chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Diarrhoea haemorrhagic, Haematochezia, Rotavirus test positive
Clinical narrative: developed mucousy, blood streaked diarrhea and tested positive for rotavirus; developed mucousy, blood streaked diarrhea and tested positive for rotavirus; developed mucousy, blood streaked diarrhea and tested positive for rotavirus; This spontaneous report was received from a nurse and refers to a 2-month-old patient. The information about the patient's medical history, drug reaction/ allergies and concomitant therapy was unknown.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally (dose, lot # and expiration date were not provided) for prophylaxis.  On unknown dates, a few days after the vaccination, the patient developed mucousy, blood streaked diarrhea and tested positive for rotavirus. The outcome of the events was unknown. The causality assessment between the events and the suspect vaccine was not provided.  Upon internal review, the event haematochezia was considered to be medically significant.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Administered an expired dose; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concomitan medications, drug allergies or reactions were not reported.  A pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # T014145 that has been verified to be valid for pneumococcal vaccine, polyvalent (23-valent), the vaccine expired on 31-AUG-2021 and was administered on 14-SEP-2021 to the patient, at a dose of 0.5 milliliter for prophylaxis (strength, administration route and vaccination scheme were not reported) (experienced expired product administered). The vaccine did not experience any temperature excursion and no adverse events were reported.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No other AE; Medical assistant called to report a temperature excursion / ROTATEQ was administered to a patient on 17/SEP/2021; This spontaneous report was received from a medical assistant referring to a 9-week-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 17-SEP-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, one time dose orally administered as prophylaxis (lot number 1741377 which has been verified to be valid, expiration date reported and validated as 07-MAR-2022). The administered dose of the vaccine was stored at a temperature of 35.02 degrees Fahrenheit (F), during a time frame of 19 hours (product storage error). There was no previous temperature excursion. No other adverse events were reported in the patient.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No other symptoms reported at this time; A pediatric patient received VAQTA twice; This spontaneous report was received from a physician referring to a 2 year-old pediatric patient whose gender was not specified. No information regarding the patient's pertinent medical history, concurrent conditions, concomitant medication, previous drug reactions, or allergies was provided.  On 20-SEP-2021, the patient received an hepatitis a vaccine, inactivated (VAQTA) twice, at a dose of  0.5 milliliter (ml) (dose number, vaccination scheme, route of administration, anatomical location of vaccination, lot number and expiration date were unknown by the reporter) as prophylaxis (extra dose administered). No symptoms were reported (no adverse event).
Sex: F
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Dysarthria, Facial paralysis, Haemorrhagic stroke, Intraventricular haemorrhage
Clinical narrative: acute stroke secondary to intraventricular bleed in left hypothalamus and intraventricular blood with no mass effect; acute stroke secondary to intraventricular bleed in left hypothalamus and intraventricular blood with no mass effect; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In or around 01-DEC-2011, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration dates were not provided) for routine adult health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving Zoster Vaccine Live (ZOSTAVAX), the pt suffered slurring speech, development of facial droop and loss of consciousness and was later diagnosed with an acute stroke secondary to intraventricular bleed in left hypothalamus and intraventricular blood with no mass effect (haemorrhagic stroke and intraventricular haemorrhage). As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX) vaccine, the pt symptoms had resulted in physical limitations not presented prior to using Zoster Vaccine Live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and or sale of Zoster Vaccine Live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence the pt 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, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. Outcome of the events was not recovered. Causal relationship of the events was reported as related to Zoster Vaccine Live (ZOSTAVAX).  The reporter considered intraventricular haemorrhage and haemorrhagic stroke to be disabling events.  Upon internal review, intraventricular haemorrhage and haemorrhagic stroke were determined to be medically significant event.
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness
Clinical narrative: acute stroke secondary to intraventricular bleed in left hypothalamus and intraventricular blood with no mass effect; acute stroke secondary to intraventricular bleed in left hypothalamus and intraventricular blood with no mass effect; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In or around 01-DEC-2011, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration dates were not provided) for routine adult health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving Zoster Vaccine Live (ZOSTAVAX), the pt suffered slurring speech, development of facial droop and loss of consciousness and was later diagnosed with an acute stroke secondary to intraventricular bleed in left hypothalamus and intraventricular blood with no mass effect (haemorrhagic stroke and intraventricular haemorrhage). As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX) vaccine, the pt symptoms had resulted in physical limitations not presented prior to using Zoster Vaccine Live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and or sale of Zoster Vaccine Live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence the pt 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, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. Outcome of the events was not recovered. Causal relationship of the events was reported as related to Zoster Vaccine Live (ZOSTAVAX).  The reporter considered intraventricular haemorrhage and haemorrhagic stroke to be disabling events.  Upon internal review, intraventricular haemorrhage and haemorrhagic stroke were determined to be medically significant event.
Age: 29.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: No additional adverse effects; missed dose with his RECOMBIVAX vaccinations; This spontaneous report was received from a 29 years old male patient referring to himself. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.       The patient was on the 3-dose schedule for hepatitis b vaccine (recombinant) (RECOMBIVAX HB). On 18-AUG-2021, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (strength, dose, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis.         On 18-SEP-2021, the patient missed the second dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (product dose omission issue). The patient had not yet to take the second dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB). No additional adverse effects.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered, Incorrect route of product administration, Product storage error
Clinical narrative: this dose of vaccine will be repeated wiht new vaccine shot; this dose of vaccine will be repeated wiht new vaccine shot; lmpropely stored vaccine administered; via Intramuscular route; This spontaneous report was received from a nurse referring to unknown number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  Since 25-JUL-2021, the patients were vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (lot # T002847, expiration date 23-JAN-2022; strength, dose, route were not reported) for prophylaxis. Temperature excursion was 37.94 Fahrenheit degrees for 100 hours. There was no previous temperature excursion (product storage error).   This is a non-valid report due to lack of patients' identifier.   Follow up information has been received from the nurse on 20-SEP-2021. Upon receipt of follow up it was determined that the case was valid as the patient's identifiers were provided. This report concerned a 12 (also reported as 13) months old male patient. On 30-JUL-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (first dose, lot #: T002847, expiration date reported as 23-JAN-2023, but upon internal validation established as 23-JAN-2022) intramuscularly in the left thigh for prophylaxis (product storage error and incorrect route of product administration). The vaccine was stored in clinical "praclice". No prescription drug was given for the events. The detected vaccine was removed immediately after contacting Merck. No future vaccine was administered. The patient was noticed and this dose of vaccine would be repeated with new vaccine shot (extra dose administered and circumstance or information capable of leading to medication error). Data logger was involved.   This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2109USA005101: US-009507513-2109USA005117: US-009507513-2109USA005154: US-009507513-2109USA005159: US-009507513-2109USA005161: US-009507513-2109USA005213: US-009507513-2109USA005225: US-009507513-2109USA005236: US-009507513-2109USA005265: US-009507513-2109USA005394: US-009507513-2109USA005405:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; expired dose of MMR II administered; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 20-SEP-2021, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (recombinant Human albumin) (M-M-R II) 0.5 milliliter, subcutaneously, lot # S023654 was confirmed to be valid, expiration date 30-JUL-2021, for prophylaxis (site of administration were not reported). No additional adverse event was provided.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: No AE; Expired Gardasil 9 Administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender.  The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.   On 21-SEP-2021, the patient was vaccinated with a expired dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1614897, expiration date 20-SE-2021; 0.5 milliliter for prophylaxis (strength, vaccination scheme, and administration route were not provided) (expired product administered). No adverse events or product quality complains were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1614897; expirationdate: 20-SEP-2021; deviceage and unit: 0; operatorofdevice: Nurse; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: Caller states patient reported no additional AE; patient was inadvertently administered a dose of PNEUMOV AX23 with a labeled expiry of 8/30/2021 on 9/21/2021; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 21-SEP-2021, the patient was inadvertently administered a dose of expired pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot #T010293, verified as valid with expiration date 30-AUG-2021) 0.5 milliliter for prophylaxis  (dose number, route of administration and anatomical location were not reported). Reporter stated that patient reported no additional adverse events. The outcome of expired product administered was unknown.
Sex: M
Vaccine: PPV
Symptoms: Incomplete course of vaccination, Pulmonary fibrosis
Clinical narrative: the caller has pulmonary fibrosis; the caller has not received the prescribed second administration of Pneumovax; This spontaneous report was received from a a male patient of unknown age referring to himself. His historical vaccine included "the 13" (the patient believed this was pneumococcal vaccine conj 13V (PREVNAR 13), but it was unable to verify), the patient stated he was vaccinated prior to 2014, but a physician noted a fictitious date of 01-JAN-2017 for this administration. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided.   On an unspecified date in December 2014, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (exact dose, dose number, lot #, expiration date, route of administration and anatomical location were not reported). On an unknown date, the patient experienced pulmonary fibrosis. The patient's physician was now recommending a second administration of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) because of the pulmonary fibrosis. The caller stated insurance had denied covering a second administration of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and would not give him  a reason for denial. Therefore, the patient had not received the prescribed second administration of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23). On an unknown date in 2021, the patient experienced the incomplete course of vaccination (onset based on information that vaccination was recommended "now"). The outcome of pulmonary fibrosis and incomplete course of vaccination was unknown.    The causality assessment between the event of pulmonary fibrosis and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not reported.   Upon internal review the event of pulmonary fibrosis was considered to be medically significant.
Age: 1.5
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AEs; temperature excursion for VARlVAX; This spontaneous report was received from a nurse referring to an 18-months-old patient of unknown gender. For all the patients, the concurrent conditions, medical history and concomitant medications were not provided.  On 15-SEP-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) 1 dose (strength, dose, route, frequency, were not provided) for prophylaxis; Lot No. U010400 has been verified to be a valid lot number for [varicella virus vaccine live (Oka/Merck)], expiration date reported as 01-MAR-2023, and upon internal validation established as the same.  The nurse reported that the vaccine dose was administered on 15-SEP-2021 and there was a temperature excursion for varicella virus vaccine live (Oka/Merck) (VARIVAX). The product experienced an excursion of 4 Celsius degrees (C) from -10 C to 8 C for 20 minutes on 07-SEP-2021 during the transport; and of 4C from -10 C to 8 C for 20 minutes on 09-SEP-2021, again during transport. Previous temperature excursion included from -10°C to 8°C (4C) for 7 hours and 30 minutes. And no adverse events were reported.  This is one of four reports received from the same source.; Sender's Comments:  US-009507513-2109USA005618: US-009507513- 2109USA005639: US-009507513-2109USA005632:
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AEs; temperature excursion for VARlVAX; This spontaneous report was received from a nurse referring to a 2-years-old patient of unknown gender. For all the patients, the concurrent conditions, medical history and concomitant medications were not provided.  On 14-SEP-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) 1 dose (strength, dose, route, frequency, were not provided) for prophylaxis; Lot No. U015682 has been verified to be a valid lot number for [varicella virus vaccine live (Oka/Merck)], expiration date reported as 18-MAY-2023, and upon internal validation established as the same.  The nurse reported that the vaccine dose was administered on 14-SEP-2021 and there was a temperature excursion for varicella virus vaccine live (Oka/Merck) (VARIVAX). The product experienced an excursion of 4 Celsius degrees (C) from -10 C to 8 C for 20 minutes on 07-SEP-2021 during the transport; and of 4C from -10 C to 8 C for 20 minutes on 09-SEP-2021, again during transport. Previous temperature excursion included from -10°C to 8°C (4C) for 7 hours and 30 minutes. And no adverse events were reported.  This is one of four reports received from the same source.; Sender's Comments:  US-009507513-2109USA005618:reference TE number : 02017200 US-009507513-2109USA005628: US-009507513-2109USA005632:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's/PQC's reported; Temperature excursion for VARIVAX; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported.   On 13-SEP-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX)  (strength, dose, anatomical location, and route of administration were not reported) (lot# U015682 with an expiration date on 18-MAY-2023) for prophylaxis wich experienced a temperature excursión of 4°C Celsius degrees for 20 minutes on 07-SEP-2021 during transport and 4°C for 20minutes on 09-SEP-2021 during transport as well as -10°C to 8°C (4°C) for 20 minutes (product storage error).  It was reported previous temperature excursions of -10°C to 8°C (4°C) for 7 hours and 30 minutes.   No additional adverse events were reported.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella virus test negative
Clinical narrative: she had a titer done after the series was completed "almost 30 years ago" which was negative / she had another titer done last week and it was also negative; This spontaneous report was received from a consumer referring on herself a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   In approximately 1995, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, as prophylaxis (dose, route of administration, anatomical site of injection, lot number, and expiration date were not reported). The patient stated she completed the series.   On an unspecified date in 1995 (conflicting information also reported as almost 30 years ago), the patient had a titer done after the series, which result was negative (varicella virus test negative). On approximately 15-SEP-2021 (also reported as last week), the patient had another titer done, which result was also negative. She was unsure about the specific name of the laboratory test, but the result was "<135 and the reference range was <135 negative" (units not provided).   At the time of reporting, the patient was not recovered from varicella virus test negative. The causal relationship between the varicella virus test negative and varicella virus vaccine live (Oka/Merck) (VARIVAX) was not provided.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no AE; expirienced an excursion; This spontaneous report was received from a nurse referring to a 4-years-old patient of unknown gender. For all the patients, the concurrent conditions, medical history and concomitant medications were not provided.  On 10-SEP-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) 1 dose (strength, dose, route, frequency, were not provided) for prophylaxis; Lot No. U015682 has been verified to be a valid lot number for [varicella virus vaccine live (Oka/Merck)], expiration date reported as 18-MAY-2023, and upon internal validation established as the same.  The nurse reported that the vaccine dose was administered on 10-SEP-2021 and there was a temperature excursion for varicella virus vaccine live (Oka/Merck) (VARIVAX). The product experienced an excursion of 4 Celsius degrees (C) from -10 C to 8 C for 20 minutes on 07-SEP-2021 during the transport; and of 4C from -10 C to 8 C for 20 minutes on 09-SEP-2021, again during transport. Previous temperature excursion included from -10°C to 8°C (4C) for 7 hours and 30 minutes. And no adverse events were reported.  This is one of four reports received from the same source.; Sender's Comments:  US-009507513-2109USA005618: US-009507513-2109USA005628: US-009507513-2109USA005632: US-009507513-2109USA005639:
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Pain in leg; Tingling in leg; This case was reported by a consumer via other manufacturer and described the occurrence of leg pain in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included ruxolitinib phosphate (Jakafi) tablet (batch number 1232373, expiry date unknown) for aplastic anemia and bone marrow failure.   Concomitant products included mesalazine (Lialda), magnesium, omeprazole, colecalciferol (Vitamin D3), rivaroxaban (Xarelto), acetylsalicylic acid (Aspirin), levothyroxine (Levothyroxin), lisinopril, vitamins nos (Multivitamin) and sertraline hydrochloride (Sertraline Hcl Oral Tablet).   On an unknown date, the patient received Shingrix and Jakafi (oral) 10 mg twice daily (20 mg daily). On an unknown date, unknown after receiving Shingrix, the patient experienced leg pain and tingling of extremity. The action taken with Jakafi was unknown. On an unknown date, the outcome of the leg pain and tingling of extremity were unknown.   It was unknown if the reporter considered the leg pain and tingling of extremity to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced pain and tingling in leg. It was unknown if the reporter considered the leg pain and tingling of extremity to be related to Jakafi.
Sex: M
Vaccine: MENB, MENB
Symptoms: Incomplete course of vaccination, Product administered to patient of inappropriate age
Clinical narrative: injection when he was 2 months and 4 months; injection when he was 2 months and 4 months; This case was reported by a consumer via interactive digital media and described the occurrence of inappropriate age at vaccine administration in a 2-month-old male patient who received Men B NVS (Bexsero) for an unknown indication.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Men B NVS (Bexsero) for prophylaxis and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero, Bexsero Pre-Filled Syringe Device, the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device and not applicable after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was the patient's parent. The reporter stated that, his or her son got Bexsero injection when was 2 months and 4 months old, which led to inappropriate age at vaccine administration. The reporter stated that, the patient did not have the last shot. The reporter asked could the patient get a catch up shot now.The patient was 31 months old at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shot but had shingles/Suspected vaccination failure; shingles/ still have problems; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 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 was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient got shot but had a really bad case of shingles and still had problems. 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 could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I got shingles; This case was reported by a consumer via media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the second shot and week later got shingles. The patient stated that it was not a bad case.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I had this and it lasted 2 weeks; This case was reported by a consumer and described the occurrence of shingles in a 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 shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got shingles and after shingles shot which lasted for 2 weeks and had no real pain. The patient said he/she will not be getting another one.
Sex: U
Vaccine: VARZOS
Symptoms: Allergy to vaccine
Clinical narrative: allergic to shingles vaccine ingredients; This case was reported by a consumer via interactive digital media and described the occurrence of allergy to vaccine in a 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 allergy to vaccine. On an unknown date, the outcome of the allergy to vaccine was unknown.   It was unknown if the reporter considered the allergy to vaccine to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age vaccination was not reported. The patient reported that he/she was allergic to ingredients in shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles/just getting over it and it was horrid; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a 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. On an unknown date, the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the 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 patient had already got one shot and was just getting over shingles and it was horrid. The patient was waiting to get their booster shot. The patient also communicated that one should not mess with shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles/I had it/ worst thing you ever had in your life/no one wants them  horrible they are horrendous; This case was reported by a consumer via media and described the occurrence of shingles in a 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 shingles. On an unknown date, the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the 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 patient had the shingles shot and was just recovering from the shingles right then. The patient had the shingles and stated that they were the worst thing one could ever have in their life, no one would want them as they are horrible and horrendous. The patient stated that they dont know what others are talking about that shot, but they had one from it.
Sex: F
Vaccine: VARZOS
Symptoms: Neuropathy peripheral
Clinical narrative: neuropathy; This case was reported by a consumer via interactive digital media and described the occurrence of neuropathy in a female 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 neuropathy (serious criteria GSK medically significant). On an unknown date, the outcome of the neuropathy was unknown.   The reporter considered the neuropathy to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter knew the patient who had terrible reactions to the shingles shot. The reporter stated that the shots had metal in them and caused neuropathy. One of the patient's friend sued and won her case.  lt took 2 years to receive the settlement. This case has been linked with US2021AMR199707, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR199707:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got this vaccine & had shingles / suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an unspecified number of patients 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 case details were reported as follows: The age at vaccination was not applicable for this report. The reporter stated that lots of friends had this vaccine and still had shingles. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required. This case has been linked with US2021AMR182894 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR182894:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the vaccine and got shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several weeks 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 reporter stated that, had the shot few years ago and got shingles few weeks later. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the vaccine and have shingles now/ Suspected vaccination failure; have shingles now; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 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 reporter was the patient. The age at vaccination was not reported. The reporter stated that, had shingles vaccine and had shingles now. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shot, 2 years later got shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 years 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 reporter stated that,got the vacine shot and 2 years later got the shingles This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the vaccine and had it\ suspected vaccination failure; had it; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 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: This case was reported by patient himself /herself. The age at vaccination was not reported. The patient stated he/she had Shingles vaccine and still had shingles twice. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: husband got the shot, didn't stop from getting them\ suspected vaccination failure; shingles, not a bad case; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male 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: This case was reported by patient's Wife. The age at vaccination was not reported. The reporter stated got Shingles shot but shot did not stop him from getting them shingles, the patient did but not a bad case. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: got vaccinated. got out of the hospital because of shingles\ suspected vaccination failure; got out of the hospital because of shingles; pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 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 hospitalization and GSK medically significant), shingles (serious criteria hospitalization) and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was recovering/resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got Shingles vaccine and just got out of the hospital because of shingles. The patient stated he/she did support getting vaxed, because the pain was quite manageable after less than a week, which seems to be due to the shot. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Condition aggravated, Fatigue, Herpes zoster, Illness
Clinical narrative: Suspected vaccination failure; shingles; sick; tired; pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 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), shingles, sickness, tiredness and pain. On an unknown date, the outcome of the vaccination failure, shingles, sickness, tiredness and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, sickness, tiredness and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient taught that you only get shingles once but the patient keep getting them so his/her doctor started doing a biopsy to make sure they were shingles and not herpes, and sure enough they were shingles.  The patient was vaccinated but still experienced shingles. The patient was so sick and tired of getting shingles, and the pain was sometimes unbearable. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset of shingles were not provided. This case has been linked with case US2021AMR200635 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR200635:same repoter
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; sick; tired; pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 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), shingles, sickness, tiredness and pain. On an unknown date, the outcome of the vaccination failure, shingles, sickness, tiredness and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, sickness, tiredness and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient taught that you only get shingles once but the patient keep getting them so his/her doctor started doing a biopsy to make sure they were shingles and not herpes, and sure enough they were shingles.  The patient was vaccinated but still experienced shingles. The patient was so sick and tired of getting shingles, and the pain was sometimes unbearable. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset of shingles were not provided. This case has been linked with case US2021AMR200635 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR200635:same repoter
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female 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 was reporter's sister. The age at vaccination was not reported. The patient was vaccinated and experienced shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided. This case has been linked with the case US2021AMR200633 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR200633:same repoter