chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine was Given; Initial Report Received on 15-Nov-2021  Non-Significant Information Received on 08-Dec-2021 and 09-Dec-2021 included confirmation of the date of vaccination with Heplisav-B and confirmation of the expiration date of 10-Aug-2021.  No additional information was provided.   A pharmacist in the reported that a 26 year-old female (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported. The patient was reported to have no known drug allergies.  No relevant concomitant medications were reported.    On 14-Nov-2021, the patient walked into the pharmacy and received an expired dose of HEPLISAV-B (Lot # 933624, expiration date 10-Aug-2021 and NDC #: 42528-003-003-01) in the left arm.   It was realized that the vaccine was expired after the injection was given.  No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP, HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: A physician reported that a 57 year-old male (race and ethnicity not provided) received "2 vials" of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as a booster. No relevant medical history was reported. No relevant concomitant medications were reported. On an unspecified date, the patient received the two doses of HEPLISAV-B (Lot #, expiration date and NDC # 43528-002-01) intramuscularly. The patient was given "two vials" of HEPLISAV-B as a booster because the person giving the injection saw that the Engerix dose was 40 mcg. Following injection, the person double checked the information and called the physician. No adverse reactions were reported. No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Vaccination failure
Clinical narrative: Titer negative After 2 Shot Series; Initial Report Received on 17-Nov-2021.   A registered nurse reported that a couple of patients (age, gender, race and ethnicity not provided) received the 2 shot series of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and had negative titers.   No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient received the first dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) in an unknown route and site.   On an unspecified date, the patient received the second dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) in an unknown route and site.   On an unspecified date, a couple of people that recently had the 2 shot series had negative titers. The number of patients and individual details were not specified.   No adverse reactions were reported. No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: 3 Doses of HEPLISAV-B; Initial Report Received on 19-Nov-2021  A registered dietician reported that a 86 year-old female patient (race and ethnicity unknown) received 3 doses of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported.  No relevant concomitant medications were reported.    On 16-Sep-2021, the patient from another dialysis center, received the first dose of HEPLISAV-B (Lot #, expiration date, and NDC # not available).   On 12-Oct-2021, the patient received the second dose of HEPLISAV-B (Lot #, expiration date, and NDC # not available).  On 09-Nov-2021, the patient received the third dose of HEPLISAV-B (Lot #, expiration date, and NDC # not available). No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: A registered nurse reported that a patient (age, gender, race and ethnicity unknown) received the second dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization one month late. Medical history was relevant for hemodialysis. No relevant concomitant medications were reported. On 13-Jul-2021, the patient received the first dose of HEPLISAV-B (Lot # 934598, expiration date and NDC # not available). On 16-Sep-2021, the patient received the second dose of HEPLISAV-B (Lot # 934973, expiration date and NDC # not available). This was one month late from the approved dosing schedule of receiving HEPLISAV-B dose #1 and dose #2 one month apart. The patient was on hemodialysis, and per their policy, the patient was to receive the third dose on 18-Nov-2021. No additional information was provided. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Given an Expired Dose of Heplisav-B; Initial Report Received on 23-Nov-2021  A physician reported that a 22 year-old male (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient did not develop any adverse reactions.  Medical history was reported as Crohn's. The patient had no known drug allergies.  No relevant concomitant medications were reported.    On 23-Nov-2021, the patient received an expired dose of HEPLISAV-B (Lot # 934259, expiration date 25-Sep-2021 and NDC # 43528-003-05) intramuscularly.  No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: A health and safety specialist reported that a female patient (age, race and ethnicity not provided) received the first and second dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization three weeks apart instead of one month apart. No relevant medical history was reported. No relevant concomitant medications were reported. On 22-May-2021, the patient received the first dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) in an unknown route and site. On 13-Jun-2021, 23 days (3 weeks) after having been vaccinated with the first dose of HEPLISAV-B, the patient received the second dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) in an unknown route and site. No additional information was reported. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Negative Titer After Receiving Both Doses; Initial Report Received on 30-Nov-2021  A pharmacist reported that a female patient (age, race and ethnicity not provided) received both doses of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and had a negative titer.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient received the first dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) in an unknown route and site.  On an unspecified date in September 2021, one month after receiving the first dose of HEPLISAV-B, the patient received the second dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) in an unknown route and site.  On 25-Nov-2021, the patient's titers were drawn and had a negative titer.  No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, Feeling abnormal, Vaccine positive rechallenge
Clinical narrative: awful, very hard on the body; Had all 3 Shots; This case was reported by a consumer via interactive digital media and described the occurrence of feels awful in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of feeling abnormal (1st dose received on an unknown date, refer case US2021AMR215043) and Shingles vaccine with an associated reaction of feeling abnormal (2nd dose received on an unknown date, refer case US2021AMR215055).   On an unknown date, the patient received the 3rd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feels awful and extra dose administered. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the feels awful and extra dose administered were unknown.   It was unknown if the reporter considered the feels awful 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 felt awful. The patient stated that he/she received all 3 shots, which led to extra dose administered. The patient also stated that be careful of these shots, they were very hard on the body. The follow-up would not possible as no contact details were available. This is one of the 3 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR215043:same patient diferent dose US-GLAXOSMITHKLINE-US2021AMR215055:same patient diferent dose
Age: 67.0
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm related to the immune response; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th December 2021, the patient received the 2nd dose of Shingrix. In December 2021, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were as follows: The patient self reported the case. The patient was in perfect shape and was not taking any medications. The patient had sore arm  in relation to the immune response after 2nd dose but felt fine.  The patient asked if patient could do exercise and normal push-ups, light weights, long walk. as it had been about 18 hours. The patient just wanted general information on exercise if patient had no serious side effects. The patient had read package insert but to no avail. The patient did not want to share personal information.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Laboratory test, X-ray
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 55-year-old female patient who received Herpes zoster (shingrix) for prophylaxis. Previously administered products included shingrix with an associated reaction of injection site pain (1st dose received in February 2021, for tolerance refer case US2021265856). In April 2021, the patient received the 2nd dose of shingrix. On an unknown date, less than 9 months after receiving shingrix, the patient experienced injected limb mobility decreased, injection site pain and tenderness. On an unknown date, the outcome of the injected limb mobility decreased, injection site pain and tenderness were not recovered/not resolved. It was unknown if the reporter considered the injected limb mobility decreased, injection site pain and tenderness to be related to shingrix. Additional details were provided as follows: The case was reported by the patient's husband. The patient received second dose of shingrix in April 2021 (exact date unknown), into her right arm this time, and again almost immediately began to experience the same type of pain in her right arm, also unresolved. On an unknown date, less than 9 months after receiving the shingrix, the patient experienced injected limb mobility decreased and tenderness. The patient had multiple tests performed and x-rays done for the issue and the doctors had not been able to identify the reason for the pain. The reporter could not provide the lot or expiration date of the shingrix vaccines administered. The reporter gave consent to contact the patient and healthcare professional. The reporter consented to follow up. GSK note- Time to onset for the event pain was provided as 5 min and in narrative it was mentioned as immediately after vaccination, patient began to have pain in her right arm. TTO captured as per structured field. Sender's Comments: US-GLAXOSMITHKLINE-US2021265856:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Illness
Clinical narrative: Felt bad after the shot; Pretty sick; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad 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 feeling bad and sickness. On an unknown date, the outcome of the feeling bad and sickness were unknown.   It was unknown if the reporter considered the feeling bad and sickness to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patients friend. The age at vaccination were not applicable. The reporter went and got both of his/her shingle vaccines after that felt pretty sick and felt bad. The reporter thought that he/she was the only one who felt bad after the shot but since then many of his/her friends had the same reaction. The reporter stated that one should still get the vaccine but they should tell them that there were side effects for some people. The reporter stated that shingles would be worse than the reaction from the vaccine. The follow-up would not possible as no contact details were available. This case has been linked with cases US2021AMR266214, US2021AMR266216 and US2021AMR266243, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR266216:Same reporter. US-GLAXOSMITHKLINE-US2021AMR266214:Same reporter. US-GLAXOSMITHKLINE-US2021AMR266216:Same reporter. US-GLAXOSMITHKLINE-US2021AMR266243:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included shingles vaccine with an associated reaction of illness (1st dose received on an unknown date, refer link case US2021AMR266342). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness 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 Shingles vaccine and got sick but all that been said, he/she did not regret it one bit. The patient stated did not want Shingles if he/she could prevent. The follow-up would not be possible as no contact details were available.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR266342:Different dose.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Pain in extremity
Clinical narrative: achey like the flu upper body; pain; sore arm; 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.   On 27th December 2021, the patient received the 1st dose of Shingles vaccine. In December 2021, less than a week after receiving Shingles vaccine, the patient experienced influenza-like symptoms, pain and pain in arm. On an unknown date, the outcome of the influenza-like symptoms, pain and pain in arm were unknown.   It was unknown if the reporter considered the influenza-like symptoms, pain and pain in arm 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 got Shingles vaccine and experienced pain, sore arm and achy like the flu upper body. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: administered frozen Fluarix; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) 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 an unknown date, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 reporter was a medical assistant. The age at vaccination was not reported. The reporter stated that, the patient was inadvertently administered frozen Fluarix vaccine (vaccine was exposed to minus 1.0 degree celsius), which led to incorrect storage of drug. The reporter did not have any information of patient available at hand and would call back later with patient information. The reporter consented to follow up. This was 1 of the 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR266361:Same reporter US-GLAXOSMITHKLINE-US2021265861:
Sex: U
Vaccine: COVID19, VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vsccnation failure; Shingles on May 7; 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 and COVID-19 VACCINE for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 11th April 2021, the patient received COVID-19 VACCINE. On 7th May 2021, more than 2 years 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 patient had reported for him/herself. The age at vaccination was not reported. The patient received Shingrix 4 years ago from the date of reporting. Less than 2 months after receiving Covid-19 vaccine, the patient got shingles. It was unknown if the reporter considered the shingles to be related to Covid-19 vaccine. This case was considered as suspected vaccination failure, since the details regarding laboratory confirmation of shingles was not provided. This case had been linked with case US2021AMR266507, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR266507:same patient - 2nd outbreak
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of chills in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 27th December 2021, the patient received the 1st dose of Shingles vaccine. On 28th December 2021, 1 days after receiving Shingles vaccine, the patient experienced chills, general body pain and fever. On an unknown date, the outcome of the chills, general body pain and fever were recovered/resolved. It was unknown if the reporter considered the chills, general body pain and 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 received first shot this past Monday and the next day patient had chills, body ache and fever for 2 days. They said it was just a few of the side effects. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: COVID19, VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles / had it twice; 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 for prophylaxis.   The patient's past medical history included hip replacement. Previously administered products included Covid 19 vaccine (received a dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine, the 1st dose of Shingles vaccine and COVID-19 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 patient had reported for him/herself. The age at vaccination was not reported but the patient was in her/his 8th decades at the time of reporting. After receiving Shingles vaccine and Covid-19 vaccine, the patient got very light cases of shingles twice. The patient stated that, a weakened immune system could cause Shingles.  The patient also stated that, each of us were not like the other and suggested to stop making statements that were based on misinformation. It was unknown if the reporter considered the shingles to be related to Covid-19 vaccine. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation of shingles was not provided.
Sex: U
Vaccine: COVID19, VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; Shingles on Sept. 6; 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 and COVID-19 VACCINE (COVID 19 VACCINE) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 11th April 2021, the patient received COVID 19 VACCINE. On 6th September 2021, more than 2 years after receiving Shingrix and Shingrix, the patient experienced shingles. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant). 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 Shingrix and Shingrix.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient received Shingrix 4 years ago from the date of reporting. Less than 2 months after receiving Covid-19 vaccine, the patient got shingles. It was unknown if the reporter considered the shingles to be related to Covid-19 vaccine. This case was considered as suspected vaccination failure, since the details regarding laboratory confirmation of shingles was not provided. This case had been linked with case US2021AMR266501, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR266501:same patient - 2nd outbreak
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the 2 shot shingles vaccine and I still got it!/ suspected vaccination failure; have it / just the skin. i am auto immune and stressed/ have it on my nose up to the corner of my eye; 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.   Concurrent medical conditions included autoimmune disorder and stress.   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 and an unknown time after starting Valtrex, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). 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 provided as follows: The patient self-reported the case. The age at vaccination was not reported. The patient was auto-immune and stressed. The patient had 2 shots of Shingles vaccine and still got shingles. The patient had shingles on his/her nose up to the corner of eye. The patient stated that the ophthalmologist said that his/her eye was not affected, just the skin around it. This case was considered as suspected vaccination failure case, because details regarding laboratory confirmation of shingles and time to onset were unknown. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: large red area which was hot at injection site; little red at injection site/large red area at the injection site again; injection site sore; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2021, the patient received the 1st dose of Shingrix. In December 2021, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site pain. On 30th December 2021, the patient experienced injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were not recovered/not resolved and the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for himself/herself. The age at vaccination was not reported. The patient received first Shingrix vaccine one week ago of reporting day. The patients arm was a little red at injection site and sore but that went away in a few days. On the reporting day, the patient noticed that he/she had a large red area, which was also hot at the injection site again.  The patient asked was this an allergic reaction.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media 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 (The patient had a single dose of Shingrix in 2018).   In December 2021, the patient received the 2nd dose of Shingrix. In December 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 case was reported by the patient. The age at vaccination was not reported. The patient had a single dose of Shingrix in 2018 and another dose this week at the time of reporting, which led to lengthening of vaccination schedule.  The reporter asked that he/she need a second dose or was the one I just had considered a second dose.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (shingrix) for prophylaxis. Previously administered products included shingrix (1st dose received over two years before reporting). 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 patient self-reported this case. The age at vaccination was not applicable to this report. Till the time of reporting the patient did not receive the 2nd dose of shingrix, which led to incomplete course of vaccination. The patient asked GlaxoSmithKline did he/she need to start over. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Product supply issue
Clinical narrative: it was not available at the time; This case was reported by a consumer via interactive digital media and described the occurrence of product supply issue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 19th April 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not applicable for this report. The patient had received initial dose of Shingrix but was not able to get the 2nd Shingrix in the 2 to 6 month period as it was not available at the time and never heard back from for the 2nd dose, which led to product supply issue. Note: VAERS reported for the 1st dose as 2nd dose was not received
Sex: U
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Severe and incapacitating 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 (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received dose on an unknown date and experienced severe and incapacitating arm pain, refer case US2021AMR266528).   On an unknown date, the patient received Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced pain in arm (serious criteria disability). Rechallenge with Shingrix was positive. 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 Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter needed to speak to someone about serious issues being experienced following Shingrix shots. The patient experienced severe and incapacitating arm pain followed the Shingrix shots almost immediately and had gone on for months. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR266528:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; 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 28th December 2021, the patient received the 2nd dose of Shingles vaccine. In December 2021, less than a week 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 patient self-reported this case. The age at vaccination was not reported. The patient had Shingles dose the day before reporting and feel fine but sore arm. The patient asked for exercise and to do normal pushups, light weights, long walk. It had been about 18 hours. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: have shingles breakouts/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 (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st shingles vaccine on an unknown date 6 years ago).   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) 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 Shingrix.  Additional details were provided as follows: The case was reported by patient's husband. The age at vaccination was not reported. The patient got her first shingles shot approximately 6 years ago and got the 2nd shot close to a year later. In the last couple of years the patient continued to have shingles breakouts.  The reporter asked if the patient should she get a second round of shots. The case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles was not reported. Note: From the narrative it was not clear if the patient received 2 doses of shingrix or received only 1 dose of shingrix hence it only single suspect was coded.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Severe and incapacitating 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 (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, 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 Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and almost immediately experienced severe and incapacitating arm pain. The severe and incapacitating arm pain had gone on for months. The reporter need to speak to someone about serious issues being experienced following Shingrix shots. The follow-up would not possible as no contact details were available. For 2nd dose tolerance, refer linked case US2021AMR266520, reported by the same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR266520:Same reporter, same patient diff dose
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: arm was pretty sore; large red, circular; 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 (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced pain in arm and erythema. On an unknown date, the outcome of the pain in arm and erythema were unknown.   It was unknown if the reporter considered the pain in arm and erythema 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 received the 2nd dose of Shingrix on Monday. Monday night, the patient's arm was pretty sore, as he/she expected. Tuesday morning, 1 day after vaccination, the patient had a large red, circular (not further specified). The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had two shots, still got the shingles; shingles, nasty; 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 case was reported by patient. The age at vaccination was not reported. The patient had the two shots and still got the shingles the beginning of December. The patient stated that nothing was guaranteed and nasty. The case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles was not reported. Note: The year of event onset was not provided hence it was not captured.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First shot in Sep-2020; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received in September 2020).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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 patient self-reported the case. The age at vaccination was not applicable. The patient recently found out that, he/she supposed to have a second shingles shot.  At the time of first shot, the patient was not informed that he/she would need another one.  Till the time of reporting, the patient did not receive 2nd dose of Shingles vaccine, which led to incomplete course of vaccination. The patient asked could he/she still get the second shot. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Pyrexia
Clinical narrative: got so so sick; Bed for 3 days with high fever; This case was reported by a consumer via interactive digital media and described the occurrence of sickness 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 sickness and fever. On an unknown date, the outcome of the sickness was unknown and the outcome of the fever was recovered/resolved.   The reporter considered the sickness to be related to Shingles vaccine. It was unknown if the reporter considered the fever to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported case for him/herself. The age at vaccination was not reported. The patient got so sick from Shingles vaccine. After receiving Shinlges vaccine, the patient was in bed for 3 days with high fever. The patient stated that, he/she would not get the other one and  would take his/her chances.
Sex: F
Vaccine: VARZOS
Symptoms: Renal failure
Clinical narrative: kidney's shut down; This case was reported by a consumer via interactive digital media and described the occurrence of renal 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 renal failure (serious criteria GSK medically significant). On an unknown date, the outcome of the renal failure was unknown.   It was unknown if the reporter considered the renal failure to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's friend. The age at vaccination was not reported. It was reported that the patient got Shingles vaccine recently and her kidney's shut down. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: 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 Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm and influenza-like symptoms. On an unknown date, the outcome of the pain in arm and influenza-like symptoms were recovered/resolved. The reporter considered the pain in arm and 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 stated that the shingles vaccine would bring a week of pain to the arm and a week of severe flu symptoms, and need two, months apart. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: swelling at injection site; itching at injection site; redness at injection site; This case was reported by a consumer via  interactive digital media and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site swelling, injection site itching and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site itching and injection site erythema were unknown.   It was unknown if the reporter considered the injection site swelling, injection site itching and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had his/her first shot on Wednesday. The patient had swelling, itching and redness at injection site.  The patient asked when should be concerned about if it was not going away.
Age: 51.0
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: 2nd has been awful; This case was reported by a consumer via call center representative and described the occurrence of feels awful in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on an unknown date).   On 3rd January 2022, the patient received the 2nd dose of Shingrix. In January 2022, less than a week after receiving Shingrix, the patient experienced feels awful. On an unknown date, the outcome of the feels awful was unknown.   It was unknown if the reporter considered the feels awful 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 received 1st dose of Shingrix and had zero issues. The patient received 2nd dose of Shingrix and had been awful. The patient enquired if he/she could get monoclonal antibodies treatment after getting Shingrix vaccine, would it be harmful.
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction 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 allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to Shingles vaccine. Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had an allergic reaction to his/her 1st Shingles vaccine. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration
Clinical narrative: 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. 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, not applicable after receiving Shingles vaccine and less than a year after receiving Shingles vaccine, the patient experienced shingles and drug dose administration interval too long. On an unknown date, the outcome of the shingles and drug dose administration interval too long were unknown. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. After receiving first shingles shot, the patient was told that he/she did not need a second shot and so none was scheduled and later that year, he/she got shingles, and shortly later, his/her second shot, which led to drug dose administration interval too long. The reporter asked to get a third shot or, might be two more shots.