chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Anxiety, Dizziness, Heart rate increased
Clinical narrative: This spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 721305), concerning a 32-year-old, adult, female patient. The patient's historical condition included Chiari malformation. The patient was allergic to penicillin and to anything in sulfa family. The current illness included head cold. The patient had not received any concomitant medications. It was reported that the patient's vitals were all normal before receiving the flu shot. On 18-Oct-2017, at 9:00 am, the patient went to the health clinic for flu shot and MMR titer test. At about 9:15 am, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195214, and expiry date: not reported). On the same day, within 1 to 2 minutes after vaccination, the patient's heart rate jumped through the roof (as reported) and started feeling dizzy. As the patient asked the doctor whether these reactions were normal, the doctor instructed the patient to take deep breaths and to leave it alone. The patient when reached home, looked up at the side effects from the flu shots, it said that fast heartbeat was a severe allergic reaction and hence wanted to report it. When the patient talked to the doctor about it, she got to know that the allergic reactions can happen to skin only and so this had to be anxiety. On the next day (19-Oct-2017), when the patient talked to the office, the patient got to know that the severe side effects would pertain to people who are receiving the flu shot for the first time in their life and that it was probably anxiety. At the time of the report, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 15.0
Sex: M
Vaccine: FLUC4
Symptoms: Feeling hot, Paraesthesia, Rash erythematous, Urticaria
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: 721365), concerns a 15-year-old, male adolescent patient. The patient's historical condition and current condition were unknown. However, the patient's concomitant medications included Ciclopirox and Terbinafine. On 18-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: 195242, expiry date: not reported]. On the same day, after vaccination, the patient developed red raised rash and hives on trunk, neck and face. The patient also experienced prickly and hot sensation. At the time of this report, the patient had recovered from the events. The reporter assessed this case as non-serious.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash generalised
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 721451), concerns a 59-year-old, adult, female patient. Patient did not have any historical conditions and was allergic to penicillin, HALDOL, and erythromycin. It was unknown if patient had any current conditions. The concomitant medications included: Olanzapine, Propranolol, Atorvastatin, Levothyroxine, allopurinol, Amlodipine, Metformin ER, Benztropine and Divalproex for unknown indications. On 12-Oct-2017, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left arm, dose: 0.5 ml (frequency reported as 1), batch number: 195216 and expiry date not reported]. On 13-Oct-2017, one day after vaccination, the patient experienced rash all over the body. The patient was advised to see the doctor. The patient made an office visit. The patient did not undergo any laboratory tests. At the time of this report, the outcome of the event was unknown. The reporter assessed the case as non-serious. Update on 29-Aug-2018: Non-significant case correction was performed with IRD 16-Aug-2018: The concomitant medications were added in the narrative. The phrase 'The patient had to' was replaced with 'patient experienced' in the narrative. The narrative was amended accordingly.
Age: 23.0
Sex: F
Vaccine: FLUC4
Symptoms: Urticaria
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: 721959), concerns a 23-year-old, adult female patient. The patient's historical condition included Dermo-graphism and she was allergic to penicillin and sulfa-drug. The patient's concomitant medications included: daily ZYRTEC, LOESTRIN and multi-vitamin. On 17-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration, anatomical location, batch number and expiry date: not reported]. On 18-Oct-2017, 1 day after vaccination (overnight as reported), the patient experienced hives. It was reported that the patient made an office visit. At the time of this report, the outcome of the event was not reported. The reporter assessed the event as non-serious.
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Lymphadenopathy, Nasal congestion
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: 722207), concerns a 56-year-old, adult female patient. The patient's historical conditions included migraine. The patient's current condition included osteopenia (reported as medical history). The patient was allergic to penicillin. The concomitant medication included Vitamin D. On 14-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: 195213 and expiry date: not reported). On 18-Oct-2017, 4 days after vaccination, the patient experienced extreme nasal congestion, chills and very swollen lymph nodes. No lab investigations were performed. 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: Lymphadenopathy, Pain in extremity
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: 722269), concerns a 60-year-old, adult, female patient. The patient's current condition included arthritis (since an unspecified date). The patient had been allergic to NARCAN and DEMEROL. The patient's concomitant medications included TYLENOL, atorvastatin, pilocarpine and naproxen. On 09-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: 195126 and expiry date: not reported]. On 10-Oct-2017, 1 day after vaccination, the patient experienced a swollen lymph node which caused pain on the same arm. The patient was instructed to consult her primary doctor. It was reported that, the physician did not believe the association of swollen lymph node to the vaccine. The patient was advised to place warm compress on the affected area and take TYLENOL. No lab investigations were done. On an unspecified date, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Paraesthesia oral, Wheezing
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: 722364), concerns a 41-year-old, adult female patient. The patient's current condition included bronchitis since an unspecified date in Sep-2017 (last month as reported). On 23-Oct-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: 195238 and expiry date: not reported]. On the same day, after vaccination, the patient experienced light-headedness, dizziness, wheezing and tingling in her mouth. The nurse checked the patient's heart rate and lung, which were found to be normal. The patient had some juice for dizziness. It was reported that, the patient was given BENADRYL to take but it was not sure whether the patient had consumed it or not. No lab investigations were done. On an unspecified date, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 61.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain, Insomnia
Clinical narrative: This spontaneous case, reported by other non-health professional (consumer) to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 722411), concerns a 61-year-old, adult male patient. The patient had no medical history, current illness and allergies. The concomitant medications included SIMBRINZA. On 18-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml (frequency reported as 5), route of administration: injection (reported as SYR), anatomical location: left arm, batch number and expiry date: not reported). On 20-Oct-2017 (reported as by Friday), 2 days after vaccination, the patient developed injection site pain and pain in the left shoulder which became more severe over the weekend. The patient too agonized so that he was not able to sleep. On an unspecified date, at around 1:30 am, the patient visited the hospital and was recommended movement, heat pads and MOTRIN.  The patient was followed up via phone conversation at workplace site. At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious. Update received on 29-Sep-2018: Non-Significant case correction (16-Aug-2018): The events were arranged according to their causality and listedness. The verbiage in case comment was changed from 'not related as insomnia' to 'not related to suspect vaccine, as insomnia'. No changes were made in the narrative.
Age: 36.0
Sex: M
Vaccine: FLUC4
Symptoms: Insomnia, Mobility decreased, Musculoskeletal pain, Pain in extremity
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: 722426), concerns a 36-year-old, adult male patient. The patient's current condition included gout (reported as medical history) and had no current illness and allergies. Concomitant medication included allopurinol for an unknown indication. On 17-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 1), route of administration: injection (reported as SYR), anatomical location: right arm, batch number and expiry date: not reported]. On 20-Oct-2017, 3 days after vaccination (few days after as reported), the patient experienced severe shoulder and upper arm pain which the patient felt like an actual injury due to which she was not able to lift and unable to sleep on that arm. 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. Update on 29-AUG-2018: Significant case correction was performed with IRD 16-AUG-2018. The event injury was removed from the event tab. The determined causality for sleep disorder was changed from related to not related. The case comment was amended accordingly.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Muscular weakness, Pain, Pain in extremity, Skin warm
Clinical narrative: This spontaneous case, reported by health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 722606), concerns a 50-year-old, adult female patient. On unspecified date in past, the patient received the influenza vaccine with no problem. On 14-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5ml (frequency reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 195213 and expiry date: not reported]. On the same day (14-Oct-2017) after vaccination, the patient experienced pain in her muscle which was close to the left shoulder. It was reported that the pain was radiating down to the arm while moving and her arm felt weak and straining. The patient stated that there was no discoloration in the area, but heat was there. It was reported that it was unable to contact the patient's primary care physician (PCP). 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. This case was linked to case number 201803260 due to same reporter.
Age: 57.0
Sex: M
Vaccine: FLUC4
Symptoms: Rash, Urticaria
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 722713), concerns a 57-year-old adult, male patient. The patient was allergic to codeine. The patient's historical condition included HIV. Concomitant medications included Losartan, Omeprazole, Aspirin and Vitamin D for unknown indications. On 25-Oct-2017, the patient received FLUCELVAX (QIVc) (dose: 0.5 ml, frequency reported as 1, route of administration: intramuscular, anatomical location: right arm, batch number: 195213, expiry date: not reported). On the same day, after the vaccination, the patient developed rash and hives. The patient's back was covered with bump like something. At the time of this report, the patient had not recovered from the events (rash, swelling and urticaria). The reporter assessed this case as non-serious. Update on 29-Aug-2018: Significant case correction was performed with IRD 16-Aug-2018: The verbatim for event rash was changed from 'rash' to 'Back is covered in bump-like'. The event rash was mapped as a symptom to urticaria. The event swelling was deleted from the event tab.
Age: 8.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pruritus
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: 723258), concerns a 08-year-old, female child patient. The patient's historical condition was not reported. The patient's current condition, allergies and concomitant medications were unknown. On 25-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency reported as unknown, route of administration: intramuscular, anatomical location: right arm, batch number: 195235 and expiry date: not reported). On 26-Oct-2017, one day after vaccination, the patient developed redness and itching at injection site. At the time of this report, the outcome of the events was not reported. The reporter assessed the case as non-serious.
Age: 24.0
Sex: F
Vaccine: FLUC4
Symptoms: Feeling jittery, Photophobia, Upper respiratory tract infection, Urticaria
Clinical narrative: This is spontaneous case, reported by other health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 723402), concerns a 24-year-old, adult female patient. The patient had no known drug allergy. The patient's current illness included acute upper respiratory illness. On 03-Oct-2017, the patient received the suspect vaccine FLUCELVAX QIVc (dose: 0.5ml [1 as reported], route of administration: intramuscular, anatomical location: not reported, batch number: 195231). On 03-Oct-2017, after vaccination, the patient felt jittery and experienced light sensitivity. The patient had an emergency room visit. The patient was evaluated and released. On 05-Oct-2017, two days later, the patient was presented with symptoms of acute upper respiratory infection. On the following day, the patient experienced urticaria which persisted. On an unspecified date, the patient had a visit to the physician's office. At the time of this report, the patient had recovered from the events upper respiratory infection, jittery, light sensitivity. The outcome of the event urticaria was not recovered (persisted). The reporter assessed the case as non-serious.
Age: 7.0
Sex: M
Vaccine: FLUC4
Symptoms: Erythema, Induration, Peripheral swelling, Skin warm
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: 723749), concerns a 07-year-old, male child patient. The patient had no historical condition, current illness and the patient was allergic to penicillin. The patient did not receive any concomitant medication. On 24-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195236 and expiry date: not reported).  On the same day (24-Oct-2017), 12 hours after vaccination, the patient's arm became swollen, hot, hard and red from the shoulder to the elbow. The patient was taken to the urgent care and was recommended to take CLARITIN. On 24-Oct-2017, the patient's arm was no longer hard but was still experiencing warmth and redness. It was reported that the patient's mother would consult a paediatrician regarding the following year's flu vaccine and the package insert was sent to her. The patient did not undergo any laboratory investigations. At the time of this report, the patient had recovered from the events, induration and peripheral swelling but had not recovered from the events, skin warmth and redness. The reporter assessed the case as non-serious. Update 29-Aug-2018: Significant case correction performed 16-Aug-2018: The listedness for the events swollen arm and induration was changed from unlisted to listed for CORE and USPI documents, and the listedness for the event erythema was changed from unlisted to listed, for CORE document.
Age: 58.0
Sex: M
Vaccine: FLUC4
Symptoms: Arthralgia, Body temperature increased, Fatigue, Headache, 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: 723759), concerns a 58-year-old, adult, male patient. The patient had no historical conditions and allergies. The current illness included chronic sinusitis (since an unspecified date) and the concomitant medications included valsartan with hydrochlorothiazide, ULORIC and atorvastatin. On 12-Oct-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: 195219 and expiry date: not reported]. On 24-Oct-2017, 12 days after vaccination, the patient experienced joint pain, fatigue, malaise, increased body temperature and headache. On an unspecified date, the patient had a physician office visit. No lab investigations were done. At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 11.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Mass, Skin warm, Swelling
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: 723767, 723761), concerns a 11-year-old, female child. The patient's historical conditions, current illness, allergies and concomitant medications were unknown. On 25-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: injection (reported as SYR), anatomical location: left arm, batch number: 195236 and expiry date: not reported]. On the same day (25-Oct-2017), after vaccination, the patient developed warm, redness, swelling and lump. The patient's lab tests were unknown. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious.
Age: 11.0
Sex: M
Vaccine: FLUC4
Symptoms: Erythema, Mass, Skin warm, Swelling
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: 723769), concerns an 11-year-old, male child. The patient's historical conditions, current conditions, allergies and concomitant medications were unknown. On 25-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: injection (reported as SYR), anatomical location: left arm, batch number: 195236 and expiry date: not reported]. On the same day (25-Oct-2017), after vaccination, the patient developed redness, lump, warm to touch and swelling. The patient's lab tests were unknown. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious.
Age: 54.0
Sex: F
Vaccine: FLUC4
Symptoms: Contusion, Neck pain, Nodule, Pain
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: 723885), concerns a 54-year-old, adult female patient. The patient had no relevant medical history and current illness. Concomitant medications included Aspirin and Levothyroxine for unknown indications. On 18-Oct-2017, the patient was administered FLUCELVAX QIV (dose: 0.5 ml, frequency: 1, anatomical location: left arm, batch number: 195227, route of administration: unknown and expiry date: not reported). On the same day, after vaccination, the patient developed a nodule for 2 days, experienced bruising for 7 days and pain for 7 days that radiated up her neck. On an unspecified date, the patient had recovered form the events. The reporter assessed the case as non-serious.
Age: 20.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling
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: 723900), concerning a 20-year-old, adult, female patient. On 28-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml (frequency reported as 1), batch number: 195231, route of administration: intramuscular, anatomical location: left arm and expiry date: not reported). On the same day (28-Oct-2017) after vaccination, the patient developed redness, swelling which was described as 'bigger than golf ball' and painful burning sensation at the site of injection. The patient had no itching or shortness of breath. The patient received BENADRYL which did not help. It was reported that, the patient could take TYLENOL or MOTRIN for pain and swelling, since she had no problem, was non-diabetic and not pregnant. The patient was advised to see doctor if needed. At the time of the report, the outcome of the events was unknown. The reporter assessed the case as non-serious.
Age: 21.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash, Urticaria
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: 724112), concerns a 21-year-old, adult, female patient. The patient's historical conditions, current illness, allergies and concomitant medications were unknown. On 13-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195124 and expiry date: not reported). On 19-Oct-2017, 6 days after vaccination, the patient developed hives and rash. On the same day, the patient went to the emergency room (ER) and diagnosed with allergic urticaria. On 20-Oct-2017, the patient went again to the ER with the same complaint and reported that BENADRYL was not working for the hives. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious. Update 29-Aug-2018: Non-significant case correction performed with IRD 16-Aug-2018: The sentence in case comment was changed from 'a 21-year-old, female patient developed rash, hives and allergic urticaria, 6 days after vaccination with FLUCELVAX QIVc' to 'a 21-year-old, female patient developed rash, hives and was diagnosed as allergic urticaria, 6 days after vaccination with FLUCELVAX QIVc'. No changes were made in the narrative.
Age: 14.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash, Urticaria
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: 724145), concerns a 14-year-old, adolescent female patient. On 21-Oct-2017, the patient received suspect vaccine FLUCELVAX QIVc (dose: 0.5ml, frequency: 1, route of administration: intramuscular, anatomical location: left arm, batch number: 195212, expiry date: not reported). On the same day (night of the vaccination) (explicitly reported as 22-Oct-2017), the patient experienced hives and rash from shoulders onto neck. The patient went to urgent care and was prescribed with prednisone and famotidine. At the time of report, the patient had recovered from all the events. The reporter assessed the case as non-serious.
Age: 2.0
Sex: M
Vaccine: FLUC4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 16-Aug-2018by Seqirus from VAERS (VAERS ID: 724161), concerning a 02-year-old, male child patient. The patient's allergies, current illness and concomitant medications were not reported. On 18-Oct-2017, the patient (less than 4 years of age) was administered wrong dose of FLUCELVAX QIVc (dose: frequency reported as 3, batch number: 195222, route of administration: intramuscular, anatomical location: left leg and expiry date: not reported). No lab investigations were performed. The reporter assessed the case as non-serious.
Age: 26.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling, Rash, Rash erythematous
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 724256), concerns a 26-year-old, adult, female patient. The patient did not have any relevant medical history, current conditions and allergies. The patient's concomitant medications were unknown. On 26-Sep-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: 195221 and expiry date: not reported). On 27-Sep-2017, 1 day after vaccination, the patient developed red rash, swelling and itching around the injection site. It was reported that, the patient and also her husband had rash on their entire arm. At the time of this report, the patient had recovered from the events. The reporter assessed this case as non-serious. Update received on 27-Sep-2018: Significant case correction (IRD: 26-Aug-2018): For the event rash, the lower level term (LLT) was changed from rash to rash over arms. A sentence in the narrative was modified from '(and also her husband)' to 'and also her husband'.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, 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: 724388), concerns a 60-year-old, adult female patient. On 26-Sep-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195221 and expiry date: not reported]. On 27-Sep-2017, 1 day after vaccination, the patient experienced red rash and swelling around the injection site as well as itching. It was reported that, the rash covered the entire arm. At the time of this report, the outcome of all the events were unknown. The reported assessed the case as non-serious.
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling, 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: 724393), concerns a 40-year-old, adult female patient. On 26-Sep-2017 the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency reported as unknown, route of administration: intramuscular, anatomical site: arm, batch number: 195221 and expiry date: not reported). On 27-Sep-2017, one day after vaccination, the patient experienced red rash, swelling and itching around the injection site. It was reported that, the rash covered the entire arm. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious. Update received on 26-Sep-2018: Significant case correction (IRD: 26-Aug-2018): Events injection site pruritus, injection site swelling and rash erythematous were mapped to the diagnosis 'injection site reaction' in the event tab.
Age: 25.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling, Rash, Rash erythematous
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: 724398), concerns a 25-year-old, adult male patient. On 26-Sep-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: arm, batch number: 195221, expiry date: not reported]. On 27-Sep-2017, 1 day after vaccination, the patient developed injection site reaction, red rash, swelling and itching around the injection site. It was reported that, the rash covered the entire arm of the patient. At the time of this report, the outcome of the events was unknown. The reporter assessed this case as non-serious. Update received on 27-Sep-2018: Significant case correction (IRD: 26-Aug-2018): In the event tab, all the events (except rash) were mapped as symptoms under injection site reaction. In the narrative, the event description was modified to reflect the onset latency as "1 day after vaccination" which was previously entered ass "On the same day, after vaccination".
Age: 14.0
Sex: M
Vaccine: FLUC4
Symptoms: 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: 724496), concerns a 14-year-old, male adolescent patient. The patient had no historical condition. The patient's current condition was unknown. The patient had no allergies. The concomitant medication was unknown. On 01-Nov-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location: left deltoid (left arm), batch number: 195220 and expiry date: not reported]. On the same day, after vaccination, the patient returned to the pharmacy about 8 minutes later and complained of injection site pain. The patient had no signs of inflammation, swelling or rash. The reporter had to hold ice pack on the patient's injection site for 10 minutes and the pain subsided. The patient felt ok after the ice pack. The reporter followed up with a call to patient and mother believed that the ice pack had fixed the patient up (as reported). The reporter recommended ibuprofen for the pain due to injection. On 01-Nov-2017, the patient had recovered from the event. The reporter assessed the case as non-serious. Update received on 20-Sep-2018: Non-significant case correction (IRD: 26-Aug-2018): The treatment received for the event (injection site pain) was changed from 'yes' to 'unk' in event tab. No changes were done in the narrative.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: 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: 724611), concerns a 53-year-old, adult female patient. The patient had no historical condition and current illness. The patient did not receive any concomitant medications. On 18-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, (frequency reported as 1), batch number: 195220, route of administration: intramuscular, anatomical location: left arm, expiry date: not reported). On the same day, 5 hours after vaccination, the patient developed hives on all extremities and trunk. The patient received the treatment with topical corticosteroid cream and antihistamine (orally). At the time of report, the patient had completely recovered from the event. The reporter assessed the case as non-serious.
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Swelling
Clinical narrative: This spontaneous case, reported by healthcare professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 724669), concerns a 52-year-old, adult female patient. The patient's medical history and current illness was unknown. The patient had no allergies. On 02-Nov-2017, at 5:30 pm, the patient received FLUCELVAX QIVc (dose: 0.5ml, frequency: 1, route of administration: intramuscular, anatomical location: right arm, batch number: 195220, expiry date: not reported). On the same day (02-Nov-2017), immediately after vaccination, the patient developed local swelling. The patient was monitored closely for 30 minutes and given ice pack to apply on the site. The patient had no itching, rash, or shortness of breath. The patient's lab data was unknown. The patient was advised to contact the medical facility if the symptoms worsened. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious.
Age: 19.0
Sex: F
Vaccine: FLUC4
Symptoms: Extra dose administered
Clinical narrative: This is spontaneous case, reported by healthcare professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 724776), concerns a 19-year-old, adult female patient. The patient did not have any medical history or current illness. The patient had IUD (intrauterine contraceptive device) placed in due for a change out Feb-2019. It was reported that, the patient had a vaccination on 08-Sep-2017 while in training. But due to the clerical error, she was re-vaccinated on 02-Nov-2017. The patient received FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195232, expiry date: not reported). The patient did not have any side effects [SE] to date. The designated medical officer and regional pharmacy executive were notified of the incident. The outcome of the event was unknown. The reporter assessed the case as non-serious.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pruritus, Injection site urticaria, Pruritus generalised, 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: 724887), concerns a 53-year-old, adult female patient. On an unspecified date in the past, the patient had migraine headache after vaccination with unspecified vaccines. The patient did not have any current conditions, allergies and concomitant medications. On 03-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: 195221 and expiry date: not reported]. On the same day, 10 minutes after vaccination, the patient experienced hives and itching at the injection site. After 15 minutes, the hives and itching had spread to the whole arm and then to the whole body. On an unspecified date, the patient made an office visit. The patient did not undergo any laboratory investigations. 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: Non-significant case correction (IRD: 26-Aug-2018): The sentence in the narrative was changed from 'On an unspecified date in the past, the patient had migraine headache' to 'On an unspecified date in the past, the patient had migraine headache after vaccination with unspecified vaccines'.
Age: 31.0
Sex: M
Vaccine: FLUC4
Symptoms: Pruritus 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: 724950), concerns a 31-year-old, adult, male patient. On 17-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: 195228 and expiry date: not reported]. On the same day, after vaccination, the patient developed severe itching all over his body. The patient went to the doctor and was prescribed with prednisone. At the time of this report, the outcome of the event was unknown. The reporter assessed the case as non-serious.
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus, Rash, Rash erythematous, Skin warm
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: 725020), concerns a 64-year-old, adult female patient. The patient's historical condition included asthma and allergic to cats, dogs, grass and some flowers. The patient experienced red rash around her deltoid muscle on the arm, also the patient's arm felt hot and itchy. On 03-Nov-2017, the patient received the suspect vaccine FLUCELVAX QIVc (dose: 0.5 ml, batch number: 195228, route of administration: intramuscular, anatomical location: left arm, expiry date: not reported). On the same day, after vaccination, the patient experienced red rash around her deltoid muscle on the arm, also the patient's arm felt hot and itchy. At the time of this report, the outcome of the events (red rash, felt hot and itchy) were not reported. The reporter assessed the case as non-serious.
Age: 38.0
Sex: F
Vaccine: FLUC4
Symptoms: 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: 725226), concerns a 38-year-old, adult female patient. The patient had no known allergy (NKA). The patient's concomitant medication included LOESTRIN for an unknown indication. On 18-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical site: arm, batch number: 195223 [reported as 1952223] and expiry date: not reported). On 20-Oct-2017, within 48 hours of vaccination, the patient developed widespread hives all over the body (trunk, arms and legs). The patient did not report any breathing difficulty. On an unspecified date, the patient consulted the doctor who advised her to take ZYRTEC over the counter (OTC) daily until the hives cleared. At the time of this 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 treatment received in the event tab was changed from 'unk' to 'yes'. The onset date of the event was changed from 'Oct-2017' to '20-Oct-2017'. The narrative was amended accordingly.
Age: 62.0
Sex: M
Vaccine: FLUC4
Symptoms: Pyrexia
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: 725241), concerns a 62-year-old, adult, male patient. The patient had no historical condition, allergies and current illness. On 26-Sep-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number; 195225A and expiry date: not reported). On the same day, after vaccination, the patient experienced high fever, which lasted for 8 days. On an unspecified date, the patient had made a physician office visit. At the time of this report, the patient had recovered from the event. The reporter assessed the case as non-serious. Update received on 20-Sep-2018: Non-significant case correction (IRD: 26-Aug-2018): The sentence in the narrative was changed from 'On the same day, after vaccination, the patient experienced high fever for 8 days' to 'On the same day, after vaccination, the patient experienced high fever, which lasted for 8 days'.
Age: 59.0
Sex: F
Vaccine: FLUC4, TDAP
Symptoms: Erythema, Induration
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: 725250), concerns a 59-year-old, adult female patient. On 27-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: 195129 and expiry date: not reported). The patient was also administered non-company suspect vaccine, ADACEL (frequency: reported as 1, route of administration: intramuscular, anatomical location: right arm, batch number: C5220AA, dose and expiry date: not reported). On 03-Nov-2017, 7 days after vaccination, the patient developed 6 x 6.5 cm area of erythema with central induration. At the time of this report, the outcome of the events was unknown. The reporter assessed this case as non-serious.
Age: 55.0
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: 725375), concerns a 55-year-old, adult, female patient. The patient's current conditions included latex allergy. The patient was not taking any medications at the time of vaccination. On 20-Sep-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency: 1), route of administration: intramuscular, anatomical location: left arm, batch number: 195210A, expiry date: not reported]. On the same day (20-Sep-2017) after vaccination, the patient experienced soreness and pain in the left deltoid, that got worse over the following 6 weeks. Left deltoid pain was the patient's main complaint and she denied experiencing any fever or chills. 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 this case as non-serious.
Age: 18.0
Sex: F
Vaccine: FLUC4, HEPA, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive, Ultrasound antenatal screen normal
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: 725400), concerns an 18-year-old, adult, pregnant female patient. On 05-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, batch number: 195125, route of administration: intramuscular, anatomical location: left arm, expiry date: not reported] (reported as vaccine exposure during pregnancy). On the same day, the patient was also administered non-company suspect vaccines HAVRIX [frequency reported as 2, route of administration: intramuscular, anatomical location: right arm, batch number: 7439F, dose, expiry date: not reported] and VARIVAX [frequency reported as 2, route of administration: subcutaneous, anatomical location: right arm, batch number: N010108, dose, expiry date: not reported]. At the time of vaccination, the patient neither knew that she was pregnant nor was she intended to be pregnant. During vaccination, the patient signed a consent form for the vaccines which noted whether the patient was pregnant or intended to be pregnant in next few months, to which the patient answered no, as she had no idea at that time that she was pregnant. The following week, the patient missed her period and on 14-Oct-2017, the patient took a home pregnancy test which came back positive. On 31-Oct-2017, the patient had her first OB appointment and had an ultrasound which was normal. At that point, the foetus measured 6 weeks and 3 days and the due date for was confirmed as 23-Jun-2018. The gestation period at the time of vaccination was noted to be 3 weeks (according to the measurement provided during OB ultrasound). The patient was scheduled for routine ultrasounds to monitor the foetus and was planned to refer to a different OB office for check-up since the current OB office was very familiar with administration of VARIVAX vaccine in pregnancy. At the time of this report, the outcome of the events was unknown. The reporter assessed this case as non-serious. Update received on 28-Sep-2018: Non-significant case correction (IRD: 26-Aug-2018): Gestation period was updated as 3 weeks. The narrative was amended accordingly.
Age: 28.0
Sex: F
Vaccine: FLUC4
Symptoms: Nausea, Vomiting
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: 725485), concerns a 28-year-old, adult, female patient. On 07-Nov-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency: 1), route of administration: intramuscular, anatomical location: left arm, batch number: 195243, expiry date: not reported]. On the same day (07-Nov-2017) after vaccination, the patient experienced nausea, and she threw up. At the time of this report, the outcome of the events was unknown. The reporter assessed this case as non-serious.
Age: 64.0
Sex: M
Vaccine: FLUC4
Symptoms: Lymphadenopathy, Oropharyngeal pain, 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: 725493), concerns a 64-year-old, adult male patient. The patient did not have any current conditions and allergies. The patient's concomitant medications included lisinopril, simvastatin, CELEXA, COQ10, fish oil, B100 and Multivitamin. On 05-Nov-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency reported as unknown, route of administration, anatomical site, batch number and expiry date: not reported). On the same day (05-Nov-2017), after administration of vaccine, the patient experienced sore throat, aches and pain, and swollen glands (reported as for of 4 days). At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling, Pain in extremity
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: 725626), concerns a 30-year-old, adult female patient. On 17-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195242 and expiry date: not reported). On the same day (17-Oct-2017) after vaccination, the patient developed swollen arm and redness of approximately 1 and half - 2-inch diameter around injection site, which was painful to touch. The patient also developed knot if pressed down hard at the injection site and pain when laid on that arm. The patient was advised to take MOTRIN and BENADRYL. It was reported that, follow up would be done with the patient. 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 as determined listedness for the event peripheral swelling was changed from unlisted to listed in both CORE and PI Flu Vaccine Cell Subunit NVD. The statement was changed from "pain on laid down" to "pain when laid down" in narrative section.