chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: patient given Priorix that was frozen prior to reconstitution; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 60-year-old male patient who received MMR (Priorix) (batch number 4ZC23, expiry date 01-SEP-2025) for prophylaxis.   On 12-FEB-2025, the patient received Priorix (subcutaneous) .5 ml. On an unknown date, an unknown time after receiving Priorix, the patient experienced incorrect storage of drug (Verbatim: patient given Priorix that was frozen prior to reconstitution). The outcome of the incorrect storage of drug was not applicable.   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: 15-APR-2025 The patient given Priorix (MMR) that was frozen prior to reconstitution, which led incorrect storage of drug.
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Myalgia
Clinical narrative: I am having headaches; muscle ache; light headed after the shingles vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache 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 headache (Verbatim: I am having headaches), muscle pain (Verbatim: muscle ache) and light headedness (Verbatim: light headed after the shingles vaccine). The outcome of the headache, muscle pain and light headedness were not reported.   It was unknown if the reporter considered the headache, muscle pain and light headedness to be related to Shingles vaccine.     It was unknown if the company considered the headache, muscle pain and light headedness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date : 15-APR-2025 This case was reported by a patient via interactive digital media. Reporter had headaches, muscle ache and light headed after the shingles vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: I had a sore arm for 3 days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (Received 1st dose of Shingles vaccine on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: I had a sore arm for 3 days). The outcome of the pain in arm was resolved (duration 3 days).   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-APR-2025 This case was reported by a patient via interactive digital media. The patient just had 2nd shot. The patient had a sore arm for 3 days. The follow-up could not be possible as no contact details were available. This case was linked with case US2025AMR048363 for husband.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Headache, Malaise, Pyrexia
Clinical narrative: fatigue; loss of appetite; fever; Headache; sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced fatigue (Verbatim: fatigue), appetite lost (Verbatim: loss of appetite), fever (Verbatim: fever), headache (Verbatim: Headache) and sickness (Verbatim: sick). The outcome of the fatigue, appetite lost, fever and headache were not reported and the outcome of the sickness was resolved (duration 2 days).   It was unknown if the reporter considered the fatigue, appetite lost, fever, headache and sickness to be related to Shingles vaccine.     It was unknown if the company considered the fatigue, appetite lost, fever, headache and sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-APR-2025 This case was reported by a patient via interactive digital media. The husband had 2nd shot. He was sick for 2 days. Had stomach loss of appetite, fever, headache and fatigue all day.
Vaccine: RVX
Symptoms: Headache, Malaise, Skin warm
Clinical narrative: my arm is still warm; headache every day; unwell; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of skin warm in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Concurrent medical conditions included shingles.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced skin warm (Verbatim: my arm is still warm), headache (Verbatim: headache every day) and unwell (Verbatim: unwell). The outcome of the skin warm was not resolved and the outcome of the headache was unknown and the outcome of the unwell was not reported.   It was unknown if the reporter considered the skin warm, headache and unwell to be related to RSV vaccine.     It was unknown if the company considered the skin warm, headache and unwell to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 17-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported that that he/she put it on shingles eight days ago. The reporter arm still had it warm. The patient got a headache every day and he/she was not in headaches. The reporter better said that the patient was unwell on body without needing.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash pruritic, Vaccination failure
Clinical narrative: Suspecyted vaccination failurre; 5  months later I got shingles/Started down my right arm, now my ankles and feet; 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, 5 months after receiving Shingles vaccine and an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspecyted vaccination failurre) (serious criteria GSK medically significant) and shingles (Verbatim: 5  months later I got shingles/Started down my right arm, now my ankles and feet). 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 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: 18-APR-2025 This case was reported by a patient via interactive digital media. The patient got the shingles shot (both of them), five months later got shingles. It has been 7 months and still have them.  No pain, just constant itching from the rashes.  They disappear from one spot, and resurface in another, started down to right arm, now on ankles and feet. This case was considered as suspected vaccination failure since the details regarding time to onset 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (dose 1) and Shingles vaccine (dose 2).
Vaccine: RVX
Symptoms: Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: suspected vaccination failure; got again later; 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.   The patient's past medical history included respiratory syncytial virus infection.   On an unknown date, the patient received RSV vaccine. On an unknown date, less than a year after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: got again later). The outcome of the vaccination failure was not reported and the outcome of the respiratory syncytial virus infection was resolved.   It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection 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 to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 17-APR-2025 This case was reported by a patient via interactive digital media. The patient got Respiratory Syncytial Virus vaccine. The patient got one respiratory syncytial virus infection but had it right before the shot, could take effect and turned serious. The patient got respiratory syncytial virus infection again later in year very mild quick recovery. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for respiratory syncytial virus infection and laboratory confirmation regarding respiratory syncytial virus infection were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (h/o respiratory syncytial virus infection, insufficient information regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK RSV vaccine.
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: didn't get a second shot. Then I got another shot in 2024; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (I got a shot in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: didn't get a second shot. Then I got another shot in 2024). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK Receipt Date: 21-APR-2025 Consumer reported that got a shot in 2018 and didn't get a second shot. Then he/she got another shot in 2024, which led to drug dose administration interval too long. Consumer wanted to know need more a seconds hot or not . This case has been linked with US2025AMR049030, US2025AMR049045 and US2025AMR049051, reported by the same reporter.; Sender's Comments:  US-GSK-US2025AMR049030:same reporter different patient US-GSK-US2025AMR049045:same reporter different patient US-GSK-US2025AMR049051:same reporter different patient
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first Shingrix shot more than 5 years ago never got the second shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first Shingrix shot more than5 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: first Shingrix shot more than 5 years ago never got the second shot). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 21-APR-2025 The patient had first Shingrix shot more than 5 years ago. Never got the second shot. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2025AMR049030:same reporter different patient US-GSK-US2025AMR049026:same reporter different patient US-GSK-US2025AMR049051:same reporter different patient US-GSK-US2025AMR049030:same reporter different patient
Vaccine: RVX
Symptoms: Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: Suspected Vaccination failure; I had the shot and still got it; 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 an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: I had the shot and still got it). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported.   It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection 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 to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 23-APR-2025 This case was reported by a patient via interactive digital media. The patient had the RSV shot and still got it This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of respiratory syncytial virus infection 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  details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine RSV vaccine
Vaccine: RVX
Symptoms: Aphonia, Arthralgia
Clinical narrative: joint pain; Lost my voice; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of joint pain in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced joint pain (Verbatim: joint pain) and loss of voice (Verbatim: Lost my voice). The outcome of the joint pain and loss of voice were not resolved.   It was unknown if the reporter considered the joint pain and loss of voice to be related to RSV vaccine.     It was unknown if the company considered the joint pain and loss of voice to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 21-APR-2025 The patient self reported this case for himself/herself. This case was reported by a patient via interactive digital media. Patient have never had bad reactions to vaccines, so he/she did not hesitate to get the RSV one.  Patient still having joint pain a month and a half after receiving it. Lost his/her voice and it was still not back to normal.  It turned out that vaccine effects could be unpredictable.
Vaccine: COVID19, COVID19, COVID19, RVX
Symptoms: Fatigue, Illness
Clinical narrative: I have been sick for 6 months; Fatigue the worst; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included COVID-19 vaccine for prophylaxis, COVID-19 vaccine for prophylaxis and COVID-19 vaccine for prophylaxis.   On an unknown date, the patient received RSV vaccine, COVID-19 vaccine, the 2nd dose of COVID-19 vaccine and the 1st dose of COVID-19 vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced sickness (Verbatim: I have been sick for 6 months) and fatigue (Verbatim: Fatigue the worst). The outcome of the sickness and fatigue were not resolved.   It was unknown if the reporter considered the sickness and fatigue to be related to RSV vaccine.     It was unknown if the company considered the sickness and fatigue to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 22-APR-2025 The patient got the Respiratory Syncytial Virus vaccine shot,  two covid and a booster vaccine. The patient has been sick for 6 months many symptoms , fatigue the worst. Could be post Viral Fatique or long Covid. The physician did not know what causes it or how to treat it.  The reporter did not know how long it lasts.  A couple of weeks to years. It was getting more prevalent.  The patient did own background research on AI. Talked to many other seniors same story.  The patient did not know the answer.  The patient took the shots because of a new born in the house. It was unknown if the reporter considered the sickness and fatigue to be related to COVID-19 vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Immediate post-injection reaction
Clinical narrative: my girlfriend got the shot and got shingles right after; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles 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, immediately after receiving Shingles vaccine, the patient experienced shingles (Verbatim: my girlfriend got the shot and got shingles right after). 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: 20-APR-2025 This case was reported by a consumer via interactive digital media. The reporter reported that his girlfriend got the shot and got shingles right after.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Road traffic accident, Stress, Vaccination failure
Clinical narrative: Suspected vaccination failure; I had both shots and still got it; 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: I had both shots and still got it). 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 : 21-APR-2025 This case was reported by a patient via interactive digital media. He/she had both shots and still got it after his/her car accident .  It was the stress from the accident. 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, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2).
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; 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: 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: 21-APR-2025 This case was reported by a patient via interactive digital media. Patient stated that it was frustrating to have received both shots for prevention and been diagnosed with 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, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine(Dose 1 & 2)..
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; got the shingles and suffering from it already seven months; 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 month after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got the shingles and suffering from it already seven months). 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 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: 20-APR-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she got the two shots of (Shingles) vaccine and The patient reported that after the month he/she got the shingles and that he/she is suffering from it already seven months. This case was considered as suspected vaccination failure as details 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  completion of primary vaccination schedule,  time to onset and laboratory confirmation regarding disease) is considered unrelated to GSK vaccine Shingles vaccine (Dose 1 & 2).
Vaccine: VARZOS
Symptoms: Herpes zoster oticus, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; Ramsey Hunt Syndrome / Shingles on left side ear; 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 ramsay-hunt syndrome (Verbatim: Ramsey Hunt Syndrome / Shingles on left side ear) (serious criteria GSK medically significant). The outcome of the vaccination failure and ramsay-hunt syndrome were not reported.   It was unknown if the reporter considered the vaccination failure and ramsay-hunt syndrome to be related to Shingles vaccine.     The company considered the vaccination failure and ramsay-hunt syndrome to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-APR-2025 The patient had all the shingles vaccines and recently diagnosed with Bell's palsy and later found out it was Ramsey Hunt Syndrome. The patient had shingles on left side ear. It was very painful. 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. Herpes zoster oticus is an unlisted event which is considered unrelated to GSK  Shingles vaccine.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspeceted vaccination failure; I got my shot but 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.   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: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got my shot but 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: 21-APR-2025 This case was reported by a patient via interactive digital media. The patient reported that if you were 50 make sure you get your shingles shot. The patient reported that he/she got his/her shot but still got shingles. The patient reported his/her father/mother told him/her said he/she had a much milder case because he/she did had the vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset 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.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pericarditis, Vaccination failure
Clinical narrative: Suspeceted vaccination failure; pericarditis; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant), pericarditis (Verbatim: pericarditis) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure, pericarditis and shingles were not reported.   It was unknown if the reporter considered the vaccination failure, pericarditis and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and pericarditis 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: 19-APR-2025 This case was reported by a consumer via interactive digital media. The reporter reported that reporter son got the shingles and pericarditis after the jab. The doctor told him so. 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 has been linked to the US2023AMR040441 case 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 vaccine Shingles vaccine. Pericarditis is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine. US-GLAXOSMITHKLINE-US2023AMR040441:same reporter
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; 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: 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: 19-APR-2025 This case was reported by a patient via interactive digital media. The patient had the two shots, and still got shingles. 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  time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (dose 1 and 2)
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm never hurt so much; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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 pain in arm (Verbatim: arm never hurt so much). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm 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.  Patient had two shots and arm never hurt so much, but indicated that it was worth it.
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected Vaccination failure; had additional outbreaks; 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.   The patient's past medical history included shingles. Concurrent medical conditions included lyme disease (have chtonic lyme disease).   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 additional outbreaks). The patient was treated with duloxetine hydrochloride (Cymbalta). 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 : 20-APR-2025 This case was reported by a patient via interactive digital media. He/she had chronic Lyme disease which activated shingles and herpes.  Pain and suffered unbearable.  He/she took cymbalta.  He/she did get the shots but also have had additional outbreaks. 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  completion of primary vaccination schedule,  time to onset and laboratory confirmation regarding disease) is considered unrelated to GSK vaccine Shingles vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dizziness postural
Clinical narrative: felt dizziness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of dizziness 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 dizziness (Verbatim: felt dizziness). The outcome of the dizziness was not reported.   It was unknown if the reporter considered the dizziness to be related to Shingles vaccine.     It was unknown if the company considered the dizziness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 22-APR-2025 Patient had the vaccine and she felt dizziness after lowering her body and standing back up.
Sex: F
Vaccine: MMR
Symptoms: Product preparation issue
Clinical narrative: It was not reconstituted with the antigen component; Priorix diluent only was administered to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of active ingredient not added to diluent in a female patient who received MMR (Priorix) (batch number 4N222, expiry date 13-SEP-2026) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced active ingredient not added to diluent (Verbatim: It was not reconstituted with the antigen component) and inappropriate dose of vaccine administered (Verbatim: Priorix diluent only was administered to a patient). The outcome of the active ingredient not added to diluent and inappropriate dose of vaccine administered were not applicable.   It was unknown if the reporter considered the active ingredient not added to diluent and inappropriate dose of vaccine administered to be related to Priorix and Priorix Pre-Filled Syringe Device.     It was unknown if the company considered the active ingredient not added to diluent and inappropriate dose of vaccine administered to be related to Priorix and Priorix 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: GSK Receipt Date: 17-APR-2025 Pharmacist reported that the Priorix diluent only was administered to a patient. It was not reconstituted with the antigen component which led to active ingredient not added to diluent and inappropriate dose of vaccine administered. Consented to follow up.
Age: 9.0
Sex: F
Vaccine: MNQ
Symptoms: Wrong patient received product
Clinical narrative: administered the one vial presentation of Menveo to a nine year old patient accidentally. It was supposed to be administered to her brother; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong patient received product in a 9-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number EK7DG, expiry date 31-DEC-2025) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong patient received product (Verbatim: administered the one vial presentation of Menveo to a nine year old patient accidentally. It was supposed to be administered to her brother). The outcome of the wrong patient received product was not applicable.   Additional Information: GSK Receipt Date: 21-APR-2025 Medical Assistant reported he administered the one vial presentation of Menveo to a nine year old patient accidentally. It was supposed to be administered to her brother which led to Wrong patient received product.
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Vaccine stored outside recommended conditions and administered to patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number PG3RP, expiry date 11-JUL-2027) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient). The outcome of the incorrect storage of drug was not applicable.   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: 21-APR-2025 The nurse called to report a temperature excursion and to find out what to, what we should be doing moving forward with the vaccines. The name of the vaccine is Boostrix, was the only one, the highest temperature it reached was 11.2 degrees Celsius it was been out of temperature for 55 days. These have been administered to a patient which led to incorrect storage of drug. This case has been linked to the US2025048460 case reported by the same reporter.; Sender's Comments:  US-GSK-US2025048460:same reporter
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose 5 years after first dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number TS525, expiry date 10-MAR-2027) for prophylaxis.   Previously administered products included Shingrix (the first dose was given 5 years ago).   On 21-APR-2025, the patient received the 2nd dose of Shingrix. On 21-APR-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Second dose 5 years after first dose). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK receipt date: 20-APR-2025 Other HCP reported that pharmacist mentioned that on the day of reporting, a patient received the second dose of Shingrix. However, the first dose was given 5 years ago. Reporter asked if the patient should received a booster dose. Consented to follow up. The patient received 2nd dose of Shingrix,?later than the recommended interval, which led to lengthening of vaccinations schedule.
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Intramuscular administration of Priorix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a specified number of patients who received MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Priorix (intramuscular). On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Intramuscular administration of Priorix). The outcome of the subcutaneous injection formulation administered by other route was not applicable.   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: 21-APR-2025 On 21 Apr 2025, a clinical pharmacy manager called to inform the following about Priorix unfortunately some of them have been administered intramuscularly which led to Subcutaneous injection formulation administered by other route. The reporter clarified that two patients had received Priorix via intramuscular administration. The gender of the patients was unknown, as well as other details such as lot number, expiration date or date of administration.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Shingrix adjuvant only administration; Shingrix adjuvant only administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number 92NN2, expiry date 30-MAR-2027) for prophylaxis.   On 18-APR-2025, the patient received Shingrix. On 18-APR-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered (Verbatim: Shingrix adjuvant only administration) and inappropriate preparation of medication (Verbatim: Shingrix adjuvant only administration). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were not applicable.   Additional Information: GSK Receipt Date: 22-APR-2025 Licensed practical nurse wanted to know how much time she needs to wait before giving a full dose of Shingrix after the patient only received the adjuvant portion which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Engerix-B Administration of expired dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 13-year-old female patient who received HBV (Engerix B) (batch number F5L5E, expiry date 11-APR-2025) for prophylaxis.   On 17-APR-2025, the patient received Engerix B. On 17-APR-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Engerix-B Administration of expired dose). The outcome of the expired vaccine used was not applicable.   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: 22-APR-2025 A nurse reported that the patient received and expired dose of Engerix-B, which led expired vaccine used.  The nurse asked if the patient should be re-vaccinated.  The reporter consented to follow up.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not received shingrix second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (The patient received Shingrix first dose on 08 July 2022 (lot number: P7K5P exp 10 September 2023)).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: not received shingrix second dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 22-APR-2025 An adult male patient received Shingrix first dose on 08 July 2022. The patient was going to have a transplant soon. The patient was not considered immunocompromised right now. The Vaccine Administration Facility was the same as Primary Reporter. Till the time of reporting the patient did not receive second dose of Shingrix which led to incomplete course of vaccination. Consented to follow up.