chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUA3, PNC13, FLUA3, PNC13
Symptoms: Vertigo, Vomiting
Clinical narrative: This spontaneous case initially received on 12-Apr-2017 was reported by other non-health professional via regulatory authority (vaccine adverse event reporting system: 679846) and concerns a 68-year-old female patient. Administration of Company suspect drug: On 26-Jan-2017, the patient was administered with FLUAD (TIV), (batch  number: 166101, dosage:0.5ml) via intramuscular route in left arm. Indication not reported. Non-company suspect drug: On 26-Jan-2017, the patient was administered with PREVNAR 13 (batch number: Q02071, dosage: not reported) via intramuscular route in left arm. Indication not reported. Adverse reactions/events and outcomes: On 27-Jan-2017 at 3:30 the patient had diarrhea, nausea, vomiting, headache, soreness, vertigo, dizziness. It was reported that both vaccines FLUAD and pneumococcal vaccine were administered on left arm which is characterized as drug administration error. Action taken with the FLUAD (TIV) was not reported and outcome of the all was not reported. Reporter's Assessment: The other non-health professional did not provide the causality between the all events and FLUAD (TIV). This report was not serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Rash, Swelling
Clinical narrative: Case number PHEH2015US026396, is an initial spontaneous report received from a physician on 15 Dec 2015. This report refers to a years-old female patient. Past medical history included sore throat and swelling on eucalyptus oil and Vitamin D3 and angiotensin 2 receptor blocker (unspecified) as historical drug. Current condition included kidney transplant on 13 Oct 1992, drug allergies and codeine allergy. Concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) on an unknown date. She experienced rash and swelling on an unknown date. On 28 May 2015, she received valsartan (manufacturer unknown) at an unknown dose and experienced allergy to red dyes and migraines (please case # PHEH2015US010768). The outcome, seriousness and causality of the events was not reported. Follow up received on 12-Apr-2017: Updated VAERS ID: 679873.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Asthenia, Chills, Dyspnoea, Fatigue
Clinical narrative: This Spontaneous case initially received via vaccine adverse event reaction systems (VAERS ID: 679903) on Apr-2017, was reported by other non-health professional and concerns a 23-years-old adult female patient. The patient had seafood allergy and was allergic to sulfa drugs. Administration of Company suspect drug: On 26-Jan-2017, the patient was administered with INN Flu vaccine Seasonal dosage, batch number, route of administration: not reported). Adverse reactions/events and outcomes: On 26-Jan-2017 the patient experienced extreme fatigue, chills, weakness, and became impossible to take deep breaths and could hyperventilate. The action taken with INN Flu Vaccine Seasonal was not reported and the outcome of the events was recovered. Reporter's Assessment: The reporter did not provided the causality between INN Flu Vaccine Seasonal and events. This report was not serious.
Age: 58.0
Sex: F
Vaccine: FLUX, FLU4, FLUX
Symptoms: Burning sensation, Injection site hypersensitivity, Injection site pain, Paraesthesia
Clinical narrative: This Spontaneous case, initially received via Vaccine Adverse Event Reaction Systems (VAERS ID: 679928) on Apr-2017 was reported by other non-healthcare professional and concerns a 58-year-old adult female patient. The patient's concomitant included SYNTHROID (dose, route of administration, batch number, expiration date: not reported) for an unknown indication. Administration of Company suspect drug: On 06-Jan-2017 the patient was administered by INN Flu Vaccine (route of administration: injection NOS, dose, batch number, expiration date: not reported). Indication not reported. Adverse events/reactions and outcomes: On 19-Jan-2017 after INN Flu Vaccine, the patient experience sun burn feeling in shoulder and upper arm, pins and needles in shoulder and upper arm, tender area where shot was given and skin is hypersensitive flu shot given. The outcome of the events was unknown. The action taken after INN Flu Vaccine was not reported. Reporter's Assessment: The other non-healthcare professional assessed sun burn feeling in shoulder and upper arm, pins and needles in shoulder and upper arm, tender area where shot was given and skin is hypersensitive flu shot given as non-serious and the causality of the events were not reported. This case report was non-serious.
Age: 58.0
Sex: F
Vaccine: FLUX, FLU4, FLUX
Symptoms: Hyperaesthesia, Injection site reaction
Clinical narrative: This Spontaneous case, initially received via Vaccine Adverse Event Reaction Systems (VAERS ID: 679928) on Apr-2017 was reported by other non-healthcare professional and concerns a 58-year-old adult female patient. The patient's concomitant included SYNTHROID (dose, route of administration, batch number, expiration date: not reported) for an unknown indication. Administration of Company suspect drug: On 06-Jan-2017 the patient was administered by INN Flu Vaccine (route of administration: injection NOS, dose, batch number, expiration date: not reported). Indication not reported. Adverse events/reactions and outcomes: On 19-Jan-2017 after INN Flu Vaccine, the patient experience sun burn feeling in shoulder and upper arm, pins and needles in shoulder and upper arm, tender area where shot was given and skin is hypersensitive flu shot given. The outcome of the events was unknown. The action taken after INN Flu Vaccine was not reported. Reporter's Assessment: The other non-healthcare professional assessed sun burn feeling in shoulder and upper arm, pins and needles in shoulder and upper arm, tender area where shot was given and skin is hypersensitive flu shot given as non-serious and the causality of the events were not reported. This case report was non-serious.
Age: 58.0
Sex: F
Vaccine: FLUX, FLU4, FLUX
Symptoms: Burning sensation, Hyperaesthesia, Injection site pain, Injection site reaction, Paraesthesia
Clinical narrative: This Spontaneous case, initially received via Vaccine Adverse Event Reaction Systems (VAERS ID: 679928) on Apr-2017 was reported by other non-healthcare professional and concerns a 58-year-old adult female patient. The patient's concomitant included SYNTHROID (dose, route of administration, batch number, expiration date: not reported) for an unknown indication. Administration of Company suspect drug: On 06-Jan-2017 the patient was administered by INN Flu Vaccine (route of administration: injection NOS, dose, batch number, expiration date: not reported). Indication not reported. Adverse events/reactions and outcomes: On 19-Jan-2017 after INN Flu Vaccine, the patient experience sun burn feeling in shoulder and upper arm, pins and needles in shoulder and upper arm, tender area where shot was given and skin is hypersensitive flu shot given. The outcome of the events was unknown. The action taken after INN Flu Vaccine was not reported. Reporter's Assessment: The other non-healthcare professional assessed sun burn feeling in shoulder and upper arm, pins and needles in shoulder and upper arm, tender area where shot was given and skin is hypersensitive flu shot given as non-serious and the causality of the events were not reported. This case report was non-serious.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Uveitis
Clinical narrative: This spontaneous case initially received on 12-Apr-2017 was reported by other non-health professional via Vaccine Adverse Event Reporting System (VAERS ID: 680075) and concerns a 61 year old male patient. Administration of Company suspect drug: On 28-Oct-2015, the patient received INN Flu Vaccine Seasonal (dose, expiry date, batch number, route of administration: not reported). On an unspecified date, the patient also received Zoster vaccine (dose, expiry date, batch number, route of administration: not reported). Adverse reactions/events and outcomes: On 30-Nov-2015 after administration of influenza vaccine, the patient experienced uveitis. Action taken with the vaccine was not reported. Treatment medications: acyclovir, glaucoma drops and topical steroids over the last twelve months. The outcome of the event was recovered/resolved. Reporter's Assessment: The reporter did not provide the causality of the event in relation to the INN Flu Vaccine Seasonal. The reporter stated that the event could be related to the zoster vaccine. Health Authority considered the case as non-serious.
Age: 31.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Influenza
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by an other-non health professional and regulatory authority (reference no: 680197) and concerns a 31 years old male patient. Administration of Company suspect drug(s): On 01-Oct-2016, patient was administered with influenza vaccine (dosage, route of administration, anatomical location: not reported). Adverse reactions/events and outcomes: On an unspecified date, the patient was diagnosed with probable influenza by personal physician. Action taken with the suspect product and outcome was not reported. Reporter's Assessment: The regulatory authority did not provide any causality assessment. This report is serious (medically significant).
Sex: M
Vaccine: FLUX, HEPA, MMR, VARCEL, FLUX, HEPA, MMR, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by other non-health professional via regulatory authority (vaccine adverse event reporting system:680748) and concerns a 1-year-old male patient. Administration of Company suspect drug: On 30-Jan-2017, the patient was administered with INN Flu Vaccine Seasonal (batch number, dose, route of administration, indication: not reported). Non-company suspect drug: On 30-Jan-2017, the patient was administered with Hepatitis A (batch number, dose, route of administration, indication: not reported), Measles mumps and rubella live attenuated free (batch number, dose, route of administration, indication: not reported) and VARIVAX (batch number, dose, route of administration, indication: not reported). Adverse reactions/events and outcomes: On 01-Feb-2017, the patient had Febrile seizure. Action taken with the INN Flu Vaccine Seasonal, Hepatitis A, Measles mumps and rubella live attenuated free, VARIVAX was not reported and outcome of the event was recovered. Reporter's Assessment: The reporter did not provide the causality between the event and INN Flu Vaccine Seasonal. This report was not serious.
Age: 81.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Malaise
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by other Non-health professional via regulatory authority (VAERS ID: 680826) and concerns a 81-years-old male patient. Patient's historical condition included: pneumonia. In 1992 the patient got sick after flu shot and didn't take it again till 1998. The patient became sick and took shot for pneumonia last winter. Administration of Company suspect drug: On 21-Jan-2017, the patient was administered with influenza virus vaccine polyvalent (dosage, route of administration, anatomical location: unknown). Adverse reactions/events and outcomes: on 21-Jan-2017, unspecified time after administration of influenza virus vaccine polyvalent, the patient got sick. The patient did not receive any corrective treatment. The action taken with influenza virus vaccine polyvalent was not reported. The outcome of the event was not reporter. Reporter's Assessment: The reporter did not provide the causality between influenza virus vaccine polyvalent and event. This report was not serious.
Age: 35.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain
Clinical narrative: This spontaneous case, initially received via Vaccine Adverse Event Reaction Systems (VAERS ID: 680856) on Apr-2017, was reported by other non-healthcare professional and concerns 35-year-old female patient. The patient's medical history included: diabetes. Administration of Company suspect drug: On 31-Oct-2016, the patient received intramuscular INN Flu Vaccine (batch number: 1618701, dose, expiration and route of administration: not reported, anatomical location: left arm). Indication was not reported. Adverse reactions/events and outcomes: On 01-Nov-2016 after administration of influenza vaccine, the patient experienced pain because of which she could not use in full range of motion and had to visit emergency room. Action taken with influenza vaccine, was not reported. The outcome of the event was not recovered. Reporter's Assessment: The reporter assessed that the causality between influenza vaccine and event as related. This report was not serious.
Age: 35.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: This spontaneous case, initially received via Vaccine Adverse Event Reaction Systems (VAERS ID: 680856) on Apr-2017, was reported by other non-healthcare professional and concerns 35-year-old female patient. The patient's medical history included: diabetes. Administration of Company suspect drug: On 31-Oct-2016, the patient received intramuscular INN Flu Vaccine (batch number: 1618701, dose, expiration and route of administration: not reported, anatomical location: left arm). Indication was not reported. Adverse reactions/events and outcomes: On 01-Nov-2016 after administration of influenza vaccine, the patient experienced pain because of which she could not use in full range of motion and had to visit emergency room. Action taken with influenza vaccine, was not reported. The outcome of the event was not recovered. Reporter's Assessment: The reporter assessed that the causality between influenza vaccine and event as related. This report was not serious.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Asthenia, Mobility decreased, Musculoskeletal pain
Clinical narrative: This spontaneous case initially received on 12-Apr-2017, was reported by other non-health professional via health authority (VAERS ID: 680944) and concerns a 50 years old male patient. Administration of company suspect drug: On 02-Nov-2016, the patient received INN Flu Vaccine Seasonal (dose, expiry date, batch number: not reported, route of administration: injection NOS). Indication was not reported. Adverse reaction/events and outcomes: On 03-Nov-2016, after administration of INN Flu Vaccine Seasonal, the patient experienced shoulder pain (musculoskeletal), loss of strength and movement. Action taken with the suspect vaccine was not reported. Treatment medications: Home therapy, anti-inflammatory and pain pills for severe shoulder pain. The outcome of the events was not recovered. Reporter's Assessment: The reporter did not provided the causality between INN Flu Vaccine Seasonal and events. This case was non-serious.
Age: 51.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Activities of daily living impaired, Grip strength decreased, Injection site pain, Paraesthesia, Sleep disorder
Clinical narrative: This spontaneous case, initially received via Vaccine Adverse Event Reaction Systems (VAERS ID: 681141) on Apr-2017 was reported by other non-healthcare professional and concerns a 51-year-old adult female patient. The patient's concomitant medication included CoQ 10, B12, CENTRUM and Vitamin C (dose, route of administration, batch number, expiration date: not reported) for an unknown indication. Administration of Company suspect drug: On 15-Oct-2016 the patient was administered by INN Flu Vaccine (route of administration, dose, batch number, expiration date: not reported). Indication not reported. Adverse events/reactions and outcomes: On 20-Oct-2016 after INN Flu Vaccine, the patient had difficulty to sleep on that side, have not able to were a hand bag on that shoulder, occasional tingling in fingers of same arm and shoulder pain in arm vaccinated. The outcome of the events was not reported. The action taken after INN Flu Vaccine was not reported. Reporter's Assessment: The other non-healthcare professional assessed difficulty to sleep on that side, have not able to were a hand bag on that shoulder, occasional tingling in fingers of same arm and shoulder pain in arm vaccinated as non-serious and the causality of the events were not reported. This case report was non-serious.
Age: 51.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, Loss of personal independence in daily activities, Paraesthesia, Sleep disorder
Clinical narrative: This spontaneous case, initially received via Vaccine Adverse Event Reaction Systems (VAERS ID: 681141) on Apr-2017 was reported by other non-healthcare professional and concerns a 51-year-old adult female patient. The patient's concomitant medication included CoQ 10, B12, CENTRUM and Vitamin C (dose, route of administration, batch number, expiration date: not reported) for an unknown indication. Administration of Company suspect drug: On 15-Oct-2016 the patient was administered by INN Flu Vaccine (route of administration, dose, batch number, expiration date: not reported). Indication not reported. Adverse events/reactions and outcomes: On 20-Oct-2016 after INN Flu Vaccine, the patient had difficulty to sleep on that side, have not able to were a hand bag on that shoulder, occasional tingling in fingers of same arm and shoulder pain in arm vaccinated. The outcome of the events was not reported. The action taken after INN Flu Vaccine was not reported. Reporter's Assessment: The other non-healthcare professional assessed difficulty to sleep on that side, have not able to were a hand bag on that shoulder, occasional tingling in fingers of same arm and shoulder pain in arm vaccinated as non-serious and the causality of the events were not reported. This case report was non-serious.
Age: 40.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: This Spontaneous case, initially received via Vaccine Adverse Event Reaction Systems (VAERS ID: 681147) on Apr-2017, was reported by other non-healthcare professional and concerns a 40-years-old male patient. The concomitant drugs included; venlafaxine and nadolol. Administration of Company suspect drug: On 02-Feb-2017, the patient was administered by INN Flu Vaccine (route of administration: intramuscular, anatomical location: left arm, dosage, batch number: not reported). Indication was not reported. Adverse reactions/events and outcomes: On 02-Feb-2017 after administration of INN Flu Vaccine, the patient developed chills, fever 101.6, aching and pain in legs. The action taken with INN Flu Vaccine was not reported. The outcome of the events was not reported. Reporter's Assessment: The reporter did not provide the causality between INN Flu Vaccine and events. This report was not serious.
Age: 40.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: This Spontaneous case, initially received via Vaccine Adverse Event Reaction Systems (VAERS ID: 681147) on Apr-2017, was reported by other non-healthcare professional and concerns a 40-years-old male patient. The concomitant drugs included; venlafaxine and nadolol. Administration of Company suspect drug: On 02-Feb-2017, the patient was administered by INN Flu Vaccine (route of administration: intramuscular, anatomical location: left arm, dosage, batch number: not reported). Indication was not reported. Adverse reactions/events and outcomes: On 02-Feb-2017 after administration of INN Flu Vaccine, the patient developed chills, fever 101.6, aching and pain in legs. The action taken with INN Flu Vaccine was not reported. The outcome of the events was not reported. Reporter's Assessment: The reporter did not provide the causality between INN Flu Vaccine and events. This report was not serious.
Age: 66.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Arthralgia, Pain
Clinical narrative: This spontaneous case, initially received on 12-APR-2017, was reported by other non-health professional via regulatory authority (VAERS ID: 681312) and concerns a 66-years-old female patient. At the time of the event the patient had coeliac disease. The patient's concomitant medication included: Levothyroxine. Administration of Company suspect drug: On 17-Nov-2016, the patient was administered with FLUAD (TIV) (dosage: not reported, batch number: 166101, route of administration: intramuscular and anatomical location: left arm). Adverse reactions/events and outcomes: On 17-Nov-2016, the patient had pain in arm from her elbow down since she received shot. She did not consult doctor yet. The action taken with the influenza vaccine, was not reported. The outcome of the events was not reported. Reporter's Assessment: The reporter did not provide causality between influenza vaccine and events. This report was not serious.
Age: 66.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: This spontaneous case, initially received on 12-APR-2017, was reported by other non-health professional via regulatory authority (VAERS ID: 681312) and concerns a 66-years-old female patient. At the time of the event the patient had coeliac disease. The patient's concomitant medication included: Levothyroxine. Administration of Company suspect drug: On 17-Nov-2016, the patient was administered with FLUAD (TIV) (dosage: not reported, batch number: 166101, route of administration: intramuscular and anatomical location: left arm). Adverse reactions/events and outcomes: On 17-Nov-2016, the patient had pain in arm from her elbow down since she received shot. She did not consult doctor yet. The action taken with the influenza vaccine, was not reported. The outcome of the events was not reported. Reporter's Assessment: The reporter did not provide causality between influenza vaccine and events. This report was not serious.
Age: 71.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by an other-non health professional via regulatory authority (reference no: 681326) and concerns a 71 years old male patient. Administration of Company suspect drug: On 30-Dec-2016, patient was administered with INN Flu Vaccine (dosage: not reported, route of administration: unknown). Adverse reactions/events and outcomes: On 30-Dec-2016, the patient experienced red, sore and itchy. Action take with the suspect product was not reported. Outcome were not recovered/not resolved. The reporter mentioned events appeared after a month later. Reporter's Assessment: The reporter did not provide any causality assessment. The case is non serious.
Age: 38.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Arthropathy, Injection site pain
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, was reported by other non-health professional via regulatory authority (VAERS ID: 681348) and concerns a 38 years old female patient. The patient's current condition included asthma. Concomitant medications included Venlafaxine, Bupropion, Albuterol, Montelukast and Pantoprazole for an unknown indication. Administration of Company suspect drug: On 26-Oct-2016, the patient was administered with INN Flu Vaccine (dosage: unknown, route of administration: injection NOS, anatomical location: arm). Adverse reactions/events and outcomes: On 26-Oct-2016, after administration of INN Flu Vaccine, the patient experienced pinched pain at the site of injection in upper arm and affects use of shoulder. The action taken with the INN Flu Vaccine was not reported. The outcome of the events was not recovered/not resolved. Reporter's Assessment: The reporter did not provided any causality assessment between influenza vaccine, and the events. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This Spontaneous case, initially received via Vaccine Adverse Event Reaction Systems (VAERS ID: 681523) on Apr-2017, was reported by other non-health professional and concerns a 48-years-old adult female patient. The patient's historical drugs included sulfa and penicillin. Administration of Company suspect drug: On 29-Nov-2016, the patient was administered with INN Flu Vaccine (dosage, batch number, route of administration: not reported). Adverse reactions/events and outcomes: On 05-Dec-2016, the patient experienced limited mobility and significant right arm pain. The action taken with INN Flu Vaccine was not reported. The outcome of the events was not reported. Reporter's Assessment: The reporter did not provide the causality between INN Flu Vaccine and events. This report was not serious.
Age: 23.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: This spontaneous case, initially received on 12-APR-2017 was reported by a other non-health professional through FDA VAERS ID: 681543 and concerns a 23 years old female patient. Administration of Company suspect drug(s): On 09-Sep-2016, INN Flu Vaccine was administered (unknown dosage, route of administration: intramuscular). Adverse reactions/events and outcomes: On 09-Sep-2016, INN Flu Vaccine was administered, on the same day the patient experienced severe shoulder pain at site of injection. Range of motion was limited, as the pain lasted for four weeks. The patient was prescribed with oral steroids for 7 days by her family physician. The condition improved after taking 7 days of oral steroid treatment. Action taken was not reported. Outcome of the events injection site pain and joint range of motion decreased is recovered. Reporter's assessment: The Health Authority considered the events injection site pain and joint range of motion decreased as non-serious. Causality between the events (injection site pain and joint range of motion decreased) and vaccine is not reported.
Age: 25.0
Sex: F
Vaccine: FLU4, PPV, FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by other non-health professional via regulatory authority (vaccine adverse event reporting system: 681601) and concerns a 25-years-old adult female patient. Administration of Company suspect drug: On 03-Feb-2017, the patient was administered with influenza vaccine (dose, route of administration, site and batch number: not reported). Non-company suspect drug: On 03-Feb-2017, the patient was administered with Pneumococcal vaccine (dose, route of administration, site and batch number: not reported). Adverse reactions/events and outcomes: On unspecified date the patient developed red, Pain around the site, Swelling around the site. Went to emergency department and got admitted overnight for observation. Action taken with the vaccines was not reported. Outcome of the events were unknown. Reporter's Assessment: The causality between the events and Pneumococcal vaccine and INN flu vaccine seasonal was not reported. This case was serious (hospitalization). Significant case correction received on 19-Apr-2017: The listedness of the events were corrected.
Sex: M
Vaccine: FLUX, MENB, MMR, FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by other health professional (nurse) via health authority (VAERS ID: 681620) and concerns a patient of an unknown age and gender. Administration of Company suspect drug: On an unspecified date in 2015, the patient received influenza vaccine (dose, expiry date, route of administration: not reported) at an unknown site for an unknown indication. Non-company suspect drugs: On an unspecified date, the patient also received MMR vaccine (dose, dose in series, expiry date, route of administration: not reported) and TRUMENBA (dose, dose in series, expiry date, route of administration: not reported) at unknown site for an unknown indication. Adverse reactions/events and outcomes: On an unspecified date after administration of influenza vaccine, the patient had Guillain Barre Syndrome. Action taken with the vaccine was not reported. The lab date and corrective treatment was not reported. The outcome of the event was not reported. The event Guillain Barre Syndrome was considered as serious (medically significant) as per IME list. Reporter's Assessment: The reporter did not provide the causality of the event in relation to the INN Flu Vaccine Seasonal. Health Authority considered the case report as serious (medically significant).
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Blood test normal, Computerised tomogram, Cough, Influenza, Mass
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, was reported by other non-health care professional via regulatory authority (Vaccine Adverse Event Reporting System: 681807) and concerns 70-years-old elderly female patient. The patient's concomitant medication included: AFINITOR. Administration of Company suspect drug(s): On an unspecified date in 2014, the patient was administered with INN Flu Vaccine Seasonal (dosage, batch number, route of administration: not reported). Adverse reactions/events and outcomes: On an unspecified date in 2014, after administration of INN Flu Vaccine Seasonal, the patient caught flu and dry cough. On 03-Nov-2015 the patient had gone through computed tomography (CAT) scan reveals that her tumour was shrinking from 3.7 to 3.5 and blood work was normal. The action taken with the INN flu vaccine seasonal was not reported. The outcome of the events was not reported. Reporter's Assessment: The reporter did not provide the causality between INN flu vaccine seasonal and events. This report was serious (medically significant).
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Blood test normal, Computerised tomogram abnormal, Cough, Influenza, Neoplasm
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, was reported by other non-health care professional via regulatory authority (Vaccine Adverse Event Reporting System: 681807) and concerns 70-years-old elderly female patient. The patient's concomitant medication included: AFINITOR. Administration of Company suspect drug(s): On an unspecified date in 2014, the patient was administered with INN Flu Vaccine Seasonal (dosage, batch number, route of administration: not reported). Adverse reactions/events and outcomes: On an unspecified date in 2014, after administration of INN Flu Vaccine Seasonal, the patient caught flu and dry cough. On 03-Nov-2015 the patient had gone through computed tomography (CAT) scan reveals that her tumour was shrinking from 3.7 to 3.5 and blood work was normal. The action taken with the INN flu vaccine seasonal was not reported. The outcome of the events was not reported. Reporter's Assessment: The reporter did not provide the causality between INN flu vaccine seasonal and events. This report was serious (medically significant).
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Malaise
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by other non-health professional via regulatory authority (vaccine adverse event reporting system: 681808) and concerns an unspecified aged male patient. Administration of Company suspect drug: On an unspecified date, the patient was administered with influenza virus vaccine polyvalent, (unknown dosage, batch number: not reported) via injection route. Adverse reactions/events and outcomes: On unspecified date after administration of INN Flu Vaccine Seasonal the patient felt sick (every time he takes it). Action taken with the AFLURIA QUADRIVALENT was not reported and outcome of the events was not reported. Reporter's Assessment: The reporter did not provide the causality between INN flu vaccine seasonal and the event. This report was not serious.
Age: 55.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site urticaria, Lymph node pain
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by other non-health professional via regulatory authority (VAERS ID; 681877) and concerns a 55-years-old female patient. The patient's allergic condition included medically verified allergies to alternaria mold and historical drug included LEVAQUIN antibiotic. The patient's concomitant medication included desvenlafaxine (dose: 50 mg/day), nabumetone (dose: 750 mg twice/day), chlorthalidone (dose: 25 mg/day), cetirizine (dose: 10 mg/day), hydroxyzine (dose: 50 mg/day) and fish oil. Administration of Company suspect drug: On 06-Feb-2017, the patient received INN Flu Vaccine (dose, expiry date, batch number: not reported) at right arm via injection NOS. Indication was not reported. Administration of Non-Company suspect drug: On 06-Feb-2017 the patient also received flu vaccine (dose, expiry date, batch number, route of administration: not reported at left arm. Adverse reactions/events and outcomes: On 07-Feb-2017 after administration of INN Flu Vaccine, the patient experienced red raised welts, hives, localised within 4-inch radius of injection site and was very painful but not itchy. Welts expanded and merged next 24 hours but did not extend beyond 4 inches of injection site. The patient also experienced swollen lymph nodes and painful in upper arm, armpit, neck on the same side as injection site. The patient had no difficulty in breathing and was recommended oral BENADRYL. Action taken with the suspect vaccine was not reported. The outcome of the events was not reported. Reporter's Assessment: The reporter did not provide the causality of the events in relation to the influenza vaccine. This report was not serious.
Age: 55.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Lymphadenopathy, Urticaria
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by other non-health professional via regulatory authority (VAERS ID; 681877) and concerns a 55-years-old female patient. The patient's allergic condition included medically verified allergies to alternaria mold and historical drug included LEVAQUIN antibiotic. The patient's concomitant medication included desvenlafaxine (dose: 50 mg/day), nabumetone (dose: 750 mg twice/day), chlorthalidone (dose: 25 mg/day), cetirizine (dose: 10 mg/day), hydroxyzine (dose: 50 mg/day) and fish oil. Administration of Company suspect drug: On 06-Feb-2017, the patient received INN Flu Vaccine (dose, expiry date, batch number: not reported) at right arm via injection NOS. Indication was not reported. Administration of Non-Company suspect drug: On 06-Feb-2017 the patient also received flu vaccine (dose, expiry date, batch number, route of administration: not reported at left arm. Adverse reactions/events and outcomes: On 07-Feb-2017 after administration of INN Flu Vaccine, the patient experienced red raised welts, hives, localised within 4-inch radius of injection site and was very painful but not itchy. Welts expanded and merged next 24 hours but did not extend beyond 4 inches of injection site. The patient also experienced swollen lymph nodes and painful in upper arm, armpit, neck on the same side as injection site. The patient had no difficulty in breathing and was recommended oral BENADRYL. Action taken with the suspect vaccine was not reported. The outcome of the events was not reported. Reporter's Assessment: The reporter did not provide the causality of the events in relation to the influenza vaccine. This report was not serious.
Age: 55.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Axillary pain, Erythema, Injection site erythema, Injection site pain, Injection site urticaria
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by other non-health professional via regulatory authority (VAERS ID; 681877) and concerns a 55-years-old female patient. The patient's allergic condition included medically verified allergies to alternaria mold and historical drug included LEVAQUIN antibiotic. The patient's concomitant medication included desvenlafaxine (dose: 50 mg/day), nabumetone (dose: 750 mg twice/day), chlorthalidone (dose: 25 mg/day), cetirizine (dose: 10 mg/day), hydroxyzine (dose: 50 mg/day) and fish oil. Administration of Company suspect drug: On 06-Feb-2017, the patient received INN Flu Vaccine (dose, expiry date, batch number: not reported) at right arm via injection NOS. Indication was not reported. Administration of Non-Company suspect drug: On 06-Feb-2017 the patient also received flu vaccine (dose, expiry date, batch number, route of administration: not reported at left arm. Adverse reactions/events and outcomes: On 07-Feb-2017 after administration of INN Flu Vaccine, the patient experienced red raised welts, hives, localised within 4-inch radius of injection site and was very painful but not itchy. Welts expanded and merged next 24 hours but did not extend beyond 4 inches of injection site. The patient also experienced swollen lymph nodes and painful in upper arm, armpit, neck on the same side as injection site. The patient had no difficulty in breathing and was recommended oral BENADRYL. Action taken with the suspect vaccine was not reported. The outcome of the events was not reported. Reporter's Assessment: The reporter did not provide the causality of the events in relation to the influenza vaccine. This report was not serious.
Age: 55.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Lymphadenopathy, Neck pain, Urticaria
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by other non-health professional via regulatory authority (VAERS ID; 681877) and concerns a 55-years-old female patient. The patient's allergic condition included medically verified allergies to alternaria mold and historical drug included LEVAQUIN antibiotic. The patient's concomitant medication included desvenlafaxine (dose: 50 mg/day), nabumetone (dose: 750 mg twice/day), chlorthalidone (dose: 25 mg/day), cetirizine (dose: 10 mg/day), hydroxyzine (dose: 50 mg/day) and fish oil. Administration of Company suspect drug: On 06-Feb-2017, the patient received INN Flu Vaccine (dose, expiry date, batch number: not reported) at right arm via injection NOS. Indication was not reported. Administration of Non-Company suspect drug: On 06-Feb-2017 the patient also received flu vaccine (dose, expiry date, batch number, route of administration: not reported at left arm. Adverse reactions/events and outcomes: On 07-Feb-2017 after administration of INN Flu Vaccine, the patient experienced red raised welts, hives, localised within 4-inch radius of injection site and was very painful but not itchy. Welts expanded and merged next 24 hours but did not extend beyond 4 inches of injection site. The patient also experienced swollen lymph nodes and painful in upper arm, armpit, neck on the same side as injection site. The patient had no difficulty in breathing and was recommended oral BENADRYL. Action taken with the suspect vaccine was not reported. The outcome of the events was not reported. Reporter's Assessment: The reporter did not provide the causality of the events in relation to the influenza vaccine. This report was not serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Headache
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, was reported by other non-health professional (consumer) via Vaccine Adverse Event Reporting System (VAERS ID: 682052) and concerns a 39-years-old female patient. Administration of Company suspect drug: On 27-Sep-2016, the patient administered with INN Flu Vaccine Seasonal (dosage: unknown, route of administration: injection NOS, anatomical location: arm). Adverse reactions/events and outcomes: On 27-Sep-2016, the patient had a 24/7 headache. The patient reported that, since the end of the September she had been experiencing headache and started that, it was 5th month with her headache. The patient reported that, she had spoken to a couple other people, who have had the same side effect. The action taken with INN Flu Vaccine Seasonal was not reported. The outcome of the event was not recovered/not resolved. Reporter's Assessment: The reporter did not provide causality between INN flu vaccine seasonal and event. This report was not serious.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Drug administered at inappropriate site, Mobility decreased, Pain, Pain in extremity
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by other-non-health professional and regulatory authority (VAERS ID: 682058) and concerns a 14-years-old male patient. Administration of Company suspect drug: On 06-Feb-2017, patient was administered with INN Flu Vaccine Seasonal (route of administration: intramuscular, anatomical location: left arm, dosage, batch number and expiry date: not reported). Adverse reactions/events and outcomes: On 06-Feb-2017, the patient experienced shooting pain down his arm/ not like the usual pain after other shots he had in the past, could not lift his arm over his head/ he could extend his arm minimally/ arm progressively lost range of motion, injection site was very high on his shoulder/ not consistent with the landmarks for IM injections for the deltoid and shooting pain down his arm. It was reported that paediatrician said to ice the shoulder and give ibuprofen. Patient was given ibuprofen treatment but still the patient has problems with range of motion. The action taken with the Inn Flu Vaccine Seasonal was not reported. Outcome of the events were not reported. Reporter's Assessment: The reporter did not provide the causality between INN Flu Vaccine Seasonal and events. This report is not serious.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Drug administered at inappropriate site, Joint range of motion decreased, Mobility decreased, Pain, Pain in extremity
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by other-non-health professional and regulatory authority (VAERS ID: 682058) and concerns a 14-years-old male patient. Administration of Company suspect drug: On 06-Feb-2017, patient was administered with INN Flu Vaccine Seasonal (route of administration: intramuscular, anatomical location: left arm, dosage, batch number and expiry date: not reported). Adverse reactions/events and outcomes: On 06-Feb-2017, the patient experienced shooting pain down his arm/ not like the usual pain after other shots he had in the past, could not lift his arm over his head/ he could extend his arm minimally/ arm progressively lost range of motion, injection site was very high on his shoulder/ not consistent with the landmarks for IM injections for the deltoid and shooting pain down his arm. It was reported that paediatrician said to ice the shoulder and give ibuprofen. Patient was given ibuprofen treatment but still the patient has problems with range of motion. The action taken with the Inn Flu Vaccine Seasonal was not reported. Outcome of the events were not reported. Reporter's Assessment: The reporter did not provide the causality between INN Flu Vaccine Seasonal and events. This report is not serious.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Antinuclear antibody positive, Coordination abnormal, Muscular weakness
Clinical narrative: This spontaneous case, initially received via Vaccine adverse event reaction systems (VAERS ID: 682169) on Apr-2017 was reported by other non-healthcare professional and concerns a 36 years male patient. Administration of Company suspect drug (s): On 10-Oct-2016 the patient administered intramuscular INN Flu Vaccine Seasonal (dose, anatomical site, batch number was not reported). Adverse reactions/events and outcomes: On 11-Oct-2016 after administration of INN Flu Vaccine Seasonal, the patient experienced progressive limb weakness and uncoordination. The antinuclear antibody was positive. Action taken with INN Flu Vaccine Seasonal was not reported. The outcome of events progressive limb weakness and uncoordination was not recovered. Reporter's Assessment: The reporter assessed the events as non-serious and the causality was not reported. This case was non serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous case, initially received via vaccine adverse event reporting system (VAERS ID: 682239) on Apr-2017, was reported by other non-health professional and concerns a 58-years-old adult female patient. Administration of Company suspect drug: On 09-Dec-16 at 11:15, the patient was administered by INN Flu Vaccine Seasonal (anatomical location: left arm, route of administration, dose, batch number, expiration date: not reported). Adverse events/reactions and outcomes: On 09-Dec-16 at 16:30, after administration of INN flu vaccine seasonal, the patient's arm was in extreme pain and not able to move it, up or to the side. The action taken with the INN flu vaccine seasonal was not reported. The outcome of the events was not recovered/not resolved. Reporter's Assessment: The reporter did not provide the causality between INN flu vaccine seasonal and events. This case report was not serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pruritus
Clinical narrative: This spontaneous case, initially received on 12-APR-2017 00:00:00 was reported by other non-health professional through FDA VAERS ID: 682407 and concerns a 82-yearrs old female patient. Administration of Company suspect drug (s): On 21-Dec-2016, INN Flu Vaccine Seasonal was administered (unknown dosage, batch number: Not reported, route of administration: unknown). Adverse reactions/events and outcomes: On 22-Dec-2016 after administration of INN Flu Vaccine Seasonal, the patient experienced itching on upper body and waistline, knees, back of thighs. Applying triamcinolone Acetonide ointment 0.1% with little relief. Action taken was not reported. Outcome of the event pruritus was not reported. Reporter's Assessment: The Health Authority assessed the case as non-serious. The causality of the event pruritus was not reported.
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by other non-health professional and concerns a 78-year-old elderly patient. Administration of Company suspect drug: On 29-Dec-2016, the patient received FLUAD (TIV) (dose: 0.5 ml, batch number: 166002, expiry date: not reported) at left arm via intramuscular route. Adverse reactions/events and outcomes: On 29-Dec-2016 after administration of influenza vaccine the patient experienced pain in left arm for 1 to 4 hours that resolved in 3 to 4 days, but the patient stated that the pain had returned again. On an unspecified date, the patient assessment of the patient was done and it was almost 6 on 1 to 10 pain scale. The patient stated that she had to see MD about the pain. Action taken with the vaccine was not reported. The patient was not recovered from the event. Reporter's Assessment: The reporter assessed the causality of the event considered to be related to the influenza vaccine. This case was non-serious.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Mobility decreased, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by other non-health professional (consumer) Health Authority (VAERS ID: 682469) and concerns a 35 years old female patient. The patient's concomitant medication included methylprednisolone injections, losartan and LOPID. Administration of Company suspect drug: On 10-Nov-2016, the patient received INN Flu Vaccine Seasonal (dose, expiry date, batch number, route of administration: not reported). Adverse reactions/events and outcomes: On 11-Nov-2016 after administration of influenza vaccine, the patient woke up at 3:30 am and was unable to move her neck side to side or up and down. The patient was in extreme pain in her neck and shoulders extending into her arms. The patient had chiropractic adjustments and physical therapy. The action taken with the vaccine was not reported. The outcome of the event was not reported. Reporter's Assessment: Health Authority did not provide the causality assessment of the events in relation to the INN Flu Vaccine Seasonal. This case was non-serious.