chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Upper respiratory tract infection, Urine analysis normal, Vitamin A deficiency, Vitamin B12 normal, Vitamin D
Clinical narrative: Patient questions if current health issues were related to past influenza vaccinations, specifically H1N1 in 2009. Patient advised he recalls no immediate reactions following any vaccination other than a sore arm prior to and since receipt of H1N1. Last vaccines given were in 2011 w/o adverse reactions (Typhoid Vi, Td and Influenza vaccination). He recalls in 2009 he was bitten by a tick on his inner left thigh and recalls that same week given flu vaccine and that this BP was elevated (during physical). He recalls he completed a cardiology eval for c/o tightness in his left arm that persisted for a few months. He advised he would have episodic tingling to various spots to left toes, calf, quadriceps, fingertips, and that his arm/leg would ache with muscles appearing to "whither". These sensations slowly resolved. In Nov/Dec 2010, the weakness/numbness and tingling returned but now to entire left side and he was having muscle spasms. (Patient is right hand dominant). Duration is reported as lasting a few seconds to minutes, worse with exercise. Over last 2 years (2014-2016) he has had multiple workups and no definitive diagnosis. He advised episodes occurred daily in 2009 but now (2017) occurs maybe once a week. He finds while he remains ready and can do his job, his ability to do long distance triathlons is affected (tingling/pain in calves/quads, and fingertips/toes).
Age: 38.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Vitamin D deficiency, Vocal cord dysfunction
Clinical narrative: Patient questions if current health issues were related to past influenza vaccinations, specifically H1N1 in 2009. Patient advised he recalls no immediate reactions following any vaccination other than a sore arm prior to and since receipt of H1N1. Last vaccines given were in 2011 w/o adverse reactions (Typhoid Vi, Td and Influenza vaccination). He recalls in 2009 he was bitten by a tick on his inner left thigh and recalls that same week given flu vaccine and that this BP was elevated (during physical). He recalls he completed a cardiology eval for c/o tightness in his left arm that persisted for a few months. He advised he would have episodic tingling to various spots to left toes, calf, quadriceps, fingertips, and that his arm/leg would ache with muscles appearing to "whither". These sensations slowly resolved. In Nov/Dec 2010, the weakness/numbness and tingling returned but now to entire left side and he was having muscle spasms. (Patient is right hand dominant). Duration is reported as lasting a few seconds to minutes, worse with exercise. Over last 2 years (2014-2016) he has had multiple workups and no definitive diagnosis. He advised episodes occurred daily in 2009 but now (2017) occurs maybe once a week. He finds while he remains ready and can do his job, his ability to do long distance triathlons is affected (tingling/pain in calves/quads, and fingertips/toes).
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Oedema peripheral
Clinical narrative: Pt. reported pain swelling (L) deltoid swelling to 2x normal size by evening after injection. Swelling/edema moved down arm now to just below elbow.
Age: 33.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site pain
Clinical narrative: Case number PHEH2017US001864, is an initial spontaneous report received from a consumer on 12 Jan 2017. This report refers to a years old male patient. Past medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with one single dose of FLUAD (batch number: 166102, expiry date: Apr 2017) into left deltoid, at a dose of 0.5 ml, intramuscularly on 18 Nov 2016 at 14:40 PM. On 31 Dec 2016, the patient experienced sharp stabbing pain at injection site. It was reported that, patient had tender in upper arm/ deltoid area. Patient stabbing pain seems to have stopped as on 31 Jan 2017 unless he moves his arm in a certain way but patient still had tender at the site of injection. No treatment or evaluation by physician at the time of report. Outcome of the event as condition unchanged and seriousness and causality was not reported. Follow up report received from a healthcare professional on 01 Feb 2017: Added patient demographic (patient height), suspect drug information (vaccination site and time of vaccination), updated event (tender at the site of injection), event onset date (changed from 30 Dec 2016 to 31 Dec 2016) and reporter comment.
Age: 82.0
Sex: M
Vaccine: FLUA3
Symptoms: Rash
Clinical narrative: Case number PHEH2016US030837, is an initial spontaneous report received from a consumer on 21 Nov 2016. This report refers to a 82 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUAD (batch number: not reported) at dose of 0.5 ml intramuscularly on 03 Nov 2016. On 10 Nov 2016, the patient experienced rash on buttocks. The patient visited his physician and was prescribed triamcinolone acetonide (0.1 percent) cream 2 to 3 times daily for 14 days to buttocks. The reporter was not sure whether the rash was due to vaccine. The outcome of the event was reported as condition improving. The seriousness and causality of the events were not reported.
Sex: F
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Case number PHEH2016US031908, is a combined initial and follow up spontaneous report received from a pharmacist (who is patient's sister) on 05 Dec 2016 and 09 Dec 2016. This report refers to a female patient. Past medical history and concomitant medications were not reported. She was vaccinated with INN (unknown manufacturer, batch number: not reported) on an unknown date 15 to 20 years ago (details unspecified). After vaccination, she developed rash on an unknown date. It was reported that she was recently administered with FLUCELVAX with no issues. The outcome of rash was unknown. The seriousness and causality of the event were not reported. The case was considered lost to follow up at initial.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Pain in extremity
Clinical narrative: Almost 2 months after vaccine is still continuing to have pain in arm.
Age: 14.0
Sex: M
Vaccine: FLUX, HPVX
Symptoms: Fatigue, Nausea, Pyrexia, Vomiting
Clinical narrative: Case number PHHY2017US024206, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 663079) website on 23 Jan 2017. This report refers to a 14 years old male patient. Past medical history was not reported. Current condition included as asthma. Concomitant medication was not reported. The patient was vaccinated with INN (manufacturer and batch number: not reported) into left arm on 31 Oct 2016. The patient also vaccinated with human papilloma virus vaccine (other manufacturer, batch number: not reported) into right arm (reported as HPV) on 31 Oct 2016. On the same day after vaccination, the patient experienced nausea, vomiting, exhaustion and fever. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dizziness, Ear pain, Nervousness, Pain in extremity
Clinical narrative: Case number PHHY2016US162714, is an initial spontaneous report received from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 638226) website on 21 Nov 2016. This report refers to a 63 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) on an unspecified date. On an unknown date, the patient experienced eyes blurry, nervous extremely, more floaters, ears hurt, teeth hurt-need crowns, weak areas intensified, dizzy and legs hurt. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Toothache, Vision blurred, Vitreous floaters
Clinical narrative: Case number PHHY2016US162714, is an initial spontaneous report received from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 638226) website on 21 Nov 2016. This report refers to a 63 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) on an unspecified date. On an unknown date, the patient experienced eyes blurry, nervous extremely, more floaters, ears hurt, teeth hurt-need crowns, weak areas intensified, dizzy and legs hurt. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Sex: U
Vaccine: FLUX
Symptoms: Malaise, Vaccination complication
Clinical narrative: Case number PHHY2016US162297, is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS reference number: 645126) website on 21 Nov 2016. This report refers to a patient of unspecified gender and age. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) on an unspecified date. On an unspecified date after vaccination the patient experienced a bad reaction to the flu shot. It was reported that in last year the patient experienced a bad reaction to the flu shot for the first time in 30 years. The patient found out that there were 03 levels. He was given the medium shot which made the patient sick therefore the patient decided to not get the flu shot that year. The patient rather had a chance on getting the flu. The outcome of events immunisation reaction and sickness was reported as condition unchanged. The seriousness and causality of the events immunisation reaction and sickness were not reported.
Age: 40.0
Sex: M
Vaccine: FLUX
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Case number PHHY2016US162876 is an initial spontaneous report received from other health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 645337) on 21 Nov 2016. This report refers to 40 year old male patient. Medical history and concomitant medication was not reported. There was no known allergy. Birth defects were reported as none. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown) intramuscular on 16 Sep 2015. On 19 Sep 2015, three days post vaccination the patient developed itching and broke out in a rash on his forearms. Symptoms progressed to urticaria all over his body. The patient required emergency room/doctor visit for the events on an unspecified date. The patient took two course of SOLU-MEDROL dose pack as corrective treatment with little improvement. No laboratory tests were done. The patient had not recovered from the events. The outcomes of the events were reported as condition improving. Events were reported as non serious. The causality of the events was not reported.
Sex: M
Vaccine: FLUX
Symptoms: Cough, Viral upper respiratory tract infection
Clinical narrative: Case number PHHY2016US162455, is an initial spontaneous report received from a consumer (patient's mother) via vaccine adverse event reporting system (VAERS reference number: 645577) on 21 Nov 2016. This report refers to a male patient, of an unknown age. Medical history and concomitant medication were not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number and expiration date were not reported) from an unknown start date. On an unspecified date following the vaccination, the patient experienced cold and cough symptoms. The outcome, seriousness and causality of the events were not reported.
Sex: M
Vaccine: FLUX
Symptoms: Cough, Viral upper respiratory tract infection
Clinical narrative: Case number PHHY2016US162890, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS, reference number: 645985) website on 21 Nov 2016. This report refers to a male patient of an unknown age. Past medical history and concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number: not reported) on an unspecified date on Friday. Next day after vaccination, on Saturday (date unspecified), the patient experienced cough and cold and on the same day the patient was treated with TYLENOL and rested. Laboratory investigation was not reported. The outcome of the events was reported as recovered on an unspecified date on Monday. Seriousness of the events was reported as non serious and causality was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Case number PHHY2016US162913, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS, reference number: 646244) website on 21 Nov 2016. This report refers to a female patient of an unknown age. Past medical history, patient's illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions and concomitant medication were not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number: not reported) in the last year on an unspecified date. On an unknown date after vaccination, the patient experienced arm pain and stiffness. Relevant diagnostic tests and corrective treatments were not reported. The final outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious and causality not reported.
Age: 84.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Myalgia, Pain
Clinical narrative: Case number PHHY2016US163188, is an initial spontaneous report received from a consumer via other pharmaceutical company (Pfizer) via Vaccine Adverse Event Reporting System (VAERS reference number: 646614) website on 21 Nov 2016. This report refers to an 84 years old female patient. Historical condition was not reported. Current conditions included lymph edema in right arm (from 1990), breast cancer (diagnosed in 1992 and 1996), she has not had cancer again for over 15 years and diabetes (controlled by exercise and a small dose diabetes pill (unspecified) and diet. Concomitant medication was not reported. On 05 Oct 2015, the patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) on an unknown date, at an unknown dose, frequency and route via left arm. On 08 Oct 2015, three days following the vaccination, the patient had joint pain and muscle pain. It was reported that the patient was in her shoulder muscle like when moving her arm. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain
Clinical narrative: Case number PHHY2016US163647, is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS reference number: 646746) website on 21 Nov 2016. This report refers to a female patient of unspecified age. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) on an unspecified date. On an unspecified date after vaccination, the patient experienced pain in shoulder. It was reported that, the patient refused to receive another flu vaccination ever again and event pain in shoulder was lasted for a month. The outcome of event pain in shoulder was reported as complete recovery on an unspecified date. On an unspecified date after vaccination, the patient experienced pain in shoulder. It was reported that, the patient refused to receive another flu vaccination ever again and event pain in shoulder was lasted for a month. The outcome of event pain in shoulder was reported as complete recovery on an unspecified date. The seriousness and causality of the event pain in shoulder was not reported.
Age: 69.0
Sex: U
Vaccine: FLUX
Symptoms: Productive cough, Respiratory tract congestion
Clinical narrative: Case number PHHY2016US163624, is an initial spontaneous report received from a consumer via other manufacturer via the Vaccine Adverse Event Reporting System (VAERS reference number: 646748) website on 21 Nov 2016. This report refers to a 69-years-old patient of unspecified gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) on an unspecified date. On an unspecified date after vaccination, the patient woke up very congested early in the morning and the phlegm was very thick. The outcome of the events productive cough and respiratory tract congestion was reported as condition unchanged. The seriousness and causality of the events productive cough and respiratory tract congestion were not reported.
Age: 74.0
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Malaise
Clinical narrative: Case number PHHY2016US163797, is an initial spontaneous report received from a consumer via other manufacturer via the Vaccine Adverse Event Reporting System (VAERS reference number: 646784) website on 21 Nov 2016. This report refers to a 74-years-old male patient of unspecified age. Past medical history was not reported. Current condition included underactive thyroid. The patient had not had flu shot within last twenty years. Concomitant medications included Thyroxine. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) on 03 Nov 2015. The patient was also vaccinated with PREVNAR 13 (batch number: not reported) on 03 Nov 2015. On 04 Nov 2015 after vaccination, the patient felt lousy for 02 to 03 weeks. The patient was recovering from the event felt lousy and was still lousy. The outcome of event feeling lousy was reported as complete recovery on an unspecified date. The seriousness and causality of event feeling lousy were not reported.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal discomfort, Pain
Clinical narrative: Case number PHHY2016US163707, is an initial spontaneous report received from a consumer via Vaccine Adverse Events Reporting System (VAERS reference number: 647099) on 21 Nov 2016. This report refers to a 60 years old female patient. Past medical history and concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number: not reported) on 01 Dec 2015. On 02 Dec 2015 after vaccination, the patient was achy, chronic pain which was really bad and her stomach did not do very well. Lab tests were not reported. Patient took ADVIL Liquid-Gels 200 mg, 80 count bottle (batch number: R21284, expiry date: Jun 2017) with her other pain medications (details unspecified) as the pain was really bad. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious and causality not reported.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Case number PHHY2016US163672, is an initial spontaneous report received from a health care professional via Pfizer via Vaccine Adverse Events Reporting System (VAERS reference number: 647103) on 21 Nov 2016. This report refers to a 52 years old female patient. Past medical history and concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine patient. Past medical history and concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number: not reported) on an unknown date in 2002. After vaccination on an unknown date in 2002, the patient experienced arm and shoulder pain. Laboratory data was not reported. The patient had received physical therapy for 6 weeks as corrective treatment. The final outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious and causality not reported.
Age: 71.0
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Cough, Decreased appetite, Influenza like illness, Malaise, Secretion discharge
Clinical narrative: Case number PHHY2016US161373, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 648189) website on 21 Nov 2016. This report refers to a 71 years old male patient. Past medical history included as cardiac operation (heart surgery). Historical medication included as REVATIO on Aug 2013. Current condition included as arteriosclerosis (hardening of the arteries in his heart), cardiac catheterization (heart catheterization) (patient had two difference catheterizations, the first in 2012, the second in 2014, and he will have it done again on 8 Dec 2015), congestive heart failure, connective tissue disorder, overlap syndrome, pulmonary hypertension and sleep apnea. Concomitant medication included as Lisinopril for high blood pressure, LIPITOR for cholesterol, Aspirin and Metformin for Diabetes, LASIX, amlodipine, LETAIRIS and BYSTOLIC, spironolactone, treprostinil. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) on 19 Oct 2015. The patient also vaccinated with PREVNAR 13 (other manufacturer, batch number: not reported) on 19 Oct 2015. On an unspecified date of Oct 2015, 10 days following the vaccination patient experienced flu-like symptoms. On an unspecified date of Oct 2015, following the vaccination patient also experienced no appetite, coughing, mucus, swells and ill/patient never has gotten sick like this before. It was also reported that, patient did not require an emergency room or doctor visit but the patient visited the emergency room. The patient received oxygen for mucus. The outcome of events flu-like symptoms, no appetite and coughing was reported as condition improving. The outcome of the event mucus was reported as complete recovery and unknown for swells and ill/never has gotten sick like this before. The final outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 71.0
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Swelling
Clinical narrative: Case number PHHY2016US161373, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 648189) website on 21 Nov 2016. This report refers to a 71 years old male patient. Past medical history included as cardiac operation (heart surgery). Historical medication included as REVATIO on Aug 2013. Current condition included as arteriosclerosis (hardening of the arteries in his heart), cardiac catheterization (heart catheterization) (patient had two difference catheterizations, the first in 2012, the second in 2014, and he will have it done again on 8 Dec 2015), congestive heart failure, connective tissue disorder, overlap syndrome, pulmonary hypertension and sleep apnea. Concomitant medication included as Lisinopril for high blood pressure, LIPITOR for cholesterol, Aspirin and Metformin for Diabetes, LASIX, amlodipine, LETAIRIS and BYSTOLIC, spironolactone, treprostinil. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) on 19 Oct 2015. The patient also vaccinated with PREVNAR 13 (other manufacturer, batch number: not reported) on 19 Oct 2015. On an unspecified date of Oct 2015, 10 days following the vaccination patient experienced flu-like symptoms. On an unspecified date of Oct 2015, following the vaccination patient also experienced no appetite, coughing, mucus, swells and ill/patient never has gotten sick like this before. It was also reported that, patient did not require an emergency room or doctor visit but the patient visited the emergency room. The patient received oxygen for mucus. The outcome of events flu-like symptoms, no appetite and coughing was reported as condition improving. The outcome of the event mucus was reported as complete recovery and unknown for swells and ill/never has gotten sick like this before. The final outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 43.0
Sex: M
Vaccine: FLUX
Symptoms: Antinuclear antibody, Blood immunoglobulin A, Blood immunoglobulin G, Blood magnesium, Blood phosphorus
Clinical narrative: Case number PHHY2016US163535 is an initial spontaneous report received from other health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 648198) on 21 Nov 2016. This report refers to 43 year old male patient. Historical condition included allergic rhinitis, Non-Hodgkin's lymphoma (in remission 3.5 year) and upper respiratory tract infection (illness/other in 4 weeks prior to onset of (Guillain-Barre syndrome) GBS symptoms). Concomitant medications were not reported. On an unspecified date, 10 days following the vaccination, patient experienced paresthesias, numbness, left side facial droop and weakness in all limbs. The patient was diagnosed with Guillain-Barre syndrome. Lab data included electromyography which was positive for mild acute demyelination. Other lab tests included complete blood count, comprehensive metabolic panel, magnesium, phosphorus, serum IgA, IgG, erythrocyte sedimentation rate and antinuclear antibodies (normal range and results not reported). The patient received corrective treatments included as Prednisolone and Acyclovir (for presumed Bell's palsy) and IVIG (intravenous immunoglobulin). The outcome of the events was reported as condition unchanged. The seriousness and causality of the events was not reported. Seriousness assessment of the event Guillain-Barre syndrome was upgraded (medically significant) based on NVS IME list.
Age: 43.0
Sex: M
Vaccine: FLUX
Symptoms: Demyelination, Electromyogram abnormal, Facial paralysis, Full blood count, Guillain-Barre syndrome
Clinical narrative: Case number PHHY2016US163535 is an initial spontaneous report received from other health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 648198) on 21 Nov 2016. This report refers to 43 year old male patient. Historical condition included allergic rhinitis, Non-Hodgkin's lymphoma (in remission 3.5 year) and upper respiratory tract infection (illness/other in 4 weeks prior to onset of (Guillain-Barre syndrome) GBS symptoms). Concomitant medications were not reported. On an unspecified date, 10 days following the vaccination, patient experienced paresthesias, numbness, left side facial droop and weakness in all limbs. The patient was diagnosed with Guillain-Barre syndrome. Lab data included electromyography which was positive for mild acute demyelination. Other lab tests included complete blood count, comprehensive metabolic panel, magnesium, phosphorus, serum IgA, IgG, erythrocyte sedimentation rate and antinuclear antibodies (normal range and results not reported). The patient received corrective treatments included as Prednisolone and Acyclovir (for presumed Bell's palsy) and IVIG (intravenous immunoglobulin). The outcome of the events was reported as condition unchanged. The seriousness and causality of the events was not reported. Seriousness assessment of the event Guillain-Barre syndrome was upgraded (medically significant) based on NVS IME list.
Age: 43.0
Sex: M
Vaccine: FLUX
Symptoms: Hypoaesthesia, Immunoglobulin therapy, Metabolic function test, Muscular weakness, Paraesthesia
Clinical narrative: Case number PHHY2016US163535 is an initial spontaneous report received from other health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 648198) on 21 Nov 2016. This report refers to 43 year old male patient. Historical condition included allergic rhinitis, Non-Hodgkin's lymphoma (in remission 3.5 year) and upper respiratory tract infection (illness/other in 4 weeks prior to onset of (Guillain-Barre syndrome) GBS symptoms). Concomitant medications were not reported. On an unspecified date, 10 days following the vaccination, patient experienced paresthesias, numbness, left side facial droop and weakness in all limbs. The patient was diagnosed with Guillain-Barre syndrome. Lab data included electromyography which was positive for mild acute demyelination. Other lab tests included complete blood count, comprehensive metabolic panel, magnesium, phosphorus, serum IgA, IgG, erythrocyte sedimentation rate and antinuclear antibodies (normal range and results not reported). The patient received corrective treatments included as Prednisolone and Acyclovir (for presumed Bell's palsy) and IVIG (intravenous immunoglobulin). The outcome of the events was reported as condition unchanged. The seriousness and causality of the events was not reported. Seriousness assessment of the event Guillain-Barre syndrome was upgraded (medically significant) based on NVS IME list.
Age: 43.0
Sex: M
Vaccine: FLUX
Symptoms: Red blood cell sedimentation rate
Clinical narrative: Case number PHHY2016US163535 is an initial spontaneous report received from other health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 648198) on 21 Nov 2016. This report refers to 43 year old male patient. Historical condition included allergic rhinitis, Non-Hodgkin's lymphoma (in remission 3.5 year) and upper respiratory tract infection (illness/other in 4 weeks prior to onset of (Guillain-Barre syndrome) GBS symptoms). Concomitant medications were not reported. On an unspecified date, 10 days following the vaccination, patient experienced paresthesias, numbness, left side facial droop and weakness in all limbs. The patient was diagnosed with Guillain-Barre syndrome. Lab data included electromyography which was positive for mild acute demyelination. Other lab tests included complete blood count, comprehensive metabolic panel, magnesium, phosphorus, serum IgA, IgG, erythrocyte sedimentation rate and antinuclear antibodies (normal range and results not reported). The patient received corrective treatments included as Prednisolone and Acyclovir (for presumed Bell's palsy) and IVIG (intravenous immunoglobulin). The outcome of the events was reported as condition unchanged. The seriousness and causality of the events was not reported. Seriousness assessment of the event Guillain-Barre syndrome was upgraded (medically significant) based on NVS IME list.
Age: 12.0
Sex: F
Vaccine: DTAP, HPV9, MNQ
Symptoms: Anxiety, Major depression, Presyncope
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring to a 12 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 05-AUG-2015, the patient was vaccinated with a first dose of GARDASIL 9 injection (strength, dose, route, anatomical location, lot number and expiration date were not provided), for prophylaxis. On the same date, the patient was vaccinated with DTaP (strength, dose, route, anatomical location, lot number and expiration date were not provided), and MENACTRA (strength, dose, route, anatomical location, lot number and expiration date were not provided), both also for prophylaxis. It was reported that since the GARDASIL 9 administration on 05-AUG-2015, the patient experienced vasovagal responses (presyncope) 8 to 10 times per day at school. Therefore, the patient was prescribed sodium tablets and increased hydration. Consequently, the patient recovered from the presyncope on an unspecified date; however, on unknown dates, she was diagnosed with a major depressive disorder and anxiety. No product quality complaint was involved. At the time of reporting, the outcome of major depressive disorder and anxiety was unknown. The causal relationship between all aforementioned events with GARDASIL 9, diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (DTaP), and MENACTRA was not reported. Upon internal review, major depressive disorder was determined to be a medically significant event. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: FLUX, HEPAB, MMRV, PPV
Symptoms: Injection site rash, Urticaria
Clinical narrative: Case number PHHY2016US163977, is an initial spontaneous report received from a healthcare professional via Vaccine Adverse Event Reporting System (VAERS reference number: 649674) website on 21 Nov 2016. This report refers to a 01-year-old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) intramuscularly on 22 Aug 2016. The patient was also vaccinated with TWINRIX (GlaxoSmithKline Biologicals, batch number: not reported), PROQUAD (Merck and Co. Inc., batch number: not reported) and pneumococcal vaccine (unknown manufacturer, batch number: not reported), all intramuscularly on 22 Aug 2016. On 24 Aug 2016, the patient had a small rash on thigh around injection site, which then spread to other thigh. The patient developed hives on back, neck, chest and abdomen. The reporter called the doctor's office and the nurse said that this was normal reaction for 7 day out from vaccinations. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events was not reported. The seriousness of all events was upgraded to medically significant based on the information provided in the source document.
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: Insomnia, Pruritus generalised
Clinical narrative: Case number PHHY2016US182412, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 651196) on 21 Dec 2016. This report refers to a 65 years old female patient. Medical history was not reported. Concomitant medication included escitalopram, NEXIUM, atorvastatin, clonazepam, amitriptyline, oxycodone, levothyroxine, metformin, estradiol, bupropion, ibuprofen. The patient was vaccinated with FLUAD (batch number: 165803) in to left arm on 01 Sep 2016. On 02 Sep 2016 after vaccination, the patient woke up during night and was feeling itchy all over, unable to sleep. It was reported that, the events gradually subsided over 03 days and till date it was gone. The outcome of the events was reported as complete recovery. The seriousness of the events was reported as non serious and causality was not reported. Seriousness assessment of the event pruritus generalised was upgraded based on information available in the source document.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Back pain, Epistaxis, Fatigue, Injection site erythema
Clinical narrative: Case number PHHY2016US163735, is an initial spontaneous report received from a healthcare professional via the Vaccine Adverse Reporting System (VAERS reference number: 644218) website on 21 Nov 2016. This report refers to a 56-years-old female patient. Past medical history of drugs included Sulfur and ZOFRAN. Current conditions included migraine headaches. Concomitant medications Metoprolol, HCTZ, Estradiol, Aspirin, Lisinopril, QVAR, nasal spray (unspecified). The patient was vaccinated with seasonal influenza vaccine inn (manufacturer unknown and batch number: not reported) intramuscularly in left arm on 09 Sep 2016. On 10 Sep 2016, the patient experienced fever 101 (units and normal range unspecified), body aches, swollen arm, red circle around injection site, stomach pain, nausea, vomiting mucus, tiredness, sore skin, nose bleeding when blow it and severe lower back pain. The patient visited the emergency room. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events was not reported.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Pain, Pain of skin, Peripheral swelling, Pyrexia
Clinical narrative: Case number PHHY2016US163735, is an initial spontaneous report received from a healthcare professional via the Vaccine Adverse Reporting System (VAERS reference number: 644218) website on 21 Nov 2016. This report refers to a 56-years-old female patient. Past medical history of drugs included Sulfur and ZOFRAN. Current conditions included migraine headaches. Concomitant medications Metoprolol, HCTZ, Estradiol, Aspirin, Lisinopril, QVAR, nasal spray (unspecified). The patient was vaccinated with seasonal influenza vaccine inn (manufacturer unknown and batch number: not reported) intramuscularly in left arm on 09 Sep 2016. On 10 Sep 2016, the patient experienced fever 101 (units and normal range unspecified), body aches, swollen arm, red circle around injection site, stomach pain, nausea, vomiting mucus, tiredness, sore skin, nose bleeding when blow it and severe lower back pain. The patient visited the emergency room. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events was not reported.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: Case number PHHY2016US163735, is an initial spontaneous report received from a healthcare professional via the Vaccine Adverse Reporting System (VAERS reference number: 644218) website on 21 Nov 2016. This report refers to a 56-years-old female patient. Past medical history of drugs included Sulfur and ZOFRAN. Current conditions included migraine headaches. Concomitant medications Metoprolol, HCTZ, Estradiol, Aspirin, Lisinopril, QVAR, nasal spray (unspecified). The patient was vaccinated with seasonal influenza vaccine inn (manufacturer unknown and batch number: not reported) intramuscularly in left arm on 09 Sep 2016. On 10 Sep 2016, the patient experienced fever 101 (units and normal range unspecified), body aches, swollen arm, red circle around injection site, stomach pain, nausea, vomiting mucus, tiredness, sore skin, nose bleeding when blow it and severe lower back pain. The patient visited the emergency room. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events was not reported.
Sex: M
Vaccine: FLUX
Symptoms: Injection site haemorrhage, Injection site pain
Clinical narrative: Case number PHHY2016US162337, is an initial spontaneous report received from a consumer (patient's friend) via Vaccine Adverse Event Reporting System (VAERS) website (VAERS reference number: 645333) on 21 Nov 2016. This report refers to a male patient, of an unknown age. Medical history and concomitant medication were not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number and expiration date were not reported) from an unknown start date. On an unspecified date following the vaccination, the patient experienced pain upon vaccination and when the needle was withdrawn, the patient had bleeding and small drop of clear fluid at site. It was reported that, the patient went for FLUZONE HD vaccination but was not sure which flu vaccine he received and he also thought that it looked like more than 0.5 ml dose. The outcome of the events was complete recovery. The seriousness and causality assessment for the events were not reported.
Age: 68.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling
Clinical narrative: Case number PHHY2016US166704, is an initial spontaneous report received from a pharmacist via Vaccine Adverse Event Reporting System (VAERS reference number: 654422) website on 21 Nov 2016. This report refers to a 68 years old female patient. Prior vaccination history included as, patient vaccinated with PREVNAR 13 vaccine (other manufacturer, batch number: not reported) on 23 Nov 2015. Past medical history was not reported. Current condition included as allergy to sulfa (drug hypersensitivity). Concomitant medication included as CRESTOR. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) on 14 Sep 2016. The patient also vaccinated with PNEUMOVAX 23 vaccine (other manufacture, batch number: M003027 and expiry date: 21 Jun 2017) into left arm, subcutaneously on 14 Sep 2016. On 14 Sep 2016, the patient experienced an adverse effect described as a softball size swelling at the injection site of the left arm and redness, which later spread to the elbow. On an unknown date in Sept 2016, the patient sought medical attention at an unspecified urgent care center and was prescribed KEFLEX 500 mg, three times per day and unspecified steroid creams as treatment of the events. The pharmacist reported that the patient sought medical attention again on 16 Sep 2016, in an emergency room, because the redness had spread past her elbow into the forearm. It was reported that the patient was most likely going to be admitted into the hospital because of the events. The outcome of the events was reported as condition unchanged. Upon internal review, the events of softball-sized swelling at the injection site and redness were determined to be medically significant. The seriousness of event redness had spread past her elbow into the forearm was not reported. The causality of the events was not reported with both the suspect drug.
Age: 54.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: Case number PHHY2017US019960, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 654458) on 23 Jan 2017. This report refers to a 54 years old male patient. Medical history was reported as the patient underwent heart ablation the prior day of vaccination. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number: not reported) and into left arm intramuscularly the pneumococcal vaccine polyvalent (polysaccharide vaccine) (other manufacturer, batch number: not reported) on 20 Sep 2016. On same day after vaccination, the patient's left arm where shot was give became very sore, as the night went on it became very hard to move or sleep. The patient stated that, this vaccine should really not be offered after any serious procedure, in my case after a heart operation, the affect of the shot have really worsened his recovery as the arm was not almost unusable. The outcome of the events was reported as unknown. The seriousness of the events was reported as non serious and causality was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Drug intolerance, No adverse event
Clinical narrative: Case Number PHHY2017US020060 is an initial spontaneous report received from other healthcare professional via vaccine adverse event reported system (Vaers number: 654770) website on 23 Jan 2017. This report female patient of unspecified age. Medical history and concomitant medication was not reported. The patient was vaccinated with Seasonal influenza virus vaccine INN (manufacturer unknown) on an unspecified date and patient did not tolerated to flu vaccine. No adverse event was reported following this (drug intolerance).
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Bladder discomfort, Urinary retention, Vision blurred
Clinical narrative: Case number PHHY2016US162017, is an initial spontaneous report received from a healthcare professional via the Vaccine Adverse Event Reporting System (VAERS reference number: 656473) website on 21 Nov 2016. This report refers to a 50-years-old female patient. Past medical history included and Raynaud's disease and TYLENOL right after the vaccination. It was also reported that, she underwent TB skin test TUBERSOL (results unspecified) and was dairy free for about a month. Current conditions included inflammatory process during allergy season that cause joints to swell, sensitivity to Gluten, turned red to CIPRO and Splenda. Concomitant medications included minocycline and BENADRYL and Multivitamins (reported as Opti Women Vitamins). The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown and batch number: not reported) intramuscularly in left arm on 28 Sep 2016. On the same day after vaccination, the patient experienced blurred eye all the day, bladder felt full and did not felt like she could void it, which lasted the day and next day. The patient reported that it was odd and bad too. She also stated that, she attributed it to the flu shot but was not certain what caused it. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Gait disturbance, Nausea, Retching
Clinical narrative: Case number PHHY2016US162873, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 656518) website on 21 Nov 2016. This report refers to a 65-years-old male patient. Past medical history was not reported. Current conditions included as aortic dissection and walker user. Concomitant medications included fluticasone propionate, metoprolol, simvastatin, fenofibrate, Warfarin sodium clathrate, ferrous sulfate, Multivitamin, HSO Probiotic Formula, Dietary Fiber, ZYRTEC, Acetaminophen and GAS-X. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown and batch number: not reported) in left arm on 30 Sep 2016. On the same day after vaccination, the patient developed extreme dizziness, unable to walk to restroom without assistance and nausea. It lasted for 30 minutes. It was also reported that, the patient heaved with some saliva and a little bile in bathroom. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious. The causality of the events was not reported. The seriousness of all event dizziness was upgraded to serious (medically significant) based on the information provided in the source document.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Heart rate increased, Injection site pruritus, Pruritus generalised
Clinical narrative: Case number PHHY2016US164436, is an initial spontaneous report received from a healthcare professional via the Vaccine Adverse Event Reporting System (VAERS reference number: 657017) website on 21 Nov 2016. This report refers to a 32-years-old female patient of unknown age. Past medical history was not reported. Current condition included physical birth defects with many hands and one arm, several food allergies to all seafood and fresh water fish, nuts, melons and spinach. Concomitant medications included MOBIC and TRI-SPRINTEC. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown and batch number: not reported) on 09 Nov 2015. On the same day after vaccination, the patient experienced heart rate increased, severe itch. The itch started in the arm where the patient was vaccinated and spread to whole body. It was reported that, the itch stopped after antihistamines (unspecified) were administered. The outcome of the events was reported as complete recovery on an unknown date. Events were reported as non serious. The causality of the events was not reported. The seriousness of event pruritus generalized was upgraded to medically significant based on the information provided in the source document.
Age: 56.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHHY2017US020053, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 657335) website on 23 Jan 2017. This report refers to a 56 years old female patient. Medical history was not reported. Current illness was reported as none. Concomitant medication was not reported. She was vaccinated with INFANRIX (other manufacturer, batch number: not reported) intramuscularly into the arm on 14 Sep 2016 instead of seasonal influenza vaccine. No adverse event was reported following this maladministration (wrong vaccine administered).