chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Injection site swelling, Myalgia, Neurological examination, Ophthalmological examination, Pruritus
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by other non-health professional via regulatory authority (Vaccine Adverse Event Reporting System ID: 679292) and concerns a 61 years old adult female patient. The patient's medication history included: Type II diabetes mellitus, degenerative joint disease, allergy to Lisinopril and AVANDIA and pseudo tumour cerebra. The patient's concomitant medication included: GLUCOPHAGE, Glyburide, HCTZ, Losartan, Multivitamins, Vitamin D, CoQ 10, Vitamin E, Magnesium, Calcium, Diclofenac sodium. Administration of Company suspect drug(s): On 10-Oct-2016, the patient was administered with INN Flu Vaccine (dosage, batch number) via intramuscular route in left arm. Adverse reactions/events and outcomes: On 10-Oct-2016 evening the patient had itching, injection site swollen and became red. After 48 hours' she experienced muscle and joint aches and pains lasted for 3 days. Itching was continued for the patient. It was reported that after a week head went silent as if under water for a few seconds and came back with loud ringing in her right ear and had a woozy feeling which was lasted for 2 weeks. Patient was seen to a neurologists, ears examined and was advised to go to a ENT physician if no improvement. It was reported that audiogram, vestibular testing was performed. Adverse events for prior vaccinations was reported as flushed face for 24 hours. Action taken with INN Flu Vaccine was not reported and outcome of the events was not reported except dizziness was reported as recovering. Reporter's Assessment: The reporter did not provide any causality between the all events and INN Flu Vaccine. This report was not serious.
Age: 61.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Tinnitus, Vestibular function test
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by other non-health professional via regulatory authority (Vaccine Adverse Event Reporting System ID: 679292) and concerns a 61 years old adult female patient. The patient's medication history included: Type II diabetes mellitus, degenerative joint disease, allergy to Lisinopril and AVANDIA and pseudo tumour cerebra. The patient's concomitant medication included: GLUCOPHAGE, Glyburide, HCTZ, Losartan, Multivitamins, Vitamin D, CoQ 10, Vitamin E, Magnesium, Calcium, Diclofenac sodium. Administration of Company suspect drug(s): On 10-Oct-2016, the patient was administered with INN Flu Vaccine (dosage, batch number) via intramuscular route in left arm. Adverse reactions/events and outcomes: On 10-Oct-2016 evening the patient had itching, injection site swollen and became red. After 48 hours' she experienced muscle and joint aches and pains lasted for 3 days. Itching was continued for the patient. It was reported that after a week head went silent as if under water for a few seconds and came back with loud ringing in her right ear and had a woozy feeling which was lasted for 2 weeks. Patient was seen to a neurologists, ears examined and was advised to go to a ENT physician if no improvement. It was reported that audiogram, vestibular testing was performed. Adverse events for prior vaccinations was reported as flushed face for 24 hours. Action taken with INN Flu Vaccine was not reported and outcome of the events was not reported except dizziness was reported as recovering. Reporter's Assessment: The reporter did not provide any causality between the all events and INN Flu Vaccine. This report was not serious.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Blood test, Computerised tomogram head normal, Impaired driving ability, Intracranial pressure increased, Neurological examination normal
Clinical narrative: This spontaneous case initially received via vaccine adverse event reporting systems (VAERS ID: 679363) on Apr-2017, was reported by other non-health professional and concerns a 41-year-old adult male patient. Administration of Company suspect drug: On 18-Jan-2017, the patient was administered with INN Flu Vaccine Seasonal (anatomical location: left arm, dose, batch number, route of administration and expiration date: not reported). Adverse events/reactions and outcomes: On 19-Jan-2017, after administration of INN Flu Vaccine Seasonal, the patient experienced sudden blurred vision and could not read anything, could not drive and sudden loss of vision. Treatment drugs: The patient's treatment drugs included Dorzolamide and Timolol Maleate (route of administration: ophthalmic, dose, batch number, expiration date: not reported) and Brimonidine (dose, route of administration, batch number, expiration date: not reported) for blurred vision. Relevant Lab Tests: The patient's lab tests included test, CT (Computerised Tomogram) for head(normal), MRI (Nuclear Magnetic Rezoning Imaging) for brain (normal), neurological examination (normal) and ophthalmic examination (normal). The patient also undergone procedures such as Intracranial pressure increased and Pupil dilation. 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 report was not serious.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Nuclear magnetic resonance imaging brain normal, Ophthalmological examination, Pupil dilation procedure, Sudden visual loss, Vision blurred
Clinical narrative: This spontaneous case initially received via vaccine adverse event reporting systems (VAERS ID: 679363) on Apr-2017, was reported by other non-health professional and concerns a 41-year-old adult male patient. Administration of Company suspect drug: On 18-Jan-2017, the patient was administered with INN Flu Vaccine Seasonal (anatomical location: left arm, dose, batch number, route of administration and expiration date: not reported). Adverse events/reactions and outcomes: On 19-Jan-2017, after administration of INN Flu Vaccine Seasonal, the patient experienced sudden blurred vision and could not read anything, could not drive and sudden loss of vision. Treatment drugs: The patient's treatment drugs included Dorzolamide and Timolol Maleate (route of administration: ophthalmic, dose, batch number, expiration date: not reported) and Brimonidine (dose, route of administration, batch number, expiration date: not reported) for blurred vision. Relevant Lab Tests: The patient's lab tests included test, CT (Computerised Tomogram) for head(normal), MRI (Nuclear Magnetic Rezoning Imaging) for brain (normal), neurological examination (normal) and ophthalmic examination (normal). The patient also undergone procedures such as Intracranial pressure increased and Pupil dilation. 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 report was not serious.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Blindness, Computerised tomogram head normal, Impaired driving ability, Intracranial pressure increased, Neurological examination normal
Clinical narrative: This spontaneous case initially received via vaccine adverse event reporting systems (VAERS ID: 679363) on Apr-2017, was reported by other non-health professional and concerns a 41-year-old adult male patient. Administration of Company suspect drug: On 18-Jan-2017, the patient was administered with INN Flu Vaccine Seasonal (anatomical location: left arm, dose, batch number, route of administration and expiration date: not reported). Adverse events/reactions and outcomes: On 19-Jan-2017, after administration of INN Flu Vaccine Seasonal, the patient experienced sudden blurred vision and could not read anything, could not drive and sudden loss of vision. Treatment drugs: The patient's treatment drugs included Dorzolamide and Timolol Maleate (route of administration: ophthalmic, dose, batch number, expiration date: not reported) and Brimonidine (dose, route of administration, batch number, expiration date: not reported) for blurred vision. Relevant Lab Tests: The patient's lab tests included test, CT (Computerised Tomogram) for head(normal), MRI (Nuclear Magnetic Rezoning Imaging) for brain (normal), neurological examination (normal) and ophthalmic examination (normal). The patient also undergone procedures such as Intracranial pressure increased and Pupil dilation. 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 report was not serious.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Nuclear magnetic resonance imaging brain normal, Ophthalmological examination normal, Pupil dilation procedure, Vision blurred
Clinical narrative: This spontaneous case initially received via vaccine adverse event reporting systems (VAERS ID: 679363) on Apr-2017, was reported by other non-health professional and concerns a 41-year-old adult male patient. Administration of Company suspect drug: On 18-Jan-2017, the patient was administered with INN Flu Vaccine Seasonal (anatomical location: left arm, dose, batch number, route of administration and expiration date: not reported). Adverse events/reactions and outcomes: On 19-Jan-2017, after administration of INN Flu Vaccine Seasonal, the patient experienced sudden blurred vision and could not read anything, could not drive and sudden loss of vision. Treatment drugs: The patient's treatment drugs included Dorzolamide and Timolol Maleate (route of administration: ophthalmic, dose, batch number, expiration date: not reported) and Brimonidine (dose, route of administration, batch number, expiration date: not reported) for blurred vision. Relevant Lab Tests: The patient's lab tests included test, CT (Computerised Tomogram) for head(normal), MRI (Nuclear Magnetic Rezoning Imaging) for brain (normal), neurological examination (normal) and ophthalmic examination (normal). The patient also undergone procedures such as Intracranial pressure increased and Pupil dilation. 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 report was not serious.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Back pain, Blood test abnormal, Headache, Limb injury, Muscular weakness
Clinical narrative: This spontaneous case, initially received via vaccine adverse event reporting system (VAERS ID: 679417) on 12-Apr-2017, was reported by other non-healthcare professional and concerns a 66-year-old male patient. The patient's medical history included COPD (Chronic obstructive pulmonary disease), Raynauds, Sjogren's, blood pressure high. The patient's concomitant medication included Lisinopril, hydrocodone, NORVASC. Administration of Company suspect drug: On 15-Dec-2015, the patient was administered with INN Flu Vaccine Seasonal (dosage, batch number, route of administration: not reported, anatomical location: left arm). Adverse reactions/events and outcomes: On 16-dec-2015 after administration of INN Flu Vaccine Seasonal, the patient experienced shoulder injury related to vaccine administration, neuropathy from dec-2017, pain in arm and shoulder from 2015 to jan-2017. The patient also had fever for 4 weeks from the 16-dec-2015. He also had itching, pain in back reoccurring, headaches on and off, from the beginning of 2105 to 2017. Other events were weakness in left hand and arm and shoulder, pain and burn, tingling in arms, hands, shoulder and back and ringing in ears. The patient had to visit emergency room due to the events. The patient underwent occupational therapy in aug-2016. The action taken with the 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: M
Vaccine: FLUX, FLUX
Symptoms: Musculoskeletal pain, Neuropathy peripheral, Pain, Pain in extremity, Paraesthesia
Clinical narrative: This spontaneous case, initially received via vaccine adverse event reporting system (VAERS ID: 679417) on 12-Apr-2017, was reported by other non-healthcare professional and concerns a 66-year-old male patient. The patient's medical history included COPD (Chronic obstructive pulmonary disease), Raynauds, Sjogren's, blood pressure high. The patient's concomitant medication included Lisinopril, hydrocodone, NORVASC. Administration of Company suspect drug: On 15-Dec-2015, the patient was administered with INN Flu Vaccine Seasonal (dosage, batch number, route of administration: not reported, anatomical location: left arm). Adverse reactions/events and outcomes: On 16-dec-2015 after administration of INN Flu Vaccine Seasonal, the patient experienced shoulder injury related to vaccine administration, neuropathy from dec-2017, pain in arm and shoulder from 2015 to jan-2017. The patient also had fever for 4 weeks from the 16-dec-2015. He also had itching, pain in back reoccurring, headaches on and off, from the beginning of 2105 to 2017. Other events were weakness in left hand and arm and shoulder, pain and burn, tingling in arms, hands, shoulder and back and ringing in ears. The patient had to visit emergency room due to the events. The patient underwent occupational therapy in aug-2016. The action taken with the 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: M
Vaccine: FLUX, FLUX
Symptoms: Pruritus, Pyrexia, Tinnitus
Clinical narrative: This spontaneous case, initially received via vaccine adverse event reporting system (VAERS ID: 679417) on 12-Apr-2017, was reported by other non-healthcare professional and concerns a 66-year-old male patient. The patient's medical history included COPD (Chronic obstructive pulmonary disease), Raynauds, Sjogren's, blood pressure high. The patient's concomitant medication included Lisinopril, hydrocodone, NORVASC. Administration of Company suspect drug: On 15-Dec-2015, the patient was administered with INN Flu Vaccine Seasonal (dosage, batch number, route of administration: not reported, anatomical location: left arm). Adverse reactions/events and outcomes: On 16-dec-2015 after administration of INN Flu Vaccine Seasonal, the patient experienced shoulder injury related to vaccine administration, neuropathy from dec-2017, pain in arm and shoulder from 2015 to jan-2017. The patient also had fever for 4 weeks from the 16-dec-2015. He also had itching, pain in back reoccurring, headaches on and off, from the beginning of 2105 to 2017. Other events were weakness in left hand and arm and shoulder, pain and burn, tingling in arms, hands, shoulder and back and ringing in ears. The patient had to visit emergency room due to the events. The patient underwent occupational therapy in aug-2016. The action taken with the 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: 47.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Arthralgia, Injection site pain, Pain in extremity
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: 679474) and concerns a 47 years old male patient. Concomitant medications included CLOMID; ARIMIDEX; flax seed oil, various vitamin and mineral supplements and fatty acid for an unknown indication. The patient also had seasonal allergies since an unspecified date. Administration of Company suspect drug: On 03-Oct-2016, patient was administered with second dose of INN Flu Vaccine (dosage: unknown, route of administration: intramuscular, anatomical location: right arm). Adverse reactions/events and outcomes: On 05-Dec-2016, the patient experienced soreness in right shoulder and Pain down right arm, elbow and forearm/Normal daily activities bring pain with use of right arm (aching pain in hands, forearms, elbows). The reporter also mentioned that it is manageable but painful. Action taken with the suspect product was not reported. Outcome of the event were not recovered/not resolved. Reporter's Assessment: The other-non health professional did not provided any causality assessment. This report is not serious.
Age: 47.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Arthralgia, Injection site pain, Pain, Pain in extremity
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: 679474) and concerns a 47 years old male patient. Concomitant medications included CLOMID; ARIMIDEX; flax seed oil, various vitamin and mineral supplements and fatty acid for an unknown indication. The patient also had seasonal allergies since an unspecified date. Administration of Company suspect drug: On 03-Oct-2016, patient was administered with second dose of INN Flu Vaccine (dosage: unknown, route of administration: intramuscular, anatomical location: right arm). Adverse reactions/events and outcomes: On 05-Dec-2016, the patient experienced soreness in right shoulder and Pain down right arm, elbow and forearm/Normal daily activities bring pain with use of right arm (aching pain in hands, forearms, elbows). The reporter also mentioned that it is manageable but painful. Action taken with the suspect product was not reported. Outcome of the event were not recovered/not resolved. Reporter's Assessment: The other-non health professional did not provided any causality assessment. This report is not serious.
Age: 2.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Abnormal behaviour, Asthenia, Decreased appetite, Fluid intake reduced, Headache
Clinical narrative: This spontaneous case initially received on 12-Apr-2017 was reported by other non-health professional via regulatory authority (Vaccine Adverse Event Reporting System: 679565) and concerns a 2-year-old female patient. Administration of Company suspect drug: On 20-Jan-2017, the patient was administered with INN Flu Vaccine Seasonal (batch number, dose, expiry date, indication: not reported) in left leg via intramuscular route. Adverse reactions/events and outcomes: On 22-Jan-2017 the patient had fever over 102 at 14:30 pm, weakness at 06:00 pm, behavior changes at 5:30pm, fussiness at 5:30pm, vomiting at 11:45 pm, paleness, loss of appetite and didn't want to drink fluids at 6:00 pm, fast heartbeat at 7:30pm, inflamed throat tissue at 8:00 pm, headache on and off days and drowsiness. Action taken with the suspect vaccine was not reported. The outcome of the events was not reported. Reporter's Assessment: The reporter did not provide the causality of the events in relation to the influenza vaccine. This report was non-serious.
Age: 2.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Heart rate increased, Irritability, Pallor, Pharyngeal inflammation, Pyrexia
Clinical narrative: This spontaneous case initially received on 12-Apr-2017 was reported by other non-health professional via regulatory authority (Vaccine Adverse Event Reporting System: 679565) and concerns a 2-year-old female patient. Administration of Company suspect drug: On 20-Jan-2017, the patient was administered with INN Flu Vaccine Seasonal (batch number, dose, expiry date, indication: not reported) in left leg via intramuscular route. Adverse reactions/events and outcomes: On 22-Jan-2017 the patient had fever over 102 at 14:30 pm, weakness at 06:00 pm, behavior changes at 5:30pm, fussiness at 5:30pm, vomiting at 11:45 pm, paleness, loss of appetite and didn't want to drink fluids at 6:00 pm, fast heartbeat at 7:30pm, inflamed throat tissue at 8:00 pm, headache on and off days and drowsiness. Action taken with the suspect vaccine was not reported. The outcome of the events was not reported. Reporter's Assessment: The reporter did not provide the causality of the events in relation to the influenza vaccine. This report was non-serious.
Age: 2.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Somnolence, Vomiting
Clinical narrative: This spontaneous case initially received on 12-Apr-2017 was reported by other non-health professional via regulatory authority (Vaccine Adverse Event Reporting System: 679565) and concerns a 2-year-old female patient. Administration of Company suspect drug: On 20-Jan-2017, the patient was administered with INN Flu Vaccine Seasonal (batch number, dose, expiry date, indication: not reported) in left leg via intramuscular route. Adverse reactions/events and outcomes: On 22-Jan-2017 the patient had fever over 102 at 14:30 pm, weakness at 06:00 pm, behavior changes at 5:30pm, fussiness at 5:30pm, vomiting at 11:45 pm, paleness, loss of appetite and didn't want to drink fluids at 6:00 pm, fast heartbeat at 7:30pm, inflamed throat tissue at 8:00 pm, headache on and off days and drowsiness. Action taken with the suspect vaccine was not reported. The outcome of the events was not reported. Reporter's Assessment: The reporter did not provide the causality of the events in relation to the influenza vaccine. This report was non-serious.
Age: 2.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Somnolence
Clinical narrative: This spontaneous case initially received on 12-Apr-2017 was reported by other non-health professional via regulatory authority (Vaccine Adverse Event Reporting System: 679565) and concerns a 2-year-old female patient. Administration of Company suspect drug: On 20-Jan-2017, the patient was administered with INN Flu Vaccine Seasonal (batch number, dose, expiry date, indication: not reported) in left leg via intramuscular route. Adverse reactions/events and outcomes: On 22-Jan-2017 the patient had fever over 102 at 14:30 pm, weakness at 06:00 pm, behavior changes at 5:30pm, fussiness at 5:30pm, vomiting at 11:45 pm, paleness, loss of appetite and didn't want to drink fluids at 6:00 pm, fast heartbeat at 7:30pm, inflamed throat tissue at 8:00 pm, headache on and off days and drowsiness. Action taken with the suspect vaccine was not reported. The outcome of the events was not reported. Reporter's Assessment: The reporter did not provide the causality of the events in relation to the influenza vaccine. This report was non-serious.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Chest X-ray, Injection site pain, Myalgia, Nuclear magnetic resonance imaging, Pain in extremity
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: 679584) and concerns a 53 years old male patient. Concomitant medication includes TIROSINT. Administration of Company suspect drug: On 04-Oct-2016, patient was administered with first dose of INN Flu Vaccine Seasonal (dosage: not reported, route of administration: intramuscular, anatomical location: right arm). Adverse reactions/events and outcomes: On 10-Oct-2016, the patient experienced pain in right arm, progressed to back muscles ending with 03 days in hospital and pain in right arm and then shoulder. Action taken with the suspect product was not reported. Outcome of the events were not recovered/not resolved. Relevant tests: On an unspecified date the patient underwent MRI neck and back, chest x-ray, right shoulder x-ray and right arm x-ray. On 01-Feb-2017 Nerve conductive test was scheduled. Reporter's Assessment: The other non-healthcare professional did not provide any causality between influenza vaccine, and the events. This report is serious (hospitalization). Significant case correction received on 19-Apr-2017: The listedness of the events was corrected.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: X-ray limb
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: 679584) and concerns a 53 years old male patient. Concomitant medication includes TIROSINT. Administration of Company suspect drug: On 04-Oct-2016, patient was administered with first dose of INN Flu Vaccine Seasonal (dosage: not reported, route of administration: intramuscular, anatomical location: right arm). Adverse reactions/events and outcomes: On 10-Oct-2016, the patient experienced pain in right arm, progressed to back muscles ending with 03 days in hospital and pain in right arm and then shoulder. Action taken with the suspect product was not reported. Outcome of the events were not recovered/not resolved. Relevant tests: On an unspecified date the patient underwent MRI neck and back, chest x-ray, right shoulder x-ray and right arm x-ray. On 01-Feb-2017 Nerve conductive test was scheduled. Reporter's Assessment: The other non-healthcare professional did not provide any causality between influenza vaccine, and the events. This report is serious (hospitalization). Significant case correction received on 19-Apr-2017: The listedness of the events was corrected.
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Asthenia, Burning sensation, Feeding disorder, Impaired driving ability, Influenza
Clinical narrative: This Spontaneous case, initially received via Vaccine Adverse Event Reaction Systems (VAERS ID: 679720) on 12-Apr-2017 was reported by other non healthcare professional and concerns a 73-years-old elderly female patient. The patient's concomitant medications included prednisone and gabapentin for an unknown indication. Administration of Company suspect drug: On 15-Oct-2016, the patient was administered with INN Flu Vaccine Seasonal (route of administration: injection NOS, dose, indication, batch number, expiration date: not reported). Adverse events/reactions and outcomes: On 15-Oct-2016, the patient reported burning sensation when shot was administrated, which went from upper arm to wrist. The patient's right arm became very painful and had lost the ability to lift or stretch it. After few days, the patient became sick with flu symptoms and reported that, she was very sick. The patient said, she could not eat, felt nauseous, shaky all over, could not think clearly and drive. At the time of this report, the patient was under physiotherapy for her right shoulder because of pain and lack of range and strength. 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 the events. This case report was serious (medically significant).
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Joint range of motion decreased, Malaise, Mobility decreased, Musculoskeletal pain, Nausea
Clinical narrative: This Spontaneous case, initially received via Vaccine Adverse Event Reaction Systems (VAERS ID: 679720) on 12-Apr-2017 was reported by other non healthcare professional and concerns a 73-years-old elderly female patient. The patient's concomitant medications included prednisone and gabapentin for an unknown indication. Administration of Company suspect drug: On 15-Oct-2016, the patient was administered with INN Flu Vaccine Seasonal (route of administration: injection NOS, dose, indication, batch number, expiration date: not reported). Adverse events/reactions and outcomes: On 15-Oct-2016, the patient reported burning sensation when shot was administrated, which went from upper arm to wrist. The patient's right arm became very painful and had lost the ability to lift or stretch it. After few days, the patient became sick with flu symptoms and reported that, she was very sick. The patient said, she could not eat, felt nauseous, shaky all over, could not think clearly and drive. At the time of this report, the patient was under physiotherapy for her right shoulder because of pain and lack of range and strength. 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 the events. This case report was serious (medically significant).
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Pain in extremity, Thinking abnormal, Tremor
Clinical narrative: This Spontaneous case, initially received via Vaccine Adverse Event Reaction Systems (VAERS ID: 679720) on 12-Apr-2017 was reported by other non healthcare professional and concerns a 73-years-old elderly female patient. The patient's concomitant medications included prednisone and gabapentin for an unknown indication. Administration of Company suspect drug: On 15-Oct-2016, the patient was administered with INN Flu Vaccine Seasonal (route of administration: injection NOS, dose, indication, batch number, expiration date: not reported). Adverse events/reactions and outcomes: On 15-Oct-2016, the patient reported burning sensation when shot was administrated, which went from upper arm to wrist. The patient's right arm became very painful and had lost the ability to lift or stretch it. After few days, the patient became sick with flu symptoms and reported that, she was very sick. The patient said, she could not eat, felt nauseous, shaky all over, could not think clearly and drive. At the time of this report, the patient was under physiotherapy for her right shoulder because of pain and lack of range and strength. 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 the events. This case report was serious (medically significant).
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Asthenia, Burning sensation, Feeding disorder, Immediate post-injection reaction, Impaired driving ability
Clinical narrative: This Spontaneous case, initially received via Vaccine Adverse Event Reaction Systems (VAERS ID: 679720) on 12-Apr-2017 was reported by other non healthcare professional and concerns a 73-years-old elderly female patient. The patient's concomitant medications included prednisone and gabapentin for an unknown indication. Administration of Company suspect drug: On 15-Oct-2016, the patient was administered with INN Flu Vaccine Seasonal (route of administration: injection NOS, dose, indication, batch number, expiration date: not reported). Adverse events/reactions and outcomes: On 15-Oct-2016, the patient reported burning sensation when shot was administrated, which went from upper arm to wrist. The patient's right arm became very painful and had lost the ability to lift or stretch it. After few days, the patient became sick with flu symptoms and reported that, she was very sick. The patient said, she could not eat, felt nauseous, shaky all over, could not think clearly and drive. At the time of this report, the patient was under physiotherapy for her right shoulder because of pain and lack of range and strength. 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 the events. This case report was serious (medically significant).
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Influenza, Joint range of motion decreased, Malaise, Mental impairment, Mobility decreased
Clinical narrative: This Spontaneous case, initially received via Vaccine Adverse Event Reaction Systems (VAERS ID: 679720) on 12-Apr-2017 was reported by other non healthcare professional and concerns a 73-years-old elderly female patient. The patient's concomitant medications included prednisone and gabapentin for an unknown indication. Administration of Company suspect drug: On 15-Oct-2016, the patient was administered with INN Flu Vaccine Seasonal (route of administration: injection NOS, dose, indication, batch number, expiration date: not reported). Adverse events/reactions and outcomes: On 15-Oct-2016, the patient reported burning sensation when shot was administrated, which went from upper arm to wrist. The patient's right arm became very painful and had lost the ability to lift or stretch it. After few days, the patient became sick with flu symptoms and reported that, she was very sick. The patient said, she could not eat, felt nauseous, shaky all over, could not think clearly and drive. At the time of this report, the patient was under physiotherapy for her right shoulder because of pain and lack of range and strength. 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 the events. This case report was serious (medically significant).
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Musculoskeletal pain, Nausea, Pain in extremity, Tremor
Clinical narrative: This Spontaneous case, initially received via Vaccine Adverse Event Reaction Systems (VAERS ID: 679720) on 12-Apr-2017 was reported by other non healthcare professional and concerns a 73-years-old elderly female patient. The patient's concomitant medications included prednisone and gabapentin for an unknown indication. Administration of Company suspect drug: On 15-Oct-2016, the patient was administered with INN Flu Vaccine Seasonal (route of administration: injection NOS, dose, indication, batch number, expiration date: not reported). Adverse events/reactions and outcomes: On 15-Oct-2016, the patient reported burning sensation when shot was administrated, which went from upper arm to wrist. The patient's right arm became very painful and had lost the ability to lift or stretch it. After few days, the patient became sick with flu symptoms and reported that, she was very sick. The patient said, she could not eat, felt nauseous, shaky all over, could not think clearly and drive. At the time of this report, the patient was under physiotherapy for her right shoulder because of pain and lack of range and strength. 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 the events. This case report was serious (medically significant).
Sex: M
Vaccine: FLUX, TDAP, FLUX, IPV, TDAP
Symptoms: Neck pain, Neuralgic amyotrophy, Pain in extremity
Clinical narrative: This spontaneous case initially received on 12-APR-2017 00:00:00 was reported by a other non-health professional through FDA VAERS ID: 679733 and concerns a 44 years old male patient. Administration of Company suspect drug (s): On 21-Dec-2016, INN Flu Vaccine Seasonal was administered for unknown indication (unknown dosage, route of administration: unknown, batch number: not reported). Non-company suspect drug (s): On 21-DEC-2016, TDAP IPV was administered for unknown indication (unknown dosage, route of administration: unknown, batch number: not reported). Adverse reactions/events and outcomes: On 21-Dec-2016, the patient was administered with Influenza virus vaccine and TDAP. On the same date, the patient was suffering from severe pain in right arm, that radiated to the neck. The patient consulted chiropractor twice, visited emergency room, urgent care and neurologist for treatment. The patient was treated with Gabapentin, TYLENOL, Prednisone. Action taken was not reported. Outcome of the events neck pain, pain in extremity and neuralgic amyotrophy was not recovered. The other non-health professional assessed the events as non-serious. The causality of the events neck pain, neuralgic amyotrophy and pain in extremity was not related to the vaccine.
Age: 63.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Musculoskeletal pain
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, was reported by other non-health professional via health authority (VAERS ID: 679740) and concerns a 63-year-old female patient. The patient's concomitant medication included: TUMS, vitamin D, atorvastatin, ASA, CoQ 10, Biotin. Administration of Company suspect drug: On 07-Nov-2016 the patient was administered with FLUAD TIV, (dose: 0.5 ml, batch number: 165903, route of administration: not reported, anatomical location: left arm). Indication was not reported. Adverse reactions/events and outcomes: On 07-Nov-2016 after administration of influenza vaccine, the patient experienced continuous shoulder pain since vaccination 2 months ago, which seemed to improve. The patient stated that due to pain he could not move arm in first month. The Action taken with the influenza vaccine, was not reported. The outcome of the event was not recovered. Reporter's Assessment: The reporter assessed that the causality between influenza vaccine, and event as related. This report was not serious.
Age: 63.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, was reported by other non-health professional via health authority (VAERS ID: 679740) and concerns a 63-year-old female patient. The patient's concomitant medication included: TUMS, vitamin D, atorvastatin, ASA, CoQ 10, Biotin. Administration of Company suspect drug: On 07-Nov-2016 the patient was administered with FLUAD TIV, (dose: 0.5 ml, batch number: 165903, route of administration: not reported, anatomical location: left arm). Indication was not reported. Adverse reactions/events and outcomes: On 07-Nov-2016 after administration of influenza vaccine, the patient experienced continuous shoulder pain since vaccination 2 months ago, which seemed to improve. The patient stated that due to pain he could not move arm in first month. The Action taken with the influenza vaccine, was not reported. The outcome of the event was not recovered. Reporter's Assessment: The reporter assessed that the causality between influenza vaccine, and event as related. This report was not serious.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUX, IPV, MMRV, DTAP, FLUX, IPV, MMRV
Symptoms: Cough, Crying, Decreased appetite, Emotional distress, Erythema
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: 679755) and concerns a 04 years old male patient. Administration of Company suspect drug: On 24-Jan-2017, patient was administered with INN Flu Vaccine (dosage, route of administration, anatomical location: unknown). Administration of Non-company suspect drug: On 24-Jan-2017, patient was also administered with first dose of DTaP, first dose of PROQUAD and poliovirus vaccine, inactivated (dosage, route of administration, anatomical location: unknown). Adverse reactions/events and outcomes: On 26-Jan-2017, the patient experienced tired/exhausted, headache, sleepy/just wanted to sleep, cold, fever, did not want to eat or drink anything, cold and hot (kept going on and off), coughing, runny noses, redness around the eyes, tender at the injection site right after the shots, very emotional and did not want to do anything at all and tears were rolling down his cheeks. Action taken with the suspect product was not reported. Outcome of the event was reported as not recovered/not resolved. Reporter's Assessment: The reporter did not provide any causality assessed as non serious.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUX, IPV, MMRV, DTAP, FLUX, IPV, MMRV
Symptoms: Fatigue, Feeling of body temperature change, Headache, Immediate post-injection reaction, Injection site 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: 679755) and concerns a 04 years old male patient. Administration of Company suspect drug: On 24-Jan-2017, patient was administered with INN Flu Vaccine (dosage, route of administration, anatomical location: unknown). Administration of Non-company suspect drug: On 24-Jan-2017, patient was also administered with first dose of DTaP, first dose of PROQUAD and poliovirus vaccine, inactivated (dosage, route of administration, anatomical location: unknown). Adverse reactions/events and outcomes: On 26-Jan-2017, the patient experienced tired/exhausted, headache, sleepy/just wanted to sleep, cold, fever, did not want to eat or drink anything, cold and hot (kept going on and off), coughing, runny noses, redness around the eyes, tender at the injection site right after the shots, very emotional and did not want to do anything at all and tears were rolling down his cheeks. Action taken with the suspect product was not reported. Outcome of the event was reported as not recovered/not resolved. Reporter's Assessment: The reporter did not provide any causality assessed as non serious.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUX, IPV, MMRV, DTAP, FLUX, IPV, MMRV
Symptoms: Lethargy, Nasopharyngitis, Pyrexia, Rhinorrhoea, Somnolence
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: 679755) and concerns a 04 years old male patient. Administration of Company suspect drug: On 24-Jan-2017, patient was administered with INN Flu Vaccine (dosage, route of administration, anatomical location: unknown). Administration of Non-company suspect drug: On 24-Jan-2017, patient was also administered with first dose of DTaP, first dose of PROQUAD and poliovirus vaccine, inactivated (dosage, route of administration, anatomical location: unknown). Adverse reactions/events and outcomes: On 26-Jan-2017, the patient experienced tired/exhausted, headache, sleepy/just wanted to sleep, cold, fever, did not want to eat or drink anything, cold and hot (kept going on and off), coughing, runny noses, redness around the eyes, tender at the injection site right after the shots, very emotional and did not want to do anything at all and tears were rolling down his cheeks. Action taken with the suspect product was not reported. Outcome of the event was reported as not recovered/not resolved. Reporter's Assessment: The reporter did not provide any causality assessed as non serious.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUX, IPV, MMRV, DTAP, FLUX, IPV, MMRV
Symptoms: Cough, Crying, Diet refusal, Emotional distress, Erythema of eyelid
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: 679755) and concerns a 04 years old male patient. Administration of Company suspect drug: On 24-Jan-2017, patient was administered with INN Flu Vaccine (dosage, route of administration, anatomical location: unknown). Administration of Non-company suspect drug: On 24-Jan-2017, patient was also administered with first dose of DTaP, first dose of PROQUAD and poliovirus vaccine, inactivated (dosage, route of administration, anatomical location: unknown). Adverse reactions/events and outcomes: On 26-Jan-2017, the patient experienced tired/exhausted, headache, sleepy/just wanted to sleep, cold, fever, did not want to eat or drink anything, cold and hot (kept going on and off), coughing, runny noses, redness around the eyes, tender at the injection site right after the shots, very emotional and did not want to do anything at all and tears were rolling down his cheeks. Action taken with the suspect product was not reported. Outcome of the event was reported as not recovered/not resolved. Reporter's Assessment: The reporter did not provide any causality assessed as non serious.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUX, IPV, MMRV, DTAP, FLUX, IPV, MMRV
Symptoms: Pyrexia, Rhinorrhoea, Somnolence, Viral upper respiratory tract infection
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: 679755) and concerns a 04 years old male patient. Administration of Company suspect drug: On 24-Jan-2017, patient was administered with INN Flu Vaccine (dosage, route of administration, anatomical location: unknown). Administration of Non-company suspect drug: On 24-Jan-2017, patient was also administered with first dose of DTaP, first dose of PROQUAD and poliovirus vaccine, inactivated (dosage, route of administration, anatomical location: unknown). Adverse reactions/events and outcomes: On 26-Jan-2017, the patient experienced tired/exhausted, headache, sleepy/just wanted to sleep, cold, fever, did not want to eat or drink anything, cold and hot (kept going on and off), coughing, runny noses, redness around the eyes, tender at the injection site right after the shots, very emotional and did not want to do anything at all and tears were rolling down his cheeks. Action taken with the suspect product was not reported. Outcome of the event was reported as not recovered/not resolved. Reporter's Assessment: The reporter did not provide any causality assessed as non serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Case number PHEH2016US001420, is an initial spontaneous report received from a physician via regulatory authority (VAERS ID: 679841) on 07 Jan 2016. This report refers to an elderly female patient. Historical condition was not reported. Concomitant medication was not reported. The patient was vaccinated with INN Flu Vaccine (dose: 1DF, anatomical location, expiry date, batch number: not reported) intramuscularly 2 years ago (year and date unspecified). The patient experienced redness and pain in upper arm on an unspecified date. Action taken with the influenza vaccine was not reported. Outcome of the events were not reported. Reporters assessment: The physician did not provide any causality assessment. This report was non serious. Follow up report received on 12-Apr-2017: VAERS ID: 679841 was added, administered by and purchased by were updated, route of administration was updated to intramuscular from injection NOS. Outcome of the events changed from unknown to not reported. The event redness and pain in upper arm of injection 2 years ago was updated to patient experienced redness and the event redness and pain in upper arm of injection 2 years ago was updated to pain in upper arm. Listedness were assessed as per data sheets.
Sex: F
Vaccine: FLUA3, PNC13, FLUA3, PNC13
Symptoms: Diarrhoea, Dizziness, Headache, Nausea, Pain
Clinical narrative: This spontaneous case initially received on 12-Apr-2017 was reported by other non-health professional via regulatory authority (vaccine adverse event reporting system: 679846) and concerns a 68-year-old female patient. Administration of Company suspect drug: On 26-Jan-2017, the patient was administered with FLUAD (TIV), (batch  number: 166101, dosage:0.5ml) via intramuscular route in left arm. Indication not reported. Non-company suspect drug: On 26-Jan-2017, the patient was administered with PREVNAR 13 (batch number: Q02071, dosage: not reported) via intramuscular route in left arm. Indication not reported. Adverse reactions/events and outcomes: On 27-Jan-2017 at 3:30 the patient had diarrhea, nausea, vomiting, headache, soreness, vertigo, dizziness. It was reported that both vaccines FLUAD and pneumococcal vaccine were administered on left arm which is characterized as drug administration error. Action taken with the FLUAD (TIV) was not reported and outcome of the all was not reported. Reporter's Assessment: The other non-health professional did not provide the causality between the all events and FLUAD (TIV). This report was not serious.