chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This is spontaneous case, reported by Other Health Professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 725681), concerns a 34-year-old, adult female patient. The patient had no known allergies. The patient's concomitant medication included SYEDA for birth control. On 30-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml [frequency: unknown], route of administration: intramuscular, anatomical location: right arm, batch number: 195222 and expiry date not reported]. On the same day, after vaccination, the patient experienced abnormal soreness in arm and decreased mobility. As of 08-Nov-2017, no treatment was taken. It was reported that, the patient would be monitored and if the symptoms worsen or does not improve soon then would consult a physician. At the time of this report, the outcome of the events (abnormal soreness in arm and decreased mobility) was unknown. The reporter assessed this case as non-serious.
Age: 4.0
Sex: M
Vaccine: FLUC4
Symptoms: Erythema
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 725696), concerning a 04-year-old, male child. On 08-Nov-2017, the patient was administered FLUCELVAX (QIVc) [dose: 0.5 ml, batch number: 195233, route of administration: intramuscular, anatomical location: left arm and expiry date: not reported]. On the same day, about 2 hours after the vaccination the patient's ears were turning red which started at bottom and later moved up. There were no other symptoms of an allergic reaction. The patient was recommended to take BENDARYL liquid. The patient's mom spoke with paediatrician who advised her to use cold compresses to the patient's ears. On the same day evening at 8 pm, the patient was followed up and the patient's mom reported that the redness in ears had gone down. At the time of the report, the patient had recovered from the event. The reporter assessed the case as non-serious. Update received on 20-Sep-2018. Significant case correction: (IRD: 26-Aug-2018): The listedness for the event (erythema was changed from 'unlisted to listed' as per the agency. No changes were done in the narrative.
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site hypoaesthesia, Injection site pain
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 725704), concerns a 40-year-old, adult female patient. The patient was allergic to sulfa drugs. The concomitant medication included unspecified birth control medication. On 26-Sep-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, [frequency reported as unknown], route of administration: intramuscular, anatomical location: left arm, batch number: 195210A and expiry date: not reported). On the same day after vaccination, the patient experienced pain and numbness that shot down about three inches from that site. The patient described that she could tell the exact site of injection (flu vaccine), when she reported that the events. The patient had a doctor's appointment to ask more clarifying questions. The reporter did not find the injection site showed by the patient as inappropriate. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious.
Age: 9.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site rash, Rash
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 725739), concerns a 09-year-old, male child patient. The patient did not have any known relevant medical history, current conditions and allergies. The patient did not receive any concomitant medications. On 25-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency reported as 1, route of administration: intramuscular, anatomical site: left arm, batch number: 195226A and expiry date: not reported). On the same day (25-Oct-2017), 10 minutes after vaccination, the patient returned to the clinic with a large red, rash around the injection site which covered the entire upper arm. The patient was immediately treated with BENADRYL and was observed for breathing difficulties which was denied. The rash further moved up the patient's neck, but he continued to deny breathing difficulty. The patient's mother was contacted to go and pick him up and to monitor him that evening. The patient's mother reported that she kept him out of school the following day for observation. On an unspecified date, the patient had recovered from the events. The reporter assessed the case as non-serious. Update on 06-Sep-2018: Non-significant case correction (IRD): 26-Aug-2018): The verbatim 'injection site reaction' was added to the third event 'injection site reaction' in the event tab.
Age: 47.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site hypoaesthesia
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 725748), concerns a 47-year-old adult female patient. On 06-Oct-2017, the patient received FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195212 and expiry date: not reported]. On 07-Oct-2017, one day after vaccination, the patient experienced numbness of right arm from below shoulder to above elbow. It was reported that, the patient made an office visit. As of 09-Oct-2017, the event numbness got resolved up to 90% (recovering). The reporter assessed this case as non-serious.
Age: 63.0
Sex: M
Vaccine: FLUC4
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 725861), concerns a 63-year-old, adult male patient. The patient had no historical conditions, current conditions or allergies. The patient's concomitant medications included simvastatin and PRESERVISION AREDS for unknown indications. On 05-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 195224 and expiry date: not reported]. On 07-Oct-2017, 2 days after vaccination, the patient developed pain, and soreness in arm, which was persistent for 4 weeks. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious. Update received on 20-Sep-2018: Non-significant case correction (IRD: 26-Aug-2018): The concomitant medication (PRESERVISION AREDS) was added in product tab. The narrative was amended accordingly.
Age: 46.0
Sex: M
Vaccine: FLUC4
Symptoms: Cough
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 725899), concerns a 46-year-old, adult, male patient. The patient's historical condition included mild asthma. The patient had occasional upper respiratory allergic reactions to dust, pollen and animal hair. The patient had no current illness. The patient did not receive any concomitant medications. On 05-Nov-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration, anatomical location, batch number and expiry date: not reported). On 07-Nov-2017, 2 days after vaccination, the patient developed moderate to severe coughing episodes on laying down. It was reported that, the symptoms lasted for approximately 24 hours and over the counter cough medications (unspecified) helped to resolve the symptoms. At the time of the report, the patient had recovered from the event. The reporter assessed the case as non-serious.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Eye pruritus, Pruritus, Rash, Rash erythematous
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 726248), concerns a 35-year-old, adult female patient. The patient's current conditions included attention deficit hyperactivity disorder (ADHD) and low blood iron anaemia (reported as medical history), sore throat and respiratory syncytial virus (RSV) infection and had hand, foot, and mouth disease. The patient's concomitant medications included VYVANSE, dextroamphetamine-amphetamine, biotin plus keratin (FINEST NUTRITION), Iron NATURE MADE and E 400IU (as reported), all for unknown indications. On 10-Nov-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency reported as 1, route of administration: intramuscular, anatomical site: left arm, batch number: 195233 and expiry date: not reported). On the same day (10-Nov-2017), about 6 hours after vaccination, the patient experienced allergic reactions which included red itchy hives in crease of both the arms, also developed slight swelling of cheeks under eyes. About 2 hours later, the patient developed swollen face and rash was slightly dissipated. On 11-Nov-2017, upon waking up in the morning, around 9 am, the patient's rash and itchiness had spread up and down her arm. The patient took shower around 1 pm and found that the rashes and redness on arms had disappeared by about 50% (recovering). At the time of this report, the patient was recovering from the events swelling face, erythema and rash and had not recovered from the events swelling of cheeks under eyes, allergic reaction, pruritus, urticaria and eye pruritus. The reporter assessed the case as non-serious. Update received on 27-Sep-2018: Significant case correction done with IRD 26-Aug-2018: Added current condition hand, foot, and mouth disease in patient tab. Narrative sentence was reframed.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Swelling face, Urticaria
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 726248), concerns a 35-year-old, adult female patient. The patient's current conditions included attention deficit hyperactivity disorder (ADHD) and low blood iron anaemia (reported as medical history), sore throat and respiratory syncytial virus (RSV) infection and had hand, foot, and mouth disease. The patient's concomitant medications included VYVANSE, dextroamphetamine-amphetamine, biotin plus keratin (FINEST NUTRITION), Iron NATURE MADE and E 400IU (as reported), all for unknown indications. On 10-Nov-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency reported as 1, route of administration: intramuscular, anatomical site: left arm, batch number: 195233 and expiry date: not reported). On the same day (10-Nov-2017), about 6 hours after vaccination, the patient experienced allergic reactions which included red itchy hives in crease of both the arms, also developed slight swelling of cheeks under eyes. About 2 hours later, the patient developed swollen face and rash was slightly dissipated. On 11-Nov-2017, upon waking up in the morning, around 9 am, the patient's rash and itchiness had spread up and down her arm. The patient took shower around 1 pm and found that the rashes and redness on arms had disappeared by about 50% (recovering). At the time of this report, the patient was recovering from the events swelling face, erythema and rash and had not recovered from the events swelling of cheeks under eyes, allergic reaction, pruritus, urticaria and eye pruritus. The reporter assessed the case as non-serious. Update received on 27-Sep-2018: Significant case correction done with IRD 26-Aug-2018: Added current condition hand, foot, and mouth disease in patient tab. Narrative sentence was reframed.
Age: 54.0
Sex: F
Vaccine: FLUC4
Symptoms: Diarrhoea, Vomiting
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 726294), concerns a 54-year-old, adult female patient. The patient had no historical condition (reported as good). The patient's current condition was unknown. The patient had no allergies. The concomitant medication included PULMICORT for an unknown indication. On 07-Nov-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency reported as 1, route of administration: intramuscular, anatomical location: left arm, batch number: 195231 and expiry date: not reported). On 08-Nov-2017, one day after vaccination, the patient experienced diarrhoea and vomiting for 3 days. On an unspecified date in Nov-2017, the patient had recovered from the events. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLUC4
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 726460), concerns a female patient of unspecified age. On 31-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, batch number: 195245, route of administration: injection [reported as SYR], anatomical location: right arm and expiry date: not reported). The next morning (01-Nov-2017), the patient developed pain and swelling on her arm where she received the flu shot. At the time of the report, the patient had recovered from the events. The reported assessed the case as non-serious. Update received on 28-Sep-2018: Non-significant case correction (IRD: 26-Aug-2018): The phrase 'on the next day (01-Nov-2017) morning, after vaccination' was changed to 'the next morning (01-Nov-2017), after vaccination' in the narrative. The narrative was amended accordingly.
Age: 64.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Diarrhoea
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 726702), concerns a 64-year-old, adult male patient. The patient's historical condition included nerve pain from degenerative disc disease. The patient's current condition included: liver function (unspecified). The patient had no allergy. The concomitant medications included Milk thistle for liver function, Men's multi, Vitamin D, calcium and magnesium, all for unknown indications. On 19-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency reported as 1, route of administration: intramuscular, anatomical location: left arm, batch number: 195214 and expiry date: not reported) and a non-company suspect vaccine, ZOSTAVAX (frequency reported as 1, route of administration: subcutaneous, anatomical location: right arm, batch number: M041085, dose and expiry date: not reported). On 21-Oct-2017, 2 days after vaccination, the patient had diarrhoea which lasted longer than a week and was not controlled by IMODIUM and over the counter (OTC) drug. The patient then was instructed by his doctor to do the bananas, rice, applesauce, toast (BRAT) diet and then BRAT diet plus a probiotic. At the time of this report, the outcome of the event was unknown. The reporter assessed the case as non-serious.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash generalised
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 726771), concerns a 59-year-old, adult, female patient. On 09-Nov-2017, the patient was administered FLUCELVAX (QIVc) (dose: 0.5 ml, batch number: 195233 (reported as 1952333), route of administration: intramuscular, anatomical location: left arm and expiry date: not reported). On the next day (10-Nov-2017), the patient developed generalized rash all over the body. At the time of the report, the patient had not recovered from the event. The reported assessed the case as non-serious.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Injection site rash
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 726803), concerns a 56-year-old, adult female patient. The patient's current conditions included an allergy to Tetanus Diphtheria toxoid. On 02-Nov-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, frequency reported as 2, route of administration: intramuscular, anatomical location: left arm, batch number: 195239, expiry date: not reported]. On the same day, after vaccination, the patient experienced pain and rash at the injection site, which she reported to the pharmacy. At the time of this report, the outcome of the events was unknown. The reporter assessed this case as non-serious.
Age: 42.0
Sex: M
Vaccine: FLUC4
Symptoms: Dehydration, Vomiting
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 726921), concerns a 42-year-old, adult male patient. The patient's current conditions included diabetes mellitus and high blood pressure (reported as medical history). The patient had no known allergies (NKA). Concomitant medications included enalapril (dose: 10 mg), atorvastatin (dose: 40 mg), Metformin ER (dose: 500 mg), TANZEUM (dose: 50 mg), amlodipine (dose: 10 mg), HCTZ (12.5), omeprazole (dose: 20 mg), BASAGLAR and NOVOLOG, for unknown indications. On 10-Nov-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195227, and expiry date: not reported]. On 15-Nov-2017, 5 days after vaccination, the patient experienced vomiting and dehydration. On an unspecified date, the patient made an emergency room visit. On an unspecified date, the patient had recovered from the events. The reporter assessed the case as non-serious. Update received on 27-Sep-2018: Significant case correction (IRD: 26-Aug-2018): The event (dehydration) was mapped as symptom to the diagnosis vomiting. The case comment amended accordingly.
Age: 4.0
Sex: F
Vaccine: FLUC4
Symptoms: Fall, Loss of control of legs, Skin discolouration
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 727279), concerns a 04-year-old, female child patient. It was reported that, the patient was born premature (at 36 weeks). The concomitant medication included Fluoride for an unknown indication. On 06-Nov-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency reported as unknown, anatomical location: right arm, batch number: 195215, route of administration: unknown and expiry date: not reported). On the same day, after vaccination, when the patient started to walk out into hallway, her knees gave way and she fell on the floor. The patient was kept in the clinic for 25 minutes. The patient had no head injury and her colour improved. The reporter called the doctor and made him aware of the above situation and had scheduled with nurse at 15:00 on the day of the report. At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 25.0
Sex: M
Vaccine: FLUC4
Symptoms: Local reaction, Vaccination site swelling
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 727413), concerns a 25-year-old, adult male patient. The patient had no relevant history, current conditions or allergies. The patient's medication at the time of vaccination included fish oil for an unknown indication. On 19-Nov-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency: unknown), route of administration: intramuscular, anatomical location: left arm, batch number: 195129, expiry date: not reported]. On the same day about 10 seconds after the vaccination, the patient experienced a localized reaction which included, swelling at the vaccination site with a diameter of 1 cm. The patient did not experience any systemic reactions, breathing difficulty or rash. At the time of this report, the outcome of the events was unknown. The reporter assessed this case as non-serious.
Age: 51.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 727824), concerns a 51-year-old, adult, male patient. The patient's current illness included high blood pressure and prostate (as reported). Concomitant medications included FLOMAX, Testosterone gel, Losartan and AVAPRO for unknown indications. On 02-Nov-2017, the patient received FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195240A and expiry date: not reported]. On 03-Nov-2017, one day after vaccination, the patient felt pain at the injection site. It was reported that, the patient made an office visit. At the time of this report, the patient had not recovered from the event (injection site pain). The reporter assessed this case as non-serious.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Local reaction, Muscle swelling
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 728002), concerning a 53-year-old, adult, female patient. The patient's historical condition included local reaction on an unspecified date (reported as occurred in prior years) and the patient had no current illness and concomitant medications. On 23-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location, left arm, batch number: 195224 and expiry date: not reported]. On the same day, within 2 hours of vaccination, the patient developed local reaction, 6 cm area of swelling in the left deltoid and pain. The patient was treated with PEPCID, BENADRYL, CLARITIN, MEDROL and ice therapy. No lab investigations were done. At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 57.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site discomfort
Clinical narrative: This is spontaneous case, reported by Other Health Professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 728013), concerns a 57-year old, adult male patient. The patient had no known allergies [NKA]. On 07-Nov-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml [frequency 1 as reported], route of administration: intramuscular, anatomical location: left arm, batch number: 195244 and expiry date not reported]. On 08-Nov-2017, one day after vaccination, the patient experienced site soreness which at times radiated down elbow to hand. At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This is spontaneous case, reported by other health professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 728028), concerns a 55-year-old, adult female patient. On 19-Nov-2017, the patient received FLUCELVAX QIVc [dose: 0.5ml, frequency: 1, batch number: 195238, route of administration: intramuscular, anatomical location: left arm, expiry date: not reported]. On 20-Nov-2017, one day after vaccination, the patient experienced redness, and swelling throughout the circumference of upper arm. The patient took BENADRYL. It was stated that, the symptoms started to resolve, however redness persisted two days post-injection. At the time of report, the outcome of the event swelling arm was recovering and the patient had not recovered from redness. The reporter assessed the case as nonserious. Update received on 20-Sep-2018: Significant case correction: (26-Aug-2018): The treatment drug (BENADRYL) was added in the product tab. The case level outcome was changed from 'recovering' to 'not recovered'. No changes were done in the narrative.
Age: 14.0
Sex: M
Vaccine: FLUC4
Symptoms: Hyperhidrosis, Nausea, Visual impairment
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 728172), concerning a 14-year-old, adolescent, male patient. The patient had no historical condition, current illness and allergies. The patient did not receive any concomitant medications. On 24-Nov-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195241 and expiry date: not reported]. On the same day (24-Nov-2017), after vaccination, the patient denoted altered vision and could see the red light briefly (as reported). The patient felt nauseous and experienced profuse sweating in arms, chest and face. On an unspecified date, the patient made an emergency room visit. At the time of this report, the outcome of the events was not reported. The reporter assessed the case as non-serious.
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Pain
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 728173), concerns a 37-year-old adult, female patient. The patient had no historical condition or current condition and no known allergies. The patient was not taking any medications at the time of vaccination. On 07-Nov-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, frequency reported as 1, route of administration: intramuscular, anatomical location: left arm, batch number: 195212, expiry date: not reported]. On an unspecified date in Nov-2017 (reported as, on 09-Nov-2017 or 10-Nov-2017, the patient experienced pain in arm when the vaccination site was pressed. It was reported that, the patient also experienced pain upon lifting her arm or lifting something heavy. The patient did not undergo any laboratory investigations. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash generalised
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 728216), concerns a 61-year-old, adult female patient. The patient had no known drug allergies. The patient's current condition included hypertension (reported as medical history). The patient's concomitant medication included Furosemide and Zolpidem. On 17-Nov-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, batch number: 195124, route of administration: intramuscular, anatomical location: left arm, expiry date: not reported). On 18-Nov-2017, 18 hours after vaccination, the patient experienced rash over most of the body which was considered as non-life threatening. The patient received prednisone. It was reported that, the patient visited office. The patient had no lab data. At the time of this report, the outcome of the event rash over most of body was unknown. The reporter assessed the case as non-serious.
Age: 9.0
Sex: F
Vaccine: FLUC4
Symptoms: Abnormal behaviour, Cold sweat, Dysstasia
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 728224), concerns a 09-year-old, child, male patient. Patient's medical history included septo-optic dysplasia, diabetes insipidus, autism, seizure disorder and asthma. Patient underwent gastrostomy. Patient had no other known allergies except seasonal allergies. On 09-Nov-2017, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: unknown, dose: 0.5 ml (frequency reported as 1), batch number: 195128 and expiry date not reported]. On the same day after vaccination, the patient was not acting like herself (as reported). Patient lied down on the bathroom floor, then classroom floor when moved. The staff was unable to have the patient stand to bring her back to school health centre. Patient's vital signs were recovered as body temperature was 97.8 (unit unspecified), pulse rate was 88 (unit unspecified), respiratory rate was 18 (unit unspecified) and blood pressure was 100/68 (unit unspecified). Patient responded to her name being called by moving head but did not sit up upon request. Patient's skin was clammy to touch. Breathing was normal and unlabored. There was no wheezing, redness or swelling to face or lips. After a bit of time and with assistance, the patient was able to walk to the health centre. At the time of this report, patient had recovered from the events. The reporter assessed the case as non-serious. Update received on 27-Sep-2018: Non-significant case correction received 26-Aug-2018: The narrative was updated. The verbiage in the narrative was updated from 'patient's vital signs like' to 'patient's vital signs were recorded as'. The narrative was amended accordingly.
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Decreased appetite, Diarrhoea, Nausea, Pyrexia
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 728242), concerns a 43-year-old, adult female patient. The patient had seasonal allergies and was allergic to sulfa drugs. The concomitant medications included Multivitamin and ALLEGRA. On 07-Nov-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency reported as unknown, route of administration: intramuscular, anatomical location: left arm, batch number: 195228 and expiry date: not reported). On the same day at 8 pm, approximately nine hours after vaccination, the patient began losing her appetite and felt a bit queasy. By 10 pm, the patient experienced intense chills, nausea and a bit of a fever that lasted through the night. On 08-Nov-2017, next morning, the patient had a bad case of diarrhoea with a bit of chills until the early afternoon but had no fever. The patient stayed in the bed for all day and by evening she felt better. In total, the patient was sick for approximately 20 hours. At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious. Update received on 27-Sep-2018: Significant case correction (26-Aug-2018): The event malaise was removed from the event tab. The case comment was amended accordingly.
Age: 64.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain, Pain, Tenderness
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 728257), concerns a 64-year-old, adult male patient. The patient's historical and current conditions were unknown. The patient did not have any allergies. The patient's medications at the time of vaccination were unknown. On 26-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency: reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 195223, expiry date: not reported]. On the same day shortly after the vaccination, the patient experienced tenderness/soreness at the injection site which radiated around to the back of the shoulder and continued for 1 month. The patient was recommended to be evaluated by a primary care provider. It was reported that the patient had visited office. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious.
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: This spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 728309), concerns a 32-year-old, adult, female patient. The patient's historical condition included asthma. The patient's current condition included, allergies to LEVAQUIN, ANCEF, shellfish and seasonal allergy. The patient was not taking any medications at the time of vaccination. On 24-Nov-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency: 1 as reported), route of administration: intramuscular, anatomical location: left arm, batch number: 195233, expiry date: not reported]. On the same day, following the vaccination, the patient experienced urticaria. It was reported that the patient did not eat anything prior to or following the vaccination. The patient did not undergo any laboratory investigations. At the time of this report, the patient had recovered from the event. The reporter assessed this case as non-serious.
Age: 21.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 728380), concerns a 21-year-old, adult female patient. The patient's current condition included seasonal allergies. On 17-Nov-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency: unknown), route of administration: intramuscular, anatomical location: left arm, batch number: 195250, expiry date: not reported]. On the same day (17-Nov-2017) after vaccination, the patient experienced redness, itching and swelling at the injection site. On an unspecified date, the itching got resolved after the patient applied ice on the affected area and took loratadine. At the time of this report, the patient had recovered from the event itching and outcome for the other events was not reported. The reporter assessed this case as non-serious.
Age: 49.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site swelling, Injection site urticaria, Local reaction
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 728447), concerning a 49-year-old, adult, female patient. The patient's current condition included high cholesterol and high blood pressure (reported as medical history). The patient had no current illnesses and was allergic to penicillin (on an unspecified date). The patient's medications included simvastatin, exemestane and bisoprolol/hctz. On 18-Nov-2017, the patient was administered FLUCELVAX QIVc, dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location: right arm, batch number: 195233 and expiry date: not reported. On 19-Nov-2017, 1 day after vaccination, the patient developed local site reaction with large welt and swelling. On an unspecified date, the patient made an office visit. At the time of the report, the patient had recovered from the events. The reporter assessed the case as non-serious. Updated received on 20-Sep-2018: Significant case correction: (IRD: 26-Aug-2018): The event (local reaction) was mapped as symptom to the event (injection site reaction). The case comment amended accordingly. No changes were done in the narrative.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site discomfort, Injection site reaction
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 728489), concerning a 61-year-old, adult, female patient. The patient had no historical conditions and current illness. The patient was allergic to penicillin. On 11-Oct-2017, the patient was administered FLUCELVAX QIVc, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195224 and expiry date: not reported. On 12-Oct-2017, 1 day after vaccination, the patient developed soreness in the left arm where shot was given, and it's been almost six weeks. The patient was on TYLENOL and started the warm compresses. At the time of the report, the patient had not recovered from the event. The reporter assessed the case as non-serious. Updated received on 20-Sep-2018: Non-significant case correction (IRD: 26-Aug-2018): The sentence in the case comment was changed from 'anatomical site-specific reaction' to 'injection site-specific reaction'. No changes were done in the narrative.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus generalised
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 728881), concerns a 48-year-old, adult female patient. The patient's current condition included diabetes mellitus type II-non-insulin dependent. The patient was allergic to lactose, walnuts, melons (cantaloupe, watermelon, honeydew) and mango. The patient did not receive any concomitant medication. On 17-Nov-2017, the patient was administered FLUCELVAX QIVc, dose: 0.5 ml, (frequency reported as 1), route of administration: intramuscular, anatomical location: right arm, batch number and expiry date: not reported). On 18-Nov-2017, one day after vaccination, the patient developed constant itching all over. At the time of this report, the patient had not recovered from the event. The reporter assessed the case as non-serious.
Age: 44.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site rash, Pruritus generalised, Rash generalised
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 728948), concerns a 44-year-old, adult female patient. The patient's vaccination history included unspecified flu vaccines without any event. The patient was allergic to penicillin. On 29-Nov-2017, the patient was administered FLUCELVAX QIVc, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195233 and expiry date: not reported. On the same day, after vaccination, the patient developed itching and rash over several areas of her body. The patient took CLARITIN at the time of reaction and Benadryl in the evening. The patient contacted her physician's office, but had not seen. On 30-Nov-2017, morning, the reporter spoke with the patient and found that the rash had resolved except for area around injection site. At the time of this report, the patient had recovered from itching and rash but had not recovered from the event rash at the injection site. The reporter assessed the case as non-serious. Update received on 20-Sep-2018: Non-significant case correction (IRD: 26-Aug-2018): The generic name for the treatment drug (CLARITIN) was changed from 'clarithromycin' to 'loratadine'. the narrative was amended accordingly.
Age: 32.0
Sex: F
Vaccine: FLUC4, MMR, TDAP
Symptoms: Exposure during pregnancy, Hepatitis B virus test positive, No adverse event
Clinical narrative: This spontaneous case, reported by health care professional (other) to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 729101), concerns a 32-year-old, adult, female pregnant patient. The patient had no medical history and no concomitant medications. The patient was carrier of chronic hepatitis B. The patient last menstrual period was reported as 15-Oct-2017 (reported as 2 weeks prior to vaccination). On 01-Nov-2017, the patient was administered with FLUCELVAX QIV, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195128 and expiry date: not reported at 2nd week of pregnancy (explicitly considered as vaccine exposure during pregnancy). On the same day, the patient was also administered with non-company suspect product MMR II, dose: 2 (as reported), route of administration: subcutaneous, anatomical location: left arm, batch number: N011004, and expiry date: not reported and ADACEL, route of administration: intramuscular, anatomical location: left arm, batch number: C5263AA, dose and expiry date: not repotted. On same day (01-Nov-2017), blood tests were performed to the patient and results showed that the patient was carrier of chronic hepatitis B. It was reported that there was no illness and no adverse event reported after vaccination in the pregnant woman. The estimated delivery date (EDD) was reported as 21-Jul-2018. The reporter assessed the case as non-serious.
Sex: M
Vaccine: FLUC4
Symptoms: Cough, Rash, Wheezing
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 17-Jul-2018 by Seqirus from VAERS (VAERS ID: 731736), concerns a 56-year-old, adult, male patient. On 08-Dec-2017, the patient was administered FLUCELVAX QIV, dose: 0.5 ml [reported as second dose], route of administration: intramuscular: unknown, anatomical location: left arm, batch number: 195246, expiry date: not reported. On 11-Dec-2017, 3 days after vaccination, the patient experienced cough, wheezing and rash. The outcome of the events was unknown. The reporter assessed the case as non-serious.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Headache, Muscle spasms, Nausea, Vomiting
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 18-Jun-2018 by Seqirus from VAERS (VAERS ID: 734109), concerns a 57-year-old, adult, female patient. The patient's vaccination history included excruciating headache due to unspecified flu vaccine (date of vaccination: 2015, lot number: 1515101) and unspecified severe reaction due to unspecified flu vaccine (date of vaccination: 2016, lot number: 12849221A). The patient's current condition included, hypothyroidism, migraine headaches and no allergies. At the time of vaccination, the patient had no other illness. On 04-Dec-2017 (Monday), at 01:04 pm, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml (reported as not applicable), route of administration: intramuscular, anatomical location: left arm, batch number: 195212, expiry date: not reported). On 05-Dec-2017, the following day of vaccination (middle of the night), the patient began to experience excruciating headache, severe nausea and vomiting, and spasms in the left arm. The patient took FIORICET first and then later that morning EXCEDRIN TENSION, but the pain sustained. Around 10:00 am, the physician visited the consulted the physician. The physician stated that, the reaction was due to flu vaccine and prescribed PHENERGAN. The patient took the medicine immediately and felt better when he woke up around 02:00 hrs. The patient continued to feel weak and  nauseous for the rest of the day. Slight headache relieved with TYLENOL. At the time of this report, the patient had recovered from the events. The reporter assessed this case as non-serious.
Age: 60.0
Sex: F
Vaccine: FLUC4, TDAP, VARZOS
Symptoms: Asthenia, Injected limb mobility decreased, Joint range of motion decreased, Pain in extremity, X-ray limb normal
Clinical narrative: This is a spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 18-Jun-2018 by Seqirus from VAERS (VAERS ID: 735258), concerns a 60-year-old, adult, female patient. The patient's medical history included hereditary hemorrhagic telangiectasia (HHT) and had no current illnesses and allergies. The patient had no allergies at the time of vaccination. Concomitant medications included daily vitamins for an unknown indication. On 18-Oct-2017, the patient was administered FLUCELVAX QIV, dose: 0.5 ml (reported as, unknown), route of administration: injection (reported as SYR), batch number: 195215, anatomical location, expiry date: not reported. On the same day (18-Oct-2017), the patient was administered ADACEL, dose: reported as first dose, route of administration: intramuscular, anatomical location: left arm, batch number: C5228AA, expiry date: not reported and ZOSTAVAX, dose: reported as first dose, route of administration: subcutaneous, anatomical location: left arm, batch number: M04420, expiry date: not reported. On the same day after vaccination, the patient experienced pain in upper left arm. The patient developed reduced range of motion and mobility of left arm. The patient experienced loss of strength in left arm. On an unspecified date, the patient underwent X-ray of left arm which showed results of no clinical significance (normal). The patient was given a shot of cortisone in left arm 24 hrs ago (reported as day) but did not help in resolving pain or range of motion. The orthopedist suggested magnetic resonance imaging (MRI). At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious. Update on 22-Jul-2018: case correction was performed with IRD 18-Jun-2018: The 'as determined causality' of the events (injected limb mobility decreased, muscle weakness upper limb, pain injection site) were changed from unassessable to related in the event assessment tab. Case comment was updated accordingly.
Age: 24.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: This spontaneous case reported by other healthcare professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 736012), concerns a 24-year-old, adult female patient. The patient's medical history, allergies and current illness were unknown. The patient's concomitant medications were reported as unknown. On 29-Jan-2018, the patient was administered FLUCELVAX QIVc, dose: 0.5 ml (frequency reported as unknown), route of administration: intramuscular, batch number: 195241, anatomical site: left arm and expiry date: not reported. On 01-Feb-2018, three days after the vaccine administration, the patient developed a quarter-sized, itchy rash at injection site. The patient did not report trouble breathing or rash spreading. The patient's grandmother was counseled, to take patient to the doctor, if the patient had trouble breathing or if the rash did not improve or spread. The patient's grandmother was also counseled that, patient could take BENADRYL for itchiness. At the time of the report, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 737547), concerns a 43-year-old, adult, female patient. The patient was allergic to penicillin. On 25-Jan-2018, the patient was administered FLUCELVAX QIVc, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195245 and expiry date: not reported. On 26-Jan-2018, one day after vaccination, the patient experienced continued pain (reported as half dollar size) in the area she received the injection. The pain was constant which started after receiving the shot and had continued (unchanged). At the time of this report, the patient had not recovered from the event. The reporter assessed the case as non-serious.
Age: 51.0
Sex: M
Vaccine: FLUC4
Symptoms: Limb discomfort
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 738979), concerns a 51-year-old, adult, male patient. On 17-Jan-2018, the patient was administered suspect vaccine FLUCELVAX QIVc, dose: 0.5 ml, frequency reported as 1, route of administration: intramuscular, anatomical location: left arm, batch number: 196498, expiry date: not reported. On 18-Jan-2018, 1 day after vaccination, the patient experienced soreness in arm which persisted for over a month. At the time of this report, the patient had not recovered from the event. The reporter assessed this case as non-serious.