chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pyrexia, Sinus congestion, Sinus disorder, Vomiting
Clinical narrative: This Spontaneous case, initially received via vaccine adverse event reaction system (VAERS ID: 674859) on 12-Apr-2017, was reported by other non-health professional and concerns a 76-year-old female patient. Administration of Company suspect drug: On an unspecified date, the patient was administered by influenza virus vaccine polyvalent, (anatomical location, route of administration, dose, batch number, expiration date: not reported) for an unknown indication. Adverse events/reactions and outcomes: On 22-Nov-16, within 4 days of vaccination of INN Flu Vaccine Seasonal, the patient was down and out, sick for two weeks, had flu with fever, vomiting, coughing, cheeks were bright red. On an unspecified date, after vaccination of INN Flu Vaccine Seasonal, the patient had sinus congestion and pain, had allergy, sinuses blew up and received double dose. Treatment medication: The patient's treatment drugs included ADVIL CONGESTION RELIEF from 21-Nov-17 to 22-Nov-17, ibuprofen (200 mg) as corrective medication three shots of Cortisone, pain shot and antibiotic shot. On an unspecified date, the sinuses were so bad and received three shots one day before received two shots of ADVIL. The action taken with INN Flu Vaccine Seasonal was not reported. The outcome of the events was recovering/resolving. Reporter's Assessment: The reporter did not provide the causality between INN Flu Vaccine Seasonal and events. This report was not serious.
Sex: F
Vaccine: FLUX
Symptoms: Allergy to vaccine
Clinical narrative: This spontaneous case, initially received via VAERS on 12-Apr-2017, was reported by a Physician and concerns a 73 years old female patient. Administration of Company suspect drug: On an unspecified date, the patient administered with INN flu vaccine seasonal (Dose, batch number, Route of administration: not reported). Adverse reactions/events and outcomes: The patient reported that, on 29-Nov-2016, with unknown timeframe following the vaccination of INN flu vaccine seasonal the patient developed allergy to vaccine. Lab data and the corrective treatment was not reported. Action taken with INN flu vaccine seasonal was not reported. Outcome for event was unknown. Reporter's Assessment: The reporter did not provide the causality between INN flu vaccine seasonal and event. Company assessed the causality between INN flu vaccine seasonal and event as not related. This report was not serious.
Sex: M
Vaccine: FLUX
Symptoms: Viral upper respiratory tract infection
Clinical narrative: This spontaneous case, initially received from consumer (patient's mother) via other company (Pfizer) (Manufacturer Report Number: 2016553075) through Health Authority (FDA VAERS number: 674861) on 12-Apr-2017 00:00:00 and concerns a male patient of unknown age. Administration of Company suspect drug(s): The patient received INN Flu Vaccine (dose: 0.5 ml) (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unknown date. Adverse reactions/events and outcomes: On an unspecified date, unspecified timeframe (reported as one month ago) following vaccination the patient experienced cold (characterized as: nasopharyngitis). Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. Action taken was not reported. Reporter's Assessment: The causality of the event was not reported. Health Authority considered this case report as non serious.
Sex: M
Vaccine: FLUX
Symptoms: Local swelling, Skin warm
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, was reported by a physician via regulatory authority vaccine adverse event reporting system: 674863) and concerns a 3-years-old child male patient. Administration of Company suspect drug: On 12-Dec-2016 the patient was administered with INN Flu Vaccine Seasonal (dosage, batch number, route of administration: not reported, anatomical location: left arm). Adverse reactions/events and outcomes: On 13-Dec-2016 in the morning the patient experienced significant swelling from shoulder to his antecubital area, and the swelling was circumferential and the area was warm to touch and was non-tender. The physician does not believe that, this was a cellulitis. The patient had previous dose of flu vaccine in the last year. The action taken with the INN flu vaccine seasonal was not reported. The action taken with 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 not serious.
Age: 66.0
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by other non-healthcare professional via Vaccine Adverse Event Reaction Systems (VAERS ID: 674864) and concerns a 66 years old male patient. The patient's concomitant medication included RAPAMUNE, an immunosuppressant (dose, dose in series, batch number, route of administration, expiration date: not reported). Administration of Company suspect drug(s): On 26-Nov-2016, the patient was administered by influenza vaccine (dose, dose in series, batch number, route of administration, expiration date: not reported). Adverse reactions/events and outcomes: On 26-Nov-2016, the patient experienced influenza. The patient was hospitalised on 27-Nov-2016 morning. The outcome of the event was not recovered/not resolved. Reporter's Assessment: The other non-healthcare professional assessed the event influenza was serious (hospitalisation), and the causality between the event and INN Flu vaccine seasonal was not reported. The case report was serious (hospitalisation). Significant case correction received on 19-Apr-2017: The listedness of the event was corrected.
Age: 68.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, was reported by other non-health professional via health authority (FDA VAERS number: 674904) and concerns a 68-years-old male patient. The patient's medical history included: loss of appetite, 2 episodes of fatigue, headache. At the time of the event the patient had prostate cancer metastatic, hot flush, contusion, depression, fatigue (third episode) joint ache and was on drug XTANDI 120mg daily. Administration of Company suspect drug: On 07-Nov-2016, the patient received influenza virus vaccine polyvalent, batch number, route of administration: not reported. Non-company suspect drug: 0n 07-Nov-2016, PNEUMOVAX (lot number: 1539683PC, 1543982PC, 1553886PC, dosage and route of administration: not reported). Adverse reactions/events and outcomes: On an unknown date in November 2016 after administration of INN Flu Vaccine Seasonal, PNEUMOVAX, the patient experienced Injection site pain, Soreness in arm. The action taken with INN Flu Vaccine Seasonal was not reported. The outcome of the events was not recovered. Reporter's Assessment: The reporter did not provide the causality between INN Flu Vaccine Seasonal and events. This report was not serious.
Age: 4.0
Sex: M
Vaccine: FLUX
Symptoms: Excessive eye blinking, Eye movement disorder, Neck pain, Pyrexia, Tic
Clinical narrative: This Spontaneous case, initially received via VAERS on 12-Apr-2017, was reported by a other non-health professional and concerns a 4 years old male child patient. Concomitant drug administered: PRILOSEC. Administration of Company suspect drug: On 14-Oct-2016, the patient administered with INN flu vaccine, (Dose, batch number, Route of administration: not reported). Adverse reactions/events and outcomes: The reporter reported that, on 20-Oct-2016 child began excessive blinking. Then woke up in the night with fever, sore neck. The child has had eye rolls and tics ever since. Went to paediatrician's, found nothing. Action taken with INN flu vaccine was not reported. Outcome for events was unknown. Reporter's Assessment: The reporter did not provide the causality between INN flu vaccine and events. Company assessed the causality between INN flu vaccine and events as related. This report was not serious.
Age: 73.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Eye disorder, Eye swelling, Lip swelling, Pterygium, Urticaria
Clinical narrative: This spontaneous case, initially received on 12-APR-2017 00:00:00 was reported by a other non-health Professional through Health Authority (FDA VAERS number: 675120) and concerns a 73 Years old male patient. The patient medical history included heart attack, hypothyroidism. The patient's concomitant medication included : levothyroxine, pravastatin. Administration of Company suspect drug(s): On 17-Nov-2016, INN Flu Vaccine Seasonal was administered for unknown indication (dose: 0.5 ml, unknown duration, batch number: not reported, Route of administration: unknown). Non-company suspect drug(s): On 17-Nov-2016, Pneumococcal vaccine polyvalent was administered for unknown indication (unspecified dose, unknown duration, batch number: not reported, Route of administration: unknown). Adverse reactions/events and outcomes: On 01-Dec-2016, after administration of INN Flu Vaccine Seasonal, Pneumococcal vaccine polyvalent, the patient experienced welts all over body, lip/eye swelling Growth on left eye pterygium which was clear/pinkish turned milky white. Both eyes are foggy. Went to the doctor a week ago, and recommended over the counter antihistamines which have helped. The patient experienced the same symptoms before 25 years when she received the Flu vaccine. Current status, eye problems continued. Action taken was not reported. Outcome of the event eye problems was reported as not recovered (continued) and for the other events was unknown. Reporter's Assessment: The Health Authority considered the case as non-serious and the causality of the events were not reported.
Age: 73.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Vision blurred
Clinical narrative: This spontaneous case, initially received on 12-APR-2017 00:00:00 was reported by a other non-health Professional through Health Authority (FDA VAERS number: 675120) and concerns a 73 Years old male patient. The patient medical history included heart attack, hypothyroidism. The patient's concomitant medication included : levothyroxine, pravastatin. Administration of Company suspect drug(s): On 17-Nov-2016, INN Flu Vaccine Seasonal was administered for unknown indication (dose: 0.5 ml, unknown duration, batch number: not reported, Route of administration: unknown). Non-company suspect drug(s): On 17-Nov-2016, Pneumococcal vaccine polyvalent was administered for unknown indication (unspecified dose, unknown duration, batch number: not reported, Route of administration: unknown). Adverse reactions/events and outcomes: On 01-Dec-2016, after administration of INN Flu Vaccine Seasonal, Pneumococcal vaccine polyvalent, the patient experienced welts all over body, lip/eye swelling Growth on left eye pterygium which was clear/pinkish turned milky white. Both eyes are foggy. Went to the doctor a week ago, and recommended over the counter antihistamines which have helped. The patient experienced the same symptoms before 25 years when she received the Flu vaccine. Current status, eye problems continued. Action taken was not reported. Outcome of the event eye problems was reported as not recovered (continued) and for the other events was unknown. Reporter's Assessment: The Health Authority considered the case as non-serious and the causality of the events were not reported.
Sex: F
Vaccine: FLUA3
Symptoms: Injection site pain, Musculoskeletal pain, Pain, Pain in extremity
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: 675139) and concerns a 65-year-old elderly female patient. Administration of Company suspect drug: On 23-Nov-2016 the patient was administered with FLUAD (TIV) (0.5 ml, Batch number: 165801) via intramuscular route. Adverse reactions/events and outcomes: On 23-Nov-2016, the patient had pain at injection site, severe pain in left arm and shoulder. The patient had seen her physician after 2 weeks of severe pain and advised to meet the specialist and was prescribed with Tramadol HCL as a pain medication on 13-Dec-2016. The patient reported that, it was still very painful to move her left arm and was planned to see another specialist on 6-Jan-2017. Action taken with the FLUAD was not reported. Outcome of the events were not recovered. Reporter's Assessment: The reporter did not provide the causality and company causality between FLUAD and events (injection site pain, pain in arm and pain) was assessed as related and between shoulder pain was assessed as not related. This case was not serious.
Age: 63.0
Sex: F
Vaccine: FLUX, PPV, TDAPIPV
Symptoms: Arthralgia, Back pain, Musculoskeletal pain
Clinical narrative: This Spontaneous case from Vaccine Adverse Event Reaction Systems (VAERS ID: 675158), initially received on Apr-2017 was reported by other non-healthcare professional and concerns a 63 years old female patient. The patient's medical history included depression and alcohol dependence. The patient's current condition included hypertension and diabetes. Administration of Company suspect drug(s): On 14-May-2015, the patient was administered by influenza virus vaccine polyvalent (batch number: 174085, route of administration: intramuscular, dose: 1, expiration date: not reported). Other Company suspect drugs: PNEUMOVAX (batch number: K021881, route of administration: intramuscular, dose: 1, expiration date: not reported) and Tdap IPV (batch number: 2224P, route of administration: intramuscular, dose: 1, expiration date: not reported). Adverse reactions/events and outcomes: On 14-May-2015, the patient experienced pain in shoulder and back/hip. The outcome of the event was not recovered/not resolved. Reporter's Assessment: The other non-healthcare professional assessed the events arthralgia, back pain and musculoskeletal pain were serious, and the causality of the event was not reported. This case report was non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This Spontaneous case, initially received on 12-Apr-2017 was reported from an other health professional via other company (Pfizer) through Health Authority (VAERS number: 675305) and concerns a female patient of unspecified age. Administration of Company suspect drug(s): On an unspecified date the patient was administered INN Flu Vaccine of unknown (dose, route, batch number, expiry date, site of administration). Adverse reactions/events and outcomes: On unspecified date after administration of INN Flu Vaccine, the patient experienced local swelling and redness at injection site. Patient's lab test and corrective treatment was not reported. Outcome of the events was unknown. Reporter's Assessment: The other health professional did not provide the causality of the event with respect to INN Flu Vaccine. This report is non-serious.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: This Spontaneous case, initially received on 12-APR-2017, which was reported by other non-health professional via health authority (VAERS number: 675307) and concerns a patient of unspecified age and gender. Administration of Company suspect drug: On an unspecified date, the patient administered with INN Flu Vaccine (Dose, batch number: not reported, Route of administration: injection NOS). Adverse reactions/events and outcomes: On an unspecified date after administration of INN Flu Vaccine, the patient had sickness. The action taken with INN Flu Vaccine was not reported. The outcome of the event was not reported. Reporter's Assessment: The reporter did not provide the causality between INN flu vaccine and event. This report was not serious.
Sex: F
Vaccine: FLUX
Symptoms: Dizziness
Clinical narrative: This Spontaneous case, initially received via VAERS on 12-Apr-2017, was reported by a other non-health professional and concerns a 56 years old female adult patient. The patient's medical history included: Hypothyroidism. Administration of Company suspect drug: On 23-Dec-2016, the patient administered with INN flu vaccine seasonal (Dose, batch number, Route of administration: not reported). Adverse reactions/events and outcomes: The reporter reported that, on an unspecified date after receiving INN flu vaccine seasonal, she experienced Dizziness with change in position. Continued for 7 days. Action taken with INN flu vaccine seasonal was not reported. Outcome for event was unknown. Reporter's Assessment: The reporter did not provide the causality between INN flu vaccine seasonal and event. Company assessed the causality between INN flu vaccine seasonal and event as related. This report was not serious.
Age: 79.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site pain, Mobility decreased, Pain
Clinical narrative: This spontaneous case, initially received on 12-APR-2017 00:00:00 was reported by an other non-health professional via Health Authority (VAERS number: 675498) and concerns a 79 Years old male patient. Administration of Company suspect drug(s): On 28-11-2016, FLUAD (TIV) was administered (dose: 0.5 ml, unknown duration, batch number/Lot number: 166103, Route of administration: unknown, anatomical site: left arm). Adverse reactions/events and outcomes: On unspecified date, after administration of FLUAD (TIV), the patient experienced sore from shot, hard time raising arm, buckling seat belt. Action taken was not reported. Outcome of the event was not recovered. Reporter's Assessment: The other non-health Professional considered the case as non-serious and the causality of the event was not reported.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Pyrexia
Clinical narrative: This initial spontaneous case, initially received on 12-Apr-2017 was reported by other non-health professional (patient's daughter) via regulatory authority (vaccine adverse event reporting system: 675546) and concerns a 77 years old female patient. Administration of Company suspect drug: On 02-Dec-2016, the patient received INN Flu Vaccine Seasonal (dosage, route of administration and batch number: not reported). Non-company suspect drug: ZOSTAVAX (route of administration: subcutaneous, dosage and batch number: not reported) administered on 02-Dec-2016. Adverse reactions/events and outcomes: On 02-Dec-2016 after administration of INN Flu Vaccine Seasonal, the patient experienced fever. Action taken with INN Flu Vaccine Seasonal was not reported. The outcome of the event was recovered. Reporter's Assessment: The reporter did not provide the causality and company causality between influenza vaccine, influenza virus vaccine polyvalent and fever was assessed as related. This report was not serious.
Sex: U
Vaccine: FLUX
Symptoms: Loss of personal independence in daily activities, Malaise
Clinical narrative: This spontaneous case initially received on 12-Apr-2017 was reported by other non-health professional (consumer) via Health authority (VAERS no: 675579). The patient age and gender was not reported. Administration of Company suspect drug: On an unspecified date, the patient received INN Flu Vaccine (batch number, expiry date, dose and site of administration not reported) (reported as one month ago). Adverse reactions/events and outcomes: On an unknown date (reported as one month ago), after the vaccination, patient was sick and missed school for next two weeks (Activities of daily living impaired). The action taken with the 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 INN Flu Vaccine. Health Authority considered the case report as non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, was reported by other non-health professional via regulatory authority (VAERS number: 675812) and concerns a female patient of unspecified age. Administration of Company suspect drug: On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dosage, batch number, route of administration: not reported). Adverse reactions/events and outcomes: On unspecified date, after administration of INN Flu vaccine seasonal, the patient had 'flue' (flu). The patient reported that, she had terrible side effects to the medication. Action taken with INN flu vaccine seasonal was not reported. The outcome of the event was not reported. Reporter's Assessment: The reporter did not provide the causality between INN flu vaccine seasonal and event. The report was serious (medically significant).
Sex: F
Vaccine: FLUX
Symptoms: Chills, Cough, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: This spontaneous case, initially received via VAERS on 12-Apr-2017, was reported by other non-health professional and concerns a 77-years-old female patient. Administration of Company suspect drug: On 16-Nov-2016, the patient administered with INN flu vaccine seasonal (Dose, batch number, route of administration: not reported). Adverse reactions/events and outcomes: The reporter reported that, on an unspecified date in Nov-2016, after the vaccination patient had flu like symptoms, upper respiratory congestion, fever, chills, muscle ached all over, coughing. It was also reported that patient thought of some flu like symptoms diagnosis upon visit in facility. Patient required emergency room (ER)/ doctor visit. Action taken with INN flu vaccine seasonal was not reported. Patient got recovered from the event coughing on 01-Dec-2016 and got improved from all other events (recovering). Reporter's Assessment: The reporter did not provide the causality between INN flu vaccine seasonal and events. This report was not serious.
Sex: F
Vaccine: FLUX
Symptoms: Upper respiratory tract congestion
Clinical narrative: This spontaneous case, initially received via VAERS on 12-Apr-2017, was reported by other non-health professional and concerns a 77-years-old female patient. Administration of Company suspect drug: On 16-Nov-2016, the patient administered with INN flu vaccine seasonal (Dose, batch number, route of administration: not reported). Adverse reactions/events and outcomes: The reporter reported that, on an unspecified date in Nov-2016, after the vaccination patient had flu like symptoms, upper respiratory congestion, fever, chills, muscle ached all over, coughing. It was also reported that patient thought of some flu like symptoms diagnosis upon visit in facility. Patient required emergency room (ER)/ doctor visit. Action taken with INN flu vaccine seasonal was not reported. Patient got recovered from the event coughing on 01-Dec-2016 and got improved from all other events (recovering). Reporter's Assessment: The reporter did not provide the causality between INN flu vaccine seasonal and events. This report was not serious.
Sex: F
Vaccine: FLUX
Symptoms: Adverse event, Malaise
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by a other non-health Professional through Health Authority (VAERS ID: 675814) and concerns a female patient of unknown age. The patient's concomitant medication included REVATIO. Administration of Company suspect drug(s): On an unspecified date, INN Flu Vaccine Seasonal was administered for unknown indication (Dosage, batch number, route of administration and anatomical site: not reported). Adverse reactions/events and outcomes: On an unspecified date, after administration of INN Flu Vaccine Seasonal, the patient felt sick and experienced unspecified adverse events. Action taken was not reported. Outcome of the events were not reported. Reporter's Assessment: The Health Authority considered the case as non-serious. The causality of the events was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: This Spontaneous case, initially received via VAERS on 12-Apr-2017, was reported by a other non-health professional and concerns a 57 years old female adult patient. The patient's concomitant medication included: WELLBUTRIN. Administration of Company suspect drug: On 27-Oct-2016, the patient administered with INN flu vaccine seasonal (Dose, batch number, route of administration: intramuscular). Adverse reactions/events and outcomes: The reporter reported that, on 28-Oct-2016 she started experiencing painful limited range of motion. Action taken with INN flu vaccine seasonal was not reported. The outcome of the events was not recovered. Reporter's Assessment: The reporter did not provide the causality between INN flu vaccine seasonal and events. This report was not serious.
Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Fatigue
Clinical narrative: This spontaneous case, initially received via Vaccine Adverse Event Reaction Systems (VAERS ID: 675924) on Apr-2017 was reported by a healthcare professional (Pharmacist) and concerns a male patient of under the age of 65 year. Administration of Company suspect drug(s): On an unspecified date, the patient received INN Flu Vaccine (dosage, batch number, expiration date, route of administration: not reported). Indication not reported. Non-company suspect drug(s): On an unspecified date, the patient received PNEUMOVAX (dosage, batch number, expiration date, route of administration: not reported). Indication not reported. Adverse reactions/events and outcomes: On unspecified date after administration of INN Flu Vaccine the patient experienced fatigue. The patient's relevant laboratory data was not reported. Action taken with of INN Flu Vaccine was not reported. The outcome of the event was not reported. Reporter's Assessment: The reporter assessed the event fatigue as non-serious and the causality was reported as Not reported. This case was non serious.
Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Fatigue
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by a Pharmacist via regulatory authority (VAERS ID: 675924) and concerns a male patient under the age of 65 year. Administration of Company suspect drug: On an unknown date, patient was administered with INN Flu Vaccine Seasonal (dosage, route of administration, anatomical location, expiry date, batch no: not reported). Non-company suspect drug: On an unknown date, patient was administered with PNEUMOVAX 23 (dosage, route of administration, anatomical location, expiry date, batch no: not reported). Adverse reactions/events and outcomes: On unspecified date, after administration of influenza vaccine and pneumococcal vaccine, the patient experienced fatigue. Action taken with the influenza vaccine was not reported. Outcome of the event fatigue was not reported. Reporter's Assessment: The pharmacist did not provide any causality assessment between influenza vaccine and fatigue. This report was not serious.
Age: 68.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Asthenia, Dizziness, Fatigue, Nausea
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by other Non-health professional via regulatory authority (VAERS ID: 676013) and concerns a 68 years old female patient. Patient's concomitant medication included: Fluoxetine (dose: 20 mg, daily). Administration of Company suspect drug: On 16-Nov-2016 FLUAD (TIV) was administered via Intramuscular route of administration (dose: unknown, anatomical location: right arm) (batch number: 70461000101). Indication was not reported. Non-company suspect drug: On 16-Nov-2016 PREVNAR 13 was administered for the via Intramuscular route of administration (dose: unknown, anatomical location: left arm) (batch number: 00005197105). Indication was not reported. Adverse reactions/events and outcomes: On 17-Nov-2016 after administration of FLUAD (TIV), PREVNAR 13, the patient experienced sudden intense light headedness and nausea and felt very much like I was going to faint and was extremely weak. Patient returned to bed, the symptoms were greatly diminished and felt very fatigued over next four days. The outcome of the event was recovered. Reporter's Assessment: The reporter assessed the events non-serious and the causality was not provided. This report was not serious.
Age: 67.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, Pain
Clinical narrative: This spontaneous case, initially received via Vaccine Adverse Event Reaction System (VAERS ID: 676029) on Apr-2017, was reported by other non-healthcare professional and concerns a 67-years-old male patient. The patient's medical history included mild seasonal allergy. Administration of Company suspect drug: On 28-Dec-2016 the patient was administered by influenza virus vaccine polyvalent, route of administration: intramuscular, dose: 1 df, anatomical location: left arm, expiration date, batch number: not reported). Adverse events/reactions and outcomes: On 01-Jan-2017 after administration of INN Flu Vaccine Seasonal, the patient experienced dull ache area of short, severe pain when muscle is stretch as raising arm up and increasing more pain all the day. The patient received 2 ALEVE for minimal relief. The action taken with INN Flu Vaccine Seasonal was not reported. The outcome of the events was not reported. Reporter Assessment: The reporter did not provide the causality between INN flu vaccine seasonal and events. This report was not serious.
Age: 67.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, Myalgia, Pain
Clinical narrative: This spontaneous case, initially received via Vaccine Adverse Event Reaction System (VAERS ID: 676029) on Apr-2017, was reported by other non-healthcare professional and concerns a 67-years-old male patient. The patient's medical history included mild seasonal allergy. Administration of Company suspect drug: On 28-Dec-2016 the patient was administered by influenza virus vaccine polyvalent, route of administration: intramuscular, dose: 1 df, anatomical location: left arm, expiration date, batch number: not reported). Adverse events/reactions and outcomes: On 01-Jan-2017 after administration of INN Flu Vaccine Seasonal, the patient experienced dull ache area of short, severe pain when muscle is stretch as raising arm up and increasing more pain all the day. The patient received 2 ALEVE for minimal relief. The action taken with INN Flu Vaccine Seasonal was not reported. The outcome of the events was not reported. Reporter Assessment: The reporter did not provide the causality between INN flu vaccine seasonal and events. This report was not serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Allergy to vaccine, Oesophageal oedema
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by an other-non health professional via regulatory authority (VAERS ID: 676060) and female patient of unspecified age. Administration of Company suspect drug: On an unspecified date the patient was administered INN Flu Vaccine Seasonal (dose, route, batch number, expiry date and site of administration: not reported). Adverse reactions/events and outcomes: On unspecified date after administration of INN Flu Vaccine Seasonal, the patient developed allergies to suspect drug and Oesophagus swell shut. Laboratory investigations and corrective treatment were not reported. Action taken with INN flu vaccine seasonal was not reported. Reporter's Assessment: The Other Health Professional did not provide the causality and assessed the events as non serious. This report is not serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Dehydration, Malaise, Muscle spasms
Clinical narrative: This Spontaneous case, initially received on 12-APR-2017 was reported by an other non health professional via Health Authority (FDA VAERS number: 676062) and concerns a female patient of unknown age. The patient's concomitant medication included Pregabalin. Administration of Company suspect drug(s): On an unspecified date, the patient received INN Flu Vaccine (unknown dosage, frequency, duration, batch number, route of administration). Adverse reactions/events and outcomes: On unspecified date, after 12 days of administration of INN Flu Vaccine, the patient got sick (Seriousness criteria: Non-Serious event), (Outcome - Not Reported). On unspecified date and timeframe, after administration of INN Flu Vaccine the patient experienced Dehydration and cramps all over the body (Seriousness criteria: Non-Serious event), (Outcome - Not Reported). The consumer, patient himself reported the events of sickness, dehydration and cramps. Action taken was not reported. Reporter's Assessment: The Health Authority assessed the events as non-serious and the causality was not reported.
Age: 69.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Allergy to vaccine
Clinical narrative: This spontaneous case, initially received via VAERS on 12-Apr-2017, was reported by a other non-health professional and concerns a 69 years old elderly female patient. Administration of Company Suspect drug: On an unspecified date, the patient administered with influenza virus vaccine polyvalent, (Dose, batch number, Route of administration: injection). Adverse reactions/events and outcomes: The reporter reported that, on unspecified date after administration of INN Flu Vaccine Seasonal, the patient developed allergies to suspect drug. Action taken with influenza virus vaccine polyvalent was not reported. The outcome of the event was unknown. Reporter's Assessment: The reporter implied that the causality between influenza virus vaccine polyvalent and event as related. This report was not serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: This spontaneous case, initially received via Vaccine Adverse Event Reaction Systems (VAERS ID: 676064) on Apr-2017 was reported by other healthcare professional and concerns a female patient of unknown age. Administration of Company suspect drug(s): The patient received INN Flu Vaccine Seasonal on an unspecified date (dosage, batch number, route, Indication: not reported). Adverse reactions/events and outcomes: On 30-Apr-2013, after administration of INN Flu Vaccine Seasonal, the patient experienced anaphylaxis. Action taken with INN Flu Vaccine Seasonal was not reported. The outcome of the event anaphylaxis was not reported. Reporter's Assessment: The reporter provided the causality as unassessable as limited information was available. The event was considered as serious (medically significant).
Age: 63.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Injection site pain
Clinical narrative: This spontaneous case, initially received via Vaccine adverse event reaction systems (VAERS ID: 676094) on Apr-2017, was reported by other non-health professional and concerns a 63-years-old female patient. Administration of Company suspect drug: On 04-Oct-16, the patient was administered by influenza virus vaccine polyvalent, (route of administration: intramuscular, anatomical location: left arm, dose, batch number, expiration date: not reported). Administration of Non-company suspect drug: On 04-Oct-16, the patient was administered by PREVNAR 13, (route of administration: intramuscular, anatomical location: right arm, batch number: N16516, dose, expiration date: not reported). Adverse events/reactions and outcomes: On 05-Oct-16, after administration of INN Flu Vaccine Seasonal, the patient experienced injection site is still sore after 2 months. The action taken with INN Flu Vaccine Seasonal was not reported. The outcome of the event was not reported. Reporter's Assessment: The reporter did not provide the causality between INN Flu Vaccine Seasonal and event. This report was not serious.
Sex: M
Vaccine: DTAP, FLUX, HEP, HIBV, DTAP, FLUX, HEP, HIBV
Symptoms: Crying, Eczema, Emotional distress, Head banging, Irritability
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by other non-health professional regulatory authority (VAERS ID: 676105) and concerns a male patient of age (0.08 as reported). Administration of Company suspect drug: On 06-Jul-2016, patient was administered with INN Flu Vaccine Seasonal (dose, expiry date, batch number: not reported) left leg via intramuscular route of administration. Non-company suspect drug: On 06-Jul-2016, the patient also received hepatitis b vaccine at right leg and diphtheria vaccine, pertussis vaccine, tetanus vaccine at left leg (dose, expiry date, batch number: not reported) via Intramuscular route of administration. Adverse reactions/events and outcomes: On 07-Jul-2016, after administration of influenza vaccine, hepatitis b vaccine and diphtheria vaccine, pertussis vaccine, tetanus vaccine, the patient experienced fever and was very upset, crying and fussing more than normal, the patient hitted his head against things since the vaccines administered. The patient also experienced extremely bad eczema which was continued to be ongoing problem. Action taken with the suspect vaccines was not reported. The patient was not recovered from the event eczema and the outcome of the other 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: M
Vaccine: DTAP, FLUX, HEP, HIBV, DTAP, FLUX, HEP, HIBV
Symptoms: Pyrexia
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by other non-health professional regulatory authority (VAERS ID: 676105) and concerns a male patient of age (0.08 as reported). Administration of Company suspect drug: On 06-Jul-2016, patient was administered with INN Flu Vaccine Seasonal (dose, expiry date, batch number: not reported) left leg via intramuscular route of administration. Non-company suspect drug: On 06-Jul-2016, the patient also received hepatitis b vaccine at right leg and diphtheria vaccine, pertussis vaccine, tetanus vaccine at left leg (dose, expiry date, batch number: not reported) via Intramuscular route of administration. Adverse reactions/events and outcomes: On 07-Jul-2016, after administration of influenza vaccine, hepatitis b vaccine and diphtheria vaccine, pertussis vaccine, tetanus vaccine, the patient experienced fever and was very upset, crying and fussing more than normal, the patient hitted his head against things since the vaccines administered. The patient also experienced extremely bad eczema which was continued to be ongoing problem. Action taken with the suspect vaccines was not reported. The patient was not recovered from the event eczema and the outcome of the other 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: M
Vaccine: DTAP, FLUX, HEP, HIBV, DTAP, FLUX, HEP, HIBV
Symptoms: Anger, Crying, Eczema, Head banging, Irritability
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by other non-health professional regulatory authority (VAERS ID: 676105) and concerns a male patient of age (0.08 as reported). Administration of Company suspect drug: On 06-Jul-2016, patient was administered with INN Flu Vaccine Seasonal (dose, expiry date, batch number: not reported) left leg via intramuscular route of administration. Non-company suspect drug: On 06-Jul-2016, the patient also received hepatitis b vaccine at right leg and diphtheria vaccine, pertussis vaccine, tetanus vaccine at left leg (dose, expiry date, batch number: not reported) via Intramuscular route of administration. Adverse reactions/events and outcomes: On 07-Jul-2016, after administration of influenza vaccine, hepatitis b vaccine and diphtheria vaccine, pertussis vaccine, tetanus vaccine, the patient experienced fever and was very upset, crying and fussing more than normal, the patient hitted his head against things since the vaccines administered. The patient also experienced extremely bad eczema which was continued to be ongoing problem. Action taken with the suspect vaccines was not reported. The patient was not recovered from the event eczema and the outcome of the other 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: 38.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, Pain, Pain in extremity, X-ray normal
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by other non-health professional via regulatory authority (VAERS ID: 676208) and concerns a 38-years-old female patient. Patient's concomitant medication included OTC Vitamin, folic acid and lysine supplement (daily). Administration of Company suspect drug: On 20-Oct-2016, patient was administered with INN Flu Vaccine (dosage, batch number: not reported, route of administration: inject NOS and anatomical location: right arm). Adverse reactions/events and outcomes: On 20-Oct-2016 after administration of INN Flu Vaccine, the patient experienced constant pain and felt somewhat throbbing in my right arm, particularly at injection site and upper arm. The patient was wondering if injection site was done too far up on my right arm and was injected into the deltoid. The pain was occurring since the actual date of the flu shot being administered on 20-Oct-2016 and was not subsided. The patient visited orthopaedic and X-ray was performed with showed the result as normal but the pain persists at the same level as the date of the flu shot. The action taken with INN Flu Vaccine was not reported. The outcome of the events was not recovered. Reporter's Assessment: The reporter did not provide the causality between INN Flu Vaccine and events. This report was not serious.
Age: 71.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Arthritis, Burning sensation, Condition aggravated, Mobility decreased, Musculoskeletal pain
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by other non-health professional (consumer) via health authority (VAERS ID: 676390) and concerns a 71 Years old female patient. The patient's current condition included arthritis. The patient's concomitant medications included TYLNOL, Biotin, Calcium magnesium, Zinc, D3, Vitamins, Glucosamine Chondroitin, Lisinopril hydrochlorothiazide, L LYSINE, Ranitidine 300, Tumeric 500 and TYLENOL PM Extra strength. Administration of Company suspect drug: On 19-Dec-2016, the patient received influenza vaccine, dose, expiry date, route of administration: not reported, batch number: IIV3) at left arm. Adverse reactions/events and outcomes: On 19-Dec-2016 after administration of influenza vaccine, the patient's arm burned to the hand before bedtime. She could not move normally in the morning, and had to leave the bed by crawling on her knees on the floor and pulling her up. The pain moved to her right shoulder and neck. She experienced arthritis, tendons and rotator cuff all seemed to get off. On an unspecified date, X-ray was performed and showed arthritis with tendon and rotator cuff involvement. On an unspecified date, the patient had physical therapy and stated that she still needed PT (Physical therapy) and a shot of cortisone. Action taken with the vaccine was not reported. The outcome of the events was not recovered/not resolved. Reporter's Assessment: The reporter did not provide the causality of the events in relation to the INN Flu Vaccine Seasonal. This case was non-serious.
Age: 71.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Neck pain, Rotator cuff syndrome, Tendon disorder, X-ray limb abnormal
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by other non-health professional (consumer) via health authority (VAERS ID: 676390) and concerns a 71 Years old female patient. The patient's current condition included arthritis. The patient's concomitant medications included TYLNOL, Biotin, Calcium magnesium, Zinc, D3, Vitamins, Glucosamine Chondroitin, Lisinopril hydrochlorothiazide, L LYSINE, Ranitidine 300, Tumeric 500 and TYLENOL PM Extra strength. Administration of Company suspect drug: On 19-Dec-2016, the patient received influenza vaccine, dose, expiry date, route of administration: not reported, batch number: IIV3) at left arm. Adverse reactions/events and outcomes: On 19-Dec-2016 after administration of influenza vaccine, the patient's arm burned to the hand before bedtime. She could not move normally in the morning, and had to leave the bed by crawling on her knees on the floor and pulling her up. The pain moved to her right shoulder and neck. She experienced arthritis, tendons and rotator cuff all seemed to get off. On an unspecified date, X-ray was performed and showed arthritis with tendon and rotator cuff involvement. On an unspecified date, the patient had physical therapy and stated that she still needed PT (Physical therapy) and a shot of cortisone. Action taken with the vaccine was not reported. The outcome of the events was not recovered/not resolved. Reporter's Assessment: The reporter did not provide the causality of the events in relation to the INN Flu Vaccine Seasonal. This case was non-serious.
Age: 71.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Arthritis, Burning sensation, Condition aggravated, Gait disturbance, Mobility decreased
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by other non-health professional (consumer) via health authority (VAERS ID: 676390) and concerns a 71 Years old female patient. The patient's current condition included arthritis. The patient's concomitant medications included TYLNOL, Biotin, Calcium magnesium, Zinc, D3, Vitamins, Glucosamine Chondroitin, Lisinopril hydrochlorothiazide, L LYSINE, Ranitidine 300, Tumeric 500 and TYLENOL PM Extra strength. Administration of Company suspect drug: On 19-Dec-2016, the patient received influenza vaccine, dose, expiry date, route of administration: not reported, batch number: IIV3) at left arm. Adverse reactions/events and outcomes: On 19-Dec-2016 after administration of influenza vaccine, the patient's arm burned to the hand before bedtime. She could not move normally in the morning, and had to leave the bed by crawling on her knees on the floor and pulling her up. The pain moved to her right shoulder and neck. She experienced arthritis, tendons and rotator cuff all seemed to get off. On an unspecified date, X-ray was performed and showed arthritis with tendon and rotator cuff involvement. On an unspecified date, the patient had physical therapy and stated that she still needed PT (Physical therapy) and a shot of cortisone. Action taken with the vaccine was not reported. The outcome of the events was not recovered/not resolved. Reporter's Assessment: The reporter did not provide the causality of the events in relation to the INN Flu Vaccine Seasonal. This case was non-serious.