chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; Nurse called to report that an expired ROTATEQ was given to a patient today 4/8/2022.   No additional AEs were reported.   No further information provided.; This spontaneous report was received from nurse and refers to a patient of unknown age or gender.  The patient's medical history, concurrent conditions, or concomitant therapies were not reported.  On 08-APR-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dose (lot #1707496, expiration date: 29-MAR-2022) administered for prophylaxis (strength, and route of administration were not provided), which had already expired. No adverse event were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; A vaccine coordinator reported VARIVAX was administered after a temperature excursion.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 25-MAR-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose and route were not reported; lot # U022320, expiration date: 15-JUL-2023) for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to a temperature of minus 11.83 degree Celsius for a time frame of 15 minutes. Previous temperature excursion included 9.37 degree Celsius for a time frame of 2 hours and 30 min.   No additional adverse event (AE) information was provided (no adverse event).  This is one of the multiple cases reported by the same reporter.; Sender's Comments:  US-009507513-2204USA002815:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Medical Assistant reporting administration of improperly stored VARIVAX; No additional adverse events reported; This spontaneous report was received from a medical assistant and refers to an unspecified patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot# U025791 with expiration date on 19-AUG-2023; lot# U020239 with expiration date on 28-JUN-2023; lot# U016063 with expiration date on 20-MAY-2023) subcutaneous injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) which experienced a temperature excursion of 5.4°C Celsius degrees during a time frame of 2 hours 42 minutes. No previous temperature excursions were reported.
Sex: F
Vaccine: PPV
Symptoms: Adverse drug reaction, Cardiac operation, Myocardial infarction
Clinical narrative: heart attack; patient experienced an unknown reaction to an unknown medication; This spontaneous report was received from a Medical Assistant referring to a female patient of unknown age. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided     On an unknown date in 2010, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported).        The reporter informed that a patient experienced an unknown reaction to an unknown medication. Medical Assistant states that it was reported to her from a Physician to inquire if pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) contains polyglycol or  lumazine due to the Physician believing that Patient experienced an reaction to a medication containing the ingredients polyglycol and lumazine (adverse drug reaction). Medical Assistant reports that Patient experienced this reaction on an unknown date in 2021 (reported as "last year") and received the medication after she had a heart attack (myocardial infarction) and needed to have heart surgery. At the time of reporting, the patient had not received more doses of the vaccine. The outcome of myocardial infarction and adverse drug reaction was unknown.   The causal relationship between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the events was unknown.   Upon internal review, the event myocardial infarction was determined to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE reported; A vaccine coordinator reported VARIVAX was administered after a temperature excursion.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 30-MAR-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose and route were not reported; lot # U022320, expiration date: 15-JUL-2023) for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to a temperature of minus 11.83 degree Celsius for a time frame of 15 minutes. Previous temperature excursion included 9.37 degree Celsius for a time frame of 2 hours and 30 min.    No additional adverse event (AE) information was provided (no adverse event).  This is one of the multiple cases reported by the same reporter.; Sender's Comments:  US-009507513-2204USA002815:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; A vaccine coordinator reported VARIVAX was administered after a temperature excursion.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 02-APR-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose and route were not reported; lot # U022320, expiration date: 15-JUL-2023) for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to a temperature of minus 11.83 degree Celsius for a time frame of 15 minutes. Previous temperature excursion included 9.37 degree Celsius for a time frame of 2 hours and 30 min.    No additional adverse event (AE) information was provided (no adverse event).  This is one of the multiple cases reported by the same reporter.; Sender's Comments:  US-009507513-2204USA002815:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; A vaccine coordinator reported VARIVAX was administered after a temperature excursion.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 04-APR-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose and route were not reported; lot # U022320, expiration date: 15-JUL-2023) for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to a temperature of minus 11.83 degree Celsius for a time frame of 15 minutes. Previous temperature excursion included 9.37 degree Celsius for a time frame of 2 hours and 30 min.    No additional adverse event (AE) information was provided (no adverse event).  This is one of the multiple cases reported by the same reporter.; Sender's Comments:  US-009507513-2204USA002815:
Sex: U
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: First Dose with Heplisav-B and Second Dose with Engerix; Initial Report Received on 10-Mar-2022  A registered pharmacist in the reported that a 51-year-old female patient (race and ethnicity unknown) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as the first dose and Engerix-B as the second dose.  No medical history or allergies at the time of vaccination were reported.   No concomitant medications at the time of vaccination were reported.  On 21-Nov-2021, the patient received dose 1 of HEPLISAV-B (Lot # 935848, expiration date 02-Dec-2022, NDC # 43528-003-05, route and injection site unknown).  On 28-Jan-2022, 69 days after having received the HEPLISAV-B vaccine, the patient received Engerix-B (Lot #, expiration date, NDC #, route, and injection site unknown) as the second dose.  No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy, Inappropriate schedule of product administration, No adverse event
Clinical narrative: 11 Weeks Pregnant; Inappropriate Schedule of Vaccine Administered; Initial Report Received on 14-Mar-2022  A pregnant patient (gestation period 11 weeks) reported to the pregnancy registry that she (age 25, race and ethnicity unknown) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history at the time of vaccination was reported.   Medications at the time of vaccination were reported as prenatal vitamins and ondansetron.  On 22-Sep-2021, the patient received the first dose of HEPLISAV-B (Lot #, expiration date, NDC #, and injection site unknown) prior to pregnancy.  On 14-Mar-2022, the patient informed the pharmacist that she was pregnant (11 weeks) and asked if it was safe to get the HEPLISAV-B vaccine during pregnancy. The pharmacist said yes and administered the second dose of HEPLISAV-B (Lot # 935848, expiration date 02-Dec-2022, and NDC # 43528-003-01) intramuscularly in an unknown site to the patient on the same date.  No adverse effects were reported at that time. After researching the HEPLISAV-B vaccine and pregnancy on her own, the patient became concerned but declined enrollment into the pregnancy registry.   No additional information was provided.  Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: powder administered with unapproved diluent; powder administered with unapproved diluent; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 4 April 2022 Reporter's Comments: Some months ago, the nurse from another facility administered a partial dose of Menveo as only the powder was administered with an unapproved diluent to the patient.  The reporter did not had any information about the patient and the vaccine as lot number and expiration date also did not had information about which diluent the nurse used to administer the dose.  The reporter consented to follow up. Additional Supportive Information: The patient received partial dose of Menveo as only the powder was administered with an unapproved diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.; Sender's Comments:  US-GLAXOSMITHKLINE-AE2022059676:Original case - Deleted
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity
Clinical narrative: arm was sore; felt fatigued; This case was reported by a physician via sales rep and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced pain in arm and fatigue. On an unknown date, the outcome of the pain in arm and fatigue were unknown.   It was unknown if the reporter considered the pain in arm and fatigue to be related to Shingrix.     Additional Information: GSK Receipt Date: 5-APR-2022 Reporter's Comment: The patient received dose of Shingrix vaccine and arm was sore and felt fatigued the next day. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: accidental third Shingrix; This case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st and 2nd dose received 3 years ago from the date of reporting).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 6-APR-2022 Reporter's Comment: The consumer reported this case via (Shingrix GSK) interactive digital media. The reporter asked an accidental third Shingrix shot given three years after the first two going to be a problem. Additional supportive information:  The patient received 3rd dose of Shingrix, which led to extra dose administered. The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Bexsero that expired 1/31/22 was administered; This case was reported by a other health professional via interactive digital media and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number unknown, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included 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 and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 6-APR-2022 Reporter's Comment: The reporter reported this case via interactive digital media. The reporter stated that the expired Bexsero vaccine was accidentally administered to a patient. Additional supportive information:  The patient received a dose of Bexsero which was already expired, which led to expired vaccine used. The follow-up would not possible, as no contact details were available. The case had been linked to US2022061072, reported for the possibly same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022061072:Possibly same patient
Sex: F
Vaccine: VARZOS
Symptoms: Contusion
Clinical narrative: Bilateral bruising on hip and thigh; This case was reported by a physician via sales rep and described the occurrence of contusion of thigh in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced contusion of thigh. On an unknown date, the outcome of the contusion of thigh was recovering/resolving.   It was unknown if the reporter considered the contusion of thigh to be related to Shingrix.     Additional Information: GSK Receipt Date: 7-APR-2022 Reporter's Comment: The patient received dose of Shingrix vaccine and experienced bilateral bruising on hip and thigh, starting to went away at time of follow up visit 2 to 3 days following vaccination. The reporter consented to follow-up.
Age: 60.0
Sex: F
Vaccine: TDAP, UNK
Symptoms: Feeling hot, Limb discomfort, Limb injury, Pain, Peripheral swelling
Clinical narrative: left side has been hurting; This case was reported by a consumer via other manufacturer and described the occurrence of pain in a 60-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included sarilumab (Kevzara) for product used for unknown indication.   Concurrent medical conditions included peripheral swelling and feeling hot.   On 16th February 2022, the patient received Boostrix. On an unknown date, the patient started Kevzara at an unknown dose and frequency. On an unknown date, less than 2 months after receiving Boostrix, the patient experienced pain. The action taken with Kevzara was unknown. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Boostrix.     Additional Information: GSK Receipt Date: 7-APR-2022 Reporter's Comment: 07-APR-2022. The patient self-reported this case. The patient developed fishhook got stuck in the heel of her foot, she then had swelling of her leg and heat started coming up her leg (feeling hot, peripheral swelling) (unknown latency) following the first dose intake of Kevzara. Since receiving Boostrix, her entire left side has been hurting following the first dose intake of Kevzara and Boostrix. The reporter asked if there was any problem with taking Kevzara dose on 23rd February 2022 when she had to have a tetanus shot this past Wednesday? The caller takes KEVZARA, as prescribed by her rheumatologist. She stepped on a fish hook in the parking lot of her condominiums. The fish hook got stuck in the heel of her foot. She then had swelling of her leg and "heat started coming up" her leg. She had to get a tetanus shot due to the fish hook on Wednesday (16Feb2022). She checked her paperwork and reports that she received Boostrix. She mentioned that since receiving Boostrix, her entire left side has been hurting. She was due for her Kevzara dose 23rd February 2022. No further information provided by the reporter. It was not reported if the patient received a corrective treatment for the events (fishhook got stuck in the heel of her foot, she then had swelling of her leg and heat started coming up her leg, fishhook got stuck in the heel of her foot, she then had swelling of her leg and heat started coming up her leg, since receiving Boostrix, her entire left side has been hurting). At time of reporting, the outcome was not recovered for peripheral swelling, feeling hot and pain. It was unknown if the reporter considered the pain to be related to Kevzera.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature decreased, Disorientation, Feeling abnormal, Laboratory test normal
Clinical narrative: didn't feel right; I didn't know who I was; low temperature; This case was reported by a consumer via sales rep and described the occurrence of feeling abnormal in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th July 2021, the patient received the 1st dose of Shingrix. On 20th July 2021, 8 days after receiving Shingrix, the patient experienced body temperature decreased. On 21st July 2021, the patient experienced feeling abnormal (serious criteria hospitalization) and disorientation (serious criteria hospitalization). On an unknown date, the outcome of the feeling abnormal and disorientation were unknown and the outcome of the body temperature decreased was recovered/resolved.   It was unknown if the reporter considered the feeling abnormal, disorientation and body temperature decreased to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-APR-2022 Reporter's Comment: The case was reported by the patient. After the first injection, the patient ran low temperature and went away, next day, she didn't feel right, following went into hospital. The patient went into hospital on 21st July 2021 and released on 24th July 2021. The patient didn't know that who she was. 9 days after receiving Shingrix,the patient experienced feeling abnormal, disorientation.  All testing in hospital was negative.  The only conclusion was the shingles vaccine with her doctor agreeing.  The patient got the second dose with no reaction. The reporter agreed to follow up.
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: temp up to 104.5; developed rash, head to toe; Hives; This case was reported by a nurse via call center representative and described the occurrence of fever in a infant female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2018-2019 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Fluarix Quadrivalent with an associated reaction of urticaria (received 1st dose of Fluarix Quadrivalent 2018-2019 season in 2018 and developed hives refer case US2022061845).   On an unknown date, the patient received the 2nd dose of Fluarix Quadrivalent 2018-2019 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, 24 hrs after receiving Fluarix Quadrivalent 2018-2019 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced fever, generalized rash and hives. Rechallenge with Fluarix Quadrivalent 2018-2019 season was positive. On an unknown date, the outcome of the fever, generalized rash and hives were recovered/resolved.   It was unknown if the reporter considered the fever, generalized rash and hives to be related to Fluarix Quadrivalent 2018-2019 season and Fluarix Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022061845   Additional Information: GSK Receipt Date: 07-Apr-2022 Reporter's Comments: The reporter stated that the patient reacted to Fluarix vaccine quadrivalent. The vaccine was administered in 2018, 24 hours after the vaccine administration developed rash, head to toe, hives and temperature up to 104.5 degree F.   Temperature reportedly lasted 1.5 days and rash/hives 2.5 weeks. The reporter wanted to resume vaccinations. The reporter was unable to provide exact date of vaccine or additional details as the vaccines were administered at a different facility. The reporter consented to follow up via post.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022061845:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: #1 - given shingrix 9/4/19, 11/14/19 and 3/3/22; This case was reported by a other health professional and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 4th September 2019) and Shingrix (2nd dose received on 14th November 2019).   On 3rd March 2022, the patient received the 3rd dose of Shingrix. On 3rd March 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 7-APR-2022 Reporter's Comment: The patient received three doses of Shingrix vaccine. The reporter asked could GlaxoSmithKline tell him/her if there were any ramification of three doses of Shingrix was given to a patient. The reporter consented to follow-up Additional supportive information: The patient received 3rd dose of Shingrix, which led to Extra dose administered. This is one of 2 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR062300:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: #2 - given shingrix 9/12/19, 11/14/19 and 3/3/22; This case was reported by a other health professional and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 12th September 2019) and Shingrix (2nd dose received on 14th November 2019).   On 3rd March 2022, the patient received the 3rd dose of Shingrix. On 3rd March 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 7-APR-2022 Reporter's Comment: The patient received three doses of Shingrix vaccine. The reporter asked could GlaxoSmithKline tell him/her if there were any ramification of three doses of Shingrix was given to a patient. The reporter consented to follow-up. Additional supportive information: The patient received 3rd dose of Shingrix, which led to extra dose administered. This is one of 2 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR062283:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Pain, Pyrexia
Clinical narrative: sick; fever; body aches; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness, fever and general body pain. On an unknown date, the outcome of the sickness, fever and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the sickness, fever and general body pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 7-APR-2022 Reporter's Comment: The case was reported by patient. The patient just received 2nd dose of Shingles vaccine and felt sick with fever and body aches for a week. The patient asked what could he/she do to help with the symptoms. Additional supportive information: The patient self-reported this case via interactive digital media. The follow-up would not possible, as no contact details were available.
Sex: M
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: sore arm for approx. 2 weeks; This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included 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 and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: Additional Information: GSK Receipt Date: 7-APR-2022 Reporter's Comment: This case was reported by the patient's parent. The patient received dose of Bexsero vaccine and experienced a sore arm for approximately 2 weeks. The reporter did not consent to follow-up.
Sex: U
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 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 Information: GSK Receipt Date: 08-Apr-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient stated that he/she got the newest shot and still got shingles. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster, Vaccination failure
Clinical narrative: had the new shot, came down with shingles/suspected vaccination failure; shingles; I felt I was on fire; 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.   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), shingles and burning sensation. On an unknown date, the outcome of the vaccination failure, shingles and burning sensation were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and burning sensation to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date:08-Apr-2022 Reporter's comment: The case was received from consumer via interactive digital media. The patient self-reported this case.  The patient had the old shots and had the new shot but still came down with shingles. It was horrible.  The patient stated that the worst was when ever he/she was in the sun, it felt the he/she was on fire. The follow-up could not be possible as no contact details were available. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: fever; flu like aches; aches and pains; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 7th April 2022, the patient received Shingles vaccine. In April 2022, less than a week after receiving Shingles vaccine, the patient experienced fever, flu-like aching and pain. On an unknown date, the outcome of the fever, flu-like aching and pain were unknown.   It was unknown if the reporter considered the fever, flu-like aching and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 8-APR-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine yesterday (day before reporting) and experienced flu like aches, pains and a fever. The patient stated that he/she was told it could happen. Additional supportive information: The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got two shots, still have a mild case of shingles/Suspected vaccination failure; Mild case of shingles; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of 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 Information: GSK Receipt Date: 08-APR-2022 Reporter's Comments: This case was received from patient via interactive digital media. The patient got the two Shingle shots and still had a mild case of the shingles. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I have them and I had the shot/Suspected vaccination failure; Shingles, I have them; 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 and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-APR-2022 Reporter's Comment: This case was reported by a consumer via  interactive digital media.  The case was reported by the patient. The patient had shingles and he/she had the shot. The patient stated that, anybody could still get shingles even after they had the shot. Additional Supportive Information: This case was considered as suspected vaccination failure as 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: M
Vaccine: VARZOS
Symptoms: Death, Herpes zoster, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Late husband had the shot; Suspected vaccination failure; Shingles around eye and topped head, almost lost eye; Shingles topped his head; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death 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, more than 2 years after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant), vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and herpes zoster. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the vaccination failure, ophthalmic herpes zoster and herpes zoster were unknown. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death, vaccination failure, ophthalmic herpes zoster and herpes zoster to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 08-Apr-2022 Reporter's Comments: This case was reported by the patient's spouse via interactive digital media. The reporter's late husband had the shingles shot and shingles attacked him two years later around his eye and topped his head, the patient almost lost his eye. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available.; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/had them, don't think vaccine made any difference; I've had them 32 times I've had them 32 times so far. I don't think the vaccine made any difference.; 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.   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 Information: GSK receipt date: 08-Apr-2022 Reporter's comment: The case was received from patient via interactive digital media. The patient had shingles 32 times so far and did not think that the vaccine made any difference. Additional Supportive Information: This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure as details regarding completion of 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: Discomfort, Headache, Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: had the shingles vaccine, have shingles/suspected vaccination failure; have shingles; headache, unbearable; itch; 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), shingles, headache and pruritus. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, headache and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, headache and pruritus to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 08-APR-2022 Reporter's Comments: This case was received from patient via interactive digital media. The patient had the shingles vaccine and had shingles as he/she was pounding this keyboard.  The patient hoped none of anyone get it.  The patient reported that it was so uncomfortable, headache was unbearable and the itch.  The patient did not wish that anyone to have it. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Rash
Clinical narrative: Anti-bodies react, huge rash; Burning reaction neck, arms and legs; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of no adverse event (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rash and burning sensation. On an unknown date, the outcome of the rash and burning sensation were recovered/resolved.   It was unknown if the reporter considered the rash and burning sensation to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 8-APR-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and experienced huge rash and burning reaction on neck, arms and legs for one year. The patient stated that not all anti-bodies reacted smoothly. Additional supportive information: The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Neuralgia, Neuropathy peripheral
Clinical narrative: Neuropathy; nerve pain at 4 surgical areas; sick; This case was reported by a consumer via interactive digital media and described the occurrence of neuropathy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (patient's mother).   In May 2021, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced neuropathy (serious criteria GSK medically significant), nerve pain and sickness. On an unknown date, the outcome of the neuropathy, nerve pain and sickness were unknown.   It was unknown if the reporter considered the neuropathy, nerve pain and sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-APR-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient got 2nd shot of Shingles vaccine and although he/she was not looking forward to it, he/she knew it was painful having shingles because his/her mom had it and he/she had a similar pain from neuropathy nerve pain at the end of 4 surgical areas. But he/she was sick with the shot and got every warning from the label. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: Shingles in my eye after 1st shot; Shingles on face after 1st shot; This case was reported by a consumer via interactive digital media and described the occurrence of ophthalmic herpes zoster in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included hashimoto's thyroiditis.   On 4th March 2022, the patient received the 1st dose of Shingles vaccine. In March 2022, 2 weeks after receiving Shingles vaccine and an unknown time after starting Valtrex, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the ophthalmic herpes zoster and shingles were unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 09-APR-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient received first shingles shot and two weeks later got shingles on his/her face and in eye. The patient was now afraid to get the second shot. The patient was still treated for shingles on my 4th refill of Valtrex . Additional Supportive Information: The follow-up would not possible as no contact details were available. Note:From the narrative Hashimoto's thyroiditis seems to be preexisting condition, hence considered as concurrent condition instead of adverse event.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Fall, Herpes zoster, Injury, Vaccination failure
Clinical narrative: Had the 2 step shingles vx, now i have broken out/Suspected vaccination failure; Now i think that i have broken out; Trauma; Trauma to my left side from a fall; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, injury and fall. On an unknown date, the outcome of the vaccination failure, shingles, injury and fall were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, injury and fall to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 09-APR-2022  Reporter's Comments: This case was received from the patient via interactive digital media. The patient had 2 step Shingle vaccine and now thought he/she had broken out across left chest and ribs after trauma to his/her left side from a fall. Additional Supportive Information:  This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure since the details regarding 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: Ophthalmic herpes zoster, Stress, Vaccination failure
Clinical narrative: Got the shots. Shingles in my eye now/Suspected vaccination failure; Shingles in eye now, after terrible stressful event; i had a terrible stressful event; 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.   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), ophthalmic herpes zoster (serious criteria GSK medically significant) and stress. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster and stress were unknown.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and stress to be related to Shingles vaccine.     Additional Information: GSK receipt date: 10-Apr-2022 Reporter's comment: The case was received from consumer via interactive digital media. This patient self reported this case. The patient had shingles and then got the shots and here he/she with shingles in his/her eye at the time of reporting. The patient stated that stress brought them out and had terrible stressful event and they appeared. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of 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.