chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: This spontaneous case, initially received via VAERS on 12-Apr-2017, was reported by a other non-health professional and concerns a 49 year old adult female patient. The patient's medication history included: diabetes, migraine, sleep apnea, asthma, rhinitis, hypertension, GERD (Gastroesophageal reflux disease), hiatal hernia and gastroparesis. The patient's concomitant medication included: PROTONIX, TRANDATE, Co-q 10+vitamin D3, LEXAPRO, Magnesium, Metformin, TOPROL (reported as toporal), MIGRELIEF. Administration of Company suspect drug: On 31-Oct-2016, the patient administered with INN flu vaccine seasonal (Dose, batch number: not reported, Route of administration: intramuscular). Adverse reactions/events and outcomes: The patient reported that, on 05-Nov-2016 after administration of INN Flu Vaccine Seasonal she had a great deal of increasing pain in her left elbow the has radiated up into shoulder and down into her fingers ever since vaccination. It is also reported that she hardly lifts up her glass to drink. Treatment medications: It was reported that nothing she take TYLENOL, Ibuprofen, EXCEDRIN, ASA, ALEVE seem to work to help the pain. Action taken with INN flu vaccine seasonal was not reported. The outcome of the event was not reported. Reporter's Assessment: The reporter implied that the causality between INN flu vaccine seasonal and events as related. Health Authority considered this as non serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Arthralgia, Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous case, initially received via VAERS on 12-Apr-2017, was reported by a other non-health professional and concerns a 49 year old adult female patient. The patient's medication history included: diabetes, migraine, sleep apnea, asthma, rhinitis, hypertension, GERD (Gastroesophageal reflux disease), hiatal hernia and gastroparesis. The patient's concomitant medication included: PROTONIX, TRANDATE, Co-q 10+vitamin D3, LEXAPRO, Magnesium, Metformin, TOPROL (reported as toporal), MIGRELIEF. Administration of Company suspect drug: On 31-Oct-2016, the patient administered with INN flu vaccine seasonal (Dose, batch number: not reported, Route of administration: intramuscular). Adverse reactions/events and outcomes: The patient reported that, on 05-Nov-2016 after administration of INN Flu Vaccine Seasonal she had a great deal of increasing pain in her left elbow the has radiated up into shoulder and down into her fingers ever since vaccination. It is also reported that she hardly lifts up her glass to drink. Treatment medications: It was reported that nothing she take TYLENOL, Ibuprofen, EXCEDRIN, ASA, ALEVE seem to work to help the pain. Action taken with INN flu vaccine seasonal was not reported. The outcome of the event was not reported. Reporter's Assessment: The reporter implied that the causality between INN flu vaccine seasonal and events as related. Health Authority considered this as non serious.
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Dizziness, Dysgeusia
Clinical narrative: This spontaneous case initially received on 12-Apr-2017, which was reported by other Non-health professional via regulatory authority (VAERS ID: 678341) and concerns a 70 years old female patient. Administration of Company suspect drug: On 12-Jan-2017, patient was administered with FLUAD via intramuscular route of administration (dose: not reported, anatomical location: right arm) (Batch number: 165803). The indication was not reported. Adverse reactions/events and outcomes: On 12-Jan-2017 after administration of FLUAD (TIV), the patient experienced dizziness and strange taste in her mouth. The patient sat down for approximately 10 minutes, drank some water and felt better. Laboratory test included (BP test: 139/80, pulse rate: 78 (R) arm). The outcome of the events was recovered. Reporter's Assessment: The reporter did not provide the causality between events and FLUAD and assessed the events as non-serious. This report was not serious.
Age: 74.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Burning sensation, Immediate post-injection reaction, Joint range of motion decreased, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: This spontaneous case, initially received via VAERS (ID: 678351) on 12-Apr-2017, was reported by an other non-health professional and concerns a 74 years old female adult patient. The patient's medical history included scoliosis. The drug history included Penicillin. The patient's concomitant medication included ESTRACE, MSIR and PRILOSEC. Administration of Company suspect drug(s): On 14-Oct-2016, the patient received intramuscular INN Flu Vaccine on left arm. Adverse reactions/events and outcomes: On 14-Oct-2016, after administration of INN Flu Vaccine the patient experienced burning, tenderness, shoulder pain, limited ROM, burning from shoulder to wrist immediately post injection, constant ache, stiffness. The patient received physical therapy. Action taken with INN Flu Vaccine was not reported. The outcome of the event was recovered. Reporter's Assessment: The reporter did not provide the causality between INN Flu Vaccine and the events. This report was non-serious.
Age: 74.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Nuclear magnetic resonance imaging, Pain, Tenderness
Clinical narrative: This spontaneous case, initially received via VAERS (ID: 678351) on 12-Apr-2017, was reported by an other non-health professional and concerns a 74 years old female adult patient. The patient's medical history included scoliosis. The drug history included Penicillin. The patient's concomitant medication included ESTRACE, MSIR and PRILOSEC. Administration of Company suspect drug(s): On 14-Oct-2016, the patient received intramuscular INN Flu Vaccine on left arm. Adverse reactions/events and outcomes: On 14-Oct-2016, after administration of INN Flu Vaccine the patient experienced burning, tenderness, shoulder pain, limited ROM, burning from shoulder to wrist immediately post injection, constant ache, stiffness. The patient received physical therapy. Action taken with INN Flu Vaccine was not reported. The outcome of the event was recovered. Reporter's Assessment: The reporter did not provide the causality between INN Flu Vaccine and the events. This report was non-serious.
Age: 1.0
Sex: M
Vaccine: FLUX, MMR, VARCEL, FLUX, MMR, VARCEL
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by other non-health professional via Health Authority (VAERS ID: 678377) and concerns a 1 year old male patient. Administration of Company suspect drug: On 05-Jan-2017, the patient received INN Flu Vaccine (dose, expiry date, batch number, route of administration: not reported). Non-company suspect drugs: On 05-Jan-2017, the patient also received M-M-R and Varicella zoster vaccine (dose, expiry date, batch number, route of administration: not reported). It was reported that there was one other vaccination given besides the above, reporter think it was HIB or HepA but she can not recall. Adverse reactions/events and outcomes: On 17-Jan-2017 after administration of influenza vaccine, M-M-R and Varicella zoster vaccine, the reporter noticed a rash of small red dots on patient's neck and sides of face and rash was all over his torso, underarms, back, neck, tops of inner thighs. It was also reported that patient had been getting TYLENOL and Ibuprofen a few times after the vaccines maybe 4 or 5 times total sporadically in the 12 days. Action taken with the vaccine was not reported. The outcome of the events was not reported. Reporter's Assessment: The reporter did not provide the causality assessment of the events in relation to the INN Flu Vaccine. This case was non-serious.
Age: 1.0
Sex: M
Vaccine: FLUX, MMR, VARCEL, FLUX, MMR, VARCEL
Symptoms: Rash erythematous
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by other non-health professional via Health Authority (VAERS ID: 678377) and concerns a 1 year old male patient. Administration of Company suspect drug: On 05-Jan-2017, the patient received INN Flu Vaccine (dose, expiry date, batch number, route of administration: not reported). Non-company suspect drugs: On 05-Jan-2017, the patient also received M-M-R and Varicella zoster vaccine (dose, expiry date, batch number, route of administration: not reported). It was reported that there was one other vaccination given besides the above, reporter think it was HIB or HepA but she can not recall. Adverse reactions/events and outcomes: On 17-Jan-2017 after administration of influenza vaccine, M-M-R and Varicella zoster vaccine, the reporter noticed a rash of small red dots on patient's neck and sides of face and rash was all over his torso, underarms, back, neck, tops of inner thighs. It was also reported that patient had been getting TYLENOL and Ibuprofen a few times after the vaccines maybe 4 or 5 times total sporadically in the 12 days. Action taken with the vaccine was not reported. The outcome of the events was not reported. Reporter's Assessment: The reporter did not provide the causality assessment of the events in relation to the INN Flu Vaccine. This case was non-serious.
Age: 29.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Hypoaesthesia, Influenza virus test, Injection site pain, Paraesthesia
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported from other non-health professional via Health Authority (reference no: 678382) and concerns a 29 years old male patient. The patient's historical condition included anxiety disorder. Administration of Company suspect drug: On 14-Jan-2017, the patient received INN Flu Vaccine Seasonal (dose, expiry date: not reported, batch no: 344771203922) via injection. Events and outcomes: On 14-Jan-2017 after administration of influenza vaccine, the patient's left shoulder started to throb uncontrollable, then he was in severe pain, following him to made at home. When he woke up started to notice that he had tingling and numbness in his feet that did not go away. 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 assessment of the events in relation to the INN Flu Vaccine Seasonal. This case was non-serious.
Age: 29.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Hypoaesthesia, Influenza virus test negative, Musculoskeletal pain, Pain, Paraesthesia
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported from other non-health professional via Health Authority (reference no: 678382) and concerns a 29 years old male patient. The patient's historical condition included anxiety disorder. Administration of Company suspect drug: On 14-Jan-2017, the patient received INN Flu Vaccine Seasonal (dose, expiry date: not reported, batch no: 344771203922) via injection. Events and outcomes: On 14-Jan-2017 after administration of influenza vaccine, the patient's left shoulder started to throb uncontrollable, then he was in severe pain, following him to made at home. When he woke up started to notice that he had tingling and numbness in his feet that did not go away. 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 assessment of the events in relation to the INN Flu Vaccine Seasonal. This case was non-serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, 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: 678388) and concerns a 49-years-old female patient. The concomitant drugs included: B12 injections. Administration of Company suspect drug: On 05-Oct-2016, the patient was administered with INN Flu Vaccine Seasonal (batch number: not reported) via intramuscular route in left arm for an unknown indication. Adverse reactions/events and outcomes: On an unspecified date after administration of INN Flu Vaccine Seasonal, the patient experienced Pain at injection site and reported that it was a dull ache but sometimes sharp and shooting pain. Action taken with the INN Flu Vaccine Seasonal was not reported and outcome of the events Pain at injection site and shooting pain was not reported. Reporter's Assessment: The reporter did not provide the causality between the all events and INN Flu Vaccine Seasonal. This report was not serious.
Sex: M
Vaccine: FLUX, TTOX, VARZOS, FLUX, TTOX, VARZOS
Symptoms: Malaise, Pyrexia, Rash
Clinical narrative: This spontaneous case, initially received via Health Authority (VAERS ID-678413) on 12-Apr-2017, was reported by pharmacist (other health professional) and concerns a 62-year-old adult male patient. Patient medical history included in 13-Oct-2014, the patient was vaccinated with a dose of ZOSTAVAX (route of administration, frequency, lot number and expiration date were not provided). Administration of Company suspect drug: On 24-Dec-2016, the patient administered with INN flu vaccine seasonal (Dose, batch number and route of administration: not reported). Non-company suspect drug (s): On 24-Dec-2016, ZOSTAVAX and Tetanus toxoid were administered (Dose, batch number and route of administration: not reported). Adverse reactions/events and outcomes: The patient reported that, on 25-Dec-2016 after administration of INN Flu Vaccine Seasonal he experienced rash and a high fever from an unspecified date in Dec 2016, he had been sick in bed. Also, reported that he sought medical attention, he contacted the pharmacist but no treatment was given nor lab diagnostic studies were performed. Action taken with INN flu vaccine seasonal was not reported. The outcome of the event was not recovered. Reporter's Assessment: The reporter implied that the causality between INN flu vaccine seasonal and events as related. The Health Authority considered the case report as non-serious.
Age: 55.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Computerised tomogram head, Hypoaesthesia, Nuclear magnetic resonance imaging brain normal, Spinal myelogram abnormal
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by other non-health professional via regulatory authority (VAERS ID: 678454) and concerns a 55-years-old male patient. The patient's family history included: multiple sclerosis, confirmed in one sister and another sister with a similar episode but no confirmed multiple sclerosis in patient. Also is from an area with a high incidence of multiple sclerosis. The patient's medical history included: Chondrocalcinosis of the right knee. Concomitant medications included: Aspirin (dose: 81 mg, daily), Calcium carbonate (dose: 1205 mg, daily), Naproxen (dose: 500 mg, BID), Multiple vitamin daily. Administration of Company suspect drug: On 18-OCT-2016, patient was administered with INN Flu Vaccine (dose, batch number not reported, route of administration: intramuscular and anatomical location: arm). Adverse reactions/events and outcomes: On 20-Oct-2016 after administration of INN Flu Vaccine, the patient woke up to have a bowel movement in the morning and noticed left gluteal region (numbness)/perianal area felt numb like he could hardly feel it when he touched it. As the day progressed, patient had the similar feeling on the left chest particularly related to heat and cold, then the process involved left upper and lower extremity and then in chest, where the things went to the midline. Patient's left hemiscrotum seemed to feel numb compared to the right side and this was not a sudden onset. The patient did not face any issue with the vision and denied any weakness. Patient thought maybe if he ran it was not quite as balanced like sometimes and felt his left knee wanted to give away but thought it was more of a sensory rather than a motor issue and did not have any trouble with speech and hearing, no facial numbness/weakness. The patient did not have rashes, fever and myalgias. Relevant Test Results: On 16-11-16, Brain and CT was performed that showed the result as: Hyperintense T2 lesion with incomplete rim enhancement in the cervical cord at C3, suspicious for active demyelinating disease. Smaller left cervical cord T2 hyperintense lesion without enhancement at C5, may also represent demyelination. On 16-11-16, MRI scan: Unsure if this onset of symptoms is related to late-onset MS (would require a second episode of symptoms like this to confirm diagnosis or a demyelinating- type adverse effect to the vaccine. The action taken with INN Flu Vaccine was not reported. The outcome of the events was not reported. Reporter's Assessment: The reporter did not provided the causality between INN Flu Vaccine and events. This report is not serious.
Age: 55.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Anal hypoaesthesia, Arthropathy, Computerised tomogram abnormal, Demyelination, Genital hypoaesthesia
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by other non-health professional via regulatory authority (VAERS ID: 678454) and concerns a 55-years-old male patient. The patient's family history included: multiple sclerosis, confirmed in one sister and another sister with a similar episode but no confirmed multiple sclerosis in patient. Also is from an area with a high incidence of multiple sclerosis. The patient's medical history included: Chondrocalcinosis of the right knee. Concomitant medications included: Aspirin (dose: 81 mg, daily), Calcium carbonate (dose: 1205 mg, daily), Naproxen (dose: 500 mg, BID), Multiple vitamin daily. Administration of Company suspect drug: On 18-OCT-2016, patient was administered with INN Flu Vaccine (dose, batch number not reported, route of administration: intramuscular and anatomical location: arm). Adverse reactions/events and outcomes: On 20-Oct-2016 after administration of INN Flu Vaccine, the patient woke up to have a bowel movement in the morning and noticed left gluteal region (numbness)/perianal area felt numb like he could hardly feel it when he touched it. As the day progressed, patient had the similar feeling on the left chest particularly related to heat and cold, then the process involved left upper and lower extremity and then in chest, where the things went to the midline. Patient's left hemiscrotum seemed to feel numb compared to the right side and this was not a sudden onset. The patient did not face any issue with the vision and denied any weakness. Patient thought maybe if he ran it was not quite as balanced like sometimes and felt his left knee wanted to give away but thought it was more of a sensory rather than a motor issue and did not have any trouble with speech and hearing, no facial numbness/weakness. The patient did not have rashes, fever and myalgias. Relevant Test Results: On 16-11-16, Brain and CT was performed that showed the result as: Hyperintense T2 lesion with incomplete rim enhancement in the cervical cord at C3, suspicious for active demyelinating disease. Smaller left cervical cord T2 hyperintense lesion without enhancement at C5, may also represent demyelination. On 16-11-16, MRI scan: Unsure if this onset of symptoms is related to late-onset MS (would require a second episode of symptoms like this to confirm diagnosis or a demyelinating- type adverse effect to the vaccine. The action taken with INN Flu Vaccine was not reported. The outcome of the events was not reported. Reporter's Assessment: The reporter did not provided the causality between INN Flu Vaccine and events. This report is not serious.
Age: 55.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Hypoaesthesia, Nuclear magnetic resonance imaging abnormal, Spinal myelogram abnormal
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by other non-health professional via regulatory authority (VAERS ID: 678454) and concerns a 55-years-old male patient. The patient's family history included: multiple sclerosis, confirmed in one sister and another sister with a similar episode but no confirmed multiple sclerosis in patient. Also is from an area with a high incidence of multiple sclerosis. The patient's medical history included: Chondrocalcinosis of the right knee. Concomitant medications included: Aspirin (dose: 81 mg, daily), Calcium carbonate (dose: 1205 mg, daily), Naproxen (dose: 500 mg, BID), Multiple vitamin daily. Administration of Company suspect drug: On 18-OCT-2016, patient was administered with INN Flu Vaccine (dose, batch number not reported, route of administration: intramuscular and anatomical location: arm). Adverse reactions/events and outcomes: On 20-Oct-2016 after administration of INN Flu Vaccine, the patient woke up to have a bowel movement in the morning and noticed left gluteal region (numbness)/perianal area felt numb like he could hardly feel it when he touched it. As the day progressed, patient had the similar feeling on the left chest particularly related to heat and cold, then the process involved left upper and lower extremity and then in chest, where the things went to the midline. Patient's left hemiscrotum seemed to feel numb compared to the right side and this was not a sudden onset. The patient did not face any issue with the vision and denied any weakness. Patient thought maybe if he ran it was not quite as balanced like sometimes and felt his left knee wanted to give away but thought it was more of a sensory rather than a motor issue and did not have any trouble with speech and hearing, no facial numbness/weakness. The patient did not have rashes, fever and myalgias. Relevant Test Results: On 16-11-16, Brain and CT was performed that showed the result as: Hyperintense T2 lesion with incomplete rim enhancement in the cervical cord at C3, suspicious for active demyelinating disease. Smaller left cervical cord T2 hyperintense lesion without enhancement at C5, may also represent demyelination. On 16-11-16, MRI scan: Unsure if this onset of symptoms is related to late-onset MS (would require a second episode of symptoms like this to confirm diagnosis or a demyelinating- type adverse effect to the vaccine. The action taken with INN Flu Vaccine was not reported. The outcome of the events was not reported. Reporter's Assessment: The reporter did not provided the causality between INN Flu Vaccine and events. This report is not serious.
Sex: F
Vaccine: FLUA3, PPV, TDAP, FLUA3, PPV, TDAP
Symptoms: Induration, Injection site swelling, Pain, Skin warm
Clinical narrative: This Spontaneous case initially received via Vaccine adverse event reaction systems (VAERS ID: 678546) on Apr-2017 was reported by other non-healthcare professional and concerns a 73-year-old elderly female patient. Administration of Company suspect drug (s): On 11-Jan-2017, the patient was administered by FLUAD (TIV) (batch number: 165803, route of administration: intramuscular, anatomical location: left arm, dose and expiration date: not reported). The patient was also administered by PNEUMOVAX (batch number: M038216, route of administration: intramuscular, anatomical location: right arm, dose and expiration date: not reported). Indication not reported and BOOSTRIX, (batch number: 9524K, route of administration: intramuscular, anatomical location: left arm, dose and expiration date: not reported). Indication not reported. Adverse events/reactions and outcomes: On an unspecified date after administration/ by FLUAD (TIV), the patient had swollen arm from shoulder to elbow right arm (vaccination site swelling), warm to touch and firm and painful. Action taken with by FLUAD (TIV) was not reported. The outcome of the events was recovered/resolved. Reporter's Assessment: The other non-healthcare professional did not provide causality between the events patient had swollen arm from shoulder to elbow right arm, warm to touch and firm and painful and by FLUAD (TIV). This case was non-serious.
Sex: F
Vaccine: FLUA3, PPV, TDAP, FLUA3, PPV, TDAP
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This Spontaneous case initially received via Vaccine adverse event reaction systems (VAERS ID: 678546) on Apr-2017 was reported by other non-healthcare professional and concerns a 73-year-old elderly female patient. Administration of Company suspect drug (s): On 11-Jan-2017, the patient was administered by FLUAD (TIV) (batch number: 165803, route of administration: intramuscular, anatomical location: left arm, dose and expiration date: not reported). The patient was also administered by PNEUMOVAX (batch number: M038216, route of administration: intramuscular, anatomical location: right arm, dose and expiration date: not reported). Indication not reported and BOOSTRIX, (batch number: 9524K, route of administration: intramuscular, anatomical location: left arm, dose and expiration date: not reported). Indication not reported. Adverse events/reactions and outcomes: On an unspecified date after administration/ by FLUAD (TIV), the patient had swollen arm from shoulder to elbow right arm (vaccination site swelling), warm to touch and firm and painful. Action taken with by FLUAD (TIV) was not reported. The outcome of the events was recovered/resolved. Reporter's Assessment: The other non-healthcare professional did not provide causality between the events patient had swollen arm from shoulder to elbow right arm, warm to touch and firm and painful and by FLUAD (TIV). This case was non-serious.
Age: 64.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site pain
Clinical narrative: This Spontaneous case, initially received via Vaccine Adverse Event Reporting Systems (VAERS ID: 678556) on Apr-2017, was reported by other non-healthcare professional and concerns a 64-year-old female patient. The patient's medical history included coronary artery disease, blood pressure high. Administration of Company suspect drug: On 02-Oct-2016, the patient administered with INN Flu Vaccine (Dose, batch number: not reported, route of administration: intramuscular and anatomical location: left arm). Indication not reported. Adverse reactions/events and outcomes: On 03-Oct-2016 after administration of INN Flu Vaccine, the patient experienced pain in arm where vaccine was administered which was never resolved. Action taken with the INN Flu Vaccine was not reported. The outcome of the event was not recovered. Reporter's Assessment: The reporter assessed that the causality between INN Flu Vaccine and event as related. This report was not serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Allergy to vaccine
Clinical narrative: This Spontaneous case initially received via vaccine adverse event reporting systems (VAERS ID: 678784) on Apr-2017, was reported by physician and concerns a female patient of unspecified age. The patient's medical history included former smoker reported as 0.26 ppd, 8.75 pack-years. Administration of Company suspect drug: On an unspecified date, the patient was administered by INN Flu Vaccine Seasonal (batch  number, expiration date: not reported). Indication was not reported. Adverse events/reactions and outcomes: On an unspecified date, after administration of INN Flu Vaccine Seasonal, the patient had allergy to vaccine. 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 report was not serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Alopecia
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: 678785) and concerns a female patient of unspecified age. Administration of Company suspect drug(s): On an unspecified date, the patient was administered with INN Flu Vaccine via unknown route. Indication was not reported. Adverse reactions/events and outcomes: On unspecified date after administration of influenza vaccine the patient experienced alopecia. The patient experienced alopecia last year also after influenza vaccine. Action taken with the vaccine was not reported. Outcome of the event was not reported. Reporter's Assessment: The reporter did not provide the causality between vaccine and event. This case was non-serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous case, initially received via Vaccine adverse event reaction systems (VAERS ID: 678959) on Apr-2017 was reported by other non-healthcare professional and concerns a 40-year-old adult female patient. The patient's medical history included latex (latex allergy) historical drug included penicillin and rubber products. The patient's concomitants included SINGULAIR and SEROQUEL (dose, anatomical location, batch number, route of administration, expiration date: not reported). Administration of Company suspect drug (s): On 07-Oct-2014 the patient was administered by INN Flu Vaccine Seasonal (dose: 0, indication, anatomical location: left arm, batch number: 4602P, route of administration, expiration date: not reported). Adverse events/reactions and outcomes: On 07-Oct-2014 after INN Flu Vaccine Seasonal, the patient experienced immediate shock like pain to left shoulder upper arm, left shoulder upper arm with redness, left shoulder upper arm with swelling pain, immediate shock like pain to left shoulder upper arm, radiated to entire arm, tenderness and decreased mobility. The outcome of the events was not recovered/not resolved. Ice initially followed by TYLENOL (dose, anatomical location, batch number, route of administration, expiration date: not reported). Indication not reported, physical therapy stated with no effect. The action taken after INN Flu Vaccine Seasonal was not reported. Reporter's Assessment: The other non-healthcare professional assessed the events immediate shock like pain to left shoulder upper arm, left shoulder upper arm with redness, left shoulder upper arm with swelling pain, immediate shock like pain to left shoulder upper arm, radiated to entire arm, tenderness and decreased mobility as non-serious and the causality of the events were not reported. This case report was non-serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain in extremity, Tenderness
Clinical narrative: This spontaneous case, initially received via Vaccine adverse event reaction systems (VAERS ID: 678959) on Apr-2017 was reported by other non-healthcare professional and concerns a 40-year-old adult female patient. The patient's medical history included latex (latex allergy) historical drug included penicillin and rubber products. The patient's concomitants included SINGULAIR and SEROQUEL (dose, anatomical location, batch number, route of administration, expiration date: not reported). Administration of Company suspect drug (s): On 07-Oct-2014 the patient was administered by INN Flu Vaccine Seasonal (dose: 0, indication, anatomical location: left arm, batch number: 4602P, route of administration, expiration date: not reported). Adverse events/reactions and outcomes: On 07-Oct-2014 after INN Flu Vaccine Seasonal, the patient experienced immediate shock like pain to left shoulder upper arm, left shoulder upper arm with redness, left shoulder upper arm with swelling pain, immediate shock like pain to left shoulder upper arm, radiated to entire arm, tenderness and decreased mobility. The outcome of the events was not recovered/not resolved. Ice initially followed by TYLENOL (dose, anatomical location, batch number, route of administration, expiration date: not reported). Indication not reported, physical therapy stated with no effect. The action taken after INN Flu Vaccine Seasonal was not reported. Reporter's Assessment: The other non-healthcare professional assessed the events immediate shock like pain to left shoulder upper arm, left shoulder upper arm with redness, left shoulder upper arm with swelling pain, immediate shock like pain to left shoulder upper arm, radiated to entire arm, tenderness and decreased mobility as non-serious and the causality of the events were not reported. This case report was non-serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling, Mobility decreased
Clinical narrative: This spontaneous case, initially received via Vaccine adverse event reaction systems (VAERS ID: 678959) on Apr-2017 was reported by other non-healthcare professional and concerns a 40-year-old adult female patient. The patient's medical history included latex (latex allergy) historical drug included penicillin and rubber products. The patient's concomitants included SINGULAIR and SEROQUEL (dose, anatomical location, batch number, route of administration, expiration date: not reported). Administration of Company suspect drug (s): On 07-Oct-2014 the patient was administered by INN Flu Vaccine Seasonal (dose: 0, indication, anatomical location: left arm, batch number: 4602P, route of administration, expiration date: not reported). Adverse events/reactions and outcomes: On 07-Oct-2014 after INN Flu Vaccine Seasonal, the patient experienced immediate shock like pain to left shoulder upper arm, left shoulder upper arm with redness, left shoulder upper arm with swelling pain, immediate shock like pain to left shoulder upper arm, radiated to entire arm, tenderness and decreased mobility. The outcome of the events was not recovered/not resolved. Ice initially followed by TYLENOL (dose, anatomical location, batch number, route of administration, expiration date: not reported). Indication not reported, physical therapy stated with no effect. The action taken after INN Flu Vaccine Seasonal was not reported. Reporter's Assessment: The other non-healthcare professional assessed the events immediate shock like pain to left shoulder upper arm, left shoulder upper arm with redness, left shoulder upper arm with swelling pain, immediate shock like pain to left shoulder upper arm, radiated to entire arm, tenderness and decreased mobility as non-serious and the causality of the events were not reported. This case report was non-serious.
Age: 62.0
Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous case, initially received via Vaccine adverse event reaction systems (VAERS ID: 678982) on Apr-2017 was reported by other non-healthcare professional and concerns a 62-year-old adult male patient. The patient had history of allergy to penicillin and bee stings. Administration of Company suspect drug: On 17-Jan-2017, the patient received influenza virus vaccine polyvalent (anatomical location, dose, frequency, route, batch number, expiry date: not reported). Non-company suspect drug(s): On 17-Jan-2017, the patient received also Pneumo 23 was administered for unknown indication. Adverse reactions/events and outcomes: On 17-Jan-2017 after administration of INN Flu Vaccine Seasonal, the patient experienced sore arm with swelling. The patient used ice pack, but was of no good. He also stated that it he had a bit sore but started to move the arm and had been 3 days. The outcome of the events was not reported. The action taken after influenza virus vaccine polyvalent was not reported. Reporter's Assessment: The other non-healthcare professional assessed the events as non-serious and the causality of the events were not reported. This case report was non-serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Chills, Cold sweat, Dizziness, Insomnia, Nausea
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by other non-health professional via Health Authority (VAERS no: 679002) and concerns a 76 years old female patient. The patient's historical condition included sulfa drug allergy. The patient's concomitant medication included levothyroxine (50 ug), multivitamin, CoQ 10, Vitamin d and magnesium. Administration of Company suspect drug: On 17-Jan-2017, the patient received INN Flu Vaccine Seasonal (dose, expiry date batch no, route of administration: not reported). Adverse reactions/events and outcomes: On 19-Jan-2017 after administration of influenza vaccine, the patient experienced high fever, chills, cold sweat, light headedness, loss of sleep during night, daytime nausea, body aches, mild fever. On 20-Jan-2017, the patient continued to experience night sweats, body aches; loss of sleep. On 21-Jan-2017, the patient continued to experienced Nausea, body aches, which were ongoing at the time of this report. Action taken with the vaccine was not reported. Treatment medications: EXCEDRIN and extra fluid intake. The outcome of the events was not reported. Reporter's Assessment: The health authority did not provide the causality assessment of the events in relation to the INN Flu Vaccine Seasonal. This case was non-serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Night sweats, Pain, Pyrexia
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by other non-health professional via Health Authority (VAERS no: 679002) and concerns a 76 years old female patient. The patient's historical condition included sulfa drug allergy. The patient's concomitant medication included levothyroxine (50 ug), multivitamin, CoQ 10, Vitamin d and magnesium. Administration of Company suspect drug: On 17-Jan-2017, the patient received INN Flu Vaccine Seasonal (dose, expiry date batch no, route of administration: not reported). Adverse reactions/events and outcomes: On 19-Jan-2017 after administration of influenza vaccine, the patient experienced high fever, chills, cold sweat, light headedness, loss of sleep during night, daytime nausea, body aches, mild fever. On 20-Jan-2017, the patient continued to experience night sweats, body aches; loss of sleep. On 21-Jan-2017, the patient continued to experienced Nausea, body aches, which were ongoing at the time of this report. Action taken with the vaccine was not reported. Treatment medications: EXCEDRIN and extra fluid intake. The outcome of the events was not reported. Reporter's Assessment: The health authority did not provide the causality assessment of the events in relation to the INN Flu Vaccine Seasonal. This case was non-serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Musculoskeletal pain, Pain, Pain in extremity, X-ray
Clinical narrative: This spontaneous case, initially received via Vaccine adverse event reporing systems (VAERS ID: 679016) on Apr-2017, was reported by other non-healthcare professional and concerns a 60-year-old female patient. The concomitant drugs included Doxycycline (dose: 50mg daily) and Estradiol patch 0.0375. Administration of Company suspect drug: On 15-Sep-2016, the patient administered with INN Flu Vaccine Seasonal (Dose, batch number: not reported, route of administration: intramuscular and anatomical location: left arm). Adverse reactions/events and outcomes: On 17-Sep-2016 after administration of INN Flu Vaccine Seasonal, the patient experienced arm continued to hurt, she thought that the pain was due to injection but after some days pain passed to shoulder and within a week she couldn't raise her arm without causing severe pain. The patient went to Emergency room on 28-Nov-2016 as pain had become unbearable. X rays, range of motion, she contacted PT and massage to remedy for this situation. Relevant lab data: It was reported that x ray was done. Action taken with the INN Flu Vaccine Seasonal was not reported. The outcome of the event was not recovered. Reporter's Assessment: The reporter assessed that the causality between INN Flu Vaccine Seasonal and event as related. This case report was non-serious.
Age: 61.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Arthralgia, Audiogram, Dizziness, Ear, nose and throat examination, Hypoacusis
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: Injection site erythema, Injection site swelling, Myalgia, Neurological examination, Ophthalmological examination
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: Pruritus, 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.
Age: 61.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Arthralgia, Audiogram, Dizziness, Ear, nose and throat examination, Injection site erythema
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.