chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles on eye; shingles in my hair; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The patient had the shingle shot and now the patient had a mild case of shingles above eye and in hair. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test positive
Clinical narrative: positive for covid; two shots in may; This case was reported by a consumer via interactive digital media and described the occurrence of COVID-19 in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included Herpes zoster (Shingles vaccine).   In May 2021, the patient received the 2nd dose of Shingles vaccine. In May 2021, unknown after receiving Shingles vaccine and an unknown time after receiving Shingles vaccine, the patient experienced drug dose administration interval too short. On 24th September 2021, the patient experienced covid-19. On an unknown date, the outcome of the covid-19 and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, received 2 shots in May 2021 and on the day of reporting was positive for COVID. The patient received 2nd dose early than the recommended time interval, which led to shortening of vaccination schedule. This case was linked with case US2021AMR202764 and US2021AMR202899, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR202764:same reporter US-GLAXOSMITHKLINE-US2021AMR202899:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: COVID-19, Illness, SARS-CoV-2 test positive
Clinical narrative: sickest; positive for covid; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On 24th September 2021, unknown after receiving Shingles vaccine, the patient experienced covid-19. On an unknown date, the patient experienced sickness. On an unknown date, the outcome of the sickness and covid-19 were unknown.   It was unknown if the reporter considered the sickness and covid-19 to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's parent. The age at vaccination was not reported. The patient one Shingles shot and got very sick. On the day of reporting, the patient was positive for Covid. The follow-up would not possible as no contact details were available. This case was linked with the case US2021AMR202764 and US2021AMR202898, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR202764:same reporter US-GLAXOSMITHKLINE-US2021AMR202898:same reporter
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: took the vaccine currently have the shingles / suspected Vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, took the shingles vaccine, it was 2 shots, 8 weeks apart and currently now had the shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort
Clinical narrative: uncomfortable side effects; This case was reported by a consumer via interactive digital media and described the occurrence of discomfort 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, unknown after receiving Shingles vaccine, the patient experienced discomfort. On an unknown date, the outcome of the discomfort was unknown.   It was unknown if the reporter considered the discomfort to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the first shot, but had a bunch of side effects.  The patient stated that it was sure this was great for most people but to be aware that there could be some pretty uncomfortable side effects.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had the shot, still got shingles/ suspected vaccination failure; shingles; so painful; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, had the shot and still got the shingles so painful. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The reporter stated that he/she had the shingles shot experienced shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: got the shot ended up with Shingles /suspected vaccination failure; Shingles; pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's son or daughter. The age at vaccination was not reported. The reporter stated that, his or her mother got the shot and ended up with the king of shingles as her physician diagnosed with so much pain for a very long time. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the vax; got it anyway/Suspected vaccination failure; got it anyway; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received shingle shot and got it anyway. The follow up would not be possible as no contact details were available. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule and time to onset and laboratory confirmation for shingles were unknown.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had both vaccine then got it again / suspected vaccination failure; got it again; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (had shingles vaccine 15 years ago and had shingles).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, had both shingles vaccine and got shingles again. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had gotten the shingles shot. Then got shingles /suspected vaccination failure; shingles; This case was reported by a other health professional via interactive digital media and described the occurrence of suspected vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, before i retired from the hospital, met a lot of people who had gotten the shingles shot, then they got shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; have them 2 times; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The reporter stated that he/she had the shingles shot experienced shingles 2 times. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles/Got the shot and still got shingle; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The reporter stated that he/she had the shingles shot experienced shingles few years later. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Malaise
Clinical narrative: The vacc knocked me for a loop/didn´t feel well at all; painful/pain in my joints; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (Patient's sister was in terrible pain all the time, her blister went away but the pain did not).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling unwell and joint pain. On an unknown date, the outcome of the feeling unwell and joint pain were unknown.   It was unknown if the reporter considered the feeling unwell and joint pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received Shingles vaccine and the vaccine knocked him/her for a loop, it was very painful and intense pain in joints. The patient said he/she took the second vaccination because he/she had seen firsthand what the shingles can do.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got it anyway! After shot/ suspected vaccination failure; Got it anyway!; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got the shingles after Shingles sh ot.  The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingles after she was vaccinated/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient got the shingles well after she was vaccinated with Shingles.  The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Blindness unilateral, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles in her eye; blind in that eye; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and unilateral blindness (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster and unilateral blindness were unknown.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and unilateral blindness to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was known to the patient. The age at vaccination was not reported. The reporter stated that, any vaccine has side effect but he/she know a lady(patient) who had the Shingle shot and then got shingles in her eye.  The physician told the patient it was a side effect, blind in that eye now at the time of reporting. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule, time to onset for event and laboratory confirmation for shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm pain; This 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 the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient had got their first shot and had arm pain for several days. The patient stated that he/she hated to go back for the second dose as that year it was 2 shots instead of one. This case has been linked with US2021AMR203609 (son's case), reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR203609:same reporter, same suspect, different patient (son's case)
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a male 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, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's parent. The age at vaccination was not reported. The patient had got his first shot along with his parent and had arm pain for several days. The reporter stated that he/she hated to go back for the second dose as that year it was 2 shots instead of one. This case has been linked with US2021AMR203606 (parent's case), reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR203606:same reporter, same suspect, different patient (parent's case)
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: both vaccines and still broke out with the rash./ suspected vaccination failure; broke out; both vaccines and still broke out with the rash.; This case was reported by a consumer via (Facebook) interactive digital media and described the occurrence of suspected 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, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had both Shingles vaccines and still broke out with the rash.  The patient stated he/she had no pain with it though. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the vaccine and he has shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a elderly male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated the patient had the Shingles vaccine and he has shingles in his 70's. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for herself/himself. The age at vaccination was not reported. The reported stated that, he/she had the shingles after was vaccinated with Shingles vaccine. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule, time to onset for event and laboratory confirmation for shingles were not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Drug ineffective, Herpes zoster, Pain
Clinical narrative: has actively had a shingles outbreak for over 3 years; did not help with her pain; This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included gabapentin.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the pain was unknown.   It was unknown if the reporter considered the shingles and pain to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient for herself. The age at vaccination was not reported. The patient had received Gabapentin as conmed. The patient received a dose of Shingrix in 2019 and dose did not help with her pain (lack of effect). The patient has actively had a shingles outbreak for over 3 years and Health care professional advised the patient to got her 1st dose. No additional information was provided by the reporter. The reporter did not consented to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: second dose not received probably due to COVID; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 28th October 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that, the patient did not return within dosing window for second dose.  The pharmacist did not have lot number or expiration date information for first dose. The pharmacist did not know reason second dose was delayed but stateed that, it was probably because of COVID, which led to social problem. The pharmacist confirmed delay was not due to supply issue. The reporter consented to follow up. The VAERS detals were reported for 1st dose of shingrix.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Pain in extremity
Clinical narrative: Body weakness; Arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st June 2021, the patient received the 1st dose of Shingrix (intramuscular). On 1st June 2021, less than a day after receiving Shingrix, the patient experienced pain in arm. On 2nd June 2021, the patient experienced weakness generalized. On an unknown date, the outcome of the pain in arm and weakness generalized were recovered/resolved.   The reporter considered the pain in arm and weakness generalized to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient had received the vaccine in the left deltoid. The patient stated that after getting the shingrix shot, he had arm soreness that lasted about 2 days after the vaccination and the day following his shot, he had body weakness.  All of his symptoms had resolved.  The patient did not consent to follow-up and no health care professional was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: Pain in her left arm; Chills; Fever; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th September 2021, the patient received the 1st dose of Shingrix. On 20th September 2021, less than a day after receiving Shingrix, the patient experienced pain in arm, chills and fever. On an unknown date, the outcome of the pain in arm, chills and fever were recovered/resolved.   It was unknown if the reporter considered the pain in arm, chills and fever to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient received Shingrix at her pharmacy on the left arm. The patient reported that the evening of the vaccine, she experienced pain in her left arm, fever and chills which had since resolved.  The patient had disconnected from call before she could be asked the Vaccine adverse events related questions (date of birth, Lot, Expiration, Route, Site of Administration) and therefore was unable to get consent to contact the patient's doctor.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Rash
Clinical narrative: Mild rash; This case was reported by a consumer via call center representative and described the occurrence of rash in a 46-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, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient received first dose of Shingrix and experienced a mild rash. The reporter consented to follow-up and provided consent to contact health care professional. The patient experienced a more severe rash with her second dose of Shingrix, for tolerance of the 2nd dose, refer US2021AMR201228 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR201228:same patient different dose
Age: 57.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient given Pediarix, 01-SEP-2021; patient given Pediarix instead of Twinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 57-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number TN7S9, expiry date 29th May 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st September 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 1st September 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse reported that a patient inadvertently was given Pediarix instead of Twinrix, which led to wrong vaccine administered. The patient received Pediarix at inappropriate age which led to inappropriate age at vaccine administration. The reporter consented to follow.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient had received an expired dose of Menveo, which led to expired vaccine used. The health care professional reported that one of the nurses from their facility administrate the vaccine and she did not have the report to provide any data.  The reporter consented to follow up.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Took 2 doses and had third; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number 7gm34, expiry date 10th February 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date) and Shingrix (received 2nd dsoe on an unknown date).   On 21st September 2021, the patient received the 3rd dose of Shingrix (intramuscular). On 21st September 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The patient received dose of Shingrix in the left deltoid. The pharmacist reported that, the patient received 3rd dose of Shingrix, which led to extra dose administered. The reporter stated that, consumer forgot that they had already received both first and second dose previously at another pharmacy. The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash erythematous, Rash pruritic
Clinical narrative: rash as local to injection site; red rash; itchy rash; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a female patient who received Herpes zoster (Shingrix) (batch number 7742Z, expiry date 25th March 2023) for prophylaxis.   On 16th September 2021, the patient received the 1st dose of Shingrix. In September 2021, less than a week after receiving Shingrix, the patient experienced injection site rash, red rash and itchy rash. On an unknown date, the outcome of the injection site rash, red rash and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the injection site rash, red rash and itchy rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine and experienced rash which was began approximately 3 to 4 days after dose and was still present. The rash was local to injection site on left deltoid, at least six inches in length, red, and itchy. The reporter consented to follow up. This case has been linked with case US2021201405, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021201405:same reporter
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Rash erythematous, Rash pruritic
Clinical narrative: rash as local to injection site; red rash; itchy rash; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 7742Z, expiry date 25th March 2023) for prophylaxis.   On 16th September 2021, the patient received the 1st dose of Shingrix. In September 2021, less than a week after receiving Shingrix, the patient experienced injection site rash, red rash and itchy rash. On an unknown date, the outcome of the injection site rash, red rash and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the injection site rash, red rash and itchy rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine and experienced rash which was reported by the patient on 22nd september 2021 and was still present. The rash was local to injection site on left deltoid, at least six inches in length, red, and itchy. The reporter consented to follow up. This case has been linked with case US2021201404, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021201404:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose greater than 6 months; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in June 2020 on an unknown date).   On 23rd September 2021, the patient received the 2nd dose of Shingrix. On 23rd September 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received 2nd dose of Shingrix greater than 6 months after 1st dose, which led to lengthening of vaccination schedule. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered adjuvant without antigen powder; administered adjuvant without antigen powder; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd September 2021, the patient received Shingrix. On 23rd September 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The pharmacist reported that, physician who works at practice with her administered Shingrix adjuvant vial to patient without reconstituting with antigen powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not have any details regarding the name of who administered the adjuvant, the patient who received the adjuvant, or the vial lot or expiration number. No additional information was provided by the caller. The reporter did not consent to follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Off label use
Clinical narrative: received 1st dose during active episode of shingles; This case was reported by a pharmacist via call center representative and described the occurrence of off label use in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number J7J4X, expiry date 31st January 2023) for prophylaxis.   Concurrent medical conditions included shingles (active episode of shingles). Concomitant products included acyclovir.   On 23rd September 2021, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced off label use. On an unknown date, the outcome of the off label use was unknown.  Additional details were reported as follows: This case was reported by the pharmacist. The health care professional provided limited information concerning date of birth and intials. The registered pharmacist reported that a patient received 1st dose of Shingrix during an active episode of shingles, which led to off label use. The pharmacist reported that patient told the health care professional that she was having an episodes of shingles once she received the whole dose of Shingrix. At the time of reporting, the patient was taking acyclovir. The reporter consented for follow up.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Accidental underdose
Clinical narrative: received half volume; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 5-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 5AJ3B, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd September 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 23rd September 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose 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 details were provided as follows: The patient accidently received half volume of a Fluarix Quadrivalent vaccine, which led to accidental underdose. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose 11/11/2020, second dose on 09/21/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 7GM34, expiry date 10th February 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 11th November 2020, batch number GM2Y4, expiry date 10th May 2022).   On 21st September 2021, the patient received the 2nd dose of Shingrix. On 21st September 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The pharmacist stated that, the patient received 2nd dose of Shingrix later than the recommended time interval, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: was given 2 portion of the liquid adjuvant only; was given 2 portion of the liquid adjuvant only; This case was reported by a nurse via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 3n3gh, expiry date 28th January 2023) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.  Additional details were provided as follows: The nurse reported that, the patient was given 2 portion of the liquid adjuvant of shignrix only, which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. The reporter consented to follow up.