chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Vaccine positive rechallenge
Clinical narrative: still dealing with pain on my forehead; This case was reported by a consumer via interactive digital media and described the occurrence of forehead headache in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received shot 8 years ago of reporting date) and Shingles vaccine with an associated reaction of headache (received 1st dose on unknown date, for tolerance refer case US2021AMR094078).   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 forehead headache. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the forehead headache was not recovered/not resolved.   It was unknown if the reporter considered the forehead headache 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 age group was not reported but was captured as adult as per vaccine indication. The patient got a shot 8 years ago and still came down with it. The patient's physician send him/her to get the new vaccine shot a series of 2 Shots. The patient received Shingles vaccine and experienced pain on forehead.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR094078:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first Shingrix/October 4, 2020/need to schedule my second one.; This case was reported by a consumer and described the occurrence of incomplete course of vaccination in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 4th October 2020) and Covid-19 vaccine moderna (1st dose received on unknown date). Concomitant products included COVID-19 MRNA-1273 VACCINE (COVID-19 VACCINE MODERNA).   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 case was reported by the patient himself/herself. The age at vaccination was not applicable for this report.  The patient asked how long she should wait to schedule the 2nd Shingrix shot since she received the 2nd dose of moderna covid -19 vaccine on the day of reporting. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Limb immobilisation, Pain in extremity
Clinical narrative: arm to ache; arm difficult to move; This case was reported by a consumer and described the occurrence of pain in arm in a adult 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 pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm and mobility decreased were unknown.   It was unknown if the reporter considered the pain in arm and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient asked if it was common for his/her arm to ache and be difficult to move after 2nd dose of Shingrix vaccine. No further details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient who had a Shingles case had recently completed Shingrix 2.; This case was reported by a other health professional via sales rep and described the occurrence of shingles in a adult 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 shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The reporter stated that patient had a shingles case and the patient had recently completed Shingrix 2. The reporter did not agree to follow up from GSK.
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram, Injection site swelling, Scan with contrast, Swelling
Clinical narrative: injection site swelling; side was swollen; This case was reported by a consumer via other manufacturer and described the occurrence of injection site swelling in a 79-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Contrast dye with an associated reaction of urticaria (Injected contrast dye for a kidney test and she had hives after the test). Concurrent medical conditions included epinephrine (Allergic to Epinephrine), drug allergy (Allergic to Tetracycline, Vicodin, and contrast dye) and food allergy (allergic to seafood particularly seafood).   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced injection site swelling and swelling. On an unknown date, the outcome of the injection site swelling and swelling were unknown.   It was unknown if the reporter considered the injection site swelling and swelling to be related to Shingles vaccine.  Additional details were provided as follows: The age at the vaccination was not reported.  Caller stated she was also allergic to Epinephrine, Tetracycline, Vicodin, and contrast dye. Caller stated that she was allergic to seafood particularly seafood. The patient received the shingles vaccine and she had a reaction a day after receiving it and she had injection site swelling and her side was swollen.  Caller would like to know if it would be safe for her to take the Pfizer COVID vaccine. Caller would like to know if these allergies would cause a problem with her receiving the Pfizer COVID vaccine. Caller stated she was injected with contrast dye for a kidney test and she had hives after the test. Caller took a list of ingredients to an HCP to compare ingredients to medications she was allergic to and saw if there were any ingredients that were the same that could cause a potential interaction.  Caller would like to know if the Covid vaccine would be safe to take. No further information was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Computerised tomogram normal, Discomfort, Fatigue
Clinical narrative: suffer from extremely painful joints; abdominal discomfort / great discomfort in my upper abdomen; intense abdominal pain / scheduled for an endoscopy; have lost 10 lbs. due to the discomfort and pain; have lost my ability to perform many of the activities / normal life disrupted; fatigue; horrible experience / disappointed, uncomfortable and discouraged I am / due to the discomfort and pain; severe flu-like symptoms; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th December 2020, the patient received the 2nd dose of Shingrix. On 10th December 2020, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the patient experienced joint pain, upper abdominal discomfort, abdominal pain, weight loss, activities of daily living impaired, fatigue and discomfort. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the joint pain, abdominal pain, weight loss, activities of daily living impaired, fatigue and discomfort were unknown and the outcome of the upper abdominal discomfort was not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, joint pain, upper abdominal discomfort, abdominal pain, weight loss, activities of daily living impaired, fatigue and discomfort to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient received shingrix and on same evening experienced flu like symptoms which lasted approximately for 4 days. At the time of reporting, the patient was suffering from extremely painful joints and abdominal discomfort which have never resolved. On 24th December 2020, the patient went to hospital due to the intense abdominal pain but all tests showed no obvious problem. The physician told that the patient was still dealing with side effects from  vaccine. The patient was scheduled for an endoscopy to determine why she still had great discomfort in her upper abdomen. The patient told that it was a horrible experience and she had lost 10 lbs. The patient stated that before vaccination she was a very active and for the most part healthy. The patient lost her ability to perform many of the activities, due to discomfort and fatigue that were with her 24 by 7. The patient's oncologist had a computerised tomogram scan and blood work done and there was no obvious reasons for this discomfort. The patient had continued contact with her general practitioner who had requested the endoscopy. The patient stated that she cannot express emphatically enough how disappointed, uncomfortable and discouraged she became to have her normal life disrupted by this vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Laboratory test normal, Loss of personal independence in daily activities, Physical examination, Weight decreased
Clinical narrative: suffer from extremely painful joints; abdominal discomfort / great discomfort in my upper abdomen; intense abdominal pain / scheduled for an endoscopy; have lost 10 lbs. due to the discomfort and pain; have lost my ability to perform many of the activities / normal life disrupted; fatigue; horrible experience / disappointed, uncomfortable and discouraged I am / due to the discomfort and pain; severe flu-like symptoms; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th December 2020, the patient received the 2nd dose of Shingrix. On 10th December 2020, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the patient experienced joint pain, upper abdominal discomfort, abdominal pain, weight loss, activities of daily living impaired, fatigue and discomfort. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the joint pain, abdominal pain, weight loss, activities of daily living impaired, fatigue and discomfort were unknown and the outcome of the upper abdominal discomfort was not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, joint pain, upper abdominal discomfort, abdominal pain, weight loss, activities of daily living impaired, fatigue and discomfort to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient received shingrix and on same evening experienced flu like symptoms which lasted approximately for 4 days. At the time of reporting, the patient was suffering from extremely painful joints and abdominal discomfort which have never resolved. On 24th December 2020, the patient went to hospital due to the intense abdominal pain but all tests showed no obvious problem. The physician told that the patient was still dealing with side effects from  vaccine. The patient was scheduled for an endoscopy to determine why she still had great discomfort in her upper abdomen. The patient told that it was a horrible experience and she had lost 10 lbs. The patient stated that before vaccination she was a very active and for the most part healthy. The patient lost her ability to perform many of the activities, due to discomfort and fatigue that were with her 24 by 7. The patient's oncologist had a computerised tomogram scan and blood work done and there was no obvious reasons for this discomfort. The patient had continued contact with her general practitioner who had requested the endoscopy. The patient stated that she cannot express emphatically enough how disappointed, uncomfortable and discouraged she became to have her normal life disrupted by this vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Nerve injury, Neuralgia, Post herpetic neuralgia, Vaccination failure
Clinical narrative: suspected vaccination failure; I got them shortly after I got the shot; Still having bad nerve damage pain; Still having bad nerve damage pain; Worse pain ever; This case was reported by a consumer via media and described the occurrence of  suspected vaccination failure in a adult 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, post herpetic neuralgia, nerve damage and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the post herpetic neuralgia, nerve damage and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia, nerve damage and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient was the reporter herself/himself. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient received Shingles vaccine and shortly after experienced shingles. It has been 2 years and the patient was still having bad nerve damage pain and stated worse pain ever. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Had both vaccines and still got shingles / Suspected Vaccination Failure; Had both vaccines and still got shingles; Pain was intense; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and 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. 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 age group was not reported but selected as adult as per the vaccine indication. The patient stated that, vaccine does not mean you wont get shingles anymore. He or she had both vaccines and still got shingles on the right side of nose and the pain was intense. This case was considered as suspected vaccination failure as details regarding the laboratory test confiding shingles and time to onset for shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination Failure; I got the shingles vaccine! / still had shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult 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 herself/himself. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The reporter stated that sorry he/she did received shingles vaccine and still had shingles but shingles was worse and stated never another vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: The first shot made me hurt all over; This case was reported by a consumer and described the occurrence of generalized aching in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced generalized aching. On an unknown date, the outcome of the generalized aching was recovered/resolved.   It was unknown if the reporter considered the generalized aching to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient itself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The 1st dose of Shingles vaccine and it hurts the patient all over. The patient got 2nd shot as well but with no problems. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: had two shots since then very painful; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles 5 times in 25 years).   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 pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient. The age group was not reported but was captured as adult as per vaccine indication.  The age at vaccination was not reported. The patient had receive 1st dose of Shingles vaccine and experienced pain. The follow-up would not possible as no contact details were available. For tolerance of 2nd dose, refer case US2021AMR095150.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR095150:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Vaccine positive rechallenge
Clinical narrative: had two shots since then very painful; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles 5 times in 25 years).   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 pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient. The age group was not reported but was captured as adult as per vaccine indication.  The age at vaccination was not reported. The patient had receive 2nd dose of Shingles vaccine and since then it was very painful. The follow-up would not possible as no contact details were available; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR095145:same reporter, same patient
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; I am just getting over shingles.; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult 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, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by patient herself/himself. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received the 2 doses of Shingles vaccine 2 years ago and had shingles. The reporter stated that he/she was just getting over of shingles. The reporter stated that from what he/she heard from others, patient's case was not as bad as it could have been so might be the vaccination was helpful. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting.
Sex: F
Vaccine: FLUX
Symptoms: Bronchitis, COVID-19, Death, General physical health deterioration, Illness
Clinical narrative: Died of Covid; Got pneumonia as well; Got bronchitis; Flu shot / her / health declined after that; got sick for over a year now; This case was reported by a consumer via other manufacturer and described the occurrence of covid-19 in a elderly female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Concurrent medical conditions included low blood pressure.   In November 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, less than 2 years after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced covid-19 (serious criteria death), pneumonia (serious criteria GSK medically significant), bronchitis, general physical health deterioration and sickness. On an unknown date, the outcome of the covid-19 was fatal and the outcome of the pneumonia, bronchitis, general physical health deterioration and sickness were unknown. The reported cause of death was covid-19.   It was unknown if the reporter considered the covid-19, pneumonia, bronchitis, general physical health deterioration and sickness to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The case was reported by patient's daughter. The age at vaccination was not reported. In 2019, the patient received Flu vaccine and got bronchitis, and pneumonia as well and ever since she got sick for over a year. The patient's health declined after that. The patient was elderly, so the reporter was very careful in following up on protocol. The reporter stated that the patient died of Covid. The reporter consented to follow up. This is 1 of 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR095136:Same reporter US-GLAXOSMITHKLINE-US2021AMR095203:Same reporter. Flu shot reporter's case.; Reported Cause(s) of Death: COVID-19
Sex: F
Vaccine: FLUX
Symptoms: Pneumonia
Clinical narrative: Died of Covid; Got pneumonia as well; Got bronchitis; Flu shot / her / health declined after that; got sick for over a year now; This case was reported by a consumer via other manufacturer and described the occurrence of covid-19 in a elderly female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Concurrent medical conditions included low blood pressure.   In November 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, less than 2 years after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced covid-19 (serious criteria death), pneumonia (serious criteria GSK medically significant), bronchitis, general physical health deterioration and sickness. On an unknown date, the outcome of the covid-19 was fatal and the outcome of the pneumonia, bronchitis, general physical health deterioration and sickness were unknown. The reported cause of death was covid-19.   It was unknown if the reporter considered the covid-19, pneumonia, bronchitis, general physical health deterioration and sickness to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The case was reported by patient's daughter. The age at vaccination was not reported. In 2019, the patient received Flu vaccine and got bronchitis, and pneumonia as well and ever since she got sick for over a year. The patient's health declined after that. The patient was elderly, so the reporter was very careful in following up on protocol. The reporter stated that the patient died of Covid. The reporter consented to follow up. This is 1 of 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR095136:Same reporter US-GLAXOSMITHKLINE-US2021AMR095203:Same reporter. Flu shot reporter's case.; Reported Cause(s) of Death: COVID-19
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Neoplasm malignant, Pain, Vaccination failure
Clinical narrative: Also have cancer thank you Lord for hospice; Hospice / so good helping me with the pain; I have them now, and I've had the shot; I have them now, and I've had the shot / Suspected vaccination failure; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult 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), cancer (serious criteria hospitalization and GSK medically significant), pain (serious criteria hospitalization) and shingles. On an unknown date, the outcome of the vaccination failure, cancer, pain and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, cancer, pain and shingles to be related to Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not reported.  The age group was not reported but was captured as adult as per vaccine indication. The patient had cancer and the patient stated that, thank you Lord for hospice they have been so good helping with the pain. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation for shingles infection and time to event onset was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had the shingles had it for 3 weeks but very little because I had the vaccine 4 years ago/Suspected Vaccination failure; very little pain; had the shingles had it for 3 weeks; This case was reported by a consumer via media and described the occurrence of Suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, more than 2 years after receiving 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 and pain were unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient got very little Shingles after vaccination. The patient had vaccine 4 years ago from reporting day and very little pain. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the shingles shot still have them but not as bad/suspected Vaccination failure; still have them but not as bad; This case was reported by a consumer via media and described the occurrence of Suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (at the age of 10 years old, also in 20s of age for about 3 times a year).   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 itself. The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient got Shingles after vaccination. The patient reported that shingles after vaccination was not bad. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory confirmation, time to onset of shingles were unknown at the time of reporting.
Sex: M
Vaccine: HEPA
Symptoms: Extra dose administered, Incorrect dose administered
Clinical narrative: inadvertently administered an extra dose of Havrix to a patient; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a adolescent male patient who received HAV (Havrix) (batch number 5575N, expiry date 19th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was physician assistant. The age at vaccination was not reported. The reporter inadvertently administered an extra dose of Havrix to the patient. No details about previous doses were provided. The reporter consented to follow up through Email.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received first dose of Shingrix on 1/13/2020 / not received the second dose to date; This case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 13th 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 reporter called on behalf of the patient. 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. No patient demographics were provided. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received / first dose / 2 years ago / second dose has not been received yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019, around 2 years ago of reporting 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 reporter provided facility details where 1st dose of Shingrix was administered but the vaccination date, expiration date and lot number could be recovered from record. Till the time of reporting, patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Age: 0.17
Sex: M
Vaccine: HEP, HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose at birth: November 3th 2020 / 3rd dose: March 12th 2021; 1st dose at birth: November 3th 2020 / 2nd dose: January 5th 2021; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 9-week-old male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HBV (Engerix B).   On 5th January 2021, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 12th March 2021, the patient received the 3rd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 5th January 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, not applicable after receiving Engerix B and Engerix B Pre-Filled Syringe Device and an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long. On 12th March 2021, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too long and drug dose administration interval too short 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 was Licensed Practical Nurse and mother of the patient. The patient received 1st dose of Engerix B at birth. The patient received 2nd dose of Engerix B, later than recommended interval of 1 month after 1st dose, which led to lengthening of vaccination schedule. The patient received 3rd dose of Engerix B, earlier than the recommended interval of 6 months after 1st dose, which led to shortening of vaccination schedule. The reporter did not administered the vaccine to the patient. She did not know the facility where the vaccines were administered and no lot number nor expiration date provided. The reporter did not consent to follow up.
Sex: M
Vaccine: MENB
Symptoms: Incomplete course of vaccination
Clinical narrative: received first dose /in March of 2020 and had not yet received the second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 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 (1st dose received in March 2020 on unknown date).   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 reported as follows: The case was reported by patient's mother. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of the Bexsero, which led to incomplete course of vaccination. The reporter did not want to provide any demographics for the patient. The reporter did not consent to follow up.
Sex: F
Vaccine: HEP, HEPAB
Symptoms: Incomplete course of vaccination, Interchange of vaccine products, Wrong product administered
Clinical narrative: Twinrix was given on 27Dec2020 and 2nd dose not administered; had a second dose with Engerix-B instead; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis and HBV (Engerix B) for prophylaxis.   Previously administered products included Twinrix (1st dose received on 27th December 2020 batch 75C72  expiry date 13th June 2022).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 20th April 2021, the patient received Engerix B. On 20th April 2021, not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device and unknown after receiving Engerix B, the patient experienced wrong vaccine administered. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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 reported as follows: The age at the time of Engerix B vaccination was not reported but it could be 59 years or 60 years. The age at vaccination was not applicable for Twinrix. After having 1st dose, the patient did not receive next dose of the Twinrix, which led to incomplete course of vaccination. The patient got 2nd dose with Engerix-B instead, which led to wrong vaccine administered. The reporter asked guidance on how to proceed on the completion of Twinrix dosing schedule. No other information was collected. The reporter consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Shingrix already expired was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a adult patient who received Herpes zoster (Shingrix) (batch number unknown, expiry date 28th February 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as per vaccine indication. The patient received expired Shingrix vaccine. The reporter did not have data form the patient or exact date from vaccination, accurate data about lot number, but knew that Vaccine had expiration date for Feb/2021. This case has been linked with US2021094214, reported by same rporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021094214:Same reporter.
Sex: U
Vaccine: RV1
Symptoms: Incorrect route of product administration
Clinical narrative: a child was administered Rotarix intramuscularly instead of orally; This case was reported by a pharmacist via call center representative and described the occurrence of wrong route of administration in a infant patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 27th April 2021, the patient received Rotarix lyophilized formulation (intramuscular) and Rotarix Oral Applicator Device. On 27th April 2021, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced wrong route of administration. On an unknown date, the outcome of the wrong route of administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at the vaccination was not reported. The patient received Rotarix intramuscularly, which led to wrong route of vaccine administration. No additional details at this time. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: administered the Shingrix second dose with less than the recommended time; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 394KF, expiry date 14th October 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix, less than the recommended time interval, which led to shortening of vaccination schedule. The health care provider asked for scheduled time for Shingrix to decide how to proceed with 2nd dose. The reporter consented to follow up. This case is been linked with US2021094190, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021094190:same reporter
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient born in 2019 was administrated with a partial dose of Havrix for adult; patient born in 2019 was administrated with a partial dose of Havrix for adult; This case was reported by a physician via call center representative and described the occurrence of adult product administered to child in a 19-month-old male patient who received HAV (Havrix adult) (batch number G99R4, expiry date 20th May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th April 2021, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On 28th April 2021, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced adult product administered to child and inappropriate age at vaccine administration. On an unknown date, the outcome of the adult product administered to child 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 was reported as follows: The patient received a dose of Havrix, administrated with a partial dose of Havrix for adult, which led to adult product administered to child and inappropriate dose of vaccine administered. No adverse event was reported . The reporter did not consent to follow-up. Note: The suspect was coded as Havrix adult conservatively as per source document narrative and regarding suspect confirmation clarification mail was marked by Hub not received any response.
Age: 54.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received 2 doses of Engerix-B / 03/19/2020 / 09/04/2020 / dynavax Hep B vaccine on 04/23/2021; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 54-year-old male patient who received HBV (Engerix B adult) (batch number 933623 ?, expiry date 22nd August 2021) (GSK note:the reported batch number did not match with any GSK lot number) for prophylaxis.   Previously administered products included Engerix-B (1st dose received on 19th March 2020 batch number 933839 ? expiry date 28th February 2021).   On 4th September 2020, the patient received the 2nd dose of Engerix B adult. On 4th September 2020, unknown after receiving Engerix B adult, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: On 23rd April 2021, the patient received 1st dose of Dynavax  (Heplisav-B). The patient received the 2nd dose of Engerix B, later than the recommended schedule, which led to lengthening of vaccination schedule. The patient received the 3rd dose of Hepatitis B vaccine, later than the recommended schedule, which led to lengthening of vaccination schedule. The reported batch number 933839 and 933623 for Engerix B was captured as 933839  ? and 933623 ? respectively, since they did not match with any GSK batch number.; Reporter's Comments: (GSK note:the reported batch number did not match with any GSK lot number)