chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shingles vaccine. She now gets them constantly; gets them constantly; 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.   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 reported as follows: The age at vaccination was not reported. The reporter stated that, his/her mother in law got the shingles vaccine. She now gets them constantly. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the shingles vaccine and still got shingles/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 reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the Shingles vaccine and still got the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the vaccine and still got shingles/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 reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Shingles vaccine and still got the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting.
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 received Shingles vaccine years ago from the date reporting. After receiving Shingles vaccine, the patient got shingles, but just a light case. The patient still went ahead and got the two shots they now suggested. 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, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; very painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and 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.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. The patient paid 150 dollars for the Shingles vaccine. After receiving Shingles vaccine, the patient got shingles. The patient stated that, it was very very painful. 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, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; I had them; hurt; 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. In August 2021, less than 2 years 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 patient had reported for him/herself. The age at vaccination was not reported. The patient received Shingles vaccine last year from the date reporting. After receiving Shingles vaccine, the patient got shingles last week from the date of reporting. The patient stated that, they surely did hurt. This case was considered as suspected vaccination failure, since the details regarding the laboratory confirmation of shingles was 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 reported. After receiving Shingles vaccine, the patient got shingles twice since then. 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: The shots to prevent did not help me I got a very bad case/ suspected vaccination failure; very bad case; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced 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 reported the case for herself/himself. The age at vaccination was not reported. The patient received shingle shot to prevent shingles, but it did not help, and the patient got a very bad case of shingles. The follow up would not be possible as no contact details were available. This case was considered as suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had both shots and i still got the shingles /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 reporter was the patient. The age at vaccination was not reported. The reporter stated that, had 2 shots and still got shingles. 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: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the shingles vaccine.she got the shingles. /suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's sister or brother. The age at vaccination was not reported. The reporter stated that, his or her sister had shingles vaccine and a year later got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shots but I also took the singles to/ 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 reporter was the patient. The age at vaccination was not reported. The reporter stated that, got the shots and also took the shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: injection site. About 3 inches by 5 inch rash.; This case was reported by a consumer via and described the occurrence of injection site rash 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 injection site rash. On an unknown date, the outcome of the injection site rash was unknown.   It was unknown if the reporter considered the injection site rash to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received shingle shot and had a very bad reaction to the Shingles vaccine injection site about 3 inches by 5 inch rash about 3 years ago. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Shingrix adjuvant only without the lyophilized antigen; Shingrix adjuvant only without the lyophilized antigen; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate dose of vaccine administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.  Additional case details were reported as follows: The age at vaccination was not reported. A pharmacist reported that a patient received a dose of the Shingrix adjuvant only without the lyophilized antigen which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. No symptoms were reported. The reporter consented to follow up. This case was 1 of 12 case reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR179303:Same reporter US-GLAXOSMITHKLINE-US2021AMR179300:Same reporter US-GLAXOSMITHKLINE-US2021AMR179306:Same reporter US-GLAXOSMITHKLINE-US2021AMR179305:Same reporter US-GLAXOSMITHKLINE-US2021AMR179304:Same reporter US-GLAXOSMITHKLINE-US2021AMR179302:Same reporter US-GLAXOSMITHKLINE-US2021AMR179301:Same reporter US-GLAXOSMITHKLINE-US2021AMR179297:Same reporter US-GLAXOSMITHKLINE-US2021AMR179299:Same reporter US-GLAXOSMITHKLINE-US2021AMR179298:Same reporter US-GLAXOSMITHKLINE-US2021178442:Same reporter
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; Had have two. That frist two didn't work/since  page is for what is shingles' and reported shot did not work; 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: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient got the shingle shots and it didn't work. The patient went back to checkup, he/she was advised to get shots done again. The cost was high and patient wanted to be safe. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure; got it; debilitating pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient got the shingle shot and got shingles.  The reporter stated they were painful and over two months of debilitating pain. 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. This case is one of the 8 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178234:Same reporter US-GLAXOSMITHKLINE-US2021AMR178222:Same reporter US-GLAXOSMITHKLINE-US2021AMR178106:Same reporter US-GLAXOSMITHKLINE-US2021AMR178101:Same reporter US-GLAXOSMITHKLINE-US2021AMR138446:Same reporter US-GLAXOSMITHKLINE-US2021AMR179367:Same reporter US-GLAXOSMITHKLINE-US2021AMR179366:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure; got it after/ the shot; debilitating pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient's friend. The age at vaccination was not reported. The patient got the shingle shot and got shingles.  The reporter stated that they were painful and over two months of debilitating pain. The follow-up would not possible as no contact details were available. 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. This case is one of the 8 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178234:Same reporter US-GLAXOSMITHKLINE-US2021AMR178222:Same reporter US-GLAXOSMITHKLINE-US2021AMR178106:Same reporter US-GLAXOSMITHKLINE-US2021AMR178101:Same reporter US-GLAXOSMITHKLINE-US2021AMR138446:Same reporter US-GLAXOSMITHKLINE-US2021AMR179350:Same reporter US-GLAXOSMITHKLINE-US2021AMR179367:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; got it after/ the shot; debilitating pain; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient's friend. The age at vaccination was not reported. The patient got the Shingle shot and got shingles.  The reporter stated that they were painful and over two months of debilitating pain. The follow-up would not possible as no contact details were available. 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. This case is one of the 8 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178234:Same reporter US-GLAXOSMITHKLINE-US2021AMR178222:Same reporter US-GLAXOSMITHKLINE-US2021AMR178106:Same reporter US-GLAXOSMITHKLINE-US2021AMR178101:Same reporter US-GLAXOSMITHKLINE-US2021AMR138446:Same reporter US-GLAXOSMITHKLINE-US2021AMR179366:Same reporter US-GLAXOSMITHKLINE-US2021AMR179350:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received shingrix a year ago but not the second dose; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received about a year ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional case details were reported as follows: The age at vaccination was not applicable for this report. A patient who received a Shingrix vaccine about a year ago from the date of reporting but never received the 2nd dose till the time of reporting which led to incomplete course of vaccination.  The reporter asked should they start the two regimen over again. No contact details were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: dozens of cases ofpeople that broke out in shingles from the vaccine /suspected vaccination failure; dozens of cases of people that broke out in shingles from the vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, doctor saiid that, he had got dozens and dozens of cases of people that broke out in shingles from the vaccine 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: F
Vaccine: VARZOS
Symptoms: Gait disturbance, Guillain-Barre syndrome, Intensive care, Walking aid user
Clinical narrative: sister had the shingles vaccine and ended up in intensive care with GBS; just starting to walk with a walker after 2 months; This case was reported by a consumer via media and described the occurrence of guillain barre syndrome 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 guillain barre syndrome (serious criteria hospitalization and GSK medically significant) and gait disturbance. On an unknown date, the outcome of the guillain barre syndrome and gait disturbance were unknown.   It was unknown if the reporter considered the guillain barre syndrome and gait disturbance to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's sister or brother. The age at vaccination was not reported The reporter stated that, his or her sister had the shingles vaccine and ended up in intensive care with guillain barre syndrome. The patient was just started to walk with a walker after 2 months.
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, several months 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: This case was reported by patient's friend. The age at vaccination was not reported. The patient got the shot and months later got shingles. The reporter said shots are not 100 precent either. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: my brother got a vaccine for shingles and has had it twice, had to be hospitalized for 7 days/ suspected vaccination failure; had it twice, on the right side of his face around his eye and forehead, had to be hospitalized for 7 days; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male 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 hospitalization and GSK medically significant) and shingles (serious criteria hospitalization). On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's sister. The age at vaccination was not reported. The reporter stated that, her brother got a vaccine for shingles and has had it twice. The reporter stated hat, her husband's nurse stated that, we all have it in us, it was just dormant. The patient had it on the right side of his face around his eye and forhead. The patient He had to be hospitalized for 7 days. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Adult dose was given to a 13-year-old; Adult dose was given to a 13-year-old; This case was reported by a other health professional via sales rep and described the occurrence of overdose in a 13-year-old female patient who received HAV (Havrix 1440 adult) for prophylaxis.   On 17th August 2021, the patient received Havrix 1440 adult. On 17th August 2021, unknown after receiving Havrix 1440 adult, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.  Additional details were provided as follows: This case was reported by the medical assistant. The reporter stated that, the 13 years old patient received adult dose of Havrix 1440, which led to overdose and adult product administered to child. No adverse events had been reported. The healthcare professional reported that an attempt had been made to contact the patient/parent regarding the medication error but was unable to speak with anyone yet. The reporter consented to follow up.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Adverse reaction, Urticaria
Clinical narrative: Head to toe hives; This case was reported by a consumer via call center representative and described the occurrence of generalized urticaria in a 35-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2013-2014) (batch number fj94n, expiry date 1st June 2014) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th September 2013, the patient received FluLaval Tetra 2013-2014 (intramuscular) and Flulaval Tetra Pre-Filled Syringe Device. On 1st June 2014, 257 days after receiving FluLaval Tetra 2013-2014 and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced generalized urticaria. On an unknown date, the outcome of the generalized urticaria was recovered/resolved.   It was unknown if the reporter considered the generalized urticaria to be related to FluLaval Tetra 2013-2014 and Flulaval Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: This case was reported by the patient herself. The patient had a adverse reaction of head to toe hives. The patient required IV antiallergy medication, Pepto-Bismol and ER visit. The patient enquired about the 2013 Flulaval product information to compare product description to current Covid-19 vaccines.  The reporter did not consent to follow-up.
Age: 5.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient 5 years of age received Boostrix; Patient received  Boostrix instead of Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number GC5NG, expiry date 1st April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th August 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 19th August 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was a medical assistant. The patient (5 years of age) received a dose of Boostrix when Kinrix was intended to be given, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: A child was given an adult dose of Havrix; A child was given an adult dose of Havrix; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 2-year-old male patient who received HAV (Havrix adult) (batch number KM72C, expiry date unknown) for prophylaxis.   On 19th August 2021, the patient received Havrix adult. On 19th August 2021, unknown after receiving Havrix adult, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.  Additional details were provided as follows: The pediatric patient was given an adult version of Havrix, which led to overdose and adult product administered to the child. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose on 12Nov2020 and has not received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 12th November 2020,batch number 2XG53, expiry date 12th February 2022).   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 did not consent to follow up.
Age: 2.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 2  year old who inadverently adminstered Kinirix.; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd August 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 23rd August 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by regulatory authority 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 Kinrix at the age of 2 years which led to inappropriate age at vaccine administration. The reporter consented to follow up. Healthcare professional declined to provide any additional patient information and did not have any vaccine details.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose of Shingrix a year and a half after the first dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2017, one and half year before receiving 2nd dose).   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 long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in 2019. The patient received 2nd dose of Shingrix, a year and a half after the first dose, later than the recommended schedule which led to lengthening of vaccination schedule. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose on 24Sep2019 and has not received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 24th Septemer 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. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. Vaccine data was not available. The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Palpitations
Clinical narrative: HEART PALPITATION; EXTREME WEAKNESS; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 18-AUG-2021 19:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 19-AUG-2021, the patient experienced heart palpitation. On 19-AUG-2021, the patient experienced extreme weakness. On 19-AUG-2021, the patient experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart palpitation, extreme weakness, and fatigue. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: MUSCLE ACHES; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle aches. This report was non-serious.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: ITCHY RED BUMPS TO LEFT ARM/BACK/CHEST; This spontaneous report received from a consumer concerned a 72 year old male. The patient's weight was 375 pounds, and height was 69 inches. The patient's past medical history included: chronic obstructive pulmonary disease, and atrial fibrillation, and concurrent conditions included: diabetic, and other pre-existing medical conditions included: Patient was on 02 therapy. Patient had no known any allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: 23-AUG-2021) dose was not reported, administered on 03-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the patient experienced itchy red bumps to left arm/back/chest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itchy red bumps to left arm/back/chest. This report was non-serious. This case, from the same reporter is linked to 20210843220.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: CHILLS; LOW GRADE FEVER; MILD HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced chills, low grade fever, and mild headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, low grade fever, and mild headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination failure, Vaccine breakthrough infection
Clinical narrative: BREAKTHROUGH INFECTIONS; SUSPECTED CLINICAL VACCINE FAILURE; This spontaneous report received from a health care professional concerned multiple patients (exact number unknown) of unspecified age, sex, race and ethnic origin. No past medical history or concurrent conditions were reported. The patient's(unknown number of individuals) received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry date: unknown) dose, start therapy date were not reported, frequency time 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, reporter was aware of a number of individuals that had breakthrough infections and suspected clinical vaccine failure. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the breakthrough infections and suspected clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000190135 This case, from the same reporter is linked to 20210837634.; Sender's Comments: V0 20210843298-COVID-19 VACCINE AD26.COV2.S-breakthrough infections. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). V0 20210843298-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head abnormal, Fatigue, Headache, Heart rate increased
Clinical narrative: Headaches.  Tiredness.   Elevated heart rate.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Injection site reaction, Joint stiffness, Lethargy
Clinical narrative: Week later extreme lethargy, muscle soreness, injection site reaction, fatigue, joint stiffness and pain lasting several days and currently still present at time of this documentation
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Week later extreme lethargy, muscle soreness, injection site reaction, fatigue, joint stiffness and pain lasting several days and currently still present at time of this documentation
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Thrombosis
Clinical narrative: MICRO BLOOD CLOT; HIGH BLOOD PRESSURE; This spontaneous report received from a company representative concerned a male of an unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient was healthy and fit. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown and expiry date: unknown) dose was not reported, 1 total administered in MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date after vaccination, the patient's blood pressure was increased and he was taken to the emergency room (ER). Later, he was diagnosed with micro blood clots and he was hospitalized . As per his doctor, micro blood clots might be linked with vaccination. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the micro blood clot and high blood pressure was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210846293-COVID-19 VACCINE AD26.COV2.S-micro blood clot, high blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).