chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Cough, Lower respiratory tract congestion, Pain, Pyrexia, Upper respiratory tract congestion
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 02-Aug-2018 by Seqirus from VAERS (VAERS ID: 744961), concerning an adult, female patient of an unspecified age. On unspecified date in 2009, the patient administered the influenza vaccine and 2 weeks after vaccination, developed reproducible likely non-immunoglobulin E [IgE] mediated reactions which included fever with a temperature 101-104, body aches, upper and lower respiratory tract congestion and cough which persisted for several weeks. The patient's current condition included allergic rhinitis (reported as medical history) and was allergic to sulfa drugs. On an unspecified date in 2010, the patient was administered Influenza vaccine, dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date in 2010, two weeks after vaccination, the patient experienced reproducible likely non-IgE mediated reactions (reproducible with subsequent vaccinations of approximately same severity) like fever (101-104-degree), body aches, upper and lower respiratory tract congestion and cough persisting for several weeks. The patient did not decline yearly vaccinations as she worked as a registered nurse in a hospital. At the time of this report, the outcome of the events was not reported. The reporter assessed this case as non-serious. This case was linked to the case (201803106) reported by the same reporter. Update 29-Aug-2018: Significant case correction was performed with IRD 02-Aug-2018: Current conditions -allergic rhinitis and sulfa drug allergy were added in patient tab. The narrative was amended accordingly.
Age: 10.0
Sex: M
Vaccine: FLUX, HEP, HPV9, MMR, FLUX, HEP, HPV9, MMR
Symptoms: Lymphadenopathy, Oropharyngeal pain, Pharyngeal oedema, Pyrexia, Ultrasound scan abnormal
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 02-Aug-2018 by Seqirus from VAERS (VAERS ID: 749397), concerning a 10-year-old male child patient. The patient did not have any relevant medical history, current illness and allergies. The patient did not receive any concomitant medications. On 07-May-2018, the patient was administered influenza vaccine, (route of administration: intramuscular, dose and anatomical location: unknown, batch number, expiry date, trade name, manufacturer: not reported). On the same day, the patient also received non-company suspect vaccines Hepatitis B (route of administration: intramuscular, dose and anatomical location: unknown, batch number, expiry date: not reported), GARDASIL 9 (route of administration: intramuscular, dose and anatomical location: unknown, batch number, expiry date: not reported) and MMR II (route of administration: intramuscular, dose and anatomical location: unknown, batch number, expiry date: not reported). On 16-May-2018, 9 days after vaccination, the patient experienced pain on the throat. The patient's throat had swollen which was painful to touch. On 17-May-2018 (the next day of vaccination), at 3 AM, the patient experienced more pain and swelling with high fever. The reporter took him to the emergency room in the hospital. On an unknown date, Ultrasound Sonography was done which detected 3 swollen lymph nodes on his throat (abnormal sonogram). The patient received unspecified antibiotics for the events. At the time of the report, the patient had not recovered from the events. The reporter assessed the case as non-serious. Update 26-Aug-2018: Significant case correction was performed with IRD 02-Aug-2018: The company causality for all the events was changed from 'related' to 'not related' and the case comment amended accordingly. The Co-suspects information was mentioned clearly in the case comment.
Age: 10.0
Sex: M
Vaccine: FLUX, HEP, HPV9, MMR, FLUX, HEP, HPV9, MMR
Symptoms: Lymphadenopathy, Oropharyngeal pain, Pain, Pharyngeal oedema, Pyrexia
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 02-Aug-2018 by Seqirus from VAERS (VAERS ID: 749397), concerning a 10-year-old male child patient. The patient did not have any relevant medical history, current illness and allergies. The patient did not receive any concomitant medications. On 07-May-2018, the patient was administered influenza vaccine, (route of administration: intramuscular, dose and anatomical location: unknown, batch number, expiry date, trade name, manufacturer: not reported). On the same day, the patient also received non-company suspect vaccines Hepatitis B (route of administration: intramuscular, dose and anatomical location: unknown, batch number, expiry date: not reported), GARDASIL 9 (route of administration: intramuscular, dose and anatomical location: unknown, batch number, expiry date: not reported) and MMR II (route of administration: intramuscular, dose and anatomical location: unknown, batch number, expiry date: not reported). On 16-May-2018, 9 days after vaccination, the patient experienced pain on the throat. The patient's throat had swollen which was painful to touch. On 17-May-2018 (the next day of vaccination), at 3 AM, the patient experienced more pain and swelling with high fever. The reporter took him to the emergency room in the hospital. On an unknown date, Ultrasound Sonography was done which detected 3 swollen lymph nodes on his throat (abnormal sonogram). The patient received unspecified antibiotics for the events. At the time of the report, the patient had not recovered from the events. The reporter assessed the case as non-serious. Update 26-Aug-2018: Significant case correction was performed with IRD 02-Aug-2018: The company causality for all the events was changed from 'related' to 'not related' and the case comment amended accordingly. The Co-suspects information was mentioned clearly in the case comment.
Age: 10.0
Sex: M
Vaccine: FLUX, HEP, HPV9, MMR, FLUX, HEP, HPV9, MMR
Symptoms: Swelling, Tenderness, Ultrasound scan abnormal
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 02-Aug-2018 by Seqirus from VAERS (VAERS ID: 749397), concerning a 10-year-old male child patient. The patient did not have any relevant medical history, current illness and allergies. The patient did not receive any concomitant medications. On 07-May-2018, the patient was administered influenza vaccine, (route of administration: intramuscular, dose and anatomical location: unknown, batch number, expiry date, trade name, manufacturer: not reported). On the same day, the patient also received non-company suspect vaccines Hepatitis B (route of administration: intramuscular, dose and anatomical location: unknown, batch number, expiry date: not reported), GARDASIL 9 (route of administration: intramuscular, dose and anatomical location: unknown, batch number, expiry date: not reported) and MMR II (route of administration: intramuscular, dose and anatomical location: unknown, batch number, expiry date: not reported). On 16-May-2018, 9 days after vaccination, the patient experienced pain on the throat. The patient's throat had swollen which was painful to touch. On 17-May-2018 (the next day of vaccination), at 3 AM, the patient experienced more pain and swelling with high fever. The reporter took him to the emergency room in the hospital. On an unknown date, Ultrasound Sonography was done which detected 3 swollen lymph nodes on his throat (abnormal sonogram). The patient received unspecified antibiotics for the events. At the time of the report, the patient had not recovered from the events. The reporter assessed the case as non-serious. Update 26-Aug-2018: Significant case correction was performed with IRD 02-Aug-2018: The company causality for all the events was changed from 'related' to 'not related' and the case comment amended accordingly. The Co-suspects information was mentioned clearly in the case comment.
Age: 79.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Injected limb mobility decreased, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: This spontaneous case, reported by the pharmacist to VAERS and initially retrieved on 03-Sep-2018 by Seqirus from VAERS (VAERS ID: 750318), concerns a 79-year-old, elderly female patient. The patient had an unspecified surgery in the past (reported as a long time ago). The patient's concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 13-Oct-2017, the patient was administered influenza vaccine [frequency reported as unknown, route of administration: injection (reported as SYR), anatomical site: left arm, dose, batch number and expiry date: not reported]. On the same day, the patient received non-company suspect vaccine PNEUMOVAX 23 (frequency reported as unknown, route of administration: intramuscular, anatomical site: right upper arm (deltoid), batch number: N012127, expiry date: 20-Jan-2019, dose: not reported). On an unspecified date in Oct-2017, the patient experienced extreme pain in the arm and was unable to lift the arm or get dressed. The patient wanted to go to emergency room but did not. It took 7 days to recover from the event injection site mobility decreased (reported as to function) and 7 to 10 days for the pain to resolve. The reporter assessed the case as non-serious. This case was cross-linked with the cases 201803696 and 201803697 due to same reporter.
Age: 66.0
Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Injected limb mobility decreased, Insomnia, Loss of personal independence in daily activities, Pain
Clinical narrative: This spontaneous case, reported by a pharmacist to VAERS and initially retrieved on 03-Sep-2018 by Seqirus from VAERS (VAERS ID: 750319), concerns a 66-year-old, elderly male patient. This is one of the 4 cases received from the same reporter. The patient's concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 17-Oct-2017, the patient was administered influenza vaccine (anatomical location: left arm, route of administration: unknown, dose, batch number, trade name, manufacturer and expiry date: not reported). On the same day, the patient also received a non-company suspect vaccine PNEUMOVAX 23 (route of administration: intramuscular, anatomical site: right upper arm, batch number N012127, expiry date: 20-Jan-2019, dose and frequency: not reported). On an unspecified date in Oct-2017 after vaccination, the patient experienced excruciating pain in the arm and at the site of injection. It was reported that, the patient could not shake hand, put clothes on or get dressed and was not able to sleep. On an unspecified date, the patient made an emergency visit. The patient was treated with ice and TYLENOL for the event injected limb mobility decreased. The patient took 7 days to be able to function and 10 days for the pain to go away. At the time of this report, the outcome of the event insomnia was unknown and other events had recovered. The reporter assessed the case as non-serious. This case (201803696) was cross-linked with the cases 201803695 and 201803697 due to same reporter. Update received on 11-Oct-2018: Non-significant case correction (IRD: 03-Sep-2018): The field treatment received for the event injection site pain was corrected from 'unknown' to 'yes'. The sentence in case comment was corrected from 'as unassessable due to lack of information regarding onset latency' to 'as unassessable due to lack of information regarding anatomical specification of the events'. No changes were made in the narrative.
Age: 66.0
Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: This spontaneous case, reported by a pharmacist to VAERS and initially retrieved on 03-Sep-2018 by Seqirus from VAERS (VAERS ID: 750319), concerns a 66-year-old, elderly male patient. This is one of the 4 cases received from the same reporter. The patient's concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 17-Oct-2017, the patient was administered influenza vaccine (anatomical location: left arm, route of administration: unknown, dose, batch number, trade name, manufacturer and expiry date: not reported). On the same day, the patient also received a non-company suspect vaccine PNEUMOVAX 23 (route of administration: intramuscular, anatomical site: right upper arm, batch number N012127, expiry date: 20-Jan-2019, dose and frequency: not reported). On an unspecified date in Oct-2017 after vaccination, the patient experienced excruciating pain in the arm and at the site of injection. It was reported that, the patient could not shake hand, put clothes on or get dressed and was not able to sleep. On an unspecified date, the patient made an emergency visit. The patient was treated with ice and TYLENOL for the event injected limb mobility decreased. The patient took 7 days to be able to function and 10 days for the pain to go away. At the time of this report, the outcome of the event insomnia was unknown and other events had recovered. The reporter assessed the case as non-serious. This case (201803696) was cross-linked with the cases 201803695 and 201803697 due to same reporter. Update received on 11-Oct-2018: Non-significant case correction (IRD: 03-Sep-2018): The field treatment received for the event injection site pain was corrected from 'unknown' to 'yes'. The sentence in case comment was corrected from 'as unassessable due to lack of information regarding onset latency' to 'as unassessable due to lack of information regarding anatomical specification of the events'. No changes were made in the narrative.
Age: 25.0
Sex: F
Vaccine: FLUX, TTOX, FLUX, TTOX
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 03-Sep-2018 by Seqirus from VAERS (VAERS ID: 751358), concerns a 25-year-old, adult female patient. The patient's current condition included depression and anxiety (reported as medical history). The patient was allergic to penicillin. The concomitant medications included DEPO PROVERA, Fluoxetine, calcium and multivitamins daily for unknown indications. On 01-Feb-2018, the patient was administered influenza vaccine, [frequency reported as 1, route of administration: injection (reported as SYR), anatomical site: right arm, dose, batch number, trade name, manufacturer and expiry date: not reported]. On the same day, the patient also received a non-company suspect vaccine Tetanus toxoid [frequency reported as 1, route of administration: injection (reported as SYR), anatomical site: left arm, dose, batch number, expiry date: not reported]. On the same day, after vaccination, the patient developed extreme pain in both arms for 1 to 2 weeks. The patient experienced pain in right shoulder which lasted up to 01-Jun-2018 (4 months after vaccination). At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 1.0
Sex: M
Vaccine: PNC13, VARCEL, PNC, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: This spontaneous report was received from a registered nurse, via a company representative, concerning 2 patients of unknown ages and genders. No information was provided regarding the patient's medical history, concurrent conditions and concomitant medications. On unknown dates, 2 patients received a vaccination with VARIVAX from the same lot #N031003 (expiration date 11-MAR-2019) for prophylaxis (strength, dose, frequency and route of administration were not reported). On an unknown dates, both patients after getting the vaccination with VARIVAX developed the same adverse reaction which was "cellulitis." The outcome of cellulitis was unknown. At the time of the report the causality assessment between cellulitis and VARIVAX was not reported. Upon internal review the event cellulitis was considered to be medically significant. Follow up information has been received on 26-DEC-2018 from the registered nurse concerning one of the patients. On 21-MAY-2018, the 12-month-old male patient was vaccinated with the first dose of VARIVAX subcutaneously in the left thigh. On the same day, he was also vaccinated with the fourth dose of PREVNAR, lot# 794427, intramuscularly in the right thigh  (dose and an expiration date were nor reported) for prophylaxis. On 02-JUN-2018, the patient experienced increased redness and swelling in the left thigh, visited physician's office and was diagnosed with cellulitis at injection site. The patient received the treatment with cepalexin 250 mg/5ml, twice a day (bid) for 10 days. The patient recovered on an unknown date in 2018. This is one of the three reports from the same reporter.; Sender's Comments:  US-009507513-1812USA011677: US-009507513-1812USA011790:
Age: 1.0
Sex: M
Vaccine: PNC13, VARCEL, PNC, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a registered nurse, via a company representative, concerning 2 patients of unknown ages and genders. No information was provided regarding the patient's medical history, concurrent conditions and concomitant medications. On unknown dates, 2 patients received a vaccination with VARIVAX from the same lot #N031003 (expiration date 11-MAR-2019) for prophylaxis (strength, dose, frequency and route of administration were not reported). On an unknown dates, both patients after getting the vaccination with VARIVAX developed the same adverse reaction which was "cellulitis." The outcome of cellulitis was unknown. At the time of the report the causality assessment between cellulitis and VARIVAX was not reported. Upon internal review the event cellulitis was considered to be medically significant. Follow up information has been received on 26-DEC-2018 from the registered nurse concerning one of the patients. On 21-MAY-2018, the 12-month-old male patient was vaccinated with the first dose of VARIVAX subcutaneously in the left thigh. On the same day, he was also vaccinated with the fourth dose of PREVNAR, lot# 794427, intramuscularly in the right thigh  (dose and an expiration date were nor reported) for prophylaxis. On 02-JUN-2018, the patient experienced increased redness and swelling in the left thigh, visited physician's office and was diagnosed with cellulitis at injection site. The patient received the treatment with cepalexin 250 mg/5ml, twice a day (bid) for 10 days. The patient recovered on an unknown date in 2018. This is one of the three reports from the same reporter.; Sender's Comments:  US-009507513-1812USA011677: US-009507513-1812USA011790:
Sex: F
Vaccine: FLU4, VARZOS, FLUX, VARZOS
Symptoms: Chills, Malaise, Pain
Clinical narrative: This is spontaneous case, reported by other non-health professional (consumer via call center representative) to VAERS and initially retrieved on 03-Sep-2018 by Seqirus from VAERS (VAERS ID: 753900), concerns an adult, female patient (age reported as 57 or 58-year-old). On an unspecified date, the patient received influenza vaccine, (dose: unknown, route of administration: unknown, anatomical location: unknown, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, the patient also received first dose of non-company suspect ZOSTAVAX (frequency: reported as 1, dose, route of administration: unknown, anatomical location: unknown, batch number, expiry date: not reported). On an unspecified date, less than a year after receiving non-company suspect SHINGRIX, the patient felt unwell, shivering and general body pain. At the time of this report, the patient had recovered from all the events. It was unknown if the reporter considered the events to be related to ZOSTAVAX. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Dyspnoea, Hypertension, Panic disorder, Swelling face, Tachycardia
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 03-Sep-2018 by Seqirus from VAERS (VAERS ID: 756960), concerns an adult female patient of unspecified age. The patient was allergic to rubber/latex. On an unspecified date, the patient was administered influenza vaccine (dose: unknown, anatomical location: unknown, route of administration, batch number, trade name, and manufacturer: not reported). Following the vaccine administration, the patient developed non-serious hives, hypertension, tachycardia (reported as tachy), panic reaction (reported as panicy), shortness of breath and swollen face. The patient was treated with SOLUMEDROL. No lab tests were performed. It was reported that the patient visited emergency room. At the time of this report, the outcome of the events was unknown. The reporter assessed this case as non-serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Urticaria
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 03-Sep-2018 by Seqirus from VAERS (VAERS ID: 756960), concerns an adult female patient of unspecified age. The patient was allergic to rubber/latex. On an unspecified date, the patient was administered influenza vaccine (dose: unknown, anatomical location: unknown, route of administration, batch number, trade name, and manufacturer: not reported). Following the vaccine administration, the patient developed non-serious hives, hypertension, tachycardia (reported as tachy), panic reaction (reported as panicy), shortness of breath and swollen face. The patient was treated with SOLUMEDROL. No lab tests were performed. It was reported that the patient visited emergency room. At the time of this report, the outcome of the events was unknown. The reporter assessed this case as non-serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Dyspnoea, Hypertension, Panic reaction, Swelling face, Tachycardia
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 03-Sep-2018 by Seqirus from VAERS (VAERS ID: 756960), concerns an adult female patient of unspecified age. The patient was allergic to rubber/latex. On an unspecified date, the patient was administered influenza vaccine (dose: unknown, anatomical location: unknown, route of administration, batch number, trade name, and manufacturer: not reported). Following the vaccine administration, the patient developed non-serious hives, hypertension, tachycardia (reported as tachy), panic reaction (reported as panicy), shortness of breath and swollen face. The patient was treated with SOLUMEDROL. No lab tests were performed. It was reported that the patient visited emergency room. At the time of this report, the outcome of the events was unknown. The reporter assessed this case as non-serious.
Age: 52.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Anxiety, Bronchial hyperreactivity, Depression, Dyspnoea, Gastrooesophageal reflux disease
Clinical narrative: This spontaneous case, reported by physician to VAERS and initially retrieved on 30-Oct-2018 by Seqirus from VAERS (VAERS ID: 758920) concerns 55-year-old, adult female patient. The patient's current conditions included reactive airway disorder, hyperlipidemia, insomnia, gastroesophageal reflux disease (GERD), anxiety, wheezing and allergic reaction. The patient was allergic to Macrodantin, KEFLEX, ANCEF, Farxiga (reported as critical), Indocin (severe), Orthovisc and sulfa drugs (moderate). The concomitant medications included PROAIR and Albuterol for reactive airway disorder, ZETIA for hyperlipidemia, AMBIEN for insomnia, ranitidine for GERD, alprazolam for anxiety, ATROVENT for wheezing, epinephrine for allergic reaction, venlafaxine hydrochloride, spironolactone, WELLBUTRIN, metformin and NEURONTIN for unknown indication and cool blood glucose tests strips in vitro strip. On 20-Nov-2014, the patient was administered INN Flu vaccin3 (dose: unknown, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported). On 16-Mar-2018, the patient started treatment with FARXIGA 5 mg daily, oral, for type 2 diabetes. On the same day, the patient experienced severe shortness of breath. On an unknown date, the patient experienced tendency to have reactions to medications, reactive airway disease, anxiety, depression, post-traumatic stress disorder (PTSD) and GERD. On 20-Mar-2018, treatment with FARXIGA was discontinued. On an unspecified date, the patient had recovered from the event of severe shortness of breath. The outcome of other events reactive airway disease, anxiety, depression, PTSD and GERD was unknown. The reporter assessed the case as non-serious. The reporter considered the event shortness of breath as related to the treatment drug FARXIGA.
Age: 52.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Hypersensitivity, Insomnia, Post-traumatic stress disorder, Type 2 diabetes mellitus, Wheezing
Clinical narrative: This spontaneous case, reported by physician to VAERS and initially retrieved on 30-Oct-2018 by Seqirus from VAERS (VAERS ID: 758920) concerns 55-year-old, adult female patient. The patient's current conditions included reactive airway disorder, hyperlipidemia, insomnia, gastroesophageal reflux disease (GERD), anxiety, wheezing and allergic reaction. The patient was allergic to Macrodantin, KEFLEX, ANCEF, Farxiga (reported as critical), Indocin (severe), Orthovisc and sulfa drugs (moderate). The concomitant medications included PROAIR and Albuterol for reactive airway disorder, ZETIA for hyperlipidemia, AMBIEN for insomnia, ranitidine for GERD, alprazolam for anxiety, ATROVENT for wheezing, epinephrine for allergic reaction, venlafaxine hydrochloride, spironolactone, WELLBUTRIN, metformin and NEURONTIN for unknown indication and cool blood glucose tests strips in vitro strip. On 20-Nov-2014, the patient was administered INN Flu vaccin3 (dose: unknown, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported). On 16-Mar-2018, the patient started treatment with FARXIGA 5 mg daily, oral, for type 2 diabetes. On the same day, the patient experienced severe shortness of breath. On an unknown date, the patient experienced tendency to have reactions to medications, reactive airway disease, anxiety, depression, post-traumatic stress disorder (PTSD) and GERD. On 20-Mar-2018, treatment with FARXIGA was discontinued. On an unspecified date, the patient had recovered from the event of severe shortness of breath. The outcome of other events reactive airway disease, anxiety, depression, PTSD and GERD was unknown. The reporter assessed the case as non-serious. The reporter considered the event shortness of breath as related to the treatment drug FARXIGA.
Age: 52.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Post-traumatic stress disorder, Type 2 diabetes mellitus
Clinical narrative: This spontaneous case, reported by physician to VAERS and initially retrieved on 30-Oct-2018 by Seqirus from VAERS (VAERS ID: 758920) concerns 55-year-old, adult female patient. The patient's current conditions included reactive airway disorder, hyperlipidemia, insomnia, gastroesophageal reflux disease (GERD), anxiety, wheezing and allergic reaction. The patient was allergic to Macrodantin, KEFLEX, ANCEF, Farxiga (reported as critical), Indocin (severe), Orthovisc and sulfa drugs (moderate). The concomitant medications included PROAIR and Albuterol for reactive airway disorder, ZETIA for hyperlipidemia, AMBIEN for insomnia, ranitidine for GERD, alprazolam for anxiety, ATROVENT for wheezing, epinephrine for allergic reaction, venlafaxine hydrochloride, spironolactone, WELLBUTRIN, metformin and NEURONTIN for unknown indication and cool blood glucose tests strips in vitro strip. On 20-Nov-2014, the patient was administered INN Flu vaccin3 (dose: unknown, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported). On 16-Mar-2018, the patient started treatment with FARXIGA 5 mg daily, oral, for type 2 diabetes. On the same day, the patient experienced severe shortness of breath. On an unknown date, the patient experienced tendency to have reactions to medications, reactive airway disease, anxiety, depression, post-traumatic stress disorder (PTSD) and GERD. On 20-Mar-2018, treatment with FARXIGA was discontinued. On an unspecified date, the patient had recovered from the event of severe shortness of breath. The outcome of other events reactive airway disease, anxiety, depression, PTSD and GERD was unknown. The reporter assessed the case as non-serious. The reporter considered the event shortness of breath as related to the treatment drug FARXIGA.
Age: 47.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Dizziness, Vertigo, Viral infection
Clinical narrative: This is a spontaneous case reported by other health professional to VAERS and initially retrieved on 30-Oct-2018 by Seqirus from VAERS (VAERS ID: 758980), concerns a 47-year-old, adult, female patient. The patient's historical conditions included venous insufficiency, lymphedema, lipedema, depression and anxiety. Current conditions included stomach reflux and irritable bowel syndrome. The patient had no allergies. Concomitant medications included Vitamin D, Omeprazole, CARAFATE, Ibuprofen, TYLENOL and Cyclobenzaprine for unknown indications. On 20-Oct-2017, the patient was administered influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported). On 22-Oct-2017, two days after vaccination, the patient experienced dizziness and vertigo. it was reported that, the two neurologist, three doctors and ENT doctor, they all felt that it was a virus. It was reported that, in Feb-2018, the patient started seeing different doctor from another location. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Musculoskeletal discomfort
Clinical narrative: This is a spontaneous case by other non-health professional to VAERS and initially retrieved on 30-Oct-2018 by Seqirus from VAERS (VAERS ID: 760533), concerns a female patient of an unspecified age. On an unspecified date, the patient was administered influenza vaccine, (dose, route of administration: unknown, anatomical location, batch number, expiry date, trade name and manufacturer: not reported). On an unspecified date, the patient experienced discomfort in her shoulder. It was not reported if the patient received a corrective treatment. At the time of this report, the outcome of the event was unknown. The reporter assessed this case as non-serious.
Age: 67.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Nuclear magnetic resonance imaging, Pain
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 30-Oct-2018 by Seqirus from VAERS (VAERS ID: 760635), concerns a 67-year-old, elderly male patient. The patient did not have any current illness. On 05-Sep-2017, the patient was administered influenza vaccine, [frequency reported as unknown, dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported]. On the same day, after vaccination, the patient experienced a lot of pain. On an unspecified date, the patient made an office visit and underwent nuclear magnetic resonance imaging (MRI) and X-ray for which results were not reported. It was reported that, the patient took an unspecified pain killer pill. At the time of this report, the patient had not recovered from the event (reported as still ongoing). The reporter assessed this case as non-serious.
Age: 67.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Nuclear magnetic resonance imaging, Pain, X-ray
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 30-Oct-2018 by Seqirus from VAERS (VAERS ID: 760635), concerns a 67-year-old, elderly male patient. The patient did not have any current illness. On 05-Sep-2017, the patient was administered influenza vaccine, [frequency reported as unknown, dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported]. On the same day, after vaccination, the patient experienced a lot of pain. On an unspecified date, the patient made an office visit and underwent nuclear magnetic resonance imaging (MRI) and X-ray for which results were not reported. It was reported that, the patient took an unspecified pain killer pill. At the time of this report, the patient had not recovered from the event (reported as still ongoing). The reporter assessed this case as non-serious.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous case, reported by other non-health professional (consumer) to VAERS and initially retrieved on 30-Oct-2018 by Seqirus from VAERS (VAERS ID: 762812), concerns an adult male patient of an unspecified age. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal [frequency reported as unknown, route of administration and anatomical location: unknown , dose, batch number, expiry date, trade name and manufacturer: not reported]. The co-suspect product included VENTOLLIN HFA inhaler for chronic obstructive pulmonary disease. On an unspecified date, after receiving vaccine and VENTOLIN HFA, the patient experienced an allergic reaction. On 06-Jul-2018, the patient went to the hospital and made an office visit due to allergic reaction. The patient stated that he was taking the VENTOLIN HFA at the time of the reaction. At the time of this report, the outcome of the event was unknown. The reporter assessed this case as non-serous and considered the causality of the event as related to the suspected vaccine.
Age: 71.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case, reported by other non-health professional (consumer) to VAERS and initially retrieved on 30-Oct-2018 by Seqirus from VAERS (VAERS ID: 762822), concerns a 71-year-old, elderly female patient. On an unspecified date in the past, the patient had received a flu vaccine for an unknown indication and experienced soreness in the arm for few days. On an unspecified date in Oct-2017, the patient was administered influenza vaccine, [frequency reported as unknown, anatomical location: left arm, route of administration: unknown, dose, batch number, expiry date, trade name and manufacturer: not reported]. On an unspecified date (reported as less than a year), after vaccination, the patient experienced pain in arm. At the time of this report, the outcome of the event was unknown. The reporter assessed this case as non-serious.
Age: 73.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Urticaria
Clinical narrative: This spontaneous case, reported by other health professional (nurse) to VAERS and initially retrieved on 30-Oct-2018 by Seqirus from VAERS (VAERS ID: 763800), concerns a 73-year-old, elderly female patient. The patient did not have an allergy to bird products. On an unspecified date (reported as four years ago), the patient was administered influenza vaccine (frequency reported as unknown, route of administration: reported as other (OT) and anatomical location: unknown, dose, batch number, expiry date, trade name and manufacturer: not reported). On an unspecified date after vaccination, the patient experienced hives all over the body. It was not reported if the patient received a corrective treatment. At the time of this report, the outcome of the event was unknown. The reporter assessed this case as non-serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, Vaccine positive rechallenge
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 30-Oct-2018 by Seqirus from VAERS (VAERS ID: 764082), concerns an adult female patient of unspecified age (age at vaccination was not reported). It was reported that the patient received influenza vaccine every year for the past nine years (as reported) with an associated reaction of injection site pain (but resolved after a couple of days, as reported). On an unspecified date, the patient was administered influenza vaccine, [route of administration: injection (reported as SYR), dose, anatomical location, batch number, frequency, expiry date, trade name, manufacturer: not reported]. On an unspecified date, less than a year (as reported) after the vaccination, the patient received experienced injection site pain. It was reported that the rechallenge with influenza vaccine was positive. On an unspecified date, the outcome of the event was recovered. The reporter assessed this case as non-serious.
Age: 55.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site pain
Clinical narrative: This spontaneous case, reported by other non-health professional via call center representative to VAERS and initially retrieved on 30-Oct-2018 by Seqirus from VAERS (VAERS ID: 765315), concerns a 55-year-old, adult female patient. The patient's medical history included pneumonia, for which she was hospitalized for 12 days. The patient's current conditions included chronic obstructive pulmonary disease and emphysema. On an unknown date, the patient was administered first dose of influenza vaccine (route of administration: unknown, dose, anatomical location, batch number, expiry date, trade name and manufacturer: not reported). On an unknown date after vaccination, the patient experienced injection site pain. At the time of this report, the outcome of the event injection site pain was unknown. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Adenovirus test, Bordetella test negative, Cough, Dyspnoea, Exposure during pregnancy
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 30-Oct-2018 by Seqirus from VAERS (VAERS ID: 765665), concerns an adult, female pregnant patient of unspecified age (equal or more than 18 years as reported). It was reported that the patient was the part of study which aims the study of acute respiratory illness due to respiratory viruses and associated clinical outcomes during pregnancy. The patient was enrolled Patients were enrolled at an outpatient obstetric (for routine and high-risk obstetric care) and gynaecologic clinic, between 1 October and 10 May to coincide with the 2015-2016 respiratory virus season. The patient's family history, medical history and the concomitant medications were not reported. On an unspecified date, the patient was administered influenza vaccine [dose, route of administration and anatomical location: unknown, batch number, expiry date, manufacturer and trade name: not reported]. It was unknown whether the vaccination was given during pregnancy or not (as reported). On an unspecified date (between 01-Oct-2015 to 10-May-2016, 2015-2016, 7-month season of respiratory virus season) after vaccination, in her second or third trimester period, during the regular prenatal and sick visits at an outpatient center and gynaecologic clinic the patient reported symptoms of acute respiratory infection which included rhinorrhea, sore throat, cough, shortness of breath, wheezing. On an unspecified date (less than or equal to 7 days of symptom onset) the visited the clinic and diagnosed with acute lower respiratory tract illness (ALRTI). The patient's nasopharyngeal secretions were collected by a combined throat and nasal swab and evaluated for respiratory viruses by real-time reverse transcription-polymerase chain reaction (RT-PCR). The respiratory syncytial virus (RSV) A and B tests, human rhinovirus (HRV) virus tests, influenza virus types A and B tests; human coronaviruses (HCoVs) NL-63, HKU1, OC43, and 229E tests, parainfluenza virus (PIV) types 1, 2, and 3 tests, human metapneumovirus (HMPV) tests, adenovirus, bocavirus, mycoplasma pneumoniae and Bordetella pertussis virus tests were performed. The virus tests, RSV tests and Bordetella pertussis tests showed negative. Influenza virus test and polymerase chain reaction was found to be positive. The normal laboratory results were not reported. On an unspecified date, the patient was diagnosed with unspecified type of influenza (considered as vaccination failure). The patient's treatment was unknown. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Human metapneumovirus test, Human rhinovirus test, Influenza, Influenza A virus test, Influenza B virus test
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 30-Oct-2018 by Seqirus from VAERS (VAERS ID: 765665), concerns an adult, female pregnant patient of unspecified age (equal or more than 18 years as reported). It was reported that the patient was the part of study which aims the study of acute respiratory illness due to respiratory viruses and associated clinical outcomes during pregnancy. The patient was enrolled Patients were enrolled at an outpatient obstetric (for routine and high-risk obstetric care) and gynaecologic clinic, between 1 October and 10 May to coincide with the 2015-2016 respiratory virus season. The patient's family history, medical history and the concomitant medications were not reported. On an unspecified date, the patient was administered influenza vaccine [dose, route of administration and anatomical location: unknown, batch number, expiry date, manufacturer and trade name: not reported]. It was unknown whether the vaccination was given during pregnancy or not (as reported). On an unspecified date (between 01-Oct-2015 to 10-May-2016, 2015-2016, 7-month season of respiratory virus season) after vaccination, in her second or third trimester period, during the regular prenatal and sick visits at an outpatient center and gynaecologic clinic the patient reported symptoms of acute respiratory infection which included rhinorrhea, sore throat, cough, shortness of breath, wheezing. On an unspecified date (less than or equal to 7 days of symptom onset) the visited the clinic and diagnosed with acute lower respiratory tract illness (ALRTI). The patient's nasopharyngeal secretions were collected by a combined throat and nasal swab and evaluated for respiratory viruses by real-time reverse transcription-polymerase chain reaction (RT-PCR). The respiratory syncytial virus (RSV) A and B tests, human rhinovirus (HRV) virus tests, influenza virus types A and B tests; human coronaviruses (HCoVs) NL-63, HKU1, OC43, and 229E tests, parainfluenza virus (PIV) types 1, 2, and 3 tests, human metapneumovirus (HMPV) tests, adenovirus, bocavirus, mycoplasma pneumoniae and Bordetella pertussis virus tests were performed. The virus tests, RSV tests and Bordetella pertussis tests showed negative. Influenza virus test and polymerase chain reaction was found to be positive. The normal laboratory results were not reported. On an unspecified date, the patient was diagnosed with unspecified type of influenza (considered as vaccination failure). The patient's treatment was unknown. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Influenza virus test positive, Lower respiratory tract infection, Mycoplasma test negative, Oropharyngeal pain, Polymerase chain reaction positive
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 30-Oct-2018 by Seqirus from VAERS (VAERS ID: 765665), concerns an adult, female pregnant patient of unspecified age (equal or more than 18 years as reported). It was reported that the patient was the part of study which aims the study of acute respiratory illness due to respiratory viruses and associated clinical outcomes during pregnancy. The patient was enrolled Patients were enrolled at an outpatient obstetric (for routine and high-risk obstetric care) and gynaecologic clinic, between 1 October and 10 May to coincide with the 2015-2016 respiratory virus season. The patient's family history, medical history and the concomitant medications were not reported. On an unspecified date, the patient was administered influenza vaccine [dose, route of administration and anatomical location: unknown, batch number, expiry date, manufacturer and trade name: not reported]. It was unknown whether the vaccination was given during pregnancy or not (as reported). On an unspecified date (between 01-Oct-2015 to 10-May-2016, 2015-2016, 7-month season of respiratory virus season) after vaccination, in her second or third trimester period, during the regular prenatal and sick visits at an outpatient center and gynaecologic clinic the patient reported symptoms of acute respiratory infection which included rhinorrhea, sore throat, cough, shortness of breath, wheezing. On an unspecified date (less than or equal to 7 days of symptom onset) the visited the clinic and diagnosed with acute lower respiratory tract illness (ALRTI). The patient's nasopharyngeal secretions were collected by a combined throat and nasal swab and evaluated for respiratory viruses by real-time reverse transcription-polymerase chain reaction (RT-PCR). The respiratory syncytial virus (RSV) A and B tests, human rhinovirus (HRV) virus tests, influenza virus types A and B tests; human coronaviruses (HCoVs) NL-63, HKU1, OC43, and 229E tests, parainfluenza virus (PIV) types 1, 2, and 3 tests, human metapneumovirus (HMPV) tests, adenovirus, bocavirus, mycoplasma pneumoniae and Bordetella pertussis virus tests were performed. The virus tests, RSV tests and Bordetella pertussis tests showed negative. Influenza virus test and polymerase chain reaction was found to be positive. The normal laboratory results were not reported. On an unspecified date, the patient was diagnosed with unspecified type of influenza (considered as vaccination failure). The patient's treatment was unknown. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious.