chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion which was administered to multiple patients.; No additional AE's reported.; This spontaneous report was received from a registered nurse referring to a patient of unknown gender and age.  The reporter did not provide information on the patient's pertinent medical history and concomitant medications.  On 08-APR-2021 the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) with dose reported as 1 administered subcutaneously(lot number T028303 and expiration date 20-AUG-2022) for prophylaxis (vaccination scheme frequency and anatomical location were not reported). It was stated that the vaccine was administered after temperature excursion (incorrect product storage). It was reported that the vaccine reached a temperature of minus 11.5 degree Celsius. This excursion had a time frame reported of 25 minutes. No previous excursions were reported, and information was provided via data logger. No additional adverse event was reported and patient was asymptomatic.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2104USA002751:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion which was administered to multiple patients.; No additional AE's reported.; This spontaneous report was received from a registered nurse referring to a patient of unknown gender and age.  The reporter did not provide information on the patient's historical drugs or reactions, pertinent medical history and concomitant medications.  On 08-APR-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) with dose reported as 1 administered subcutaneously (lot number T028303 and expiration date 20-AUG-2022) for prophylaxis (vaccination scheme frequency and anatomical location were not reported). It was stated that the vaccine was administered after temperature excursion (incorrect product storage). It was reported that the vaccine reached a temperature of minus 11.5 degree Celsius. This excursion had a time frame reported of 25 minutes. No previous excursions were reported, and information was provided via data logger. No additional adverse event was reported and patient was asymptomatic.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2104USA002751:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion which was administered to multiple patients.; No additional AE's reported.; This spontaneous report was received from a registered nurse referring to a patient of unknown gender and age.  The reporter did not provide information on the patient's historical drugs or reactions, pertinent medical history and concomitant medications.  On 08-APR-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX)  with dose reported as 1 administered subcutaneously  (lot number T028303 and expiration date 20-AUG-2022) for prophylaxis (vaccination scheme frequency and anatomical location were not reported). It was stated that the vaccine was administered after temperature excursion (incorrect product storage). It was reported that the vaccine reached a temperature of minus 11.5 degree Celsius. This excursion had a time frame reported of 25 minutes. No previous excursions were reported, and information was provided via data logger. No additional adverse event was reported and patient was asymptomatic.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2104USA002751:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; VAQTA was inadvertently administered on 13 APR202 l after a temperature excursion occurred; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant medications, drug reactions and allergies were not reported.    On 13-APR-2021, the patient was inadvertently vaccinated with improperly stored hepatitis A vaccine, inactivated (VAQTA) (lot # T033304 has been verified to be a valid lot number, expiration date reported as 23-JUN-2022, however upon internal validation established as 02-APR-2022; strength, dose, frequency, route, anatomical location were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to a temperature of 9.0 degree Celsius for 10 hours 56 minutes and 0 seconds. There was no previous temperature excursion for the vaccine. The digital data logger was involved. No additional adverse event was reported (no adverse event).  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T033304; expirationdate: 02-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA003768: US-009507513-2104USA003782: US-009507513-2104USA003622: US-009507513-2104USA003606:
Sex: U
Vaccine: VARZOS
Symptoms: Eye pain, Eyelid rash, Headache, Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: shingles/herpes zoster-viral infection of the periocular and facial region; cornea keratitis herpes zoster; postherpetic polyneuropathy; Information has been received from a lawyer regarding a case in litigation which referred to a patient (pt) of unknown gender and age. Information regarding concomitant medications, concurrent conditions or medical history was not provided. On 28-JUN-2017, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) for its intended purpose: the prevention of shingles (herpes zoster) and for routine health maintenance (exact dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided). Afterwards, on an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine), the pt suffered recurrent rash on the side of her head, face, hair line, nose and eye, accompanied by extreme pain on the right sde of head, scalp, and eye, and blurred vision. The pt was diagnosed with Herpes Zoster-viral infection of the periocular and facial region and shingles (herpes zoster), cornea keratitis herpes zoster (ophthalmic herpes zoster), and postherpetic polyneuropathy (post herpetic neuralgia). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt sustained severe and permanent personal injuries; the pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. Further, the pt had suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Finally, as direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered as not recovered. The causal relationship between the events and zoster vaccine live (ZOSTAVAX) was assessed as related.  Herpes zoster, post herpetic neuralgia and ophthalmic herpes zoster were considered as disabling events by the reporter.   Upon internal review, the event ophthalmic herpes zoster was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Pain of skin, Post herpetic neuralgia, Rash, Vaccination complication, Viral infection
Clinical narrative: shingles/herpes zoster-viral infection of the periocular and facial region; cornea keratitis herpes zoster; postherpetic polyneuropathy; Information has been received from a lawyer regarding a case in litigation which referred to a patient (pt) of unknown gender and age. Information regarding concomitant medications, concurrent conditions or medical history was not provided. On 28-JUN-2017, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) for its intended purpose: the prevention of shingles (herpes zoster) and for routine health maintenance (exact dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided). Afterwards, on an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine), the pt suffered recurrent rash on the side of her head, face, hair line, nose and eye, accompanied by extreme pain on the right sde of head, scalp, and eye, and blurred vision. The pt was diagnosed with Herpes Zoster-viral infection of the periocular and facial region and shingles (herpes zoster), cornea keratitis herpes zoster (ophthalmic herpes zoster), and postherpetic polyneuropathy (post herpetic neuralgia). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt sustained severe and permanent personal injuries; the pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. Further, the pt had suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Finally, as direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered as not recovered. The causal relationship between the events and zoster vaccine live (ZOSTAVAX) was assessed as related.  Herpes zoster, post herpetic neuralgia and ophthalmic herpes zoster were considered as disabling events by the reporter.   Upon internal review, the event ophthalmic herpes zoster was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: shingles/herpes zoster-viral infection of the periocular and facial region; cornea keratitis herpes zoster; postherpetic polyneuropathy; Information has been received from a lawyer regarding a case in litigation which referred to a patient (pt) of unknown gender and age. Information regarding concomitant medications, concurrent conditions or medical history was not provided. On 28-JUN-2017, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) for its intended purpose: the prevention of shingles (herpes zoster) and for routine health maintenance (exact dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided). Afterwards, on an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine), the pt suffered recurrent rash on the side of her head, face, hair line, nose and eye, accompanied by extreme pain on the right sde of head, scalp, and eye, and blurred vision. The pt was diagnosed with Herpes Zoster-viral infection of the periocular and facial region and shingles (herpes zoster), cornea keratitis herpes zoster (ophthalmic herpes zoster), and postherpetic polyneuropathy (post herpetic neuralgia). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt sustained severe and permanent personal injuries; the pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. Further, the pt had suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Finally, as direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered as not recovered. The causal relationship between the events and zoster vaccine live (ZOSTAVAX) was assessed as related.  Herpes zoster, post herpetic neuralgia and ophthalmic herpes zoster were considered as disabling events by the reporter.   Upon internal review, the event ophthalmic herpes zoster was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles/painful rash on left side of the chest area; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On or about 25-NOV-2014, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, lot # and expiration date were not reported) for routine health maintenance and the prevention of shingles (herpes zoster).  On an unspecified date, shortly after receiving the vaccine, the patient suffered a painful rash on the left side of the chest area and was diagnosed with shinlgles. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), Plaintiff's symptoms have resulted in physical limitations not present prior to using the product. Plaintiff also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), Plaintiff sustained severe and permanent personal injuries. Further, as a tragic consequence of the wrongful conduct, Plaintiff suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Defendants' conduct, Plaintiff has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 52.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No additional AE reported.; A medical assistant called to report an expired  VAQTA was administered to a patient.; This spontaneous report was received from a medical assistant and refers to a 52-year-old male patient. The patient's pertinent medical history, concomitant medication, previous drug reactions, and allergies were not reported.      On 21-APR-2021, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) prefilled syringe (lot number T014590, which has been verified to be valid, the expiration date was reported and validated as 15-APR-2021) 1 milliliter (ml) once, as prophylaxis (expired product administered) (route of administration and anatomical site of vaccination were not provided). The suspect vaccine had not had any prior temperature excursions. Supported disclaimer was provided. No additional adverse event was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T014590; expirationdate: 15-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia, Visual impairment
Clinical narrative: herpes zoster/pain; postherpetic neuralgia; vision problems; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered herpes zoster, pain, postherpetic neuralgia and vision problems. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of all events was considered as not recovered. The causality between the events and zoster vaccine live (ZOSTAVAX) was related.   The reporter considered all events to be disability.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; the vaccines have been administered after a temperature excursion; This spontaneous report was received from a medical assistant and referred to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided.  On unknown date, the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 ml (route of administration: oral; lot # 1684166, expiration date  27-JUN-2021) for prophylaxis.   Administered dose of vaccine experienced the temperature excursion of 8.88 degrees Celsius (C) for 15 minutes, 9.17 C for 15 minutes and 8.24 C for 15 minutes. There were no previous temperature excursions. The event was reported due to digital data logger. There was no additional adverse event (AE) reported.  Follow-up information has been received from the medical assistant on 22-APR-2021 referring to a 2 months female patient. The reporter had not reported the adverse event previously. On 30-DEC-2020, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (number of previous doses was reported as 9) for prophylaxis at public health clinic/hospital. The patient received the vaccine after temperature excursion occurred. She did not experience an adverse reaction due to this administrated vaccine. Excursion was noticed after administration upon review of quarterly temperature logs.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2103USA005002:
Sex: F
Vaccine: HPV4
Symptoms: Product storage error
Clinical narrative: temp excursion due to moving products to other refrigerators, with no AE [Incorrect product storage]; This spontaneous report was received from a pharmacist referring to a female patient of unknown age. Information about medical history, concurrent conditions and concomitant therapies was not provided.   This case involved no identifiable patient (conflict information, due to the patient was a female) and it was reported that temp excursion due to moving products to other refrigerators (product storage error), with insulin glargine (TOUJEO), insulin lispro (ADMELOG), dulaglutide (TRULICITY), semaglutide (OZEMPIC), galcanezumab-gnlm (EMGALITY), etonogestrel (+) ethinyl estradiol (NUVARING), calcium undecylenate (+) undecylenic acid (+) zinc undecylenate (CRUEX), gabapentin, acyclovir (reported as aciclovir (ZOSTER)), insulin aspart (NOVOLOG), insulin human (HUMULIN R), quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (dose, route, lot# and expiration date were not reported), insulin glargine (BASAGLAR) and insulin lispro (HUMALOG) batch number and expiry unknown for all.  On an unknown date (latency unknown), the pharmacist reported a temperature excursion due to moving products to other refrigerators (product storage error). Excursion limits: 50.3 degree F for 3 hours. No lab data provided. It was not reported if the corrective treatment received.  Action taken and outcome of the event, both were not applicable.  Disclaimer: this suspected adverse reaction report was submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in directive 2001/83/ec and module VI of the good pharmacovigilance practices. The classification as a medical error was in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party had contributed to or was to be held liable for the occurrence of this medication error.  There would be no information about batch number was reported for this case.  No further relevant information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time, Blood gases, Bradycardia, Chest X-ray, Chest discomfort
Clinical narrative: Bradycardia; chest tightness; Dry mouth; sandy eye sensation; This case was received on 20-Apr-2021 and was forwarded to Moderna on 20-Apr-2021.    This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of BRADYCARDIA (Bradycardia), CHEST DISCOMFORT (chest tightness), DRY MOUTH (Dry mouth) and FOREIGN BODY SENSATION IN EYES (sandy eye sensation) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L-20A) for COVID-19 vaccination.     Concurrent medical conditions included Hyperbaric oxygen therapy, Renal stone and Drug allergy. Concomitant products included METOPROLOL TARTRATE for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced BRADYCARDIA (Bradycardia) (seriousness criterion medically significant), CHEST DISCOMFORT (chest tightness) (seriousness criterion medically significant) and DRY MOUTH (Dry mouth) (seriousness criterion medically significant). 14-Jan-2021, the patient experienced FOREIGN BODY SENSATION IN EYES (sandy eye sensation) (seriousness criterion medically significant). At the time of the report, BRADYCARDIA (Bradycardia), CHEST DISCOMFORT (chest tightness) and DRY MOUTH (Dry mouth) had resolved and FOREIGN BODY SENSATION IN EYES (sandy eye sensation) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Activated partial thromboplastin time: normal (normal) normal. On 14-Jan-2021, Blood gases: normal (normal) normal. On 14-Jan-2021, Chest X-ray: normal (normal) normal. On 14-Jan-2021, Electrocardiogram: normal (normal) normal. On 14-Jan-2021, Full blood count: normal (normal) normal. On 14-Jan-2021, Metabolic function test: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Electrocardiogram, Foreign body sensation in eyes, Full blood count, Metabolic function test
Clinical narrative: Bradycardia; chest tightness; Dry mouth; sandy eye sensation; This case was received on 20-Apr-2021 and was forwarded to Moderna on 20-Apr-2021.    This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of BRADYCARDIA (Bradycardia), CHEST DISCOMFORT (chest tightness), DRY MOUTH (Dry mouth) and FOREIGN BODY SENSATION IN EYES (sandy eye sensation) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L-20A) for COVID-19 vaccination.     Concurrent medical conditions included Hyperbaric oxygen therapy, Renal stone and Drug allergy. Concomitant products included METOPROLOL TARTRATE for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced BRADYCARDIA (Bradycardia) (seriousness criterion medically significant), CHEST DISCOMFORT (chest tightness) (seriousness criterion medically significant) and DRY MOUTH (Dry mouth) (seriousness criterion medically significant). 14-Jan-2021, the patient experienced FOREIGN BODY SENSATION IN EYES (sandy eye sensation) (seriousness criterion medically significant). At the time of the report, BRADYCARDIA (Bradycardia), CHEST DISCOMFORT (chest tightness) and DRY MOUTH (Dry mouth) had resolved and FOREIGN BODY SENSATION IN EYES (sandy eye sensation) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Activated partial thromboplastin time: normal (normal) normal. On 14-Jan-2021, Blood gases: normal (normal) normal. On 14-Jan-2021, Chest X-ray: normal (normal) normal. On 14-Jan-2021, Electrocardiogram: normal (normal) normal. On 14-Jan-2021, Full blood count: normal (normal) normal. On 14-Jan-2021, Metabolic function test: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Thrombosis
Clinical narrative: stroke; blood clots; This case was reported by a consumer and described the occurrence of stroke in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced stroke (serious criteria GSK medically significant) and clot blood (serious criteria GSK medically significant). On an unknown date, the outcome of the stroke and clot blood were unknown.   It was unknown if the reporter considered the stroke and clot blood to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received the dose of Shingles vaccine and patient experienced stroke and blood clots. The reporter was talked about covid vaccine and its similar reactions except the stroke and blood clots with shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Vaccination failure
Clinical narrative: Had the shingles shot in 2018 / but got the shingles in 2020/Suspected vaccination failure; Had the shingles shot in 2018 / but got the shingles in 2020 / again in 2021; They were very painful / so painful; They / burnt like fire; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, between 1 and 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and burning sensation. On an unknown date, the outcome of the vaccination failure, shingles, pain and burning sensation were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and burning sensation to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported case for herself/himself. The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The patient had the shingles shot in 2018 but got the shingles. The patient stated that the shingles were so painful and burnt like fire, the patient got them in 2020 and broke out again in 2021. The patient stated that the shingles shot did not work and hence the patient's physician told the patient to wait 6 months then get the new shingles shot. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR091462:duplicate case
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the shot but still had bad case of shingles / suspected vaccination failure; bad case of shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported the case for himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient received Shingles vaccine shot but still had bad case of shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the shingles vaccine and still got them/ suspected vaccination failure; I had the shingles vaccine and still got them; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but selected as adult as per the vaccine indication. The patient received Shingles vaccine and still got the shingles. This case was considered as suspected vaccination failure as details regarding the completion of primary vaccination schedule, laboratory test confiding shingles and time to onset for shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the shot and still go them twice / Suspected vaccination failure; I had the shot and still go them twice; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported the case for himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient received Shingles vaccine shot and still got shingles twice. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Vaccination failure
Clinical narrative: I got the shot for shingles and got them anyway/ Suspected vaccination failure; I got the shot for shingles and got them anyway; Had some blasters and they were very pain full; Had some blasters and they were very pain full; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, blister and pain. On an unknown date, the outcome of the vaccination failure, shingles, blister and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, blister and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient got the shot for shingles and got them anyway and had some blisters and they were very painful. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the vaccine and booster and still got shingles/ Suspected vaccination failure; got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient reported case for herself/himself. The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The patient stated he/she received the vaccine and booster and still got shingles. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown. No event for booster dose were captured because it was not clearly reported that the patient received both doses and than booster dose. Thus dose no. were also kept blank.
Sex: F
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: taken the flu vaccine 4-5 years ago / felt very sick; This case was reported by a consumer via licensee and described the occurrence of sickness in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Concurrent medical conditions included penicillin allergy (the patient was allergic to penicillin).   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional information was provided as follows: This case was reported by patient herself. The age at vaccination was not reported. The patient received the flu vaccine 4 to 5 years ago and felt very sick. The patient was advised to check with her vaccination provider, doctor, or other qualified health care professional about whether a specific treatment or medication was right for her. The reporter's and healthcare professional s consent to follow-up was reported as not applicable.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Spinal pain
Clinical narrative: "spinal ache" of the whole spine; Fatigue for 2 days; This case was reported by a physician and described the occurrence of pain in spine in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included guillain barre syndrome. Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in spine and fatigue. On an unknown date, the outcome of the pain in spine and fatigue were recovered/resolved.   It was unknown if the reporter considered the pain in spine and fatigue to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient with remote history of GBS (guillain barre syndrome) reported spinal ache of the whole spine and fatigue for 2 days after 2nd dose of Shingrix. She recovered completely on the 3rd day. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; he went and got the shot and got the shingles again / Even if you get the shingles shots you can still get the shingles; he's had him the third time shot; This case was reported by a consumer via  media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 3rd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was patient's brother. The age at vaccination was not reported. The reporter stated that, the patient had the shingles 6 weeks later he went and got the shot and got the shingles again and guess what he's had him the third time shots does not do any good at all based on nervous condition and other stressors in your life you would get the shingles. This case was considered as suspected vaccination failure since the time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Got them for the second time, but very mild; This case was reported by a consumer via media and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient had got the new Shingrix shots for and still got shingles for the second time, but it was very mild. The reporter advised that one should get the shots. This case was considered as suspected vaccination failure since the details regarding time to onset and lab test confirmation was unknown at the time of reporting
Sex: F
Vaccine: VARZOS
Symptoms: Pericarditis, Pleurisy
Clinical narrative: pericarditis; Pleurisy; This case was reported by a consumer and described the occurrence of pericarditis in a 54-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 16th April 2021, the patient received the 2nd dose of Shingles vaccine. In April 2021, less than a week after receiving Shingles vaccine, the patient experienced pericarditis (serious criteria GSK medically significant) and pleurisy. On an unknown date, the outcome of the pericarditis and pleurisy were unknown.   It was unknown if the reporter considered the pericarditis and pleurisy to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported case for herself. The age at vaccination was not reported, but the patient could be 54 or 53 years at the time of vaccination. The patient stated she was healthy. She received her shingles vaccine last week from the time of reporting and developed pleurisy and pericarditis 3-4 days later.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Nerve injury
Clinical narrative: Got shingles with first vacine.; Bad; Nerve damage; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles, feeling bad and nerve damage. On an unknown date, the outcome of the shingles, feeling bad and nerve damage were unknown.   It was unknown if the reporter considered the shingles, feeling bad and nerve damage to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by patient. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient experienced shingles, nerve damage and felt bad after first dose of Shingles vaccine. The patient went back and got updated second shot. The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got the shingles 9 months after getting the vaccine/ Suspected vaccination failure; shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 9 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported case for herself/himself. The age at vaccination was not reported. The age group was not reported, however it was captured as an adult as per vaccine indication. The patient stated that he/she got the shingles 9 months after getting the vaccine. The patient asked if there were any thoughts. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule and laboratory confirmation for shingles were unknown.