chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Musculoskeletal pain, Neck pain, Rotator cuff syndrome, Tendon disorder, X-ray normal
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by other non-health professional (consumer) via health authority (VAERS ID: 676390) and concerns a 71 Years old female patient. The patient's current condition included arthritis. The patient's concomitant medications included TYLNOL, Biotin, Calcium magnesium, Zinc, D3, Vitamins, Glucosamine Chondroitin, Lisinopril hydrochlorothiazide, L LYSINE, Ranitidine 300, Tumeric 500 and TYLENOL PM Extra strength. Administration of Company suspect drug: On 19-Dec-2016, the patient received influenza vaccine, dose, expiry date, route of administration: not reported, batch number: IIV3) at left arm. Adverse reactions/events and outcomes: On 19-Dec-2016 after administration of influenza vaccine, the patient's arm burned to the hand before bedtime. She could not move normally in the morning, and had to leave the bed by crawling on her knees on the floor and pulling her up. The pain moved to her right shoulder and neck. She experienced arthritis, tendons and rotator cuff all seemed to get off. On an unspecified date, X-ray was performed and showed arthritis with tendon and rotator cuff involvement. On an unspecified date, the patient had physical therapy and stated that she still needed PT (Physical therapy) and a shot of cortisone. Action taken with the vaccine was not reported. The outcome of the events was not recovered/not resolved. Reporter's Assessment: The reporter did not provide the causality of the events in relation to the INN Flu Vaccine Seasonal. This case was non-serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Immediate post-injection reaction, Mass, Mobility decreased, Pain
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by other non-health professional via regulatory authority (VAERS ID: 676399) and concerns a 64-years-old female patient. Concomitant medications included TOPAMAX, BUTRANS patch, Tizanidine, CELEXA, TYLENOL and Levothyroxine. Administration of Company suspect drug: On 14-Oct-2016, the patient was administered with INN Flu Vaccine Seasonal (dosage: unknown, route of administration: unknown). Adverse reactions/events and outcomes: On 14-Oct-2016, the patient experienced immediate pain/hurt so badly and large lump. On 03-Mar-2017, the patient still had great amount of pain and limited motion in left arm. The action taken with INN Flu Vaccine Seasonal was not reported. The outcome of the event was not reported. Reporter's Assessment: The reporter did not provide the causality between INN flu vaccine seasonal and event. This report was not serious.
Age: 68.0
Sex: F
Vaccine: FLUA3, PNC13, FLUA3, PNC13
Symptoms: Fibromyalgia, Myalgia
Clinical narrative: This spontaneous case, initially received via Vaccine Adverse Event Reaction Systems (VAERS ID: 676617) on Apr-2017 was reported by other non-healthcare professional and concerns a 68 years female patient. The patient's medical history included diabetes. Administration of Company suspect drug(s): On 14-Nov-2016, the patient received intramuscular FLUAD (TIV) (dose: not reported, batch number: 165Z03) via intramuscular route on left arm. Indication was not reported. Non-company suspect drug(s): On 14-Nov-2016, the patient received PREVNAR (dose: not reported, batch number N97935) on left arm via intramuscular route. Adverse reactions/events and outcomes: On 17-NOV-2016, after receiving FLUAD (TIV) the patient experienced severe muscle ache for which she consulted physician on 28-Nov-2016 and was prescribed with naproxen 500 mg. As there was no change in pain she again consulted physician on 15-Dec-2016 and was advised with alprazolam 0.5 mg. The event also led to emergency room visit. Patient contacted MD on 03-Jan-2017, MD notes showed that pain is from fibromyalgia and did not mentioned vaccination reactions. Action taken with FLUAD (TIV) was not reported. The event was not recovered. Reporter's Assessment: The reporter assessed event myalgia and fibromyalgia as not serious. The causality was not related. This case was non serious.
Age: 57.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Rash
Clinical narrative: This spontaneous case, initially received via Vaccine Adverse Event Reaction Systems (VAERS ID: 676664) on Apr-2017, was reported by other non-health professional and concerns a 57-years-old male patient. The patient's medical history included: kidney disease polycystic and concomitant medication included: labetalol, fluticasone, cholecalciferol. Administration of Company suspect drug: On 29-Sep-2016, the patient was administered with INN Flu Vaccine (dosage, route of administration: not reported, anatomical location: right arm). Adverse reactions/events and outcomes: The patient visited tanning booth for treatment and stated that same thing happened last time with flu shot in 2013. On 19-Dec-2016 after administration of INN Flu Vaccine, the patient experienced skin rash. It started on forearms backs of hands, back and buttocks. The action taken with INN Flu Vaccine Seasonal was not reported. The outcome of the event was not reported. Reporter's Assessment: The reporter did not provided the causality between INN Flu Vaccine and events. This report was not serious.
Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Fatigue
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by a Pharmacist via regulatory authority (VAERS ID: 676697) and concerns a Male patient under the age of 65 year. At the time of vaccination, the patient had Prophylaxis since an unspecified date. Administration of Company suspect drug: On an unknown date, patient was administered with INN Flu Vaccine (dosage, route of administration, anatomical location: unknown). Non-company suspect drug: On an unknown date, patient was administered with PNEUMOVAX 23 (dosage, route of administration, anatomical location: unknown). Adverse reactions/events and outcomes: On unspecified date and time after administration of INN Flu Vaccine, the patient experienced fatigue. Outcome of the event fatigue was not reported. Reporter's Assessment: The Pharmacist assessed the event as non-serious and the reporter considered the event was related to PNEUMOVAX 23, the causality for influenza virus vaccine was unknown. This report was not serious.
Sex: F
Vaccine: FLUX, PNC13, FLUX, PPV, FLUX, PNC13
Symptoms: Influenza, Pneumonia
Clinical narrative: This Spontaneous case initially received via Vaccine adverse event reaction systems (VAERS ID: 676758) on Apr-2017 was reported by other non-health professional and concerns a 72-years-old elderly female patient. Administration of Company suspect drug: On an unspecified date, the patient was administered by INN Flu Vaccine Seasonal (route of administration, anatomical location, dose, batch number, expiration date: not reported). Administration of Non-company suspect drugs: On an unspecified date, the patient was administered by PREVNAR 13 (route of administration, anatomical location, dose, batch number, expiration date: not reported) and XELJANZ (route of administration, anatomical location, dose, batch number, expiration date: not reported). Adverse events/reactions and outcomes: On unspecified date, after by INN Flu Vaccine Seasonal, the patient experienced ended up getting the flu as well as pneumonia. The action taken with INN Flu Vaccine Seasonal was not reported. The outcome of the events was not reported. Reporter's Assessment: The reporter did not provide the causality between INN Flu Vaccine Seasonal and events. This case report was non-serious.
Sex: F
Vaccine: FLUA3, PNC13, FLUA3, PNC13
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by other non-health professional via Vaccine Adverse Event Reporting System (VAERS ID: 676783) and concerns a 66 years old female patient. The patient's current condition included mild asthma. The patient received PREVNAR in 2015. Administration of Company  suspect drug: On 22-Dec-2016, the patient received FLUAD (TIV) (dose: 0.5ml, batch number: 165703) at left arm via intramuscular route. Non-company suspect drug: On 22-Dec-2016, the patient also received PREVNAR 13 (dose number: 1, dose, expiry date, batch number: R19477) at right arm via intramuscular route. Adverse reactions/events and outcomes: On 22-Dec-2016, the patient arrived at pharmacy to get pneumonia "Booster" and patient was given pneumococcal vaccine which was already received in 2015. Action taken with the vaccine was not reported. The outcome of the event was recovered/resolved. Reporter's Assessment: Health Authority assessed the event as non serious. The reporter did not assess the causality of the event.
Sex: F
Vaccine: FLUA3, PNC13, FLUA3, PNC13
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by other non-health professional via Vaccine Adverse Event Reporting System (VAERS ID: 676783) and concerns a 66 years old female patient. The patient's current condition included mild asthma. The patient received PREVNAR in 2015. Administration of Company  suspect drug: On 22-Dec-2016, the patient received FLUAD (TIV) (dose: 0.5ml, batch number: 165703) at left arm via intramuscular route. Non-company suspect drug: On 22-Dec-2016, the patient also received PREVNAR 13 (dose number: 1, dose, expiry date, batch number: R19477) at right arm via intramuscular route. Adverse reactions/events and outcomes: On 22-Dec-2016, the patient arrived at pharmacy to get pneumonia "Booster" and patient was given pneumococcal vaccine which was already received in 2015. Action taken with the vaccine was not reported. The outcome of the event was recovered/resolved. Reporter's Assessment: Health Authority assessed the event as non serious. The reporter did not assess the causality of the event.
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, was reported by other non-health professional via regulatory authority (VAERS ID: 676795) and concerns a 73 years old female patient. The patient's adverse events after previous vaccination are tooth pain at the age of 71 years after administration of Influenza (seasonal) vaccine. Administration of Company suspect drug: On 16-Nov-2016, patient was administered with FLUAD (TIV) (dosage: 1 DF, route of administration: intramuscular, anatomical location: left arm, batch no: 166002). Adverse reactions/events and outcomes: On 19-Nov-2016, the patient experienced upper arm and entire shoulder became painful. The reporter also mentioned the pain lasted approximately 10 days. Outcome of the events were recovered/resolved. Reporter's Assessment: The reporter assessed that the causality between FLUAD (TIV) and events as related.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Drug administered at inappropriate site, Pain
Clinical narrative: This Spontaneous case initially received via vaccine adverse event reaction systems (VAERS ID: 676824) on Apr-2017, was reported by other non-health professional and concerns a 37-years-old adult female patient. Administration of Company suspect drug: On 11-Nov-2016, the patient was administered with INN Flu Vaccine Seasonal (dosage, batch number: not reported, route of administration: intramuscular and anatomical location: left arm). Adverse events/reactions and outcomes: On 13-Nov-2016, the patient experienced severe pain in raising her arm above the head (pain an injected limb mobility decreased). She went to a doctor and reported that it is about 8 weeks, she had taken the flu shot and still have severe pain in her shoulder, it was reported that the injection was to be way too high after she got injected (drug administered at inappropriate site and never had a flu shot injected before. She was told to it will take time to heal but she was nervous considering 8 weeks passed. The action taken with INN Flu vaccine Seasonal was not reported. The outcome of the events was not recovered. Reporter's Assessment: The reporter did not provide the causality between INN Flu Vaccine Seasonal and events. This report was not serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Drug administered at inappropriate site, Musculoskeletal pain, Pain
Clinical narrative: This Spontaneous case initially received via vaccine adverse event reaction systems (VAERS ID: 676824) on Apr-2017, was reported by other non-health professional and concerns a 37-years-old adult female patient. Administration of Company suspect drug: On 11-Nov-2016, the patient was administered with INN Flu Vaccine Seasonal (dosage, batch number: not reported, route of administration: intramuscular and anatomical location: left arm). Adverse events/reactions and outcomes: On 13-Nov-2016, the patient experienced severe pain in raising her arm above the head (pain an injected limb mobility decreased). She went to a doctor and reported that it is about 8 weeks, she had taken the flu shot and still have severe pain in her shoulder, it was reported that the injection was to be way too high after she got injected (drug administered at inappropriate site and never had a flu shot injected before. She was told to it will take time to heal but she was nervous considering 8 weeks passed. The action taken with INN Flu vaccine Seasonal was not reported. The outcome of the events was not recovered. Reporter's Assessment: The reporter did not provide the causality between INN Flu Vaccine Seasonal and events. This report was not serious.
Age: 45.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, X-ray limb normal
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by an other-non health professional via regulatory authority (VAERS ID: 676870) and concerns a 45 years old female patient. At the time of vaccination patient had type II diabetes and had historical condition of fatty liver. Patient was allergic to prednisone and sulfa. Concomitant medications included BYDUREON, FORFIVI XL, glipizide, JANUVIA, levothyroxine, NORA-BE, pantoprazole and WELCHOL for an unknown indication. Administration of Company suspect drug: On 25-Oct-2016, patient was administered with INN Flu Vaccine (dosage, route of administration, anatomical location, batch no, expiry date: not reported). Adverse reactions/events and outcomes: On 25-Oct-2016, the patient experienced chronic worsening pain at injection site over two months after the injection. The reporter reported that the date of vaccination was approximate. Action taken with the influenza vaccine, influenza virus vaccine polyvalent was not reported. Outcome of the events were not recovered/not resolved. Lab data includes negative X ray of left shoulder. Reporter's Assessment: The other non-health care professional did not provide any causality assessment. This report is not serious.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Body temperature increased, Malaise, Pyrexia
Clinical narrative: This Spontaneous case, initially received via Vaccine adverse event reaction systems (VAERS ID: 676875) on Apr-2017 was reported by other non-health professional and concerns a 0.58 month (as reported in source document) male patient. The patient's current condition included runny nose and watery eyes. Administration of Company suspect drug: On 05-Jan-17, the patient was administered by INN Flu Vaccine Seasonal (route of administration, anatomical location, dose, batch number, expiration date: not reported). Adverse events/reactions and outcomes: On 05-Jan-17, after by INN Flu Vaccine Seasonal, the patient experienced fever and malaise. On an unknown date, the patient's body temperature was elevated. The patient was given TYLENOL. The action taken with INN Flu Vaccine Seasonal was not reported. Relevant Lab Test: The patient's lab test body temperature elevated, currently resting. Reporter's Assessment: The reporter did not provide the causality between INN Flu Vaccine Seasonal and events. This case report was non-serious.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Malaise, Pyrexia
Clinical narrative: This Spontaneous case, initially received via Vaccine adverse event reaction systems (VAERS ID: 676875) on Apr-2017 was reported by other non-health professional and concerns a 0.58 month (as reported in source document) male patient. The patient's current condition included runny nose and watery eyes. Administration of Company suspect drug: On 05-Jan-17, the patient was administered by INN Flu Vaccine Seasonal (route of administration, anatomical location, dose, batch number, expiration date: not reported). Adverse events/reactions and outcomes: On 05-Jan-17, after by INN Flu Vaccine Seasonal, the patient experienced fever and malaise. On an unknown date, the patient's body temperature was elevated. The patient was given TYLENOL. The action taken with INN Flu Vaccine Seasonal was not reported. Relevant Lab Test: The patient's lab test body temperature elevated, currently resting. Reporter's Assessment: The reporter did not provide the causality between INN Flu Vaccine Seasonal and events. This case report was non-serious.
Age: 52.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Asthenia, Headache, Inflammation, Injected limb mobility decreased, Injection site pain
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by other Non-health professional via regulatory authority (VAERS ID: 676924) and concerns a 52 years old female patient. Patient's concomitant medication included: Tramadol (dose: 50 mg), Vitamin D3 (dose: 25,000 IU). Administration of Company suspect drug: On 15-Nov-2016 patient was administered INN Flu Vaccine via injection NOS (dose: unknown, anatomical location: left arm). Adverse reactions/events and outcomes: On 15-Nov-2016 after administration of INN Flu Vaccine, the patient experienced soreness to left shoulder and surrounding area to include left scapula and bicep and unable to lift arm above shoulder. On 23-11-2016 the patient called the doctor, was directed to take Ibuprofen and return to quick care if symptoms persist. On 25-11-2016, the patient was unable to lift arm over head for more than a few seconds and experienced weakness, caused headache from surrounding inflammation. On 27-11-2016, patient returned to quick care and was prescribed 800 mg MOTRIN that alleviates the pain but pain returns when patient stops. Treatment medications included: Ibuprofen, MOTRIN. Outcome of the events was not recovered. Reporter's Assessment: The reporter assessed the events as non-serious and the causality was not provided. This report was not serious.
Age: 52.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Musculoskeletal pain
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by other Non-health professional via regulatory authority (VAERS ID: 676924) and concerns a 52 years old female patient. Patient's concomitant medication included: Tramadol (dose: 50 mg), Vitamin D3 (dose: 25,000 IU). Administration of Company suspect drug: On 15-Nov-2016 patient was administered INN Flu Vaccine via injection NOS (dose: unknown, anatomical location: left arm). Adverse reactions/events and outcomes: On 15-Nov-2016 after administration of INN Flu Vaccine, the patient experienced soreness to left shoulder and surrounding area to include left scapula and bicep and unable to lift arm above shoulder. On 23-11-2016 the patient called the doctor, was directed to take Ibuprofen and return to quick care if symptoms persist. On 25-11-2016, the patient was unable to lift arm over head for more than a few seconds and experienced weakness, caused headache from surrounding inflammation. On 27-11-2016, patient returned to quick care and was prescribed 800 mg MOTRIN that alleviates the pain but pain returns when patient stops. Treatment medications included: Ibuprofen, MOTRIN. Outcome of the events was not recovered. Reporter's Assessment: The reporter assessed the events as non-serious and the causality was not provided. This report was not serious.
Age: 14.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Abdominal pain, Anaemia, Arthralgia, Back pain, Fatigue
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by other non-health professional via health authority (VAERS ID: 676976) and concerns a 14 years old female patient. The patient's medical history included seasonal allergies and Hashimoto's thyroiditis. The patient's concomitant medication included Levothyroxine. Administration of Company suspect drug: On 26-Sep-2016, the patient received INN Flu Vaccine (dose, expiry date, batch number: not reported) via intramuscular route. Adverse reactions/events and outcomes: On 30-Sep-2016 after administration of influenza vaccine, the patient experienced severe abdominal pain, neck pain, back pain, swollen lymph nodes, menstrual period for 3 months, anaemia, headache, swollen joints, achy joints, heat intolerance, fatigue and weight gain. Action taken with the vaccine was not reported. On an unspecified date, inflammatory marker increased, haemoglobin decreased (anaemic) was performed and blood pressure measurement was noted to be elevated. The outcome of the events was not recovered/not resolved. Reporter's Assessment: The reporter did not provide the causality of the events in relation to the INN Flu Vaccine. Health Authority considered the case report as non-serious.
Age: 14.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Haemoglobin decreased, Headache, Hypertension, Inflammatory marker increased, Joint swelling
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by other non-health professional via health authority (VAERS ID: 676976) and concerns a 14 years old female patient. The patient's medical history included seasonal allergies and Hashimoto's thyroiditis. The patient's concomitant medication included Levothyroxine. Administration of Company suspect drug: On 26-Sep-2016, the patient received INN Flu Vaccine (dose, expiry date, batch number: not reported) via intramuscular route. Adverse reactions/events and outcomes: On 30-Sep-2016 after administration of influenza vaccine, the patient experienced severe abdominal pain, neck pain, back pain, swollen lymph nodes, menstrual period for 3 months, anaemia, headache, swollen joints, achy joints, heat intolerance, fatigue and weight gain. Action taken with the vaccine was not reported. On an unspecified date, inflammatory marker increased, haemoglobin decreased (anaemic) was performed and blood pressure measurement was noted to be elevated. The outcome of the events was not recovered/not resolved. Reporter's Assessment: The reporter did not provide the causality of the events in relation to the INN Flu Vaccine. Health Authority considered the case report as non-serious.
Age: 14.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Lymphadenopathy, Menstrual disorder, Neck pain, Temperature intolerance, Weight increased
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by other non-health professional via health authority (VAERS ID: 676976) and concerns a 14 years old female patient. The patient's medical history included seasonal allergies and Hashimoto's thyroiditis. The patient's concomitant medication included Levothyroxine. Administration of Company suspect drug: On 26-Sep-2016, the patient received INN Flu Vaccine (dose, expiry date, batch number: not reported) via intramuscular route. Adverse reactions/events and outcomes: On 30-Sep-2016 after administration of influenza vaccine, the patient experienced severe abdominal pain, neck pain, back pain, swollen lymph nodes, menstrual period for 3 months, anaemia, headache, swollen joints, achy joints, heat intolerance, fatigue and weight gain. Action taken with the vaccine was not reported. On an unspecified date, inflammatory marker increased, haemoglobin decreased (anaemic) was performed and blood pressure measurement was noted to be elevated. The outcome of the events was not recovered/not resolved. Reporter's Assessment: The reporter did not provide the causality of the events in relation to the INN Flu Vaccine. Health Authority considered the case report as non-serious.
Age: 14.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Abdominal pain, Anaemia, Arthralgia, Back pain, Blood pressure increased
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by other non-health professional via health authority (VAERS ID: 676976) and concerns a 14 years old female patient. The patient's medical history included seasonal allergies and Hashimoto's thyroiditis. The patient's concomitant medication included Levothyroxine. Administration of Company suspect drug: On 26-Sep-2016, the patient received INN Flu Vaccine (dose, expiry date, batch number: not reported) via intramuscular route. Adverse reactions/events and outcomes: On 30-Sep-2016 after administration of influenza vaccine, the patient experienced severe abdominal pain, neck pain, back pain, swollen lymph nodes, menstrual period for 3 months, anaemia, headache, swollen joints, achy joints, heat intolerance, fatigue and weight gain. Action taken with the vaccine was not reported. On an unspecified date, inflammatory marker increased, haemoglobin decreased (anaemic) was performed and blood pressure measurement was noted to be elevated. The outcome of the events was not recovered/not resolved. Reporter's Assessment: The reporter did not provide the causality of the events in relation to the INN Flu Vaccine. Health Authority considered the case report as non-serious.
Age: 14.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Fatigue, Haemoglobin decreased, Headache, Inflammatory marker increased, Joint swelling
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by other non-health professional via health authority (VAERS ID: 676976) and concerns a 14 years old female patient. The patient's medical history included seasonal allergies and Hashimoto's thyroiditis. The patient's concomitant medication included Levothyroxine. Administration of Company suspect drug: On 26-Sep-2016, the patient received INN Flu Vaccine (dose, expiry date, batch number: not reported) via intramuscular route. Adverse reactions/events and outcomes: On 30-Sep-2016 after administration of influenza vaccine, the patient experienced severe abdominal pain, neck pain, back pain, swollen lymph nodes, menstrual period for 3 months, anaemia, headache, swollen joints, achy joints, heat intolerance, fatigue and weight gain. Action taken with the vaccine was not reported. On an unspecified date, inflammatory marker increased, haemoglobin decreased (anaemic) was performed and blood pressure measurement was noted to be elevated. The outcome of the events was not recovered/not resolved. Reporter's Assessment: The reporter did not provide the causality of the events in relation to the INN Flu Vaccine. Health Authority considered the case report as non-serious.
Age: 14.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Lymphadenopathy, Neck pain, Oligomenorrhoea, Temperature intolerance, Weight increased
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by other non-health professional via health authority (VAERS ID: 676976) and concerns a 14 years old female patient. The patient's medical history included seasonal allergies and Hashimoto's thyroiditis. The patient's concomitant medication included Levothyroxine. Administration of Company suspect drug: On 26-Sep-2016, the patient received INN Flu Vaccine (dose, expiry date, batch number: not reported) via intramuscular route. Adverse reactions/events and outcomes: On 30-Sep-2016 after administration of influenza vaccine, the patient experienced severe abdominal pain, neck pain, back pain, swollen lymph nodes, menstrual period for 3 months, anaemia, headache, swollen joints, achy joints, heat intolerance, fatigue and weight gain. Action taken with the vaccine was not reported. On an unspecified date, inflammatory marker increased, haemoglobin decreased (anaemic) was performed and blood pressure measurement was noted to be elevated. The outcome of the events was not recovered/not resolved. Reporter's Assessment: The reporter did not provide the causality of the events in relation to the INN Flu Vaccine. Health Authority considered the case report as non-serious.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: HIV test positive
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by other healthcare professional regulatory authority (VAERS ID: 677020) and concerns a Male patient of unspecified age. At the time of vaccination, the patient had diabetes since an unspecified date. Concomitant medication included: insulin injection. Administration of Company suspect drug (s): On 27-Oct-2016, the patient was administered with high dose of INN Flu Vaccine Seasonal (dosage, route of administration, anatomical location: unknown) for an unknown indication. Adverse reactions/events and outcomes: On an unknown date following the vaccination, the patient was tested positive to a recent HIV test. And it was reported that the patient was given insulin injection by a staff member. After the injection, the staff member was accidently stuck with the needle and both the patient and the staff member were tested for HIV and the positive had a positive result. The administrator stated that false positive HIV test results were possible in patients who received a flu vaccine. Lab Test included: HIV test (positive). Outcome of the event was not reported. Reporter's Assessment: The reporter did not provide the causality of the event. This case report was considered as non serious.
Age: 37.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Musculoskeletal pain, Tendonitis, Vaccination complication
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by other non-health professional via regulatory authority (VAERS ID: 677146) and concerns a 37-years-old female patient. Administration of Company suspect drug: On 05-Oct-2016, the patient was administered with INN Flu Vaccine (dosage: unknown, route of administration: intramuscular, anatomical location: right arm). Adverse reactions/events and outcomes: On 05-Oct-2016 after administration of INN Flu Vaccine, the patient experienced soreness of shoulder especially with use and movement, tendonitis and the patient visited orthopaedist, who confirmed pain was from shot. Physical therapy session was done to rehabilitate shoulder from tendonitis caused by vaccine administration. The action taken with INN Flu Vaccine was not reported. The outcome of the events was not recovered. Reporter's Assessment: The reporter did not provide any causality assessment between INN Flu Vaccine and the events. This report was not serious.
Age: 37.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Musculoskeletal pain, Tendonitis
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by other non-health professional via regulatory authority (VAERS ID: 677146) and concerns a 37-years-old female patient. Administration of Company suspect drug: On 05-Oct-2016, the patient was administered with INN Flu Vaccine (dosage: unknown, route of administration: intramuscular, anatomical location: right arm). Adverse reactions/events and outcomes: On 05-Oct-2016 after administration of INN Flu Vaccine, the patient experienced soreness of shoulder especially with use and movement, tendonitis and the patient visited orthopaedist, who confirmed pain was from shot. Physical therapy session was done to rehabilitate shoulder from tendonitis caused by vaccine administration. The action taken with INN Flu Vaccine was not reported. The outcome of the events was not recovered. Reporter's Assessment: The reporter did not provide any causality assessment between INN Flu Vaccine and the events. This report was not serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Insomnia, Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous case initially received on 12-Apr-2017 was reported by other non-health professional via Health Authority (VAERS ID: 677171) and concerns a 63 years old female patient. Administration of Company suspect drug: On 31-Aug-2016, the patient received INN Flu Vaccine Seasonal (dose, expiry date, batch number, route of administration: not reported). Adverse reactions/events and outcomes: On 31-Aug-2016 after administration of influenza vaccine, the sore arm pain could not lift above head and could not lay on it (Mobility decreased) and it hurt bad with dot where shot was given (Pain in extremity). The patient stated that it had been 4 months still is hurt bad and could not sleep (Insomnia). Action taken with the vaccine was not reported. The outcome of the events was not resolved/recovered. Reporter's Assessment: The reporter assessed the causality of the events considered to be related to the INN Flu Vaccine Seasonal. The case was non-serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, Insomnia, Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous case initially received on 12-Apr-2017 was reported by other non-health professional via Health Authority (VAERS ID: 677171) and concerns a 63 years old female patient. Administration of Company suspect drug: On 31-Aug-2016, the patient received INN Flu Vaccine Seasonal (dose, expiry date, batch number, route of administration: not reported). Adverse reactions/events and outcomes: On 31-Aug-2016 after administration of influenza vaccine, the sore arm pain could not lift above head and could not lay on it (Mobility decreased) and it hurt bad with dot where shot was given (Pain in extremity). The patient stated that it had been 4 months still is hurt bad and could not sleep (Insomnia). Action taken with the vaccine was not reported. The outcome of the events was not resolved/recovered. Reporter's Assessment: The reporter assessed the causality of the events considered to be related to the INN Flu Vaccine Seasonal. The case was non-serious.
Sex: F
Vaccine: DTAPIPV, FLUX, HEP, MMRV, DTAPIPV, FLUX, HEP, MMRV
Symptoms: Nasopharyngitis, Pyrexia, Rash generalised
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by an other non-health professional via regulatory authority (vaccine adverse event reported system: 677172) and concerns a 5 years old female patient. Administration of Company suspect drug(s): On 13-Dec-2016 the patient was administered with INN Flu Vaccine Seasonal (dosage, batch number, route of administration: not reported) at arm for unspecified indication. Non-company suspect drug (s): On 13-Dec-2016 the patient was administered with Dtap ipv szczepionka, Hepatitis b vaccine, Measles vaccine w/Mumps vaccine/Rubella vaccine/Varicella zoster vaccine, (dosage, batch number, route of administration: not reported) at arm. Adverse reactions/events and outcomes: On 13-Dec-2016 the 5 years old patient was administered with vaccines at arm. On 06-Jan-2017 the patient started with fever, cold symptoms and broke out in head to toe rash. Action taken with influenza vaccine, influenza virus vaccine polyvalent was not reported and outcome of the events was reported as not recovered. Reporter's Assessment: The other non-health professional did not assessment between the events and study vaccine. This case was non-serious.
Sex: F
Vaccine: DTAPIPV, FLUX, HEP, MMRV, DTAPIPV, FLUX, HEP, MMRV
Symptoms: Pyrexia, Rash generalised, Viral upper respiratory tract infection
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by an other non-health professional via regulatory authority (vaccine adverse event reported system: 677172) and concerns a 5 years old female patient. Administration of Company suspect drug(s): On 13-Dec-2016 the patient was administered with INN Flu Vaccine Seasonal (dosage, batch number, route of administration: not reported) at arm for unspecified indication. Non-company suspect drug (s): On 13-Dec-2016 the patient was administered with Dtap ipv szczepionka, Hepatitis b vaccine, Measles vaccine w/Mumps vaccine/Rubella vaccine/Varicella zoster vaccine, (dosage, batch number, route of administration: not reported) at arm. Adverse reactions/events and outcomes: On 13-Dec-2016 the 5 years old patient was administered with vaccines at arm. On 06-Jan-2017 the patient started with fever, cold symptoms and broke out in head to toe rash. Action taken with influenza vaccine, influenza virus vaccine polyvalent was not reported and outcome of the events was reported as not recovered. Reporter's Assessment: The other non-health professional did not assessment between the events and study vaccine. This case was non-serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Burning sensation, Chest discomfort, Defaecation urgency, Dyspnoea, Facial pain
Clinical narrative: This spontaneous case initially received on 12-Apr-2017, which was reported by an other-non health professional via regulatory authority (VAERS ID: 677175) and concerns a 59 years old female patient. The patient's current condition included Parkinson's disease, borderline Type II diabetes, hypertension, elevated cholesterol since an unspecified date. Historical condition included pulsatile tinnitus, migraines, face pain, neck pain, low back pain, GERD, LPRD and esophageal spasms. Historical drug included SINEMET since Oct-2016 which was later eliminated by neurologist. Concomitant medication included AZILECT, SPIRIVA, MUCINEX, pantoprazole, DEXILANT, ranitidine, LIBRAX, MIRALAX, COLACE, lisinopril, fenofibrate, magnesium, B12, Niacin, RESTASIS, SYSTANE, ibuprofen, aspirin, clonazepam for an unknown indication and Botox injections for migraine every 03 months. Administration of Company suspect drug: On 21-Dec-2016, patient was administered with INN Flu Vaccine Seasonal (dosage: unknown, route of administration: intramuscular, anatomical location: left arm, Lot no: tbd). Adverse reactions/events and outcomes: On 26-Dec-2016, the patient experienced tingling in legs/tingling all over/tingling all over all day (paraesthesia generalised) only in evening, tingling all over and burning sensation in hands and feet all day (extremities burning sensation of), sensation of urgent bowel movement, frequent, scanty urination, on/off mild chest tightness, shortness of breath, increased neck pain, face pain and increased headache intensity. Action taken with the suspect product was not reported. Outcome of the events were unknown. The reporter mentioned that on 06-Jan-2017, when her neurologist was treating her for Parkinson's (early stage), she suspected Parkinson's medication were causing those event/ symptoms but later she came to know that flu shot can also cause those rare symptoms. The reporter also mentioned that she was getting worse since medication changes. Reporter's Assessment: The health authority did not provided any causality assessment. This report is not serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Headache, Neck pain, Oliguria, Paraesthesia
Clinical narrative: This spontaneous case initially received on 12-Apr-2017, which was reported by an other-non health professional via regulatory authority (VAERS ID: 677175) and concerns a 59 years old female patient. The patient's current condition included Parkinson's disease, borderline Type II diabetes, hypertension, elevated cholesterol since an unspecified date. Historical condition included pulsatile tinnitus, migraines, face pain, neck pain, low back pain, GERD, LPRD and esophageal spasms. Historical drug included SINEMET since Oct-2016 which was later eliminated by neurologist. Concomitant medication included AZILECT, SPIRIVA, MUCINEX, pantoprazole, DEXILANT, ranitidine, LIBRAX, MIRALAX, COLACE, lisinopril, fenofibrate, magnesium, B12, Niacin, RESTASIS, SYSTANE, ibuprofen, aspirin, clonazepam for an unknown indication and Botox injections for migraine every 03 months. Administration of Company suspect drug: On 21-Dec-2016, patient was administered with INN Flu Vaccine Seasonal (dosage: unknown, route of administration: intramuscular, anatomical location: left arm, Lot no: tbd). Adverse reactions/events and outcomes: On 26-Dec-2016, the patient experienced tingling in legs/tingling all over/tingling all over all day (paraesthesia generalised) only in evening, tingling all over and burning sensation in hands and feet all day (extremities burning sensation of), sensation of urgent bowel movement, frequent, scanty urination, on/off mild chest tightness, shortness of breath, increased neck pain, face pain and increased headache intensity. Action taken with the suspect product was not reported. Outcome of the events were unknown. The reporter mentioned that on 06-Jan-2017, when her neurologist was treating her for Parkinson's (early stage), she suspected Parkinson's medication were causing those event/ symptoms but later she came to know that flu shot can also cause those rare symptoms. The reporter also mentioned that she was getting worse since medication changes. Reporter's Assessment: The health authority did not provided any causality assessment. This report is not serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Headache, Neck pain, Paraesthesia, Pollakiuria, Urine output decreased
Clinical narrative: This spontaneous case initially received on 12-Apr-2017, which was reported by an other-non health professional via regulatory authority (VAERS ID: 677175) and concerns a 59 years old female patient. The patient's current condition included Parkinson's disease, borderline Type II diabetes, hypertension, elevated cholesterol since an unspecified date. Historical condition included pulsatile tinnitus, migraines, face pain, neck pain, low back pain, GERD, LPRD and esophageal spasms. Historical drug included SINEMET since Oct-2016 which was later eliminated by neurologist. Concomitant medication included AZILECT, SPIRIVA, MUCINEX, pantoprazole, DEXILANT, ranitidine, LIBRAX, MIRALAX, COLACE, lisinopril, fenofibrate, magnesium, B12, Niacin, RESTASIS, SYSTANE, ibuprofen, aspirin, clonazepam for an unknown indication and Botox injections for migraine every 03 months. Administration of Company suspect drug: On 21-Dec-2016, patient was administered with INN Flu Vaccine Seasonal (dosage: unknown, route of administration: intramuscular, anatomical location: left arm, Lot no: tbd). Adverse reactions/events and outcomes: On 26-Dec-2016, the patient experienced tingling in legs/tingling all over/tingling all over all day (paraesthesia generalised) only in evening, tingling all over and burning sensation in hands and feet all day (extremities burning sensation of), sensation of urgent bowel movement, frequent, scanty urination, on/off mild chest tightness, shortness of breath, increased neck pain, face pain and increased headache intensity. Action taken with the suspect product was not reported. Outcome of the events were unknown. The reporter mentioned that on 06-Jan-2017, when her neurologist was treating her for Parkinson's (early stage), she suspected Parkinson's medication were causing those event/ symptoms but later she came to know that flu shot can also cause those rare symptoms. The reporter also mentioned that she was getting worse since medication changes. Reporter's Assessment: The health authority did not provided any causality assessment. This report is not serious.
Age: 25.0
Sex: F
Vaccine: FLUX, HPV4, FLUX, HPV4
Symptoms: Exposure during pregnancy, No adverse event, Prenatal screening test
Clinical narrative: This spontaneous prospective pregnancy case, initially received on 12-Apr-2017 was reported by physician via regulatory authority (Vaccine Adverse Event Reporting System: 677202) and concerns a 25-year-old female patient. Administration of Company suspect drug: On 21-Dec-2016, the patient was administered with INN Flu Vaccine (batch number, dose: not reported) via injection NOS route. Non-company suspect drug: On 21-Dec-2016, the patient was administered with GARDASIL (batch number: M031557 (verified as invalid) dose: not reported) via injection NOS route after 15 minutes of INN Flu Vaccine. It was reported that the patient was 17 weeks pregnant at the time of the report and the last menstrual period date was 24-Aug-2016, estimated date of delivery was 31-May-2017 patient was exposed to GARDASIL and INN Flu Vaccine at 17 weeks of pregnancy that was second trimester. Adverse reactions/events and outcomes: On 21-Dec-2016 the patient was administered with INN Flu Vaccine and GARDASIL which was characterized by "Exposure during pregnancy". No adverse effects reported characterized by "No adverse event" and lab diagnostic studies included test for Down's syndrome. Action taken with INN Flu Vaccine and GARDASIL was not reported and outcome of the events was unknown. Reporter's Assessment: The Physician did provide the causality between the all events INN Flu Vaccine Seasonal. This report was non-serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Allergy to vaccine
Clinical narrative: This spontaneous case, initially received via Vaccine Adverse Event Reaction Systems (VAERS ID: 677211) on Apr-2017 was reported by other healthcare professional and concerns a female patient of unknown age. Administration of Company suspect drug(s): On an unspecified date the patient received INN Flu Vaccine, (dosage, batch number, route of administration: not reported). Adverse reactions/events and outcomes: On unspecified date after administration of INN Flu Vaccine, the patient experienced allergy to vaccine. Action taken with INN Flu Vaccine was not reported. Outcome of the event was not reported. Reporter's Assessment: The reporter did not provide the causality for the event allergy to vaccine. This case was non serious.
Age: 69.0
Sex: F
Vaccine: FLUA3, PNC13, FLUA3, PNC13
Symptoms: Headache, Neck pain, Pain in extremity
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by other Non-health professional via regulatory authority (VAERS ID: 677337) and concerns a 69 years old female patient. Administration of Company suspect drug(s): On 28-Dec-2016, patient was administered FLUAD (TIV) (dose, route of administration: unknown, anatomical location: left arm) (batch number: 165703). Indication not reported. Non-company suspect drug: On 28-Dec-2016, patient was administered Pneumococcal 13 valent vaccine (dose, route of administration: unknown, anatomical location: right arm) (batch number: N34936). Adverse reactions/events and outcomes: On 29-Dec-2016 after administration of FLUAD (TIV) and Pneumococcal 13 valent vaccine, the patient experienced Headache, Painful arms (both) and neck. Doctor was contacted and doctor will contact the patient it was stated. Outcome of the events was not reported. Reporter's Assessment: The reporter assessed the events as non-serious and causality was not provided. This report was not serious.
Sex: F
Vaccine: DTAP, FLUX, HEP, IPV, PPV, DTAP, FLUX, HEP, PPV
Symptoms: Abdominal discomfort, Abdominal pain, Constipation, Discomfort, Erythema
Clinical narrative: This spontaneous case, initially received on 12-APR-2017 was reported by a other non-health professional via health authority (VAERS ID: 677536) concerns a 05 months old female patient. There were no any medical history and current condition of the patient. There were no any medical history and current condition of the patient. Administration of Company suspect drug: On 19-Oct-2016, the patient received INN Flu Vaccine Seasonal (dose, expiry date, batch number: not reported) at left gluteus via injection NOS route. Non-company suspect drugs: On 19-Oct-2016, the patient also received Diphtheria tetanus acellular pertussis, Hepatitis B, Poliovirus vaccine and Pneumococcal vaccine polyvalent (dose number: 2, dose, batch number, expiry date: not reported) at left gluteus via injection NOS. Adverse reactions/events and outcomes: On 19-Oct-2016 after the administration of the vaccine suspect es, the patient experienced hives, redness under eyes, abdominal pain, constipation for 5 days, followed by BMs with large globs of mucus, green BMs. The reporter stated that the abdominal distress was continued for a week. The patient got up hourly at night with discomfort. Action taken with the suspect vaccines was not reported. The patient was recovered from the events. Reporter's Assessment: The reporter did not provide the causality of the events in relation to the influenza vaccine.