chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Pain in extremity
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: 721714), concerns an 18-year-old, adult female patient. She had no problem with any of the previous year's flu shots. The patient had no historical condition, current illness or allergies. The patient's concomitant medications included DAYSEE for birth control. On 14-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 the same day (14-Oct-2017) after vaccination, the patient experienced soreness in arm and numbness in hand for 3 hours. On an unspecified date in Oct-2017, the patient had recovered from all the events. The reporter assessed the events as non-serious. Update 29-Aug-2018: Non-significant case correction was performed 16-Aug-2018: The case comment was corrected and the latency (on the same day) was added in the case comment.
Age: 44.0
Sex: F
Vaccine: FLUC4
Symptoms: Cheilitis, Injection site reaction, Laryngeal oedema, Pruritus, Rash
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: 721733), concerns a 44-year-old, adult female patient. The patient had no historical conditions. The patient was allergic mango. The patient was not taking any medications at the time of vaccination. On 17-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml [frequency:1], route of administration: intramuscular, anatomical location: right arm, batch number: 195231, expiry date: not reported). On 18-Oct-2017, 1 day after vaccination, the patient developed large welts around the area of injection after which she developed itching on her scalp and arm area. Later, hives and rash started to develop all over her body which spread to different areas of the body over the course of the following few days. By 21-Oct-2017 (reported as day 4 of the symptoms), the hives and rash had spread to the patient's face and lips and her vocal cords became swollen (laryngeal oedema). 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.
Age: 44.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash generalised, Urticaria
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: 721733), concerns a 44-year-old, adult female patient. The patient had no historical conditions. The patient was allergic mango. The patient was not taking any medications at the time of vaccination. On 17-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml [frequency:1], route of administration: intramuscular, anatomical location: right arm, batch number: 195231, expiry date: not reported). On 18-Oct-2017, 1 day after vaccination, the patient developed large welts around the area of injection after which she developed itching on her scalp and arm area. Later, hives and rash started to develop all over her body which spread to different areas of the body over the course of the following few days. By 21-Oct-2017 (reported as day 4 of the symptoms), the hives and rash had spread to the patient's face and lips and her vocal cords became swollen (laryngeal oedema). 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.
Age: 79.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site bruising, Pain in extremity
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: 721765), concerns a 79-year-old, elderly female patient. On 09-Oct-2017, the patient was vaccinated with FLUCELVAX (QIV) (dose: 0.5 ml, frequency reported as 1, route of administration: intramuscular, anatomical location: right arm, batch number: 195210A, expiry date not reported). On the same day after vaccination, the patient experienced a huge bruise at the injection site and sore arm for several days post vaccination. Patient complained of vaccine administration at an inappropriate site, missing the deltoid muscle. However, the health care professional confirmed that the injection was administered correctly in the deltoid muscle. At the time of this report, the outcome of the events was unknown. The reporter assessed the events as non-serious.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Injection site hypoaesthesia
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: 721780), concerns a 36-year-old, adult female patient. The patient's concomitant medications included: DEPAKOTE, CYMBALTA and VALTREX. On 20-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: left arm, batch number: 195210A, expiry date: not reported). On 21-Oct-2017, a day after the vaccination, the patient experienced numbness in left shoulder radiating to right shoulder. It was reported that, the patient visited office. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious.
Age: 59.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Asthenia, Decreased appetite, Dizziness, Lymphadenopathy, Nausea
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 16-Aug-2017 by Seqirus from VAERS (VAERS ID: 721791), concerns a 59-year-old, adult female patient. The patient's current condition included bursitis of the hip (right side) (reported as medical history). The patient was allergic to mango, juniper bush and BIAXIN (antibiotic). The concomitant medications included estradiol, DAYPRO, non-steroidal anti-inflammatory drug (NSAID) and Multivitamins. On 17-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, (frequency reported as 1), anatomical location: right arm, route of administration, batch number and expiry date: not reported) and non-company vaccine PNEUMOVAX (dose: frequency reported as 1, route of administration: intramuscular, anatomical location: right arm, dose, lot number and expiry date: not reported). The FLUCELVAX QIVc and PNEUMOVAX, both were given in the same arm (right arm). On the same day, within 1 hour of vaccination, the patient's arm, above the elbow was very sore and lymph node came up a bit (lymphadenopathy). On 18-Oct-2017, in morning, the patient experienced sustained racing heartbeat, dizziness, weakness and slight nausea. Additionally, the patient felt achy, and had little appetite that day and night. It was reported, the patient had to sleep with pillow under her arm to be comfortable. At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious. Update received on 27-Sep-2018: Non-significant case correction (16-Aug-2018): Co-suspect was added in the case comment.
Age: 59.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Pain, Pain in extremity, Palpitations
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 16-Aug-2017 by Seqirus from VAERS (VAERS ID: 721791), concerns a 59-year-old, adult female patient. The patient's current condition included bursitis of the hip (right side) (reported as medical history). The patient was allergic to mango, juniper bush and BIAXIN (antibiotic). The concomitant medications included estradiol, DAYPRO, non-steroidal anti-inflammatory drug (NSAID) and Multivitamins. On 17-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, (frequency reported as 1), anatomical location: right arm, route of administration, batch number and expiry date: not reported) and non-company vaccine PNEUMOVAX (dose: frequency reported as 1, route of administration: intramuscular, anatomical location: right arm, dose, lot number and expiry date: not reported). The FLUCELVAX QIVc and PNEUMOVAX, both were given in the same arm (right arm). On the same day, within 1 hour of vaccination, the patient's arm, above the elbow was very sore and lymph node came up a bit (lymphadenopathy). On 18-Oct-2017, in morning, the patient experienced sustained racing heartbeat, dizziness, weakness and slight nausea. Additionally, the patient felt achy, and had little appetite that day and night. It was reported, the patient had to sleep with pillow under her arm to be comfortable. At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious. Update received on 27-Sep-2018: Non-significant case correction (16-Aug-2018): Co-suspect was added in the case comment.
Age: 26.0
Sex: M
Vaccine: FLUC4
Symptoms: Loss of consciousness
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: 721824), concerns a 26-year-old, adult male patient. The patient experienced unspecified problems with unspecified vaccines in the past. On 18-Oct-2017, the patient received the suspect vaccine FLUCELVAX QIVc (dose: 0.5 ml, frequency: 1, route of administration: intramuscular, anatomical location: left arm, batch number: 195228). On the same day, after vaccination, the patient passed out and stated that, it was due to fear of needles (which was not informed to the pharmacist prior to vaccination). The patient regained consciousness quickly (recovered). The pharmacist provided some ice for his head, gave water and called an ambulance. The outcome of the event (fear of needles) was not reported. The reporter assessed the case as non-serious.
Age: 5.0
Sex: M
Vaccine: FLUC4
Symptoms: Abdominal pain upper, Abnormal behaviour, Asthenia, Cold sweat, Feeling cold
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: 718402), concerns a 5-year-old, child, male patient. The patient did not have any medical history and reporter was not aware of any allergies. The patient did not have any current illnesses and did not take any medications at the time of vaccination as per reporter. On 22-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: 95228 and expiry date not reported]. On the same day, a few minutes after vaccination, the patient said that he did not feel well. The patient was very pale, cool to touch and clammy on his face. He felt nauseous and weak. The patient's father held him up as he spit in the toilet. The patient was quiet and not himself. When questioned, patient said that his stomach hurts. He did not feel well and eventually stated that he felt there was no big space to take a breath. The reporter called 911 and put a cool cloth on patient's head and made him rest on the bench with his father. The patient's breathing was monitored which was normal but patient was pale. After a few minutes, patient got some color back in his face and was more responsive and even smiled eventually. The rescue squad assessed him and said that the patient's heart rate was elevated but otherwise he was fine. At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious. Update 29-Aug-2018: Non-significant case correction was performed with IRD 16-Aug-2018: The sentences in the narrative was changed from 'when questioned the patient, patient said that his stomach hurt' to 'when questioned, patient said that his stomach hurts' and 'was not a big space' to 'was no big space'.
Age: 5.0
Sex: M
Vaccine: FLUC4
Symptoms: Heart rate increased, Hyporesponsive to stimuli, Malaise, Nausea, Pallor
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: 718402), concerns a 5-year-old, child, male patient. The patient did not have any medical history and reporter was not aware of any allergies. The patient did not have any current illnesses and did not take any medications at the time of vaccination as per reporter. On 22-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: 95228 and expiry date not reported]. On the same day, a few minutes after vaccination, the patient said that he did not feel well. The patient was very pale, cool to touch and clammy on his face. He felt nauseous and weak. The patient's father held him up as he spit in the toilet. The patient was quiet and not himself. When questioned, patient said that his stomach hurts. He did not feel well and eventually stated that he felt there was no big space to take a breath. The reporter called 911 and put a cool cloth on patient's head and made him rest on the bench with his father. The patient's breathing was monitored which was normal but patient was pale. After a few minutes, patient got some color back in his face and was more responsive and even smiled eventually. The rescue squad assessed him and said that the patient's heart rate was elevated but otherwise he was fine. At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious. Update 29-Aug-2018: Non-significant case correction was performed with IRD 16-Aug-2018: The sentences in the narrative was changed from 'when questioned the patient, patient said that his stomach hurt' to 'when questioned, patient said that his stomach hurts' and 'was not a big space' to 'was no big space'.
Age: 5.0
Sex: M
Vaccine: FLUC4
Symptoms: Vomiting
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: 718402), concerns a 5-year-old, child, male patient. The patient did not have any medical history and reporter was not aware of any allergies. The patient did not have any current illnesses and did not take any medications at the time of vaccination as per reporter. On 22-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: 95228 and expiry date not reported]. On the same day, a few minutes after vaccination, the patient said that he did not feel well. The patient was very pale, cool to touch and clammy on his face. He felt nauseous and weak. The patient's father held him up as he spit in the toilet. The patient was quiet and not himself. When questioned, patient said that his stomach hurts. He did not feel well and eventually stated that he felt there was no big space to take a breath. The reporter called 911 and put a cool cloth on patient's head and made him rest on the bench with his father. The patient's breathing was monitored which was normal but patient was pale. After a few minutes, patient got some color back in his face and was more responsive and even smiled eventually. The rescue squad assessed him and said that the patient's heart rate was elevated but otherwise he was fine. At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious. Update 29-Aug-2018: Non-significant case correction was performed with IRD 16-Aug-2018: The sentences in the narrative was changed from 'when questioned the patient, patient said that his stomach hurt' to 'when questioned, patient said that his stomach hurts' and 'was not a big space' to 'was no big space'.
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Inflammation, Mobility decreased, Musculoskeletal pain, 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: 721990), concerns a 40-year-old adult female patient. The patient had no allergies. On 18-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195224 and expiry date: not reported]. On the same day, after vaccination, the patient experienced severe shoulder pain, trouble in moving arm, lot of pain and inflammation. The patient was seen by the physician at clinic and started to receive prednisone taper, TYLENOL, AUGMENTIN for pain an inflammation. At the time of this report, the outcome of the events was unknown. The reporter assessed this case as non-serious.
Age: 33.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site joint pain, Injection site pain, Injection site swelling, Product administered at inappropriate site, Shoulder injury related to vaccine administration
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: 722024), concerns a 33-year-old, adult male patient. The patient had no historical conditions. The patient was allergic to shellfish. The patient was not taking any medications at the time of vaccination. On 12-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml [frequency: unknown], route of administration: intramuscular, anatomical location: right arm, batch number: 195217, expiry date: not reported). It was reported that, the vaccine was administered 'much higher than normal' into his right shoulder. On the same day, after vaccination, the patient experienced soreness in the joint, swelling, pain when trying to move his shoulder in certain directions and shoulder injury related to vaccine administration (SIRVA). The patient firmly believed that the events occurred because the nurse had incorrectly injected the vaccine into his shoulder bursa instead of having injected it into his deltoid. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious. Update received on 27-Sep-2018: Non-significant case correct (16-Aug-2018): The verbatim was changed from 'Shoulder pain after vaccine injection' to 'Shoulder injury related to vaccine administration' in the event tab.
Age: 59.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Nausea, Vomiting
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: 722028), concerning a 59-year-old, adult, male patient. In past the patient received FLUCELVAX (QIVc) and no side effects occurred. The patients historical condition included: high blood pressure. The patient had penicillin allergy. The patients current illness was not reported. The patient's concomitant medications were unknown. On 21-Oct-2017, the patient was administered FLUCELVAX (QIVc (dose: 0.5 ml [frequency reported as 1], batch number: 195128, route of administration: intramuscular, anatomical location: left arm and expiry date: not reported). The was also administered with PNEUMOVAX (dose: 0.5 ml [frequency reported as 1], batch number: N001007 [frequency reported as 1], route of administration: intramuscular, anatomical location: left arm and expiry date: not reported) (explicitly coded as drug administration error). On the same day after the vaccination, the patient developed nausea and vomiting for at least 2 days. The patient suspected PNEUMOVAX 23, as she had not received this vaccine in the past. At the time of the report, the outcome of the events was unknown. The reporter assessed the case as non-serious.
Age: 77.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Diarrhoea, Feeling cold, Ill-defined disorder, Pain, Pyrexia
Clinical narrative: This non-serious spontaneous case, reported by other health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 722031), concerns a 77-year-old, elderly, female patient. On 19-Sep-2016, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, batch number: 185286, route of administration, anatomical location and expiry date: not reported]. On an unspecified date, after vaccination, the patient was ill and experienced chills, fever, body aches, vomiting and diarrhoea. At the time of this report, the outcome of the events was not reported. This case was cross-linked to case 201803409 due to same patient. Update received on 06-Sep-2018: Non-significant case correction with IRD 16-Aug-2018: The general information in vaccine administration of products tab was added.
Age: 77.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Vomiting
Clinical narrative: This non-serious spontaneous case, reported by other health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 722031), concerns a 77-year-old, elderly, female patient. On 19-Sep-2016, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, batch number: 185286, route of administration, anatomical location and expiry date: not reported]. On an unspecified date, after vaccination, the patient was ill and experienced chills, fever, body aches, vomiting and diarrhoea. At the time of this report, the outcome of the events was not reported. This case was cross-linked to case 201803409 due to same patient. Update received on 06-Sep-2018: Non-significant case correction with IRD 16-Aug-2018: The general information in vaccine administration of products tab was added.
Age: 77.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Chills, Erythema, Headache, Nausea, Pain
Clinical narrative: This non-serious spontaneous case, reported by other health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 722031), concerns a 77-year-old, elderly, female patient. On 19-Sep-2016, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, batch number: 185286, route of administration, anatomical location and expiry date: not reported]. On an unspecified date, after vaccination, the patient was ill and experienced chills, fever, body aches, vomiting and diarrhoea. At the time of this report, the outcome of the events was not reported. This case was cross-linked to case 201803409 due to same patient. Update received on 06-Sep-2018: Non-significant case correction with IRD 16-Aug-2018: The general information in vaccine administration of products tab was added.
Age: 77.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: This non-serious spontaneous case, reported by other health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 722031), concerns a 77-year-old, elderly, female patient. On 19-Sep-2016, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, batch number: 185286, route of administration, anatomical location and expiry date: not reported]. On an unspecified date, after vaccination, the patient was ill and experienced chills, fever, body aches, vomiting and diarrhoea. At the time of this report, the outcome of the events was not reported. This case was cross-linked to case 201803409 due to same patient. Update received on 06-Sep-2018: Non-significant case correction with IRD 16-Aug-2018: The general information in vaccine administration of products tab was added.
Age: 78.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Diarrhoea, Feeling cold, Ill-defined disorder, Pain, Pyrexia
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: 722031), concerns a 78-year-old, elderly, female patient. Patient's historical conditions included influenza, chills, fever, vomiting, diarrhea, body aches and was ill due to FLUCELVAX Quadrivalent vaccine. Patient's current conditions included high blood pressure, high cholesterol (reported as history). Patient had penicillin, sulfonamide and environmental allergies. Patient did not have food allergies. Patient's concomitant medications included atorvastatin, amlodipine and levocetirizine. On 20-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 1), batch number: 195221, route of administration: intramuscular, anatomical location: left arm and expiry date: not reported]. On the same day, after vaccination, at 10 pm, the patient had red and swollen arm, headache, chills, fever (101 degrees). The patient felt nauseated but did not vomit, and had body ache all over. It was reported that events lasted until 22-Oct-2017 approximately till 4 pm. The patient did not undergo any laboratory tests. At the time of this report, the outcome of the events was recovered. The reporter considered the case as non-serious. This case was linked to case 201803410 due to same patient. Update received on 27-Sep-2018: Significant case correct (16-Aug-2018): The listedness for the event 'Swelling arm' was corrected from 'unlisted' to 'listed'. No changes were made in the narrative.
Age: 78.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Vomiting
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: 722031), concerns a 78-year-old, elderly, female patient. Patient's historical conditions included influenza, chills, fever, vomiting, diarrhea, body aches and was ill due to FLUCELVAX Quadrivalent vaccine. Patient's current conditions included high blood pressure, high cholesterol (reported as history). Patient had penicillin, sulfonamide and environmental allergies. Patient did not have food allergies. Patient's concomitant medications included atorvastatin, amlodipine and levocetirizine. On 20-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 1), batch number: 195221, route of administration: intramuscular, anatomical location: left arm and expiry date: not reported]. On the same day, after vaccination, at 10 pm, the patient had red and swollen arm, headache, chills, fever (101 degrees). The patient felt nauseated but did not vomit, and had body ache all over. It was reported that events lasted until 22-Oct-2017 approximately till 4 pm. The patient did not undergo any laboratory tests. At the time of this report, the outcome of the events was recovered. The reporter considered the case as non-serious. This case was linked to case 201803410 due to same patient. Update received on 27-Sep-2018: Significant case correct (16-Aug-2018): The listedness for the event 'Swelling arm' was corrected from 'unlisted' to 'listed'. No changes were made in the narrative.
Age: 78.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Chills, Erythema, Headache, Nausea, 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: 722031), concerns a 78-year-old, elderly, female patient. Patient's historical conditions included influenza, chills, fever, vomiting, diarrhea, body aches and was ill due to FLUCELVAX Quadrivalent vaccine. Patient's current conditions included high blood pressure, high cholesterol (reported as history). Patient had penicillin, sulfonamide and environmental allergies. Patient did not have food allergies. Patient's concomitant medications included atorvastatin, amlodipine and levocetirizine. On 20-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 1), batch number: 195221, route of administration: intramuscular, anatomical location: left arm and expiry date: not reported]. On the same day, after vaccination, at 10 pm, the patient had red and swollen arm, headache, chills, fever (101 degrees). The patient felt nauseated but did not vomit, and had body ache all over. It was reported that events lasted until 22-Oct-2017 approximately till 4 pm. The patient did not undergo any laboratory tests. At the time of this report, the outcome of the events was recovered. The reporter considered the case as non-serious. This case was linked to case 201803410 due to same patient. Update received on 27-Sep-2018: Significant case correct (16-Aug-2018): The listedness for the event 'Swelling arm' was corrected from 'unlisted' to 'listed'. No changes were made in the narrative.
Age: 78.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Peripheral swelling, Pyrexia
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: 722031), concerns a 78-year-old, elderly, female patient. Patient's historical conditions included influenza, chills, fever, vomiting, diarrhea, body aches and was ill due to FLUCELVAX Quadrivalent vaccine. Patient's current conditions included high blood pressure, high cholesterol (reported as history). Patient had penicillin, sulfonamide and environmental allergies. Patient did not have food allergies. Patient's concomitant medications included atorvastatin, amlodipine and levocetirizine. On 20-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 1), batch number: 195221, route of administration: intramuscular, anatomical location: left arm and expiry date: not reported]. On the same day, after vaccination, at 10 pm, the patient had red and swollen arm, headache, chills, fever (101 degrees). The patient felt nauseated but did not vomit, and had body ache all over. It was reported that events lasted until 22-Oct-2017 approximately till 4 pm. The patient did not undergo any laboratory tests. At the time of this report, the outcome of the events was recovered. The reporter considered the case as non-serious. This case was linked to case 201803410 due to same patient. Update received on 27-Sep-2018: Significant case correct (16-Aug-2018): The listedness for the event 'Swelling arm' was corrected from 'unlisted' to 'listed'. No changes were made in the narrative.
Age: 43.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Injected limb mobility decreased, 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: 722073), concerns a 43-year-old, adult female patient. The patient's medical history included asthma. The patient did not receive any concomitant medications. On 17-Oct-2017, the patient received FLUCELVAX QIVc [dose: 0.5 ml (frequency: 1), route of administration: injection (reported as SYR), anatomical location: right arm, batch number and expiry date: not reported] and non-company suspect vaccine PNEUMOVAX [dose: unknown (frequency: 1), route of administration: injection (reported as SYR), anatomical location: left arm, batch number: not reported]. On the same day, after vaccination, the patient experienced extreme pain and could not lift her left arm above shoulder even after 5 days. It was reported that, the patient still had pain. At the time of report, the patient had not yet recovered from the events. The reporter assessed the case as non-serious. Update 29-Aug-2018: Significant case correction performed with IRD 16-Aug-2018: The 'as determined causality' for the event pain, was changed from 'related' to 'not related'. The case comment was updated accordingly.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Tendonitis, X-ray limb abnormal
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: 722488), concerns a 51-year-old, adult female patient. On 18-Sep-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency unknown), route of administration: intramuscular, anatomical location: left arm, batch number: 195211, expiry date: not reported]. On 23-Sep-2017, 5 days after vaccination, the patient experienced shoulder pain especially with rotation. On 4-Oct-2017, the patient underwent X-ray screening. The patient was evaluated by a physician assistant (PA) and was assessed as having left shoulder pain, left shoulder tendonitis and possible inflammatory reaction in the upper deltoid area which was resolving. The patient also experienced injection site pain. Outpatient physical therapy was advised to the patient. It was reported that the patient visited office. At the time of this report, the outcome of the events was unknown. The reporter assessed this case as non-serious. Update received on 29-Sep-2018: Non-significant case correction: (IRD: 16-Aug-2018): The phrase in the narrative (event description) was changed from 'injection site reaction' to 'injection site pain'. Added 'plausible temporal relationship' as rationale for the events in the case comment.
Age: 13.0
Sex: M
Vaccine: FLUC4
Symptoms: Loss of consciousness
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: 722609), concerns a 13-year-old, male adolescent patient. The patient's historical conditions, allergies, current illness and concomitant medications were unknown. On 23-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, expiry date: not reported). On the same day, after vaccination, the patient passed out. At the time of this report, the outcome of the event was unknown. The reporter assessed the case as non-serious.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Lip swelling, Paraesthesia oral
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: 722629), concerns a 41-year-old, adult, female patient. The patient had no historical conditions and current illness. The patient did not receive any concomitant medications. On 24-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195224, expiry date: not reported]. On the same day, approximately 6 hours after vaccination, the patient experienced tingling and swelling to upper lip which progressed to the lower lip by the arm (as reported). At the time of this report, the outcome of the events was unknown. The reporter assessed this case as non-serious.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Cough
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: 722712), concerns a 34-year-old, adult, female patient. The patient did not have any medical history, allergies and current illnesses. Patient did not take any concomitant medications at the time of vaccination. On 12-Oct-2017, Thursday afternoon, the patient was administered FLUCELVAX QIV [route of administration: intramuscular, anatomical location: left arm, dose: 0.5 ml (frequency reported as N/A), batch number and expiry date not reported]. On 14-Oct-2017 (Saturday night), 2 days after vaccination, patient started having cough. Patient stated she did not have any other symptoms except the cough (no fever, throat issues, no runny nose, no sputum, no abdominal pain, diarrhea, vomiting, no malaise, etc.). On 21-Oct-2017, patient went to urgent care and received a Z-PAK to make sure it wasn't a case of bacterial bronchitis and TESSALON Perles. Patient then started taking DELSYM 30 mg (cough suppressant). At the time of this report, the patient had not recovered from the event. The reporter assessed the case as non-serious.
Age: 40.0
Sex: M
Vaccine: FLUC4
Symptoms: Nodule, Pain in extremity, Scab
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: 722977), concerns a 40-year-old, adult male patient. The patient had no known drug allergy. The patient's concomitant medications included temazepam, LIPITOR, Vit. D3, omeprazole, PROZAC for unknown indications. On 12-Oct-2017, the patient received the suspect vaccine FLUCELVAX QIVc (dose: 0.5 ml, frequency reported as 1, route of administration: intramuscular, anatomical location: left arm, batch number: 195224, expiry date: not reported). On an unspecified date in Oct-2017, the patient experienced soreness in the left arm which persisted at the time of report and knotted up, also had a scab. At the time of report, the patient had not yet recovered from the events (left arm sore, knotted up and scab). The reporter assessed the case as non-serious. Update on 29-Aug-2018: Significant case correction was performed with IRD 16-Aug-2018: The onset date for all the events were changed from '26-Oct-2017' to 'on an unspecified date in Oct-2017'. The adverse event description was removed from the case comment. The narrative amended accordingly.
Age: 49.0
Sex: F
Vaccine: FLUC4, TDAP
Symptoms: Headache, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: This is spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 723014), concerns a 49-year-old, adult female patient. The patient's current condition included latex allergy. On 23-Oct-2018, the patient received FLUCELVAX QIVc [dose: 0.5 ml (frequency: reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 195228, expiry date: not reported]. On the same day, the patient also received non-company suspect BOOSTRIX [dose: (frequency reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number 9XJ5L, expiry date: not reported]. On 25-Oct-2018, 2 days after vaccination, the patient experienced redness at the injection site and the surrounding area. The patient developed rash at the injection site and was swollen. The patient also experienced headache. It was reported that, the symptoms had progressively worsened since the vaccination (reported as injection). At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 45.0
Sex: M
Vaccine: FLUC4
Symptoms: Asthenia, Headache, Nasal congestion, Oropharyngeal pain, Rhinorrhoea
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: 723056), concerns a 45-year-old, adult, male patient. The patient did not have any medical history, allergies and current illnesses. Patient did not take any medications at the time of vaccination. On 5-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: 195219 and expiry date not reported]. On 19-Oct-2017, 14 days after the vaccination, patient experienced runny and stuffy nose, sore throat, headache and general weakness. At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 20.0
Sex: F
Vaccine: FLUC4
Symptoms: Eye 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: 723122), concerns a 20-year-old, adult, female patient. The patient had no known drug allergies. On 24-Oct-2017, around 13:00 hours, the patient was administered FLUCELVAC QIVc [dose: 0.5 ml, frequency reported as 1, route of administration: intramuscular, anatomical location: left arm, batch number: 017355 (as reported) and expiry date: not reported]. The reported batch number (017355), does not match Seqirus batch numbers, however, because the reporter named Seqirus product 'FLUCELVAX QIVc' as the suspect vaccine, this report has been conservatively entered as a Seqirus case. On 25-Oct-2017, one day after vaccination, the patient developed swelling in her eyes. On an unspecified date, the patient made an emergency room and office visit. The patient was treated at emergency room with Ranitidine 150 mg, Prednisone 50 mg and Hydroxyzine 25 mg. At the time of this report, the patient had recovered from the event. The reporter assessed the case as non-serious.
Age: 46.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Hypoaesthesia, Injected limb mobility decreased, 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: 723163), concerns a 46-year-old, adult, male patient. On 15-Oct-2017, the patient was administered FLUCELVAX (QIV) [dose: 0.5 ml (reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 195234, expiry date: not reported] and co-suspect product PNEUMOVAX, [route of administration: intramuscular, anatomical location: left arm, batch number: N11867, dose: 0.5 (as reported 1) and expiry date: not reported]. On 18-Oct-2017, 3 days after vaccination, the patient complained of pain, numbness and had a decreased mobility in the left arm. At the time of this report, the outcome of the events was unknown. The reporter assessed this case as non-serious.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Cough, Dizziness, Feeling cold, Headache
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: 723168), concerns a 60-year-old, adult female patient. The patient's medical device history included, continuous positive airway pressure (CPAP) machine for historical condition of sleep apnea. The patient had no known allergies. On 16-Oct-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 17-Oct-2017, 1 day after vaccination, the patient experienced sore throat, cough, joint pain, headache, chills, nasal congestion and dizziness. No laboratory investigations were done. On an unspecified date, the patient took DIMETAPP, BENADRYL and TYLENOL PM which made her feel better except for a cough, nasal congestion, and a sore throat. The patient also took TESSALON PERLE and warm saline gargles. The patient's condition was improved but not completely recovered. It was reported that the patient visited emergency room and office. At the time of this report, the patient was recovering from the events. The reporter assessed this case as non-serious. Update on 29-Aug-2018: Non-significant case correction was performed with IRD 16-AUG-2018. The sentences were modified in the narrative. Captured age at vaccination in the patient tab.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Nasal congestion, Oropharyngeal pain
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: 723168), concerns a 60-year-old, adult female patient. The patient's medical device history included, continuous positive airway pressure (CPAP) machine for historical condition of sleep apnea. The patient had no known allergies. On 16-Oct-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 17-Oct-2017, 1 day after vaccination, the patient experienced sore throat, cough, joint pain, headache, chills, nasal congestion and dizziness. No laboratory investigations were done. On an unspecified date, the patient took DIMETAPP, BENADRYL and TYLENOL PM which made her feel better except for a cough, nasal congestion, and a sore throat. The patient also took TESSALON PERLE and warm saline gargles. The patient's condition was improved but not completely recovered. It was reported that the patient visited emergency room and office. At the time of this report, the patient was recovering from the events. The reporter assessed this case as non-serious. Update on 29-Aug-2018: Non-significant case correction was performed with IRD 16-AUG-2018. The sentences were modified in the narrative. Captured age at vaccination in the patient tab.
Age: 9.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
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: 723217), concerns a 09-year-old, female child patient. The patient's current condition included legal blindness. The patient had an egg allergy (eggs caused vomiting). The patient's concomitant medications were unknown. On 25-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195235 and expiry date: not reported). On the same day, after vaccination, the patient developed swelling and redness at the injection site. Patient's skin was hot to touch at the injection site. On an unspecified date, the patient made a physician office visit. At the time of this report, the outcome of the events was not reported. The reporter assessed the case as non-serious. Update 29-Aug-2018: Significant case correction performed with IRD 16-Aug-2018: The current condition (vomiting) has been removed from the patient tab. The case comment was corrected.
Age: 49.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Myalgia, Nasopharyngitis, Throat irritation
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: 723266), concerns a 49-year-old, adult, female patient. The patient had no medical history, current illness and allergies. The patient's concomitant medications included flaxseed oil, turmeric and multivitamins. On 10-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, batch number: 195219, anatomical location and expiry date: not reported]. On 16-Oct-2017, 6 days after the vaccination the patient experienced muscle aches, scratchy throat, cold symptoms and shivers for one week. At the time of this report the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Chest pain, Fatigue, Oedema, Vision blurred
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: 723288), concerns a 51-year-old, adult female patient. The patient's historical condition included: smoker. Occasional bilateral carpal tunnel. The patient had no current illness and no allergies. The patient did not received any concomitant medications. On 20-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195228, expiry date: not reported). On 24-Oct-2017, 4 days after vaccination, the patient developed intermittent blurred vision, edema, right sided chest pain and fatigue. On 26-Oct-2017, the patient was evaluated in hospital's emergency department. The patient's blood pressure (BP) was 164/75 (unit unspecified), heart rate (HR) was 77 (unit unspecified), temperature was 98.5 (unit unspecified) and oxygen saturation was 99 percent on pulse oximetry at room air. At the time of this report, the patient had not yet recovered from the events. The reporter assessed the case as non-serious.