chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU4
Symptoms: Chills, Cough, Dyspnoea, Nail discolouration, Ocular hyperaemia
Clinical narrative: This serious initial spontaneous case, was received from other health professional via health authority (VAERS ID: 718105) on 05-Dec-2017, concerns a 39-year-old, adult, female patient. The patient's medical history and current illness were not reported. Concomitant medications included DEXILANT, TRINESSA and iron. On 05-Oct-2017, the patient received AFLURIA QUADRIVALENT (dose: 0.5 ml (reported as 1), route of administration: intramuscular, anatomical location: left arm, batch no: 00544611A, expiry date: not reported). On the same day, at 10 am, the patient had difficulty in breathing, followed by chills and achiness. It was reported that, the patient had trouble taking deep breath and had cough forcefully. Her hands and fingers were cold and white, nail beds turned purple, eyes were red and blood shot. She also had cloudy vision. The outcome of the events was not reported.    This serious initial spontaneous case, was received from other health professional via health authority (VAERS ID: 718105) on 05-Dec-2017, concerns a 39-year-old, adult, female patient. The patient's medical history and current illness were not reported. Concomitant medications included DEXILANT, TRINESSA and iron for unknown indication. On 05-Oct-2017, the patient received AFLURIA QUADRIVALENT (dose: 0.5 ml (reported as 1), route of administration: intramuscular, anatomical location: left arm, batch no: 00544611A, expiry date: not reported). On the same day, at 10 am, the patient had difficulty in breathing, followed by chills and achiness. It was reported that, the patient had trouble taking deep breath and had cough forcefully. Her hands and fingers were cold and white, nail beds turned purple, eyes were red and blood shot. She also had cloudy vision. The outcome of the events was not reported.
Sex: F
Vaccine: FLU4
Symptoms: Pain, Peripheral coldness, Skin discolouration, Vision blurred
Clinical narrative: This serious initial spontaneous case, was received from other health professional via health authority (VAERS ID: 718105) on 05-Dec-2017, concerns a 39-year-old, adult, female patient. The patient's medical history and current illness were not reported. Concomitant medications included DEXILANT, TRINESSA and iron. On 05-Oct-2017, the patient received AFLURIA QUADRIVALENT (dose: 0.5 ml (reported as 1), route of administration: intramuscular, anatomical location: left arm, batch no: 00544611A, expiry date: not reported). On the same day, at 10 am, the patient had difficulty in breathing, followed by chills and achiness. It was reported that, the patient had trouble taking deep breath and had cough forcefully. Her hands and fingers were cold and white, nail beds turned purple, eyes were red and blood shot. She also had cloudy vision. The outcome of the events was not reported.    This serious initial spontaneous case, was received from other health professional via health authority (VAERS ID: 718105) on 05-Dec-2017, concerns a 39-year-old, adult, female patient. The patient's medical history and current illness were not reported. Concomitant medications included DEXILANT, TRINESSA and iron for unknown indication. On 05-Oct-2017, the patient received AFLURIA QUADRIVALENT (dose: 0.5 ml (reported as 1), route of administration: intramuscular, anatomical location: left arm, batch no: 00544611A, expiry date: not reported). On the same day, at 10 am, the patient had difficulty in breathing, followed by chills and achiness. It was reported that, the patient had trouble taking deep breath and had cough forcefully. Her hands and fingers were cold and white, nail beds turned purple, eyes were red and blood shot. She also had cloudy vision. The outcome of the events was not reported.
Sex: F
Vaccine: FLU4
Symptoms: Chills, Fatigue, Feeling cold, Headache, Influenza
Clinical narrative: This serious initial spontaneous case, was received from other health professional via health authority (VAERS ID: 720302) on 05-Dec-2017, concerning a 41-year-old, adult female patient. It was reported that the patient had mild reaction to flu vaccine on an unspecified day in the past and experienced flu symptoms for a day but not that severe. The patient's current illness included: bacterial vaginitis and STD (sexually transmitted disease). Concomitant medications included: vitamins and unspecified antibiotics for STD. On 12-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (route of administration: SYR (as reported), anatomical location: left arm, batch number, expiry date: not reported). On 13-Oct-2017, after 1 day of vaccination, the patient experienced severe/extreme headache along with extreme fatigue, extreme body ache, painful and burning sore throat. She had severe chills and high fever 102.5. Hence, covered herself with six blankets but still she felt very cold. The patient had the flu and reported she do not want to have the vaccine again. It was reported that the patient was already fighting with bacteria. The health authority provided the preferred term loss of personal independence in daily activities. At the time of this report, the outcome of the events was recovered.
Sex: F
Vaccine: FLU4
Symptoms: Loss of personal independence in daily activities, Oropharyngeal pain, Pain, Pyrexia, Throat irritation
Clinical narrative: This serious initial spontaneous case, was received from other health professional via health authority (VAERS ID: 720302) on 05-Dec-2017, concerning a 41-year-old, adult female patient. It was reported that the patient had mild reaction to flu vaccine on an unspecified day in the past and experienced flu symptoms for a day but not that severe. The patient's current illness included: bacterial vaginitis and STD (sexually transmitted disease). Concomitant medications included: vitamins and unspecified antibiotics for STD. On 12-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (route of administration: SYR (as reported), anatomical location: left arm, batch number, expiry date: not reported). On 13-Oct-2017, after 1 day of vaccination, the patient experienced severe/extreme headache along with extreme fatigue, extreme body ache, painful and burning sore throat. She had severe chills and high fever 102.5. Hence, covered herself with six blankets but still she felt very cold. The patient had the flu and reported she do not want to have the vaccine again. It was reported that the patient was already fighting with bacteria. The health authority provided the preferred term loss of personal independence in daily activities. At the time of this report, the outcome of the events was recovered.
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Influenza
Clinical narrative: This serious spontaneous case, reported by health care professional (other) to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 720633), concerns a 33-year-old, adult, female patient. The patient was allergic to LEVAQUIN. On an unspecified date in 2010, the patient was administered with influenza vaccine, (dose, route of administration, anatomical location, manufacturer, trade name, batch number and expiry date: not reported). On an unspecified date in 2010, after vaccination, the patient had real flu (influenza).
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Paraesthesia
Clinical narrative: This serious spontaneous case, reported by health care professional (other) to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 720633), concerns a 33-year-old, adult, female patient. The patient was allergic to LEVAQUIN. On an unspecified date in 2010, the patient was administered with influenza vaccine, (dose, route of administration, anatomical location, manufacturer, trade name, batch number and expiry date: not reported). On an unspecified date in 2010, after vaccination, the patient had real flu (influenza).
Sex: F
Vaccine: FLUX
Symptoms: Borrelia test, Facial paralysis
Clinical narrative: This is a serious spontaneous case, reported by other health professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 721035), concerning a 28-year-old, adult, female patient. It was reported that the patient had no known allergies or current illness. The patient's historical condition included: had Bell's palsy on the left side in 2014. Historical drug included: yearly flu shot. Concomitant medication included: CELEXA. On 24-Sep-2017, the patient was administered with influenza vaccine (route of administration: intramuscular, anatomical location: left arm, dose, batch number, expiry date, trade name, manufacturer: not reported). On 16-Oct-2017, after 23 days of vaccination (reported as about 3 weeks later), the patient developed left sided Bell's palsy (on the same side as in 2014) and visited the emergency room. Lyme and borrelia test were done but the result was not reported. At the time of this report, the patient had not yet recovered from the event (left sided Bell's palsy).
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Febrile convulsion
Clinical narrative: This is a serious spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 721292), concerning a 15-month-old, female infant of unspecified ethnicity. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2017, the patient was administered with INN Flu Vaccine Seasonal (dose: single dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date in 2017, the patient was administered with non-company suspect drug PREVNAR 13 (dose: single dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date in 2017 (same day as the immunization), later that night (as reported), the patient experienced febrile seizure. The patient's mother stated that, the patient was fine after her temperature came down. However, the clinical outcome of febrile seizure was unknown. At the time of this report, the outcome of event (febrile seizure) was unknown. Case was opened in error on 14-Feb-2018.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous case, reported by pharmacist to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 721937), concerns a 41-year-old, adult, female patient. The patient had no relevant medical history and no drug reactions or allergies. On 19-Aug-2017, the patient was administered with influenza vaccine (route of administration, anatomical location: unknown, dose, batch number, expiry date: not reported). On the same day (19-Aug-2017), the patient was also administered with PNEUMOVAX (route of administration: subcutaneous, batch number: N010105, expiry date: 15-Nov-2018, anatomical location, dose: not reported). On the same day, after the administration of vaccine, the patient experienced pain, redness, swelling at the site of injection. It was reported that, injection site was warm to touch during night. The patient consulted a physician and was diagnosed with cellulitis. The patient was treated with unspecified antibiotics. On an unspecified date in Aug 2017, after few days of receiving treatment, the patient recovered from the events.
Sex: M
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Erythema, Injection site bruising, Peripheral swelling
Clinical narrative: This is serious spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 722358), concerns a 58-year-old, elderly male patient. The patient's medical history was not reported. On 21-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml, batch number: XF32908, anatomical location: left arm, route of administration: intramuscular). On the same day, the patient was also administered with PNEUMOVAX (dose: 1 as reported, batch number: N013521, anatomical location: left arm, route of administration: intramuscular). On 22-Oct-2017, 1 day after vaccines administration, the patient developed bruising at the site of injection, redness and swelling on the left arm. He sought medical attention and was diagnosed with cellulitis. The outcome of the events was not reported.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Facial paralysis, Headache, Hypoaesthesia
Clinical narrative: This is a serious spontaneous case, reported by other health care professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 722902), concerning a 45-year-old, adult female patient. On 02-Oct-2017, the patient was administered with influenza vaccine (route of administration: intramuscular, anatomical location: left arm, dose, batch number, expiry date: not reported). On the same day, after the administration of vaccine, the patient experienced severe headache, numbness in right arm and leg, diagnosed as Bell's palsy (on a unspecified date). The patient was treated with prednisone and acyclovir. At the time of this report, the outcome of the events was not recovered.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Facial paralysis, Headache, Hypoaesthesia
Clinical narrative: This is a serious spontaneous case, reported by other health care professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 722902), concerning a 45-year-old, adult female patient. On 02-Oct-2017, the patient was administered with INN  Flu  Vaccine  Seasonal  (route of administration: intramuscular, anatomical location: left arm, dose, batch number, expiry date: not reported). On the same day, after the administration of vaccine, the patient experienced severe headache,  numbness in right arm and leg, diagnosed as bell's palsy (on a unspecified date). The patient was treated with prednisone and acyclovir. At the time of this report, the outcome of the events was not recovered.
Age: 53.0
Sex: F
Vaccine: FLU4, HEP, PNC13
Symptoms: Abdominal discomfort, Body temperature, Chills, Fatigue, Feeling cold
Clinical narrative: This serious spontaneous case, reported by other health care professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 722984), concerns a 53-year-old, adult, female patient. The patient had no relevant medical history and had no known allergies. The patient's concomitant medications included calcium, biotin, Luetin and multivitamins. On 24-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml, route of administration, anatomical location, batch number and expiry date: not reported), RECOMBIVAX HB (dose, route of administration, anatomical location, batch number and expiry date: not reported) and PREVNAR 13 (dose, route of administration, anatomical location, batch number and expiry date: not reported). On 25-Oct-2017, after 1 day of vaccination, the patient had flu symptoms as extreme headache, body soreness, temperature, upset stomach, cold chills and fatigue. At the time of this report, the patient had not recovered from flu symptoms.
Age: 53.0
Sex: F
Vaccine: FLU4, HEP, PNC13
Symptoms: Headache, Influenza, Pain
Clinical narrative: This serious spontaneous case, reported by other health care professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 722984), concerns a 53-year-old, adult, female patient. The patient had no relevant medical history and had no known allergies. The patient's concomitant medications included calcium, biotin, Luetin and multivitamins. On 24-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml, route of administration, anatomical location, batch number and expiry date: not reported), RECOMBIVAX HB (dose, route of administration, anatomical location, batch number and expiry date: not reported) and PREVNAR 13 (dose, route of administration, anatomical location, batch number and expiry date: not reported). On 25-Oct-2017, after 1 day of vaccination, the patient had flu symptoms as extreme headache, body soreness, temperature, upset stomach, cold chills and fatigue. At the time of this report, the patient had not recovered from flu symptoms.
Sex: F
Vaccine: FLUX
Symptoms: Cellulitis, Erythema, Pain, Pyrexia, Swelling
Clinical narrative: This is a serious spontaneous case, reported by other health professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 723314), concerning a 03-year-old, female child. The patient had no relevant medical history and had no known allergies. On 26-Oct-2017, the patient was administered with influenza vaccine (route of administration: intramuscular, anatomical location: right arm, dose, batch number, expiry date, trade name and manufacturer: not reported). On the same day (26-Oct-2017), the patient developed 104.6-degree fever, severe swelling, redness, pain and cellulitis. It was reported that the patient had consulted a physician. At the time of this report, the patient had not yet recovered from the events (cellulitis, redness, pain, swelling and fever).
Sex: M
Vaccine: FLUX
Symptoms: Facial paralysis
Clinical narrative: This is a serious spontaneous case, reported by other health professional to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 723400), concerning a 26-year-old, adult, male patient. It was reported that, the patient had no medical history of HSV (herpes simplex virus), lyme or any kind of paralysis. The patient's historical condition included strep throat, which was diagnosed on an unspecified date (reported as last year). The patient was allergic to fruits that caused mild mouth itchiness and had spring hay fever allergy (since an unspecified date). Current condition included: mild right sided sore throat (since an unspecified date). It was reported that, the patient had similar symptoms 10 days prior at the same location of pain. No evaluation was done, and no antibiotics were taken for the symptoms. Concomitant medications included: AIR-BORNE VITAMIN C taken for the past 2 months (as reported) without any adverse incidences and AMBIEN as needed (prn) for 6 months. On 25-Oct-2017, the patient was administered with influenza vaccine (dose: 1 dose (as reported), route of administration: intramuscular, anatomical location: left arm, batch number, expiry date, trade name and manufacturer: not reported). On 27-Oct-2017, on Friday, after 2 days of vaccination, the patient developed right sided facial nerve paralysis consistent with Bell's palsy. Informal evaluation by board certified otolaryngologist outside the clinic was done to confirm the diagnosis of Bell's palsy. The patient had not yet recovered from the event- Bell's palsy.
Sex: F
Vaccine: FLU4
Symptoms: Dysarthria, Guillain-Barre syndrome, Speech disorder
Clinical narrative: This serious spontaneous case, reported by other health professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 724121), concerning a 77-year-old, elderly female patient. The patient's historical condition included: CLL (Chronic lymphocytic leukemia). The patient had no any allergies. Current illness included: respiratory illness. The patient was taking concomitant medications as potassium, multivitamin, water pill and unspecified thyroid medication. On 27-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml (as reported unk), route of administration, anatomical location, batch number, expiry date: not reported). On 28-Oct-2017, after 1 day of vaccine administration, the patient experienced symptoms of Guillain-Barre disease (GBS) such as difficulty in speaking, slurred speech and difficulty in articulating words. It was reported that within one day, the symptoms were resolved. At the time of report, the patient recovered from the event Guillain-Barr disease.
Sex: M
Vaccine: FLU4
Symptoms: Blood culture, Blood test, Chest X-ray, Computerised tomogram head, Diplopia
Clinical narrative: This spontaneous case, reported by non-healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 725578), concerns a 49-year-old adult, male patient. The patient's current condition included high cholesterol and concomitant medication included CRESTOR. On 23-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number, expiry date: not reported). On 16-Oct-2017, after 24 days of vaccination, the had watery eyes and a runny nose. On 17-Oct-2017, the patient's eyes were watering profusely and were extremely red and inflamed. On 18-Oct-2017, he woke up with tingling sensation in hands and feet. Hence the patient did not report to work. It was reported that tingling sensation resolved but had watering eyes. The patient visited a quick-care facility and was told that it was a viral cold. On 18-Oct-2017, the patient woke up and felt worse and did not report to work again. Patient had tingling hands and feet again, which was not resolved. The patient was unable to climb stairs and felt that he had a problem in controlling muscles to walk. The patient's voice sounded strange. The patient went to emergency room for consultation. The patient underwent blood tests, computed tomography (CT) scan, and magnetic resonance imaging (MRI) (results were not provided). On 20-Oct-2017, the patient consulted a neurologist, who recommended for the transfer to another hospital. On the same day (evening), the patient was admitted in the critical care unit (CCU) (after the transfer). It was reported that, the patient's symptoms had progressed and was unable to walk, had extremely slurred speech, inability to swallow, numbness in hands, feet and face, blurred and double vision, extreme head and neck pain and nausea. The patient had no control on his limbs. On 21-Oct-2017, at 04:00 hrs, a lumbar puncture and chest x-ray were done (results were not provided). Additional x-rays were taken during hospitalization. Over the following days, patient's health declined, and a feeding tube was inserted. The patient was put on intubation. Eventually the patient was diagnosed with Guillain Barre Syndrome (GBS). The patient was hospitalized for 10 days. On an unspecified date, the patient was discharged from the hospital. At the time of this report, the patient had not recovered from GBS. The reporter assessed the case as serious (life-threatening, hospitalization and disability).
Sex: M
Vaccine: FLU4
Symptoms: Dysarthria, Dysphagia, Dysphonia, Endotracheal intubation, Eye inflammation
Clinical narrative: This spontaneous case, reported by non-healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 725578), concerns a 49-year-old adult, male patient. The patient's current condition included high cholesterol and concomitant medication included CRESTOR. On 23-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number, expiry date: not reported). On 16-Oct-2017, after 24 days of vaccination, the had watery eyes and a runny nose. On 17-Oct-2017, the patient's eyes were watering profusely and were extremely red and inflamed. On 18-Oct-2017, he woke up with tingling sensation in hands and feet. Hence the patient did not report to work. It was reported that tingling sensation resolved but had watering eyes. The patient visited a quick-care facility and was told that it was a viral cold. On 18-Oct-2017, the patient woke up and felt worse and did not report to work again. Patient had tingling hands and feet again, which was not resolved. The patient was unable to climb stairs and felt that he had a problem in controlling muscles to walk. The patient's voice sounded strange. The patient went to emergency room for consultation. The patient underwent blood tests, computed tomography (CT) scan, and magnetic resonance imaging (MRI) (results were not provided). On 20-Oct-2017, the patient consulted a neurologist, who recommended for the transfer to another hospital. On the same day (evening), the patient was admitted in the critical care unit (CCU) (after the transfer). It was reported that, the patient's symptoms had progressed and was unable to walk, had extremely slurred speech, inability to swallow, numbness in hands, feet and face, blurred and double vision, extreme head and neck pain and nausea. The patient had no control on his limbs. On 21-Oct-2017, at 04:00 hrs, a lumbar puncture and chest x-ray were done (results were not provided). Additional x-rays were taken during hospitalization. Over the following days, patient's health declined, and a feeding tube was inserted. The patient was put on intubation. Eventually the patient was diagnosed with Guillain Barre Syndrome (GBS). The patient was hospitalized for 10 days. On an unspecified date, the patient was discharged from the hospital. At the time of this report, the patient had not recovered from GBS. The reporter assessed the case as serious (life-threatening, hospitalization and disability).
Sex: M
Vaccine: FLU4
Symptoms: Gait disturbance, Gait inability, Gastrointestinal tube insertion, General physical health deterioration, Guillain-Barre syndrome
Clinical narrative: This spontaneous case, reported by non-healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 725578), concerns a 49-year-old adult, male patient. The patient's current condition included high cholesterol and concomitant medication included CRESTOR. On 23-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number, expiry date: not reported). On 16-Oct-2017, after 24 days of vaccination, the had watery eyes and a runny nose. On 17-Oct-2017, the patient's eyes were watering profusely and were extremely red and inflamed. On 18-Oct-2017, he woke up with tingling sensation in hands and feet. Hence the patient did not report to work. It was reported that tingling sensation resolved but had watering eyes. The patient visited a quick-care facility and was told that it was a viral cold. On 18-Oct-2017, the patient woke up and felt worse and did not report to work again. Patient had tingling hands and feet again, which was not resolved. The patient was unable to climb stairs and felt that he had a problem in controlling muscles to walk. The patient's voice sounded strange. The patient went to emergency room for consultation. The patient underwent blood tests, computed tomography (CT) scan, and magnetic resonance imaging (MRI) (results were not provided). On 20-Oct-2017, the patient consulted a neurologist, who recommended for the transfer to another hospital. On the same day (evening), the patient was admitted in the critical care unit (CCU) (after the transfer). It was reported that, the patient's symptoms had progressed and was unable to walk, had extremely slurred speech, inability to swallow, numbness in hands, feet and face, blurred and double vision, extreme head and neck pain and nausea. The patient had no control on his limbs. On 21-Oct-2017, at 04:00 hrs, a lumbar puncture and chest x-ray were done (results were not provided). Additional x-rays were taken during hospitalization. Over the following days, patient's health declined, and a feeding tube was inserted. The patient was put on intubation. Eventually the patient was diagnosed with Guillain Barre Syndrome (GBS). The patient was hospitalized for 10 days. On an unspecified date, the patient was discharged from the hospital. At the time of this report, the patient had not recovered from GBS. The reporter assessed the case as serious (life-threatening, hospitalization and disability).
Sex: M
Vaccine: FLU4
Symptoms: Headache, Hypoaesthesia, Impaired work ability, Lacrimation increased, Loss of control of legs
Clinical narrative: This spontaneous case, reported by non-healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 725578), concerns a 49-year-old adult, male patient. The patient's current condition included high cholesterol and concomitant medication included CRESTOR. On 23-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number, expiry date: not reported). On 16-Oct-2017, after 24 days of vaccination, the had watery eyes and a runny nose. On 17-Oct-2017, the patient's eyes were watering profusely and were extremely red and inflamed. On 18-Oct-2017, he woke up with tingling sensation in hands and feet. Hence the patient did not report to work. It was reported that tingling sensation resolved but had watering eyes. The patient visited a quick-care facility and was told that it was a viral cold. On 18-Oct-2017, the patient woke up and felt worse and did not report to work again. Patient had tingling hands and feet again, which was not resolved. The patient was unable to climb stairs and felt that he had a problem in controlling muscles to walk. The patient's voice sounded strange. The patient went to emergency room for consultation. The patient underwent blood tests, computed tomography (CT) scan, and magnetic resonance imaging (MRI) (results were not provided). On 20-Oct-2017, the patient consulted a neurologist, who recommended for the transfer to another hospital. On the same day (evening), the patient was admitted in the critical care unit (CCU) (after the transfer). It was reported that, the patient's symptoms had progressed and was unable to walk, had extremely slurred speech, inability to swallow, numbness in hands, feet and face, blurred and double vision, extreme head and neck pain and nausea. The patient had no control on his limbs. On 21-Oct-2017, at 04:00 hrs, a lumbar puncture and chest x-ray were done (results were not provided). Additional x-rays were taken during hospitalization. Over the following days, patient's health declined, and a feeding tube was inserted. The patient was put on intubation. Eventually the patient was diagnosed with Guillain Barre Syndrome (GBS). The patient was hospitalized for 10 days. On an unspecified date, the patient was discharged from the hospital. At the time of this report, the patient had not recovered from GBS. The reporter assessed the case as serious (life-threatening, hospitalization and disability).
Sex: M
Vaccine: FLU4
Symptoms: Loss of personal independence in daily activities, Lumbar puncture, Motor dysfunction, Nasopharyngitis, Nausea
Clinical narrative: This spontaneous case, reported by non-healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 725578), concerns a 49-year-old adult, male patient. The patient's current condition included high cholesterol and concomitant medication included CRESTOR. On 23-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number, expiry date: not reported). On 16-Oct-2017, after 24 days of vaccination, the had watery eyes and a runny nose. On 17-Oct-2017, the patient's eyes were watering profusely and were extremely red and inflamed. On 18-Oct-2017, he woke up with tingling sensation in hands and feet. Hence the patient did not report to work. It was reported that tingling sensation resolved but had watering eyes. The patient visited a quick-care facility and was told that it was a viral cold. On 18-Oct-2017, the patient woke up and felt worse and did not report to work again. Patient had tingling hands and feet again, which was not resolved. The patient was unable to climb stairs and felt that he had a problem in controlling muscles to walk. The patient's voice sounded strange. The patient went to emergency room for consultation. The patient underwent blood tests, computed tomography (CT) scan, and magnetic resonance imaging (MRI) (results were not provided). On 20-Oct-2017, the patient consulted a neurologist, who recommended for the transfer to another hospital. On the same day (evening), the patient was admitted in the critical care unit (CCU) (after the transfer). It was reported that, the patient's symptoms had progressed and was unable to walk, had extremely slurred speech, inability to swallow, numbness in hands, feet and face, blurred and double vision, extreme head and neck pain and nausea. The patient had no control on his limbs. On 21-Oct-2017, at 04:00 hrs, a lumbar puncture and chest x-ray were done (results were not provided). Additional x-rays were taken during hospitalization. Over the following days, patient's health declined, and a feeding tube was inserted. The patient was put on intubation. Eventually the patient was diagnosed with Guillain Barre Syndrome (GBS). The patient was hospitalized for 10 days. On an unspecified date, the patient was discharged from the hospital. At the time of this report, the patient had not recovered from GBS. The reporter assessed the case as serious (life-threatening, hospitalization and disability).
Sex: M
Vaccine: FLU4
Symptoms: Neck pain, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Ocular hyperaemia, Paraesthesia
Clinical narrative: This spontaneous case, reported by non-healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 725578), concerns a 49-year-old adult, male patient. The patient's current condition included high cholesterol and concomitant medication included CRESTOR. On 23-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number, expiry date: not reported). On 16-Oct-2017, after 24 days of vaccination, the had watery eyes and a runny nose. On 17-Oct-2017, the patient's eyes were watering profusely and were extremely red and inflamed. On 18-Oct-2017, he woke up with tingling sensation in hands and feet. Hence the patient did not report to work. It was reported that tingling sensation resolved but had watering eyes. The patient visited a quick-care facility and was told that it was a viral cold. On 18-Oct-2017, the patient woke up and felt worse and did not report to work again. Patient had tingling hands and feet again, which was not resolved. The patient was unable to climb stairs and felt that he had a problem in controlling muscles to walk. The patient's voice sounded strange. The patient went to emergency room for consultation. The patient underwent blood tests, computed tomography (CT) scan, and magnetic resonance imaging (MRI) (results were not provided). On 20-Oct-2017, the patient consulted a neurologist, who recommended for the transfer to another hospital. On the same day (evening), the patient was admitted in the critical care unit (CCU) (after the transfer). It was reported that, the patient's symptoms had progressed and was unable to walk, had extremely slurred speech, inability to swallow, numbness in hands, feet and face, blurred and double vision, extreme head and neck pain and nausea. The patient had no control on his limbs. On 21-Oct-2017, at 04:00 hrs, a lumbar puncture and chest x-ray were done (results were not provided). Additional x-rays were taken during hospitalization. Over the following days, patient's health declined, and a feeding tube was inserted. The patient was put on intubation. Eventually the patient was diagnosed with Guillain Barre Syndrome (GBS). The patient was hospitalized for 10 days. On an unspecified date, the patient was discharged from the hospital. At the time of this report, the patient had not recovered from GBS. The reporter assessed the case as serious (life-threatening, hospitalization and disability).
Sex: M
Vaccine: FLU4
Symptoms: Rhinorrhoea, Scan with contrast, Viral infection, Vision blurred, X-ray
Clinical narrative: This spontaneous case, reported by non-healthcare professional to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 725578), concerns a 49-year-old adult, male patient. The patient's current condition included high cholesterol and concomitant medication included CRESTOR. On 23-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number, expiry date: not reported). On 16-Oct-2017, after 24 days of vaccination, the had watery eyes and a runny nose. On 17-Oct-2017, the patient's eyes were watering profusely and were extremely red and inflamed. On 18-Oct-2017, he woke up with tingling sensation in hands and feet. Hence the patient did not report to work. It was reported that tingling sensation resolved but had watering eyes. The patient visited a quick-care facility and was told that it was a viral cold. On 18-Oct-2017, the patient woke up and felt worse and did not report to work again. Patient had tingling hands and feet again, which was not resolved. The patient was unable to climb stairs and felt that he had a problem in controlling muscles to walk. The patient's voice sounded strange. The patient went to emergency room for consultation. The patient underwent blood tests, computed tomography (CT) scan, and magnetic resonance imaging (MRI) (results were not provided). On 20-Oct-2017, the patient consulted a neurologist, who recommended for the transfer to another hospital. On the same day (evening), the patient was admitted in the critical care unit (CCU) (after the transfer). It was reported that, the patient's symptoms had progressed and was unable to walk, had extremely slurred speech, inability to swallow, numbness in hands, feet and face, blurred and double vision, extreme head and neck pain and nausea. The patient had no control on his limbs. On 21-Oct-2017, at 04:00 hrs, a lumbar puncture and chest x-ray were done (results were not provided). Additional x-rays were taken during hospitalization. Over the following days, patient's health declined, and a feeding tube was inserted. The patient was put on intubation. Eventually the patient was diagnosed with Guillain Barre Syndrome (GBS). The patient was hospitalized for 10 days. On an unspecified date, the patient was discharged from the hospital. At the time of this report, the patient had not recovered from GBS. The reporter assessed the case as serious (life-threatening, hospitalization and disability).
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Malaise, Pruritus, Rash erythematous
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 76-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 20th March 2020) for prophylaxis. On 27th March 2018, the patient received SHINGRIX .5 ml. On 28th March 2018, 1 days after receiving SHINGRIX, the patient experienced headache. On 30th March 2018, the patient experienced heat rash and erythematous rash. On an unknown date, the outcome of the headache, heat rash and erythematous rash were not recovered/not resolved. The reporter considered the headache, heat rash and erythematous rash to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that one of their patients received the SHINGRIX. The day after getting the SHINGRIX, the patient had a bad headache and stayed in bed all day. Three days after receiving SHINGRIX, the patient noticed a red round rash on her arm, but it was not at the injection. It was a little bit lower and more towards the front of her upper arm and it was hot to touch. Follow up information received from pharmacist on 8th June 2018: The patient received the 1st dose of SHINGRIX intramuscularly. It was reported that, the patient came to receive the 2nd dose, but she still had a large red circle on her upper arm. It seemed to permanently discolor her arm. The pharmacist advised the patient not to receive the 2nd dose. The VAERS details were updated. Sender's Comments: US2018054843: Previous VAERS submission in paper format.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Miliaria, Rash erythematous
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 76-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 20th March 2020) for prophylaxis. On 27th March 2018, the patient received SHINGRIX .5 ml. On 28th March 2018, 1 days after receiving SHINGRIX, the patient experienced headache. On 30th March 2018, the patient experienced heat rash and erythematous rash. On an unknown date, the outcome of the headache, heat rash and erythematous rash were not recovered/not resolved. The reporter considered the headache, heat rash and erythematous rash to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that one of their patients received the SHINGRIX. The day after getting the SHINGRIX, the patient had a bad headache and stayed in bed all day. Three days after receiving SHINGRIX, the patient noticed a red round rash on her arm, but it was not at the injection. It was a little bit lower and more towards the front of her upper arm and it was hot to touch. Follow up information received from pharmacist on 8th June 2018: The patient received the 1st dose of SHINGRIX intramuscularly. It was reported that, the patient came to receive the 2nd dose, but she still had a large red circle on her upper arm. It seemed to permanently discolor her arm. The pharmacist advised the patient not to receive the 2nd dose. The VAERS details were updated. Sender's Comments: US2018054843: Previous VAERS submission in paper format.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Fatigue, Headache, Injection site erythema, Injection site warmth
Clinical narrative: Muscle pain in all my body.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: Muscle pain in all my body.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood creatine phosphokinase, Blood magnesium, Blood phosphorus, Full blood count, Hepatitis B core antibody
Clinical narrative: Muscle pain in all my body.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Metabolic function test, Myalgia, Red blood cell sedimentation rate, Rheumatoid factor, Thyroxine
Clinical narrative: Muscle pain in all my body.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Thyroxine free, Vitamin B12
Clinical narrative: Muscle pain in all my body.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old male patient who received Shingrix (batch number B9739, expiry date unknown) for prophylaxis. The patient's past medical history included squamous cell carcinoma (named head, neck and shoulder cancer and required chemo and radiation 10-15 years ago), thyroidectomy and cancer surgery. Concurrent medical conditions included muscle atrophy (muscle loss in left arm from cancer surgery done 10 to 15 years ago). Concomitant products included Shingrix, Baking Soda, Levothyroxine, Magnesium, morphine, Mucinex, Percocet and Potassium. On 4th June 2018, the patient received the 2nd dose of Shingrix. On 4th June 2018, 2 hrs after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced injection site pain and injected limb mobility decreased. On 5th June 2018, the patient experienced appetite lost. On an unknown date, the outcome of the injection site pain, appetite lost and injected limb mobility decreased were not recovered/not resolved. The reporter considered the injection site pain to be related to Shingrix. It was unknown if the reporter considered the appetite lost and injected limb mobility decreased to be related to Shingrix. Additional details were provided as follows: The reporter was the patient. The Shingrix vaccine was administered in the right arm and pain presented in his right arm 2 to 3 hours after receiving the Shingrix vaccine. The patient described the pain a little worse the second time and had not resolved yet. He also reported a loss of appetite after the second shot. The patient also mentioned that he takes large amounts of morphine daily and it did not help with the arm pain. This case was linked with US2018100634, reported for same patient for1st dose of Shingrix.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Decreased appetite, Injected limb mobility decreased, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old male patient who received Shingrix (batch number B9739, expiry date unknown) for prophylaxis. The patient's past medical history included squamous cell carcinoma (named head, neck and shoulder cancer and required chemo and radiation 10-15 years ago), thyroidectomy and cancer surgery. Concurrent medical conditions included muscle atrophy (muscle loss in left arm from cancer surgery done 10 to 15 years ago). Concomitant products included Shingrix, Baking Soda, Levothyroxine, Magnesium, morphine, Mucinex, Percocet and Potassium. On 4th June 2018, the patient received the 2nd dose of Shingrix. On 4th June 2018, 2 hrs after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced injection site pain and injected limb mobility decreased. On 5th June 2018, the patient experienced appetite lost. On an unknown date, the outcome of the injection site pain, appetite lost and injected limb mobility decreased were not recovered/not resolved. The reporter considered the injection site pain to be related to Shingrix. It was unknown if the reporter considered the appetite lost and injected limb mobility decreased to be related to Shingrix. Additional details were provided as follows: The reporter was the patient. The Shingrix vaccine was administered in the right arm and pain presented in his right arm 2 to 3 hours after receiving the Shingrix vaccine. The patient described the pain a little worse the second time and had not resolved yet. He also reported a loss of appetite after the second shot. The patient also mentioned that he takes large amounts of morphine daily and it did not help with the arm pain. This case was linked with US2018100634, reported for same patient for1st dose of Shingrix.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Myalgia, Nausea, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 74-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included citalopram. On 6th June 2018 11:00, the patient received the 2nd dose of SHINGRIX .5 ml. On 6th June 2018, several hours after receiving SHINGRIX, the patient experienced headache, fever and nausea. On 6th June 2018 16:00, the patient experienced fatigue. On 6th June 2018 22:00, the patient experienced chills. On 7th June 2018, the outcome of the headache, fever, chills and nausea were recovered/resolved. On an unknown date, the outcome of the fatigue was recovering/resolving.  The reporter considered the fatigue, headache, fever, chills and nausea to be related to SHINGRIX. Additional details were provided as follows: The reporter herself was the patient. The patient received dose around 11:00 AM, and that by 4:00 PM, she felt fatigued and at 10: PM she had chills and during the night she had nausea with dry heaves, fever with body temperature of 101.2 degrees F, and severe headache. The patient reported that, nausea lasted through most of next day and then resolved and that headache, chills and fever resolved around mid-day next day. On the day of reporting, she continues to feel fatigued.