chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Pain, Vaccination failure
Clinical narrative: received both Shingrix vaccines, shingles/ suspected vaccination failure; shingles; painful; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 71-year-old 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 (4-6 times a year, each debilitating).   On an unknown date, the patient received the 1st dose of Shingrix. On 3rd December 2018, the patient received the 2nd dose of Shingrix. In September 2021, unknown after receiving Shingrix and more than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received both the doses of Shingrix and still got shingles. For shingles experienced on 20th July 2021, refer case US2021AMR207912. The patient received the shingrix shot and had painful attack, milder one in September 2021. The patient was feeling the signature pain again this morning. The patient had several small, short duration attacks several times since last vaccine and was grateful for the overall effect. The patient asked if GSK working on any booster option. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting. This case was linked with US2021AMR207912, reported by the same reporter for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR207912:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Skin exfoliation
Clinical narrative: swelling, heat pain vaccination site.; swelling, heat pain vaccination site.; swelling, heat pain vaccination site.; peeling skin at shingrix vaccination site; This case was reported by a consumer via (Shingrix GSK Chatbot) call center representative and described the occurrence of injection site exfoliation in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2021, the patient received Shingrix. In October 2021, 2 weeks after receiving Shingrix, the patient experienced injection site exfoliation. On an unknown date, the patient experienced injection site swelling, injection site warmth and injection site pain. On an unknown date, the outcome of the injection site exfoliation was unknown and the outcome of the injection site swelling, injection site warmth and injection site pain were recovered/resolved.   It was unknown if the reporter considered the injection site exfoliation, injection site swelling, injection site warmth and injection site pain to be related to Shingrix.  Additional details provided were as follows: The case was self-reported by the patient. The patient received a dose of Shingrix vaccine and experienced swelling, heat and pain at the vaccination site and it cleared up. On the reporting week, the patient had peeling skin at the vaccination site. The patient asked if the peeling skin at injection site 2 weeks after the Shingrix vaccine was serious. After reviewing the patient was replied with that they did not see the peeling that the patient had described listed in their adverse events. Follow-up would not be possible as no contact details available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Had the vaccine and still got shingles for the third time; 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 the patient. The age at vaccination was not reported. The patient had the vaccine and still got shingles for the third time. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and lab test confirmation was unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/I got vaccinated several years back, and currently have what I consider an horrific case of Shingles.; horrific case of 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, 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 provided were as follows: The case was self-reported by the patient. The age at vaccination was not reported. The patient received a dose of Shingles vaccine several years back, and currently experienced a horrific case of Shingles. The patient would not wish this on anyone.  The patient hope that the current vaccine would be better than the one he/she got. Follow-up would not be possible as no contact details available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: had a temperature excursion and was administered; This case was reported by a other health professional via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received HBV (Engerix B) (batch number T2S4Z, expiry date 20th November 2022) for prophylaxis.   On 15th September 2021, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were reported as follows: This case was reported by the medical assistant. The age at vaccination was not reported. The reporter reported that Engerix B had a temperature excursion and was administered to a patient.  The vaccine was stored at 8.3C for 1 hour. No additional information was known. No additional adverse event reported. No PQC.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: mild flu-like reaction; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles before).   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 influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms 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 had received Shingles vaccine and had a mild flu-like reaction. The patient had shingles before and was hoping to not have it again. For tolerance of second dose, refer case US2021AMR208490.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR208490:same patient and reporter
Sex: U
Vaccine: VARZOS
Symptoms: Facial pain, Immediate post-injection reaction
Clinical narrative: I still have the pain/ affected my left side of my face; This case was reported by a consumer via interactive digital media and described the occurrence of facial pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced facial pain. On an unknown date, the outcome of the facial pain was not recovered/not resolved.   It was unknown if the reporter considered the facial pain 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 first shingles shot and right after it affected left side of face. The patient have to go get 2 ration for the pain still have the pain and never again would he/she take another. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Palpitations
Clinical narrative: heart palpitations; This case was reported by a consumer and described the occurrence of palpitation in a patient who received Herpes zoster (Shingrix) 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 palpitation. On an unknown date, the outcome of the palpitation was not recovered/not resolved.   It was unknown if the reporter considered the palpitation to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The patient received a dose of Shingrix vaccine and experienced heart palpitations. The patient asked to be in touch with a nurse at GlaxoSmithKline (GSK) to discuss his/her heart palpitations. Follow-up would not be possible as no contact details provided.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: Vaccination that had expired.; This case was reported by a other health professional via interactive digital media and described the occurrence of expired vaccine used in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter gave a Pediarix Vaccination that had expired. The reporter enquired what was the procedure to fix this error.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the shot still gets shingles/ Suspected vaccination failure; shingles; This case was reported by a consumer via Shingrix  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, 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 reported as follows: The age at vaccination was not reported. The patient received the shot still gets shingles. The reporter asked are there any studies that might help. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: sore arm; arm swelling; redness at injection site; itching at injection site; This case was reported by a consumer via (facebook) interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In September 2021, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 weeks after receiving Shingles vaccine, the patient experienced pain in arm, swelling arm, injection site erythema and injection site itching. On an unknown date, the outcome of the pain in arm, swelling arm, injection site erythema and injection site itching were unknown.   It was unknown if the reporter considered the pain in arm, swelling arm, injection site erythema and injection site itching 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 dose of Shingles vaccine and experienced sore arm when he/she moved it ,arm swelling, redness and itching at injection site. The patient reported that his/her second shot in 3 months. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash macular, Skin discolouration, Vaccination failure
Clinical narrative: had both shingle shots/ shingles/ suspected vaccination failure; shingles dark blotchy; dark blotchy; shingles dark; This case was reported by a consumer via Shingrix 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, blotchy and darkened skin. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, blotchy and darkened skin were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, blotchy and darkened skin to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient received both Shingles shot and have what looks to shingles dark blotchy. The patient stated no pain was there. The patient asked anything to do or take to make shingles go away. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles and time to onset were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 10 months since my first shot; This case was reported by a consumer via media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date 10 months ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not applicable for this report. The patient received 1st dose 10 months ago and asked if it is too late to get the 2nd dose. Till the time of reporting, patient did not received 2nd dose which led to incomplete course of vaccination. Follow-up would not be possible as no contact details available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Herpes zoster, Vaccination failure
Clinical narrative: had shingles for years, and had the shots./ suspected vaccination failure; had shingles for years,; red spot; 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), shingles and localized erythema. On an unknown date, the outcome of the vaccination failure, shingles and localized erythema were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and localized erythema to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient received the shots and had shingles for years. The patient guess that he/she had been lucky. All that the patient ever get was a 2-inch red spot on butt for a week every year. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles and time to onset were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient only received the liquid; Patient only received the liquid; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 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 reported as follows: This case was reported by the office manager. The age at vaccination was not reported. The office manager stated that after doing a count, they noticed there was one vial of powder left. They thought a patient only received the liquid and not the powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated that they would have to research to try and narrow down the patient. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; This case was reported by a consumer via (facebook) interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In October 2021, less than a month after receiving Shingles vaccine, the patient experienced fever. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever 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 just received dose of Shingles vaccine and experienced fever from the last three days. The patient was taking Tylenol as a treatment medication. The reporter wanted GlaxoSmithKline comment. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Mild case of shingles two weeks after the shots; This case was reported by a consumer via (Facebook) 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, 2 weeks after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles 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 dose of Shingles vaccine and experienced mild case of shingles two weeks after the shot. The follow-up would not possible as no contact details were available. For 2nd dose refer case US2021AMR209336, reported by the same reporter for the same patient; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR209336:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccine positive rechallenge
Clinical narrative: Mild case of shingles two weeks after the shots; This 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.   Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (1st dose received on an unknown date, refer case US2021AMR209331).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles 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 reporter reported that the shots helped, but he/she got a mild case of shingles two weeks after the shots. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR209331:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Pain
Clinical narrative: Got vx 2 weeks ago. Now shingles in eye; Now I have shingles in my face; So painful; This case was reported by a consumer via interactive digital media and described the occurrence of ophthalmic herpes zoster in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 3 weeks after receiving Shingles vaccine, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the ophthalmic herpes zoster, shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the ophthalmic herpes zoster, shingles and pain to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient got vaccinated 2 weeks before the date of reporting and at the time of reporting the patient had shingles in eye and face and stated it was so painful.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose 10/2/2020, has not received third dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix with an associated reaction of no adverse event (1st dose of Twinrix vaccine was received on 4th September 2020, batch number 3Y7NL and expiry date 24-MAY-2022) and Twinrix with an associated reaction of no adverse event (2nd dose the of Twinrix vaccine received on 2nd October 2020, batch number 3Y7NL and expiry date 24-MAY-2022).   On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: This case was reported by the pharmacist. The age at vaccination was not applicable for this report. The patient also received first and second dose of twinrix but third dose was not received till the time of reporting, which led to incomplete course of vaccination. This case has been linked to the case US2021208799,reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021208799:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort, Pain
Clinical narrative: Not comfortable; a bit sore; 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 and pain. On an unknown date, the outcome of the discomfort was unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the discomfort and 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 reporter hoped that both doses were included in 190 dollars. The patient received dose of Shingles vaccine and felt not comfortable and stays a bit sore. The patient stated that only have to do it once in a lifetime. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had shingles despite both shingles vaccines/ Suspected vaccination failure; shingles on right side; 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 and COVID-19 VACCINE (COVID 19 VACCINE (MANUFACTURER UNKNOWN)) for prophylaxis.   The patient's past medical history included shingles (previously had shingles on right side). Previously administered products included Shingles vaccine.   On an unknown date, the patient received the 2nd dose of Shingles vaccine, the 1st dose of Shingles vaccine and COVID 19 VACCINE (MANUFACTURER UNKNOWN). 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 reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient recently had shingles on right side related to the COVID vaccine despite the fact that the patient has had both of the shingles vaccines for a total of 3 shots. The patient stated that look it up online about Shingles and COVID vaccines. The patient stated that the shingles was also a possible side effect of the COVID Vaccine. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles and time to onset were unknown.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got two shots have Shingles/ Suspected vaccination failure; went to er, 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, less than 2 years 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 reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient received the two Shingles shots a year before the date of reporting and went to the emergency room last Friday and had the Shingles. The patient stated it was horrible. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose more than six months ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.  Previously administered products included Shingrix (received 1st dose on 17th October 2019, batch no 5k99).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. This case was for few patients who received their first dose of Shingrix more than six months ago. Till the time of reporting, the patients did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter consented to follow-up for the other patient. This case had been linked with case US2021208838, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a consumer via media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the first Shingrix shot and 2 days later was down with shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Red area on arm below injection site; Swollen area on arm below injection site; The area is sore; The area gets itchy; This case was reported by a consumer via interactive digital media and described the occurrence of erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th October 2021, the patient received the 1st dose of Shingrix. On 6th October 2021, 2 days after receiving Shingrix, the patient experienced erythema, swelling, pain and pruritus. The patient was treated with non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the erythema, swelling, pain and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the erythema, swelling, pain and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had received the first shot and the next day and had the side effects.  The third day the patient developed a red swollen area on my arm below the injection site. The patient applied ice periodically, it was sore and got  itchy.  The patient asked if this was an allergic reaction.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Swelling
Clinical narrative: Red area on arm below injection site; Swollen area on arm below injection site; The area is sore; The area gets itchy; This case was reported by a consumer via interactive digital media and described the occurrence of erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th October 2021, the patient received the 1st dose of Shingrix. On 6th October 2021, 2 days after receiving Shingrix, the patient experienced erythema, swelling, pain and pruritus. The patient was treated with non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the erythema, swelling, pain and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the erythema, swelling, pain and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had received the first shot and the next day and had the side effects.  The third day the patient developed a red swollen area on my arm below the injection site. The patient applied ice periodically, it was sore and got  itchy.  The patient asked if this was an allergic reaction.
Sex: U
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Product prescribing error
Clinical narrative: Shingrix to patients under 50; This case was reported by a pharmacist via call center representative and described the occurrence of drug prescribing error in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug prescribing error. On an unknown date, the outcome of the drug prescribing error was unknown.  Additional details were provided as follows: Age at vaccination was not applicable to this report. The pharmacist reported that the doctors had been prescribing Shingrix to patients under the age of 50, which led to drug prescribing error. The HCP did not have patients information, she was looking for general information about Shingrix in patients under 50. The reporter consented to follow up. This case has been linked with case US2021209477, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021209477:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Got 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 (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows The age at vaccination was not reported. After receiving Shingrix, the patient got shingles. This case was considered as suspected vaccination failure, since the details regarding time to onset and laboratory confirmation of shingles were not provided. On 9th October 2021, the patient got shingles again, refer case US2021AMR210317. The patient asked if there was something wrong with vaccines.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR210317:Same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had 2 shingle vx and today got shingles again/ Suspected vaccination failure; And today got shingles again; This case was reported by a consumer via (Shingrix 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.   The patient's past medical history included shingles (occurred on an unknown date, refer case US2021AMR210315).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On 9th October 2021, 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 was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient received 2 shingle vaccines and again on the day of reporting got shingles.  The reporter asked was there something wrong with vaccines. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles and time to onset were unknown.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR210315:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: 2 shingles vx 3 years ago and last year got shingles/ suspected Vaccination failure; Last year got 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. In February 2020, more than a year 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 reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient received the two shingle vaccines 3 years before the date of reporting and last year the patient got shingles in February 2020. The patient asked was there something wrong with the vaccines why was this happening. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown. For 2nd occurrence of shingles refer linked case US2021AMR210325, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR210325:Same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: 2 shingles vx 3 years ago, just diagnosed with shingles again/ suspected Vaccination failure; Just diagnosed with shingles again; This case was reported by a consumer via (Shingrix  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.   The patient's past medical history included shingles (occurred in February 2020, refer case US2021AMR210321).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, more than 2 years 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 was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient received the two shingle vaccines 3 years before the date of reporting and have just been yet again diagnosed with shingles. The patient asked was there something wrong with the vaccines why was this happening. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR210321:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: administered subcutaneously; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in an unknown number of patients who received Herpes zoster (Shingrix) (batch number J7J4X, expiry date 31st January 2023) for prophylaxis.   On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that Shingrix was administered subcutaneously for unknown total of patients by a new employee, which led to intramuscular formulation administered by other route.  The reporter consented to follow up. This case has been linked with the case US2021209477 and US2021209480.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021209477:Same reporter US-GLAXOSMITHKLINE-US2021209480:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Headache, Herpes zoster, Hypoaesthesia, Malaise
Clinical narrative: experienced shingles/Suspected vaccination failure; Shingles; rash on side of the body, face, along nerve path; Blisters; Scabs; Pain; Itching; Tingling; Numbness; Fever; Headache; Not feeling well; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash, blister, scab, pain, pruritus, tingling, numbness, fever, headache and feeling unwell. On an unknown date, the outcome of the vaccination failure, pain, pruritus, tingling, numbness, fever, headache and feeling unwell were unknown and the outcome of the shingles, rash, blister and scab were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash, blister, scab, pain, pruritus, tingling, numbness, fever, headache and feeling unwell to be related to Shingrix.  Additional details were reported as follows: This case was reported by patients wife. The age at vaccination was not reported. The patient experienced all symptoms listed except gastrointestinal issues. The listed symptoms were as follows: Shingles typically produces a painful rash that blisters and scabs over in 7 to 10 days and clears up within 2 to 4 weeks. The reporter stated that 1 to 5 days before the rash appears, people might experience pain, itching, tingling, or numbness in the area where the rash would develop. Other symptoms at this time could include fever, headache, and a sense of not feeling well. The rash usually erupts in a single stripe on either the left or right side of the body, or sometimes the face, along a nerve path. The reporter stated that it could develop on the arm, thigh, head and even the ear or eye. It was most common on the chest and abdomen. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided. The follow-up would not possible as contact information not available.