chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: DTAP, FLUX
Symptoms: Decreased appetite, Pyrexia, Seizure, Tremor, Vomiting
Clinical narrative: This serious initial spontaneous case, was received from other non-health professional via health authority (VAERS ID: 700777) on 10-Dec-2017, concerning a female patient of age 0.50 (unit unspecified). The patient had no medical history and current illness. On 27-Jan-2017, the patient was administered with INN Flu Vaccine Seasonal (dose: 2 (as reported), route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On the same day, the patient was administered with Pneumo 23, dose: 2 (as reported), route of administration, anatomical location, batch number, expiry date: not reported). On the same day, the patient also was administered with Diphtheria vaccine w/Hepatitis B vaccine/Pertussis vaccine/Polio vacci (dose: 3 (as reported), route of administration, anatomical location, batch number, expiry date: not reported). On the same day (27-Jan-2017), the patient experienced fever over 104, seizure, tremor, vomiting and decreased appetite (not feeding). On an unknown date, the patient recovered from the events.
Sex: F
Vaccine: FLUX, HEP
Symptoms: Influenza like illness
Clinical narrative: This is a spontaneous case, initially received from health authority (VAERS ID: 702919) (reported to health authority by other non-health professional) on 10-Dec-2017, concerning a female patient of unspecified age. On an unspecified date, the patient was administered with influenza vaccine, (dose, route of administration, anatomical location, batch number, expiry date, manufacture and trade name: not reported). On an unspecified date, the patient was administered with RECOMBIVAX (dose: numerous booster (as reported), route of administration, anatomical location, batch number and expiry date: not reported). On unspecified date, after vaccination the patient experienced flu like symptoms (worse than normal). At the time of this report, the outcome of event was not reported. The reporter considered this case as non-serious.
Age: 72.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Pruritus, Secretion discharge, Sneezing, Throat irritation
Clinical narrative: This non-serious initial spontaneous case, was received from other health professional via health authority (VAERS ID: 703789) on 10-Dec-2017, concerning a 72-year-old, elderly male patient. The patient's current condition included: Ailments (face) (itchiness). On 05-Jun-2017, the patient was administered with influenza vaccine, (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On 12-Jun-2017, after 8 days of vaccination, the patient complained of cough, sneezing, throat irritation, mucus and ailments (face) (itchiness) (as reported). At the time of this report, the patient had not yet recovered from the events. The reporter assessed the events as non-serious.
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: This serious initial spontaneous case, was received from other health professional via health authority (VAERS ID: 703912) on 10-Dec-2017, concerning a 65-year-old, elderly, male patient. The patient's relevant medical history and concomitant medications were not reported. On 01-Oct-2016, the patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, following vaccination, the patient had GBS (Guillain Barre Syndrome). Lab data and corrective treatment were not reported. At the time of this report, the outcome of the event was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Pyrexia, Skin disorder, Skin reaction, Skin warm
Clinical narrative: This is a spontaneous case, initially received from regulatory authority (VAERS ID: 706078) (reported to RA by other non-health professional) on 10-Dec-2017, concerning a 12-year-old, adolescent, female patient. The patient was allergic to penicillin and cephalosporins. The patient's concomitant medication included Ibuprofen. On unspecified date in 2016, the patient received INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported). On unspecified date in 2016, after the administration of vaccine, the patient experienced severe skin reaction to flu vaccine. She developed redness, webbing, hot to touch, swelling with low grade fever. At the time of the report the outcome of the events was not reported. The reporter assessed this case as non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Swelling
Clinical narrative: This is a spontaneous case, initially received from regulatory authority (VAERS ID: 706078) (reported to RA by other non-health professional) on 10-Dec-2017, concerning a 12-year-old, adolescent, female patient. The patient was allergic to penicillin and cephalosporins. The patient's concomitant medication included Ibuprofen. On unspecified date in 2016, the patient received INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported). On unspecified date in 2016, after the administration of vaccine, the patient experienced severe skin reaction to flu vaccine. She developed redness, webbing, hot to touch, swelling with low grade fever. At the time of the report the outcome of the events was not reported. The reporter assessed this case as non-serious.
Sex: F
Vaccine: FLUC4
Symptoms: Drug intolerance, Erythema, Mobility decreased, Urticaria
Clinical narrative: This is a spontaneous case, initially received from regulatory authority (VAERS ID: 706468) (reported to health authority by other non-health professional) on 10-Dec-2017, concerning a 70-year-old elderly female patient. The patient's current condition included cardiovascular disorder. On unspecified date, the patient was administered with INN flu vaccine seasonal (route of administration: injection (SYR as reported), anatomical location, dose, manufacturer, tradename, batch number, expiry date: not reported). On unspecified date, the patient was administered with non-company suspect product alirocumab for cardiovascular disorder. It was reported that patient had taken 6 praluent injections and she had no issues with the first 5, but with sixth one, she experienced a red welt and he was unable to tolerate statins. On an unspecified date, after vaccine administration, the patient was unable to move her arm for a week. The patient's lab data and corrective treatment was not reported. At the time of this report, the patient recovered from the events. The reporter assessed the events as non-serious.
Sex: U
Vaccine: FLUX, PNC13
Symptoms: Peripheral swelling, Skin discolouration
Clinical narrative: This non-serious initial spontaneous case, was received from other health professional via health authority (VAERS ID: 706876) on 10-Dec-2017, concerning a patient of unspecified age and gender. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On the same day the patient also received PREVNAR 13 (single dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On 03-Aug-2016, the patient's hand was swelling and the skin turned rainbow color. The patient was treated with BACTRIM. At the time of this report, the outcome of the events was not reported. The reporter assessed the event as non-serious.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous case, was initially received on 10-Dec-2017 from other non-health professional via regulatory authority (VAERS ID: 708129), concerns an adult female patient of age in her 60's (as reported). On an unspecified date, the patient was administered with Influenza vaccine, (anatomical location: arm, route of administration, manufacturer, trade name, batch number, expiry date: not reported). On an unspecified date, the patient was administered with non-company suspect product PREVNAR 13 9anatomical location: arm, route of administration, batch number, expiry date: not reported). On unspecified date, after vaccine administration, the patient experienced soreness, redness and purplish bruise around the injection site. It was reported that the patient received the flu vaccine at the same time as the pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), but it was unknown if they were administered in the same arm. 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: Hypersensitivity
Clinical narrative: This spontaneous case, initially received from Health authority (VAERS ID: 708436) (reported to HA by other health professional) on 10-Dec-2017, concerns a female patient of unspecified age. The patient's medical history was not reported, and she had no allergies. The patient's concomitant medications included LYRICA, Irbesartan, fenofibrate atorvastatin calcium, fludrocortisone, metformin hydrochloride, duloxetine hydrochloride, levothyroxine insulin lispro and CRESTOR for an unknown indication. On an unspecified date, the patient was administered influenza vaccine, (route of administration: reported as OT, dose, anatomical location, batch number, expiry date, trade name and manufacturer not reported). On an unspecified date, after vaccination, the patient experienced allergy. At the time of this report, the outcome of the event was not reported. The reporter assessed this case as non-serious.
Age: 17.0
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Hyperhidrosis, Nausea, Pallor, Syncope, Visual impairment
Clinical narrative: This non-serious initial spontaneous case, was received from Other Health Professional via health authority (VAERS ID: 708830) on 10-Dec-2017, concerning a 17-year-old, adolescent male patient. The patient's historical condition, current illness and allergies were not reported. On 15-AUG-2017, the patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On the same day, the patient was administered with PREVNAR 13 (reported as 1 dose, route of administration: intramuscular, anatomical location: left arm, batch number: R70446, expiry date: not reported). On the same day, the patient fainted after giving shot. He also experienced sweating, nausea, paleness and visual disturbances. It was reported that the patient took ADVIL. The patient recovered from all the events. The reporter assessed the events as non-serious.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: This initial spontaneous case was received on 10-Dec-2017 from pharmacist and consumer via health authority (VAERS ID: 708878), concerns a 67-year-old elderly female patient. The patient's current conditions included thyroid problem, Alzheimer's disease and memory issue (since an unspecified date). The patient's concomitant medications included levothyroxine and it had been receiving from past 3 years (as reported) for thyroid problem and memantine for Alzheimer's disease and memory issues. On 10-Aug-2017, the patient was administered with influenza vaccine (anatomical location: arm, dose, route of administration, manufacturer, trade name, batch number, expiry date: not reported) and non-company product PREVNAR 13 (dose: 0.5 ml, frequency: single, anatomical location: arm, route of administration: intramuscular, batch number: R28322, expiry date: 31-Mar-2018). It was reported that, both the vaccines were administered to opposite arms. On the same day, the patient's arm, where PREVNAR 13 was given got hurt and was warm to touch. The patient was advised to take ibuprofen and she applied the ice pack. At the time of this report, the patient had not yet recovered from the events. The reporter assessed the events as non-serious.
Age: 60.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Dizziness, Dyspnoea, Headache, Malaise
Clinical narrative: This non-serious spontaneous case, initially received from health authority (reported to health authority by other non-health professional) (VAERS ID: 710990) on 10-Dec-2017, concerning a 60-year-old, adult male patient. On 01-Aug-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 the same day, the patient experienced heavy coughing, dizziness, headache, runny nose and was sick for 3 days. He experienced 3 days of hell. Hence, he used nebulizer with XOPENEX about 3 times daily for breathing difficulties. The health authority provided the preferred term as dyspnoea. At the time of this report, the patient had not yet recovered from the events dizziness, runny nose, sickness, headache, dyspnoea and coughing. The reporter assessed the events as non-serious. Case correction received with IRD 10-Dec-2017: the causality of the events coughing and dyspnoea was changed from not related to related. Route of administration was updated to injection. The narrative was amended accordingly.
Age: 60.0
Sex: M
Vaccine: FLUX
Symptoms: Rhinorrhoea
Clinical narrative: This non-serious spontaneous case, initially received from health authority (reported to health authority by other non-health professional) (VAERS ID: 710990) on 10-Dec-2017, concerning a 60-year-old, adult male patient. On 01-Aug-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 the same day, the patient experienced heavy coughing, dizziness, headache, runny nose and was sick for 3 days. He experienced 3 days of hell. Hence, he used nebulizer with XOPENEX about 3 times daily for breathing difficulties. The health authority provided the preferred term as dyspnoea. At the time of this report, the patient had not yet recovered from the events dizziness, runny nose, sickness, headache, dyspnoea and coughing. The reporter assessed the events as non-serious. Case correction received with IRD 10-Dec-2017: the causality of the events coughing and dyspnoea was changed from not related to related. Route of administration was updated to injection. The narrative was amended accordingly.
Age: 67.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Dizziness, Fatigue, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous case, was initially received on 10-Dec-2017 from other non-health professional via regulatory authority (VAERS ID: 711557), concerns a 67-year-old, elderly, female patient. The patient medical history included influenza vaccination every year from past 15 years. On 31-Aug-2017, the patient was administered with Influenza vaccine, (anatomical location: right arm, route of administration: intramuscular, dose: 0.5 ml, manufacturer, trade name, batch number, expiry date: not reported). On the same day, the patient was administered with PREVNAR 13 (dose: 0.5 ml, anatomical location: left arm, route of administration: intramuscular, batch number, expiry date: not reported). On 31-Aug-2017, after vaccine administration, the patient experienced injection site swelling, redness and warmth. On 01-Sep-2017, it was reported that the patient had not been feeling well since she had the injection. On an unspecified date, the patient experienced tiredness and dizziness. At the time of this report, the outcome of events injection site swelling, injection site redness, injection site warmth and malaise was not recovered. The outcome of the events tiredness and dizziness was not reported. The reporter assessed the events as non-serious.
Age: 67.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Malaise
Clinical narrative: This spontaneous case, was initially received on 10-Dec-2017 from other non-health professional via regulatory authority (VAERS ID: 711557), concerns a 67-year-old, elderly, female patient. The patient medical history included influenza vaccination every year from past 15 years. On 31-Aug-2017, the patient was administered with Influenza vaccine, (anatomical location: right arm, route of administration: intramuscular, dose: 0.5 ml, manufacturer, trade name, batch number, expiry date: not reported). On the same day, the patient was administered with PREVNAR 13 (dose: 0.5 ml, anatomical location: left arm, route of administration: intramuscular, batch number, expiry date: not reported). On 31-Aug-2017, after vaccine administration, the patient experienced injection site swelling, redness and warmth. On 01-Sep-2017, it was reported that the patient had not been feeling well since she had the injection. On an unspecified date, the patient experienced tiredness and dizziness. At the time of this report, the outcome of events injection site swelling, injection site redness, injection site warmth and malaise was not recovered. The outcome of the events tiredness and dizziness was not reported. The reporter assessed the events as non-serious.
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Discomfort
Clinical narrative: This initial spontaneous case, was received from other non-health professional (consumer) via health authority (VAERS ID: 711558), concerning a 77-year-old elderly male patient. The patient's historical vaccine included influenza vaccine (since past 15 years) and pneumococcal vaccine (had perhaps 5 years ago). The patient's current conditions included elevated blood pressure and high cholesterol. The patient's concomitant medications included Doxazosin for an unknown indication. On 31-Aug-2017, the patient was administered with INN Flu Vaccine Seasonal (route of administration: intramuscular, anatomical location: right arm, dose, batch number, expiry date, manufacturer, trade name: not reported) and PREVNAR 13 (dose: 1 dose, route of administration: intramuscular, anatomical location: left arm, batch number, expiry date, manufacturer, trade name: not reported). On 01-Sep-2017, after 1 day of vaccination, the patient experienced discomfort. On 03-Sep-2017, the patient was recovered from the event. The reporter assessed the event as non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal disorder, Nerve conduction studies, Nuclear magnetic resonance imaging, Pain in extremity, X-ray
Clinical narrative: This initial spontaneous case, received on 10-Dec-2017 reported by other non-health professional and concerns 59-year-old, adult, female patient. The patient's relevant medical history and concomitant medications were not reported. On 28-Oct-2016, the patient received Influenza vaccine (anatomical location: left arm, dose, route of administration, batch number, expiry date, trade name, manufacturer: not reported). On 29-Oct-2016, after administration of Inn Flu Vaccine Seasonal, the patient's arm was hurting and could not use the arm. It was reported that, the patient's finger started hurting and felt like picking up broken glass. On an unspecified date, X-ray, MRI and nerve test were performed. The results of which were not available. At the time of this report, the patient had not yet recovered from the event.
Sex: F
Vaccine: FLUX
Symptoms: Rash, Skin warm, Urticaria
Clinical narrative: The initial spontaneous case, was received from the other non-health care professional via health authority (VAERS ID: 714033) on 10-Dec-2017, concerning a female patient of unspecified age. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was administered with influenza vaccine, (route of administration: SYR (as reported), manufacture, trade name, dose, batch number, expiry date: not reported). On an unspecified date, after vaccination, the patient experienced rash, very large welt that lasted a few days and it was warm to touch. On an unspecified date, the patient recovered from the events. The reporter considered this case as non-serious.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Eyelid oedema, Visual impairment
Clinical narrative: This is a spontaneous case, was initially received on 10-Dec-2017 from other non-health professional via regulatory authority (VAERS ID: 714327), concerns a 52-year-old, adult female patient. The patient's historical conditions included sciatica and herniated disc of back (unspecified dates). The patient's current condition included diabetes (since an unspecified date). The patient had no allergies. On 11-Sep-2017, the patient was administered with Influenza vaccine, (anatomical location: right arm, dose, route of administration, batch number, expiry date, manufacturer, trade name: not reported). On 12-Sep-2017, after 2 days of vaccine administration, the patient's right eye had swollen which made her hard to see out which lasted for four days. The outcome of the events was recovered. The reporter assessed the events as non-serious. Non-significant case correction received with IRD 10-Dec-2017: The patient's medical history (historical condition: sciatica, herniated disc of back; current condition: diabetes) were captured in the narrative. The narrative was amended accordingly.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal discomfort, Crying, Headache, Mood altered, Myalgia
Clinical narrative: This spontaneous case, was initially received from other health professional via health authority (VAERS ID: 714805) on 10-Dec-2017, concerning a 33-year-old female patient. The patient's medical history included seizures (unspecified date). The patient had no allergies. The patient did not receive any concomitant medications. On 04-Sep-2017, the patient was administered with influenza vaccine, (route of administration: syr (as reported), dose, anatomical location, batch number, expiry date, manufacturer and trade name: not reported). On 05-Sep-2017, after 1 day of vaccination, the patient experienced skin hurt, stomach upset, headache and muscles ache. Her mood became awful (as reported). She screamed and cried. The patient heard some noise, which was never heard before. At the time of this report, the outcome of the events was not reported. The reporter assessed the events as non-serious.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Pain of skin, Screaming, Tinnitus
Clinical narrative: This spontaneous case, was initially received from other health professional via health authority (VAERS ID: 714805) on 10-Dec-2017, concerning a 33-year-old female patient. The patient's medical history included seizures (unspecified date). The patient had no allergies. The patient did not receive any concomitant medications. On 04-Sep-2017, the patient was administered with influenza vaccine, (route of administration: syr (as reported), dose, anatomical location, batch number, expiry date, manufacturer and trade name: not reported). On 05-Sep-2017, after 1 day of vaccination, the patient experienced skin hurt, stomach upset, headache and muscles ache. Her mood became awful (as reported). She screamed and cried. The patient heard some noise, which was never heard before. 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, PPV
Symptoms: Chills, Erythema, Pain, Peripheral swelling, Tenderness
Clinical narrative: This initial spontaneous case, was received on 10-Dec-2017 from other non-health professional via regulatory authority (VAERS ID: 714889), concerns a 53-year-old, adult female patient. The patient's current conditions included hypothyroidism, asthma, hepatitis C and COPD (chronic obstructive pulmonary disease) since an unspecified date. Concomitant medications included Levothyroxine, PERCOCET, PROAIR, Methocarbamol, Gabapentine, SPIRIVA and benzonatate for an unknown indication. On 18-Sep-2017, the patient was administered with INN (anatomical location: right arm, dose, route of administration, manufacturer, trade name, batch number, expiry date: not reported). On the same day, the patient was administered with non-company suspect product Pneumococcal vaccine (dose, anatomical location, route of administration, manufacturer, batch number, expiry date: not reported). On 19-Sep-2017, after 24 hours of vaccine administration, the patient developed chills, body aches, raised, erythematous patch on right arm with tenderness to touch. Outcome of the events was not reported. The reporter considered this report as non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Chills, Hot flush
Clinical narrative: This non-serious spontaneous case, initially received from other health professional via health authority (VAERS ID: 715373) on 05-Dec-2017, concerning an 48-year-old, adult, female patient of an unspecified age. On an unspecified date in Sep-2016, the patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date manufacturer, trade name: not reported). On an unspecified date, after the vaccination, the patient had chills, hot flashes and arthritic pain. The outcome of the events was not reported. The reporter considered the causality of the events as related to the suspect vaccine.
Sex: M
Vaccine: FLUX, MENB
Symptoms: Chills, Pyrexia, Tuberculin test
Clinical narrative: This spontaneous case, initially received from FDA (VAERS ID: 715510) (reported to HA by a physician) on 10-Dec-2017, concerning a 19-year-old, adult, male patient of an unspecified ethnicity. The patient historical vaccine included meningococcal group B Vaccine (first dose). The patient's medical history and concomitant medication were not reported. On 19-Sep-2017, the patient administered INN Flu Vaccine Seasonal (route of administration: injection (reported as SYR), dose, batch number, expiry date, manufacturer, trade name, anatomical location: not reported) and TRUMENBA (dose: single, dose number: 2, anatomical location: deltoid, route of administration: intramuscular, batch number: S26985 and expiry date: not reported). On the same day, after the vaccination, the patient experienced fever of 102-degree F, chills and received Ibuprofen. On an unspecified date, the patient underwent purified protein derivative skin test (Tuberculin test). It was reported that, the patient was followed up after 3 days and he was fine. On an unspecified date in Sep-2017, the patient recovered from the events. The reporter assessed the case as non-serious and considered the causality of the events as related.
Sex: M
Vaccine: FLUX
Symptoms: Blood pressure increased, Dysgeusia, Myalgia
Clinical narrative: This spontaneous case, was initially received on 10-Dec-2017 from other health professional via regulatory authority (VAERS ID: 715821), concerns a 76-year-old elderly male patient. On 16-Sep-2017, the patient was administered with Influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, manufacturer, trade name: not reported). On 17-Sep-2017, after 1 day of vaccine administration the patient experienced (L) left muscular pain, metallic taste in mouth and elevated blood pressure. At the time of this report, the outcome of events was not reported. The reporter assessed the events as non-serious.
Sex: M
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: This is a spontaneous case, initially received on 10-Dec-2017, from health authority (VAERS ID: 715970) via other non-health professional (consumer), concerning a male patient of unspecified age. The patient's medical history and concomitant medications were not reported. On an unspecified date (reported as almost 2-years ago), the patient was administered with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, manufacturer, trade name: not reported). On an unspecified date, after the vaccination, the patient experienced pain (unspecified). It was reported that, patient went through lot of pain and received Cortisone shot, therapy (unspecified) for months. The patient went to emergency room. The doctor talk about the surgery for the patient. At the time of this report, the outcome of the event was reported as not-recovered. The reporter assessed the event as non-serious. Significant case correction received with IRD 10-Dec-2017: The causality of the event pain NOS was changed from unassessable to related. The case comment was amended by including all the factors for the assessment.
Sex: F
Vaccine: FLUX
Symptoms: Heart rate increased, Pruritus, Urticaria
Clinical narrative: This is a spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 03-Fex-2018 by Seqirus from VAERS (VAERS ID: 716010) on 03-Feb-2018, concerning a 66-year-old, elderly, female patient. The patient's current condition included: pre-diabetic. Concomitant medications included: Pravastatin, metformin and calcium for an unknown indication. On 28-Sep-2017, the patient was administered with INN Flu Vaccine Seasonal (reported as 1 dose, route of administration: intramuscular, anatomical location: left arm, dose, batch number, expiry date, trade name, manufacturer: not reported). On the same day, about 3 hours after vaccination, the patient started itching. Later, in about 10 hours, she had a fast heart rate and hives all over her trunk front and back. Hence, she took BENADRYL at 10 am and 2 pm. Subsequently, after 24 hours, the hives went away, and her heart was at a normal rate. The patient recovered from all the events (heart rate increased, itch and hives). The reporter assessed the events as non-serious. Significant case correction received with the IRD 03-Feb-2018: The onset latency was corrected for the event itch.
Sex: M
Vaccine: FLUX
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: This spontaneous case, reported by health care professional (other) to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 716108), concerns a 05-year-old, child male patient. The patient's current condition included strep throat since an unspecified date. The patient's concomitant medications included amoxicillin for strep throat and ADVIL for an unknown indication. On 02-Oct-2017, the patient was administered with INN Flu Vaccine Seasonal (dose: unknown, route of administration, anatomical location, batch number, expiry date: not reported). On the same day, around 6:30PM after vaccination, the patient complained his legs where itchy, upon inspection hives were discovered and he was taken to emergency room. At the time of this report, the patient recovered from the events. The reporter assessed this case as non-serious.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Headache, Hypoaesthesia, Injection site pain, Mobility decreased
Clinical narrative: This is a spontaneous case, reported by a non-health professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (regulatory reference number: 716180), concerning a 38-year-old, adult female patient. The patient's historical condition included tetanus and the patient was allergic to amoxicillin. The patient was using birth control pills. The patient had no current illness. On 02-Oct-2017, the patient was administered with INN Flu Vaccine Seasonal (dose: unk, route of administration injection (SYR), anatomical location: right arm, batch number, expiry date, trade name, and manufacturer). On the same day, after administration of vaccine, the patient experienced sharp elbow pain, even though the vaccine was administered at the top of her should. In overnight, the patient developed a terrible stiff neck and intense shoulder pain which persisted through the following day. The patient also had slight numbness in her fingers, on her right hand and the right side of her face. She had pain which was radiating from the injection site over the front and back of her shoulder, up her neck through the back of her head. She could barely turn her head and had lot of pain when she was moving it. The patient was planning to visit doctor 2 days after vaccination. At the time of the report, the outcome of the events was not recovered. The reporter assessed the event as non-serious.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Neck pain, Pain
Clinical narrative: This is a spontaneous case, reported by a non-health professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (regulatory reference number: 716180), concerning a 38-year-old, adult female patient. The patient's historical condition included tetanus and the patient was allergic to amoxicillin. The patient was using birth control pills. The patient had no current illness. On 02-Oct-2017, the patient was administered with INN Flu Vaccine Seasonal (dose: unk, route of administration injection (SYR), anatomical location: right arm, batch number, expiry date, trade name, and manufacturer). On the same day, after administration of vaccine, the patient experienced sharp elbow pain, even though the vaccine was administered at the top of her should. In overnight, the patient developed a terrible stiff neck and intense shoulder pain which persisted through the following day. The patient also had slight numbness in her fingers, on her right hand and the right side of her face. She had pain which was radiating from the injection site over the front and back of her shoulder, up her neck through the back of her head. She could barely turn her head and had lot of pain when she was moving it. The patient was planning to visit doctor 2 days after vaccination. At the time of the report, the outcome of the events was not recovered. The reporter assessed the event as non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Cough, Diarrhoea, Ear pruritus, Headache, Pain in extremity
Clinical narrative: This is spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 716218) concerns 60-year-old, adult female patient. The patient's current condition included allergic to Ibuprofen. It was reported that, the patient always become sick with at least a cold for one week, after receiving the influenza vaccine. On 22-Sep-2017 at 11:00 hrs, the patient was administered with influenza vaccine (route of administration: intramuscular, anatomical site: left arm, dose, manufacturer, trade name, batch number and expiry date: not reported). On the same day, after one hour of vaccination, the patient had diarrhoea and it continued for 5 days. The patient had pain in left arm and left thigh for 5 days. Around 29-30 September, the patient experienced irritated itch on both ears. On 02-Oct-2017, the patient had headache and runny nose and on the next day 03-Oct-2017, she had sneezing, coughing running nose and scratchy throat. At the time of this report, the outcome of the events not recovered. The reporter considered this case as non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Rhinorrhoea, Sneezing, Throat irritation
Clinical narrative: This is spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 716218) concerns 60-year-old, adult female patient. The patient's current condition included allergic to Ibuprofen. It was reported that, the patient always become sick with at least a cold for one week, after receiving the influenza vaccine. On 22-Sep-2017 at 11:00 hrs, the patient was administered with influenza vaccine (route of administration: intramuscular, anatomical site: left arm, dose, manufacturer, trade name, batch number and expiry date: not reported). On the same day, after one hour of vaccination, the patient had diarrhoea and it continued for 5 days. The patient had pain in left arm and left thigh for 5 days. Around 29-30 September, the patient experienced irritated itch on both ears. On 02-Oct-2017, the patient had headache and runny nose and on the next day 03-Oct-2017, she had sneezing, coughing running nose and scratchy throat. At the time of this report, the outcome of the events not recovered. The reporter considered this case as non-serious.
Sex: M
Vaccine: DTAPIPV, FLUX, MMRV
Symptoms: Gait inability
Clinical narrative: This spontaneous case, reported by health care professional (other) to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 716250), concerns a 04-year-old, child male patient. On 02-Oct-2017, the patient was administered with INN Flu Vaccine Seasonal (route of administration: intramuscular, anatomical location: right leg, dose, expiry date, batch number, manufacture and trade name: not reported). On the same day, the patient was also administered with PROQUAD (route of administration: intramuscular, anatomical location: left leg, batch number: (reported as N019251), dose, expiry date: not reported) and KINRIX (route of administration: intramuscular, anatomical location: left leg, batch number: (reported as: 7574T), dose expiry date: not reported). On 03-Oct-2017, 2 days after the administration of vaccine, the patient refused as he was unable to walk for 12 hours. It was reported that, there was no swelling, induration, erythema, no fever or chills or other systemic symptoms. The outcome of the event reported as recovered. The reporter assessed this case as non-serious.
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: This spontaneous case, reported by health care professional (other) to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 716336), concerns a 57-year-old, adult male patient. The patient's historical condition included Lyme disease. The patient's concomitant medication included unspecified vitamins for an unknown indication. On 26-Sep-2017, the patient was administered with influenza vaccine (dose, route of administration, anatomical location: unknown, batch number, expiry date, trade name and manufacture: not reported). On 29-Sep-2017, 4 days after the administration of vaccine, the patient experienced joint pain in right elbow, fingers, knee and both sides of hip joints and right toes. At the time of this report, the outcome of the events was not recovered. The reporter assessed this case as non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Malaise, Nasopharyngitis, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 716412), concerns a 36-year-old, adult, female patient. The patient's medical history was not reported. The concomitant medication's included ADDERALL, Probiotics, Spironolactone and Contraceptives (as reported as birth control) for an unknown indication. On 01-Oct-2017, the patient was administered with INN flu vaccine seasonal (route of administration: injection, anatomical location: left arm, dose, batch number and expiry: not reported). On the same day, after 2 hours of vaccination, the patient had sore throat. On next day, the patient felt sick and had cold symptoms (sneezing, fatigue, runny nose and sore throat). It was reported that, the patient was treated with ADVIL for sore throat and was not effective. On the second day, it was reported that patient felt sick with same symptoms. The reporter assessed the event (cold symptoms) as non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Sneezing
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 716412), concerns a 36-year-old, adult, female patient. The patient's medical history was not reported. The concomitant medication's included ADDERALL, Probiotics, Spironolactone and Contraceptives (as reported as birth control) for an unknown indication. On 01-Oct-2017, the patient was administered with INN flu vaccine seasonal (route of administration: injection, anatomical location: left arm, dose, batch number and expiry: not reported). On the same day, after 2 hours of vaccination, the patient had sore throat. On next day, the patient felt sick and had cold symptoms (sneezing, fatigue, runny nose and sore throat). It was reported that, the patient was treated with ADVIL for sore throat and was not effective. On the second day, it was reported that patient felt sick with same symptoms. The reporter assessed the event (cold symptoms) as non-serious.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain, Arthralgia, Eye pain, Fatigue, Joint noise
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 716443), concerns a 33-year-old, adult female patient. The patient's current conditions included asthma, autosomal dominant polycystic kidney disease (ADPKD), depression and allergy to amoxicillin. The patient's concomitant medications included LEXAPRO, Albuterol, QVAR, Magnesium, Calcium, zinc and melatonin for an unknown indication. On 30-Oct-2017, the patient was administered with influenza vaccine, (route of administration: injection (reported as SYR), anatomical location: left arm, dose, batch number, manufacturer, trade name, and expiry date: not reported). On the same day of the vaccination, the patient had muscle pain, joint pain, increased joint crepitus, elevated body temperature (99-degree F) and was fatigue. On 01-Oct-2017, after 02 days of vaccination, the patient had fever (100-degree F), extreme stabbing pain in abdomen (back front and back) near bottom of rib cage, muscle spasms, eye pain and muscle pain had increased. On 02-Oct-2017, temperature was normal. No lab investigations were done for the events. On an unspecified date, the patient recovered from the all the events except abdominal pain which was reported as not recovered (continuing). The reporter assessed the events as non-serious.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Muscle spasms, Myalgia, Pyrexia
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 716443), concerns a 33-year-old, adult female patient. The patient's current conditions included asthma, autosomal dominant polycystic kidney disease (ADPKD), depression and allergy to amoxicillin. The patient's concomitant medications included LEXAPRO, Albuterol, QVAR, Magnesium, Calcium, zinc and melatonin for an unknown indication. On 30-Oct-2017, the patient was administered with influenza vaccine, (route of administration: injection (reported as SYR), anatomical location: left arm, dose, batch number, manufacturer, trade name, and expiry date: not reported). On the same day of the vaccination, the patient had muscle pain, joint pain, increased joint crepitus, elevated body temperature (99-degree F) and was fatigue. On 01-Oct-2017, after 02 days of vaccination, the patient had fever (100-degree F), extreme stabbing pain in abdomen (back front and back) near bottom of rib cage, muscle spasms, eye pain and muscle pain had increased. On 02-Oct-2017, temperature was normal. No lab investigations were done for the events. On an unspecified date, the patient recovered from the all the events except abdominal pain which was reported as not recovered (continuing). The reporter assessed the events as non-serious.
Age: 24.0
Sex: F
Vaccine: FLUX
Symptoms: Aphonia, Dizziness, Injection site reaction, Mobility decreased, Oropharyngeal pain
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (regulatory reference number: 716571), concerning a 24-year-old, adult, female patient. The patient's historical condition included PCOS (polycystic ovary syndrome) and asthma. Historical drugs included Mushrooms, PROVERA, metformin, Bactria, WELLBUTRIN and OMNICEF all for an unknown indication. The patient had currently asthma difficulty. The patient's concomitant medications included SINGULAIR, spironolactone, progesterone, supplements (LENTRA, PROLENT, METHYLMAX, PROCITE-D, Inositol, DHA/EPA, multivitamin, vitamin D3, vitamin B2), albuterol and VENTOLIN inhaler all for unknown indication. On 04-Oct-2017, the patient was administered with Influenza vaccine (dose: unk, route of administration, anatomical location, batch number, expiry date, trade name, and manufacturer). On the same day, after administration of vaccine, the patient experienced fever, dizzy, sore throat. The patient also lost her voice and developed rash on her right side. She had body aches and welts (2X1 as reported) at the injection site. The patient also had soreness in arm and she could barely move it. At the time of this report, the outcome of the events was not recovered. The reporter assessed the events as non-serious.
Age: 24.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pain in extremity, Pyrexia, Rash, Urticaria
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (regulatory reference number: 716571), concerning a 24-year-old, adult, female patient. The patient's historical condition included PCOS (polycystic ovary syndrome) and asthma. Historical drugs included Mushrooms, PROVERA, metformin, Bactria, WELLBUTRIN and OMNICEF all for an unknown indication. The patient had currently asthma difficulty. The patient's concomitant medications included SINGULAIR, spironolactone, progesterone, supplements (LENTRA, PROLENT, METHYLMAX, PROCITE-D, Inositol, DHA/EPA, multivitamin, vitamin D3, vitamin B2), albuterol and VENTOLIN inhaler all for unknown indication. On 04-Oct-2017, the patient was administered with Influenza vaccine (dose: unk, route of administration, anatomical location, batch number, expiry date, trade name, and manufacturer). On the same day, after administration of vaccine, the patient experienced fever, dizzy, sore throat. The patient also lost her voice and developed rash on her right side. She had body aches and welts (2X1 as reported) at the injection site. The patient also had soreness in arm and she could barely move it. At the time of this report, the outcome of the events was not recovered. The reporter assessed the events as non-serious.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injected limb mobility decreased, Pain, Vaccination site pain
Clinical narrative: This spontaneous case, reported by non-other health professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 716679), concerns a 46-year-old, adult, female patient. The patient's relevant medical history included protein in kidney (on an unknown date) and acid reflux (on an unknown date). The current illnesses of patient included gastritis and sinusitis (since unspecified dates). The patient had penicillin, almond and peanut allergies (since unspecified dates). The historical vaccine included unspecified flu vaccine which the patient had been taking for 18 years. The concomitant medication included losartan for unknown indication and unspecified allergy medicine (since unspecified dates). On 03-Oct-2017, the patient was administered with influenza vaccine (route of administration: intramuscular, anatomical location: arm, dose: UNK (as reported), batch number, expiry date, trade name, manufacturer: not reported). On the same day (03-Oct-2017), the patient was administered with non-company suspect product pneumococcal vaccine (dose: UNK (as reported), anatomical location: arm, route of administration, batch number, expiry date: not reported). On the same day (03-Oct-2017) after vaccination, the patient had severe body aches and had a lot of pain in the arm where the vaccines were administered. The body aches were severe for 2 days, later their severity reduced, but it continued (severity: mild). It was reported that, the patient could hardly use the injected arm to get dressed or to do anything. At the time of this report, the patient had not recovered from all the events. The reporter assessed this case as non-serious. Significant case correction received with IRD 03-Feb-2018: Company causality was changed from related to unassessable.