chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had the shingles shot and experienced shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Got shingles years later; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The patient had the shot and got shingles years later. The patient had the shingles shot years ago but got shingles many years later. The patient was still happy he/she got the shot. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Eye disorder, Herpes zoster, Hypoaesthesia, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; almost lost my R eye,; residual  pain; numbness; 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), shingles, eye disorder, residual pain and numbness. On an unknown date, the outcome of the vaccination failure and eye disorder were unknown and the outcome of the shingles, residual pain and numbness were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, eye disorder, residual pain and numbness to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient was one of the 5 percent who got shingles after receiving Shingles vaccine. The patient almost lost right eye. At the time of reporting, the patient still had residual pain and numbness. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; have them; 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.   The patient's past medical history included shingles (twice).   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. The action taken with Shingles vaccine was unknown. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles again twice. The patient was sure, Shingles shot helped but did not prevent from getting them again. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity
Clinical narrative: Sore arm; headache; 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 27th August 2021, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced pain in arm and headache. The patient was treated with paracetamol (Pain Relief). On an unknown date, the outcome of the pain in arm and headache were recovered/resolved.   It was unknown if the reporter considered the pain in arm and headache to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient heard nothing but bad stories about the shot. The patient had one shot last Friday from the date of reporting and had a sore arm and a headache.   The patient took pain reliever and a small nap and felt great, arm was sore for 2 or 3 days but not bad overall, worth it. No contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for herself/himself. The age at vaccination was not reported. The patient reported that, he/she got the Shingle vaccination for shingles and guess what the patient had shingles on his/her back at the time of reporting. The patient said, yep. It's shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule, time to onset for event and laboratory confirmation for shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; 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.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, 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 Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient contracted shingles after the 1st shot, 1 week later the patient came down with shingles. The patient said that the shots did not help he/she any. No contact details were available.
Age: 1.17
Sex: U
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1 year and 2 months old received IInfanrix and was supposed to be receiving at 15 months of age; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 14-month-old patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (received Dtap-Pediarix on unknown date at 2, 4 and 6 month of age).   On 30th August 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 30th August 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short 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 medical assistant reported that, the patient of 1 year and 2 months old received Infanrix at an unknown location.  The patient received Dtap-Pediarix at 2, 4 and 6 month of age and was supposed to receive Infanrix at 15 months of age but received at 14 months of age, which led to drug dose administration interval too short.
Sex: M
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a male patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, 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 pharmacist. The age at vaccination was not reported. The pharmacist reported that an excursion happened during shipping of Hiberix from an external wholesaler on the way to the pharmacist's facility, which led to incorrect storage of drug. The pharmacist stated, feel comfortable using the product now. The pharmacist had been provided extended stability data which does not apply to shipping.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Blister, Pruritus
Clinical narrative: Single small pimple under her left breast; Single small itchy vesicle or pimple; Single small vesicle under her left breast; This case was reported by a consumer via call center representative and described the occurrence of pimples in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th August 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 30th August 2021, 2 days after receiving Shingrix, the patient experienced pimples, pruritus and vesicles. On an unknown date, the outcome of the pimples, pruritus and vesicles were not recovered/not resolved.   It was unknown if the reporter considered the pimples, pruritus and vesicles to be related to Shingrix.  Additional details were provided as follows: The patient was the reporter. The patient received Shingrix on an unknown arm. Two days after the vaccination, on Monday; the patient noticed a single small, itchy vesicle or pimple under her left breast (small pimple or vesicle) which had not resolved till the time of reporting. The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: second dose of Shingrix outside of the time frame recommended due to the COVID; This case was reported by a physician via call center representative and described the occurrence of social problem in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 6 months ago on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The physician stated that, several of their patients would be receiving the second dose of Shingrix outside of the time frame recommended due to the COVID vaccine, which led to social problem. The reporter stated that, approximately 10 or 20 of the patients did not yet receive the second dose of the vaccine and 6 months from the first dose already passed. There were no details on each one of the patients and the doctor preferred not to be contacted for follow up. No further events were reported. The reporter did not consent to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Nausea, Vomiting
Clinical narrative: Throwing up; Stomach was upset; Nausea; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix. In October 2020, less than a day after receiving Shingrix, the patient experienced vomiting, upset stomach and nausea. On an unknown date, the outcome of the vomiting, upset stomach and nausea were recovered/resolved.   It was unknown if the reporter considered the vomiting, upset stomach and nausea to be related to Shingrix.  Additional details were provided as follows: The patient was the reporter. The patient received Shingrix and was throwing up on the 1st night and her stomach was upset for 1 week. The events resolved after 1 week.  Due to that experience, the patient did not get the 2nd dose.  The reporter consented to follow up even though she did not have the exact date of vaccination.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR186600:Same reporter, same Suspect product, same AE, different dose (1st dose) invalid
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: Mild arm soreness; Nausea; Headache; Chills; Fatigue; This case was reported by a physician and described the occurrence of pain in arm in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th August 2021, the patient received the 1st dose of Shingrix. On 31st August 2021, 1 days after receiving Shingrix, the patient experienced pain in arm, nausea, headache, chills and fatigue. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the pain in arm, nausea, headache, chills and fatigue were recovered/resolved.   It was unknown if the reporter considered the pain in arm, nausea, headache, chills and fatigue to be related to Shingrix.  Additional details were reported as follows: The reporter was a GlaxoSmithKline employee and relative of the patient. The patient reported that he received received Shingrix vaccine and experienced fatigue, chills, nausea, headache and mild arm soreness. The patient took Tylenol. The patient does not have any symptoms. The lot number and expiration date are not available. The reporter consented to follow up.  This is one of the 5 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020148003:Same Reporter US-GLAXOSMITHKLINE-US2019089947:Same Reporter US-GLAXOSMITHKLINE-US2019137709:Same Reporter US-GLAXOSMITHKLINE-US2019158430:Same Reporter US-GLAXOSMITHKLINE-US2020113059:Same Reporter
Sex: U
Vaccine: DTAP
Symptoms: Incorrect route of product administration, Product administered at inappropriate site
Clinical narrative: infanrix administered below deltoid muscle / administered below the deltoid; Infanrix administered subcutaneouslyy; Havrix administered below deltoid muscle / administered below the deltoid; Havrix  administered subcutaneously; This case was reported by a nurse via call center representative and described the occurrence of vaccine administered at inappropriate site in a patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st August 2021, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 1st September 2021, the patient received Infanrix (subcutaneous) and Infanrix Pre-Filled Syringe Device. On 31st August 2021, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device and not applicable after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced vaccine administered at inappropriate site and intramuscular formulation administered by other route. On 1st September 2021, the patient experienced vaccine administered at inappropriate site and intramuscular formulation administered by other route. The action taken with Havrix Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the vaccine administered at inappropriate site, intramuscular formulation administered by other route, vaccine administered at inappropriate site and intramuscular formulation administered by other route were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: Registered nurse reported that Havrix was administered below deltoid muscle to a pediatric patient and also administered subcutaneously which led to vaccine administered at inappropriate site and intramuscular formulation administered by other route. The reporter declined for providing demographic details from patient.  Reporter provided limited information. Health care professional noted the product Infanrix was also administered below the deltoid also stated it was likely subcutaneously administered which led to vaccine administered at inappropriate site and intramuscular formulation administered by other route. Health care professional did not provide lot number or expiration date of product.  The reporter did not consent to follow-up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Headache, Injection site pain, Nausea
Clinical narrative: Dizzy; Fever; sore at the injection site; Headache; weakness; Nausea; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st August 2021 05:00, the patient received the 1st dose of Shingrix (intramuscular). On 31st August 2021, 3 hrs after receiving Shingrix, the patient experienced injection site pain, headache, weakness and nausea. On 1st September 2021, the patient experienced dizziness and fever. The patient was treated with paracetamol (Tylenol). On 1st September 2021, the outcome of the fever was recovered/resolved. On 2nd September 2021, the outcome of the dizziness was recovered/resolved. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the headache, weakness and nausea were recovered/resolved.   It was unknown if the reporter considered the injection site pain, headache, weakness, nausea, dizziness and fever to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for herself. The patient received Shingrix vaccine in the left arm and about 3 hours after receiving her Shingrix vaccine she experienced a sore arm at the injection site, a headache, weakness and nausea. The patient also stated that she felt dizzy during the night, but resolved this morning. The patient also had slight fever of 99 degree F. Health care professional told her to take Tylenol, which resolved the fever a few hours later. The patients left arm was still sore at injection site. The patient overall feeling better, the headache, weakness and nausea resolved on the day of reporting. The reporter did not consented to follow up. The reporter does not give permission to contact health care professional.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Accidental underdose, Exposure via skin contact
Clinical narrative: did not receive a full dose/ Underdose; some of vaccine was running down on patient's arm; some of vaccine was running down on patient's arm; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 95JR5, expiry date 5th October 2022) and (batch number CL2S5, expiry date 5th November 2022) for prophylaxis.   On 1st September 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On 1st September 2021, unknown after receiving Shingrix, the patient experienced accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the accidental underdose, exposure via skin contact and inadvertent exposure to vaccine were unknown.  Additional details were reported as follows: This case was reported by the pharmacist. The reporter reported that while administering the first dose of Shingrix to the patient, some of vaccine was running down on patient's arm, which led to exposure via skin contact and inadvertent exposure to vaccine. The reporter's concern was that the patient did not receive a full dose of Shingrix, which led to accidental underdose. The reporter gave a consent to follow-up with her. She has an email address however, it does not accept external emails. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Still has pain; Had shingles despite getting 2 doses of SHINGRIX/ Suspected vaccination failure; Shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 68-year-old female 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 1st dose of Shingrix (intramuscular) and the 2nd dose of Shingrix (intramuscular). On 20th September 2018, less than a year after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced pain. On an unknown date, the outcome of the vaccination failure and shingles were recovered/resolved and the outcome of the pain was 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 the case. The age at vaccination was not reported. The patient received 2 doses Shingrix vaccine about 3 years ago and had shingles despite getting 2 doses of Shingrix and pain. The vaccine was administered into the muscle in the right deltoid. The patient shingles were disappeared, however, she still has pain from shingles. The patient does not have lot number/expiry date, dose of Shingrix, date of administration, and how soon after the vaccination did the shingles occur. The reporter gave a consent to follow-up with health care practitioner however,  does not have the name of the facility, full mailing address, fax number and an email address to health care practitioner. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles were unknown.
Sex: F
Vaccine: TDAP
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Dose was clear and not shaken; Dose was clear and not shaken; This case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a 49-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 1st September 2021, the patient received the 1st dose of Boostrix. On 1st September 2021, unknown after receiving Boostrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: Age at vaccination was not reported. The patient self reported this case. The physician reported that she received dose of Boostrix which was clear and not shaken by pharmacist, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. HCP will do some testing to evaluate antigen levels after this. No lot number available. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Injection site reaction, Pyrexia
Clinical narrative: injection site (reactions); fever; tiredness; This case was reported by a consumer and described the occurrence of injection site reaction in an unspecified number of patients 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 injection site reaction, fever and tiredness. On an unknown date, the outcome of the injection site reaction and tiredness were unknown and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the injection site reaction, fever and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated everyone he/she knew who has had Shingrix has had the injection site, the tiredness, people have run the fever and then the fever breaks. The reporter stated everybody said the second shot was worse. The reporter expected fever or chills after second shot. This case was linked with the case US2021182206 and US2021AMR183233, reported by same the reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021182206:same reporter US-GLAXOSMITHKLINE-US2021AMR183233:same reporter
Age: 86.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm Pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 86-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   On 8th July 2021, the patient received Boostrix, Boostrix Pre-Filled Syringe Device and the 1st dose of Shingrix. On 14th July 2021, 6 days after receiving Boostrix, Boostrix Pre-Filled Syringe Device and Shingrix, 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 Boostrix, Boostrix Pre-Filled Syringe Device and Shingrix.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 reported that, the patient received the dose of Shingrix and Boostrix on same day in same injection site and experienced return of arm pain. The reporter had limited information at that time but would call back with further details. The reporter consented to follow up. The case was linked with case US2021AMR188527 reported by the same reporter for 1st occurrence of arm pain.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR188527:same patient, 1st occurance of arm pain
Age: 86.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Pain in extremity, Product administered at inappropriate site, Rash
Clinical narrative: Arm Pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 86-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   On 8th July 2021, the patient received Boostrix, Boostrix Pre-Filled Syringe Device and the 1st dose of Shingrix. On 14th July 2021, 6 days after receiving Boostrix, Boostrix Pre-Filled Syringe Device and Shingrix, 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 Boostrix, Boostrix Pre-Filled Syringe Device and Shingrix.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 reported that, the patient received the dose of Shingrix and Boostrix on same day in same injection site and experienced return of arm pain. The reporter had limited information at that time but would call back with further details. The reporter consented to follow up. The case was linked with case US2021AMR188527 reported by the same reporter for 1st occurrence of arm pain.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR188527:same patient, 1st occurance of arm pain
Age: 86.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Rash; Shingrix and boostrix in the same site of injection.; Arm Pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis and dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th July 2021, the patient received the 1st dose of Shingrix, Boostrix and Boostrix Pre-Filled Syringe Device. On 8th July 2021, less than a day after receiving Shingrix, Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced pain in arm and vaccine administered at inappropriate site. On 14th July 2021, the patient experienced rash. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the rash and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the pain in arm and rash to be related to Shingrix, Boostrix and Boostrix Pre-Filled Syringe Device.This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The Pharm D reported that, the patient received the dose of Shingrix and Boostrix on same day in same injection site, which led to vaccine administered at inappropriate site. Less than a day after the vaccination patient had arm pain. The patient also had rash and return of arm pain. The caller had limited information at that time but would call back with further details. The reporter consented to follow up. The case was linked with US2021187608 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021187608:same patient
Age: 86.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Pain in extremity, Product administered at inappropriate site, Rash
Clinical narrative: Rash; Shingrix and boostrix in the same site of injection.; Arm Pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis and dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th July 2021, the patient received the 1st dose of Shingrix, Boostrix and Boostrix Pre-Filled Syringe Device. On 8th July 2021, less than a day after receiving Shingrix, Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced pain in arm and vaccine administered at inappropriate site. On 14th July 2021, the patient experienced rash. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the rash and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the pain in arm and rash to be related to Shingrix, Boostrix and Boostrix Pre-Filled Syringe Device.This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The Pharm D reported that, the patient received the dose of Shingrix and Boostrix on same day in same injection site, which led to vaccine administered at inappropriate site. Less than a day after the vaccination patient had arm pain. The patient also had rash and return of arm pain. The caller had limited information at that time but would call back with further details. The reporter consented to follow up. The case was linked with US2021187608 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021187608:same patient
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: vaccine, not reconstituted properly; injected only one of the vials; This case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 13th April 2021).   On 23rd August 2021, the patient received the 2nd dose of Shingrix. On 23rd August 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: It was reported that the patient had received his 2nd dose of Shingrix  When the pharmacist gave the patient the vaccine he/she did not reconstituted properly, thus, he/she injected only one of the vials (patient could not specify if the lyophilized or the adjuvant), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. On that same day, the patient got the properly reconstituted 2nd dose of Shingrix. The patient nor the Doctor had any information regarding the vaccines, such as lot numbers and expiration dates. No further details were provided at the time of the reporting.  The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose not yet given; This case was reported by a physician 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 on an unknown date).   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 reported as follows: Age at vaccination was not applicable for this report. Physician reported 2nd dose of Shingrix greater than 6 months and 2nd dose not yet given which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Hypomenorrhoea, Social problem
Clinical narrative: unable to receive second dose due to COVID; This case was reported by a consumer via call center representative and described the occurrence of social problem in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in Left deltoid by intramuscular route, 2 years ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were reported as follows: The case was reported by patient. Age at vaccination was not applicable for this report. The patient was unable to receive the 2nd dose due to traveling, Shingrix also shortage at the pharmacy, as well as the COVID situation (patient did not have COVID) which led to social problem. The reporter did not consent to follow-up with health care professional.  The reporter did not consent to follow-up. The patient was misinformed by Pharmacy to restart Shingrix vaccine series. VAERS details were reported for the 1st dose of Shingrix.
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Bexsero administered instead of Menactra; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB02BA, expiry date 28th February 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th August 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 30th August 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered 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 provided were as follows: The reporter was a clinic administrator. Age at vaccination was not reported. The patient received a dose of Bexsero instead of Menactra which led to wrong vaccine administered. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Eczema, Incomplete course of vaccination
Clinical narrative: Eczema all over her body; This case was reported by a consumer and described the occurrence of eczema in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th May 2021, the patient received the 1st dose of Shingrix. On 28th May 2021, 14 days after receiving Shingrix, the patient experienced eczema. On an unknown date, the outcome of the eczema was not recovered/not resolved.   It was unknown if the reporter considered the eczema to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient had received Shingrix in the left arm.and two weeks after vaccination, the patient developed eczema.   The patient had eczema all over her body and was told by her dermatologist that she will have it for the rest of her life.  The reporter stated that she did not plan on getting her second dose because of eczema. The reporter did not know the lot number or expiration date. The patient consented to follow-up and gave permission to contact dermatologist.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Pain, Vaccination failure
Clinical narrative: second dose in 2020/ Shingles outbreak in 2021/Suspected Vaccination failure; Shingles outbreak; pain; blisters; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 1st dose of Shingrix. On 11th August 2021, between 10 and 12 months after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and blister. 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 and the outcome of the blister was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and blister to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient reported the case for herself. The age at vaccination was not reported for 1st dose. The patient received Shingrix vaccine and was diagnosed with a shingles outbreak and the patient still had pain from the Shingles outbreak, but the blisters were gone. The reporter consented to follow up. This case was considered to be a suspected vaccination failure case, laboratory confirmation for shingles was unknown at the time of reporting.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Headache, Nausea, Pyrexia
Clinical narrative: Nausea; Stomach pain; Fever; Headache; This case was reported by a consumer and described the occurrence of nausea in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2021, the patient received the 1st dose of Shingrix (intramuscular). On 2nd September 2021, 1 days after receiving Shingrix, the patient experienced nausea, stomach pain, fever and headache. On 3rd September 2021, the outcome of the nausea, stomach pain and fever were recovered/resolved. On an unknown date, the outcome of the headache was recovering/resolving.   It was unknown if the reporter considered the nausea, stomach pain, fever and headache to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient received the vaccine in the left arm and experienced nausea, stomach pain, and fever that began in the morning of the next day after vaccination and resolved in the morning of the reporting date. The patient had also experienced a headache that started on next day after vaccination and had gotten better, but it had not totally resolved till the time of reporting. The reporter did not consent to follow-up and did not give permission to contact health care professional.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Social problem
Clinical narrative: wait until they were vaccinated for Covid before getting their second vaccination; This case was reported by a pharmacist and described the occurrence of social problem in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix over one year ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional information was provided as follows: The age at vaccination was not applicable for this report. The patient received the first dose of Shingrix over one year ago. The patient did not receive the 2nd dose of Shingrix till the time of reporting and was told to wait until he was vaccinated for Covid before getting the second Shingrix vaccination.  The pharmacist reported inappropriate schedule of vaccine and inquired if Shingrix series should be restarted. The patient received the full Covid vaccinations over 14 days before the day of reporting.  The reporter did not know exact dates of Shingrix or Covid immunizations. The reporter did not consent to follow up. This case is linked to case US2021AMR189788 reported by same reporter for another patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR189788:Same reporter
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: Vertigo; This case was reported by a consumer via call center representative and described the occurrence of vertigo in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In September 2021, 24 hrs after receiving Shingrix, the patient experienced vertigo. On an unknown date, the outcome of the vertigo was not recovered/not resolved.   The reporter considered the vertigo to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient. On 2nd September 2021, about 24 hours after vaccination, the patient began to experience vertigo.  The patient was asking if this was a side effect of Shingrix and how long it would last.  No Lot number or expiration date was provided. The reporter consented to follow up.
Age: 16.0
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: administrated with an expired dose of Menveo; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA398A, expiry date 31st August 2021) for prophylaxis.   On 7th September 2021, the patient received Menveo. On 7th September 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: On 7th September 2021, patient received an expired dose of Menveo, which is expired on 31st August 2021, which led to expired vaccine used. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021190968:deleted duplicate case
Sex: M
Vaccine: VARZOS
Symptoms: Product supply issue
Clinical narrative: unable to get his second dose due to a local shortage at his pharmacy; This case was reported by a consumer and described the occurrence of product supply issue in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 4 years ago in 2017).   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 case was reported by the consumer for himself. The age at vaccination is not applicable for this report. The patient stated that, he was unable to get his second dose due to a local shortage at his pharmacy, which led to product supply issue. The reporter gave medical disclaimer, referred to health care professional. The patient stated that, he would speak to his health care professional before he go to get the second dose.  The reporter spoke per PI and content and gave caller PAP outside number and provided cold transfer. The reporter consented to follow up.