chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLUX, FLUX, FLUX
Symptoms: Visual acuity tests abnormal, Visual field tests abnormal
Clinical narrative: Case number PHHY2013US147575, is an initial literature report received on 13 Dec 2013. The authors in this article discussed about a case of multiple evanescent white dot syndrome following recent influenza vaccination. This report refers to a 53-year-old male patient. Ocular history was significant for remote pterygium excision in right eye. Medical history, in addition to hepatitis B and C, was significant for polysubstance abuse, for which he had recently entered rehabilitation. Concomitant medications included buprenorphine and naloxone. He was vaccinated with influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date, he complained of seeing a purple haze in his right eye for 3 days. On an unknown date, initial examination revealed corrected visual acuity of 20/25 (-2) in right eye and 20/20 in left eye. However, the results of pupillary reactions, confrontational visual field, color vision, and intraocular pressure were all within normal limits. Anterior segment examination was unremarkable and quiet vitreous were noted. On an unknown date, fundus examination in right eye revealed multiple white lesions at the level of outer retina/retinal pigment epithelium (RPE) with a granular foveal appearance and fluorescein angiography revealed early multiple punctate hyperfluorescent spots with late staining, which also involved the optic nerve head. On an unknown date initial Humphrey 30-2 visual field testing was of low reliability, however the follow-up testing revealed residual enlargement of the blind spot with a para-central scotoma which improved over time. He was given a diagnosis of multiple evanescent white dot syndrome (MEWDS). He was followed with serial examinations. At the 1-month visit, there was improvement in symptoms, fundus lesions resolved and vision recovered to 20/20. The author concluded that the exact pathophysiology behind the development of MEWDS was yet to be determined. Both infectious and autoimmune-mediated inflammatory mechanisms have been implicated as underlying causes. MEWDS developed in this patient after the influenza vaccination, but the patient was also a hepatitis carrier, making definitive conclusions regarding causative factors difficult. However, with the common use of the influenza vaccine, it would be prudent for ophthalmologists to be aware of this finding and consider this association.
Sex: M
Vaccine: FLUX, FLUX, FLUX
Symptoms: Angiogram abnormal, Colour vision tests normal, Fundoscopy abnormal, Intraocular pressure test normal, Pupillary light reflex tests abnormal
Clinical narrative: Case number PHHY2013US147575, is an initial literature report received on 13 Dec 2013. The authors in this article discussed about a case of multiple evanescent white dot syndrome following recent influenza vaccination. This report refers to a 53-year-old male patient. Ocular history was significant for remote pterygium excision in right eye. Medical history, in addition to hepatitis B and C, was significant for polysubstance abuse, for which he had recently entered rehabilitation. Concomitant medications included buprenorphine and naloxone. He was vaccinated with influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date, he complained of seeing a purple haze in his right eye for 3 days. On an unknown date, initial examination revealed corrected visual acuity of 20/25 (-2) in right eye and 20/20 in left eye. However, the results of pupillary reactions, confrontational visual field, color vision, and intraocular pressure were all within normal limits. Anterior segment examination was unremarkable and quiet vitreous were noted. On an unknown date, fundus examination in right eye revealed multiple white lesions at the level of outer retina/retinal pigment epithelium (RPE) with a granular foveal appearance and fluorescein angiography revealed early multiple punctate hyperfluorescent spots with late staining, which also involved the optic nerve head. On an unknown date initial Humphrey 30-2 visual field testing was of low reliability, however the follow-up testing revealed residual enlargement of the blind spot with a para-central scotoma which improved over time. He was given a diagnosis of multiple evanescent white dot syndrome (MEWDS). He was followed with serial examinations. At the 1-month visit, there was improvement in symptoms, fundus lesions resolved and vision recovered to 20/20. The author concluded that the exact pathophysiology behind the development of MEWDS was yet to be determined. Both infectious and autoimmune-mediated inflammatory mechanisms have been implicated as underlying causes. MEWDS developed in this patient after the influenza vaccination, but the patient was also a hepatitis carrier, making definitive conclusions regarding causative factors difficult. However, with the common use of the influenza vaccine, it would be prudent for ophthalmologists to be aware of this finding and consider this association.
Sex: M
Vaccine: FLUX, FLUX, FLUX
Symptoms: Retinal exudates, Retinal pigment epitheliopathy, Scotoma, Vision blurred, Visual acuity reduced
Clinical narrative: Case number PHHY2013US147575, is an initial literature report received on 13 Dec 2013. The authors in this article discussed about a case of multiple evanescent white dot syndrome following recent influenza vaccination. This report refers to a 53-year-old male patient. Ocular history was significant for remote pterygium excision in right eye. Medical history, in addition to hepatitis B and C, was significant for polysubstance abuse, for which he had recently entered rehabilitation. Concomitant medications included buprenorphine and naloxone. He was vaccinated with influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date, he complained of seeing a purple haze in his right eye for 3 days. On an unknown date, initial examination revealed corrected visual acuity of 20/25 (-2) in right eye and 20/20 in left eye. However, the results of pupillary reactions, confrontational visual field, color vision, and intraocular pressure were all within normal limits. Anterior segment examination was unremarkable and quiet vitreous were noted. On an unknown date, fundus examination in right eye revealed multiple white lesions at the level of outer retina/retinal pigment epithelium (RPE) with a granular foveal appearance and fluorescein angiography revealed early multiple punctate hyperfluorescent spots with late staining, which also involved the optic nerve head. On an unknown date initial Humphrey 30-2 visual field testing was of low reliability, however the follow-up testing revealed residual enlargement of the blind spot with a para-central scotoma which improved over time. He was given a diagnosis of multiple evanescent white dot syndrome (MEWDS). He was followed with serial examinations. At the 1-month visit, there was improvement in symptoms, fundus lesions resolved and vision recovered to 20/20. The author concluded that the exact pathophysiology behind the development of MEWDS was yet to be determined. Both infectious and autoimmune-mediated inflammatory mechanisms have been implicated as underlying causes. MEWDS developed in this patient after the influenza vaccination, but the patient was also a hepatitis carrier, making definitive conclusions regarding causative factors difficult. However, with the common use of the influenza vaccine, it would be prudent for ophthalmologists to be aware of this finding and consider this association.
Sex: M
Vaccine: FLUX, FLUX, FLUX
Symptoms: Visual field tests abnormal, Visual impairment
Clinical narrative: Case number PHHY2013US147575, is an initial literature report received on 13 Dec 2013. The authors in this article discussed about a case of multiple evanescent white dot syndrome following recent influenza vaccination. This report refers to a 53-year-old male patient. Ocular history was significant for remote pterygium excision in right eye. Medical history, in addition to hepatitis B and C, was significant for polysubstance abuse, for which he had recently entered rehabilitation. Concomitant medications included buprenorphine and naloxone. He was vaccinated with influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date, he complained of seeing a purple haze in his right eye for 3 days. On an unknown date, initial examination revealed corrected visual acuity of 20/25 (-2) in right eye and 20/20 in left eye. However, the results of pupillary reactions, confrontational visual field, color vision, and intraocular pressure were all within normal limits. Anterior segment examination was unremarkable and quiet vitreous were noted. On an unknown date, fundus examination in right eye revealed multiple white lesions at the level of outer retina/retinal pigment epithelium (RPE) with a granular foveal appearance and fluorescein angiography revealed early multiple punctate hyperfluorescent spots with late staining, which also involved the optic nerve head. On an unknown date initial Humphrey 30-2 visual field testing was of low reliability, however the follow-up testing revealed residual enlargement of the blind spot with a para-central scotoma which improved over time. He was given a diagnosis of multiple evanescent white dot syndrome (MEWDS). He was followed with serial examinations. At the 1-month visit, there was improvement in symptoms, fundus lesions resolved and vision recovered to 20/20. The author concluded that the exact pathophysiology behind the development of MEWDS was yet to be determined. Both infectious and autoimmune-mediated inflammatory mechanisms have been implicated as underlying causes. MEWDS developed in this patient after the influenza vaccination, but the patient was also a hepatitis carrier, making definitive conclusions regarding causative factors difficult. However, with the common use of the influenza vaccine, it would be prudent for ophthalmologists to be aware of this finding and consider this association.
Age: 53.0
Sex: M
Vaccine: FLUX, FLUX, FLUX
Symptoms: Angiogram abnormal, Colour vision tests normal, Fundoscopy abnormal, Intraocular pressure test normal, Ophthalmological examination
Clinical narrative: This literature report (initial receipt 16-Dec-2013) concerns a 53-year-old male patient who had a medical history of hepatitis B and C and polysubstance abuse, for which he had recently entered rehabilitation. His ocular history included remote pterygium excision OD. The patient's concomitant medication included buprenorphine and naloxone. On an unspecified date, the patient received an influenza vaccine (manufacturer and batch number not specified). On an unspecified date, 10 days after the vaccination, the patient noted visual symptoms. The patient presented with a complaint of seeing a purple haze in his right eye (OD) for 3 days. Initial examination revealed visual acuity of 20/25 -2OD and 20/20 OS. Results of pupillary reactions, confrontational visual field, colour vision and intraocular pressure were all within normal limits. An unremarkable anterior segment examination and quiet vitreous were noted. Fundus examination in right eye revealed multiple white lesions at the level of outer retina/RPE (retinal pigment epithelium) with a granular foveal appearance. Fluorescein angiography (FA) revealed early multiple punctate hyperfluorescent spots with late staining, which also involved the optic nerve head. Initial Humphrey 30-2 visual field was of low reliability, but follow-up testing revealed residual enlargement of the blind spot with a paracentral scotoma which improved over time. A diagnosis of Multiple Evanescent White Dot Syndrome (MEWDS) was made at the patient was followed with serial examinations. At the 1-month visit, the patient noted improvement in symptoms. Fundus lesions resolved and vision recovered to 20/20. Reporter's comment: The reporter stated that MEWDS developed in this patient after the influenza vaccination, but the patient was also a hepatitis carrier, making definitive conclusions regarding causative factors difficult.
Age: 53.0
Sex: M
Vaccine: FLUX, FLUX, FLUX
Symptoms: Ophthalmological examination abnormal, Pupillary light reflex tests normal, Retinal exudates, Retinal pigment epitheliopathy, Scotoma
Clinical narrative: This literature report (initial receipt 16-Dec-2013) concerns a 53-year-old male patient who had a medical history of hepatitis B and C and polysubstance abuse, for which he had recently entered rehabilitation. His ocular history included remote pterygium excision OD. The patient's concomitant medication included buprenorphine and naloxone. On an unspecified date, the patient received an influenza vaccine (manufacturer and batch number not specified). On an unspecified date, 10 days after the vaccination, the patient noted visual symptoms. The patient presented with a complaint of seeing a purple haze in his right eye (OD) for 3 days. Initial examination revealed visual acuity of 20/25 -2OD and 20/20 OS. Results of pupillary reactions, confrontational visual field, colour vision and intraocular pressure were all within normal limits. An unremarkable anterior segment examination and quiet vitreous were noted. Fundus examination in right eye revealed multiple white lesions at the level of outer retina/RPE (retinal pigment epithelium) with a granular foveal appearance. Fluorescein angiography (FA) revealed early multiple punctate hyperfluorescent spots with late staining, which also involved the optic nerve head. Initial Humphrey 30-2 visual field was of low reliability, but follow-up testing revealed residual enlargement of the blind spot with a paracentral scotoma which improved over time. A diagnosis of Multiple Evanescent White Dot Syndrome (MEWDS) was made at the patient was followed with serial examinations. At the 1-month visit, the patient noted improvement in symptoms. Fundus lesions resolved and vision recovered to 20/20. Reporter's comment: The reporter stated that MEWDS developed in this patient after the influenza vaccination, but the patient was also a hepatitis carrier, making definitive conclusions regarding causative factors difficult.
Age: 53.0
Sex: M
Vaccine: FLUX, FLUX, FLUX
Symptoms: Vision blurred, Visual acuity reduced, Visual field tests normal, Visual impairment
Clinical narrative: This literature report (initial receipt 16-Dec-2013) concerns a 53-year-old male patient who had a medical history of hepatitis B and C and polysubstance abuse, for which he had recently entered rehabilitation. His ocular history included remote pterygium excision OD. The patient's concomitant medication included buprenorphine and naloxone. On an unspecified date, the patient received an influenza vaccine (manufacturer and batch number not specified). On an unspecified date, 10 days after the vaccination, the patient noted visual symptoms. The patient presented with a complaint of seeing a purple haze in his right eye (OD) for 3 days. Initial examination revealed visual acuity of 20/25 -2OD and 20/20 OS. Results of pupillary reactions, confrontational visual field, colour vision and intraocular pressure were all within normal limits. An unremarkable anterior segment examination and quiet vitreous were noted. Fundus examination in right eye revealed multiple white lesions at the level of outer retina/RPE (retinal pigment epithelium) with a granular foveal appearance. Fluorescein angiography (FA) revealed early multiple punctate hyperfluorescent spots with late staining, which also involved the optic nerve head. Initial Humphrey 30-2 visual field was of low reliability, but follow-up testing revealed residual enlargement of the blind spot with a paracentral scotoma which improved over time. A diagnosis of Multiple Evanescent White Dot Syndrome (MEWDS) was made at the patient was followed with serial examinations. At the 1-month visit, the patient noted improvement in symptoms. Fundus lesions resolved and vision recovered to 20/20. Reporter's comment: The reporter stated that MEWDS developed in this patient after the influenza vaccination, but the patient was also a hepatitis carrier, making definitive conclusions regarding causative factors difficult.
Age: 53.0
Sex: M
Vaccine: FLUX, FLUX, FLUX
Symptoms: Angiogram abnormal, Angiogram retina abnormal, Colour vision tests normal, Fundoscopy abnormal, Intraocular pressure test normal
Clinical narrative: This literature report (initial receipt 16-Dec-2013) concerns a 53-year-old male patient who had a medical history of hepatitis B and C and polysubstance abuse, for which he had recently entered rehabilitation. His ocular history included remote pterygium excision OD. The patient's concomitant medication included buprenorphine and naloxone. On an unspecified date, the patient received an influenza vaccine (manufacturer and batch number not specified). On an unspecified date, 10 days after the vaccination, the patient noted visual symptoms. The patient presented with a complaint of seeing a purple haze in his right eye (OD) for 3 days. Initial examination revealed visual acuity of 20/25 -2OD and 20/20 OS. Results of pupillary reactions, confrontational visual field, colour vision and intraocular pressure were all within normal limits. An unremarkable anterior segment examination and quiet vitreous were noted. Fundus examination in right eye revealed multiple white lesions at the level of outer retina/RPE (retinal pigment epithelium) with a granular foveal appearance. Fluorescein angiography (FA) revealed early multiple punctate hyperfluorescent spots with late staining, which also involved the optic nerve head. Initial Humphrey 30-2 visual field was of low reliability, but follow-up testing revealed residual enlargement of the blind spot with a paracentral scotoma which improved over time. A diagnosis of Multiple Evanescent White Dot Syndrome (MEWDS) was made at the patient was followed with serial examinations. At the 1-month visit, the patient noted improvement in symptoms. Fundus lesions resolved and vision recovered to 20/20. Reporter's comment: The reporter stated that MEWDS developed in this patient after the influenza vaccination, but the patient was also a hepatitis carrier, making definitive conclusions regarding causative factors difficult.
Age: 53.0
Sex: M
Vaccine: FLUX, FLUX, FLUX
Symptoms: Pupillary light reflex tests normal, Retinal exudates, Retinal pigment epitheliopathy, Scotoma, Vision blurred
Clinical narrative: This literature report (initial receipt 16-Dec-2013) concerns a 53-year-old male patient who had a medical history of hepatitis B and C and polysubstance abuse, for which he had recently entered rehabilitation. His ocular history included remote pterygium excision OD. The patient's concomitant medication included buprenorphine and naloxone. On an unspecified date, the patient received an influenza vaccine (manufacturer and batch number not specified). On an unspecified date, 10 days after the vaccination, the patient noted visual symptoms. The patient presented with a complaint of seeing a purple haze in his right eye (OD) for 3 days. Initial examination revealed visual acuity of 20/25 -2OD and 20/20 OS. Results of pupillary reactions, confrontational visual field, colour vision and intraocular pressure were all within normal limits. An unremarkable anterior segment examination and quiet vitreous were noted. Fundus examination in right eye revealed multiple white lesions at the level of outer retina/RPE (retinal pigment epithelium) with a granular foveal appearance. Fluorescein angiography (FA) revealed early multiple punctate hyperfluorescent spots with late staining, which also involved the optic nerve head. Initial Humphrey 30-2 visual field was of low reliability, but follow-up testing revealed residual enlargement of the blind spot with a paracentral scotoma which improved over time. A diagnosis of Multiple Evanescent White Dot Syndrome (MEWDS) was made at the patient was followed with serial examinations. At the 1-month visit, the patient noted improvement in symptoms. Fundus lesions resolved and vision recovered to 20/20. Reporter's comment: The reporter stated that MEWDS developed in this patient after the influenza vaccination, but the patient was also a hepatitis carrier, making definitive conclusions regarding causative factors difficult.
Age: 53.0
Sex: M
Vaccine: FLUX, FLUX, FLUX
Symptoms: Visual acuity tests abnormal, Visual field tests abnormal
Clinical narrative: This literature report (initial receipt 16-Dec-2013) concerns a 53-year-old male patient who had a medical history of hepatitis B and C and polysubstance abuse, for which he had recently entered rehabilitation. His ocular history included remote pterygium excision OD. The patient's concomitant medication included buprenorphine and naloxone. On an unspecified date, the patient received an influenza vaccine (manufacturer and batch number not specified). On an unspecified date, 10 days after the vaccination, the patient noted visual symptoms. The patient presented with a complaint of seeing a purple haze in his right eye (OD) for 3 days. Initial examination revealed visual acuity of 20/25 -2OD and 20/20 OS. Results of pupillary reactions, confrontational visual field, colour vision and intraocular pressure were all within normal limits. An unremarkable anterior segment examination and quiet vitreous were noted. Fundus examination in right eye revealed multiple white lesions at the level of outer retina/RPE (retinal pigment epithelium) with a granular foveal appearance. Fluorescein angiography (FA) revealed early multiple punctate hyperfluorescent spots with late staining, which also involved the optic nerve head. Initial Humphrey 30-2 visual field was of low reliability, but follow-up testing revealed residual enlargement of the blind spot with a paracentral scotoma which improved over time. A diagnosis of Multiple Evanescent White Dot Syndrome (MEWDS) was made at the patient was followed with serial examinations. At the 1-month visit, the patient noted improvement in symptoms. Fundus lesions resolved and vision recovered to 20/20. Reporter's comment: The reporter stated that MEWDS developed in this patient after the influenza vaccination, but the patient was also a hepatitis carrier, making definitive conclusions regarding causative factors difficult.
Age: 53.0
Sex: M
Vaccine: FLUX, FLUX, FLUX
Symptoms: Angiogram abnormal, Colour vision tests normal, Fundoscopy abnormal, Intraocular pressure test normal, Pupillary light reflex tests abnormal
Clinical narrative: This literature report (initial receipt 16-Dec-2013) concerns a 53-year-old male patient who had a medical history of hepatitis B and C and polysubstance abuse, for which he had recently entered rehabilitation. His ocular history included remote pterygium excision OD. The patient's concomitant medication included buprenorphine and naloxone. On an unspecified date, the patient received an influenza vaccine (manufacturer and batch number not specified). On an unspecified date, 10 days after the vaccination, the patient noted visual symptoms. The patient presented with a complaint of seeing a purple haze in his right eye (OD) for 3 days. Initial examination revealed visual acuity of 20/25 -2OD and 20/20 OS. Results of pupillary reactions, confrontational visual field, colour vision and intraocular pressure were all within normal limits. An unremarkable anterior segment examination and quiet vitreous were noted. Fundus examination in right eye revealed multiple white lesions at the level of outer retina/RPE (retinal pigment epithelium) with a granular foveal appearance. Fluorescein angiography (FA) revealed early multiple punctate hyperfluorescent spots with late staining, which also involved the optic nerve head. Initial Humphrey 30-2 visual field was of low reliability, but follow-up testing revealed residual enlargement of the blind spot with a paracentral scotoma which improved over time. A diagnosis of Multiple Evanescent White Dot Syndrome (MEWDS) was made at the patient was followed with serial examinations. At the 1-month visit, the patient noted improvement in symptoms. Fundus lesions resolved and vision recovered to 20/20. Reporter's comment: The reporter stated that MEWDS developed in this patient after the influenza vaccination, but the patient was also a hepatitis carrier, making definitive conclusions regarding causative factors difficult.
Age: 53.0
Sex: M
Vaccine: FLUX, FLUX, FLUX
Symptoms: Retinal exudates, Retinal pigment epitheliopathy, Scotoma, Vision blurred, Visual acuity reduced
Clinical narrative: This literature report (initial receipt 16-Dec-2013) concerns a 53-year-old male patient who had a medical history of hepatitis B and C and polysubstance abuse, for which he had recently entered rehabilitation. His ocular history included remote pterygium excision OD. The patient's concomitant medication included buprenorphine and naloxone. On an unspecified date, the patient received an influenza vaccine (manufacturer and batch number not specified). On an unspecified date, 10 days after the vaccination, the patient noted visual symptoms. The patient presented with a complaint of seeing a purple haze in his right eye (OD) for 3 days. Initial examination revealed visual acuity of 20/25 -2OD and 20/20 OS. Results of pupillary reactions, confrontational visual field, colour vision and intraocular pressure were all within normal limits. An unremarkable anterior segment examination and quiet vitreous were noted. Fundus examination in right eye revealed multiple white lesions at the level of outer retina/RPE (retinal pigment epithelium) with a granular foveal appearance. Fluorescein angiography (FA) revealed early multiple punctate hyperfluorescent spots with late staining, which also involved the optic nerve head. Initial Humphrey 30-2 visual field was of low reliability, but follow-up testing revealed residual enlargement of the blind spot with a paracentral scotoma which improved over time. A diagnosis of Multiple Evanescent White Dot Syndrome (MEWDS) was made at the patient was followed with serial examinations. At the 1-month visit, the patient noted improvement in symptoms. Fundus lesions resolved and vision recovered to 20/20. Reporter's comment: The reporter stated that MEWDS developed in this patient after the influenza vaccination, but the patient was also a hepatitis carrier, making definitive conclusions regarding causative factors difficult.
Age: 53.0
Sex: M
Vaccine: FLUX, FLUX, FLUX
Symptoms: Visual field tests abnormal, Visual impairment
Clinical narrative: This literature report (initial receipt 16-Dec-2013) concerns a 53-year-old male patient who had a medical history of hepatitis B and C and polysubstance abuse, for which he had recently entered rehabilitation. His ocular history included remote pterygium excision OD. The patient's concomitant medication included buprenorphine and naloxone. On an unspecified date, the patient received an influenza vaccine (manufacturer and batch number not specified). On an unspecified date, 10 days after the vaccination, the patient noted visual symptoms. The patient presented with a complaint of seeing a purple haze in his right eye (OD) for 3 days. Initial examination revealed visual acuity of 20/25 -2OD and 20/20 OS. Results of pupillary reactions, confrontational visual field, colour vision and intraocular pressure were all within normal limits. An unremarkable anterior segment examination and quiet vitreous were noted. Fundus examination in right eye revealed multiple white lesions at the level of outer retina/RPE (retinal pigment epithelium) with a granular foveal appearance. Fluorescein angiography (FA) revealed early multiple punctate hyperfluorescent spots with late staining, which also involved the optic nerve head. Initial Humphrey 30-2 visual field was of low reliability, but follow-up testing revealed residual enlargement of the blind spot with a paracentral scotoma which improved over time. A diagnosis of Multiple Evanescent White Dot Syndrome (MEWDS) was made at the patient was followed with serial examinations. At the 1-month visit, the patient noted improvement in symptoms. Fundus lesions resolved and vision recovered to 20/20. Reporter's comment: The reporter stated that MEWDS developed in this patient after the influenza vaccination, but the patient was also a hepatitis carrier, making definitive conclusions regarding causative factors difficult.
Age: 78.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Aldolase normal, Areflexia, Asthenia, Blood creatine phosphokinase normal, Blood electrolytes normal
Clinical narrative: This medically confirmed literature report (initial receipt 16-Dec-2013) concerns a 78 year old male patient. The patient had a medical history of similar illness with respiratory issues requiring tracheostomy after an upper respiratory infection when he was 10 years old. The episode that the patient developed during childhood was presumably an episode of Guillain Barre Syndrome (GBS) which developed into chronic demyelinating inflammatory polyneuropathy (CIDP). On an unspecified date, the patient received influenza vaccine shot (manufacturer and batch number not provided). On an unspecified date, few days after the vaccination, the patient complained of five days of generalized weakness. He also experienced difficulty in getting up from a chair and difficulty while lifting his arm. A physical exam showed significant proximal as well as distal muscle weakness in bilateral upper and lower extremities. His sensations were preserved and reflexes were absent. His laboratory work up including electrolytes, TSH (thyroid stimulating hormone), CPK (creatine phosphokinase) and aldolase levels were normal. MRI (magnetic resonance imaging) of the head was unremarkable. An Electromyogram with Nerve Conduction Study showed evidence of CIDP. The patient was promptly started on treatment with corticosteroids. He showed gradual improvement in weakness and was advised to avoid influenza vaccines. Outcome was reported as recovering. Reporter's comment: CIPD can have relapses with triggers. This episode was probably from activation of CIDP triggered by influenza vaccination. The episode during childhood was presumably an episode of GBS which developed into CIDP. Studies have shown only small or no risk of these disorders from influenza vaccine.
Age: 78.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Blood thyroid stimulating hormone normal, Chronic inflammatory demyelinating polyradiculoneuropathy, Condition aggravated, Dysstasia, Electromyogram abnormal
Clinical narrative: This medically confirmed literature report (initial receipt 16-Dec-2013) concerns a 78 year old male patient. The patient had a medical history of similar illness with respiratory issues requiring tracheostomy after an upper respiratory infection when he was 10 years old. The episode that the patient developed during childhood was presumably an episode of Guillain Barre Syndrome (GBS) which developed into chronic demyelinating inflammatory polyneuropathy (CIDP). On an unspecified date, the patient received influenza vaccine shot (manufacturer and batch number not provided). On an unspecified date, few days after the vaccination, the patient complained of five days of generalized weakness. He also experienced difficulty in getting up from a chair and difficulty while lifting his arm. A physical exam showed significant proximal as well as distal muscle weakness in bilateral upper and lower extremities. His sensations were preserved and reflexes were absent. His laboratory work up including electrolytes, TSH (thyroid stimulating hormone), CPK (creatine phosphokinase) and aldolase levels were normal. MRI (magnetic resonance imaging) of the head was unremarkable. An Electromyogram with Nerve Conduction Study showed evidence of CIDP. The patient was promptly started on treatment with corticosteroids. He showed gradual improvement in weakness and was advised to avoid influenza vaccines. Outcome was reported as recovering. Reporter's comment: CIPD can have relapses with triggers. This episode was probably from activation of CIDP triggered by influenza vaccination. The episode during childhood was presumably an episode of GBS which developed into CIDP. Studies have shown only small or no risk of these disorders from influenza vaccine.
Age: 78.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Mobility decreased, Muscular weakness, Nerve conduction studies abnormal, Nuclear magnetic resonance imaging brain normal
Clinical narrative: This medically confirmed literature report (initial receipt 16-Dec-2013) concerns a 78 year old male patient. The patient had a medical history of similar illness with respiratory issues requiring tracheostomy after an upper respiratory infection when he was 10 years old. The episode that the patient developed during childhood was presumably an episode of Guillain Barre Syndrome (GBS) which developed into chronic demyelinating inflammatory polyneuropathy (CIDP). On an unspecified date, the patient received influenza vaccine shot (manufacturer and batch number not provided). On an unspecified date, few days after the vaccination, the patient complained of five days of generalized weakness. He also experienced difficulty in getting up from a chair and difficulty while lifting his arm. A physical exam showed significant proximal as well as distal muscle weakness in bilateral upper and lower extremities. His sensations were preserved and reflexes were absent. His laboratory work up including electrolytes, TSH (thyroid stimulating hormone), CPK (creatine phosphokinase) and aldolase levels were normal. MRI (magnetic resonance imaging) of the head was unremarkable. An Electromyogram with Nerve Conduction Study showed evidence of CIDP. The patient was promptly started on treatment with corticosteroids. He showed gradual improvement in weakness and was advised to avoid influenza vaccines. Outcome was reported as recovering. Reporter's comment: CIPD can have relapses with triggers. This episode was probably from activation of CIDP triggered by influenza vaccination. The episode during childhood was presumably an episode of GBS which developed into CIDP. Studies have shown only small or no risk of these disorders from influenza vaccine.
Age: 78.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Blood thyroid stimulating hormone normal, Chronic inflammatory demyelinating polyradiculoneuropathy, Dysstasia, Electromyogram abnormal, Mobility decreased
Clinical narrative: This medically confirmed literature report (initial receipt 16-Dec-2013) concerns a 78 year old male patient. The patient had a medical history of similar illness with respiratory issues requiring tracheostomy after an upper respiratory infection when he was 10 years old. The episode that the patient developed during childhood was presumably an episode of Guillain Barre Syndrome (GBS) which developed into chronic demyelinating inflammatory polyneuropathy (CIDP). On an unspecified date, the patient received influenza vaccine shot (manufacturer and batch number not provided). On an unspecified date, few days after the vaccination, the patient complained of five days of generalized weakness. He also experienced difficulty in getting up from a chair and difficulty while lifting his arm. A physical exam showed significant proximal as well as distal muscle weakness in bilateral upper and lower extremities. His sensations were preserved and reflexes were absent. His laboratory work up including electrolytes, TSH (thyroid stimulating hormone), CPK (creatine phosphokinase) and aldolase levels were normal. MRI (magnetic resonance imaging) of the head was unremarkable. An Electromyogram with Nerve Conduction Study showed evidence of CIDP. The patient was promptly started on treatment with corticosteroids. He showed gradual improvement in weakness and was advised to avoid influenza vaccines. Outcome was reported as recovering. Reporter's comment: CIPD can have relapses with triggers. This episode was probably from activation of CIDP triggered by influenza vaccination. The episode during childhood was presumably an episode of GBS which developed into CIDP. Studies have shown only small or no risk of these disorders from influenza vaccine.
Age: 78.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Muscular weakness, Nerve conduction studies abnormal, Nuclear magnetic resonance imaging brain normal
Clinical narrative: This medically confirmed literature report (initial receipt 16-Dec-2013) concerns a 78 year old male patient. The patient had a medical history of similar illness with respiratory issues requiring tracheostomy after an upper respiratory infection when he was 10 years old. The episode that the patient developed during childhood was presumably an episode of Guillain Barre Syndrome (GBS) which developed into chronic demyelinating inflammatory polyneuropathy (CIDP). On an unspecified date, the patient received influenza vaccine shot (manufacturer and batch number not provided). On an unspecified date, few days after the vaccination, the patient complained of five days of generalized weakness. He also experienced difficulty in getting up from a chair and difficulty while lifting his arm. A physical exam showed significant proximal as well as distal muscle weakness in bilateral upper and lower extremities. His sensations were preserved and reflexes were absent. His laboratory work up including electrolytes, TSH (thyroid stimulating hormone), CPK (creatine phosphokinase) and aldolase levels were normal. MRI (magnetic resonance imaging) of the head was unremarkable. An Electromyogram with Nerve Conduction Study showed evidence of CIDP. The patient was promptly started on treatment with corticosteroids. He showed gradual improvement in weakness and was advised to avoid influenza vaccines. Outcome was reported as recovering. Reporter's comment: CIPD can have relapses with triggers. This episode was probably from activation of CIDP triggered by influenza vaccination. The episode during childhood was presumably an episode of GBS which developed into CIDP. Studies have shown only small or no risk of these disorders from influenza vaccine.
Age: 0.77
Sex: F
Vaccine: HIBV
Symptoms: Abnormal behaviour, Body temperature increased, Feeding disorder of infancy or early childhood, Insomnia, Irritability
Clinical narrative: Since the vaccination patient has been very clingy, fussy, difficulty staying asleep, a mild temperature, and has had difficulty feeding her.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic, Rash vesicular, Scab
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old male patient. The patient's medical history included chicken pox. On 15-NOV-2013 the patient was vaccinated with a dose of ZOSTAVAX (Lot number [J00431] is an invalid lot number, Expire date 12-JUL-2014) Vial 19400 PFU in the left arm for routine vaccination (route and dose not reported). On an unknown date in 2013, the patient experienced some "lesions" on his arm and torso, two lesions on his right upper arm and one lesion on his right lower abdomen (stomach). The patient said that the lesions were itchy and red and looked like chicken pox. When the nurse examined him the two spots on his right upper arm were about a quarter of an inch cross, raised, pink, itchy and crusty (scaly) and the lesion on his stomach was described as one third to one half of an inch across light brown raised and itchy (the nurse felt the scabs had come off the lesions on his upper arm). The patient reported that the lesions had become progressively less itchy and were getting better. The pharmacist reported that no samples from the lesions were able to be collected. The patient sought medical attention by notified pharmacist. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old male patient with hypertension. On 05-DEC-2013 the patient was vaccinated with ZOSTAVAX, (Lot# reported as J007858, Expiry date: 28-SEP-2014) subcutaneous (Single dose). Concomitant medication included unspecified blood pressure medication. On 06-DEC-2013, 2 days after onset of therapy the patient experienced pain and burning on the plantar surface of his right foot. Patient sought medical attention by calling Pharmacist. The pain resolved in 2 hours without requiring treatment. Causality was not provided. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to 3 patients of unknown age and gender. The reporter stated that three doses of unsupported VARIVAX (Merck) (Lot# J008229, expiry date: 12-JUL-2015) subcutaneous, (dose, frequency and location unspecified) might have been administered to three patients. No adverse effects reported. At the time of report, the outcome of the event was unknown. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Fatigue, Lymphadenopathy, Malaise, Mumps, Mumps antibody test
Clinical narrative: This spontaneous report as received from a company representative refers to a female patient over 40 years of age. On an unknown date the patient was "allergedly" vaccinated with M-M-R II (subcutaneous injection). Dosing information and lot number were not provided. On 08-DEC-2013 the patient developed mumps, sore throat, fatigue, "extreme" malaise and swollen glands. The patient sought medical attention because of the adverse events, by going to the health department. A buccal test and blood test for mumps were performed on an unknown date. The results of the tests were unknown. The patient had not recovered from the events. A causality assessment was not provided. This report is linked with report 1312USA006048, 1312USA006064 and 1312USA008378, received from the same reporter, regarding five additional patients, who also allegedly underwent vaccination with M-M-R II, and then developed mumps. It was stated that all patients in the linked reports were in close contact to one another by being related or working together. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Oropharyngeal pain, Smear buccal
Clinical narrative: This spontaneous report as received from a company representative refers to a female patient over 40 years of age. On an unknown date the patient was "allergedly" vaccinated with M-M-R II (subcutaneous injection). Dosing information and lot number were not provided. On 08-DEC-2013 the patient developed mumps, sore throat, fatigue, "extreme" malaise and swollen glands. The patient sought medical attention because of the adverse events, by going to the health department. A buccal test and blood test for mumps were performed on an unknown date. The results of the tests were unknown. The patient had not recovered from the events. A causality assessment was not provided. This report is linked with report 1312USA006048, 1312USA006064 and 1312USA008378, received from the same reporter, regarding five additional patients, who also allegedly underwent vaccination with M-M-R II, and then developed mumps. It was stated that all patients in the linked reports were in close contact to one another by being related or working together. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding an unspecified 6 patients of unknown age and gender. This report pertains to the patient who on 02-DEC-2013 was vaccinated with a dose of M-M-R II, (lot # J003002, expiry date 14-MAR-2015) (dosage regimen unspecified). The healthcare worker reported that 6 clients were vaccinated with the same lot of improperly stored M-M-R II. The healthcare worker reported details of a supported temperature excursion for M-M-R II that were exposed to temperatures of 47Fahrenheit (F) for 1 hour 48 minutes (min), 48.5F for 1 hour 13 min, and 48.5F 1 hour 13 min (also reported as the vaccine was not stored improperly, the products would not be adversely affected by this specific temperature excursion). No adverse effect reported. No further information was available. This case is linked to 1312USA005771, 1312USA010204, 1312USA010206, 1312USA010207 (Same reporter link)). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from other health professional refers to a patient of unknown age and gender. On 19-DEC-2013 the patient was vaccinated with M-M-R II 0.5 ml, first dose subcutaneous. On 19-DEC-2013, second dose of M-M-R II was administered and no adverse effects were reported. No product quality issue has been involved. The outcome of first dose of event was unknown. Additional information has been requested.
Age: 0.74
Sex: M
Vaccine: HBHEPB
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from other health professional refers to a 9 month old male patient. On 03-DEC-2013, patient received expired dose of COMVAX with lot number (lot# H014513 and expiry date 29-OCT-2013), (strength, frequency unknown) 0.5 ml, intramuscularly and no adverse effect was reported. The outcome of received expired dose of COMVAX was unknown. No further information was provided. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to approximately 65 year old female patient. The patient was allergic to penicillin. None concomitant medications reported. On 10-DEC-2013 the patient was vaccinated with a dose of ZOSTAVAX lot # J008528 and expiry date 19-OCT-2014 (dosage regimen unspecified). On 12-DEC-2013 the patient developed an injection site reaction following vaccination. The injection site reaction was described as a raised, red, itchy area. The pharmacist reported that the patient had stated that the size of the injection site reaction had increased slightly reportedly since yesterday (approximately 12-DEC-2013) however exact size change was unspecified. The event was treated with cold packs. None lab diagnostics studies performed. The patient sought medical attention via contacting the pharmacist. The event was reported as not recovered. Reporter's causality was not provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding an unspecified 6 patients of unknown age and gender. This report pertains to the patient who on 21-NOV-2013 was vaccinated with a dose of M-M-R II, (lot # J003002, expiry date 14-MAR-2015) (dosage regimen unspecified). The healthcare worker reported that 6 clients were vaccinated with the same lot of improperly stored M-M-R II. The healthcare worker reported details of a supported temperature excursion for M-M-R II that were exposed to temperatures of 47Fahrenheit (F) for 1 hour 48 minutes (min), 48.5F for 1 hour 13 min, and 48.5F 1 hour 13 min (also reported as the vaccine was not stored improperly, the products would not be adversely affected by this specific temperature excursion). No adverse effect reported. No further information was available. This case is linked to 1312USA010204, 1312USA010205, 1312USA010206, 1312USA010207 (Same reporter link). Additional information has been requested.