chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MMR
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barré syndrome; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a female patient who received MMR (MMR vaccine) for prophylaxis.   On an unknown date, the patient received MMR vaccine. On an unknown date, an unknown time after receiving MMR vaccine, the patient experienced guillain barre syndrome (Verbatim: Guillain-Barré 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 MMR vaccine.     It was unknown if the company considered the guillain barre syndrome to be related to MMR vaccine.   Additional Information: GSK receipt date: 17-Mar-2023 The case was received from the patient's parent via interactive digital media. The reporter stated that they said you can get guillain-barre syndrome from it. That's why the reporter was afraid of the shot. The patient got them from the MMR vaccine and so not sure the reporter want to chance it. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: HORRIFIC SHINGLES POST SHINGLES VACCINATION/Suspected vaccination failure; HORRIFIC 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: HORRIFIC SHINGLES POST SHINGLES VACCINATION/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: HORRIFIC 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: 16-MAR-2023 The case was received from the consumer via  interactive digital media. The reporter reported that funny 3 people he/she know personally contracted horrific shingles post shingles vaccination. 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. This is 1 of 3 linked cases reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR050702:same reporter, patient 2 US-GSK-US2023AMR050704:same reporter, patient 3
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: HORRIFIC SHINGLES POST SHINGLES VACCINATION/Suspected vaccination failure; HORRIFIC 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: HORRIFIC SHINGLES POST SHINGLES VACCINATION/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: HORRIFIC 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: 16-MAR-2023 The case was received from the consumer via interactive digital media. The reporter reported that funny 3 people he/she know personally contracted horrific shingles post shingles vaccination. 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. This is 2 of 3 linked cases reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR050695:same reporter US-GSK-US2023AMR050704:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: horrific shingles post shingles vaccination/suspected vaccination failure; horrific 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: horrific shingles post shingles vaccination/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: horrific 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: 16-Mar-2023 The case was received from the consumer via interactive digital media. The reporter reported that funny 3 people he/she know personally contracted horrific shingles post shingles vaccination. 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. This is 3 of 3 linked cases reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR050695:same reporter, patient 1 US-GSK-US2023AMR050702:same reporter, patient 2 US-GSK-US2023AMR050695:same reporter, patient 3
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Has gotten shingles multiple times; 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: Has gotten shingles multiple 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: 17-MAR-2023 This case was reported by a consumer via  interactive digital media. The reporter stated that everyone client he/she had that was bullied into getting that shingles vaccine and had gotten shingles multiple times.  The reporter further stated that another poisonous jab. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available. The case had been linked to US2023AMR050711 and US2023AMR050710, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023AMR050711:same reporter - Female patient case US-GSK-US2023AMR050710:same reporter - Male patient case
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Keep getting as well; 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) and shingles (Verbatim: Keep getting as well). 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: 17-MAR-2023 This case was reported by a patient's child via  interactive digital media. The patient kept getting shingles as well.  They patient was bullied by his doctor as well.  The reporter asked that how much dollar he got for each shingles shot. That was a conflict of interest (for your information).  The patient fired his doctors as did many of his clients.  The reporter stated that most doctors were drug pushers now and just sad.  The reporter further stated that selling your soul for dollar never ended well. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available. The case had been linked to US2023AMR050706 and US2023AMR050711, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023AMR050706:Same reporter - Batch report US-GSK-US2023AMR050711:Same reporter - Female patient case
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; keep getting as well; 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: keep getting as well). 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: 17-MAR-2023 This case was reported by a patient's child via interactive digital media. The patient kept getting shingles as well.  They patient was bullied by her doctor as well.  The reporter asked that how much dollar she got for each shingles shot. That was a conflict of interest (for your information).  The patient fired her doctors as did many of his clients.  The reporter stated that most doctors were drug pushers now and just sad.  The reporter further stated that selling your soul for dollar never ended well. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available. The case had been linked to US2023AMR050710 and US2023AMR050706, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023AMR050710:Same reporter - Male patient case US-GSK-US2023AMR050706:Same reporter - Batch report
Sex: U
Vaccine: VARZOS
Symptoms: Deafness, Herpes zoster, Herpes zoster oticus, Pain
Clinical narrative: lost hearing totally, hearing adi's; so painful; shingles 3 times, in hair and ears; This serious case was reported by a consumer via interactive digital media and described the occurrence of hearing loss in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. In MAR-2023, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: shingles 3 times, in hair and ears). On an unknown date, the patient experienced hearing loss (Verbatim: lost hearing totally, hearing adi's) (serious criteria GSK medically significant) and pain (Verbatim: so painful). The outcome of the hearing loss and pain were not reported and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the hearing loss, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the hearing loss, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 16-Mar-2023 The case was received from the patient via interactive digital media. The patient never had them after having his/her 1st shingles shot now have had them 3 times (at the time of reporting), so painful and even in his/her hair and ears. The patient had lost his/her hearing totally getting hearing adi's made. 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 severe case, hospital 4x; had shot and got severe case/suspected vaccination failure; 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 them at 14 year of age), bedridden (was in bed 2 months) and sickness (was very sick).   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 and got severe case/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got severe case, hospital 4x) (serious criteria hospitalization). The outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved (duration 8 months).   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: 16-Mar-2023 The case was received from the patient via  interactive digital media. The patient asked that what was shingles. The patient had the shot and contacted a severe case and under he/she hospital 4 times took 8 months to get over. 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: Discomfort, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; small patch, felt like arrow piercing body; Felt like what I think an arrow would feel like that pierced your body; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), herpes zoster (Verbatim: small patch, felt like arrow piercing body) and discomfort (Verbatim: Felt like what I think an arrow would feel like that pierced your body). The outcome of the vaccination failure was unknown and the outcome of the herpes zoster and discomfort were not reported.   It was unknown if the reporter considered the vaccination failure, herpes zoster and discomfort to be related to Shingles vaccine.  It was unknown if the company considered the vaccination failure, herpes zoster and discomfort to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-MAR-2023 This case was reported by the patient via interactive digital media. The patient received dose of Shingles vaccine before he/she experienced much but reported what he/she had, even though it was just a small patch, felt like what he/she thought an arrow would feel like that pierced your body. This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. Follow-up would not possible, as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shots but she got them/ suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Family history included shingles (had to four sisters) and chickenpox (sister or brother when he or she was a kid).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got shots but she got them/ 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: 17-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that he or she had five sisters and all of them experienced shingles. The reporter stated that his or her one sister experienced shingles so bad as she was suffered terrible. The reporter reported that he or she and his or her younger sister received Shingles vaccine but she experienced shingles but not as bad. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the shots and still got 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 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 shots and still got 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: 17-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and still experienced shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Vaccination failure
Clinical narrative: Shingles; Pain/hurt that bad/still it hurt worse than childbirth; Rash; Got shingles shot but got shingles/ suspected vaccination failure; 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 shot but got shingles/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) (serious criteria hospitalization), pain (Verbatim: Pain/hurt that bad/still it hurt worse than childbirth) (serious criteria hospitalization) and rash (Verbatim: Rash) (serious criteria hospitalization). The outcome of the vaccination failure was unknown and the outcome of the shingles and rash were not reported and the outcome of the pain was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and rash to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pain and rash to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAR-2023 This case was reported by a patient via  interactive digital media. The patient reported that he or she received Shingles vaccine and experienced shingles on his or her right side of lower back.. The patient was in pain all over and stated that he or she never had hurt that bad. The patient stated that he or she went to the hospital two times and three times to his or her physician. The patient reported that someone thought that to look to see if it was a rash and check for shingles and after 2 weeks they know that it was shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This non-serious case was reported by a other health professional via sales rep and described the occurrence of expired vaccine used in a male patient who received HAV (Havrix 1440) (batch number 2BA99, expiry date 16-DEC-2022) for prophylaxis.   On an unknown date, the patient received Havrix 1440. On an unknown date, an unknown time after receiving Havrix 1440, the patient experienced expired vaccine used (Verbatim: Expired Havrix administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 24-Mar-2023 The patient received 1440 el u/mL of Havrix that was expired.  Also the reporter wanted to understand if it was allowable dose.  The representative would put on task as well as reporter would like interaction. The reporter agree to follow up from GSK. The patient was administered an expired dose of Havrix 1440, which led to expired vaccine used. This case has been linked to the case US2023046061 reported by the same reporter.; Sender's Comments:  US-GSK-US2023046061:Same reporter/different patient
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Insomnia, Limb discomfort, Musculoskeletal discomfort, Pain
Clinical narrative: Injection site was very sore/injection site is no longer sore in that area; Discomfort in neck, shoulder, lower back and hip; Discomfort in arm; Pain is interfering with sleep; Pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site 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 injection site pain (Verbatim: Injection site was very sore/injection site is no longer sore in that area), musculoskeletal discomfort (Verbatim: Discomfort in neck, shoulder, lower back and hip), arm discomfort (Verbatim: Discomfort in arm), difficulty sleeping (Verbatim: Pain is interfering with sleep) and pain (Verbatim: Pain). The patient was treated with paracetamol (Tylenol) and medication unknown (Muscle Cream (Nos)). The outcome of the injection site pain, musculoskeletal discomfort, arm discomfort, difficulty sleeping and pain were resolving.  It was unknown if the reporter considered the injection site pain, musculoskeletal discomfort, arm discomfort, difficulty sleeping and pain to be related to Shingles vaccine.  It was unknown if the company considered the injection site pain, musculoskeletal discomfort, arm discomfort, difficulty sleeping and pain to be related to Shingles vaccine.  Linked case(s) involving the same patient: US2023AMR045975  Additional Information: GSK receipt date 25-MAR-2023 The patient had gotten shingle shots last year. The second dosage was received November 2022. The patient had reported that, he/she was feeling good and the injection site was very sore even after some time. Lately, he/she had been experiencing neck discomfort which traveled to his/her shoulder then his/her arm, to his/her lower back and lastly to his/her hip and this was on his/her left side of the body, were he/she had received his/her injections. He/She would like to know if this could be a side effect from his/her shingle shots and had stated that, the injection site was no longer sore in that area. He/she had also asked if this was associated with his/her injections, what could he/she could do at night to ease the pain, because it was interfering with his/her sleep.  He/She had been using Tylenol and muscle creams with very little help. The reporter had consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 17Sep2021, 2nd 24Oct2022; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on 17th September 2021, expiry date 25th January 2023 and LOT number C4NC5).   On 24-OCT-2022, the patient received the 2nd dose of Shingrix. On 24-OCT-2022, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose 17Sep2021, 2nd 24Oct2022). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date-27-MAR-2023 The patient received his/her Immunization record and it showed that a 2nd Shingrix vaccine was given on 24th October 2022. The patient did receive the vaccine (which was his/her first shot) but not the one on 17th September 2021. The reporter wanted to know could GlaxoSmithKline verify that the expiry date and lot number was even a Shingrix vaccine.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: COVID-19, Feeling abnormal, SARS-CoV-2 test positive
Clinical narrative: Feels bad; Diagnosed with Covid-19; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling bad in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In JAN-2023, the patient received the 1st dose of Shingrix. On 02-MAR-2023, between 1 and 3 months after receiving Shingrix, the patient experienced covid-19 (Verbatim: Diagnosed with Covid-19). On an unknown date, the patient experienced feeling bad (Verbatim: Feels bad). The outcome of the feeling bad and covid-19 were unknown.   It was unknown if the reporter considered the feeling bad and covid-19 to be related to Shingrix.     It was unknown if the company considered the feeling bad and covid-19 to be related to Shingrix.   Linked case(s) involving the same patient:  US2023046077   Additional Information: GSK Receipt date: 27-MAR-2023 The patient felt really bad with 1st shot of Shingrix. The patient did not provide any details about adverse reactions after the 1st dose of Shingrix, and reported that she received the dose of Shingrix in January 2023 (she did not have an exact date). The patient also reported that she was diagnosed with COVID. The reporter did not consent to follow-up. The patient said safety could follow up with her pharmacy if necessary. For tolerance to the 2nd dose refer case US2023AMR046548.; Sender's Comments:  US-GSK-US2023046077:Same reporter
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Sore arm; not as painful as 1st dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On an unknown date patient received shingrix dose 1).   On 24-MAR-2023, the patient received the 2nd dose of Shingrix (right arm). On 24-MAR-2023, less than a day after receiving Shingrix, the patient experienced pain in arm (Verbatim: Sore arm) and pain (Verbatim: not as painful as 1st dose). Rechallenge with Shingrix was positive. The outcome of the pain in arm and pain were resolved.   It was unknown if the reporter considered the pain in arm and pain to be related to Shingrix.     It was unknown if the company considered the pain in arm and pain to be related to Shingrix.   Linked case(s) involving the same patient:  US2023046101   Additional Information: GSK Receipt Date- 27-MAR-2023 The patient reported that when she received her dose of Shingrix, it was not as painful as the 1st dose, and her right arm was sore only that afternoon on the day of vaccination.  The reporter consented to follow up with HCP obtained.; Sender's Comments:  US-GSK-US2023046101:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 16-MAR-2023, the patient received the 2nd dose of Shingles vaccine. On 16-MAR-2023, less than a day after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Sore arm). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-MAR-2023 This case was reported by the patient via interactive digital media. The patient received his/her second shot of Shingles vaccine today (on day of reporting) and experienced sore arm, but he/she had that with any shot.  Follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm was little sore, no side effects; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 15-MAR-2023, the patient received the 1st dose of Shingles vaccine. In MAR-2023, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Arm was little sore, no side effects). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 16-MAR-2023 This case was reported by a patient via interactive digital media. The patient got her/his first shot yesterday and go get the 2nd one in 2 months ,no side affects at all just her/his arm was a little sore. The follow-up could not be possible as no contact details were available. This report was one of several cases received as part of a line-listing, each containing minimal information.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: 2nd shot was  little achy; 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.   In MAR-2023, the patient received the 2nd dose of Shingles vaccine. In MAR-2023, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: 2nd shot was  little achy). The outcome of the pain was resolved (duration 2 days).   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: 16-MAR-2023 This case was reported by a patient via interactive digital media. The patient just got his/ her second shot was a little achy for two days but it's all good now. The follow-up could not be possible as no contact details were available. This report was one of several cases received as part of a line-listing, each containing minimal information.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced fever (Verbatim: Fever). The outcome of the fever was not resolved.   It was unknown if the reporter considered the fever to be related to Shingles vaccine.     It was unknown if the company considered the fever to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAR-2023 This case was reported by the patient via interactive digital media. The patient received the Shingles shot and now have fever. Follow-up would not possible, as no contact details were available.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Did not receive Twinrix 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received HAB (Twinrix) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: Did not receive Twinrix 2nd dose). The outcome of the incomplete course of vaccination 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: 27-MAR-2023 A pharmacist informed that in January 2023, the patient came back to receive the 2nd dose but received a dose of Heplisav-B instead. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  Till the time of reporting, the patient did not receive 2nd dose of Twinrix (for Hepatitis A component), which led to incomplete course of vaccination. VAERS details pertains to 1st dose of Twinrix in product tab.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: The dose was diluted with sterile diluent instead of the supplied CYW-135 diluent; Inappropriate dose of vaccine administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA767A, expiry date 31-DEC-2023) for prophylaxis.   On 27-MAR-2023, the patient received Menveo. On 27-MAR-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: The dose was diluted with sterile diluent instead of the supplied CYW-135 diluent) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 27-MAR-2023 Nurse reports a staff member administered a dose of Menveo. The dose was diluted with sterile diluent instead of the supplied CYW-135 diluent.  At the time of reporting, the dose has not been repeated.  The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter. The dose was diluted with sterile diluent instead of the supplied CYW-135 diluent which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.; Sender's Comments: Nurse reports a staff member administered a dose of Menveo to a 16 year old female patient on 27Mar2023 from lot number AMVA767A (expiration date 27Mar2023).  The dose was diluted with sterile diluent instead of the supplied CYW-135 diluent.  At the time of reporting, the dose has not been repeated.  ~~~~~~~Consented to follow up. "The Vaccine Administration Facility is the same as Primary Reporter", Call Notes:Reporter gave permission for follow-up
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: the second dose has not been administered yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose with batch number 397A2, expiry date 27th May 2022, on 30th October 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: the second dose has not been administered yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 27-Mar-2023 The reporter asked should restart the vaccine series. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. The Vaers details were reported for the 1st dose of Shingrix. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: Reconstituted with sterile water; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 12-month-old male patient who received Hib (Hiberix) (batch number DM5G2, expiry date 15-MAY-2024) for prophylaxis.   On 24-MAR-2023, the patient received Hiberix. On 24-MAR-2023, an unknown time after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Reconstituted with sterile water). The outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 27-MAR-2023 The medical assistant reported a dose of Hiberix was reconstituted with sterile water. Adverse event (AE) contained all reported information.  The health care professional (HCP) gave consent for safety team follow up. The patient received Hiberix which was reconstituted with sterile water, which led to wrong solution used in drug reconstitution.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Myalgia, Vaccine positive rechallenge
Clinical narrative: Feels really bad (worse than 1st dose); Tired; Muscle aches; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling bad in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of feeling abnormal (received 1st dose in January 2023 and also experienced Covid, refer case US2023AMR046548).   On 26-MAR-2023 20:00, the patient received the 2nd dose of Shingrix (right arm). In MAR-2023, an unknown time after receiving Shingrix, the patient experienced feeling bad (Verbatim: Feels really bad (worse than 1st dose)), tiredness (Verbatim: Tired) and muscle pain (Verbatim: Muscle aches). Rechallenge with Shingrix was positive. The outcome of the feeling bad, tiredness and muscle pain were unknown.   It was unknown if the reporter considered the feeling bad, tiredness and muscle pain to be related to Shingrix.     It was unknown if the company considered the feeling bad, tiredness and muscle pain to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR046548   Additional Information: GSK Receipt date:27-MAR-2023 The patient self-reported this case. Patient received 2nd dose of Shingrix around 8 PM, and she reported that she was feeling really bad, (worse than the 1st shot of Shingrix), was tired and had the muscle aches, she stated that muscle ache could be contributed to just having got back from the gym that morning. The patient did not have a lot for her 2nd dose, as she threw away the paperwork.  The reporter did not consent to follow-up.  The patient stated safety could follow up with her pharmacy if necessary.; Sender's Comments:  US-GSK-US2023AMR046548:Same reporter
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash papular, Rash pruritic
Clinical narrative: bumpy rash; rash was itchy; This non-serious case was reported by a consumer via call center representative and described the occurrence of papular rash in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21-MAR-2023, the patient received the 1st dose of Shingrix (left arm). On 22-MAR-2023, 1 days after receiving Shingrix, the patient experienced papular rash (Verbatim: bumpy rash) and itchy rash (Verbatim: rash was itchy). The patient was treated with steroids nos (Steroid Pack (Nos)). The outcome of the papular rash and itchy rash were not resolved.   It was unknown if the reporter considered the papular rash and itchy rash to be related to Shingrix.     It was unknown if the company considered the papular rash and itchy rash to be related to Shingrix.   Additional Information: GSK Receipt date:27-Mar-2023 Patient stated the next morning when she woke up with a horrible itchy rash across her chest.  She stated that the rash spread to under her arms and to the back of her neck in the next couple of days after.  She stated that she went to an urgent care where she was given a metradose steroid pack to take for 5 days and she had 1 day left to take the steroid pack. She described the rash was itchy and bumpy. The reporter consent to follow up with her and healthcare professional.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Haemorrhoids
Clinical narrative: Internal hemorrhoids; This non-serious case was reported by a consumer via call center representative and described the occurrence of internal hemorrhoids in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 08-DEC-2022, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced internal hemorrhoids (Verbatim: Internal hemorrhoids). The outcome of the internal hemorrhoids was not resolved.   It was unknown if the reporter considered the internal hemorrhoids to be related to Shingrix.     It was unknown if the company considered the internal hemorrhoids to be related to Shingrix.   Additional Information: GSK Receipt date: 27-Mar-2023 The patient self-reported this case. The patient received Shingrix at his MD office, but did not wish to provide HCP information. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: late for the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose with batch number 5P9DR, expiry date 20th March 2023, on 21st September 2021 at a different pharmacy location).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: late for the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 27-MAR-2023 The reporter consent to follow up either through mail or email. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Expired Shingrix administered; 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 69-year-old male patient who received Herpes zoster (Shingrix) (batch number 74FB9, expiry date 17-MAR-2023) for prophylaxis.   On 22-MAR-2023, the patient received the 1st dose of Shingrix (right deltoid). On 22-MAR-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: Expired Shingrix administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 27-MAR-2023 The reporter consented to follow up.  The patient was administered an expired Shingrix vaccine inadvertently, which led to expired vaccine used. This case was 1 of 3 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023046086:Same reporter US-GSK-US2023046092:Same reporter