chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shots, covered waist down/suspected vaccination failure; covered from waist down; 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: got the shots, covered waist down/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: covered from waist down). 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: 22-MAR-2023 This case was reported by a patient's sister via interactive digital media The patient had the shingles shot, he was covered in shingles from waist down. The reporter never had shingles. The reporter's husband had shingles and he had not had the shingles shot. The reporter stated that the shingles shot was worth getting and she thought but did not work on everyone. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: Had shingles after the shot/ suspected vaccination failure; Shingles; Had to get better to feel terrible/ miserable; 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 shingles after the shot/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and feeling miserable (Verbatim: Had to get better to feel terrible/ miserable). The outcome of the vaccination failure was unknown and the outcome of the shingles and feeling miserable were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and feeling miserable to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and feeling miserable to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 22-MAR-2023 This case was reported by patient via interactive digital media. The patient reported that he or she received shingles vaccine and experienced shingles and it was miserable disease. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory details were unknown at a time of reporting. The follow-up could not be possible as the as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shingles form the vaccine/ 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.   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 form the vaccine/ 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.   The reporter considered the vaccination failure and shingles to be possibly related to Shingles vaccine.     The company considered the vaccination failure and shingles to be possibly related to Shingles vaccine.   Additional Information: GSK Receipt date: 22-MAR-2023 This case was reported by a patient's family member via interactive digital media. The reporter reported that his or her aunty received Shingles vaccine and experienced shingles from the vaccine. This case was consider as a suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory data was not provided at a time of reporting. The follow-up could not be possible as no contact details were available. According to narrative verbatim the causality was conservatively captured as possible.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had shingles after vaccinated/ 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 chickenpox (had chicken pox as 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: Had shingles after vaccinated/ 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: 22-MAR-2023 This case was reported by patients' daughter member via interactive digital media. The reporter reported that his or her mother had shingles after received Shingles vaccine. The reporter figuring the vaccine will not do good for him or her as 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 could not be possible as no contact details were available. This case had been linked with US2023AMR058210 by same reporter for different patient.; Sender's Comments:  US-GSK-US2023AMR058210:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had shingles were vaccinated / 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 male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (had chickenpox as 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: Had shingles were vaccinated / 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: 22-MAR-2023 This case was reported by patients' daughter member via  interactive digital media. The reporter reported that his or her father had shingles after received Shingles vaccine. The reporter figuring the vaccine will not do good for him or her as 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 could not be possible as no contact details were available. This case had been linked with US2023AMR058207 by same reporter for different patient.; Sender's Comments:  US-GSK-US2023AMR058207:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In JUN-2019, the patient received Shingrix. In MAY-2022, more than 2 years after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK receipt date: 23-MAR-2023 The case  was received from the patient via  interactive digital media. The patient got shingles in early May 2022. 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, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: 2 Shots Didn't Help Me/Suspected Vaccination Failure; Didn't Help Me; Very 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: 2 Shots Didn't Help Me/Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: Didn't Help Me) and pain (Verbatim: Very 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 and Shingles vaccine.  It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 22-MAR-2023 This case was reported by a patient via interactive digital media The reporter sated that it was very painful and two shingles shots did not help him/her. This case was considered as suspected vaccination failure as details regarding 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Still came down with them/ Suspected vaccination failure; Still came down with them; 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: still came down with them/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still came down with them). 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: 23-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that he or she got the shot and still came down with them and was going in to get the two shot injections. 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. Follow-up was not possible, as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Ageusia, Anosmia
Clinical narrative: Lost my sense of smell; Lost my sense of taste; This non-serious case was reported by a consumer and described the occurrence of loss of smell in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13-APR-2023, the patient received the 1st dose of Shingrix. On 13-APR-2023, 4 hrs after receiving Shingrix, the patient experienced loss of smell (Verbatim: Lost my sense of smell) and taste loss (Verbatim: Lost my sense of taste). The outcome of the loss of smell and taste loss were not resolved.   It was unknown if the reporter considered the loss of smell and taste loss to be related to Shingrix.     It was unknown if the company considered the loss of smell and taste loss to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-APR-2023 The case was self reported by the patient. This case was submitted by public reporting reference via the online direct entry reporting system. The patient received first dose of Shingrix and stated that the patient lost sense of smell and taste (could not smell and taste) within 4 hours of administration.  The patient reported that symptoms were not treated. The reporter consenedt to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Can I take a pain reliever for the side effects; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In APR-2023, the patient received the 2nd dose of Shingrix. In APR-2023, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: Can I take a pain reliever for the side effects). The outcome of the pain was not resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.     It was unknown if the company considered the pain to be related to Shingrix.   Additional Information: GSK receipt date: 18-Apr-2023 The patient just received my second shingles shot.  The patient wanted to know could we take a pain reliever for the side effect. The patient wanted to know is if it was safe to take a pain reliever after getting my 2nd shingles shot.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: chills; 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 the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced fever (Verbatim: fever) and chills (Verbatim: chills). The outcome of the fever was resolved (duration 1 day) and the outcome of the chills was resolved.   It was unknown if the reporter considered the fever and chills to be related to Shingles vaccine.     It was unknown if the company considered the fever and chills to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-Mar-2023 The patient just got the first vaccine, and he/she got a fever and chills for a day at the time of reporting,  after 3 to 6 months he/she had to get the second dose but she did not care about the fever, it was more painful to have it, a friend got it and it was very strong.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: gotten the 1st shingles shot but never got the 2nd one; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included shingles vaccine (received 1st dose 5 or 6 years before).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: gotten the 1st shingles shot but never got the 2nd one). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 22-Mar-2023 The patient had gotten the 1st shingles shot but never got the 2nd one. The reporter asked if anyone know if they could get the 2nd one only if it had been 5-6 years since getting the 1st or would he/ she need to start the whole round of both shots again. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: no adverse event, It keeps reoccurring in one spot after vaccinated; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of nerve 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 nerve pain (Verbatim: no adverse event, It keeps reoccurring in one spot after vaccinated). The outcome of the nerve pain was not reported.   It was unknown if the reporter considered the nerve pain to be related to Shingles vaccine.     It was unknown if the company considered the nerve pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 22-MAR-2023 This case was reported via consumer interactive digital media. The reporter reported that, the why patient had nerve pain, the vaccine, patient was the 3rd person reporter had heard this from and one was reporter friend, it keeps reoccurring in one spot after vaccinated. The reporter had it because of medication side effects and never got it since. Follow up was not possible, as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2023AMR056691:Same reporter US-GSK-US2023AMR057506:Same reporter US-GSK-US2023AMR057511:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: no adverse event, It keeps reoccurring in one spot after vaccinated; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of nerve 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 nerve pain (Verbatim: no adverse event, It keeps reoccurring in one spot after vaccinated). The outcome of the nerve pain was unknown.   It was unknown if the reporter considered the nerve pain to be related to Shingles vaccine.     It was unknown if the company considered the nerve pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 22-MAR-2023 This case was reported via consumer interactive digital media. The reporter said that's why you had nerve pain. The reporter had heard this from 3 persons, one was his/ her friend. It keeps recurring in one spot after vaccination. The reporter had it because of medication side effects and never got it since.; Sender's Comments:  US-GLAXOSMITHKLINE-US2023AMR056691:Same reporter US-GSK-US2023AMR057502:Same reporter US-GLAXOSMITHKLINE-US2023AMR056691:Same reporter US-GSK-US2023AMR057506:Same reporter US-GSK-US2023AMR057506:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: that's why you have nerve pain the vaccine your the 3rd person; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of nerve 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 nerve pain (Verbatim: that's why you have nerve pain the vaccine your the 3rd person ). The outcome of the nerve pain was not reported.   It was unknown if the reporter considered the nerve pain to be related to Shingles vaccine.     It was unknown if the company considered the nerve pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 22-MAR-2023 This case was reported via consumer interactive digital media. The reorter reported that, the why patient had nerve pain, the vaccine, patient was the 3rd person reporter had heard this from and one was reporter friend, it keeps reoccurring in one spot after vaccinated. The reporter had it because of medication side effects and never got it since. Follow up was not 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.; Sender's Comments:  US-GLAXOSMITHKLINE-US2023AMR056691:Same reporter US-GSK-US2023AMR057502:Same reporter US-GSK-US2023AMR057506:Same reporter US-GLAXOSMITHKLINE-US2023AMR056691:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Aches and Pain; 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: Aches and Pain). 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: 22-MAR-2023 This case was reported by a patient via interactive digital media. The patient have received the first dose and ended up in the ER with Aches and Pain, but, kept him/her in his. 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: Injection site rash, Pain in extremity
Clinical narrative: Rash around the injection site; Arm is sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site rash 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 injection site rash (Verbatim: Rash around the injection site) and pain in arm (Verbatim: Arm is sore). The outcome of the injection site rash and pain in arm were not reported.   It was unknown if the reporter considered the injection site rash and pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the injection site rash and pain in arm to be related to Shingles vaccine.   Additional Information: GSK receipt date: 22-MAR-2023 This case was reported by patient via interactive digital media. The patient just got his/her first dose of the new shingles shot. The patient's arm was sore and had a rash around the injection site, and would need his/her next one in July. The patient stated that, It was better to be safe than sorry. get your shot. Follow up was not 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: Injection site erythema, Pruritus
Clinical narrative: Red at injection site; Itches; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema 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 injection site erythema (Verbatim: Red at injection site) and pruritus (Verbatim: Itches). The outcome of the injection site erythema and pruritus were not reported.   It was unknown if the reporter considered the injection site erythema and pruritus to be related to Shingles vaccine.     It was unknown if the company considered the injection site erythema and pruritus to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 22-MAR-2023 This case was reported by a patient via interactive digital media. The patient got his/her 2nd shot it's red at injection site and itches. anyone else. This report was one of several cases received as part of a line-listing, each containing minimal information.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: Got shingles a year later.; Patient had one shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Got shingles a year later.) and incomplete course of vaccination (Verbatim: Patient had one shot). The outcome of the shingles was not reported and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 22-MAR-2023 This case was reported by patient via interactive digital media. The patient received one Shingles vaccine and got shingles after one year. The patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The follow-up could not possible as no contact details were available.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Pain, Rash, Rash pruritic
Clinical narrative: it was painful; rash itching; pain and rash attacked my breasts/rash went to the stomach; Had mine a year ago, In January 2021ust need to get the second and finally shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a female 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 shingles.   In JAN-2021, the patient received the 1st dose of Shingles vaccine. On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced pain (Verbatim: it was painful), itchy rash (Verbatim: rash itching), rash (Verbatim: pain and rash attacked my breasts/rash went to the stomach) and incomplete course of vaccination (Verbatim: Had mine a year ago, In January 2021ust need to get the second and finally shot). The outcome of the pain, itchy rash and rash were not reported and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pain, itchy rash and rash to be related to Shingles vaccine.   It was unknown if the company considered the pain, itchy rash and rash to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 22-MAR-2023 This case was reported by a patient via interactive digital media. The patient had shingles vaccine a year ago in January 2021. The patient had the first shingles shot already, when she first knew she was getting the shingles. The reporter stated that it was painful, rash itching and the pain and rash attacked her breasts so she could not and would not put on any bra period only a lite top to cover her top torso and the rash went to the stomach as well it about drove him/her nuts. The patient just need to get the second shingles shot and finally shot and hope to do that soon. Till the time of reporting, the patent did not receive the 2nd dose of shingles vaccine, which led to incomplete course of vaccination. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: shot has your arm sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: shot has your arm sore). 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: 22-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that he or she got it, but that shot had the arm sore, and the patient did good with shots, but guessed it was better than shingles. Follow-up was not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injury
Clinical narrative: People injured taking the single vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injury 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 injury (Verbatim: People injured taking the single vaccine). The outcome of the injury was not reported.   It was unknown if the reporter considered the injury to be related to Shingles vaccine.     It was unknown if the company considered the injury to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 23-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that, the check out all the lawsuits for people who get injured taking the shingles vaccine. This report was one of several cases received as part of a line-listing, each containing minimal information. This case has been linked with case US2023AMR045907 reported by the same reporter Note: This case and linked case had same source document and since the linked case was processed as per the 2nd comment from the source document, this case was processed as per the first comment (check out all the lawsuits for people who get injured taking the shingles vaccine) as a master case for people who got injuried from taking shingles vaccine. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2023AMR045907:Same reporter
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Pain, Tendon pain
Clinical narrative: Low level ache, pain 1 out of 10 /continued slight ache outside elbow; around the top and side of his elbow around to the tendon; around the top and side of his elbow around to the tendon; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In JAN-2023, the patient received the 1st dose of Shingrix (left deltoid). On an unknown date, 1 day after receiving Shingrix, the patient experienced pain (Verbatim: Low level ache, pain 1 out of 10 /continued slight ache outside elbow), tendon pain (Verbatim: around the top and side of his elbow around to the tendon) and pain in elbow (Verbatim: around the top and side of his elbow around to the tendon). The outcome of the pain, tendon pain and pain in elbow were not resolved.   It was unknown if the reporter considered the pain, tendon pain and pain in elbow to be related to Shingrix.     It was unknown if the company considered the pain, tendon pain and pain in elbow to be related to Shingrix.   Additional Information: GSK Receipt date:08-APR-2023 and 11-APR-2023. The reporter was the patient.  The patient received his first dose of Shingrix on left upper arm.  The following day, he began to experience a low level ache around the top and side of his elbow around to the tendon.  He had been experiencing this ache every day since the vaccine.  The ache begins when he first wakes up in the morning, and lasts for about an hour.  The pain intensity was described as 1 out of 10. Patient awaken every morning with a slight ache on the outside of my elbow that diminishes in about a couple of hours.  Pharmacists stated that about 1 in one hundred people get this, but it is over in a few days, and then look surprised at patient's complaint of continued aches.
Sex: U
Vaccine: HEP
Symptoms: Injury associated with device
Clinical narrative: Needle injury; This non-serious case was reported by a other health professional via call center representative and described the occurrence of needle injury in a patient who received HBV (Engerix B) (batch number x9ft7, expiry date 31-MAR-2024) for prophylaxis.   On 13-MAR-2023, the patient received Engerix B. On 13-MAR-2023, immediately after receiving Engerix B, the patient experienced needle injury (Verbatim: Needle injury). The outcome of the needle injury was unknown.   It was unknown if the reporter considered the needle injury to be related to Engerix B and Engerix B Pre-Filled Syringe Device.     It was unknown if the company considered the needle injury to be related to Engerix B and Engerix B Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date:12-APR-2023 The healthcare professional informed that the back stop came off Engerix-B pre-filled syringe during injection and resulted in instability of the product and a needle stick injury.  The reporter consented to follow up.
Sex: U
Vaccine: HEP, HEPA
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st Hep A and B in 2016, 2nd HepB in 2017; 1st Hep A and B in 2016, 2nd HepB in 2017; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis A vaccine for prophylaxis.   Concomitant products included HEPATITIS B VACCINE, HEPATITIS B VACCINE and HEPATITIS A VACCINE.   On an unknown date, the patient did not receive the 3rd dose of Hepatitis B vaccine and the 2nd dose of Hepatitis A vaccine. On an unknown date, an unknown time after receiving Hepatitis B vaccine and not applicable after receiving Hepatitis A vaccine, the patient experienced incomplete course of vaccination (Verbatim: 1st Hep A and B in 2016, 2nd HepB in 2017) and incomplete course of vaccination (Verbatim: 1st Hep A and B in 2016, 2nd HepB in 2017). The outcome of the incomplete course of vaccination and incomplete course of vaccination were unknown.   Additional Information: GSK Receipt Date: 13-APR-2023 The patient stated that a patient received first dose of an unknown hepatitis A vaccine and hepatitis B vaccine on 19th December 2016. The second dose of hepatitis B was given on 20th January 2017.  This was at another facility.  The reporter opted out of providing additional information and follow-up due to being short on time. This was being reported as a possible adverse event due to the unknown vaccine brand names. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive 3rd dose of hepatitis B vaccine, which led to incomplete course of vaccination. Till the time of reporting, the patient did not receive 2nd dose of hepatitis A vaccine, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal distension, Flatulence
Clinical narrative: Extreme abdominal gas, very gassy; Extreme abdominal bloating, very bloated; This non-serious case was reported by a consumer via call center representative and described the occurrence of gas in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 04-APR-2023, the patient received the 2nd dose of Shingrix (intramuscular). On 12-APR-2023, 8 days after receiving Shingrix, the patient experienced gas (Verbatim: Extreme abdominal gas, very gassy) and abdominal bloating (Verbatim: Extreme abdominal bloating, very bloated). The outcome of the gas and abdominal bloating were not resolved.   It was unknown if the reporter considered the gas and abdominal bloating to be related to Shingrix.     It was unknown if the company considered the gas and abdominal bloating to be related to Shingrix.   Additional Information: GSK receipt date: 13-Apr-2023 The patient wanted to know if abdominal gas and bloating are side effects of Shingrix vaccine.  The patient spoke, gave medical disclaimer, referred to healthcare professional.  The reporter was offered medical information telephone number to give to her healthcare professional but she declined.  The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vomiting; Fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of vomiting in a 54-year-old male 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 vomiting (Verbatim: Vomiting) and fever (Verbatim: Fever). The outcome of the vomiting and fever were resolved (duration 1 day).   It was unknown if the reporter considered the vomiting and fever to be related to Shingrix.     It was unknown if the company considered the vomiting and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-APR-2023 The reporter was the mother of the patient. The patient received first dose of Shingrix and experienced fever and vomiting for only one day. The reporter did not know the vaccination date but reported that it was provided at a pharmacy facility. The reporter was not sure if it was administered in the left arm. No additional information was provided. Lot and expiration date were unknown. The reporter did not want to provide personal information or demographics. Consent for follow up was not obtained.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Diarrhoea, Fatigue, Pyrexia, Rash
Clinical narrative: Feel tired, comes and goes; Low fever, comes and goes; Diarrhea only twice; Rash; This non-serious case was reported by a consumer via call center representative and described the occurrence of tiredness in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.  On 30-MAR-2023, the patient received the 2nd dose of Shingrix. On 31-MAR-2023, 1 days after receiving Shingrix, the patient experienced tiredness (Verbatim: Feel tired, comes and goes), fever (Verbatim: Low fever, comes and goes), diarrhea (Verbatim: Diarrhea only twice) and rash (Verbatim: Rash). The outcome of the tiredness, fever and rash were unknown and the outcome of the diarrhea was resolved.  It was unknown if the reporter considered the tiredness, fever, diarrhea and rash to be related to Shingrix.  It was unknown if the company considered the tiredness, fever, diarrhea and rash to be related to Shingrix.  Additional Information: GSK Receipt Date: 17-APR-2023 Consumer was the reporter herself. She stated that, she had the second dose of Shingrix administered and had started feeling tired (comes and goes), low fever (comes and goes), diarrhea (only twice) and rash a day after the vaccine was administered. She also stated that, she had gone to the physician on 10 April, 2023 and had bloodwork done and her physician said the bloodwork looked fine.  No further information was known. The reporter had consented to follow-up.
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABXC06AA, expiry date 31-MAR-2023) for prophylaxis.   On 17-APR-2023, the patient received the 2nd dose of Bexsero. On 17-APR-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired Bexsero administered). 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: 18-APR-2023 The nurse reported that an expired dose of Bexsero was accidentally given and wished to know what information was available.  The reporter gave information about the vaccine and patient. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up. The patient received a Bexsero vaccine which was already expired, which led to expired vaccine used.
Sex: U
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: BECAME PARALYZED FROM THE WASTE DOWN; This spontaneous report received from a consumer via a company representative via a social media concerned a patient of unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient became paralyzed from the waste down. Reporter reported that," This is (PII) who became paralyzed from the waste down after the Johnson and Johnson shot Learn more about his story and several others here." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of became paralyzed from the waste down was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230445204-became paralyzed from the waste down. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: U
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: CANCER; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) 1 in total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the reported stated that a lot of people got Covid shot and got cancer and shit out of it.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cancer was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20230447238 and 20230446012.; Sender's Comments: V0: 20230445860-cancer. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary mass
Clinical narrative: MASS IN LUNG; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced mass in lung. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mass in lung was not reported. This report was non-serious. This case, from the same reporter is linked to 20230445860 and 20230446012.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Cold (Really bad). Concurrent medical conditions included Allergy to NSAIDs (Aspirin), Multiple sclerosis, Allergy to animals, Penicillin allergy, Juvenile diabetes, Type 2 diabetes mellitus and Anxiety. Concomitant products included METFORMIN, DEXTROMETHORPHAN HYDROBROMIDE, QUINIDINE SULFATE (NUEDEXTA [DEXTROMETHORPHAN HYDROBROMIDE;QUINIDINE SULFATE]), FAMPRIDINE (AMPYRA), EMPAGLIFLOZIN (JARDIANCE), GABAPENTIN, SEMAGLUTIDE (OZEMPIC), CEFIXIME (FLEXERIL [CEFIXIME]), ROSUVASTATIN, VITAMIN C [ASCORBIC ACID], LORATADINE, DICLOFENAC (VOLTAREN [DICLOFENAC]), ACETAMINOPHEN and OCRELIZUMAB (OCREVUS) for an unknown indication.  On 16-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  It was reported that patient had a fever and other stuff after the vaccinations. No treatment medications were reported.