chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: M
Vaccine: FLU3, HEP
Symptoms: Blood test, Computerised tomogram, Facial paralysis, Nuclear magnetic resonance imaging
Clinical narrative: This serious spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 720587), concerns a 54-year-old, adult, male patient. The patient had no known allergies. The patient's current condition included type 2 diabetes mellitus (since an unspecified date). The patient's concomitant medications included HUMULIN 70/30 and Metformin for unknown indications. On 19-Sep-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml [reported as unk], route of administration: intramuscular, anatomical location: left arm, batch number and expiry date: not reported) and non-company suspect product ENGERIX-B (dose: reported as unknown, route of administration: intramuscular, anatomical location: right arm, batch number and expiry date: not reported). On an unspecified date, the patient went to the emergency room and consulted a physician. Computed tomography (CT) scan, magnetic resonance imaging (MRI) and blood tests (unspecified) were performed, results were not reported. On 14-Oct-2017, 25 days after vaccination, the patient was diagnosed with Bell's palsy. On an unspecified date, the patient had recovered from the event. Update 02-Jul-2018: Non-significant case correction received with IRD 20-Jun-2018: The narrative statement regarding current condition was corrected from 'current indication' to 'current condition' and case comment were corrected.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain, Paraesthesia
Clinical narrative: The spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 721014), concerns a 52-year-old, adult, male patient. On an unspecified date (between 10-11 AM), the patient was administered with FLUVIRIN (dose: 0.5 ml (reported as unknown), route of administration: intramuscular, anatomical location: unknown, batch number: 179602P, expiry date: not reported). On the same day after vaccination, the patient experienced pain at the injection site (shoulder), numbness and tingling in the arm. Approximately at 5 PM, the patient reported that, pain at injection site was better. At the time of this report, the patient had recovered from the events. The reporter assessed this case as non-serious.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose, Blood pressure decreased, Dizziness, Syncope
Clinical narrative: This is a serious spontaneous case, reported by other health professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 721175), concerns a 20-year-old, adult female patient. The patient had been using unspecified medication for birth control. On 08-Oct-2017, the patient was administered with FLUVIRIN Thiomersal (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 1720801, expiry date: not reported). On the same day of vaccination, the patient experienced lightheadedness, dizziness and fainting which was suspected to be possible seizure. The paramedic arrived and checked blood pressure, sugar. Upon standing, the patient's blood pressure dropped, and she became dizzy again. Hence, the patient was taken to the emergency room. At the time of this report, the outcome of the events was unknown.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Vaccination site pain
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 721812), concerns a 71-year-old elderly, female patient. The patient had no history of pain related to vaccinations. The patient had no historical conditions and current illness. The patient was allergic to penicillin. The patient did not receive any concomitant medications. On 01-Sep-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 1720801 and expiry date: not reported). On the same day, after vaccination, the patient experienced pain at vaccination site and could not sleep on that side due to unbearable pain. The events were reported after 2 days. On 22-Oct-2017, (reported as almost six week later), the patient complained that, soreness at the site persisted and thought that, it might be a muscle damage. Even though, there was no visible signs of any damage the patient was advised to check with her primary physician. The patient was recommended with over the counter (OTC) remedies. No lab investigations were performed. At the time of this report, the patient had not yet recovered from the events. The reporter assessed the case as non-serious.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Musculoskeletal stiffness
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 721832), concerns a 62-year-old, adult female patient. On 30-Sep-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml [reported as first dose], route of administration: intramuscular, anatomical location: left arm, batch number: 179601P and expiry date: not reported). On 01-Oct-2017, 1 day after vaccination, the patient experienced continuous stiffness running up through the deltoid into the neck and trapezius which had prolonged and was irritating. It was reported that, the patient was unable to sleep on the side of vaccination. Patient initially thought that, soreness would subside, but it lingered. At the time of this report, the outcome of the events was not reported. The reporter assessed the events as non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria, Syncope
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 722998), concerns an adolescent, female patient. On an unknown date in 2016, the patient was administered influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date: not reported). After vaccine administration, the patient fainted and experienced hives, itching and redness around injection site. At the time of this report, the outcome of the events was not reported. The reporter assessed this case as non-serious.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness, Syncope
Clinical narrative: This is a serious spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 723770), concerns an 08-year-old male child. The patient neither had any medical history nor illness at the time of vaccination. On 28-Oct-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml (reported as 2 doses), route of administration: intramuscular, batch number: 179804P, anatomical location, expiry date: not reported). On the same day, 5 minutes after vaccination, the patient fainted and regained consciousness after a few seconds.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram normal, Headache
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 10-Jul-2018 by Seqirus from VAERS (VAERS ID: 724457), concerns a 44-year-old, adult, female patient. The patient had no allergies. It was reported that, the patient had never suffered from any type of headache. The patient's current condition included facial numbness of unknown aetiology for approximately 7 years (reported as medical history). The patient's concomitant medication included gabapentin for an unknown indication. On 26-Sep-2017, the patient was administered FLUVIRIN (dose: 0.5 ml [reported as first dose], route of administration: intramuscular, anatomical location: left arm, batch number and expiry date: not reported). On the same day (26-Sep-2017-evening), after vaccination, the patient started to experience headache (reported as non-stop) which persisted. On 20-Oct-2017, the patient was treated with TORADOL injection but had no relief. On 21-Oct-2017, computed tomography (CT) scan was performed, which showed negative results. It was reported that, several appointments were made for consultation and steroids were used to break the cycle of the headache. At the time of this report, the patient had not recovered from the event.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Back pain, Dizziness, Headache, Injection site cellulitis
Clinical narrative: This is a serious spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 10-Jul-2018 by Seqirus from VAERS (VAERS ID: 724941), concerns a 57-year-old, adult female patient. The patient's adverse events after vaccination (unspecified) in 2016 (reported as last year) included soreness in armpit, back pain, dizziness, headache, injection site cellulitis, injection site pain and fever (all the reactions were mild in intensity) (reported as similar reaction last year but milder and didn't last as long). The patient's current conditions included hypothyroidism and gastrooesophageal reflux disease. The patient was allergic to neomycin, shellfish and Sulfonamide. The patient's concomitant medications included levothyroxine for hypothyroidism and omeprazole for gastrooesophageal reflux disease. On 26-Oct-2017, the patient was administered FLUVIRIN Thiomersal (dose: 0.5 ml, route of administration: injection (reported as SYR), anatomical location: left arm, batch number: 1721401, expiry date: not reported). On the following day (27-Oct-2017), the patient developed cellulitis in the left arm from the injection site in a wide band down the elbow, soreness in the entire left shoulder including upper left back and left armpit (all these symptoms lasted for a week). On 28-Oct-2017, the patient had fever (99.5-degree Fahrenheit). In addition, headache and dizziness started on the same day, lasted until 30-Oct-2017. It was reported that, the patient made a visit to the physician's office on an unspecified date. At the time of this report, the patient had recovered from the events.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pyrexia
Clinical narrative: This is a serious spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 10-Jul-2018 by Seqirus from VAERS (VAERS ID: 724941), concerns a 57-year-old, adult female patient. The patient's adverse events after vaccination (unspecified) in 2016 (reported as last year) included soreness in armpit, back pain, dizziness, headache, injection site cellulitis, injection site pain and fever (all the reactions were mild in intensity) (reported as similar reaction last year but milder and didn't last as long). The patient's current conditions included hypothyroidism and gastrooesophageal reflux disease. The patient was allergic to neomycin, shellfish and Sulfonamide. The patient's concomitant medications included levothyroxine for hypothyroidism and omeprazole for gastrooesophageal reflux disease. On 26-Oct-2017, the patient was administered FLUVIRIN Thiomersal (dose: 0.5 ml, route of administration: injection (reported as SYR), anatomical location: left arm, batch number: 1721401, expiry date: not reported). On the following day (27-Oct-2017), the patient developed cellulitis in the left arm from the injection site in a wide band down the elbow, soreness in the entire left shoulder including upper left back and left armpit (all these symptoms lasted for a week). On 28-Oct-2017, the patient had fever (99.5-degree Fahrenheit). In addition, headache and dizziness started on the same day, lasted until 30-Oct-2017. It was reported that, the patient made a visit to the physician's office on an unspecified date. At the time of this report, the patient had recovered from the events.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Migraine, Muscular weakness, Vertigo
Clinical narrative: This serious spontaneous case, reported by other non-healthcare professional (consumer) to VAERS and initially retrieved on 10-Jul-2018 by Seqirus from VAERS (VAERS ID: 724998), concerns a 33-year-old, adult, female patient. The patient's current condition included Factor V Leiden thrombophilia (reported as medical history). The patient was allergic to COMPAZINE, MACROBID, REGLAN, TORADOL, tramadol and NUBAIN. The patient's concomitant medications included ZOLOFT, XARELTO, FLEXERIL, TYLENOL, PHENERGAN, ZOFRAN, melatonin and probiotics, all for an unknown indications. On 30-Oct-2017, the patient was administered FLUVIRIN [dose: 0.5 ml, route of administration: injection (reported as SYR), anatomical location: left arm, batch number and expiry date: not reported]. On 01-Nov-2017, 02 days after vaccination, the patient developed severe vertigo with leg muscle weakness. The patient felt as she was on a boat (as reported). Within an hour of those episodes, the patient developed a severe migraine. The patient had an emergency room and office visit on an unspecified date. At the time of this report, the patient had not recovered from the events. Update 05-Sep-2018: Non-significant case correction was performed with IRD 10-Jul-2018. The patient's age at vaccination (33 years) was added in patient tab.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: This serious spontaneous case, initially received from other non-health professional on 10-Jul-2018,  concerning a female patient of unspecified age. On an unspecified date, the patient was administered influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, manufacturer and trade name: not reported). On an unspecified date after vaccination, the patient was diagnosed with flu. It was reported that, the patient had declined the vaccine for many years. At the time of this report, the outcome of the event (flu) was not reported. The reporter assessed the causality as related to suspect vaccine. This case was linked to case-201802797 due to same patient.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Syncope, Vomiting
Clinical narrative: This serious spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 10-Jul-2018 by Seqirus from VAERS (VAERS ID: 726850), concerns a 11-year-old child. The patient had no current illnesses. On 04-Nov-2017, the patient was administered FLUVIRIN (dose: 0.5 ml (reported as 1st dose), route of administration: intramuscular, anatomical location: left arm, batch number: 179803P, expiry date: not reported). On the same day (04-Nov-2017), after vaccination, the patient fainted, had nausea and vomiting. Blood pressure [BP] measurement was done by emergency medical services, but the result was not reported. At the time of this report, the patient had recovered from the events.
Age: 18.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Echocardiogram normal, Electrocardiogram normal, Full blood count normal, Syncope
Clinical narrative: This is a serious spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 10-Jul-2018 by Seqirus from VAERS (VAERS ID: 726946), concerns an 18-year-old, adult, male patient. The patient had no relevant medical history, concomitant medication and allergy. The patient had no illness at the time of vaccination. On 13-Nov-2017, the patient was administered FLUVIRIN (dose: 0.5 ml [reported as unknown], route of administration, anatomical location, batch number, expiry date: not reported). On the same day, the patient also received non-company suspect GARDASIL (dose, route of administration, anatomical location, batch number, expiry date: not reported). On 14-Nov-2017, one day after vaccination, the patient fainted, without any other symptoms before or after the event. Subsequently, the patient was taken for consultation, to the physician. On the same day (14-Nov-2017), electrocardiography (EKG), full blood panel test and echocardiogram (reported as echo) with doppler test were performed and the results were found to be normal. At the time of this report, the patient had recovered from the events.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoglycaemia, Syncope
Clinical narrative: This is serious spontaneous case, reported by other health professional to VAERS and initially retrieved on 10-Jul-2018 by Seqirus from VAERS (VAERS ID: 727999), concerns a 16-year-old, adolescent female patient. The patient had no current illness at the time of report. On 11-Nov-2017, at 2:30, the patient was administered FLUVIRIN (dose: 0.5ml [unknown as reported], batch number: 1720701, route of administration: intramuscular, anatomical location: left arm). On the same day, after vaccination, the patient fainted most likely due to low sugar, since the patient ate only one egg in the whole day. The patient was observed and given fluids. Afterwards, the patient's blood pressure was noted for 3 times within a period of one hour (result not reported). At the time of report, the patient had recovered from the events (syncope and hypoglycemia).
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 06-Jun-2018 by Seqirus from VAERS (VAERS ID: 729118), concerning a 61-year-old, adult, female patient. The patient's current illness included asthma and high blood pressure. The patient was allergic to peanuts, X-ray dye, dust, cold air and other unspecified medications that the patient was no longer using (reported as don't have a list). Concomitant medications included: Amlodipine, Clonazepam, SINGULAIR, BREO, Zolpidem and Atorvastatin. On 20-Sep-2017, the patient was administered influenza vaccine (route of administration: intramuscular, dose, anatomical location, batch number, expiry date, trade name and manufacturer: not reported). On 22-Sep-2017, 2 days after vaccination, the patient's arm hurt for more than 2 months (reported as arm hurt 2 months plus later). It was reported that, the patient made physician's office visit for the event. At the time of this report, the patient had not recovered from the event. The reporter assessed this case as non-serious. Update 11-Jul-2018: Case correction was performed 06-Jun-2018: The case comment was corrected from 'a 61-year-old, adult, female patient experienced hurt in the arm for more than 2 months, after 2 days of vaccination' to 'a 61-year-old female patient experienced hurt in the arm (which lasted for more than 2 months), 2 days after vaccination with INN flu vaccine'.
Age: 61.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Dry skin, Injection site dryness, Injection site paraesthesia, Paraesthesia, Throat irritation
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 06-Jun-2018 by Seqirus from VAERS (VAERS ID: 729219), concerning a 61-year-old, adult, female patient. The patient's current conditions included: allergic reaction to antibiotics, chronic rhinitis, hypercholesterolaemia, penicillin allergy and sulfonamide allergy. The patient had drug hypersensitivity to the drugs ASTELIN, ASTEPRO, AUGMENTIN, cephalexin, clindamycin, erythromycin, MACROBID, penicillin, prednisone, FLAGYL, and BACTRIM. Concomitant medications included: CRESTOR, LEVOXYL, Omega-3 marine triglycerides and Cholecalciferol for an unknown indication. On 06-Nov-2017, the patient was administered influenza vaccine (batch number, expiry date, trade name, manufacturer: not reported, dose, route of administration and anatomical location: unknown) and non-company suspect product ZOSTAVAX (route of administration: injection (SYR as reported), batch number and expiry date: not reported, dose and anatomical location: unknown). On an unspecified date in Nov-2017, after vaccination, the patient experienced injection site tingling and dryness. The patient also experienced tingling in her arms and through the rest of her body. Furthermore, the patient experienced dryness of skin and itching of throat. At the time of this report, the outcome of the event injection site paresthesia and injection site dryness was unknown. The patient had not yet recovered from the events itchy throat and dry skin. The patient was recovering from the event paresthesia. The reporter assessed the case as non-serious. Update 11-Jul-2018: Significant case correction received with IRD 06-Jun-2018: The as determined causality of the events (injection site dryness and injection site paresthesia) was corrected from related to not related. The case comment was corrected accordingly. Update 19-Jul-2018: Non-significant case correction received with IRD 06-Jun-2018: The verbatims for all the events were corrected and minor changes were done in the narrative and case comment.
Age: 11.0
Sex: F
Vaccine: DTAP, FLUX, HPV9, MEN
Symptoms: Fall, Loss of consciousness, Pain
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 06-June-2018 by Seqirus from VAERS (VAERS ID: 729235), concerns a 11-year-old female child. The patient's current condition included immune disorder (NOS) [reported as medical history]. On an unspecified date, the patient was administered influenza vaccine (anatomical location: left arm, dose, route of administration, batch number, expiry date, trade name and manufacture: not reported), DTAP (anatomical location: right arm, dose, route of administration, batch number, expiry date: not reported), GARDASIL 9 (anatomical location: left arm, batch number: A013698, expiry date: 19-Dec-2019, dose, route of administration: not reported), meningococcal vaccine (anatomical location: right arm, dose, route of administration, batch number, expiry date: not reported). On an unspecified date (reported as couple of weeks ago), after the administration of vaccine, the patient experienced pain. The patient's father thought that, patient stood up and passed out, subsequently fell on the floor. The patient woke up once her father picked up. It was reported that, the patient did not seek medical attention for the events. At the time of this report, the patient had recovered from the events. The reporter assessed this case as non-serious. Update 11-Jul-2018: Non-significant case correction performed with IRD 06-Jun-2018: In the narrative, 'prevention of human papilloma virus' was changed to 'prevention of human papilloma virus infection'.
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Headache, Hypersomnia, Respiratory tract congestion, Sneezing
Clinical narrative: This spontaneous case, reported by other non-healthcare professional (consumer) to VAERS and initially retrieved on 06-Jun-2018 by Seqirus from VAERS (VAERS ID: 729375), concerns a 63-year-old, adult, female patient. The patient's historical conditions included Raynaud's disease, GERD (gastrooesophageal reflux disease) and long-standing cold (during month of November that had resolved several days prior to influenza vaccination). The patient's current conditions included high cholesterol (since an unspecified date) (reported as history). The patient had been allergic to sulfa drugs, iodine and MONISTAT. The patient's concomitant medications included LIPITOR, NORVASC, PRILOSEC and Multivitamins. On 29-Nov-2017, the patient was administered influenza vaccine (route of administration: intramuscular, anatomical location: left arm, dose, batch number, expiry date, manufacturer and trade name: not reported). On 30-Nov-2017, one day after vaccination, the patient had extreme fatigue and experienced headache, congestion, sneezing, shaking hands. It was reported that, the patient slept (reported as on and off) for more than 48 hours. On an unspecified date, the patient had recovered from the events. The reporter assessed this case as non-serious. Update 18-Jun-2018: Significant case correction was performed 06-Jun-2018: The causality of the events- respiratory tract congestion and sneezing were changed from not related to related. Case comment was amended accordingly. No changes were made in the narrative. Update 12-Jul-2018: Non-significant case correction was performed 06-Jun-2018: In the narrative, as reported history was mentioned for the current condition 'high cholesterol'. 'On 29-Nov-2017, the patient was administered with INN Flu Vaccine Seasonal' was changed to 'On 29-Nov-2017, the patient was administered INN Flu Vaccine Seasonal'. Amended narrative accordingly.
Sex: F
Vaccine: FLUX
Symptoms: Tremor
Clinical narrative: This spontaneous case, reported by other non-healthcare professional (consumer) to VAERS and initially retrieved on 06-Jun-2018 by Seqirus from VAERS (VAERS ID: 729375), concerns a 63-year-old, adult, female patient. The patient's historical conditions included Raynaud's disease, GERD (gastrooesophageal reflux disease) and long-standing cold (during month of November that had resolved several days prior to influenza vaccination). The patient's current conditions included high cholesterol (since an unspecified date) (reported as history). The patient had been allergic to sulfa drugs, iodine and MONISTAT. The patient's concomitant medications included LIPITOR, NORVASC, PRILOSEC and Multivitamins. On 29-Nov-2017, the patient was administered influenza vaccine (route of administration: intramuscular, anatomical location: left arm, dose, batch number, expiry date, manufacturer and trade name: not reported). On 30-Nov-2017, one day after vaccination, the patient had extreme fatigue and experienced headache, congestion, sneezing, shaking hands. It was reported that, the patient slept (reported as on and off) for more than 48 hours. On an unspecified date, the patient had recovered from the events. The reporter assessed this case as non-serious. Update 18-Jun-2018: Significant case correction was performed 06-Jun-2018: The causality of the events- respiratory tract congestion and sneezing were changed from not related to related. Case comment was amended accordingly. No changes were made in the narrative. Update 12-Jul-2018: Non-significant case correction was performed 06-Jun-2018: In the narrative, as reported history was mentioned for the current condition 'high cholesterol'. 'On 29-Nov-2017, the patient was administered with INN Flu Vaccine Seasonal' was changed to 'On 29-Nov-2017, the patient was administered INN Flu Vaccine Seasonal'. Amended narrative accordingly.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Emotional distress, Fall, Syncope
Clinical narrative: This is a serious spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 17-Jul-2018 by Seqirus from VAERS (VAERS ID: 729511), concerns a 34-year-old, adult, male patient. The patient's relevant medical history, allergies, current illness and concomitant medications were not reported. On 01-Dec-2017, the patient was administered FLUVIRIN (dose: 0.5 ml [reported as first dose], route of administration: intramuscular, anatomical location: right arm, batch number: 170105P, expiry date: not reported). After the vaccination, the pharmacist instructed the patient to sit until the documentation was printed. When the patient stood up, he fainted backwards into the partition dividing the immunization area. The patient and the partner were assisted by pharmacist and technician. The patient was conscious the entire time (as reported). The patient and his partner denied repeated requests to contact emergency services. Ice pack was applied to the patient and cold fluids were provided. The patient denied blood pressure check-up. No lab tests were required. The pharmacist stayed with patient until he recovered and helped him to a sitting position when he was ready. It took about 10 minutes. After continuous observation, the patient was assisted to a chair where he sat and drank more fluids. The patient reported that, he was fine and was just embarrassed. The patient was asked to leave after 10 minutes, when he was ready. The pharmacist assured the patient was stable and would not drive or perform any other taxing duties. The patient was instructed to contact his primary care physician (PCP) or emergency service in case of any other symptoms. At the time of this report, the patient had recovered from the events.
Age: 53.0
Sex: M
Vaccine: FLUX
Symptoms: Aphasia, Clumsiness, Eyelid function disorder, Eyelid ptosis, Fatigue
Clinical narrative: This is serious spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 729529), concerning a 53-year-old, adult, male patient. The patient's concurrent conditions included multiple sclerosis, clumsiness, fatigue, hands' weakness and tiredness (since unspecified dates). On 13-Sep-2017, the patient was initiated with treatment with AUGABIO (coated tablet 14 mg daily via oral route) for multiple sclerosis and reported that, the patient did not take any medication other than the teriflunomide. Since an unspecified date in Sep-2017, the patient experienced episodes of feeling cold down the knees which was reported as "feeling like standing in ice water and the legs were not cold to touch", which occurred especially at night while on the bed, it lasted for few hours and then disappeared. It was reported that, these symptoms increased in occurrence after receiving AUGABIO. On 29-Sep-2017, the patient was administered with influenza vaccine (route of administration: injection (reported as SYR), dose, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date in 2017, after few weeks of vaccination, the patient experienced low-grade fever, fatigue, was not feeling well and aches/often had pain. Hence, due to pain the patient needed to sit. He also had difficulty walking and bad episodes such as his hands were weak and clumsy from the elbows to the hands which was reported as "dropping a plastic cup of shake". The patient's left eye was drooping which was reported as "feeling like the eyelid was closing but not happening that seemed really bad". In addition, the patient felt more tired  and fatigue. These symptoms increased in occurrence after receiving influenza vaccine. For the last three to  four weeks in Oct-2017 (latency: few weeks), the patient became more tired, fatigue and weak which  continuously got worsened. On 9-Nov-2017, after 9  weeks of vaccination, the patient had trouble in speaking which was reported as "the words were not coming out". The patient's treatment included: ibuprofen in the morning and aspirin in the evening respectively. At the time of this report, the patient had not recovered from all the events.
Age: 53.0
Sex: M
Vaccine: FLUX
Symptoms: Gait disturbance, Grip strength decreased, Malaise, Muscular weakness, Pain
Clinical narrative: This is serious spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 729529), concerning a 53-year-old, adult, male patient. The patient's concurrent conditions included multiple sclerosis, clumsiness, fatigue, hands' weakness and tiredness (since unspecified dates). On 13-Sep-2017, the patient was initiated with treatment with AUGABIO (coated tablet 14 mg daily via oral route) for multiple sclerosis and reported that, the patient did not take any medication other than the teriflunomide. Since an unspecified date in Sep-2017, the patient experienced episodes of feeling cold down the knees which was reported as "feeling like standing in ice water and the legs were not cold to touch", which occurred especially at night while on the bed, it lasted for few hours and then disappeared. It was reported that, these symptoms increased in occurrence after receiving AUGABIO. On 29-Sep-2017, the patient was administered with influenza vaccine (route of administration: injection (reported as SYR), dose, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date in 2017, after few weeks of vaccination, the patient experienced low-grade fever, fatigue, was not feeling well and aches/often had pain. Hence, due to pain the patient needed to sit. He also had difficulty walking and bad episodes such as his hands were weak and clumsy from the elbows to the hands which was reported as "dropping a plastic cup of shake". The patient's left eye was drooping which was reported as "feeling like the eyelid was closing but not happening that seemed really bad". In addition, the patient felt more tired  and fatigue. These symptoms increased in occurrence after receiving influenza vaccine. For the last three to  four weeks in Oct-2017 (latency: few weeks), the patient became more tired, fatigue and weak which  continuously got worsened. On 9-Nov-2017, after 9  weeks of vaccination, the patient had trouble in speaking which was reported as "the words were not coming out". The patient's treatment included: ibuprofen in the morning and aspirin in the evening respectively. At the time of this report, the patient had not recovered from all the events.
Age: 53.0
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia, Speech disorder
Clinical narrative: This is serious spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 729529), concerning a 53-year-old, adult, male patient. The patient's concurrent conditions included multiple sclerosis, clumsiness, fatigue, hands' weakness and tiredness (since unspecified dates). On 13-Sep-2017, the patient was initiated with treatment with AUGABIO (coated tablet 14 mg daily via oral route) for multiple sclerosis and reported that, the patient did not take any medication other than the teriflunomide. Since an unspecified date in Sep-2017, the patient experienced episodes of feeling cold down the knees which was reported as "feeling like standing in ice water and the legs were not cold to touch", which occurred especially at night while on the bed, it lasted for few hours and then disappeared. It was reported that, these symptoms increased in occurrence after receiving AUGABIO. On 29-Sep-2017, the patient was administered with influenza vaccine (route of administration: injection (reported as SYR), dose, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date in 2017, after few weeks of vaccination, the patient experienced low-grade fever, fatigue, was not feeling well and aches/often had pain. Hence, due to pain the patient needed to sit. He also had difficulty walking and bad episodes such as his hands were weak and clumsy from the elbows to the hands which was reported as "dropping a plastic cup of shake". The patient's left eye was drooping which was reported as "feeling like the eyelid was closing but not happening that seemed really bad". In addition, the patient felt more tired  and fatigue. These symptoms increased in occurrence after receiving influenza vaccine. For the last three to  four weeks in Oct-2017 (latency: few weeks), the patient became more tired, fatigue and weak which  continuously got worsened. On 9-Nov-2017, after 9  weeks of vaccination, the patient had trouble in speaking which was reported as "the words were not coming out". The patient's treatment included: ibuprofen in the morning and aspirin in the evening respectively. At the time of this report, the patient had not recovered from all the events.
Age: 1.0
Sex: M
Vaccine: FLUX
Symptoms: Body temperature increased, Decreased appetite, Vomiting
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 06-Jun-2018 by Seqirus from VAERS (VAERS ID: 729597), concerns a 1.08-year-old (as reported), male infant patient. The patient's historical vaccines included: hepatitis A, varicella virus vaccine, rubella virus vaccine and influenza virus vaccine. On 30-Oct-2017, within 2 hours of vaccination, the patient experienced diarrhea which lasted for a week. It was reported that, the patient eats eggs but had no reaction. On 05-Dec-2017, the patient was administered with influenza vaccine, (route of administration: injection (reported as SYR), dose, route of administration, anatomical location, batch number, expiry date: not reported). Within an hour of receiving vaccine, the patient vomited. Even after 11 hours of receiving the shot, the patient could not keep anything until 2 AM (reported as was throwing up). At morning, the patient did not vomit anymore and had no appetite. Around 07:15 AM, the patient's body temperature was checked which showed 100.2-degree Fahrenheit. On 12-May-2017, around 4:05 PM, the patient called the doctor who stated that, there was no link between patient throwing up and the flu shot. At the time of this report, the patient had not yet recovered from the events. The reporter assessed the case as non-serious.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Chills, Decreased appetite, Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous case, reported by other non-healthcare professional (consumer) to VAERS and initially retrieved on 06-Jun-2018 by Seqirus from VAERS (VAERS ID: 730015), concerns a 50-year-old, adult, female patient. The patient had no historical, current conditions and allergies. The patient did not receive any concomitant medications. On 30-Nov-2017, the patient was administered with influenza vaccine (route of administration: injection (reported as SYR), anatomical location: left arm, dose, batch number, expiry date, manufacturer and trade name: not reported). On the same day, after vaccination, the patient developed redness, itching at injection site for 1 week and experienced no appetite. On 06-Dec-2017, at around 5:00 pm, after 6 days of vaccination, the patient experienced stomach ache with nausea and vomiting began at around 8:00 pm and lasted until about 2:30 pm on 07-Dec-2017. On 07-Dec-2017, at 04:30 pm, after 7 days 4 hrs of vaccination, the patient experienced fever of 100.4, 102 at 8:00 pm, chills and muscle aches. On 08-Dec-2017, in morning, the patient experienced low-grade fever of 98.3 and around 2:00 pm, low-grade fever of 100.4. The patient still had no appetite and her stomach hurt after eating few bites of soup and crackers. No lab investigations were performed. It was reported that, the patient never had stomach bug which lasted that long and fever with influenza vaccine. At the time of this report, the patient had not yet recovered from the events (stomach ache and decreased appetite) and outcome of the events (nausea, vomiting, fever, chills, muscle ache, injection site redness and itching) were not reported. The reporter assessed the events as related to the suspect vaccine. The reporter assessed the case as non-serious.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: This spontaneous case, reported by other non-healthcare professional (consumer) to VAERS and initially retrieved on 06-Jun-2018 by Seqirus from VAERS (VAERS ID: 730015), concerns a 50-year-old, adult, female patient. The patient had no historical, current conditions and allergies. The patient did not receive any concomitant medications. On 30-Nov-2017, the patient was administered with influenza vaccine (route of administration: injection (reported as SYR), anatomical location: left arm, dose, batch number, expiry date, manufacturer and trade name: not reported). On the same day, after vaccination, the patient developed redness, itching at injection site for 1 week and experienced no appetite. On 06-Dec-2017, at around 5:00 pm, after 6 days of vaccination, the patient experienced stomach ache with nausea and vomiting began at around 8:00 pm and lasted until about 2:30 pm on 07-Dec-2017. On 07-Dec-2017, at 04:30 pm, after 7 days 4 hrs of vaccination, the patient experienced fever of 100.4, 102 at 8:00 pm, chills and muscle aches. On 08-Dec-2017, in morning, the patient experienced low-grade fever of 98.3 and around 2:00 pm, low-grade fever of 100.4. The patient still had no appetite and her stomach hurt after eating few bites of soup and crackers. No lab investigations were performed. It was reported that, the patient never had stomach bug which lasted that long and fever with influenza vaccine. At the time of this report, the patient had not yet recovered from the events (stomach ache and decreased appetite) and outcome of the events (nausea, vomiting, fever, chills, muscle ache, injection site redness and itching) were not reported. The reporter assessed the events as related to the suspect vaccine. The reporter assessed the case as non-serious.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness, Nausea, Syncope, Vomiting
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 17-Jul-2018 by Seqirus from VAERS (VAERS ID: 730184), concerns a 15-year-old, adolescent, female patient. On 09-Dec-2017, the patient was administered FLUVIRIN (dose: 0.5 ml [reported as first dose], route of administration: intramuscular, anatomical location: left arm, batch number: 179805P and expiry date: not reported). On the same day approximately 1 minute after vaccination, the patient fainted. Shortly thereafter, the patient regained consciousness (reported as came back), felt nauseous and vomited. At the time of this report, the patient had recovered from all the events.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Fatigue, Feeling abnormal, Malaise
Clinical narrative: This spontaneous case, reported by a pharmacist via a company representative to VAERS and initially retrieved on 06-Jun-2018 by Seqirus from VAERS (VAERS ID: 730290), concerning a female patient of an unspecified age. The patient's relevant medical history and concomitant medications were not reported. On unspecified date in 2017 (reported as within the last 2 months), the patient was administered with influenza vaccine, (route of administration: injection (reported as SYR), dose, anatomical location, batch number, expiry date, trade name and manufacturer: not reported) and non-company suspect drug ZOSTAVAX (dose, route of administration, anatomical location, batch number, expiry date: not reported). On an unknown date in 2017, after receiving both vaccinations, the patient felt run-down (as reported), tired and very sick for an unspecified amount of time. At the time of this report, the outcome of the events was unknown. The reporter considered this case as non-serious.
Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Arthritis, Injection site pain, Pain, X-ray limb abnormal
Clinical narrative: This is spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 06-Jun-2018 by Seqirus from VAERS (VAERS ID: 730352), concerns a 73-year-old, elderly female patient. The patient's current conditions high blood pressure, arthritis in knee and allergy to Lisinopril (since an unspecified date). It was reported that, the patient had some foreign matter in hand. The patient's concomitant medications included atenolol, losartan, hydrochlorothiazide, levothyroxine (reported as prescribed), low dose aspirin, magnesium, omega Q plus and multivitamin for unknown indication. On 16-Oct-2017, the patient was administered with influenza vaccine (route of administration: intramuscular, anatomical location: left arm, dose, batch number, manufacturer and trade name were not reported). On the same day, after vaccination, the patient experienced pain and achiness in upper left arm, which moved into the shoulder caused pain with certain movements similar to rotator cuff as well as movements behind back. On 30-Nov-2017, the patient consulted the doctor and suggested for X-ray and therapy. The results of the X-ray were abnormal which showed minor arthritis in shoulder. At the time of report, the patient had not yet recovered from the events. The case was assessed as non-serious. Update 03-Jul-2018: Non-significant case correction received with IRD 06-Jun-2018: The narrative was corrected.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Chest X-ray, Computerised tomogram head, Computerised tomogram spine, Differential white blood cell count
Clinical narrative: This serious spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 17-Jul-2018 by Seqirus from VAERS (VAERS ID: 730597), concerning a 46-year-old, adult, female patient. On an unspecified date, the patient's nuclear magnetic resonance imaging (MRI) contrast was performed. The patient's current conditions included hypothyroidism, diabetes, high blood pressure (reported as medical history), cervical bulging discs, toothache and dry socket. The patient was allergic to sulfa drugs, CIPRO, tetracycline, excessive lidocaine, pecan, tomatoes, oranges and latex (since an unspecified date). The patient's concomitant medications included levothyroxine and DHEA for unknown indications. It was reported that on 11-Dec-2017, the patient went to hospital to collect MRI result (unspecified) and was unexpectedly administered FLUVIRIN (dose: 0.5 ml, route of administration: injection [SYR as reported], anatomical location: arm, batch number and expiry date: not reported). On the same day (11-Dec-2017), at about 11:15 AM,  when the patient was driving, she had an intense itching at the injection site in the shoulder. The patient felt that injected arm was entirely on fire (as reported) and burning. Later, the patient had passed out and then car ran off the road, hit an embankment, the car went airborne (as reported) and the patient rolled over for several times in the car. The patient was taken by air evacuation to the nearest hospital. It was reported that, the patient was administered Td vaccine. On an unspecified date, the patient had undergone complete blood count (CBC) with differential white blood cell count, comprehensive metabolic function tests, computed tomography (CT) for head and cervical spine, X-ray for chest, shoulder, pelvis and hip were performed, the results of all the tests were not reported. At the time of this report, the patient had not recovered from the events (passed out, injection site itching, burning sensation and road traffic accident).
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Full blood count, Injection site pain, Injection site pruritus, Loss of consciousness, Metabolic function test
Clinical narrative: This serious spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 17-Jul-2018 by Seqirus from VAERS (VAERS ID: 730597), concerning a 46-year-old, adult, female patient. On an unspecified date, the patient's nuclear magnetic resonance imaging (MRI) contrast was performed. The patient's current conditions included hypothyroidism, diabetes, high blood pressure (reported as medical history), cervical bulging discs, toothache and dry socket. The patient was allergic to sulfa drugs, CIPRO, tetracycline, excessive lidocaine, pecan, tomatoes, oranges and latex (since an unspecified date). The patient's concomitant medications included levothyroxine and DHEA for unknown indications. It was reported that on 11-Dec-2017, the patient went to hospital to collect MRI result (unspecified) and was unexpectedly administered FLUVIRIN (dose: 0.5 ml, route of administration: injection [SYR as reported], anatomical location: arm, batch number and expiry date: not reported). On the same day (11-Dec-2017), at about 11:15 AM,  when the patient was driving, she had an intense itching at the injection site in the shoulder. The patient felt that injected arm was entirely on fire (as reported) and burning. Later, the patient had passed out and then car ran off the road, hit an embankment, the car went airborne (as reported) and the patient rolled over for several times in the car. The patient was taken by air evacuation to the nearest hospital. It was reported that, the patient was administered Td vaccine. On an unspecified date, the patient had undergone complete blood count (CBC) with differential white blood cell count, comprehensive metabolic function tests, computed tomography (CT) for head and cervical spine, X-ray for chest, shoulder, pelvis and hip were performed, the results of all the tests were not reported. At the time of this report, the patient had not recovered from the events (passed out, injection site itching, burning sensation and road traffic accident).