chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Axillary pain, Chest pain, Cough, Dry eye, Eye discharge
Clinical narrative: This is a spontaneous case, reported by Physician to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 713526), concerns a 45-year-old, adult female patient. The patient's current conditions included migraine headaches and pituitary adenoma (reported as medical history). The patient had no medical history, concomitant medications or allergies. On 12-Sep-2017, the patient was administered FLUCELVAX QIV (dose: 0.5ml [1 as reported], route of administration: intramuscular, anatomical location: arm, batch number: 1012617195226A as reported). The reported batch number (1012617195226A) does not match Seqirus batch numbers, however, because the reporter named Seqirus product 'FLUCELVAX QIV' as the suspect vaccine, this report has been conservatively entered as a Seqirus case. However, the query regarding batch number has been raised. On the same day, after vaccination, the patient experienced little soreness in deltoid and in armpit (but not as expected proportion). Within 4 hours, the patient experienced nasal congestion and scratchy feeling in eyes. Within 6 hours, the nasal symptoms increased with postnasal drip, watery and slightly red eyes. Same day evening, the symptoms worsened with cough, ache in chest and redness in eyes. It was reported that, the patient had oculo-respiratory syndrome. It was stated that overnight, the patient's eyes were very gummy with crusting and dry feeling. The patient was awake due to cough and nose was congested with copious thick post nasal drip. The symptoms persisted till next day morning (reported as 'am') and was very ill. However, by evening the patient felt better. The symptoms completely recovered within the 48-hours. The reporter assessed the case as non-serious. Update 22-Jul-2018: Case correction was performed with IRD 11-Jun-2018: The oculo-respiratory syndrome was added in the case comment.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Eye irritation, Eyelid margin crusting, Lacrimation increased, Malaise, Nasal congestion
Clinical narrative: This is a spontaneous case, reported by Physician to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 713526), concerns a 45-year-old, adult female patient. The patient's current conditions included migraine headaches and pituitary adenoma (reported as medical history). The patient had no medical history, concomitant medications or allergies. On 12-Sep-2017, the patient was administered FLUCELVAX QIV (dose: 0.5ml [1 as reported], route of administration: intramuscular, anatomical location: arm, batch number: 1012617195226A as reported). The reported batch number (1012617195226A) does not match Seqirus batch numbers, however, because the reporter named Seqirus product 'FLUCELVAX QIV' as the suspect vaccine, this report has been conservatively entered as a Seqirus case. However, the query regarding batch number has been raised. On the same day, after vaccination, the patient experienced little soreness in deltoid and in armpit (but not as expected proportion). Within 4 hours, the patient experienced nasal congestion and scratchy feeling in eyes. Within 6 hours, the nasal symptoms increased with postnasal drip, watery and slightly red eyes. Same day evening, the symptoms worsened with cough, ache in chest and redness in eyes. It was reported that, the patient had oculo-respiratory syndrome. It was stated that overnight, the patient's eyes were very gummy with crusting and dry feeling. The patient was awake due to cough and nose was congested with copious thick post nasal drip. The symptoms persisted till next day morning (reported as 'am') and was very ill. However, by evening the patient felt better. The symptoms completely recovered within the 48-hours. The reporter assessed the case as non-serious. Update 22-Jul-2018: Case correction was performed with IRD 11-Jun-2018: The oculo-respiratory syndrome was added in the case comment.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Ocular hyperaemia, Oculorespiratory syndrome, Pain in extremity, Upper-airway cough syndrome
Clinical narrative: This is a spontaneous case, reported by Physician to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 713526), concerns a 45-year-old, adult female patient. The patient's current conditions included migraine headaches and pituitary adenoma (reported as medical history). The patient had no medical history, concomitant medications or allergies. On 12-Sep-2017, the patient was administered FLUCELVAX QIV (dose: 0.5ml [1 as reported], route of administration: intramuscular, anatomical location: arm, batch number: 1012617195226A as reported). The reported batch number (1012617195226A) does not match Seqirus batch numbers, however, because the reporter named Seqirus product 'FLUCELVAX QIV' as the suspect vaccine, this report has been conservatively entered as a Seqirus case. However, the query regarding batch number has been raised. On the same day, after vaccination, the patient experienced little soreness in deltoid and in armpit (but not as expected proportion). Within 4 hours, the patient experienced nasal congestion and scratchy feeling in eyes. Within 6 hours, the nasal symptoms increased with postnasal drip, watery and slightly red eyes. Same day evening, the symptoms worsened with cough, ache in chest and redness in eyes. It was reported that, the patient had oculo-respiratory syndrome. It was stated that overnight, the patient's eyes were very gummy with crusting and dry feeling. The patient was awake due to cough and nose was congested with copious thick post nasal drip. The symptoms persisted till next day morning (reported as 'am') and was very ill. However, by evening the patient felt better. The symptoms completely recovered within the 48-hours. The reporter assessed the case as non-serious. Update 22-Jul-2018: Case correction was performed with IRD 11-Jun-2018: The oculo-respiratory syndrome was added in the case comment.
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Pain
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 713669), concerns a 29-year-old adult female patient. It was reported that the patient had no relevant medical history, no current illness and no allergies. However, it was also reported that the patient's concomitant medications included PROZAC, XANAX and Trazodone for an unknown indication. On 18-Sep-2017, the patient received FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195210A/195216 (as reported) and expiry date: not reported). On 20-Sep-2017, after 2 days after vaccination, the patient's soreness was progressed. Subsequently, the patient experienced more and more sore and she was unable to move her right shoulder in certain positions. The patient also experienced dull ache with bursts of excruciating pain on movement. No lab test was done. At the time of this report, the patent had not recovered from the events (injected limb mobility decreased, injection site pain and pain). The reporter assessed this case as non-serious.
Sex: F
Vaccine: FLUC4
Symptoms: Balance disorder, Cerebrovascular accident, Computerised tomogram normal, Disturbance in attention, Dizziness
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 713721), concerns a 60-year-old, adult, female patient. The patient's current conditions included osteopenia. The concomitant medications included SYNTHROID, omeprazole, vitamin B12 and B6. The patient was allergic to sulfa drugs. On 11-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml (reported as, unknown), route of administration: intramuscular, anatomical location: left arm, batch number: 195221, expiry date: not reported) On 12-Sep-2017 (the next day of vaccination), at 11:30 am, the patient experienced sudden light-headedness, decreased balance/stability and difficulty in focusing. As the symptoms intensified, the patient was taken to the emergency room for consultation, suspecting stroke. The results of computed tomography (CT) scan, carotid ultrasound and EKG (electrocardiogram) performed were normal. After 3 to 4 hours the symptoms eased and the patient returned home. The patient took off from work, the following day due to light-headedness and difficulty in focusing. At the time of this report, the patient had recovered from the events. The reporter assessed this case as non-serious.
Sex: F
Vaccine: FLUC4
Symptoms: Electrocardiogram normal, Ultrasound Doppler normal
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 713721), concerns a 60-year-old, adult, female patient. The patient's current conditions included osteopenia. The concomitant medications included SYNTHROID, omeprazole, vitamin B12 and B6. The patient was allergic to sulfa drugs. On 11-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml (reported as, unknown), route of administration: intramuscular, anatomical location: left arm, batch number: 195221, expiry date: not reported) On 12-Sep-2017 (the next day of vaccination), at 11:30 am, the patient experienced sudden light-headedness, decreased balance/stability and difficulty in focusing. As the symptoms intensified, the patient was taken to the emergency room for consultation, suspecting stroke. The results of computed tomography (CT) scan, carotid ultrasound and EKG (electrocardiogram) performed were normal. After 3 to 4 hours the symptoms eased and the patient returned home. The patient took off from work, the following day due to light-headedness and difficulty in focusing. At the time of this report, the patient had recovered from the events. The reporter assessed this case as non-serious.
Age: 44.0
Sex: M
Vaccine: FLUC4
Symptoms: Nodule
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 713735), concerns a 44-year-old, adult, male patient. The patient had no known allergies. The patient had no current illness. The patient's historical condition and concomitant medications were not reported. On 20-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number; 195225 [reported as 195225A], expiry date: not reported). On the same day after vaccination, the patient experienced a golf ball sized knot. On an unspecified date, the patient had recovered from the events. The reporter assessed this as non-serious.
Age: 60.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Burning sensation, Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 713887), concerns a 60-year-old adult female patient. The patient's medical history was unknown, and the patient's concomitant medications were not reported. On 12-Sep-2017, the patient received FLUCELVAX QIV [dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195210A and expiry date: not reported] and non-company suspect ZOSTAVAX (dose: 1 DF [1 as reported], route of administration: subcutaneous, anatomical site: right arm, batch number: N016185 as reported and expiry date: not reported). On the same day (Tuesday), after vaccination, the patient noticed local redness and itchiness on the right upper arm. By 13-Sep-2017 (Wednesday) and 14-Sep-2017 (Thursday), the redness spread to most of her right upper arm and the patient felt burning sensation. The patient was advised to consult a doctor. It was reported that no lab tests were performed. At the time of this report, the patient had not yet recovered from the events (burning sensation, injection site erythema and injection site pruritis). The reporter assessed this case as non-serious. Update 11-Jul-2018: Non-significant case correction was performed with IRD 11-Jun-2018: Suspect vaccine (FLUCELVAX QIV) and co-suspect (ZOSTAVAX) was added in the case comment.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Asthenia, Insomnia, Mobility decreased, Pain
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 714041), concerns a 57-year-old, adult female patient. The patient's concomitant medications included levothyroxine, however, relevant medical history and current illness were reported as none. The patient was allergic to penicillin and sulfa drugs. On 06-Sep-2017, the patient was administered FLUCELVAX QIV (dose: 0.5 ml (reported as, unknown), route of administration: intramuscular, anatomical location: left arm, batch number: 195220, expiry date: not reported). On the same day, after vaccination, the patient experienced pain and was unable to lift arm as of 1 week. The patient developed decreased range of motion and strength. The patient was unable to sleep without pain. It was reported that, the patient visited office. At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious. Update on 01-Aug-2018: Non-significant case correction was performed with IRD 11-Jun-2018: The verbatim for the event (difficulty sleeping) was changed from 'Unable to sleep without pain' to 'Unable to sleep [without pain]' in the event tab. The sentence in para 3 was changed from 'the patient was administered with FLUCELVAX QIV' to 'the patient was administered FLUCELVAX QIV' in narrative. The sentence 'on an unspecified date, the patient consulted a physician for the events' was reframed to 'it was reported that the patient visited office' in the narrative.
Age: 31.0
Sex: M
Vaccine: FLUC4
Symptoms: Rash erythematous
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 714138), concerns a 31-year-old, adult male patient. The patient was vaccinated in 2015 and 2016. The patient stated that, he had mild adverse reactions to prior flu vaccines. The patient has no current illness and no known allergies. On 21-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml (reported as 1 dose), route of administration: intramuscular, anatomical location: left arm, batch number: 195221, expiry date: not reported). On the same day of vaccination, the patient experienced red circular spots on face, torso, on back and upper extremities. The patient denied of any itching or pain. At the time of this report, the outcome of the event was unknown. The reporter assessed the case as non-serious.
Age: 23.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Injection site warmth, Rash erythematous, Rash macular, Rash pruritic
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 714223), concerns a 23-year-old adult female patient. The patient's current illness included attention deficit hyperactive disorder (ADHD), anxiety, hypertension, tachycardia, migraine with aura and the patient was allergic to penicillins, KEFLEX and latex (reported as mild). The patient's concomitant medications included Venlafaxine XR, Metoprolol, Alprazolam and Trazodone. On 22-Sep-2017, the patient received FLUCELVAX QIV [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number and expiry date: not reported]. On the same day, approximately 30 minutes after vaccination, the patient experienced itchy, blotch red rash, small red bumps on arms, neck and abdomen. The injection site was sore and warm to touch. The patient took diphenhydramine (dose: 25 mg) 35 minutes after the vaccination, after which the patient felt relief from the symptoms. Approximately at 4:00 pm, all the symptoms were completely resolved. On the same day (22-Sep-2017), the patient had recovered from the events (injection site pain, injection site warmth, rash, rash erythematous, rash macular and rash pruritic). The reporter assessed this case as non-serious.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Ear pain, Lymphadenopathy
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 714436), concerns a 60-year-old, adult female patient. The patient's medical history and concomitant medications were not reported. On 20-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml (reported as 1st dose), route of administration: intramuscular, anatomical location: left arm, batch number: 195210A, expiry date: not reported). On 22-Sep-2017, two days after vaccination, the patient experienced enlargement of lymph nodes and slight pain in ears. At the time of this report, the outcome of the event was unknown. The reporter assessed the case as non-serious. Update on 03-Jul-2018: Case correction was performed with IRD 11-Jun-2018: The 'as determined causality' of the events (enlargement of lymph nodes and ear pain) was changed from related to unassessable in the event tab. Case comment was updated accordingly.
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 714459), concerns a 30-year-old, adult female patient. The patient's medical history and concomitant medications were not reported. On 22-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195218, expiry date: not reported). On 23-Sep-2017, one day after vaccination, the patient experienced dizziness, severe itching, swelling, hot to touch, red in color on and around the area. At the time of this report, the outcome of the events was not reported. The reporter assessed the case as non-serious.
Age: 40.0
Sex: M
Vaccine: FLUC4
Symptoms: Erythema, Rash, Urticaria
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 714489), concerns a 40-year-old, adult, male patient. The patient's current condition included seasonal allergies and exercise induced asthma (reported as medical history) (since an unspecified date) and the concomitant medications included ADVAIR, XYZAL and ranitidine for an unknown indication. On 19-Sep-2017, the patient was administered FLUCELVAX QIV (dose: 0.5 ml, route of administration: injection [SYR as report], anatomical location: left arm, batch number: 195215 and expiry date: not reported). On 20-Sep-2017, 1 day after vaccination, at approximately 04:00 PM, the patient developed a rash on arms, legs and treated with one BENADRYL [as reported] at approximately 06:00 PM. On the same day, at 10:00 PM, the patient developed large red hives all over his back and treated with two adult BENADRYL [as reported]. The rash was resolved by the next morning and on 21-Sep-2017 (in the afternoon as reported), the rash was returned, but only on arm. The patient again treated with two adult BENADRYL and then the rash did not return again. At the time of the report, the patient had recovered from the events (redness, hives and rash). The reporter assessed the case as non-serious.
Age: 20.0
Sex: F
Vaccine: FLUC4
Symptoms: Flushing, Lip swelling, Swollen tongue
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved o 11-Jun-2018 by Seqirus from VAERs (VAERS ID: 714578), concerns a 20-year-old, adult, female patient. The patient's historical vaccine included unspecified vaccines in childhood, which cause an unspecified reaction. The patient's current illness was unknown. The patient's historical conditions and concomitant medications were not reported. The patient had been allergic to egg. On 14-Sep-2017, approximately at 3:00 pm, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195216 and expiry date; not reported). On 15-Sep-2017, after one day vaccination, in morning, the patient woke up with a swollen tongue, lips, flushed face and received antihistamine (unspecified). The patient reported the incident to the employee health Office at 09:15 am. The patient was recommended to ER (emergency room) for work up, however patient had declined. No lab investigations were performed. On an unspecified date, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 74.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash, Swollen tongue
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 714639), concerns a 74-year-old, elderly female patient. The patient's current conditions included: type 2 diabetes mellitus, hypertension and hyperlipidemia. The patient had no known drug allergies. On 16-Sep-2017, the patient received FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, lot number: (reported as 7046130110), batch number and expiry date: not reported). On the same day, after vaccination, the patient experienced rash on neck, arms, torso, inner thighs and swollen tongue. The patient made physician's office visit for the events. The patient had recovered from the events (swollen tongue and rash). The reporter assessed this case as non-serious.
Age: 21.0
Sex: F
Vaccine: FLUC4
Symptoms: Feeling abnormal, Pain, Pain in extremity
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 714848), concerns a 21-year-old, adult, female patient. The patient's medical history, concomitant medications and allergies were not reported. On 08-Sep-2017, 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, expiry date: not reported). On the same day, after vaccination, the patient experienced pain, soreness in the left arm and was unable to lift or move the arm without soreness. The patient had abnormal feeling described as 'popping feeling in the arm'. Even though, the patient took ibuprofen, pain had not resolved. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Flushing, Urticaria
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS: 714938), concerns a 33-year-old, adult, female patient. The patient's historical conditions included other cerebral palsy, constipation, dysphagia, unspecified exotropia, unspecified hearing loss, and Q 87.89 (as reported). The patient's current conditions included Angelman's syndrome, unspecified intellectual disabilities, chromosomal abnormality, unspecified, hypothyroidism, unspecified, gastroesophageal reflux disease and allergic rhinitis due to pollen (since an unspecified date). The patient had been allergic to penicillin, dicloxacillin and codeine. The patient's concomitant medications included calcium carbonate, Cetirizine, esomeprazole, FLONASE nasal, Ipratropium spray, Levothyroxine, Multivitamin, risperidone, spironolactone, Valproic acid, THICK-IT2 powder (unspecified). On 25-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195221 and expiry date: not reported). On 26-Sep-2017, approximately 28 hours after receiving vaccine, the patient developed flushed bright redness on face, torso, extremities and hives on her upper back. No difficulty in breathing was reported. The patient was taken to the ER (emergency room) and given BENADRYL. No lab investigations were performed. On an unspecified date, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 714941) concerns a 40-year-old, adult, female patient. The patient was allergic to penicillin. The patient's current conditions included thyroid, depression and frequent headache. The patient's concomitant medications included SYNTHROID and WELLBUTRIN for an unknown indication. On 18-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml [reported as unk], route of administration: intramuscular, anatomical location: right arm, batch number: 195218, expiry date: not reported). On the same day after vaccination, the patient experienced redness on the arm which was warm and indurated. On an unspecified date, the patient had recovered from the events. The reporter assessed this case as non-serious.
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 715111), concerns a 53-year-old, adult, female patient. The patient had no current illness. The patient had been allergic to Thimerosal (preservatives). The patient's historical condition and concomitant medications were not reported. On 25-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml [reported as 1], route of administration: intramuscular, batch number: 195221, expiry date and anatomical location: not reported). On an unspecified date, after vaccination the patient developed lump, redness, warmth of skin and pain at injection site. The patient received ADVIL and cold compress therapy. It was reported that, pharmacist consulted her and advised her to call her primary care physician if she still felt uncomfortable. At the time of this report, the outcome of the events was unknown. The reporter assessed the events as non-serious.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Headache, Hypoaesthesia oral, Nausea, Nervousness
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 715206), concerns a 33-year-old, adult female patient. The patient's historical condition included: back pain. The patient was allergic to TOBRADEX, CIPRO eye drops and scallops. Concomitant medication was reported as none. On 28-Sep-2017 at 09:10 hours, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195232, expiry date: not reported). It was reported that, after vaccination, the patient initially had hurt in her right arm than usual. At 09:25 hours, the patient complained of headache and nausea. At 09:45 hours, the patient experienced tingling around her lips and dizziness. Later, the patient was placed on and examination table with feet elevated. At 09:53 hours, the patient was on intravenous fluid (IV, unspecified) in the right hand. The patient was also given BENADRYL and SOLUMEDROL. The patient also received normal saline of 500 ml. The patient's VS (as reported) blood pressure was 139/94, pulse rate was 83, respiratory rate was 20 and temperature was 97.7. Additionally, the patient complained of dizziness and numbness or tingling around lips. However, the patient denied of pain. At 10:07 hours, VS BP was 149/106, pulse rate was 90 and respiratory rate was 20. The patient denied dizziness and numbness of right hand. The patient felt shaky, without any symptoms of cold and denied the use of blanket. At 10:19 hours, the normal saline was completed. The patient was ambulated to bathroom with assistance. At 10:25 hours, the patient returned from the bathroom. The patient had no complaints of dizziness, numbness or tingling. Normal saline of 500 ml was re-started again. At 10:32 hours, VS BP was 138/96, pulse rate was 73 and respiratory rate was 18. The patient denied dizziness, numbness or tingling and pain. At 10:45 hours, the patient was resting comfortable. At 11:00 hours, VS BP was 130/80, pulse rate was 69. Later, IV was discontinued and the patient was released from the clinic with assistance. The patient had recovered from all the events (shaking, dizziness, headache, numbness in hand, numbness lips, injection site pain, nausea and tingling lips). The reporter assessed this case as non-serious. Update 22-Jul-2018: Case correction was performed with IRD 11-Jun-2018: The case comment was corrected from "A 33-year-old, adult, female patient experienced shaking, dizziness, headache, numbness in hand, numbness lips, injection site pain, nausea and tingling lips on the same day after vaccination with FLUCELVAX QIV'. The case comment was amended accordingly.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity, Paraesthesia oral
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 715206), concerns a 33-year-old, adult female patient. The patient's historical condition included: back pain. The patient was allergic to TOBRADEX, CIPRO eye drops and scallops. Concomitant medication was reported as none. On 28-Sep-2017 at 09:10 hours, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195232, expiry date: not reported). It was reported that, after vaccination, the patient initially had hurt in her right arm than usual. At 09:25 hours, the patient complained of headache and nausea. At 09:45 hours, the patient experienced tingling around her lips and dizziness. Later, the patient was placed on and examination table with feet elevated. At 09:53 hours, the patient was on intravenous fluid (IV, unspecified) in the right hand. The patient was also given BENADRYL and SOLUMEDROL. The patient also received normal saline of 500 ml. The patient's VS (as reported) blood pressure was 139/94, pulse rate was 83, respiratory rate was 20 and temperature was 97.7. Additionally, the patient complained of dizziness and numbness or tingling around lips. However, the patient denied of pain. At 10:07 hours, VS BP was 149/106, pulse rate was 90 and respiratory rate was 20. The patient denied dizziness and numbness of right hand. The patient felt shaky, without any symptoms of cold and denied the use of blanket. At 10:19 hours, the normal saline was completed. The patient was ambulated to bathroom with assistance. At 10:25 hours, the patient returned from the bathroom. The patient had no complaints of dizziness, numbness or tingling. Normal saline of 500 ml was re-started again. At 10:32 hours, VS BP was 138/96, pulse rate was 73 and respiratory rate was 18. The patient denied dizziness, numbness or tingling and pain. At 10:45 hours, the patient was resting comfortable. At 11:00 hours, VS BP was 130/80, pulse rate was 69. Later, IV was discontinued and the patient was released from the clinic with assistance. The patient had recovered from all the events (shaking, dizziness, headache, numbness in hand, numbness lips, injection site pain, nausea and tingling lips). The reporter assessed this case as non-serious. Update 22-Jul-2018: Case correction was performed with IRD 11-Jun-2018: The case comment was corrected from "A 33-year-old, adult, female patient experienced shaking, dizziness, headache, numbness in hand, numbness lips, injection site pain, nausea and tingling lips on the same day after vaccination with FLUCELVAX QIV'. The case comment was amended accordingly.
Age: 38.0
Sex: M
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Limb discomfort, Paraesthesia
Clinical narrative: This is spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 715284), concerns a 38-year-old, adult male patient. The patient's medical history was not reported. On 15-Aug-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5ml, route of administration: unknown, anatomical location: left arm, batch number: 195213, expiry date: not reported). On an unspecified date, after vaccination, the patient experienced tingling and numbness in arm and discomfort in fingers. At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLUC4
Symptoms: Diarrhoea, Hyperhidrosis, Injection site erythema, Injection site oedema, Injection site swelling
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 715317), concerns a 59-year-old, adult, female patient. The patient's historical, current conditions, allergies and concomitant medications were not reported. On 25-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0. 5ml [reported as 1], route of administration: intramuscular, anatomical location: left arm, batch number: 195224 and expiry date: not reported). On 26-Sep-2017, after 1 day of vaccination, the patient experienced nausea, diarrhea, sweating and pale complexion. On 27-Sep-2017, after 2 days of vaccination, the patient experienced localized swelling, redness and edema at injection site. At the time of this report, the outcome of the events was unknown. The reporter assessed the events as non-serious.
Sex: F
Vaccine: FLUC4
Symptoms: Nausea, Pallor
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 715317), concerns a 59-year-old, adult, female patient. The patient's historical, current conditions, allergies and concomitant medications were not reported. On 25-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0. 5ml [reported as 1], route of administration: intramuscular, anatomical location: left arm, batch number: 195224 and expiry date: not reported). On 26-Sep-2017, after 1 day of vaccination, the patient experienced nausea, diarrhea, sweating and pale complexion. On 27-Sep-2017, after 2 days of vaccination, the patient experienced localized swelling, redness and edema at injection site. At the time of this report, the outcome of the events was unknown. The reporter assessed the events as non-serious.
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 715395), concerns a 34-year-old adult female patient. The patient had no known medical history. On 15-Sep-2017, the patient received FLUCELVAX QIV (dose: 0.5 ml (unk as reported), route of administration: intramuscular, anatomical location: unknown, batch number: 195222 and expiry date: not reported). On 16-Sep-2017, the next day of vaccination, the patient had swelling, redness and lump under the skin at the injection site. which lasted for several days. The patient had recovered from all the events (injection site erythema, injection site mass and injection site swelling). The reporter assessed this case as non-serious.
Sex: F
Vaccine: FLUC4
Symptoms: Chest pain, Cough
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 715479), concerns a 70-year-old, elderly, female patient. The patient was allergic to Amoxicillin and celecoxib (since an unspecified date). On 19-Sep-2017, the patient was administered FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195126, expiry date: not reported). On an unspecified date, after vaccination, the patient experienced chest pain and dry cough. On an unspecified date, the patient had recovered from the events. The reporter assessed this case as non-serious. Update 11-Jul-2018: Significant case correction received with IRD 11-Jun-2018: The as determined causality of the event (dry cough) was corrected form related to unassessable. The case comment was corrected accordingly.
Age: 66.0
Sex: F
Vaccine: FLUC4
Symptoms: Sensation of foreign body, Swollen tongue
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 715526), concerns a 66-year-old, elderly, female patient. The patient's historical conditions included colonic polyps, large cell acanthoma and basal cell carcinoma. The patient's current conditions included hypothyroidism, hyperlipidemia, asthma, sternocostoclavicular hyperostosis, aortic regurgitation, hepatic steatosis, vitamin D deficiency (since an unspecified date). The patient had allergic to egg, sulpha drugs, ampicillin, iodine, niacin, Pravachol, Propofol and ZITHROMAX. The patient's concomitant medications included SYMBICORT, DYMISTA, SINGULAIR, CELEXA, ZANTAC, PROAIR, SYNTHROID, EPIPEN, ZYRTEC, CLARITIN, TESSALON Perle and Multivitamins. It was reported that, the patient had URI (upper respiratory tract infection) for one week prior to vaccination and felt that she was recovering but had a slight cough. On 28-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: arm, batch number: 195231 and expiry date: not reported). On the same day, after about 20 minutes of vaccination, the patient experienced globus sensation in the throat and swelling of tongue. Although no visible angioedema was noted, but her symptoms began to worsen over the next 10 minutes. The patient was treated with epinephrine and cetirizine. No lab investigations were performed for the events. On an unspecified date in Sep-2017, the patient began to feel better, with complete resolution of symptoms in about 40 minutes. The patient released to home. The reporter assessed the case as non-serious.
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Diarrhoea, Fatigue, Headache, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 715582), concerns a 30-year-old, adult, female patient. The patient's historical procedure included implantable cardioverter defibrillator (ICD) and heart valve replacement (reported as pig valve) (on an unspecified date). The patient's current condition included complex congenital heart defects and sulfa allergy (since and unspecified date) and the concomitant medications included ethacrynic acid, Spironolactone, SYNTHROID, Sotalol, aspirin for an unknown indication. On 28-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml [1 as reported], route of administration: intramuscular, anatomical location: left arm, batch number and expiry date: not reported). On the same day (28-Sep-2017), after vaccine administration, the patient developed redness, swelling and warm around the injection site.The patient also experienced nausea, diarrhoea, headache and fatigue. No lab investigations were performed. At the time of the report, the outcome of the events (injection site warmth, injection site swelling, injection site redness, diarrhoea, headache, fatigue and nausea) was unknown. The reporter assessed the case as non-serious.
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site warmth, Nausea
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 715582), concerns a 30-year-old, adult, female patient. The patient's historical procedure included implantable cardioverter defibrillator (ICD) and heart valve replacement (reported as pig valve) (on an unspecified date). The patient's current condition included complex congenital heart defects and sulfa allergy (since and unspecified date) and the concomitant medications included ethacrynic acid, Spironolactone, SYNTHROID, Sotalol, aspirin for an unknown indication. On 28-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml [1 as reported], route of administration: intramuscular, anatomical location: left arm, batch number and expiry date: not reported). On the same day (28-Sep-2017), after vaccine administration, the patient developed redness, swelling and warm around the injection site.The patient also experienced nausea, diarrhoea, headache and fatigue. No lab investigations were performed. At the time of the report, the outcome of the events (injection site warmth, injection site swelling, injection site redness, diarrhoea, headache, fatigue and nausea) was unknown. The reporter assessed the case as non-serious.
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Eye swelling, Rash generalised, Urticaria
Clinical narrative: This is spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 715634), concerns a 52-year-old, adult female patient. The patient's medical history was not reported. It was unknown whether the patient was taking any medications at the time of vaccination. On 21-Sep-2017, the patient was administered FLUCELVAX QIV (dose: 0.5ml [1 as reported], route of administration: intramuscular, anatomical location: left arm, batch number: 195222). On the same day (21-Sep-2017), after vaccination, the patient's eye was swollen and had rash/hives on the body. It was reported that the patient had no trouble while breathing. The patient had recovered from events (eye swelling, generalised rash and urticaria). The reporter assessed the events as non-serious.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Cold sweat, Dizziness, Headache, Impaired work ability, Malaise
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 715708), concerns a 59-year-old, adult, female patient. The patient's medical history included episodes of dizziness in 2007 and 2009. The current illnesses included allergic rhinitis, hypothyroidism, dysfunction of eustachian tube disorder, foot callus, spinal stenosis in cervical region, osteopenia and malignant neoplasm of skin. The patient's concomitant medications included docusate sodium, acidophilus, meclizine, ESTRACE, PRILOSEC, Colestipol, LEVSIN/SL and meloxicam for unknown indications. The patient had sensitivity to amoxicillin and no known food allergies. On 26-Sep-2017 at 7:30 am, the patient was administered FLUCELVAX (QIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195210A, expiry date: not reported). On 26-Sep-2017 at 08:00 am, the patient reported having the symptoms as progressive headache, feeling of illness, dizziness, cold sweats, shakiness, nauseated and was unable to work. The patient was unable to work so prompted a visit to APRN (nurse). The nurse diagnosed the symptoms as dizziness, likely adverse reaction to influenza vaccine. The patient was prescribed with prednisone tab 20 mg daily for 5 days, and ZOFRAN for nausea and meclizine for dizziness. It was reported that a note was given to the nurse stating the patient was ill and had likely reaction to influenza vaccine. The other healthcare professional commented that the patient should avoid influenza vaccine in future. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Nausea, Tremor, Vaccination complication
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 715708), concerns a 59-year-old, adult, female patient. The patient's medical history included episodes of dizziness in 2007 and 2009. The current illnesses included allergic rhinitis, hypothyroidism, dysfunction of eustachian tube disorder, foot callus, spinal stenosis in cervical region, osteopenia and malignant neoplasm of skin. The patient's concomitant medications included docusate sodium, acidophilus, meclizine, ESTRACE, PRILOSEC, Colestipol, LEVSIN/SL and meloxicam for unknown indications. The patient had sensitivity to amoxicillin and no known food allergies. On 26-Sep-2017 at 7:30 am, the patient was administered FLUCELVAX (QIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195210A, expiry date: not reported). On 26-Sep-2017 at 08:00 am, the patient reported having the symptoms as progressive headache, feeling of illness, dizziness, cold sweats, shakiness, nauseated and was unable to work. The patient was unable to work so prompted a visit to APRN (nurse). The nurse diagnosed the symptoms as dizziness, likely adverse reaction to influenza vaccine. The patient was prescribed with prednisone tab 20 mg daily for 5 days, and ZOFRAN for nausea and meclizine for dizziness. It was reported that a note was given to the nurse stating the patient was ill and had likely reaction to influenza vaccine. The other healthcare professional commented that the patient should avoid influenza vaccine in future. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Contusion, Pain, Swelling, Ultrasound scan
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 16-AUG-2018 by Seqirus from VAERS (VAERS ID: 715714), concerns a 58-year-old, adult, female patient. The patient did not have any known drug allergy. The patient had no reactions in the past. The patient's concomitant medications included meloxicam and bupropion XL unknown indications. On 31-Aug-2017, the patient was administered FLUCELVAX QIV [route of administration: intramuscular, anatomical location: left arm, dose: 0.5 ml (frequency reported as unknown), batch number: 195213 and expiry date: not reported]. On 03-Sep-2017, 03 days after vaccination, the patient started with symptoms of pain, swelling and irritability to lift arm. The patient presented with bruising over 2 months later. The patient claimed that there was no pain during administration. Patient stated her family doctor said that the pain and swelling might be due to improper administration. The physician (MD) sent the patient to the hospital to rule out blood clot with ultrasound (results were not reported). At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious. Update 26-Aug-2018: Significant case correction performed with IRD 16-Aug-2018: As determined causality for the event 'contusion' was changed from related to not related. Case comment was updated accordingly.