chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the vaccine and sitting here with shingles; sitting here with shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had the vaccine and sitting here with shingles) (serious criteria GSK medically significant) and shingles (Verbatim: sitting here with shingles). The outcome of the vaccination failure was unknown 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.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-MAR-2023 Reporter's Comments:  The reporter reported the case via interactive digital media. The patient had the vaccine and he/she was sitting there with shingles on day of reporting. The reporter said no you were not good. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available. 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: had the vaccine and sitting here with shingles) (serious criteria GSK medically significant) and shingles (Verbatim: sitting here with shingles). The outcome of the vaccination failure was unknown 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.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-MAR-2023 Reporter's Comments:  The reporter reported the case via interactive digital media. The patient had the vaccine and he/she was sitting there with shingles on day of reporting. The reporter said no you were not good. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I did also but still got shingles; got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I did also but still got shingles) (serious criteria GSK medically significant) and shingles (Verbatim: got 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: 21-MAR-2023 The reporter reported the case via interactive digital media. The patient said yes, he/ she did also but still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shingles and was vaccinated/ suspected vaccination failure; Got shingles twice; 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: Got shingles and was vaccinated/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got shingles twice). 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: 21-MAR-2023 This case was reported by consumer via interactive digital media. The reporter reported that it happened to her/his mom, and her physician was a dick and told her that it was probably something else because physician really could not believed she got shingles twice, especially when she was vaccinated. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow up was not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Influenza like illness, Pain, Vaccination failure
Clinical narrative: second shot and still get flare ups/Suspected Vaccination Failure; still get occasional flare ups; soreness; put me down for the day like the flu; 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.   The patient's past medical history included pain and muscle cramp.   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: second shot and still get flare ups/Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: still get occasional flare ups), influenza-like symptoms (Verbatim: put me down for the day like the flu) and pain (Verbatim: soreness). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved and the outcome of the influenza-like symptoms was resolved (duration 1 day) and the outcome of the pain was resolved.   It was unknown if the reporter considered the vaccination failure, shingles, influenza-like symptoms and pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, influenza-like symptoms and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 21-MAR-2023 The case  was received from the patient via interactive digital media. The patient stated that his/her first bout brought him/her to the floor in excruciating pain with muscle cramping in my shoulder blades. The patient stated that even after getting the shots (the second shot put him/her down for the day like the flu). The patient still get occasional flared ups.  The massage, light exercise, and yoga helped and the soreness went away in a few days.  The patient stated that being mindful of one's diet was extremely helpful and not eating a lot of crap.     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: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got shingles with vaccine/Suspected Vaccination Failure; 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: got shingles with vaccine/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: got 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: 21-MAR-2023 The case  was received from the patient via  interactive digital media. The patient stated he/she got shingles along with vaccine twice. 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: FLUX
Symptoms: Influenza, Nasopharyngitis, Vaccination failure
Clinical narrative: gotten the flu since getting the flu shot; gotten the flu; slight cold; This serious case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   The patient's past medical history included influenza.   On an unknown date, the patient received Flu vaccine. On an unknown date, an unknown time after receiving Flu vaccine, the patient experienced vaccination failure (Verbatim: gotten the flu since getting the flu shot) (serious criteria GSK medically significant), influenza (Verbatim: gotten the flu) and cold (Verbatim: slight cold). The outcome of the vaccination failure was unknown and the outcome of the influenza and cold were not reported.   It was unknown if the reporter considered the vaccination failure, influenza and cold to be related to Flu vaccine.     It was unknown if the company considered the vaccination failure, influenza and cold to be related to Flu vaccine.   Additional Information: GSK Receipt Date: 21-MAR-2023 The reporter reported the case via interactive digital media. The reporter said it was unusual that the patient got the flu, since getting the flu shot. The patient would never go without the flu shot. The patient had the full-blown flu before he/she started getting the flu shot, it was horrible, it was like a slight cold after getting the flu shot. The patient got his/ her first shingles shot day before reporting. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: taken the shots still had it/suspected vaccination failure; had it at least three times; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: taken the shots still had it/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had it at least three 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: 21-MAR-2023 The case  was received from the patient's friend via interactive digital media. The patient had taken the shots but still had shingles at least three times. 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: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had shingles vaccines still had shingles; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had shingles vaccines still had shingles) (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: 21-MAR-2023 The reporter reported the case via interactive digital media. The patient had his/her shingles vaccines and still had shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had the shot too but still got it/suspected vaccination failure; had the shot too but still got it; painful; 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: had the shot too but still got it/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: had the shot too but still got it) 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 receipt date: 21-MAR-2023 The case was received from the patient via interactive digital media. The patient stated that he or she hope that's right for you but did not count on it, it was not 100 percent. The patient had the shot too but still got them, not assess bad but was still very painful. The patient wish well. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of 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/had all inoculations still have contracted shingles; shingles 4 times; 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 an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure/had all inoculations still have contracted shingles) (serious criteria GSK medically significant), shingles (Verbatim: shingles 4 times) 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: 21-Mar-2023 The case was received from the patient via interactive digital media. The patient have had all of the inoculations and had still contracted shingles 4 times. The patient believed the shots minimized the severity of pain and duration. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of 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: had shot had mild case; mild case broke out; mild case broke out; This serious case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 82-year-old 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: had shot had mild case) (serious criteria GSK medically significant), shingles (Verbatim: mild case broke out) and shingles (Verbatim: mild case broke out). The outcome of the vaccination failure was unknown and the outcome of the shingles and shingles were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-MAR-2023 The reporter reported the case via interactive digital media. The reporter's mother was 82 and her doctor recommended her to get the shot.  The reporter suspected he had patients with Shingles.  She had to pay about 128 dollars for the shot.  2 weeks later she had a very mild case.  She broke out a couple more times, but they were tolerable. The reporter got the Shingrex vaccine and had a mild couple cases. This case has been linked with the case US2023AMR057461, reported by the same reporter. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR057461:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had shingrix vaccine had couple cases/suspected vaccination faliure; had shingrix vaccine had couple cases mild; 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.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: had shingrix vaccine had couple cases/suspected vaccination faliure) (serious criteria GSK medically significant) and shingles (Verbatim: had shingrix vaccine had couple cases mild). 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 Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK receipt date: 21-MAR-2023 The case was received from the patient via interactive digital media. The patient got the Shingrix vaccine and have had a couple of mild cases. The case was linked with case US2023AMR057460, reported by same reporter for his/her mother. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR057460:same reporter
Sex: M
Vaccine: FLUX
Symptoms: Herpes zoster, Illness, Influenza, Pneumonia, Vaccination failure
Clinical narrative: got 1st flu shot, got flu; got flu; sick; This serious case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 70-year-old male patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Previously administered products included covid vaccine with an associated reaction of covid-19 (received 3 doses).   On an unknown date, the patient received Flu vaccine. On an unknown date, an unknown time after receiving Flu vaccine, the patient experienced vaccination failure (Verbatim: got 1st flu shot, got flu) (serious criteria GSK medically significant), influenza (Verbatim: got flu) and sickness (Verbatim: sick). The outcome of the vaccination failure was unknown and the outcome of the influenza was not reported and the outcome of the sickness was resolved (duration 4 weeks).   It was unknown if the reporter considered the vaccination failure, influenza and sickness to be related to Flu vaccine.     It was unknown if the company considered the vaccination failure, influenza and sickness to be related to Flu vaccine.   Linked case(s) involving the same patient:  US2023AMR051846   Additional Information: GSK Receipt Date: 21-MAR-2023 The case was received from the patient's friend via interactive digital media. The reporter had a friend who was healthy all of his life, he recently turned 70. A very healthy person until COVID. He was vaccinated 3 times and got COVID, nearly died. Afterwards he got his 1st Flu shot, got flu, sick for 4 weeks. Later got his 1st Pneumonia shot, got Pneumonia, nearly died again. He got his 1st Shingles shot, got Shingles and wanted to die. The reporter asked what this told about vaccines that trust your own immunity. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR051846:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Insomnia, Lethargy, Malaise
Clinical narrative: feeling unwell; headache; nausea; fever/ temperature the first night; lethargic; muscle pain; insomnia; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling bad 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 bad (Verbatim: feeling unwell), headache (Verbatim: headache), nausea (Verbatim: nausea), fever (Verbatim: fever/ temperature the first night), lethargy (Verbatim: lethargic), muscle pain (Verbatim: muscle pain) and insomnia (Verbatim: insomnia). The outcome of the feeling bad, headache, nausea, fever, lethargy, muscle pain and insomnia were unknown.   It was unknown if the reporter considered the feeling bad, headache, nausea, fever, lethargy, muscle pain and insomnia to be related to Shingles vaccine.     It was unknown if the company considered the feeling bad, headache, nausea, fever, lethargy, muscle pain and insomnia to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-Apr-2023 The patient got the first vaccine and felt bad for more than 4 days, headache, nausea, temperature the first night, lethargy, muscle pain, insomnia but, it was nothing compared to what people who do not get vaccinated suffer. The reporter had seen it in relatives, and it was not pleasant at all. The patient going for the 2nd vaccine 2 months later.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: feeling unwell; headache; nausea; fever/ temperature the first night; lethargic; muscle pain; insomnia; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling bad 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 bad (Verbatim: feeling unwell), headache (Verbatim: headache), nausea (Verbatim: nausea), fever (Verbatim: fever/ temperature the first night), lethargy (Verbatim: lethargic), muscle pain (Verbatim: muscle pain) and insomnia (Verbatim: insomnia). The outcome of the feeling bad, headache, nausea, fever, lethargy, muscle pain and insomnia were unknown.   It was unknown if the reporter considered the feeling bad, headache, nausea, fever, lethargy, muscle pain and insomnia to be related to Shingles vaccine.     It was unknown if the company considered the feeling bad, headache, nausea, fever, lethargy, muscle pain and insomnia to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-Apr-2023 The patient got the first vaccine and felt bad for more than 4 days, headache, nausea, temperature the first night, lethargy, muscle pain, insomnia but, it was nothing compared to what people who do not get vaccinated suffer. The reporter had seen it in relatives, and it was not pleasant at all. The patient going for the 2nd vaccine 2 months later.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Hyperaesthesia, Pain in extremity, Peripheral swelling
Clinical narrative: arm pain/swelling; arm pain/swelling; Arm  was sensitive to touch and radiated warmth; Arm  was sensitive to touch and radiated warmth; This non-serious case was reported by a nurse via sales rep and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 07-APR-2023, the patient received the 1st dose of Shingrix .5 ml. In APR-2023, less than a week after receiving Shingrix, the patient experienced pain in arm (Verbatim: arm pain/swelling), swelling arm (Verbatim: arm pain/swelling), touch sensitivity increased (Verbatim: Arm  was sensitive to touch and radiated warmth) and feeling of warmth (Verbatim: Arm  was sensitive to touch and radiated warmth). The outcome of the pain in arm was not recovered/not resolved and the outcome of the swelling arm, touch sensitivity increased and feeling of warmth were recovering/resolving.   It was unknown if the reporter considered the pain in arm, swelling arm, touch sensitivity increased and feeling of warmth to be related to Shingrix.     It was unknown if the company considered the pain in arm, swelling arm, touch sensitivity increased and feeling of warmth to be related to Shingrix.   Additional Information: GSK receipt date:13-APR-2023 The nurse reported that the patient was office manager in practice. The patient received a dose of Shingrix and on the day of reporting the patient complaint about arm pain or arm swelling. According to nurse in office the patient's arm was sensitive to touch and radiated warmth. The reporter reported that events appears to be resolving but was still painful. The reporter did not agree to consent for follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pruritus
Clinical narrative: Pain; Itching; 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 the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Pain) and pruritus (Verbatim: Itching). The outcome of the pain and pruritus were resolved.   It was unknown if the reporter considered the pain and pruritus to be related to Shingles vaccine.     It was unknown if the company considered the pain and pruritus to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-MAR-2023 This case was reported by patient via interactive digital media. The patient thankfully had the shots. The second shot caused pain a few days but then it started itching on the inside. It was gone now. Follow up was not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Painful; 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 the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Painful). 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: 21-MAR-2023 This case was reported by patient via interactive digital media. The patient got shots 2nd time and it was so painful, cost almost 400 dollars.  The patient stated that it was worth it. Follow up was not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: still sore; 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 the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: still sore). The outcome of the pain was not resolved.   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: 21-MAR-2023 The reporter reported the case via interactive digital media. The reporter stated that 5 weeks still sore. The patient getting ready for the second shot.
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort, Pain in extremity, Sleep disorder
Clinical narrative: sore arm muscle, like someone had slugged me hard; uncomfortable sleeping; Discomfort lasted about 4 days; 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.   The patient's past medical history included chickenpox (chicken pox in 7th grade). Previously administered products included gamma globulin injection. Family history included shingles (aunt had shingles long before there was a vaccine).   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: sore arm muscle, like someone had slugged me hard), discomfort (Verbatim: Discomfort lasted about 4 days) and sleep disturbance (Verbatim: uncomfortable sleeping). The outcome of the pain in arm and sleep disturbance were not reported and the outcome of the discomfort was resolved (duration 4 days).   It was unknown if the reporter considered the pain in arm, discomfort and sleep disturbance to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm, discomfort and sleep disturbance to be related to Shingles vaccine.   Additional Information: GSK receipt date: 21-MAR-2023 The case  was received from the patient via interactive digital media. The patient said sorry as you got Shingles. The patient recommended to do get the 2-dose vaccine.  The patient got chicken pox and there was not a specific vaccine then he/she was given the generic gamma globulin injection. The patient stated that only reaction he/she had was a very sore arm muscle, like someone had slugged him/her hard.  The discomfort lasted about 4 days, but patient was glad to deal with that instead of the disease.  The patient stated that one of his/her colleagues had Shingles and she was out of work for quite a while affected her eyes (she was an artist) and she had nerve pain.  The patient stated that if you sleep on your side, get your vaccine in the arm you did not sleep on so you were not too uncomfortable sleeping. The follow-up could not be possible as no contact details were available. This case is linked with US2023AMR056753, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR056753:Same patient/same product
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: sore shoulder; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shoulder soreness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On 18-MAR-2023, an unknown time after receiving Shingles vaccine, the patient experienced shoulder soreness (Verbatim: sore shoulder). The outcome of the shoulder soreness was not reported.   It was unknown if the reporter considered the shoulder soreness to be related to Shingles vaccine.     It was unknown if the company considered the shoulder soreness to be related to Shingles vaccine.   Additional Information: GSK receipt date: 21-Mar-2023 The case was received from the patient via interactive digital media. The patient got shingles shot and 4 days prior to the reporting date, the patient had no problem, just a little sore on the shoulder. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Lethargy, Nausea, Pain, Pyrexia
Clinical narrative: lethargy; sleepy; sore area were shot was administered; body ache; sinus like headache; nausea; fever; restlessness; 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 (Shingles vaccine) for prophylaxis.   On 19-MAR-2023, the patient received the 1st dose of Shingles vaccine. On 19-MAR-2023, less than a day after receiving Shingles vaccine, the patient experienced injection site pain (Verbatim: sore area were shot was administered), general body pain (Verbatim: body ache), sinus headache (Verbatim: sinus like headache), nausea (Verbatim: nausea), fever (Verbatim: fever) and restlessness (Verbatim: restlessness). On 20-MAR-2023, the patient experienced lethargy (Verbatim: lethargy) and sleepiness (Verbatim: sleepy). On 21-MAR-2023, the outcome of the injection site pain, general body pain, sinus headache, nausea, fever and restlessness were resolved (duration 2 days) and the outcome of the lethargy and sleepiness were recovered/resolved (duration 1 day).   It was unknown if the reporter considered the injection site pain, general body pain, sinus headache, nausea, fever, restlessness, lethargy and sleepiness to be related to Shingles vaccine.     It was unknown if the company considered the injection site pain, general body pain, sinus headache, nausea, fever, restlessness, lethargy and sleepiness to be related to Shingles vaccine.   Additional Information: GSK receipt date: 22-Mar-2023 The case was received from the patient via interactive digital media. The patient just got a shingles shot 3 days ago and first night had ache body, sinus like headache, nausea, fever all night with restlessness and sore area were shot was administered, next day same with lethargy and very sleepy and third day everything subsided. The patient had seen family who has had shingles and it can go on for over a month of non stop pain and all of the above symptoms with rash and skin irritation. The patient would be having the second shot in 2 months. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Restlessness, Sinus headache, Somnolence
Clinical narrative: lethargy; sleepy; sore area were shot was administered; body ache; sinus like headache; nausea; fever; restlessness; 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 (Shingles vaccine) for prophylaxis.   On 19-MAR-2023, the patient received the 1st dose of Shingles vaccine. On 19-MAR-2023, less than a day after receiving Shingles vaccine, the patient experienced injection site pain (Verbatim: sore area were shot was administered), general body pain (Verbatim: body ache), sinus headache (Verbatim: sinus like headache), nausea (Verbatim: nausea), fever (Verbatim: fever) and restlessness (Verbatim: restlessness). On 20-MAR-2023, the patient experienced lethargy (Verbatim: lethargy) and sleepiness (Verbatim: sleepy). On 21-MAR-2023, the outcome of the injection site pain, general body pain, sinus headache, nausea, fever and restlessness were resolved (duration 2 days) and the outcome of the lethargy and sleepiness were recovered/resolved (duration 1 day).   It was unknown if the reporter considered the injection site pain, general body pain, sinus headache, nausea, fever, restlessness, lethargy and sleepiness to be related to Shingles vaccine.     It was unknown if the company considered the injection site pain, general body pain, sinus headache, nausea, fever, restlessness, lethargy and sleepiness to be related to Shingles vaccine.   Additional Information: GSK receipt date: 22-Mar-2023 The case was received from the patient via interactive digital media. The patient just got a shingles shot 3 days ago and first night had ache body, sinus like headache, nausea, fever all night with restlessness and sore area were shot was administered, next day same with lethargy and very sleepy and third day everything subsided. The patient had seen family who has had shingles and it can go on for over a month of non stop pain and all of the above symptoms with rash and skin irritation. The patient would be having the second shot in 2 months. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza
Clinical narrative: felt like had the flu; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 21-MAR-2023, the patient received the 1st dose of Shingles vaccine. On 22-MAR-2023, 1 days after receiving Shingles vaccine, the patient experienced influenza (Verbatim: felt like had the flu). The outcome of the influenza was not recovered/resolved.   It was unknown if the reporter considered the influenza to be related to Shingles vaccine.     It was unknown if the company considered the influenza to be related to Shingles vaccine.   Additional Information: GSK receipt date: 22-MAR-2023 The case was received from the patient via interactive digital media. The patient got a shot one day before the reporting date and on the day of reporting felt like he or she had flu, but after reading all of the comments the patient was so grateful that he or she never got shingles. The patient stated that 2nd shot was scheduled for 3 months from the 1st shot date (one day before the reporting date). The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph node in the neck after 1st vaccine; This non-serious case was reported by a other health professional via sales rep and described the occurrence of lymphadenopathy cervical in a patient who received Herpes zoster (Shingrix) for prophylaxis.   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 lymphadenopathy cervical (Verbatim: swollen lymph node in the neck after 1st vaccine). The outcome of the lymphadenopathy cervical was resolved (duration 1 week).   It was unknown if the reporter considered the lymphadenopathy cervical to be related to Shingrix.     It was unknown if the company considered the lymphadenopathy cervical to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-APR-2023 The medical assistant reported an adverse event that happened last year after a patient's 1st dose of Shingrix vaccine.  In 2022, the patient experienced a swollen lymph node in the neck and the swelling subsided after a week.  The patient discussed with doctor at next visit. No patient demographics were known. The exact date of vaccination was not reported, and it was unsure if patient received 2nd dose of Shingrix vaccine. Permission for Safety follow-up unknown. No additional data was available about this adverse event.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Kinrix as 2nd dose on DTap series; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 5-year-old female patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 09-NOV-2023) for prophylaxis.   On 09-NOV-2022, the patient received Kinrix. On 09-NOV-2022, an unknown time after receiving Kinrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: Kinrix as 2nd dose on DTap series). The outcome of the inappropriate schedule of vaccine administered 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: 13-Apr-2023 On 9-Nov-2022 Kinrix was administered to a patient as the 2nd dose of the DTap series instead of being the 5th dose of the series.  Consented to follow up. The reporter said to HCP that such thing had also happened to a lot of other patients, but in that moment, she only had available the information of one patient The patient received Kinrix as 2nd dose, which led to Inappropriate schedule of vaccine administered.; Sender's Comments:  US-GSK-US2023AMR055143:Same reporter. Other patients master case.
Age: 54.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Administered an expired Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 54-year-old female patient who received HAV (Havrix adult) (batch number 2BA99, expiry date 16-DEC-2022) for prophylaxis.   On 13-APR-2023, the patient received Havrix adult. On 13-APR-2023, an unknown time after receiving Havrix adult, the patient experienced expired vaccine used (Verbatim: Administered an expired Havrix). 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: 14-MAR-2023 The reporter was a medical assistant. The reporter reported that they inadvertently administered Havrix vaccine in their facility which was expired. The reporter wanted to know should this vaccine be re administered. The reporter did not consent to follow up. The patient received a Havrix which was already expired, which led to expired vaccine used.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Malaise, Myalgia
Clinical narrative: Myalgia; Shivering; Fatigue; Malaise; This non-serious case was reported by a consumer via call center representative and described the occurrence of myalgia in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14-FEB-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced myalgia (Verbatim: Myalgia), shivering (Verbatim: Shivering), fatigue (Verbatim: Fatigue) and malaise (Verbatim: Malaise). The outcome of the myalgia, shivering, fatigue and malaise were resolved.   It was unknown if the reporter considered the myalgia, shivering, fatigue and malaise to be related to Shingrix.     It was unknown if the company considered the myalgia, shivering, fatigue and malaise to be related to Shingrix.   Additional Information: GSK Receipt date: 14-APR-2023 The patient received a dose of Shingrix and experienced myalgia, shivering, fatigue, and malaise. Reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient got the diluent only portion; Patient got the diluent only portion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Patient got the diluent only portion) and inappropriate dose of vaccine administered (Verbatim: Patient got the diluent only portion). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 17-APR-2023 The pharmacist did not had any patient information and did not had any information on the dosing date, lot number, expiration date. The reporter believed that the clinic might had already reported the adverse event. The reporter provided a contact email for any follow-up needed. The reporter consented to follow up. The patient was administered the diluent portion only of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.