chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Under 18 years old, and Received Heplisav-B; Initial report received on 22-Jan-2024.  A pharmacist reported that a 12-year-old male patient (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history and concomitant medications at the time of vaccination were not reported. The patient had no known drug allergies.  On 18-Jan-2024, the 12-year-old patient received a dose of HEPLISAV-B (Lot number 944609, expiration date 29 Jan 2026, and NDC number 43528-0003-05) intramuscularly in the left deltoid. The patient was under 18-years-old. No adverse effects were reported by the patient.  No further information was available.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia, Vaccination failure, Varicella
Clinical narrative: Suspected vaccination failure; I got shingles on right back side; Chickenpox; still have nerve pain; I still had severe sharp pain; 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 12-DEC-2023, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: I still had severe sharp pain). On 27-FEB-2024, the patient experienced post herpetic neuralgia (Verbatim: still have nerve pain). On an unknown date, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I got shingles on right back side) and chickenpox (Verbatim: Chickenpox). The outcome of the vaccination failure was unknown and the outcome of the shingles and chickenpox were not reported and the outcome of the post herpetic neuralgia and pain were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia, pain and chickenpox to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, post herpetic neuralgia, pain and chickenpox to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 28-FEB-2024 The patient self-reported this case. The patient stated that no effects from shingles vaccination but 1 year later he/she got shingles.  He/she thought vaccine helped him/her and had might be a milder case.  The patient still had severe sharp pain and still had nerve pain.  The patient suggested of getting vaccinated. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; I still get shingles; I still get shingles. Not as bad though. They still hurt as bad; 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 (had since i was 18).   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: I still get shingles) and pain (Verbatim: I still get shingles. Not as bad though. They still hurt as bad). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 06-Mar-2024 This case was reported by the patient via interactive digital media. The patient stated that he/she had shingles since he/she was 18. The patient stated that he/she had the vaccine last year and still got shingles. The patient further stated that they were not as bad though, but still hurt as bad. 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.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; had them 22 times; 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: had them 22 times). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 06-Mar-2024 This case was reported by the patient's sibling via interactive digital media. The patient got the vaccine and has had them 22 times after getting the vaccine. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I have friends that never had them until the depop shot/Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving 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 was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 06-Mar-2024 This case was reported by the consumer via interactive digital media. The reporter stated that he/she had friends that never had them until the depop shot. 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.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; Pain; 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: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and pain (Verbatim: Pain). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 06-MAR-2024 This case was reported by the reporter for a patient via interactive digital media. The reporter got both shingles shots. Nothing happened. No one the reporter know got shingles except one man. He had had shingles 5 times. He got vaccinated and 4 months later had shingles again, but much lighter case. A lot less pain. 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. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Guillain-Barre syndrome
Clinical narrative: guilliain barre syndrome; This serious case was reported by a consumer via other manufacturer and described the occurrence of guillain barre syndrome in a unspecified number of patients who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patients received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patients experienced guillain barre syndrome (Verbatim: guilliain barre syndrome) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was not reported.   It was unknown if the reporter considered the guillain barre syndrome to be related to Arexvy.     It was unknown if the company considered the guillain barre syndrome to be related to Arexvy.   Additional Information: GSK Receipt date: 07-MAR-2024 The reporter reported that new safety data for two RSV vaccines, presenting of scientific advisers to the center of disease control and prevention, indicated that Guillain barre syndrome might had occurred in adults over 60 who received Arexvy vaccine. The follow-up could not be possible as no contact details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I know some people got those vaccines then they got the shingles/ Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I know some people got those vaccines then they got the shingles/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 06-MAR-2024 This case was received from the consumer via interactive digital media. The reporter reported that get those vaccines and get shingles. The reporter reported that he/she know some people who got those vaccines and then they got the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Herpes zoster, Vaccination failure
Clinical narrative: Patient received the vaccine shots and got shingles/Suspected vaccination failure; Shingles; Red face; 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 (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Patient received the vaccine shots and got shingles/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and red face (Verbatim: Red face). The patient was treated with gabapentin. The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the red face was resolved (duration 10 days).   It was unknown if the reporter considered the vaccination failure, shingles and red face to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles and red face to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 06-MAR-2024 This case was reported by a patient via interactive digital media. The patient stated that the patient received both shingrix shots. Did get shingles last year. Was prescribed gabapentin. Red face that faded completely in 10 days. No pain whatsoever.  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. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: COVID19, VARZOS
Symptoms: Chest discomfort, Dementia, Headache, Herpes zoster, Insomnia
Clinical narrative: Might have dementia; Shingles; Everything hurts/Pain; Cold; Chest was heavy; Bad shoulder; Didn´t sleep at all; Headache; This serious case was reported by a consumer via other manufacturer and described the occurrence of dementia in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Elasomeran (Moderna COVID-19 vaccine) (batch number AS764SB) for prophylaxis.   On 02-AUG-2023, the patient received Shingrix and the 6th dose of Moderna COVID-19 vaccine. On 02-AUG-2023, less than a day after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles), general body pain (Verbatim: Everything hurts/Pain), cold (Verbatim: Cold), chest heaviness (Verbatim: Chest was heavy), shoulder discomfort (Verbatim: Bad shoulder), insomnia (Verbatim: Didn´t sleep at all) and headache (Verbatim: Headache). On an unknown date, the patient experienced dementia (Verbatim: Might have dementia) (serious criteria GSK medically significant). The outcome of the dementia, shingles, general body pain, cold, chest heaviness, shoulder discomfort, insomnia and headache were unknown.   The reporter considered the dementia, shingles, general body pain, cold, chest heaviness, shoulder discomfort, insomnia and headache to be possibly related to Shingrix.     The company considered the dementia, shingles, general body pain, cold, chest heaviness, shoulder discomfort, insomnia and headache to be possibly related to Shingrix.   Additional Information: GSK Receipt Date: 06-Mar-2024 The patient received Moderna Covid-19 vaccine and Shingrix vaccine and experienced shingles, cold, chest was heavy, bad shoulder, did not sleep at all and headache. The patient had a bad night, with similar side effects with that of the husband.  The reporter mentioned that the patient might had dementia as it was not diagnosed yet and the patient mentioned that everything hurts.  The reporter reported that a few times that the reporter believed that this was because of the Shingles vaccine, because it hurt, but the Moderna vaccine they did not felt it. It was the shingles shot the one that hurt them. No treatment medication was reported It was unknown if the reporter considered the dementia, shingles, general body pain, cold, chest heaviness, shoulder discomfort, insomnia and headache to be related to Moderna COVID-19 vaccine. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: COVID19, VARZOS
Symptoms: Musculoskeletal discomfort, Nasopharyngitis, Pain
Clinical narrative: Might have dementia; Shingles; Everything hurts/Pain; Cold; Chest was heavy; Bad shoulder; Didn´t sleep at all; Headache; This serious case was reported by a consumer via other manufacturer and described the occurrence of dementia in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Elasomeran (Moderna COVID-19 vaccine) (batch number AS764SB) for prophylaxis.   On 02-AUG-2023, the patient received Shingrix and the 6th dose of Moderna COVID-19 vaccine. On 02-AUG-2023, less than a day after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles), general body pain (Verbatim: Everything hurts/Pain), cold (Verbatim: Cold), chest heaviness (Verbatim: Chest was heavy), shoulder discomfort (Verbatim: Bad shoulder), insomnia (Verbatim: Didn´t sleep at all) and headache (Verbatim: Headache). On an unknown date, the patient experienced dementia (Verbatim: Might have dementia) (serious criteria GSK medically significant). The outcome of the dementia, shingles, general body pain, cold, chest heaviness, shoulder discomfort, insomnia and headache were unknown.   The reporter considered the dementia, shingles, general body pain, cold, chest heaviness, shoulder discomfort, insomnia and headache to be possibly related to Shingrix.     The company considered the dementia, shingles, general body pain, cold, chest heaviness, shoulder discomfort, insomnia and headache to be possibly related to Shingrix.   Additional Information: GSK Receipt Date: 06-Mar-2024 The patient received Moderna Covid-19 vaccine and Shingrix vaccine and experienced shingles, cold, chest was heavy, bad shoulder, did not sleep at all and headache. The patient had a bad night, with similar side effects with that of the husband.  The reporter mentioned that the patient might had dementia as it was not diagnosed yet and the patient mentioned that everything hurts.  The reporter reported that a few times that the reporter believed that this was because of the Shingles vaccine, because it hurt, but the Moderna vaccine they did not felt it. It was the shingles shot the one that hurt them. No treatment medication was reported It was unknown if the reporter considered the dementia, shingles, general body pain, cold, chest heaviness, shoulder discomfort, insomnia and headache to be related to Moderna COVID-19 vaccine. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; Had them in my 50s under my right arm; Painful; 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.   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: Had them in my 50s under my right arm) and pain (Verbatim: Painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK received date: 08-Mar-2024 This case was reported by a patient via interactive digital media. The patient had them (shingles) in 50s under the right arm, painful and had 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.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: revaccinated with Shingrix developed mild shingles/ Suspected vaccination failure; Patient developed mild shingles; This serious case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (had vaccinated with Zostavax in the year 2015.).   On 03-JAN-2022, the patient received the 1st dose of Shingrix. On 29-MAR-2022, the patient received the 2nd dose of Shingrix. On 01-JAN-2024, 728 days after receiving Shingrix and 643 days after receiving Shingrix, the patient experienced vaccination failure (Verbatim: revaccinated with Shingrix developed mild shingles/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Patient developed mild shingles). The patient was treated with valaciclovir hydrochloride (Valtrex). On 06-JAN-2024, the outcome of the shingles was resolved (duration 5 days). The outcome of the vaccination failure was unknown.   The reporter considered the vaccination failure and shingles to be unrelated to Shingrix and Shingrix.   The company considered the vaccination failure and shingles to be unrelated to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 05-MAR-2024 The nurse reported that the patient experienced the mild shingles after vaccinated with the 2 dose series of Shingrix vaccine. The reporter did not felt this was an adverse event for Shingrix. The health care professional prescribed Valtrex and the condition resolved within days. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting. The reporter did not consent to follow up. This case is linked with case US2024AMR029781, reported by the same reporter for different patient.; Sender's Comments:  US-GSK-US2024AMR029781:different patient
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: its effect on me was bad/ it put me down; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feeling abnormal (Verbatim: its effect on me was bad/ it put me down). The outcome of the feeling abnormal was not reported.   The reporter considered the feeling abnormal to be related to Shingles vaccine.     The company considered the feeling abnormal to be related to Shingles vaccine.   Additional Information: GSK received date: 28-Feb-2024 This case was reported by a patient via interactive digital media. Patient went to the acupucturist. Patient stated, the long term effect of shingles are worse that the rash itself. Patient took one part of two parts of vaccine. It put the patient down. Its effect on patient was bad. Patient stated, people don't usually die from shingles. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Pyrexia
Clinical narrative: Injection site pain; headache; slight fever; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received first dose on an unknown date with no adverse event).   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 injection site pain (Verbatim: Injection site pain), headache (Verbatim: headache) and fever (Verbatim: slight fever). The outcome of the injection site pain, headache and fever were not reported.   It was unknown if the reporter considered the injection site pain, headache and fever to be related to Shingrix.     It was unknown if the company considered the injection site pain, headache and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-MAR-2024 The case was received from the patient via interactive digital media. The patient reported that shingles were a result to a childhood communicable disease, called chicken pox. The ox organism goes formant and was under the neurons. As their age, and their immune system decreases, the organism awakens, and follows the nerve track, forming blisters and extreme pain.  The vaccine was called shingrix and must be given in two doses, at least 4 to 6 weeks apart.  After the second one, the patient had a headache, slight fever, and pain at the injection site.  The patient had to pay 49 dollar out of pocket for each injection.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: sore arm; never got the second dose; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: sore arm) and incomplete course of vaccination (Verbatim: never got the second dose). The outcome of the pain in arm was not resolved and the outcome of the incomplete course of vaccination was unknown.   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: 02-MAR-2024 This case was reported by a patient via interactive digital media. The patient got the first vaccination 2 1/2 years ago (from the date of reporting). His/her arm was still sore.  The patient never got the second dose till the time of reporting, which led to an incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: most painful thing I've ever felt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain 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 (Verbatim: most painful thing I've ever felt). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 03-Mar-2024 This case was reported by the patient via interactive digital media. The patient got the shot and stated that the most painful thing he/she had ever felt. The patient sated that it took two months from his/her life and stated that please get the vaccine. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Fibromyalgia
Clinical narrative: fibromyalgia; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fibromyalgia 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 fibromyalgia (Verbatim: fibromyalgia). The outcome of the fibromyalgia was not reported.   The reporter considered the fibromyalgia to be related to Shingles vaccine.     The company considered the fibromyalgia to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 03-MAR-2024 This case was reported by the consumer via interactive digital media. The reporter stated that his/her friend (patient) took the vaccine, and then came down with fibromyalgia from it and suffered for years.
Sex: U
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.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 1 week 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: 03-MAR-2024 This case was reported by the patient via interactive digital media. The reporter stated that, he/she had the shot, back when just got one shot a week later he/she got shingles.  The doctor said he/she would had it worse without shot.
Sex: U
Vaccine: RSV
Symptoms: Headache, Pain
Clinical narrative: headache; Bodyache; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache in a 65-year-old patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced headache (Verbatim: headache) and general body pain (Verbatim: Bodyache). The outcome of the headache and general body pain were not reported.   It was unknown if the reporter considered the headache and general body pain to be related to Arexvy.     It was unknown if the company considered the headache and general body pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 04-MAR-2024 This case was reported by a consumer via (Open field AE monitoring) interactive digital media. The patient had head and body aches on day.
Sex: U
Vaccine: RSV
Symptoms: Fatigue, Headache, Pain, Performance status decreased
Clinical narrative: splitting headache; tired; had hurt all over; cannot function; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced headache (Verbatim: splitting headache), tiredness (Verbatim: tired), pain (Verbatim: had hurt all over) and performance status decreased (Verbatim: cannot function). The outcome of the headache, tiredness, pain and performance status decreased were not reported.   It was unknown if the reporter considered the headache, tiredness, pain and performance status decreased to be related to Arexvy.     It was unknown if the company considered the headache, tiredness, pain and performance status decreased to be related to Arexvy.   Additional Information: GSK Receipt Date: 01-MAR-2024 The case was received from the patient via (Open field AE monitoring) interactive digital media. The patient reported that had all of them, had a splitting headache and hurt all over and so tired that could not function.
Sex: U
Vaccine: RSV
Symptoms: Illness
Clinical narrative: sick; 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 (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced sickness (Verbatim: sick). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Arexvy.     It was unknown if the company considered the sickness to be related to Arexvy.   Additional Information: GSK Receipt Date: 03-MAR-2024 This case was reported by a patient via (Open field AE monitoring) interactive digital media. The patient had RSV and been (illegible text) sick.
Sex: U
Vaccine: FLUX, RSV
Symptoms: Chills
Clinical narrative: chills; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of chills in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included Influenza vaccine for prophylaxis.   On an unknown date, the patient received Arexvy and Influenza vaccine. On an unknown date, an unknown time after receiving Arexvy, the patient experienced chills (Verbatim: chills). The outcome of the chills was not reported.   It was unknown if the reporter considered the chills to be related to Arexvy.     It was unknown if the company considered the chills to be related to Arexvy.   Additional Information: GSK Receipt Date: 01-MAR-2024 This case was reported by a patient via (Open field AE monitoring) interactive digital media. It was reported that, the patient had all of those (unspecified adverse event) and chills, but also patient had Flu vax (vaccine) at the same time. It was unknown if the reporter considered the chills to be related to Influenza vaccine.
Sex: U
Vaccine: RSV
Symptoms: Arthralgia, Cough, Headache, Injection site pain, Malaise
Clinical narrative: injection site pain; joint in my body aches; headache; coughing; Feel terrible; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: injection site pain), joint pain (Verbatim: joint in my body aches), headache (Verbatim: headache), cough (Verbatim: coughing) and feeling bad (Verbatim: Feel terrible). The outcome of the injection site pain, joint pain, headache, cough and feeling bad were not reported.   It was unknown if the reporter considered the injection site pain, joint pain, headache, cough and feeling bad to be related to Arexvy.     It was unknown if the company considered the injection site pain, joint pain, headache, cough and feeling bad to be related to Arexvy.   Additional Information: GSK Receipt Date: 01-MAR-2024  This case was reported by a patient via (Open field AE monitoring) interactive digital media. The patient stated, all the side effects listed he/she had.  The patient stated, joint in his/her body aches, headache, injection site pain was an understatement. The patient also had some coughing and felt terrible.
Sex: U
Vaccine: RSV
Symptoms: Injection site pain
Clinical narrative: Injection site pain is continuing at 48 hours; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: Injection site pain is continuing at 48 hours). The outcome of the injection site pain was not resolved.   It was unknown if the reporter considered the injection site pain to be related to Arexvy.     It was unknown if the company considered the injection site pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 01-MAR-2024 This case was reported by a patient via (Open field AE monitoring) interactive digital media. The patient mentioned that he/she had all of the side effects for about 36 hours. Injection site pain was continuing at 48 hours
Sex: U
Vaccine: RSV
Symptoms: Fall, Gait disturbance, Mobility decreased
Clinical narrative: difficulty lifting my legs; Difficulty lifting my legs and hips to walk; actually fell trying to walk; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of mobility decreased in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced mobility decreased (Verbatim: difficulty lifting my legs), walking difficulty (Verbatim: Difficulty lifting my legs and hips to walk) and fall (Verbatim: actually fell trying to walk). The outcome of the mobility decreased, walking difficulty and fall were not reported.   It was unknown if the reporter considered the mobility decreased, walking difficulty and fall to be related to Arexvy.     It was unknown if the company considered the mobility decreased, walking difficulty and fall to be related to Arexvy.   Additional Information: GSK Receipt Date: 01-MAR-2024 This case was reported by a patient via (Open field AE monitoring) interactive digital media. The reporter reported that he/she experienced difficulty lifting their legs and hips to walk (actually fell trying to walk up a curb).
Sex: U
Vaccine: VARZOS
Symptoms: Local reaction
Clinical narrative: Increased local reaction; This non-serious case was reported by a nurse via sales rep and described the occurrence of local reaction in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunocompromised.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced local reaction (Verbatim: Increased local reaction). The outcome of the local reaction was not reported.   It was unknown if the reporter considered the local reaction to be related to Shingrix.     It was unknown if the company considered the local reaction to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-MAR-2024 The nurse reported that the patient aged 70 plus received Shingrix. The patient had increased local reaction to the 1st dose of the vaccine. The patient was receiving immunosuppressive medication at the time of reporting. This case had been linked with US2024AMR031180, reported by the same reporter for different patient. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2024AMR031180:same reporter, different patient
Age: 10.0
Sex: M
Vaccine: HEPAB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Twinrix, nurse administered not realizing it was only for adults; Twinrix vaccine that was given to a pediatric patient/nurse administered not realizing it was only for adults; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 10-year-old male patient who received HAB (Twinrix adult) (batch number H7RF2, expiry date 17-JAN-2026) for prophylaxis.   On 12-FEB-2024, the patient received Twinrix adult. On 12-FEB-2024, an unknown time after receiving Twinrix adult, the patient experienced accidental overdose (Verbatim: Twinrix, nurse administered not realizing it was only for adults) and adult product administered to child (Verbatim: Twinrix vaccine that was given to a pediatric patient/nurse administered not realizing it was only for adults). The outcome of the accidental overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-FEB-2024 The nurse had a question about a Twinrix vaccine that was given to a pediatric patient.  The patient was due for a Hepatitis A and Hepatitis B vaccine, the nurse administered not realizing it was only for adults. In the database it shows an invalid vaccine, but patient did receive it. The vaccine administration facility was the same as primary reporter. The patient received Twinrix adult below than the recommended age limit, which led to accidental overdose and adult product administered to child.
Sex: U
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administration of Boostrix in patients under 10 years of age; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in an unspecified number of patients who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: administration of Boostrix in patients under 10 years of age). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-FEB-2024 The healthcare professional sent a medical information inquiry and requested information about the administration of Boostrix in patients under 10 years of age. The unspecified number of patients received the Boostrix vaccine below than the recommended age limit, which led to inappropriate age at vaccine administration.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Boostrix stored at minus 2.8 degree C into 50 minutes; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 33-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number P5SR5, expiry date 26-APR-2026) for prophylaxis.   On 27-FEB-2024, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Boostrix stored at minus 2.8 degree C into 50 minutes). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-MAR-2024  A medical assistant reported to request stability data for Boostrix stored at minus 2.8 degree Celsius for 50 minutes and administered to patient on 27-FEB-2024, which led to an incorrect storage of drug.  The reporter consented to follow up. This was 1 of 5 linked cases, reported by same reporter.; Sender's Comments:  US-GSK-US2024027787:Different patient US-GSK-US2024027789:Different patient US-GSK-US2024027790:Different patient US-GSK-US2024027788:Diffrent patient
Sex: F
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Frozen vaccine was administered to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 4-day-old female patient who received HBV (Engerix B) (batch number 32M5G, expiry date 14-SEP-2025) for prophylaxis.   On 01-MAR-2024, the patient received the 1st dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incorrect storage of drug (Verbatim: Frozen vaccine was administered to a patient). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt date: 04-MAR-2024 The reporter reported that the vaccine Engerix-B was exposed to temperature below freezing negative 2.2 Celsius. Patient was administered the frozen product, which led to incorrect storage of drug. The reporter consented to follow-up. This case had been linked with the case US2024028545, reported by same reporter.; Sender's Comments:  US-GSK-US2024028545:2 of 2 report
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: administered a dose of Infanrix to a 4 year 9 month old patient on 04Mar2024 from lot number Y4259, which had an expiration date of 03Mar2024; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa (Infanrix) (batch number Y4259, expiry date 03-MAR-2024) for prophylaxis.   On 04-MAR-2024, the patient received Infanrix. On 04-MAR-2024, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: administered a dose of Infanrix to a 4 year 9 month old patient on 04Mar2024 from lot number Y4259, which had an expiration date of 03Mar2024). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 04-MAR-2024 The nurse practitioner stated one of her nurses administered a dose of Infanrix to a 4 year 9 month old patient on 04th March 2024 which had an expiration date of 03rd March 2024, which led to expired vaccine used The Vaccine Administration Facility was the same as Primary Reporter The reporter consented to follow up.
Age: 16.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: report an expired Engerix-B vaccine with expiration date 2-23-2024 was administered 3-4-2024; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received HBV (Engerix B) (batch number 39A3L, expiry date 23-FEB-2024) for prophylaxis.   On 04-MAR-2024, the patient received Engerix B. On 04-MAR-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: report an expired Engerix-B vaccine with expiration date 2-23-2024 was administered 3-4-2024). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 05-MAR-2024 The nurse called to report an expired Engerix-B vaccine was administered to a patient. The reporter consented to follow up.