chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown gender and age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 30-APR-2010, the patient was inoculated with ZOSTAVAX by a healthcare provider as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. On or about 21-FEB-2011, the patient was treated by a healthcare provider for shingles. As a further proximate result, the patient had suffered and would continue to suffer significant medical expenses, and pain and suffering, and other medical related expenses which includes but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was unknown. Causality assessment was related.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown gender and age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 26-SEP-2012, the patient was inoculated with ZOSTAVAX by a healthcare provider as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. On or about an unknown date in October 2012, the patient was treated by a healthcare provider for shingles. As a further proximate result, the patient had suffered and would continue to suffer significant medical expenses, and pain and suffering, and other medical related expenses which includes but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was unknown. Causality assessment was related.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown gender and age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 12-NOV-2016, the patient was inoculated with ZOSTAVAX by a healthcare provider as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. On or about 14-NOV-2016, the patient was treated by a healthcare provider for shingles. As a further proximate result, the patient had suffered and would continue to suffer significant medical expenses, and pain and suffering, and other medical related expenses which includes but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was unknown. Causality assessment was related.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown gender and age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about an unknown date in 2016, the patient was inoculated with ZOSTAVAX by a healthcare provider as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. On or about later in 2016, the patient was treated by a healthcare provider for shingles. As a further proximate result, the patient had suffered and would continue to suffer significant medical expenses, and pain and suffering, and other medical related expenses which includes but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was unknown. Causality assessment was related.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Information has been received regarding a case in litigation, from a lawyer, regarding a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. On 14-OCT-2013, the patient was vaccinated with ZOSTAVAX (strength, dose, route, anatomical location, lot number and expiration date were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) as recommended by the health provider. On unknown date, the patient experienced shingles (herpes zoster) and on 06-DEC-2016, the patient was treated for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX (vaccination failure) and suffered serious physical, emotional, and economic damages, as a result of patient's injuries. The patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffered (emotional distress, pain); extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (quality of life decreased and condition aggravated); lost wages; loss of earnings capacity; and other losses and damages. At the time of the report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforementioned adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Information has been received regarding a case in litigation, from a lawyer, regarding a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. On 02-OCT-2012 (reported as on or about 02-OCT-2012), the patient was vaccinated with ZOSTAVAX (strength, dose, route, anatomical location, lot number and expiration date were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries as recommended by the health provider. On unknown date, the patient experienced shingles and on or about 04-DEC-2015, the patient was treated for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages, as a result of patient's injuries. The patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffered; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. At the time of the report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforementioned adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 09-JAN-2013, a pharmacist administered the ZOSTAVAX (dose, route, and lot # not provided) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries. Late in 2014, the patient was treated by a healthcare provider for Shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the event was not recovered/not resolved. Causality assessment was related.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 17-JAN-2008, a healthcare provider administered the ZOSTAVAX (dose, route, and lot # not provided) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries. On 02-DEC-2016, the patient was treated by a healthcare provider for herpes zoster. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was unknown. Causality assessment was related.
Sex: U
Vaccine: MNQ
Symptoms: Back pain, Decreased appetite, Headache, Meningitis viral, Nausea
Clinical narrative: This case was reported by a pharmacist via regulatory authority and described the occurrence of viral meningitis in a female patient who received Meningococcal ACWY Vaccine (potential MENVEO) for an unknown indication. On 11th August 2009, the patient received Meningococcal ACWY Vaccine (potential MENVEO). On 12th August 2009, 1 days after receiving Meningococcal ACWY Vaccine (potential MENVEO), the patient experienced viral meningitis (serious criteria hospitalization and GSK medically significant), headache (serious criteria hospitalization), back pain (serious criteria hospitalization) and fever (serious criteria hospitalization). On 16th August 2009, the patient experienced rash (serious criteria hospitalization), nausea (serious criteria hospitalization) and decreased appetite (serious criteria hospitalization). On an unknown date, the outcome of the viral meningitis, headache, back pain, fever, rash, nausea and decreased appetite were recovered/resolved. It was unknown if the reporter considered the viral meningitis, headache, back pain, fever, rash, nausea and decreased appetite to be related to Meningococcal ACWY Vaccine (potential MENVEO). Additional information was provided as follows: The age at vaccination was not reported. On 16th August 2009, 5 days after vaccination, the patient experienced rash, nausea and decreased appetite. Correction done on 26 November 2018, following an internal QC. This case downloaded from Regulatory Authority was incorrectly considered as received via the regulatory authority; this prevented report to FDA to auto schedule.
Sex: U
Vaccine: MNQ
Symptoms: Pyrexia, Rash
Clinical narrative: This case was reported by a pharmacist via regulatory authority and described the occurrence of viral meningitis in a female patient who received Meningococcal ACWY Vaccine (potential MENVEO) for an unknown indication. On 11th August 2009, the patient received Meningococcal ACWY Vaccine (potential MENVEO). On 12th August 2009, 1 days after receiving Meningococcal ACWY Vaccine (potential MENVEO), the patient experienced viral meningitis (serious criteria hospitalization and GSK medically significant), headache (serious criteria hospitalization), back pain (serious criteria hospitalization) and fever (serious criteria hospitalization). On 16th August 2009, the patient experienced rash (serious criteria hospitalization), nausea (serious criteria hospitalization) and decreased appetite (serious criteria hospitalization). On an unknown date, the outcome of the viral meningitis, headache, back pain, fever, rash, nausea and decreased appetite were recovered/resolved. It was unknown if the reporter considered the viral meningitis, headache, back pain, fever, rash, nausea and decreased appetite to be related to Meningococcal ACWY Vaccine (potential MENVEO). Additional information was provided as follows: The age at vaccination was not reported. On 16th August 2009, 5 days after vaccination, the patient experienced rash, nausea and decreased appetite. Correction done on 26 November 2018, following an internal QC. This case downloaded from Regulatory Authority was incorrectly considered as received via the regulatory authority; this prevented report to FDA to auto schedule.
Sex: U
Vaccine: MNQ
Symptoms: Amnesia, Decreased appetite, Dizziness, Fatigue, Headache
Clinical narrative: This case was reported by a other health professional via regulatory authority and described the occurrence of fatigue in a adult female patient who received Meningococcal ACWY Vaccine (potential MENVEO) for prophylaxis. Concomitant products included valsartan, Levothyroxine Sodium and sertraline hydrochloride. On 18th June 2009, the patient received Meningococcal ACWY Vaccine (potential MENVEO) (intramuscular). On 24th June 2009, 6 days after receiving Meningococcal ACWY Vaccine (potential MENVEO), the patient experienced fatigue (serious criteria disability and other: as per reporter), shallow breathing (serious criteria disability and other: as per reporter), memory loss (serious criteria disability and other: as per reporter), nausea (serious criteria disability and other: as per reporter), headache (serious criteria disability and other: as per reporter), weight loss (serious criteria disability and other: as per reporter) and decreased appetite (serious criteria disability and other: as per reporter). On an unknown date, the patient experienced malaise (serious criteria disability and other: as per reporter) and dizziness (serious criteria disability and other: as per reporter). On an unknown date, the outcome of the fatigue, shallow breathing, memory loss, nausea, headache, weight loss, decreased appetite, malaise and dizziness were recovered/resolved. It was unknown if the reporter considered the fatigue, shallow breathing, memory loss, nausea, headache, weight loss, decreased appetite, malaise and dizziness to be related to Meningococcal ACWY Vaccine (potential MENVEO). Additional details were provided as follows: The patient received concomitant (drug name unknown) for Arthralgia. The patient received Valsartan for hypertension, Thyroxine sodium for hypothyroidism and Sertraline hydrochloride for depression. The age at vaccination was not reported. The patient experienced extreme fatigue. Correction done on 26 November 2018, following an internal QC. This case downloaded from Agency was incorrectly considered as received via the regulatory authority; this prevented report to FDA to auto schedule.
Sex: U
Vaccine: MNQ
Symptoms: Hypopnoea, Malaise, Nausea, Weight decreased
Clinical narrative: This case was reported by a other health professional via regulatory authority and described the occurrence of fatigue in a adult female patient who received Meningococcal ACWY Vaccine (potential MENVEO) for prophylaxis. Concomitant products included valsartan, Levothyroxine Sodium and sertraline hydrochloride. On 18th June 2009, the patient received Meningococcal ACWY Vaccine (potential MENVEO) (intramuscular). On 24th June 2009, 6 days after receiving Meningococcal ACWY Vaccine (potential MENVEO), the patient experienced fatigue (serious criteria disability and other: as per reporter), shallow breathing (serious criteria disability and other: as per reporter), memory loss (serious criteria disability and other: as per reporter), nausea (serious criteria disability and other: as per reporter), headache (serious criteria disability and other: as per reporter), weight loss (serious criteria disability and other: as per reporter) and decreased appetite (serious criteria disability and other: as per reporter). On an unknown date, the patient experienced malaise (serious criteria disability and other: as per reporter) and dizziness (serious criteria disability and other: as per reporter). On an unknown date, the outcome of the fatigue, shallow breathing, memory loss, nausea, headache, weight loss, decreased appetite, malaise and dizziness were recovered/resolved. It was unknown if the reporter considered the fatigue, shallow breathing, memory loss, nausea, headache, weight loss, decreased appetite, malaise and dizziness to be related to Meningococcal ACWY Vaccine (potential MENVEO). Additional details were provided as follows: The patient received concomitant (drug name unknown) for Arthralgia. The patient received Valsartan for hypertension, Thyroxine sodium for hypothyroidism and Sertraline hydrochloride for depression. The age at vaccination was not reported. The patient experienced extreme fatigue. Correction done on 26 November 2018, following an internal QC. This case downloaded from Agency was incorrectly considered as received via the regulatory authority; this prevented report to FDA to auto schedule.
Sex: U
Vaccine: MNQ
Symptoms: Asthenia, Chills, Decreased appetite, Headache, Malaise
Clinical narrative: This case was reported by a other health professional via regulatory authority and described the occurrence of suspected vaccination failure in a adult male patient who received Men ACWY-CRM NVS (Meningococcal ACWY Vaccine (potential MENVEO)) for prophylaxis. On 26th June 2008, the patient received Meningococcal ACWY Vaccine (potential MENVEO) (intramuscular). In April 2013, unknown after receiving Meningococcal ACWY Vaccine (potential MENVEO), the patient experienced vaccination failure (serious criteria GSK medically significant), meningitis (serious criteria hospitalization and GSK medically significant), syncope (serious criteria hospitalization), headache (serious criteria hospitalization), fever (serious criteria hospitalization), stiff neck (serious criteria hospitalization), chills (serious criteria hospitalization), photophobia (serious criteria hospitalization), decreased appetite (serious criteria hospitalization), nausea (serious criteria hospitalization), malaise (serious criteria hospitalization) and weakness (serious criteria hospitalization). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the meningitis, syncope, headache, fever, stiff neck, chills, photophobia, decreased appetite, nausea, malaise and weakness were recovered/resolved. It was unknown if the reporter considered the vaccination failure, meningitis, syncope, headache, fever, stiff neck, chills, photophobia, decreased appetite, nausea, malaise and weakness to be related to Meningococcal ACWY Vaccine (potential MENVEO). Additional details were provided as follows: The age at vaccination was not reported. On 20th April 2013, the patient received tuberculin purified protein derivative (suspect). This case was considered as suspected vaccination failure as the confirmatory lab test, and basic immunization schedule, were not provided.
Sex: U
Vaccine: MNQ
Symptoms: Meningitis, Musculoskeletal stiffness, Nausea, Photophobia, Pyrexia
Clinical narrative: This case was reported by a other health professional via regulatory authority and described the occurrence of suspected vaccination failure in a adult male patient who received Men ACWY-CRM NVS (Meningococcal ACWY Vaccine (potential MENVEO)) for prophylaxis. On 26th June 2008, the patient received Meningococcal ACWY Vaccine (potential MENVEO) (intramuscular). In April 2013, unknown after receiving Meningococcal ACWY Vaccine (potential MENVEO), the patient experienced vaccination failure (serious criteria GSK medically significant), meningitis (serious criteria hospitalization and GSK medically significant), syncope (serious criteria hospitalization), headache (serious criteria hospitalization), fever (serious criteria hospitalization), stiff neck (serious criteria hospitalization), chills (serious criteria hospitalization), photophobia (serious criteria hospitalization), decreased appetite (serious criteria hospitalization), nausea (serious criteria hospitalization), malaise (serious criteria hospitalization) and weakness (serious criteria hospitalization). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the meningitis, syncope, headache, fever, stiff neck, chills, photophobia, decreased appetite, nausea, malaise and weakness were recovered/resolved. It was unknown if the reporter considered the vaccination failure, meningitis, syncope, headache, fever, stiff neck, chills, photophobia, decreased appetite, nausea, malaise and weakness to be related to Meningococcal ACWY Vaccine (potential MENVEO). Additional details were provided as follows: The age at vaccination was not reported. On 20th April 2013, the patient received tuberculin purified protein derivative (suspect). This case was considered as suspected vaccination failure as the confirmatory lab test, and basic immunization schedule, were not provided.
Sex: U
Vaccine: MNQ
Symptoms: Syncope, Vaccination failure
Clinical narrative: This case was reported by a other health professional via regulatory authority and described the occurrence of suspected vaccination failure in a adult male patient who received Men ACWY-CRM NVS (Meningococcal ACWY Vaccine (potential MENVEO)) for prophylaxis. On 26th June 2008, the patient received Meningococcal ACWY Vaccine (potential MENVEO) (intramuscular). In April 2013, unknown after receiving Meningococcal ACWY Vaccine (potential MENVEO), the patient experienced vaccination failure (serious criteria GSK medically significant), meningitis (serious criteria hospitalization and GSK medically significant), syncope (serious criteria hospitalization), headache (serious criteria hospitalization), fever (serious criteria hospitalization), stiff neck (serious criteria hospitalization), chills (serious criteria hospitalization), photophobia (serious criteria hospitalization), decreased appetite (serious criteria hospitalization), nausea (serious criteria hospitalization), malaise (serious criteria hospitalization) and weakness (serious criteria hospitalization). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the meningitis, syncope, headache, fever, stiff neck, chills, photophobia, decreased appetite, nausea, malaise and weakness were recovered/resolved. It was unknown if the reporter considered the vaccination failure, meningitis, syncope, headache, fever, stiff neck, chills, photophobia, decreased appetite, nausea, malaise and weakness to be related to Meningococcal ACWY Vaccine (potential MENVEO). Additional details were provided as follows: The age at vaccination was not reported. On 20th April 2013, the patient received tuberculin purified protein derivative (suspect). This case was considered as suspected vaccination failure as the confirmatory lab test, and basic immunization schedule, were not provided.
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Asthenia, Decreased appetite, Dizziness, Dyspnoea, Feeling abnormal
Clinical narrative: This case was reported by a other health professional via regulatory authority and described the occurrence of vaccination site pain in a adolescent male patient who received Men ACWY-CRM NVS (potential MENVEO)) for prophylaxis. Co-suspect products included GARDASIL for prophylaxis. On 20th April 2016, the patient received Meningococcal ACWY Vaccine (potential MENVEO) (intramuscular) and GARDASIL. On 21st April 2016, 1 days after receiving Meningococcal ACWY Vaccine (potential MENVEO), the patient experienced vaccination site pain (serious criteria hospitalization), feeling unwell (serious criteria hospitalization), unable to walk (serious criteria hospitalization), anorexia (serious criteria hospitalization), feeling bad (serious criteria hospitalization), facial flushing (serious criteria hospitalization), migraine aggravated (serious criteria hospitalization), faint (serious criteria hospitalization), weakness (serious criteria hospitalization), shortness of breath (serious criteria hospitalization), throat swelling (serious criteria hospitalization), rash (serious criteria hospitalization) and dizziness (serious criteria hospitalization). On 22nd April 2016, the outcome of the vaccination site pain, feeling unwell, unable to walk, anorexia, feeling bad, facial flushing, migraine aggravated, faint, weakness, shortness of breath, throat swelling, rash and dizziness were recovered/resolved. It was unknown if the reporter considered the vaccination site pain, feeling unwell, unable to walk, anorexia, feeling bad, facial flushing, migraine aggravated, faint, weakness, shortness of breath, throat swelling, rash and dizziness to be related to Meningococcal ACWY Vaccine (potential MENVEO). Additional details were provided as follows: The age at vaccination was not reported. On 20th April 2016, the patient received GARDASIL intramuscularly. It was unknown if the reporter considered the vaccination site pain, feeling unwell, unable to walk, anorexia, feeling bad, facial flushing, migraine aggravated, faint, weakness, shortness of breath, throat swelling, rash and dizziness to be related to GARDASIL as well. Correction done on 26 November 2018, following an internal QC. This case downloaded was incorrectly considered as received via the regulatory authority; this prevented report to FDA to auto schedule.
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Flushing, Gait inability, Malaise, Migraine, Pharyngeal oedema
Clinical narrative: This case was reported by a other health professional via regulatory authority and described the occurrence of vaccination site pain in a adolescent male patient who received Men ACWY-CRM NVS (potential MENVEO)) for prophylaxis. Co-suspect products included GARDASIL for prophylaxis. On 20th April 2016, the patient received Meningococcal ACWY Vaccine (potential MENVEO) (intramuscular) and GARDASIL. On 21st April 2016, 1 days after receiving Meningococcal ACWY Vaccine (potential MENVEO), the patient experienced vaccination site pain (serious criteria hospitalization), feeling unwell (serious criteria hospitalization), unable to walk (serious criteria hospitalization), anorexia (serious criteria hospitalization), feeling bad (serious criteria hospitalization), facial flushing (serious criteria hospitalization), migraine aggravated (serious criteria hospitalization), faint (serious criteria hospitalization), weakness (serious criteria hospitalization), shortness of breath (serious criteria hospitalization), throat swelling (serious criteria hospitalization), rash (serious criteria hospitalization) and dizziness (serious criteria hospitalization). On 22nd April 2016, the outcome of the vaccination site pain, feeling unwell, unable to walk, anorexia, feeling bad, facial flushing, migraine aggravated, faint, weakness, shortness of breath, throat swelling, rash and dizziness were recovered/resolved. It was unknown if the reporter considered the vaccination site pain, feeling unwell, unable to walk, anorexia, feeling bad, facial flushing, migraine aggravated, faint, weakness, shortness of breath, throat swelling, rash and dizziness to be related to Meningococcal ACWY Vaccine (potential MENVEO). Additional details were provided as follows: The age at vaccination was not reported. On 20th April 2016, the patient received GARDASIL intramuscularly. It was unknown if the reporter considered the vaccination site pain, feeling unwell, unable to walk, anorexia, feeling bad, facial flushing, migraine aggravated, faint, weakness, shortness of breath, throat swelling, rash and dizziness to be related to GARDASIL as well. Correction done on 26 November 2018, following an internal QC. This case downloaded was incorrectly considered as received via the regulatory authority; this prevented report to FDA to auto schedule.
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Rash, Syncope, Vaccination site pain
Clinical narrative: This case was reported by a other health professional via regulatory authority and described the occurrence of vaccination site pain in a adolescent male patient who received Men ACWY-CRM NVS (potential MENVEO)) for prophylaxis. Co-suspect products included GARDASIL for prophylaxis. On 20th April 2016, the patient received Meningococcal ACWY Vaccine (potential MENVEO) (intramuscular) and GARDASIL. On 21st April 2016, 1 days after receiving Meningococcal ACWY Vaccine (potential MENVEO), the patient experienced vaccination site pain (serious criteria hospitalization), feeling unwell (serious criteria hospitalization), unable to walk (serious criteria hospitalization), anorexia (serious criteria hospitalization), feeling bad (serious criteria hospitalization), facial flushing (serious criteria hospitalization), migraine aggravated (serious criteria hospitalization), faint (serious criteria hospitalization), weakness (serious criteria hospitalization), shortness of breath (serious criteria hospitalization), throat swelling (serious criteria hospitalization), rash (serious criteria hospitalization) and dizziness (serious criteria hospitalization). On 22nd April 2016, the outcome of the vaccination site pain, feeling unwell, unable to walk, anorexia, feeling bad, facial flushing, migraine aggravated, faint, weakness, shortness of breath, throat swelling, rash and dizziness were recovered/resolved. It was unknown if the reporter considered the vaccination site pain, feeling unwell, unable to walk, anorexia, feeling bad, facial flushing, migraine aggravated, faint, weakness, shortness of breath, throat swelling, rash and dizziness to be related to Meningococcal ACWY Vaccine (potential MENVEO). Additional details were provided as follows: The age at vaccination was not reported. On 20th April 2016, the patient received GARDASIL intramuscularly. It was unknown if the reporter considered the vaccination site pain, feeling unwell, unable to walk, anorexia, feeling bad, facial flushing, migraine aggravated, faint, weakness, shortness of breath, throat swelling, rash and dizziness to be related to GARDASIL as well. Correction done on 26 November 2018, following an internal QC. This case downloaded was incorrectly considered as received via the regulatory authority; this prevented report to FDA to auto schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: This case was reported by a consumer and described the occurrence of muscle pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was not recovered/not resolved. It was unknown if the reporter considered the muscle pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient recently had a SHINGRIX shot, and the patient was experiencing some muscular pain. She asked if it was safe to have aspirin and EXCEDERIN for the event.
Sex: F
Vaccine: VARZOS
Symptoms: Cheilitis, Feeling abnormal, Myalgia, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a female patient who received Shingles vaccine for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced muscle pain, nausea, rash lips and feels awful. On an unknown date, the outcome of the muscle pain, nausea, rash lips and feels awful were unknown. It was unknown if the reporter considered the muscle pain, nausea, rash lips and feels awful to be related to Shingles vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient recently had the shingles vaccine. She felt awful and had tremendous symptoms. She had a lot of muscle aches and nausea and at the reporting time she had an outbreak on her lip. The patient enquired if the company had heard that before.
Sex: M
Vaccine: FLU4
Symptoms: Allergy to vaccine, Erythema, Feeling hot, Local reaction, Peripheral swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of erythema of extremities in a male patient who received FLULVAL QUADRIVALENT (2018-2019 season) for prophylaxis. Previously administered products included FLULVAL QUADRIVALENT 2017-2018 season with an associated reaction of erythema (all other events experienced after dose 1, refer case US2018196965). On an unknown date, the patient received FLULVAL QUADRIVALENT 2018-2019 season at an unknown dose. On an unknown date, less than a year after receiving FLULVAL QUADRIVALENT 2018-2019 season, the patient experienced erythema of extremities, extremities hot feeling of, swelling arm, local reaction and allergy to vaccine. Rechallenge with FLULVAL QUADRIVALENT 2018-2019 season was positive. On an unknown date, the outcome of the erythema of extremities, extremities hot feeling of, swelling arm, local reaction and allergy to vaccine were unknown. It was unknown if the reporter considered the erythema of extremities, extremities hot feeling of, swelling arm, local reaction and allergy to vaccine to be related to FLULVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: This case was reported by an allergist. The age at vaccination was not reported. The patient did not not have an egg allergy. The patient received FLULAVAL vaccination two years in a row and has had large local reactions with each vaccination. In 2018 the patient received FLULVAL QUADRIVALENT 2018-2019 season and experienced large local reaction which was hot, red swelling and involved whole arm. The patient underwent skin testing and intradermal testing. Intradermal testing was very positive. The reporter reported that that this does not predict future reactions to the vaccine, but it has progressively worsened. The reporter was concerned that the patient may be reacting to a component of the vaccine (glycerin, gelatin, etc). The reporter did not know what components were in the vaccine. The reporter recommended receiving an intranasal version of the vaccine.
Sex: M
Vaccine: FLU4
Symptoms: Skin test positive, Vaccine positive rechallenge
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of erythema of extremities in a male patient who received FLULVAL QUADRIVALENT (2018-2019 season) for prophylaxis. Previously administered products included FLULVAL QUADRIVALENT 2017-2018 season with an associated reaction of erythema (all other events experienced after dose 1, refer case US2018196965). On an unknown date, the patient received FLULVAL QUADRIVALENT 2018-2019 season at an unknown dose. On an unknown date, less than a year after receiving FLULVAL QUADRIVALENT 2018-2019 season, the patient experienced erythema of extremities, extremities hot feeling of, swelling arm, local reaction and allergy to vaccine. Rechallenge with FLULVAL QUADRIVALENT 2018-2019 season was positive. On an unknown date, the outcome of the erythema of extremities, extremities hot feeling of, swelling arm, local reaction and allergy to vaccine were unknown. It was unknown if the reporter considered the erythema of extremities, extremities hot feeling of, swelling arm, local reaction and allergy to vaccine to be related to FLULVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: This case was reported by an allergist. The age at vaccination was not reported. The patient did not not have an egg allergy. The patient received FLULAVAL vaccination two years in a row and has had large local reactions with each vaccination. In 2018 the patient received FLULVAL QUADRIVALENT 2018-2019 season and experienced large local reaction which was hot, red swelling and involved whole arm. The patient underwent skin testing and intradermal testing. Intradermal testing was very positive. The reporter reported that that this does not predict future reactions to the vaccine, but it has progressively worsened. The reporter was concerned that the patient may be reacting to a component of the vaccine (glycerin, gelatin, etc). The reporter did not know what components were in the vaccine. The reporter recommended receiving an intranasal version of the vaccine.
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a adult male patient who received Flu Seasonal QIV Dresden for prophylaxis. The patient's past medical history included spinal operation, hepatitis C, arthritis (back arthritic issues) and spinal disorder. Previously administered products included ZEPATIER and ZOSTAVAX. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced injection site muscle pain and injection site erythema. On an unknown date, the outcome of the injection site muscle pain and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site muscle pain and injection site erythema to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were reported as follows: The age at vaccination was not reported. The patient reported that he suffered from Hepatitis C for the past 48 years that damaged his liver and for a three month period of 84 days he was taking an anti-viral medication by Merck called ZEPATIER. He also had suffered with spinal issues for many years including having back surgery and back arthritic issues. The patient also reported that he has had multiple flu shots over the years (manufacture and product name unknown) and he had experienced a little muscle soreness and redness at the injection site occasionally with the flu shot. The patient described this occurrence as happening once every several years but it was rare. The patient claims that he would be slightly sore for the next day and then it would resolve. He completed his treatment by 4th March 2018. The reporter gave consent to follow up. The patient refused to provide physician permission. This case has been linked with US2018198761, reported by same reporter for the same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Scar, Urticaria
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of allergic reaction in a elderly female patient who received SHINGRIX for prophylaxis. The patient's past medical history included drug allergy (allergic to DEMEROL). Previously administered products included SHINGRIX with an associated reaction of paraesthesia (refer case US2018GSK213488). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced allergic reaction (serious criteria hospitalization), hives and scar. On an unknown date, the outcome of the allergic reaction and hives were recovered/resolved and the outcome of the scar was not recovered/not resolved. It was unknown if the reporter considered the allergic reaction, hives and scar to be related to SHINGRIX. Additional details were provided as follows: This case was reported via Merck National Service Center. The age at vaccination was not reported, the patient was in her 80's. The patient received the SHINGRIX booster shot 6 months after receiving 1st dose. After receiving the 2nd dose the patient developed a terrible allergic reaction and developed hives and welts and was hospitalized (unspecified details). The patient received unspecified treatment at the hospital and was recovered at the reporting time, but she had ugly scars on her skin from the reaction to the vaccine. In addition the patient was allergic to DEMEROL and asked if the vaccine contained that product. No further adverse event information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Paraesthesia, Pruritus
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of tingling sensation in a elderly female patient who received SHINGRIX for prophylaxis. The patient's past medical history included drug allergy (allergic to DEMORAL). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced tingling sensation and pruritus. On an unknown date, the outcome of the tingling sensation and pruritus were unknown. It was unknown if the reporter considered the tingling sensation and pruritus to be related to SHINGRIX. Additional details were provided as follows: This case was reported via Merck National Service Center. The age at vaccination was not reported, the patient was in her 80's. Shortly after receiving Shingrix, the patient felt tingling and itching between her fingers. In addition the patient said she is allergic to DEMORAL and asked if the vaccine contained that product. No further adverse event information was provided. For tolerance to next dose, refer case US2018GSK211136, reported by same reporter for same patient.
Sex: M
Vaccine: FLU4
Symptoms: Allergy to vaccine, Erythema, Feeling hot, Local reaction, Swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of erythema in a male patient who received FLULAVAL QUADRIVALENT 2017-2018 season) for prophylaxis. On an unknown date, the patient received FLULAVAL QUADRIVALENT 2017-2018 season at an unknown dose. On an unknown date, less than a year after receiving FLULAVAL QUADRIVALENT 2017-2018 season, the patient experienced erythema, feeling hot, swelling, local reaction and allergy to vaccine. On an unknown date, the outcome of the erythema, feeling hot, swelling and local reaction were recovered/resolved and the outcome of the allergy to vaccine was unknown. It was unknown if the reporter considered the erythema, feeling hot, swelling, local reaction and allergy to vaccine to be related to FLULAVAL QUADRIVALENT 2017-2018 season. Additional details were provided as follows: This case was reported by an allergist. The age at vaccination was not reported. The patient does not have an egg allergy. After receiving FLULAVAL vaccine, the patient experienced large local reaction which was just hot, red swelling. The reporter was concerned that the patient may be reacting to a component of the vaccine (glycerin, gelatin, etc). The reporter does not know what components were in the vaccine. For tolerance to the further dose of FLULAVAL refer case US2018GSK210320, reported by same reporter for the same patient.