chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Vaccination failure
Clinical narrative: Shingle shot 5 years ago had shingles/Suspected vaccination failure; Had it in eyes; Hearing loss; Shingles on scalp; Blisters in forehead; pounding headache on right side of head; Painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Shingle shot 5 years ago had shingles/Suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Had it in eyes) (serious criteria GSK medically significant), hearing loss (Verbatim: Hearing loss) (serious criteria GSK medically significant), shingles (Verbatim: Shingles on scalp), blister (Verbatim: Blisters in forehead), pounding in head (Verbatim: pounding headache on right side of head) and pain (Verbatim: Painful). The outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster, hearing loss, shingles, blister and pounding in head were not reported and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, hearing loss, shingles, blister, pounding in head and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, ophthalmic herpes zoster, hearing loss, shingles, blister, pounding in head and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received Shingles vaccine five years ago. The patient experienced shingles in his/her eyes and scalp head area, horrible blisters in his/her forehead, pounding headache on right side and hearing loss that was five months old and it was still painful. The patient stated that nobody told him/her that the shingles vaccine was ineffective. 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 shingles shot 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 shingles shot 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: 09-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received Shingles vaccine and did not have chicken pox 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: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got swings after got the shot/suspected vaccination failure; Got swings; 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 swings after got the shot/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got swings). 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: 10-Mar-2023 The case was received from the patient's wife via interactive digital media. The patient's wife and the patient got swings after they got the shot. The patient stated figure that out. 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. The case was linked with case US2023AMR041182, reported by same reporter for her husband.; Sender's Comments:  US-GSK-US2023AMR041182:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the vax still got it/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 vax still got it/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: 09-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/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, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Had 2 doses and still got shingles/suspected vaccination failure; Shingles; Extremely 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: Had 2 doses and still got shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Extremely 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: 09-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she hate to burst everyone bubble but he/she received two doses of Shingles vaccine and still experienced shingles. The patient stated that it was extremely painful. 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, VARZOS
Symptoms: Herpes zoster, Mobility decreased, Pain of skin, Vaccination failure
Clinical narrative: Had 2 differents vaccines and had 3 mild cases/suspected vaccination failure; 3 mild cases; Could not sit because of location on spine; Felt like severe fiberglass rubbed deeped into my skin; 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: Had 2 differents vaccines and had 3 mild cases/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: 3 mild cases), mobility decreased (Verbatim: Could not sit because of location on spine) and pain (Verbatim: Felt like severe fiberglass rubbed deeped into my skin). The outcome of the vaccination failure was unknown and the outcome of the shingles, mobility decreased and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, mobility decreased and pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, mobility decreased and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAR-2023 This case was reported by a patient via interactive digital media. The patient have had three mild cases of shingles and would go without eating if I had to, in order to afford the vaccine not covered by his/her insurance. The patient received two different shingles vaccine and his/her first reaction was it felt like severe fiberglass rubbed deep into his/her skin but got worse. The patient could not sit because of location on spine and had to lay on his/her stomach. 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: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Erythema of eyelid, Herpes zoster, Vaccination failure
Clinical narrative: Shingrix in Jan2022 and Mar2022, shingles in Mar2023; Shingles diagnosis; Red blister on eyelid; Red blister on her eyelid; This serious case was reported by a consumer via sales rep and described the occurrence of vaccination failure in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had 4 cases of shingles prior to getting the vaccine).   In MAR-2022, the patient received the 2nd dose of Shingrix. In JAN-2022, the patient received the 1st dose of Shingrix. On 05-MAR-2023, less than 2 years after receiving Shingrix and Shingrix, the patient experienced blister (Verbatim: Red blister on eyelid) and erythema eyelid (Verbatim: Red blister on her eyelid). On 13-MAR-2023, the patient experienced vaccination failure (Verbatim: Shingrix in Jan2022 and Mar2022, shingles in Mar2023) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles diagnosis). The patient was treated with antibiotics nos (Antibiotic (Active Ingredient Unknown)) and valaciclovir (Valacyclovir). The outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving and the outcome of the blister and erythema eyelid were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, blister and erythema eyelid to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles, blister and erythema eyelid to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 15-Mar-2023 The patient received two doses of Shingrix  and was woke up with red blister on her eyelid. The patient saw an eye physician who thought it was infection and prescribed antibiotics which did not help. On 13th March 2023, the patient saw her primary care physician who diagnosed shingles and prescribed valacyclovir.  After 2 days of valcyclovir the outbreak was getting much better. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had shot had shingles/Suspected vaccination failure; Shingles twice; 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 shot had shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles twice). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received Shingles vaccine and experienced Shingles twice. 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, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: Had shots had shingles anyway suspected/Suspected vaccination failure; Mild case of shingles; Had three of the shots; 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 and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had shots had shingles anyway suspected/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Mild case of shingles) and extra dose administered (Verbatim: Had three of the shots). The outcome of the vaccination failure and extra dose administered were 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, Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 09-MAR-2023 The case  was received from the patient via interactive digital media. The patient had three of the Shingles shots and had a small case of shingles anyway. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The patient received 3rd dose of Shingles vaccine, which led to extra dose administered. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Skin discolouration, Vaccination failure
Clinical narrative: Had the Shingles vaccine and broke out/Suspected Vaccination failure; Broke out spots under arm turned dark; Very painful; Turned dark; 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: Had the Shingles vaccine and broke out/Suspected Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Broke out spots under arm turned dark), pain (Verbatim: Very painful) and skin discoloration (Verbatim: Turned dark). The outcome of the vaccination failure was unknown and the outcome of the shingles and skin discoloration were not recovered/not resolved and the outcome of the pain was not reported.   It was unknown if the reporter considered the vaccination failure, shingles, pain and skin discoloration to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pain and skin discoloration to be related to Shingles vaccine.   Additional Information: GSK receipt date: 09-MAR-2023 The case  was received from the patient via interactive digital media. The patient reported that her husband and she, both had the Shingles vaccine. The patient broke out under my arm and then spots up and down in her right arm and it was very painful but not really itching as yet. The patient reported that it had turned dark now and physician had her on medication. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingles shot gave me light case/ suspected vaccination failure; gave me light case; 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: shingles shot gave me light case/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: gave me light case). 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: 09-MAR-2023 This case was reported by a patient via interactive digital media. The patient had the shingles shot which gave him/her a light case of shingles, he/she guessed because he/she had no pain. 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: Herpes zoster, Vaccination failure
Clinical narrative: Had them on face even after shot/suspected vaccination failure; Shinles had on face; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (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 them on face even after shot/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shinles had on face). 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: 09-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received Shingles vaccine and experienced shingles on face. 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: Vaccine gave me shingles/Suspected Vaccination Failure; Gave 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: Vaccine gave me shingles/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: Gave 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: 10-MAR-2023 The case  was received from the patient via interactive digital media. The patient reported that the Shingles vaccine gave him/her shingles. 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: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: To my dad too, later after the vaccine/Suspected vaccination failure; To my dad too (shingles); This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: To my dad too, later after the vaccine/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: To my dad too (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: 10-MAR-2023 The case was received from the patient's son/daughter via interactive digital media. The patient got shingles too later after the Shingles vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Varicella
Clinical narrative: I had chicken pox / shingles shot almost killed me / nearly died; This serious case was reported by a consumer via interactive digital media and described the occurrence of chickenpox in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced chickenpox (Verbatim: I had chicken pox / shingles shot almost killed me / nearly died) (serious criteria hospitalization and life threatening). The outcome of the chickenpox was not reported.   It was unknown if the reporter considered the chickenpox to be related to Shingles vaccine.   It was unknown if the company considered the chickenpox to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that the shingles shot almost killed him/her.  The patient had chicken pox as an adult and nearly died, spent 11 days in the hospital. The reporter further stated that everyone wanted him/her to take the shingles shot and it was the worst thing he/she ever did. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: UNK
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: given only 1 vial of the 2 vial presentation; given only 1 vial of the 2 vial presentation; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Meningitis ACWY vaccine (potential Menveo)) for prophylaxis.   On an unknown date, the patient received Meningitis ACWY vaccine (potential Menveo). On an unknown date, an unknown time after receiving Meningitis ACWY vaccine (potential Menveo), [the patient experienced inappropriate preparation of medication (Verbatim: given only 1 vial of the 2 vial presentation) and inappropriate dose of vaccine administered (Verbatim: given only 1 vial of the 2 vial presentation). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 08-MAR-2023 This case was submitted by public reporting reference via the online direct entry reporting system. The pharmacist reported that the patient in health system were given only 1 vial of the 2 vial of Menveo presentation of Meningitis ACWY vaccine (potential Menveo). Nursing thought they were giving the one vial presentation. The reporter did not consent to follow up. The patient in health system were given only 1 vial of the 2 vial of Menveo presentation of Meningitis ACWY vaccine (potential Menveo), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case was linked with US2023AMR037153 which was reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR037153:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Middle insomnia, Rash pruritic
Clinical narrative: rash is extending beyond injection/ pruritic rash is extending, itch gets worse at night; wakes me up/keeps me up all night; This non-serious case was reported by a other health professional and described the occurrence of itchy rash in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-MAR-2023, the patient received Shingrix. In MAR-2023, an unknown time after receiving Shingrix, the patient experienced nocturnal awakening (Verbatim: wakes me up/keeps me up all night). On an unknown date, the patient experienced itchy rash (Verbatim: rash is extending beyond injection/ pruritic rash is extending, itch gets worse at night). The outcome of the itchy rash was not recovered/not resolved and the outcome of the nocturnal awakening was not reported.   It was unknown if the reporter considered the itchy rash and nocturnal awakening to be related to Shingrix.     It was unknown if the company considered the itchy rash and nocturnal awakening to be related to Shingrix.   Additional Information: GSK Receipt date: 09-Mar-2023 The patient had pruritic rash which was extending beyond injection site and gravitating dismally. The itch got worse at night and wakes her up or keeps her up all night and last 3 nights. The patient was worried if it was safe to get the second dose or not. The patient's symptoms were not treated. The reporter did not consent to follow up.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: expired Havrix administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix adult) (expiry date 30-JAN-2023) for prophylaxis.   In MAR-2023, the patient received Havrix adult. In MAR-2023, an unknown time after receiving Havrix adult, [the patient experienced expired vaccine used (Verbatim: expired Havrix administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 07-MAR-2023 Pharmacist reported that he/she just gave a vaccine and had not checked the expiration date, the expiration was 30th January 2023. Pharmacist asked does he/she need to have the patient redo the dose and if so, after how long of an interval. The reporter consented to follow up. The pharmacist gave a dose of Havrix adult vaccine which was already expired, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy breast, Pyrexia
Clinical narrative: Lowgrade fever; This non-serious case was reported by a consumer via patient support programs and described the occurrence of fever in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included malignant neoplasm of fallopian tube. Concomitant products included niraparib tosilate (Zejula).   On 13-FEB-2023, the patient received Shingles vaccine. On 13-FEB-2023, less than a day after receiving Shingles vaccine and 238 days after starting Zejula, the patient experienced fever (Verbatim: Lowgrade fever).The outcome of the fever was not reported.  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: 07-MAR-2023 The case was reported by a consumer via patient support programs.  The reporter was the patient. The patient stated that she received Shingles vaccine and ever since had low grade fever every morning. A week after the patient received Shingles vaccine, she underwent biopsy of breast. The patient disconnected from the call. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 3 yrs ago, 2nd not yet, missed; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 3 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose 3 yrs ago, 2nd not yet, missed). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 08-MAR-2023  The reporter enquired for the recommendations for a missed second Shingrix dose. The reporter asked should we proceed with the second dose or start with first dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: UNK
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: given only 1 vial of the 2 vial presentation; given only 1 vial of the 2 vial presentation; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Meningitis ACWY vaccine (potential Menveo)) for prophylaxis.   On an unknown date, the patient received Meningitis ACWY vaccine (potential Menveo). On an unknown date, an unknown time after receiving Meningitis ACWY vaccine (potential Menveo), the patient experienced inappropriate preparation of medication (Verbatim: given only 1 vial of the 2 vial presentation) and inappropriate dose of vaccine administered (Verbatim: given only 1 vial of the 2 vial presentation). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 08-MAR-2023 This case was submitted by public reporting reference via the online direct entry reporting system. The pharmacist reported that the patient in health system were given only 1 vial of the 2 vial of Menveo presentation of Meningitis ACWY vaccine (potential Menveo). Nursing thought they were giving the one vial presentation. The reporter did not consent to follow up. The patient in health system were given only 1 vial of the 2 vial of Menveo presentation of Meningitis ACWY vaccine (potential Menveo), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case was linked with US2023036692, reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2023036692:same reporter
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: getting the second dose on 12 February 2023; 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 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.  Previously administered products included Shingrix (The first dose was received on 21 September 2018).  On 12-FEB-2023, the patient received the 2nd dose of Shingrix. On 12-FEB-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: getting the second dose on 12 February 2023). The outcome of the drug dose administration interval too long was unknown.  Additional Information: GSK Receipt Date: 08-MAR-2023 The patient had reported that he had received a dose of Shingrix vaccine and since he does not remember getting the second dose on 12 February 2023 and therefore, he had got a new dose. He had asked if he should get the second dose and if so when and was there any problem having had already a dose back in 2018.  The reporter had denied to provided further contact details. The patient had received the second dose later than the recommended interval, which had led to lengthening of vaccination schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Nausea, Pyrexia
Clinical narrative: Mild fatigue; Queasiness; Low fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of fatigue in a 57-year-old female 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 fatigue (Verbatim: Mild fatigue), queasy (Verbatim: Queasiness) and fever (Verbatim: Low fever). The outcome of the fatigue, queasy and fever were not reported.  It was unknown if the reporter considered the fatigue, queasy and fever to be related to Shingrix.  It was unknown if the company considered the fatigue, queasy and fever to be related to Shingrix.  Additional Information: GSK Receipt Date: 09-MAR-2023 This case was reported by the patient via call center.  The patient stated that the she was just wondering how long side effects of the shot would be lasted.  She had mild fatigue, queasiness, and a low fever. Nothing terrible, just bleh. The reporter had consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Back pain, Chills, Injection site erythema, Pain, Pyrexia
Clinical narrative: Red patches on injection site; Pain in body; Fever, side effects; Chills, it is horrible; Back pain; 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.   In MAR-2023, the patient received Shingles vaccine (unknown arm). On 05-MAR-2023, an unknown time after receiving Shingles vaccine, the patient experienced injection site erythema (Verbatim: Red patches on injection site), general body pain (Verbatim: Pain in body), fever (Verbatim: Fever, side effects), chills (Verbatim: Chills, it is horrible) and back pain (Verbatim: Back pain).The outcome of the injection site erythema, general body pain, fever, chills and back pain were not recovered/not resolved.   The reporter considered the injection site erythema, general body pain, fever, chills and back pain to be related to Shingles vaccine.     The company considered the injection site erythema, general body pain, fever, chills and back pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 06-MAR-2023 and 07-MAR-2023 This case was reported by a patient via interactive digital media. The patient was vaccinated with Shingles vaccine and experienced body pain, back pain, fever, chills and red patches on arm. The patient reported that he/she still had the side effects.  and stated that it was horrible and can imagine how painful the Shingles disease can be. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR023309:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Alopecia
Clinical narrative: hair loss; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of hair loss 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 hair loss (Verbatim: hair loss).  The outcome of the hair loss was not reported.   It was unknown if the reporter considered the hair loss to be related to Shingles vaccine.     It was unknown if the company considered the hair loss to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 07-MAR-2023 This case was reported by a patient via interactive digital media. The patient stated that one could had hair loss and the patient had hair loss after the booster. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: bad enough; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feeling bad (Verbatim: bad enough).  The outcome of the feeling bad was not reported.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.     It was unknown if the company considered the feeling bad to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 07-Mar-2023 This case was reported by a patient via interactive digital media. The reporter reported that his/her shingles vaccination was bad enough. The follow up would not be possible as no contact details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Pain was torturous; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Pain was torturous). The outcome of the pain was recovering/resolving.   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: 08-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received Shingles vaccine and experienced pain that was torturous for 11 weeks and still  is there, but now much better. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: COVID19, FLUX, VARZOS
Symptoms: Feeling abnormal
Clinical narrative: felt bad like I wanted to die; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis and COVID-19 VACCINE (COVID VACCINE) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine, Flu vaccine and COVID VACCINE. In DEC-2022, an unknown time after receiving Shingles vaccine and Flu vaccine, the patient experienced feeling bad (Verbatim: felt bad like I wanted to die).The outcome of the feeling bad was not reported.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine and Flu vaccine.  It was unknown if the company considered the feeling bad to be related to Shingles vaccine and Flu vaccine.   Additional Information: GSK receipt date: 07-Mar-2023 This case was reported by a patient via interactive digital media. The patient was due to get second shot this month.  The patient felt really bad in December when got the first shot, but also had the Covid, Flu and Shingles shot the same day.  The patient felt like zI wanted to die. Hopefully this time with just the one it won't be bad. The follow up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Dyskinesia, Gait disturbance
Clinical narrative: Jerk; Wobble; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of jerkiness 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 jerkiness (Verbatim: Jerk) and walking difficulty (Verbatim: Wobble). The outcome of the jerkiness and walking difficulty were not reported.   It was unknown if the reporter considered the jerkiness and walking difficulty to be related to Shingles vaccine.     It was unknown if the company considered the jerkiness and walking difficulty to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received first dose of Shingles vaccine and experienced jerk and wobble so the vaccine did not work. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I have something like them / Really nasty; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles (Verbatim: I have something like them/Really nasty). The outcome of the shingles was not recovered/not resolved.   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: 08-MAR-2023 This case was reported by a consumer via interactive digital media. The patient had something like them (shingles), which started shortly after his/her first shingles vaccine.  The patient stated really nasty. Seeing doctor tomorrow to find out what it was.  Follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus
Clinical narrative: Shingles on my waist left side; Itches real bad; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles on my waist left side) and pruritus (Verbatim: Itches real bad). The outcome of the shingles and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the shingles and pruritus to be related to Shingles vaccine.   It was unknown if the company considered the shingles and pruritus to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAR-2023 This case was reported by a patient via interactive digital media. The patient had a mild case of shingles on his/her waist left side, right after shingles vaccine.  When he/she questioned his/her doctor about it she said not unusual but being vaccinated was why it was so mild (but still miserable).  No breakouts since but when exercising if he/she was hot and sweaty, it still itched real bad on the side. The follow up would not possible as no contact details were available.