chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Rheumatoid factor negative, Splinter haemorrhages, Treponema test, Treponema test negative, Urine analysis normal
Clinical narrative: This case was reported in a literature article and described the occurrence of ischemic optic neuropathy in a 47-year-old female subject who was vaccinated with Influenza vaccine ((unspecified), manufacturer unspecified). This case corresponds to case 1 in the literature article. Concurrent medical conditions included mild strabismic amblyopia in her right eye. In October 1994, the subject received an unspecified dose of Influenza vaccine (unknown) (administration site and route unspecified, batch number not provided). 1 week after vaccination with Influenza vaccine (unspecified), the subject experienced decreased vision with transient eye pain. 5 days later, she developed blurriness in her left eye and optic disc atrophy. This case was assessed as medically serious by GSK. On examination, her visual acuity was 20/20 in both eyes, but Goldman perimetry showed a superior arcuate defect in right eye and an inferior altitudinal defect in left eye. There was no relative afferent pupillary defect. Both optic discs were moderately edematous with splinter hemorrhages and cotton-wool spots. The serum protein electrophoresis with immunofixation showed a nonspecific polyclonal hypergammaglobulinemia. The subject was treated with methylprednisolone and prednisone. The final diagnosis was bilateral anterior ischemic optic neuropathy rather than demyelinative optic neuritis due to the close temporal relationship to influenza vaccination and the bilateral involvement. According the authors, it might be an immune complex -mediated vasculopathy. This presumptive mechanism might also account for abnormal serum markers (elevated sedimentation rate and polyclonal hypergammaglobulinemia). The visual field defects in either eye didn't improve and eventually, segmental disc atrophy appeared. At the time of reporting, the events were unresolved. Summary of the literature article: Optic neuritis is an occasional complication of vaccination. Visual loss can be unilateral or bilateral and most subjects recover substantially without treatment. The presumptive mechanism is an immune-mediated demyelinating injury of the optic nerve. The authors report 2 subjects who had permanent visual loss following influenza vaccination. Their pattern of visual loss, segmental optic disc changes and failure of visual recovery were atypical for demyelinating optic neuritis and reminiscent of a primary ischemic injury to the optic nerve. The authors speculate that an immune complex-mediated vasculopathy following vaccination can cause anterior ischemic optic neuropathy. Clinicians should be aware of this entity because of the less favorable prognosis for visual recovery in these cases.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Vision blurred, Visual acuity reduced, Visual field defect, Visual field tests abnormal, Vitamin B12 normal
Clinical narrative: This case was reported in a literature article and described the occurrence of ischemic optic neuropathy in a 47-year-old female subject who was vaccinated with Influenza vaccine ((unspecified), manufacturer unspecified). This case corresponds to case 1 in the literature article. Concurrent medical conditions included mild strabismic amblyopia in her right eye. In October 1994, the subject received an unspecified dose of Influenza vaccine (unknown) (administration site and route unspecified, batch number not provided). 1 week after vaccination with Influenza vaccine (unspecified), the subject experienced decreased vision with transient eye pain. 5 days later, she developed blurriness in her left eye and optic disc atrophy. This case was assessed as medically serious by GSK. On examination, her visual acuity was 20/20 in both eyes, but Goldman perimetry showed a superior arcuate defect in right eye and an inferior altitudinal defect in left eye. There was no relative afferent pupillary defect. Both optic discs were moderately edematous with splinter hemorrhages and cotton-wool spots. The serum protein electrophoresis with immunofixation showed a nonspecific polyclonal hypergammaglobulinemia. The subject was treated with methylprednisolone and prednisone. The final diagnosis was bilateral anterior ischemic optic neuropathy rather than demyelinative optic neuritis due to the close temporal relationship to influenza vaccination and the bilateral involvement. According the authors, it might be an immune complex -mediated vasculopathy. This presumptive mechanism might also account for abnormal serum markers (elevated sedimentation rate and polyclonal hypergammaglobulinemia). The visual field defects in either eye didn't improve and eventually, segmental disc atrophy appeared. At the time of reporting, the events were unresolved. Summary of the literature article: Optic neuritis is an occasional complication of vaccination. Visual loss can be unilateral or bilateral and most subjects recover substantially without treatment. The presumptive mechanism is an immune-mediated demyelinating injury of the optic nerve. The authors report 2 subjects who had permanent visual loss following influenza vaccination. Their pattern of visual loss, segmental optic disc changes and failure of visual recovery were atypical for demyelinating optic neuritis and reminiscent of a primary ischemic injury to the optic nerve. The authors speculate that an immune complex-mediated vasculopathy following vaccination can cause anterior ischemic optic neuropathy. Clinicians should be aware of this entity because of the less favorable prognosis for visual recovery in these cases.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Angiogram abnormal, Angiotensin converting enzyme, Autoantibody positive, Blindness, Blood test normal
Clinical narrative: This case was reported in a literature article and described the occurrence of ischemic optic neuropathy in a 51-year-old female subject who was vaccinated with INFLUENZA (manufacturer unspecified). This case corresponds to case 2 in literature article. In October 1994, the subject received an unspecified dose of INFLUENZA (unspecified) (administration site and route unknown, batch number not provided). 1 day after vaccination with INFLUENZA (unspecified), the subject experienced fever, chills and myalgia. After 3 weeks, the events were resolved. 4 weeks later, the subject had ear pain, headache and blurry vision first in her right eye then in her left eye. Examination revealed acuities of 25/50 on right eye and 20/25 on left eye with an inferonasal visual field defect on right eye and a supernasal defect on left eye. Both optic discs were edematous, worse segmentally superiorly on right eye and inferiorly on left eye. This case was assessed as medically serious by GSK. The subject was treated with methylprednisolone. Despite this, her vision progressively worsened over several weeks to count-fingers right eye and 20/100 on left eye. Fluorescein angiography showed late optic disc staining consistent with disc edema. Her visual function was unchanged at 2 months and bilateral optic disc atrophy had developed. At the time of reporting the events were unresolved. The final diagnosis was bilateral anterior ischemic optic neuropathy rather than demyelinative optic neuritis due to the close temporal relationship to influenza vaccination and the bilateral involvement. According the authors, it might be an immune complex -mediated vasculopathy. This presumptive mechanism might also account for the systemic symptoms experienced by the subject prior to visual loss. Summary of the literature article: Optic neuritis is an occasional complication of vaccination. Visual loss can be unilateral or bilateral and most subject recover substantially without treatment. The presumptive mechanism is an immune-mediated demyelinating injury of the optic nerve. The authors report 2 subjects who had permanent visual loss following influenza vaccination. Their pattern of visual loss, segmental optic disc changes and failure of visual recovery were atypical for demyelinating optic neuritis and reminiscent of a primary ischemic injury to the optic nerve. The authors speculate that an immune complex-mediated vasculopathy following vaccination can cause anterior ischemic optic neuropathy. Clinicians should be aware of this entity because of the less favorable prognosis for visual recovery in these cases.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: CSF test normal, Cardiolipin antibody negative, Chills, Ear pain, Headache
Clinical narrative: This case was reported in a literature article and described the occurrence of ischemic optic neuropathy in a 51-year-old female subject who was vaccinated with INFLUENZA (manufacturer unspecified). This case corresponds to case 2 in literature article. In October 1994, the subject received an unspecified dose of INFLUENZA (unspecified) (administration site and route unknown, batch number not provided). 1 day after vaccination with INFLUENZA (unspecified), the subject experienced fever, chills and myalgia. After 3 weeks, the events were resolved. 4 weeks later, the subject had ear pain, headache and blurry vision first in her right eye then in her left eye. Examination revealed acuities of 25/50 on right eye and 20/25 on left eye with an inferonasal visual field defect on right eye and a supernasal defect on left eye. Both optic discs were edematous, worse segmentally superiorly on right eye and inferiorly on left eye. This case was assessed as medically serious by GSK. The subject was treated with methylprednisolone. Despite this, her vision progressively worsened over several weeks to count-fingers right eye and 20/100 on left eye. Fluorescein angiography showed late optic disc staining consistent with disc edema. Her visual function was unchanged at 2 months and bilateral optic disc atrophy had developed. At the time of reporting the events were unresolved. The final diagnosis was bilateral anterior ischemic optic neuropathy rather than demyelinative optic neuritis due to the close temporal relationship to influenza vaccination and the bilateral involvement. According the authors, it might be an immune complex -mediated vasculopathy. This presumptive mechanism might also account for the systemic symptoms experienced by the subject prior to visual loss. Summary of the literature article: Optic neuritis is an occasional complication of vaccination. Visual loss can be unilateral or bilateral and most subject recover substantially without treatment. The presumptive mechanism is an immune-mediated demyelinating injury of the optic nerve. The authors report 2 subjects who had permanent visual loss following influenza vaccination. Their pattern of visual loss, segmental optic disc changes and failure of visual recovery were atypical for demyelinating optic neuritis and reminiscent of a primary ischemic injury to the optic nerve. The authors speculate that an immune complex-mediated vasculopathy following vaccination can cause anterior ischemic optic neuropathy. Clinicians should be aware of this entity because of the less favorable prognosis for visual recovery in these cases.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Lumbar puncture normal, Myalgia, Nuclear magnetic resonance imaging normal, Optic atrophy, Optic ischaemic neuropathy
Clinical narrative: This case was reported in a literature article and described the occurrence of ischemic optic neuropathy in a 51-year-old female subject who was vaccinated with INFLUENZA (manufacturer unspecified). This case corresponds to case 2 in literature article. In October 1994, the subject received an unspecified dose of INFLUENZA (unspecified) (administration site and route unknown, batch number not provided). 1 day after vaccination with INFLUENZA (unspecified), the subject experienced fever, chills and myalgia. After 3 weeks, the events were resolved. 4 weeks later, the subject had ear pain, headache and blurry vision first in her right eye then in her left eye. Examination revealed acuities of 25/50 on right eye and 20/25 on left eye with an inferonasal visual field defect on right eye and a supernasal defect on left eye. Both optic discs were edematous, worse segmentally superiorly on right eye and inferiorly on left eye. This case was assessed as medically serious by GSK. The subject was treated with methylprednisolone. Despite this, her vision progressively worsened over several weeks to count-fingers right eye and 20/100 on left eye. Fluorescein angiography showed late optic disc staining consistent with disc edema. Her visual function was unchanged at 2 months and bilateral optic disc atrophy had developed. At the time of reporting the events were unresolved. The final diagnosis was bilateral anterior ischemic optic neuropathy rather than demyelinative optic neuritis due to the close temporal relationship to influenza vaccination and the bilateral involvement. According the authors, it might be an immune complex -mediated vasculopathy. This presumptive mechanism might also account for the systemic symptoms experienced by the subject prior to visual loss. Summary of the literature article: Optic neuritis is an occasional complication of vaccination. Visual loss can be unilateral or bilateral and most subject recover substantially without treatment. The presumptive mechanism is an immune-mediated demyelinating injury of the optic nerve. The authors report 2 subjects who had permanent visual loss following influenza vaccination. Their pattern of visual loss, segmental optic disc changes and failure of visual recovery were atypical for demyelinating optic neuritis and reminiscent of a primary ischemic injury to the optic nerve. The authors speculate that an immune complex-mediated vasculopathy following vaccination can cause anterior ischemic optic neuropathy. Clinicians should be aware of this entity because of the less favorable prognosis for visual recovery in these cases.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Papilloedema, Pyrexia, Red blood cell sedimentation rate normal, Treponema test negative, Vision blurred
Clinical narrative: This case was reported in a literature article and described the occurrence of ischemic optic neuropathy in a 51-year-old female subject who was vaccinated with INFLUENZA (manufacturer unspecified). This case corresponds to case 2 in literature article. In October 1994, the subject received an unspecified dose of INFLUENZA (unspecified) (administration site and route unknown, batch number not provided). 1 day after vaccination with INFLUENZA (unspecified), the subject experienced fever, chills and myalgia. After 3 weeks, the events were resolved. 4 weeks later, the subject had ear pain, headache and blurry vision first in her right eye then in her left eye. Examination revealed acuities of 25/50 on right eye and 20/25 on left eye with an inferonasal visual field defect on right eye and a supernasal defect on left eye. Both optic discs were edematous, worse segmentally superiorly on right eye and inferiorly on left eye. This case was assessed as medically serious by GSK. The subject was treated with methylprednisolone. Despite this, her vision progressively worsened over several weeks to count-fingers right eye and 20/100 on left eye. Fluorescein angiography showed late optic disc staining consistent with disc edema. Her visual function was unchanged at 2 months and bilateral optic disc atrophy had developed. At the time of reporting the events were unresolved. The final diagnosis was bilateral anterior ischemic optic neuropathy rather than demyelinative optic neuritis due to the close temporal relationship to influenza vaccination and the bilateral involvement. According the authors, it might be an immune complex -mediated vasculopathy. This presumptive mechanism might also account for the systemic symptoms experienced by the subject prior to visual loss. Summary of the literature article: Optic neuritis is an occasional complication of vaccination. Visual loss can be unilateral or bilateral and most subject recover substantially without treatment. The presumptive mechanism is an immune-mediated demyelinating injury of the optic nerve. The authors report 2 subjects who had permanent visual loss following influenza vaccination. Their pattern of visual loss, segmental optic disc changes and failure of visual recovery were atypical for demyelinating optic neuritis and reminiscent of a primary ischemic injury to the optic nerve. The authors speculate that an immune complex-mediated vasculopathy following vaccination can cause anterior ischemic optic neuropathy. Clinicians should be aware of this entity because of the less favorable prognosis for visual recovery in these cases.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Visual acuity tests abnormal, Visual field defect, Visual impairment
Clinical narrative: This case was reported in a literature article and described the occurrence of ischemic optic neuropathy in a 51-year-old female subject who was vaccinated with INFLUENZA (manufacturer unspecified). This case corresponds to case 2 in literature article. In October 1994, the subject received an unspecified dose of INFLUENZA (unspecified) (administration site and route unknown, batch number not provided). 1 day after vaccination with INFLUENZA (unspecified), the subject experienced fever, chills and myalgia. After 3 weeks, the events were resolved. 4 weeks later, the subject had ear pain, headache and blurry vision first in her right eye then in her left eye. Examination revealed acuities of 25/50 on right eye and 20/25 on left eye with an inferonasal visual field defect on right eye and a supernasal defect on left eye. Both optic discs were edematous, worse segmentally superiorly on right eye and inferiorly on left eye. This case was assessed as medically serious by GSK. The subject was treated with methylprednisolone. Despite this, her vision progressively worsened over several weeks to count-fingers right eye and 20/100 on left eye. Fluorescein angiography showed late optic disc staining consistent with disc edema. Her visual function was unchanged at 2 months and bilateral optic disc atrophy had developed. At the time of reporting the events were unresolved. The final diagnosis was bilateral anterior ischemic optic neuropathy rather than demyelinative optic neuritis due to the close temporal relationship to influenza vaccination and the bilateral involvement. According the authors, it might be an immune complex -mediated vasculopathy. This presumptive mechanism might also account for the systemic symptoms experienced by the subject prior to visual loss. Summary of the literature article: Optic neuritis is an occasional complication of vaccination. Visual loss can be unilateral or bilateral and most subject recover substantially without treatment. The presumptive mechanism is an immune-mediated demyelinating injury of the optic nerve. The authors report 2 subjects who had permanent visual loss following influenza vaccination. Their pattern of visual loss, segmental optic disc changes and failure of visual recovery were atypical for demyelinating optic neuritis and reminiscent of a primary ischemic injury to the optic nerve. The authors speculate that an immune complex-mediated vasculopathy following vaccination can cause anterior ischemic optic neuropathy. Clinicians should be aware of this entity because of the less favorable prognosis for visual recovery in these cases.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Antinuclear antibody positive, Blood test abnormal, Laboratory test abnormal, Nuclear magnetic resonance imaging abnormal, Optic neuritis
Clinical narrative: This case was reported in a literature article and described the occurrence of optic neuritis in a 59-year-old female subject who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified). On an unspecified date, the subject received an unspecified dose of Influenza vaccine unspecified (administration site and route unknown, batch number not provided). 2 weeks after vaccination with Influenza vaccine unspecified, the subject experienced optic neuritis. It happened on 2 occasions, each time after influenza vaccination. This case was assessed as medically serious by GSK. There were no evidence of neuroretinitis, syphilis or systemic lupus erythematous. At the time of reporting, the outcome of the event was unspecified. The authors considered the event was almost certainly related to vaccination with Influenza vaccine unspecified.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Treponema test positive
Clinical narrative: This case was reported in a literature article and described the occurrence of optic neuritis in a 59-year-old female subject who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified). On an unspecified date, the subject received an unspecified dose of Influenza vaccine unspecified (administration site and route unknown, batch number not provided). 2 weeks after vaccination with Influenza vaccine unspecified, the subject experienced optic neuritis. It happened on 2 occasions, each time after influenza vaccination. This case was assessed as medically serious by GSK. There were no evidence of neuroretinitis, syphilis or systemic lupus erythematous. At the time of reporting, the outcome of the event was unspecified. The authors considered the event was almost certainly related to vaccination with Influenza vaccine unspecified.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Infectious mononucleosis, Staphylococcal infection
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a 15 year old female patient who on 24-FEB-2011, was vaccinated with 1st dose of GARDASIL in the left deltoid (lot# 1498Y, expiration date, 06-OCT-2011). On 03-JUN-2013, was vaccinated with 2nd dose of GARDASIL in the right deltoid (lot# 1561Z, expiration date, 23-MAR-2013). No concomitant medication, pertinent medical history and drug reactions/allergies were reported. No laboratory test was performed. On 24-FEB-2011, after the first dose of GARDASIL the patient developed methicillin-resistant staphylococcal aureus (MRSA). Then on 03-JUN-2011, after second dose of GARDASIL the patient developed mononucleosis. The patient saw her unspecified primary care physician on an unspecified date. The patient was now concerned about receiving the third dose of GARDASIL. As of today, 06-MAY-2013, the patient had not received the third dose of GARDASIL and she did not have MRSA or mononucleosis. The relationship between MRSA and mononucleosis and GARDASIL vaccines was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The pharmacist was informed by an unspecified physician, that the patient received the first dose of GARDASIL (lot number and expiration date not reported) (dose and route not reported) several years ago and then a second dose of GARDASIL on 03-MAY-2013. Concomitant therapy was not reported. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a registered nurse referring that an unspecified numbers of patients may had been vaccinated on unspecified dates with PNEUMOVAX23 (lot # not reported) that was improperly stored, within the month of April. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site anaesthesia, Injection site erythema, Injection site reaction, Injection site swelling, Paraesthesia
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 13 year old male patient. On 30-APR-2013 the patient was vaccinated with VARIVAX (Merck) (lot # h016057, expiration date 30-APR-2013), 0.5 ml, via intramuscular (anatomical location unknown). On 30-APR-2013, the patient developed numbness, tingling, redness and swelling with no induration at the injection site. The patient sought medical attention (office visit) and no treatment was given at this time. The outcome of numbness, swelling, redness and tingling was reported as not recovered/not resolved. Additional information has been assistant.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: Information has been received from a consumer to report an adverse event on behalf of her 13 year old male son. No drug reactions/allergies were reported. No pertinent medical history was reported. On 12-APR-2013 the patient was vaccinated with a dose of GARDASIL (route of administration, lot and dose # not reported). No concomitant medications were reported. About one week after receiving GARDASIL (19-APR-2013), the patient suffered from right supraclavicular lymphadenopathy. Patient did seek medical attention from the physician and was treated for this adverse event. He was recovering. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to unspecified patient(s) of unknown age. On unknown date(s), unspecified patient(s) were vaccinated with GARDASIL (lot # not reported) (strength and total daily dose not reported). It was reported that unspecified patient(s) did not complete series or take a long time to complete. No adverse events were reported. It was unspecified whether the patient(s) sought for medical attention. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a master of science in nursing (MSN) refers to a patient of unknown age and gender who on 20-MAR-2013 was vaccinated with VARIVAX (merck) 5 ml, subcutaneous (route and application site unspecified) (lot # H012506 exp date 25-JUN-2013). The reporter stated that the patient was vaccinated with an improperly VARIVAX (merck) dose. No adverse effect was reported. This is one of several cases from the same reporter. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 14 year old patient with unknown gender. On 02-MAY-2013 the patient was vaccinated with PROQUAD, 0.5 ml (anatomical location, dose number, lot number and expiration date unknown) via subcutaneous, concomitant medications were not reported. The reporter stated that on 02-MAY-2013 (yesterday), the 14 year old patient received a dose (merck) PROQUAD, and no adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a master of science in nursing (MSN) refers to a patient of unknown age and gender who on 20-MAR-2013 was vaccinated with VARIVAX (Merck) 5 ml, subcutaneous (route and application site unspecified) (lot # H012506 exp date 25-JUN-2013). The reporter stated that the patient was vaccinated with an improperly VARIVAX (Merck) dose. No adverse effect was reported. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. It was reported that on an unknown date the patient was given 1st and 2nd doses of GARDASIL (lot number and expiration date not reported) (dose and route not reported), 11 days apart. Concomitant therapy was not reported. No adverse event reported. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Activities of daily living impaired, Asthma, Condition aggravated, Dyspnoea, Hypersensitivity
Clinical narrative: This spontaneous report was received from a 49 year old female patient with animal and seasonal allergies, and allergies to BACTRIM, "viaxin" and "boxy cyclemc chlorsyamum." She had always received the flu vaccine (manufacturer and dates unknown). On 29-NOV-2011, the patient was vaccinated with PNEUMOVAX23, lot # 1420AA. Concomitant therapies included albuterol inhaler, pregnenolone as needed and alprazolam (manufacturers unknown), CRESTOR, ZETIA, Vitamin B12, aspirin, ZOFRAN for nausea, PROAIR, PREVACID, "notopropol," "Sythrodi," and "amateser." The patient reported ongoing adverse symptoms after receiving the PNEUMOVAX23 on 29-NOV-2011. The reaction included immediate pain, "like nothing I had ever experienced," numbness and the inability to breathe. After receiving PNEUMOVAX23, she experienced a hypersensitivity reaction of the skin. The patient reported that the "NOVOCAIN-like numbness" is still present, and that her prior allergies have intensified to the debilitating level, rendering her unable to work or pursue higher education. She reported that she is "acutely asthmatic," has experienced closure of the throat when exposed to allergens, and "needs to carry two EPI-PENS with her at all times." She received breathing treatments for allergic reactions, was hospitalized (not prolonged) and underwent 6-7 months of therapy and tests with an allergist. Her present status is not recovered. Prior allergies intensified to debilitating level was considered to be disabling. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Pain, Throat tightness
Clinical narrative: This spontaneous report was received from a 49 year old female patient with animal and seasonal allergies, and allergies to BACTRIM, "viaxin" and "boxy cyclemc chlorsyamum." She had always received the flu vaccine (manufacturer and dates unknown). On 29-NOV-2011, the patient was vaccinated with PNEUMOVAX23, lot # 1420AA. Concomitant therapies included albuterol inhaler, pregnenolone as needed and alprazolam (manufacturers unknown), CRESTOR, ZETIA, Vitamin B12, aspirin, ZOFRAN for nausea, PROAIR, PREVACID, "notopropol," "Sythrodi," and "amateser." The patient reported ongoing adverse symptoms after receiving the PNEUMOVAX23 on 29-NOV-2011. The reaction included immediate pain, "like nothing I had ever experienced," numbness and the inability to breathe. After receiving PNEUMOVAX23, she experienced a hypersensitivity reaction of the skin. The patient reported that the "NOVOCAIN-like numbness" is still present, and that her prior allergies have intensified to the debilitating level, rendering her unable to work or pursue higher education. She reported that she is "acutely asthmatic," has experienced closure of the throat when exposed to allergens, and "needs to carry two EPI-PENS with her at all times." She received breathing treatments for allergic reactions, was hospitalized (not prolonged) and underwent 6-7 months of therapy and tests with an allergist. Her present status is not recovered. Prior allergies intensified to debilitating level was considered to be disabling. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Device leakage, No adverse event, Product reconstitution issue
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified patient. On an unknown date the patient might have received less than a full dose of ZOSTAVAX (lot# not reported) due to excessive foaming of the vaccine following reconstitution, and due to leaking of the vaccine vial during withdrawal of the vaccine. No adverse effect was reported. It was unknown if the patient sought medical attention. The outcome of adverse events was unknown. Follow up information was received from the pharmacist stating no adverse event in patient due to ZOSTAVAX. The pharmacist called to verify official data since the patient did not receive full 0.65 ml volume due to product foam. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Erythema, Spleen disorder, Swelling
Clinical narrative: Case number PHHY2013US044794 is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 484116) web site on 06 May 2013. This report refers to a 26-year-old female patient. Her current condition included "too many platelets". She was vaccinated with MENVEO (batch number: M10125) on 05 Feb 2013 into the left deltoid region of arm. It was reported that there were no signs and symptoms when the patient left the clinic. On 06 Feb 2013, one day after vaccination she had a "red raised reaction which was in a size of quarter". It was reported that she called her physician regarding the event. On an unknown date, she underwent a lab test (not specified) "to have spleen removed" and no other information was provided regarding this condition. The outcome of the events was reported as completely recovered. The seriousness and causality of the events were not reported.
Age: 26.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Erythema, Laboratory test, Spleen disorder, Swelling
Clinical narrative: Case number PHHY2013US044794 is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 484116) web site on 06 May 2013. This report refers to a 26-year-old female patient. Her current condition included "too many platelets". She was vaccinated with MENVEO (batch number: M10125) on 05 Feb 2013 into the left deltoid region of arm. It was reported that there were no signs and symptoms when the patient left the clinic. On 06 Feb 2013, one day after vaccination she had a "red raised reaction which was in a size of quarter". It was reported that she called her physician regarding the event. On an unknown date, she underwent a lab test (not specified) "to have spleen removed" and no other information was provided regarding this condition. The outcome of the events was reported as completely recovered. The seriousness and causality of the events were not reported.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Dizziness, Dysstasia, Headache, Injection site erythema
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 year old female patient with no medical history or drug reaction. On 23-OCT-2013, the patient was vaccinated with 0.5 ml dose 1 of GARDASIL 0.5 ml intramuscularly. On 10-JAN-2013, the patient was vaccinated with dose 2. The patient did not have any adverse symptoms after dose 1 and 2. On 30-APR-2013 the patient was vaccinated with GARDASIL (lot # H020002, exp 08-AUG-2015) dose 3, 0.5 ml, intramuscular. On 30-APR-2013, the patient wokeup inthe middle of the night with a fever of 103F, chills, headache, dizziness and malaise. The patient also had an injection site reaction of swelling and redness. The patient visited office of medical attention and was treated with ibuprofen. Currently, the patient's temperature was at 100.8F and redness and swelling at the injection site currently were no longer present. The patient no longer had a headache. The injection site currently was warm to the touch and tender. The outcome of events were reported as recovering/resolving. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 year old female patient with no medical history or drug reaction. On 23-OCT-2013, the patient was vaccinated with 0.5 ml dose 1 of GARDASIL 0.5 ml intramuscularly. On 10-JAN-2013, the patient was vaccinated with dose 2. The patient did not have any adverse symptoms after dose 1 and 2. On 30-APR-2013 the patient was vaccinated with GARDASIL (lot # H020002, exp 08-AUG-2015) dose 3, 0.5 ml, intramuscular. On 30-APR-2013, the patient wokeup inthe middle of the night with a fever of 103F, chills, headache, dizziness and malaise. The patient also had an injection site reaction of swelling and redness. The patient visited office of medical attention and was treated with ibuprofen. Currently, the patient's temperature was at 100.8F and redness and swelling at the injection site currently were no longer present. The patient no longer had a headache. The injection site currently was warm to the touch and tender. The outcome of events were reported as recovering/resolving. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Chills, Dizziness, Headache, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 year old female patient with no medical history or drug reaction. On 23-OCT-2013, the patient was vaccinated with 0.5 ml dose 1 of GARDASIL 0.5 ml intramuscularly. On 10-JAN-2013, the patient was vaccinated with dose 2. The patient did not have any adverse symptoms after dose 1 and 2. On 30-APR-2013 the patient was vaccinated with GARDASIL (lot # H020002, exp 08-AUG-2015) dose 3, 0.5 ml, intramuscular. On 30-APR-2013, the patient wokeup inthe middle of the night with a fever of 103F, chills, headache, dizziness and malaise. The patient also had an injection site reaction of swelling and redness. The patient visited office of medical attention and was treated with ibuprofen. Currently, the patient's temperature was at 100.8F and redness and swelling at the injection site currently were no longer present. The patient no longer had a headache. The injection site currently was warm to the touch and tender. The outcome of events were reported as recovering/resolving. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site swelling, Injection site warmth, Malaise, Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 year old female patient with no medical history or drug reaction. On 23-OCT-2013, the patient was vaccinated with 0.5 ml dose 1 of GARDASIL 0.5 ml intramuscularly. On 10-JAN-2013, the patient was vaccinated with dose 2. The patient did not have any adverse symptoms after dose 1 and 2. On 30-APR-2013 the patient was vaccinated with GARDASIL (lot # H020002, exp 08-AUG-2015) dose 3, 0.5 ml, intramuscular. On 30-APR-2013, the patient wokeup inthe middle of the night with a fever of 103F, chills, headache, dizziness and malaise. The patient also had an injection site reaction of swelling and redness. The patient visited office of medical attention and was treated with ibuprofen. Currently, the patient's temperature was at 100.8F and redness and swelling at the injection site currently were no longer present. The patient no longer had a headache. The injection site currently was warm to the touch and tender. The outcome of events were reported as recovering/resolving. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Fever, redness and swelling at site, site warm to touch.
Age: 21.0
Sex: F
Vaccine: HEPAB
Symptoms: Dizziness, Erythema, Headache, Pain
Clinical narrative: 6 May - TWINRIX administered (R) deltoid. Dizziness; global HA; localized redness & soreness. 6.1 cm x 4 cm (wxh) tx - 9 May- Prednisone 10 mg po 2d for 5d; TYLENOL 325 mg two every 4-6 H PRN.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea, Haematochezia, Mucous stools
Clinical narrative: Child had vaccines in morning - at 3pm had first of 2 bloody mucoid stools (about dime size). Stool was a little looser than before. Belly remained soft, child not fussy. No vomiting or fever. Patient subsequently slept well and had normal stool in morning.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: No treatment. (R) vastus lateralis rash started out like quarter size around 7:00 and spread. Rash is warm to touch, itchy.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 5 year old patient. Illness at the time of vaccination was none. On 29-APR-2013, the patient was vaccinated with a second dose of VARIVAX (H018457, expiry date was 05-OCT-2007, dose were not reported) subcutaneous in the right leg. On 30-APR-2013, the patient had a localized reaction of quarter sized red raised area to right lateral leg. The outcome of the reported event was unknown. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Limb discomfort, Musculoskeletal discomfort, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: This spontaneous consumer report (received on 26-APR-2013) concerns a 52 year old male patient, who had a medical history of penicillin allergies. At the time of the event, concomitant medications included simvastatin. In JAN-2013, the patient received the flu vaccine (batch number not provided) in his upper left arm only a few inches from his shoulders. The patient believed that the vaccine administered was manufactured by Merck. Since receiving the vaccine, the patient has had pain and discomfort in his arms and shoulders with any rotation or movements. The outcome was reported as not recovered.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Deep vein thrombosis, Optic neuritis, Retinal haemorrhage, Retinitis, Varicella virus test positive
Clinical narrative: Optic neuritis and retinitis (right eye) resulting in retinal bleeding due to DVT. Five day course IV steroids starting day 13. Bromfenac ophthalmic BID starting (day 40). Intramuscular steroid injection (day 51).
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Audiogram, Deafness unilateral, Ophthalmological examination abnormal, Optic neuritis, Retinitis
Clinical narrative: Optic neuritis and retinitis (right eye) resulting in retinal bleeding due to DVT. Five day course IV steroids starting day 13. Bromfenac ophthalmic BID starting (day 40). Intramuscular steroid injection (day 51).
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Varicella virus test positive
Clinical narrative: Optic neuritis and retinitis (right eye) resulting in retinal bleeding due to DVT. Five day course IV steroids starting day 13. Bromfenac ophthalmic BID starting (day 40). Intramuscular steroid injection (day 51).
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age with trigeminal neuralgia. On 08-DEC-2011 the patient was vaccinated with ZOSTAVAX single 0.65 ml, subcutaneous (lot number not reported). No other concomitant medications were reported. Physician reported that on an unknown date, patient experienced blistering and rash on face. Reporter noted that the patient "had had a like experience (this is not clear) "over one year ago. The outcome of blistering and rash on face was reported as recovering/resolving. The relationship between ZOSTAVAX and the events was unknown. The patient did not receive any treatment for the adverse events. The patient sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a master of science in nursing (MSN) refers to a patient of unknown age and gender who on 20-MAR-2013 was vaccinated with (merck) VARIVAX 5 ml, subcutaneous (route and application site unspecified) (lot # H012506 exp date 25-JUN-2013). The reporter stated that the patient was vaccinated with an improperly (merck) VARIVAX dose. No adverse effect was reported. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Dermatitis contact, Rash
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On 03-MAY-2013 the patient was vaccinated with the second dose of GARDASIL (lot# unspecified). On 05-MAY-2013, the patient developed a rash (described as a contact dermatitis) on the hands and face that had spread down to the knees. The outcome of the event was reported as not recovered. The patient contacted the physician. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Information has been received from a healthcare worker, for VARIVAX (Merck), a pregnancy registry product, concerning an approximately 20 year old female patient with sulfonamide allergy, drug hypersensitivity to AUGMENTIN and SEPTRA, and a history of abnormal uterine bleeding who on 11-AUG-2011 was vaccinated with the first dose of VARIVAX (Merck) (lot number: 669650/0413AA, expiry 26-MAR-2013), 0.5ml, via subcutaneous route. Concomitant therapy included CAMILA. On 30-AUG-2011, the patient went to the reporter's office and she reported that she was pregnant. According to the healthcare worker, an urine pregnancy test was performed prior vaccination and was negative. No treatment was given to the patient. The patient did not seek medical attention. Follow up information received from the healthcare worker who reported that she did not have any information regarding the outcome of pregnancy. Case was lost to follow up. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers about 30 patients. The reporter stated that since 2007, on unspecified dates, about 30 patients had received ZOSTAVAX subcutaneously, where the final ZOSTAVAX was only about 0.5 ml in each case. No lot# was reported. No known adverse effects. PQC filed for ZOSTAVAX having a smaller volume than expected. Additional information has been requested.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to an 9 year old female patient with arthritis. The patient was allergic to iodine, macrolides, SULFA, and organic nitrates. On 24-APR-2013 the patient was vaccinated subcutaneously with ZOSTAVAX (lot # H021711, expiry date 07-MAR-2014) (dose, frequency, site unspecified). The patient developed diarrhea the night she received the vaccine and "a red area about the size of a quarter at the injection site" on 24-APR-2013. The patient had contacted the pharmacist for medical attention. The outcome of the events was reported as recovering/resolving. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Injection site pain, Injection site rash, Injection site swelling, Pain
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a 51 year old female patient with no drug reactions and allergies. On 26-APR-2013 the patient was vaccinated with PNEUMOVAX23 (lot number, route and dose were not reported). Concomitant medication included OTC for pain relief/unspecified and antibiotics unspecified. The nurse at physician office stated patient presented with "joint pain, body aches all over, fever, soreness, and swelling with rash at the injection site" with an onset on 27-APR-2013. Lab diagnostics studies performed on 27-APR-2013 included full blood cells count (white blood cells count was 12.5), (white blood cells count was 5.5 on 12-APR-2013). It was also reported that patient did not seek medical attention. The outcome of events is unknown. Additional information has been requested.