peanuts and tree nuts. Information on concomitant medications, current illnesses and prior vaccinations were not reported. On 07-MAY-2016, the patient was vaccinated with second dose of GARDASIL 9 lot # L038503, through unknown route (dose and expiration date unknown) in the right arm for prophylaxis. On 01-JUN-2016, the patient experienced petechiae. It became pronounced on 04-JUL-2016 so his mother took him to urgent care. On an unspecified date in July 2016, patient was diagnosed with low platelets (decreased 22) and immune thrombocytopenic purpura. He was seen by hematologist on 10-JUL-2016. On an unspecified date in July 2016, the patient received intravenous immunoglobulin therapy in the 50's. The outcome of all the events were reported as not recovered. Causality assessment was not reported. The agency considered all the events to be serious due to life threatening. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Facial paralysis, Gait disturbance, Headache, Hypoaesthesia, Nerve injury
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 # 658334) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 20 year old female patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and other medications were not reported. On 05-JAN-2016 the patient was vaccinated with GARDASIL 9 lot # L017407, intramuscular in the right arm (dose, dose number, frequency and lot expiration dated were not reported) for prophylaxis. On an unknown date the patient experienced facial paralysis (face drawing on one side), gait disturbance, headache, hypoaesthesia (numbness in hands and feet) and tremendous nerve damage and visited emergency room. The outcome of events facial paralysis, gait disturbance, headache, hypoaesthesia and nerve injury was reported as not recovered/not resolved. Causality assessment was not reported. The agency considered the case to be serious due to hospitalization. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Balance disorder, Computerised tomogram, Emotional disorder, Fall, Frustration tolerance decreased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (Agency #665088) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 16 year old female patient. The patient had no pertinent medical history at the time of vaccination and no concurrent illnesses were reported. On 08-SEP-2016, the patient was vaccinated with GARDASIL 9 lot # M020103, dose 1, intramuscularly in the left arm for prophylaxis. Other suspect therapies included vaccination with MENACTRA (dose number: 1, manufacturer: Sanofi Pasteur, vaccinated date: 08-SEP-2016, intramuscularly in the right arm, lot# U5392AA; dose and expiration date unknown) and HAVRIX (dose number: 1, manufacturer: GlaxoSmithKline, vaccinated date: 08-SEP-2016, intramuscularly in the left arm, lot# KT54C; dose and expiration date unknown) for prophylaxis. On 07-OCT-2016, the patient developed headache, blurred vision, loss of balance and was falling at school. It was also reported that the patient was feeling emotional with frustration tolerance decreased. On 11-OCT-2016, symptoms were continuing and she was taken to the emergency room. A CAT scan (Computerised tomogram) was done on the same day and she was admitted to the hospital. On 12-OCT-2016 an MRI (magnetic resonance imaging) was done. She was seen by a neurologist and diagnosed with fluid on brain and was treated with medication at that time. She was seen on 26-OCT-2016 and a spinal tap done to relieve pressure/fluid. She was having a shunt placed on 14-NOV-2016. The outcome of the events were unknown. Causality assessment was not provided. The Agency considered the events to be serious due to hospitalization. Additional information is not expected as no follow-up can be requested from local health authority.