chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Pain, Vaccination failure
Clinical narrative: both shots and still got them; still got them; less painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles and pain.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's friend. The age at vaccination was not reported. The reporter stated that, he/she thought shingles vaccine was supposed lessen the severity and not make it worse. The reporter stated that, the patient got both the Shingles shots and still got the shingles but ere less painful then what she had before the shots. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation for shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Illness, Skin disorder, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; was sick; had painless bumps on it; 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, sickness and skin disorder. On an unknown date, the outcome of the vaccination failure, shingles, sickness and skin disorder were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, sickness and skin disorder to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient got the shingles vaccine a few years ago. Ithe patient was sick and went to the physician for something else. The patient had painless bumps on it , and when asked , the physician  looked and said it was shingles. It was very light, painless case because the patient had the 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: 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 patient. The age at vaccination was not reported. The patient received shingles and still got the shingles.  The patient stated that like all vaccines just because you got it does not mean you won't get it. 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: M
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 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 the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was patient's son/ daughter. The age at vaccination was not reported. The patient got shingles vaccine and had a terrible case of shingles.  The ad shouldn't say you would not get shingles. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: more than 6 months since first 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.   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 received 2nd dose, which led to incomplete course of vaccination. The patient also inquired what can be done if 1st dose of Shingrix vaccine has been more than 6 months.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure / have had them 11 times since the vaccine; have had them 11 times; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had Shingles 11 times since the Shingles vaccine. The patient would never have let the doctor talk him/ her into it if the patient would have known. The patient stated that the stupid pneumonia shot the doctor had talked him/ her into last year almost killed the patient.  The patient would not take any more vaccine of any kind. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles anyway. 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: F
Vaccine: VARZOS
Symptoms: Death, Hypersensitivity
Clinical narrative: allergic reaction; This case was reported by a consumer via media and described the occurrence of allergic reaction in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced allergic reaction (serious criteria death and GSK medically significant). On an unknown date, the outcome of the allergic reaction was fatal. The reported cause of death was allergic reaction.   It was unknown if the reporter considered the allergic reaction to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported for the reporter's sister in laws mother. The age at vaccination was not reported. After receiving Shingles vaccine, the patient passed due to allergic reaction complications to the Shingles vaccine about a month ago from the date of reporting. This case had been linked with case US2021AMR188219, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR188219:same reporter; Reported Cause(s) of Death: Allergic reaction
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 patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. 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: 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 patient had reported for him/herself. The age at vaccination was not reported. The patient did not get shingles until he/she got Shingles vaccine. 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: M
Vaccine: VARZOS, 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 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 the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient's wife. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Death, Hypersensitivity
Clinical narrative: allergic reaction; This case was reported by a consumer via media and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced allergic reaction (serious criteria death and GSK medically significant). On an unknown date, the outcome of the allergic reaction was fatal. The reported cause of death was allergic reaction.   It was unknown if the reporter considered the allergic reaction to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient's friend. The age at vaccination was not reported. After receiving Shingles vaccine, the patient passed due to allergic reaction complications to the Shingles vaccine about a month ago from the date of reporting. This case had been linked with case US2021AMR188176, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR188176:same reporter; Reported Cause(s) of Death: Allergic reaction
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 age at vaccination was not reported. The patient received every Shingles vaccine out there. After receiving Shingles vaccine, the patient got shingles three times. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation of shingles were not provided.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Condition aggravated, Herpes zoster, Pain, Tenderness
Clinical narrative: got the shots, it made the other times much easier / suspected vaccination failure; other times much easier; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 77-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had Shingles 2.5 years ago) and pregnancy (had four children with natural birth).   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The reporter stated if you had suffered like how she did  or do you would feel differently. The patient had shingles 2.5 years before day of reporting. It was so bad she could not walk. She had four children with natural birth and the pain combined did not exceed the pain of Shingles.  The patient had never hurt so bad from anything in my 77 years. Unfortunately, had the aftermath of Shingles, meaning she would have this pain the rest of her life. Her side and back hurts to touch. She could not even wear the clothes she want to wear because she could not stand for her clothes to touch her skin. The patient suggested to get the shots. Her family did after seeing she suffer. The patient got the shots after my first attack and it made the other times much easier. The patient not selling but trying to save others from pain. This case was considered as suspected vaccination failure, as details regarding laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: got the shots, it made the other times much easier / suspected vaccination failure; other times much easier; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 77-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had Shingles 2.5 years ago) and pregnancy (had four children with natural birth).   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The reporter stated if you had suffered like how she did  or do you would feel differently. The patient had shingles 2.5 years before day of reporting. It was so bad she could not walk. She had four children with natural birth and the pain combined did not exceed the pain of Shingles.  The patient had never hurt so bad from anything in my 77 years. Unfortunately, had the aftermath of Shingles, meaning she would have this pain the rest of her life. Her side and back hurts to touch. She could not even wear the clothes she want to wear because she could not stand for her clothes to touch her skin. The patient suggested to get the shots. Her family did after seeing she suffer. The patient got the shots after my first attack and it made the other times much easier. The patient not selling but trying to save others from pain. This case was considered as suspected vaccination failure, as details regarding laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received first dose in January; This case was reported by a other health professional via (Shingrix GSK interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in January 2020).   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 course of vaccination. The reporter asked should the series be restarted now or just completed with the second dose now.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: has a rash going up and down her arm that resembles chicken pox/Rash going up and down her arm; This case was reported by a consumer via call center representative and described the occurrence of vesicular rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th August 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced vesicular rash. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the vesicular rash was not recovered/not resolved.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional details were provided as follows: This case was self-reported by the patient. The patient received first dose and had rash which were going up and down her arm that resembled chickenpox. The patient's doctor prescribed her Benadryl. The patient did not want to provide health care professional information. The patient was hesitant to provide any adverse event details, demographic and information. The reporter did not consent to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Distractibility, Disturbance in attention, Fatigue, Injection site erythema, Injection site hypersensitivity
Clinical narrative: Injection site is painful / Injection site is tender; Injection site is sensitive; Red near the injection site; red, raised spot near the injection site; Tired; Easily distracted; Can't focus; Not sleeping well; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 25th August 2021, the patient received the 2nd dose of Shingrix. In August 2021, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site hypersensitivity, injection site erythema, injection site papule, tiredness, distractibility, mental concentration difficult and poor sleep. On an unknown date, the outcome of the injection site pain, injection site hypersensitivity, injection site erythema, injection site papule, tiredness, distractibility, mental concentration difficult and poor sleep were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site hypersensitivity, injection site erythema, injection site papule, tiredness, distractibility, mental concentration difficult and poor sleep to be related to Shingrix.  Additional detail were provided as follows: The age at vaccination was not reported. The patient stated that, she had her first Shingrix shot on 25th June 2021 and had no side effects. She had got her second dose of Shingrix and was experienced the following side effects like tired, easily distracted, could not focus, was not sleeping well, injection site was sensitive, painful, and tender, and a red, raised spot near the injection site. The patient did not want to provide her HCP (health care professional) information. The reporter did not consent to follow-up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site papule, Poor quality sleep
Clinical narrative: Injection site is painful / Injection site is tender; Injection site is sensitive; Red near the injection site; red, raised spot near the injection site; Tired; Easily distracted; Can't focus; Not sleeping well; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 25th August 2021, the patient received the 2nd dose of Shingrix. In August 2021, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site hypersensitivity, injection site erythema, injection site papule, tiredness, distractibility, mental concentration difficult and poor sleep. On an unknown date, the outcome of the injection site pain, injection site hypersensitivity, injection site erythema, injection site papule, tiredness, distractibility, mental concentration difficult and poor sleep were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site hypersensitivity, injection site erythema, injection site papule, tiredness, distractibility, mental concentration difficult and poor sleep to be related to Shingrix.  Additional detail were provided as follows: The age at vaccination was not reported. The patient stated that, she had her first Shingrix shot on 25th June 2021 and had no side effects. She had got her second dose of Shingrix and was experienced the following side effects like tired, easily distracted, could not focus, was not sleeping well, injection site was sensitive, painful, and tender, and a red, raised spot near the injection site. The patient did not want to provide her HCP (health care professional) information. The reporter did not consent to follow-up.
Age: 75.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: pediatric dose given to adult patient; pediatric dose given to adult patient; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 75-year-old female patient who received HAV (Havrix pediatric) (batch number YG7YJ, expiry date 3rd February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th August 2021, the patient received Havrix pediatric and Havrix Pre-Filled Syringe Device. On 17th August 2021, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product 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 received pediatric dose of the Havrix vaccine, which led to underdose and adult use of a child product. The reporter wanted to know if they had to revaccinate the patient or just give her another pediatric dose of Havrix. No further events were reported at the time of reporting. The health care professional did not specify which was the exact name of the vaccine other than saying pediatric dose of Havrix. The reporter consent to follow-up by email.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Missed the second 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 patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 20th September 2019).   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 health care professional stated that, till the time of reporting, the patient did not receive 2nd dose of shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up. The VAERS details were reported for 1st dose of Shingrix.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea
Clinical narrative: Nausea; Headache; This case was reported by a consumer and described the occurrence of nausea in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th June 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th June 2021, 1 days after receiving Shingrix, the patient experienced nausea and headache. On 30th June 2021, the outcome of the nausea and headache were recovered/resolved.   It was unknown if the reporter considered the nausea and headache to be related to Shingrix.  Additional details were provided as follows: This case was self-reported by the patient. The patient received 1st dose of Shingrix and on next day experienced nausea and headache for 1 day. Patient declined to provide health care professional information. The reporter did not consent to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Sore arm (at the injection site); This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2021, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   The reporter considered the injection site pain to be unrelated to Shingrix.  Additional details were provided as follows: This case was self-reported by the patient. The patient received 1st dose of Shingrix in the left deltoid and experienced injection site pain. The patient had her routine physical checkup in May 2021. The patient did not know if the shot was given intramuscularly. The patient said that doctor's office did not think her symptoms were due to Shingrix. The patient did not have information about lot number and expiration date. The patient did not receive any paperwork from pharmacy. The patient did not want to provide her doctor of medicine (MD) contact information. The reporter did not consent to follow up. For the tolerance of 2nd dose, refer case US2021AMR185129.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR185129:Same reporter.
Age: 43.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose August 27th 2020 and 2nd dose December 20th 2020; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 43-year-old female patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device injection syringe for prophylaxis.   Previously administered products included Havrix (received 1st dose on 27th August 2020).   On 20th December 2020, the patient received the 2nd dose of Havrix and hepatitis A vaccine pre-filled syringe device. On 20th December 2020, unknown after receiving Havrix and hepatitis A vaccine 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 pharmacist reported that the patient received 2nd dose of Havrix earlier than the recommended interval, which led to shortening of vaccine schedule. The reporter consented to follow up.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: administration of a pediatric dose to an adult patient; administration of a pediatric dose to an adult patient; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 31-year-old female patient who received HBV (Engerix B pediatric) (batch number 53yl7, expiry date 22nd December 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th August 2021, the patient received the 2nd dose of Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 30th August 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. The action taken with Engerix B Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse reported that pediatric dose was administered to adult patient, which led to underdose and adult use of a child product. No other details were reported. The reporter consented to follow up through email address.
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: giving a pediatric dose to two adults; giving a pediatric dose to two adults; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a adult male patient who received HAV (Havrix pediatric) for prophylaxis.   On 13th February 2020, the patient received the 1st dose of Havrix pediatric. On 13th February 2020, unknown after receiving Havrix pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional details provided were as follows: The age at vaccination was not reported. The health care professional called to report that a pediatric dose of Havrix was administered to an adult which led to underdose and adult use of a child product.  The health care professional did not have the batch number or any additional information.  The reporter consented to follow up. The case has been linked with case US2021183445, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021183445:Same reporter
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; experienced cases of Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a adult 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 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. It was reported that the patient had completed the series of Shingrix but experienced cases of Shingles after that and now Physician indicated a 3rd dose. Also Pharmacist reported that physician told her to re start the series. No vaccination details. The reporter did not consent to follow-up. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were not provided.
Age: 0.67
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: given an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 8-month-old female patient who received HBV (Engerix B pediatric) (batch number 4RB3J, expiry date 3rd April 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th August 2021, the patient received Engerix B pediatric (intramuscular) .5 ml and Engerix B Pre-Filled Syringe Device. On 30th August 2021, unknown after receiving Engerix B pediatric and Engerix B 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 provided were as follows: Nurse reported that the patient was administered with an expired dose of Engerix-B pediatric in left thigh which led to expired vaccine used. The reporter consented to follow-up.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: reconstituted with a liquid other than the supplied AS01B adjuvant.; reconstituted with a liquid other than the supplied AS01B adjuvant.; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 54-year-old male patient who received Herpes zoster (Shingrix) (batch number 27PA5, expiry date 3rd February 2023) for prophylaxis.   On 26th August 2021, the patient received the 1st dose of Shingrix. On 26th August 2021, unknown after receiving Shingrix, 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 pharmacist reported that another colleague administered to a patient 1st dose of Shingrix which was reconstituted with a liquid other than the supplied AS01B adjuvant, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: U
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 7-10-year-old patients were administered Boostrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a unspecified number of patients who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report The reporter stated that 7 to 10 year old patients were administered Boostrix, which led to inappropriate age at vaccine administration. The reporter did not consent to follow up.  No more information was provided.  This case was linked with US2016177194 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE INC.-US2016177194:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on October 17th 2019, didn´t received second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 17th October 2019).   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 pharmacist stated that, till the time of reporting, the patient did not receive 2nd dose of shingrix, which led to incomplete course of vaccination. The reporter consented to follow up. This case was linked with case US2019055807, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019055807:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: has not received the second dose yet; This case was reported by a consumer 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 (1st dose received on December 2019).   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 reporter was the patient. The age at vaccination was not applicable for this report. The reporter stated that, till the time of reporting, the patient did not receive 2nd dose of shingrix, which led to incomplete course of vaccination. The reporter declined to provide his date of birth or health care professional information. The reporter did not consent to follow up.
Age: 23.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: received a pediatric dose of Havrix vaccine.; received a pediatric dose of Havrix vaccine.; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 23-year-old female patient who received HAV (Havrix pediatric) (batch number YG7YJ, expiry date 3rd February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th August 2021, the patient received Havrix pediatric and Havrix Pre-Filled Syringe Device. On 17th August 2021, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced underdose. On an unknown date, the patient experienced adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product 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 are as follows: A medical assistant reported that, a 23 years old patient received a pediatric dose of Havrix vaccine, led to underdose and adult use of a child product. The reporter consented to follow-up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered only adjuvant; administered only adjuvant; This case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 2LC3P, expiry date 15th November 2022) for prophylaxis.   On 30th August 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 30th 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: The patient received dose of Shingrix in the right deltoid. The reporter stated that, administered only Shingrix adjuvant to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The nurse then got another vial of adjuvant, mixed it with the lyophilized powder and administered a full dose of Shingrix to the patient. The reporter consented to follow up.