chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first shot years ago, never got second; 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 (received 1st dose, several years ago from the date of reporting).   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 for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingles vaccine, which led to incomplete vaccination schedule. The reporter asked, if he/she should start over.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: two years since first dose, never received second; 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 (received 1st dose, two 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 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 for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The patient asked, what he/she should do.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash; This case was reported by a other health professional via interactive digital media and described the occurrence of rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. The patient was treated with steroids nos (Oral Steroids). On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingles vaccine and experienced rash. The patient was treated with oral steroids and responded well but 5 days after rash came back. The reporter asked for recommendations. The follow-up would not possible, as no contact, details were available.
Sex: M
Vaccine: MENB
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose at nine months; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a 2-year-old male patient who received Men B NVS (Bexsero) 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.   Previously administered products included Bexsero (received 1st dose at the age of 9 months).   On an unknown date, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The case was reported by the patient's parent. The patient was 2 years 4 months old at the time of reporting. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Bexsero, which led to incomplete vaccination schedule. The parent asked, if the patient needed one or two more doses.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash macular
Clinical narrative: red spots; skin has been itchy; This case was reported by a consumer and described the occurrence of red spotty rash in a 56-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles a couple of years ago).   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 red spotty rash and pruritus. On an unknown date, the outcome of the red spotty rash and pruritus were unknown.   It was unknown if the reporter considered the red spotty rash and pruritus to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingles vaccine to prevent reoccurrence of shingles and experienced her skin had been itchy of late with red spots appearing. The patient's mother was a nurse and she thought the patient should go to urgent care. The reporter asked would GlaxoSmithKline concur. The reporter did not know which shingles shot she received. She said it was only one shot that she had (not 2) and it was about 2-3 years ago and it was after a shingles outbreak. The reporter gave GlaxoSmithKline safety permission to contact her general practitioner to confirm if she received Shingrix in the past. The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Social problem
Clinical narrative: first dose of vaccine in 2019, never went back for my second due to COVID; This case was reported by a consumer via interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in fall of 2019).   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 patient self-reported the case. The age at vaccination was not applicable for this report. Till the time of reporting, the patient never received 2nd dose of Shingrix due to covid outbreak The parent asked, did he/she need to start over with the 2 doses regimen or should just get 2nd dose.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose 2 years ago. Didn't get second dose; 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 (received 1st dose, 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 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 for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash after vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had rash after vaccine. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Musculoskeletal chest pain, Vaccination failure
Clinical narrative: have it now / I was vaxed/ suspected vaccination failure; I have it now; pain under my right rib; bad back pain; 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, rib pain and back pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, rib pain and back pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rib pain and back pain to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. At the time of reporting, the patient had shingles, but no rash or blisters. The patient experienced bad back pain and pain under right rib after vaccinaation with shingles vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had them twice but I got the shot/suspected vaccination failure; had them twice; had them 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and shingles. On an unknown date, the outcome of the vaccination failure, shingles and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and 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. The patient had shingles twice, but he/she got the Shingles shot. The follow up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: missed 2nd shingrix..over 2 yrs; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose, 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 incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter asked if the patient start over.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: I got a 3rd shingrix vaccination; This case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.  Previously administered products included Shingrix (received 2 doses, 3 years ago from the date of reporting).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The patient self-reported the case. The age at vaccination was not reported. The patient received 3rd dose of Shingrix, because he/she forgot that he/she had the vaccine 3 years ago, which led to extra dose administered. The patient asked if this was dangerous.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm is still sore; 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 17th February 2022, the patient received Shingles vaccine. In February 2022, 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 not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were reported as follows: Age at vaccination was not reported. The patient received a dose of Shingles vaccine and experienced arm soreness. Consent to follow up was not possible as no contact details were available.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: currently suffering from shingles/ Suspected vaccination failure; My husband is currently suffering from shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male 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 Shingles vaccine and 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 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 was the reporter's spouse. The age at vaccination was not reported. The reporter stated that the patient was currently suffering from shingles and he had the shingles shot but after his booster shot this happened. The follow-up would not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of time to onset and laboratory test confirming shingles were unknown at the time of reporting.
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 an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had experienced nothing except a sore arm.  The reporter stated that nothing compared to shingle pain. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: getting it, mild case/suspected vaccination failure; getting it, mild case; 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 suspected vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the suspected vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the suspected vaccination failure and shingles 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 received Shingles vaccine and just had a mild case of shingles which was recovered in a week and it had not come back. The patient stated that the Shingles shot did not prevent him/her from getting shingles. The patient stated that if this was mild then he/she sure would not want a full blown case of it, so yes get the shot. Consent to follow up was not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: Had the 2 doses, had shingles/ Suspected vaccination failure; minor case of shingles; rash; 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, 4 months after receiving Shingles vaccine and unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient had 2 doses of shingles shot and had a very minor case of shingles about 4 months later. The physician said that, it would had been a bad case if the patient had not had the shot based on locations of the rash. The patient was thankful for getting the shot. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles were not provided.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 15 year old received adult vaccine; This case was reported by a pharmacist via other manufacturer and described the occurrence of adult product administered to child in a 15-year-old female patient who received HAV (Havrix adult) for prophylaxis.   On an unknown date, the patient received Havrix adult. On an unknown date, unknown after receiving Havrix adult, the patient experienced adult product administered to child. On an unknown date, the outcome of the adult product administered to child was unknown.  Additional details were provided as follows: The patient inadvertently received adult dose of Havrix, which led to adult product administered to child. This case had been linked with case US2022AMR032557, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR032557:Same reporter
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: 18 year old received adult vaccine; This case was reported by a pharmacist via other manufacturer and described the occurrence of adult product administered to child in a 18-year-old female patient who received HAV (Havrix adult) for prophylaxis.   On an unknown date, the patient received Havrix adult. On an unknown date, unknown after receiving Havrix adult, the patient experienced adult product administered to child. On an unknown date, the outcome of the adult product administered to child was unknown.  Additional details were provided as follows: The patient inadvertently received adult dose of Havrix, which led to adult product administered to child. This case had been linked with case US2022AMR032529, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR032529:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue
Clinical narrative: Fatigue; Chills; This case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (had shingles many years ago). Previously administered products included Shingles vaccine with an associated reaction of no adverse event (1st dose received on an unknown date).   In February 2022, the patient received the 2nd dose of Shingles vaccine. In February 2022, less than a week after receiving Shingles vaccine, the patient experienced fatigue and chills. On an unknown date, the outcome of the fatigue and chills were recovered/resolved.   It was unknown if the reporter considered the fatigue and chills to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and experienced 24 hours of fatigue and chills but would go through it a thousand times to avoid the horrific case of shingles, the patient's mother had it many years before reporting. The patient stated that a day of being tired was nothing compared to shingles. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: COVID19, VARZOS
Symptoms: Vaccination complication
Clinical narrative: Severe reactions including hospitalization; This case was reported by a pharmacist via sales rep and described the occurrence of hospitalization in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included COVID 19 VACCINE.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced hospitalization (serious criteria hospitalization). On an unknown date, the outcome of the hospitalization was unknown.   It was unknown if the reporter considered the hospitalization to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was given Shingrix a few weeks after Covid vaccine and had severe reactions including hospitalization. The reporter agrees to follow up from GlaxoSmithKline. This case has been linked to the case US2022AMR033567 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR033567:Same reporter. Patient 2 of 2.
Sex: U
Vaccine: COVID19, VARZOS
Symptoms: Vaccination complication
Clinical narrative: Severe reactions including hospitalization; This case was reported by a pharmacist via sales rep and described the occurrence of hospitalization in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included COVID 19 VACCINE.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced hospitalization (serious criteria hospitalization). On an unknown date, the outcome of the hospitalization was unknown.   It was unknown if the reporter considered the hospitalization to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was given Shingrix a few weeks after Covid vaccine and had severe reactions including hospitalization. The reporter agrees to follow up from GlaxoSmithKline. This case has been linked to the case US2022AMR033535 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR033535:Same reporter. Patient 1 of 2.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Never had the second dose; 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 (received 1st dose, 3 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 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 for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The patient asked, if he/she should get the 2nd dose at the time of reporting or if he/she was okay.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Muscle fatigue, Muscular weakness, Pain in extremity
Clinical narrative: Redness at injection site; decreased mobility in left arm; Weakness in left arm; Soreness in left arm; left arm "feel fatigued"; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th January 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced injection site erythema, injected limb mobility decreased, weakness of arms, pain in arm and muscle fatigue. On an unknown date, the outcome of the injection site erythema was recovered/resolved and the outcome of the injected limb mobility decreased, weakness of arms, pain in arm and muscle fatigue were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injected limb mobility decreased, weakness of arms, pain in arm and muscle fatigue to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received first dose of Shingrix in the left arm. The patient experienced redness at the injection site for a couple of days after receiving dose, redness had resolved. The patient experienced weakness, soreness and decreased mobility in the left arm approximately 2 weeks before reporting, the muscles and tissues in her left arm felt fatigue. The patient stated that, weakness, soreness, decreased mobility were ongoing at the time of reporting. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Unsure if received 1 or 2 doses, unsure if had 2nd dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 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 provided as follows: The age at vaccination was not applicable for this report. The patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The patient was unsure if he ever had his second dose of Shingrix. The reporter asked if she could just send the patient for a 2nd dose. The reporter consented to follow up. However, it was unable to verify consent to follow-up because Healthcare professional was unable to be reached. Note: The case was kept valid conservatively.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: infanrix was administered to an 11 y/o instead of Boostrix.; infanrix was administered to an 11 y/o; 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 female patient who received DTPa (Infanrix) (batch number 23T73, expiry date 30th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th February 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 11th February 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that Infanrix was administered to the patient instead of Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: hives all over her body; This case was reported by a consumer via call center representative and described the occurrence of hives in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   In February 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 16th February 2022, less than a week after receiving Shingrix, the patient experienced hives. The patient was treated with benadryl (nos) (Benadryl) and prednisone. On an unknown date, the outcome of the hives was not recovered/not resolved.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received her second Shingrix vaccine, in the left arm, 3 to 5 days before reporting. The patient reported, she had hives all over her body, she went to the emergency room last night before day of reporting because of the hives. The healthcare professional at the emergency room gave her Benadryl and Prednisone to help treat the hives. The patient stated that the hives were still everywhere on her body. The reporter did not consent to follow-up.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: freezing excursion, doses were administered; 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 HAV (Havrix) for prophylaxis.   On an unknown date, the patient received Havrix. On 8th February 2022, unknown after receiving Havrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that there was a freezing excursion in the fridge at her work location on 8th February 2022and some doses of Havrix may or may have not been in that fridge, which led to incorrect storage of drug. The reporter stated that two doses of Havrix were administered on 09th February 2022 at the facility but reporter did not know if the doses had been in the fridge that had the temperature excursion. The reporter consented to follow up.
Sex: U
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose AUG 2021, 2nd FEB 2022/no record of the second dose being received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose in August 2021).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Upon follow up, the reporter reported that, there was no documentation of the patient receiving their 2nd dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter did not provide demographic details from patient since they were not available. The reporter did not consent to follow-up.
Age: 0.17
Sex: U
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: Patient was given Kinrix at months 2 and 4; Patient was given Kinrix at months 2 and 4; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis and dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Kinrix, Kinrix Pre-Filled Syringe Device, the 2nd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device and not applicable after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and extra dose administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and extra dose administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The pediatric patient was given Kinrix as an infant at the age of 2 and 4 months, which led to inappropriate age at vaccine administration and extra dose administered. The reporter consented to follow up.
Age: 11.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: MA stated they inadvertently administered an expired dose to a patient; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA87AZ, expiry date 31st January 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 17th February 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 17th February 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Medical assistant stated that, they inadvertently administered an expired dose of Bexsero to the patient, which led to expired vaccine used. The reporter inquired if the dose was okay. The reporter consented to follow up.
Age: 22.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Female patient received and expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 22-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA82AZ, expiry date 31st January 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 18th February 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 18th February 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received an expired dose of Bexsero, which led to expired vaccine used. The reporter declined to provide her last name and the patient's date of birth but did state that, the patient was 22 years old.  The reporter consented to follow up.
Age: 1.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: HCP reports that a 1 year old patient inadevertedley received Kinrix instead of Havrix; HCP reports that a 1 year old patient inadevertedley received Kinrix instead of Havrix; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old male patient who received DTPa-IPV (Kinrix) (batch number d24g7, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th September 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 9th September 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient inadvertently received Kinrix instead of Havrix at the age of 1 year, which led to inappropriate age at vaccine administration and wrong vaccine administered.  No further events were reported.  The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter.
Age: 49.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: reconstituted with diluent other than the supplied diluent.; reconstituted with diluent other than the supplied diluent.; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 49-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA591A, expiry date 31st August 2022) for prophylaxis.   On 18th February 2022, the patient received Menveo. On 18th February 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter reconstituted Menveo with diluent other than the supplied diluent and was unsure if the used diluent was normal saline or sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The Healthcare professional gave permission for safety to follow up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Pain, Pyrexia
Clinical narrative: Fever; Chills; total body aches; joint pain and then the joint pain localized into both hands; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number N7NP4, expiry date 9th April 2023) for prophylaxis.   On 22nd December 2021, the patient received the 2nd dose of Shingrix .5 ml. On 23rd December 2021, 1 days after receiving Shingrix, the patient experienced fever, chills, general body pain and joint pain. On an unknown date, the outcome of the fever, chills and general body pain were recovered/resolved and the outcome of the joint pain was not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, general body pain and joint pain to be related to Shingrix.  Additional details were provided as follows: The reporter that the patient experienced fever, total body aches/joint pain and chills the day after receiving her second dose of Shingrix. The reporter further stated that these symptoms subsequently resolved, however, after approximately 1 week after receiving the vaccine, the joint pain localized into both hands. The reporter stated that the joint pain in the hands was described as a pain level 5 and had not resolved.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: NAUSEA; VOMITING; ARM SORENESS; FEVER; CHILLS; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event.   On 16th February 2022, the patient received the 2nd dose of Shingrix. On 16th February 2022, 4 hrs after receiving Shingrix, the patient experienced pain in arm, fever and chills. On 17th February 2022, the patient experienced nausea and vomiting. On an unknown date, the outcome of the pain in arm, fever, chills, nausea and vomiting were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, fever, chills, nausea and vomiting to be related to Shingrix.  Additional details were reported as follows: Age at vaccination was not reported. The reporter declined to give her address and date of birth. The patient stated that she did not experience anything after first dose of shingrix. The patient received a dose of Shingrix and 4 hours later experienced arm soreness, fever, chills and the next day experienced nausea and vomiting. All events were ongoing. Consent obtained to contact consumer and health care professional. The reporter did not have any health care professional contact information or the name of the health care professional. The reporter disconnected the call and agent was unable to transfer call to after call survey.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received  3 doses; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date) and Shingrix (received 2nd dose on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, an unknown patient received 3 doses of Shingrix vaccine, which led to extra dose administered. The reporter consented to follow up.
Sex: U
Vaccine: FLUX
Symptoms: Wrong product administered
Clinical narrative: Received a flu shot instead of Shingrix; This case was reported by a physician via call center representative and described the occurrence of wrong vaccine administered in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   Linked case(s) involving the same patient:  US2022030608.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, there was a patient with a potential vaccine error. The patient was supposed to receive the 2nd Shingrix and he/she might have received a flu shot instead, which led to wrong vaccine administered. The reporter was not sure if the patient had received a flu shot instead or if they actually received their 2nd Shingrix. No additional information was provided. The reporter did not consent to follow up. Note: This case was kept valid conservatively, considering the possible error and no event was regarding the incomplete course was added as no vaccine dates or schedule was reported.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022030608:Same reporter