chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Abdominal pain upper, Chest pain, Chills, Dyspnoea, General physical condition abnormal
Clinical narrative: Fever; Chills; Body pain; Stomach pain; Chest pain; Cannot breathe/ his throat closes up; Spit up blood; Flu symptoms like cold; Irritated throat; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included 10PN-PD-Dit (Pneumococcal vaccine) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on unknown date).   On 22-APR-2025, the patient received the 2nd dose of Shingrix (right arm) and Pneumococcal vaccine (left arm). On 22-APR-2025, an unknown time after receiving Shingrix and Pneumococcal vaccine, the patient experienced fever (Verbatim: Fever), chills (Verbatim: Chills), general body pain (Verbatim: Body pain), stomach pain (Verbatim: Stomach pain), chest pain (Verbatim: Chest pain), difficulty breathing (Verbatim: Cannot breathe/ his throat closes up), sputum bloody (Verbatim: Spit up blood), cold (Verbatim: Flu symptoms like cold) and throat irritation (Verbatim: Irritated throat). The outcome of the fever, chills, general body pain, stomach pain, chest pain, difficulty breathing, sputum bloody, cold and throat irritation were not resolved.   It was unknown if the reporter considered the fever, chills, general body pain, stomach pain, chest pain, difficulty breathing, sputum bloody, cold and throat irritation to be related to Shingrix and Pneumococcal vaccine.     It was unknown if the company considered the fever, chills, general body pain, stomach pain, chest pain, difficulty breathing, sputum bloody, cold and throat irritation to be related to Shingrix and Pneumococcal vaccine.   Additional Information: GSK Receipt Date: 23-APR-2025 The reporter is the wife calling on behalf of her husband who was a male patient that received his second dose of Shingrix a day before reporting, 22-APR-2025, in his right arm, and reported that ever since he received the vaccine, he had had a lot of fever, chills, body pain, stomach pain, chest pain, and flu symptoms like a cold.  The reporter also reported that when the patient was sleeping, he felt like he cannot breathe, his throat closes, and he had to spit up blood it was so irritated.  The reporter stated that the patient was still experiencing all the above reported adverse events on the day of reporting, 23-APR-2025.  The reporter also reported that the patient received his Pneumonia Vaccine at the same time as his second Shingrix vaccine, but in his left arm.  The reporter had no paperwork from either vaccine.
Age: 71.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Haematemesis, Influenza, Pyrexia, Throat irritation, Throat tightness
Clinical narrative: Fever; Chills; Body pain; Stomach pain; Chest pain; Cannot breathe/ his throat closes up; Spit up blood; Flu symptoms like cold; Irritated throat; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included 10PN-PD-Dit (Pneumococcal vaccine) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on unknown date).   On 22-APR-2025, the patient received the 2nd dose of Shingrix (right arm) and Pneumococcal vaccine (left arm). On 22-APR-2025, an unknown time after receiving Shingrix and Pneumococcal vaccine, the patient experienced fever (Verbatim: Fever), chills (Verbatim: Chills), general body pain (Verbatim: Body pain), stomach pain (Verbatim: Stomach pain), chest pain (Verbatim: Chest pain), difficulty breathing (Verbatim: Cannot breathe/ his throat closes up), sputum bloody (Verbatim: Spit up blood), cold (Verbatim: Flu symptoms like cold) and throat irritation (Verbatim: Irritated throat). The outcome of the fever, chills, general body pain, stomach pain, chest pain, difficulty breathing, sputum bloody, cold and throat irritation were not resolved.   It was unknown if the reporter considered the fever, chills, general body pain, stomach pain, chest pain, difficulty breathing, sputum bloody, cold and throat irritation to be related to Shingrix and Pneumococcal vaccine.     It was unknown if the company considered the fever, chills, general body pain, stomach pain, chest pain, difficulty breathing, sputum bloody, cold and throat irritation to be related to Shingrix and Pneumococcal vaccine.   Additional Information: GSK Receipt Date: 23-APR-2025 The reporter is the wife calling on behalf of her husband who was a male patient that received his second dose of Shingrix a day before reporting, 22-APR-2025, in his right arm, and reported that ever since he received the vaccine, he had had a lot of fever, chills, body pain, stomach pain, chest pain, and flu symptoms like a cold.  The reporter also reported that when the patient was sleeping, he felt like he cannot breathe, his throat closes, and he had to spit up blood it was so irritated.  The reporter stated that the patient was still experiencing all the above reported adverse events on the day of reporting, 23-APR-2025.  The reporter also reported that the patient received his Pneumonia Vaccine at the same time as his second Shingrix vaccine, but in his left arm.  The reporter had no paperwork from either vaccine.
Vaccine: RVX
Symptoms: Rotavirus infection, Vaccination failure
Clinical narrative: Suspected vaccination failure; breakthrough Rotavirus cases after administration with Rotarix with multiple patients; This serious case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a patient who received Rotavirus vaccine for prophylaxis.   On an unknown date, the patient received Rotavirus vaccine. On an unknown date, an unknown time after receiving Rotavirus vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and rotavirus infection (Verbatim: breakthrough Rotavirus cases after administration with Rotarix with multiple patients) (serious criteria other: Serious as per reporter). The outcome of the vaccination failure was not reported and the outcome of the rotavirus infection was unknown.   The reporter considered the vaccination failure and rotavirus infection to be related to Rotavirus vaccine and Rotarix Unspecified Oral Administation Device.     The company considered the vaccination failure and rotavirus infection to be unrelated to Rotavirus vaccine and Rotarix Unspecified Oral Administation 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: GSK Receipt Date : 24-APR-2025 Clinical lead reported breakthrough Rotavirus cases after administration with Rotarix with multiple patients. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Rotavirus vaccine and Rotarix UNSPECIFIED ORAL ADMINISTATION DEVICE. Rotavirus is an unlisted event which is considered unrelated to GSK vaccine Rotavirus vaccine and Rotarix UNSPECIFIED ORAL ADMINISTATION DEVICE.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Blister rupture, Chest pain, Herpes zoster, Pain
Clinical narrative: Suspected vaccination failure; shingles/ blisters on his right side of neck/ somewhat painful; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 86-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) and the 1st dose of Shingrix (intramuscular). On 20-APR-2025, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles/ blisters on his right side of neck/ somewhat painful). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   The reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. The company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 24-APR-2025 The reporter called and stated he was a healthcare professional that had taken both Shingrix vaccine and on Sunday, noticed 2 blisters on his right side of neck that erupted and was ongoing.  On Monday, (21-APR-2025) on the right side of the chest was somewhat painful and was ongoing.  On Thursday, (24-APR-2025) reporter went to the doctor and was diagnosed with shingles. All the shingles vaccines that were administered to patient, this was a normal occurrence. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles/ blisters on his right side of neck/ somewhat painful; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 86-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) and the 1st dose of Shingrix (intramuscular). On 20-APR-2025, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles/ blisters on his right side of neck/ somewhat painful). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   The reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. The company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 24-APR-2025 The reporter called and stated he was a healthcare professional that had taken both Shingrix vaccine and on Sunday, noticed 2 blisters on his right side of neck that erupted and was ongoing.  On Monday, (21-APR-2025) on the right side of the chest was somewhat painful and was ongoing.  On Thursday, (24-APR-2025) reporter went to the doctor and was diagnosed with shingles. All the shingles vaccines that were administered to patient, this was a normal occurrence. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).
Sex: F
Vaccine: RVX
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Arm pain, and muscular pain; Arm pain, and muscular pain; This non-serious case was reported by a consumer and described the occurrence of myalgia upper extremities in a 72-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Concurrent medical conditions included ulcerative colitis and anxiety. Concomitant products included mesalazine (Lialda), alprazolam (Xanax) and zolpidem tartrate (Zopidem).   On 25-APR-2025, the patient received RSV vaccine. On 25-APR-2025, less than a day after receiving RSV vaccine, the patient experienced myalgia upper extremities (Verbatim: Arm pain, and muscular pain) and pain in arm (Verbatim: Arm pain, and muscular pain). The outcome of the myalgia upper extremities and pain in arm were not resolved.   It was unknown if the reporter considered the myalgia upper extremities and pain in arm to be related to RSV vaccine.     It was unknown if the company considered the myalgia upper extremities and pain in arm to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 28-APR-2025 The reporter reported that had ulcerated colitis being treated with a drug that impairs immune system  been in total remission for this same 13 year. The patient received RSV vaccine and experienced mild to moderate arm pain from any vaccine, but this was the worst yet.
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-MAY-2025 The reporter reported a friend of his developed shingles after receiving the first dose of Shingrix.
Vaccine: RVX
Symptoms: Cough, Feeling abnormal, Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: Feeling miserable; Suspected vaccination failure; here I am on March 20 for Easter with RVS; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On 03-JAN-2025, the patient received RSV vaccine. On 20-MAR-2025, 76 days after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: here I am on March 20 for Easter with RVS). On an unknown date, the patient experienced feeling miserable (Verbatim: Feeling miserable). The outcome of the vaccination failure and feeling miserable were not reported and the outcome of the respiratory syncytial virus infection was not resolved.   It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection and feeling miserable to be related to RSV vaccine.     The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection and feeling miserable to be related to RSV vaccine.   Additional Information: GSK receipt date: 21-APR-2025 This case was reported by a patient via interactive digital media.  Patient got the vaccine on January 3 and here on March 20 for Easter with RVS. Patient asked why? Patient was feeling very miserable and coughing like never coughed before. Patient did breathing treatments every 4 hours and keeping track of breathe saturation levels making sure it does not drop below 90 if it does patient had to go directly to hospital. Patient asked if the vaccine worth getting it or not. This case was considered as suspected vaccination failure as laboratory confirmation regarding RSV were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding laboratory confirmation of disease) is considered unrelated to GSK RSV vaccine.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; now suffer with shingles today as I type; This serious 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, between 1 and 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: now suffer with shingles today as I type). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 20-APR-2025 This case was reported by a patient via interactive digital media. The patient got vaccinated 2 years ago on the 30th of this month and now suffered with shingles today as I type This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; got the vaccine as an adult and still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (had as a kid).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got the vaccine as an adult and still got shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 24-APR-2025 This case was reported by a patient via interactive digital media. The patient had chicken pox as a kid, got the vaccine as an adult and still got shingles. The patient thought that his/her case wasn't as bad as some get, because he/she had the vaccine shot. The patient suggested to get vaccinated, if did not want shingles. The patient had a mild case but was painful. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Post herpetic neuralgia, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got shingles recently; and still had some nerve pain in  shoulder, neck and the back of my head; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: still got shingles recently) and post herpetic neuralgia (Verbatim: and still had some nerve pain in  shoulder, neck and the back of my head). The outcome of the vaccination failure and shingles were not reported and the outcome of the post herpetic neuralgia was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 22-APR-2025 This case was reported by a patient via interactive digital media. Consumer reported that he/she got the vaccine and still got shingles recently. Reporter reported didn't had a lot of blisters but the pain was horrible and still had some nerve pain in  shoulder, neck and the back of my head. 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 could not be possible as no contact details were available.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS
Symptoms: Nervous system disorder
Clinical narrative: neurologically compromised; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of neurological disorder nos in a specified number of patients 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, an unknown time after receiving Shingles vaccine, the patient experienced neurological disorder nos (Verbatim: neurologically compromised). Shingles vaccine was discontinued. The outcome of the neurological disorder nos was resolved (duration 2 weeks).   It was unknown if the reporter considered the neurological disorder nos to be related to Shingles vaccine.     It was unknown if the company considered the neurological disorder nos to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 22-APR-2025 This case was reported by a consumer via interactive digital media. The reporter reported that these comments would drive reporter to the vaccination but 2 of reporter best friends had horrible reactions to the vaccination, that being neurologically compromised for about 2 weeks. It was bad, one phoned her doctor and said do not take the second vaccination.
Vaccine: VARZOS
Symptoms: Deafness unilateral, Neuralgia, Nodule, Pruritus, Pyrexia
Clinical narrative: Suspected vaccination failure; lost my hearing in my right ear; went blind in my right eye; shingles; I throw up yellow stuff; I get knots all over my body; it hurts my nerves in my body; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), hearing loss unilateral (Verbatim: lost my hearing in my right ear) (serious criteria GSK medically significant), blind right eye (Verbatim: went blind in my right eye) (serious criteria GSK medically significant), shingles (Verbatim: shingles), vomiting (Verbatim: I throw up yellow stuff), nodule (Verbatim: I get knots all over my body) and post herpetic neuralgia (Verbatim: it hurts my nerves in my body). The outcome of the vaccination failure, hearing loss unilateral, blind right eye and vomiting were not reported and the outcome of the shingles, nodule and post herpetic neuralgia were not resolved.   It was unknown if the reporter considered the vaccination failure, hearing loss unilateral, blind right eye, shingles, vomiting, nodule and post herpetic neuralgia to be related to Shingles vaccine.     The company considered the vaccination failure, hearing loss unilateral and blind right eye to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles, vomiting, nodule and post herpetic neuralgia to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 22-APR-2025 This case was reported by a patient via interactive digital media. Patient had taken vaccine and thought he/she was going to die.  Patient threw up yellow stuff, had run, and a high fever for three days. He/she came down with shingles, but they never appeared came out.  He/she had been on medication for five years now.  He/she had also nearly gone blind in his/her right eye and lost hearing in his/her right ear.  Patient had developed knots all over his/her body and itching.  The physician had said it was affecting the nerves in his/her body.  He/she had felt like it was killing him/her from the inside out. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Blindness unilateral Deafness unilaterial are unlisted event which is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS
Symptoms: Vaccination failure, Visual impairment, Vomiting, Zoster sine herpete
Clinical narrative: Suspected vaccination failure; lost my hearing in my right ear; went blind in my right eye; shingles; I throw up yellow stuff; I get knots all over my body; it hurts my nerves in my body; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), hearing loss unilateral (Verbatim: lost my hearing in my right ear) (serious criteria GSK medically significant), blind right eye (Verbatim: went blind in my right eye) (serious criteria GSK medically significant), shingles (Verbatim: shingles), vomiting (Verbatim: I throw up yellow stuff), nodule (Verbatim: I get knots all over my body) and post herpetic neuralgia (Verbatim: it hurts my nerves in my body). The outcome of the vaccination failure, hearing loss unilateral, blind right eye and vomiting were not reported and the outcome of the shingles, nodule and post herpetic neuralgia were not resolved.   It was unknown if the reporter considered the vaccination failure, hearing loss unilateral, blind right eye, shingles, vomiting, nodule and post herpetic neuralgia to be related to Shingles vaccine.     The company considered the vaccination failure, hearing loss unilateral and blind right eye to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles, vomiting, nodule and post herpetic neuralgia to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 22-APR-2025 This case was reported by a patient via interactive digital media. Patient had taken vaccine and thought he/she was going to die.  Patient threw up yellow stuff, had run, and a high fever for three days. He/she came down with shingles, but they never appeared came out.  He/she had been on medication for five years now.  He/she had also nearly gone blind in his/her right eye and lost hearing in his/her right ear.  Patient had developed knots all over his/her body and itching.  The physician had said it was affecting the nerves in his/her body.  He/she had felt like it was killing him/her from the inside out. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Blindness unilateral Deafness unilaterial are unlisted event which is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got shingles; This serious 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, 1 year after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 23-APR-2025 This case was reported by a patient via interactive digital media. The patient had both Shingles shots and still got shingles a year later the suffering was horrible. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided regarding laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2)
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This non-serious 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.   The patient's past medical history included shingles (Shingles 2 times).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 23-APR-2025 This case was reported by a patient via interactive digital media. The patient had shingles 3 times, the last time was after first shot of the vaccine.
Vaccine: VARZOS
Symptoms: Blood pressure increased, Chills, Fatigue, Influenza, Malaise
Clinical narrative: made you feel like you have the flu,; made their blood pressure go sky high; Shivers; fever; so tired; Shingrix made a lot of people sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patients received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced influenza (Verbatim: made you feel like you have the flu,), blood pressure high (Verbatim: made their blood pressure go sky high), shivers (Verbatim: Shivers ), fever (Verbatim: fever), tiredness (Verbatim: so tired) and sickness (Verbatim: Shingrix made a lot of people sick). The outcome of the influenza, blood pressure high, shivers, fever, tiredness and sickness were not reported.   It was unknown if the reporter considered the influenza, blood pressure high, shivers, fever, tiredness and sickness to be related to Shingrix.     It was unknown if the company considered the influenza, blood pressure high, shivers, fever, tiredness and sickness to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-APR-2025 This case was reported by a consumer via interactive digital media. The Shingrix vaccine made a lot of people (patients) sick, made their blood pressure go sky high and made you feel like you have the flu, shivers, fever and so tired This case has been linked to the US2025AMR037927 case reported by the same reporter.; Sender's Comments:  US-GSK-US2025AMR037927:Same reporter case created for multiple patient
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: made you feel like you have the flu,; made their blood pressure go sky high; Shivers; fever; so tired; Shingrix made a lot of people sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patients received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced influenza (Verbatim: made you feel like you have the flu,), blood pressure high (Verbatim: made their blood pressure go sky high), shivers (Verbatim: Shivers ), fever (Verbatim: fever), tiredness (Verbatim: so tired) and sickness (Verbatim: Shingrix made a lot of people sick). The outcome of the influenza, blood pressure high, shivers, fever, tiredness and sickness were not reported.   It was unknown if the reporter considered the influenza, blood pressure high, shivers, fever, tiredness and sickness to be related to Shingrix.     It was unknown if the company considered the influenza, blood pressure high, shivers, fever, tiredness and sickness to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-APR-2025 This case was reported by a consumer via interactive digital media. The Shingrix vaccine made a lot of people (patients) sick, made their blood pressure go sky high and made you feel like you have the flu, shivers, fever and so tired This case has been linked to the US2025AMR037927 case reported by the same reporter.; Sender's Comments:  US-GSK-US2025AMR037927:Same reporter case created for multiple patient
Vaccine: VARZOS, VARZOS
Symptoms: Injection site discharge, Underdose
Clinical narrative: After the pharmacist gave my shot I noticed the shot site was leaking the shingrix. I immediately put pressure on it . Did I get enough of the vaccine?; This non-serious case was reported by a consumer via call center representative and described the occurrence of underdose in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced underdose (Verbatim: After the pharmacist gave my shot I noticed the shot site was leaking the shingrix. I immediately put pressure on it . Did I get enough of the vaccine?). The outcome of the underdose was not applicable.   Additional Information: GSK Receipt Date: 25-APR-2025 The reporter reported that after the pharmacist gave shot noticed the shot site was leaking the Shingrix.  The patient immediately put pressure on it .  The reporter was ask did get enough of the vaccine or did it need to be repeated, which led to underdose.  The patient have had shingles in the past.
Vaccine: VARZOS, VARZOS
Symptoms: Exposure via skin contact, Incorrect route of product administration, Injection site discharge, Injection site erythema, Injection site induration
Clinical narrative: After the pharmacist gave my shot I noticed the shot site was leaking the shingrix. I immediately put pressure on it . Did I get enough of the vaccine?; This non-serious case was reported by a consumer via call center representative and described the occurrence of underdose in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced underdose (Verbatim: After the pharmacist gave my shot I noticed the shot site was leaking the shingrix. I immediately put pressure on it . Did I get enough of the vaccine?). The outcome of the underdose was not applicable.   Additional Information: GSK Receipt Date: 25-APR-2025 The reporter reported that after the pharmacist gave shot noticed the shot site was leaking the Shingrix.  The patient immediately put pressure on it .  The reporter was ask did get enough of the vaccine or did it need to be repeated, which led to underdose.  The patient have had shingles in the past.
Vaccine: VARZOS, VARZOS
Symptoms: Injection site mass, Injection site swelling, Underdose
Clinical narrative: After the pharmacist gave my shot I noticed the shot site was leaking the shingrix. I immediately put pressure on it . Did I get enough of the vaccine?; This non-serious case was reported by a consumer via call center representative and described the occurrence of underdose in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced underdose (Verbatim: After the pharmacist gave my shot I noticed the shot site was leaking the shingrix. I immediately put pressure on it . Did I get enough of the vaccine?). The outcome of the underdose was not applicable.   Additional Information: GSK Receipt Date: 25-APR-2025 The reporter reported that after the pharmacist gave shot noticed the shot site was leaking the Shingrix.  The patient immediately put pressure on it .  The reporter was ask did get enough of the vaccine or did it need to be repeated, which led to underdose.  The patient have had shingles in the past.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected accination failure; had them 6 times; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected accination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had them 6 times). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-APR-2025 The case was received from the patient via interactive digital media. The reporter reported that just got over shingles again and had them 6 times even got the shot. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This case was linked with US2025AMR054251, reported by the same reporter.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; had them three times even after the vaccine; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had them three times even after the vaccine). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-APR-2025 The patient had them three times even after the vaccine. The reporter wanted to know why. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; got it after they got the shot; This serious case was reported by a consumer via interactive digital media and described the occurrence of 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got it after they got the shot). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-APR-2025 This case was reported by a patient's child via interactive digital media. The patient (parents) had got it after they got the Shingles shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This case is linked with US2025AMR053264, reported by same reporter.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. US-GSK-US2025AMR053264:Original Case : US2025AMR051995
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got shingles; This serious 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, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 27-APR-2025 This case was reported by a patient via interactive digital media. Reporter had both shots and still got shingles. It was a very mild case.  Reporter stated that he/she could not imagine what it would have been like without them. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine(Dose 1 & 2).