chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: took the shot and still had 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 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 age at vaccination was not applicable to this report. The reporter knows people (patients) that took the shingles shot and still had 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 and time to onset and laboratory confirmation for shingles were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Bell's palsy, Immediate post-injection reaction
Clinical narrative: husband got Bell's palsy right after this new vaccine; This case was reported by a consumer via media and described the occurrence of bell's palsy 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, immediately after receiving Shingles vaccine, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was unknown.   It was unknown if the reporter considered the bell's palsy to be related to Shingles vaccine.  Additional case details were reported as follows: The case was reported by patient's wife. The age at vaccination was not reported. The patient got Bell's palsy right after this new Shingles vaccine. The reporter asked was this coincidence or not. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: several people I had known who got the shot, developed shingles anyway. those who contracted shingles after having the shot were probably given the live virus/Suspected Vaccination failure; developed shingles anyway; 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 reported as follows: The age at vaccination was not applicable for this reported. The reporter put off himself/herself getting the shot, as the reporter knew several patient's experienced shingles after getting shot. 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. This case has been linked with case US2021AMR178371, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178371:Same reporter
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shots and also 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.   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 reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Shingle shots and also 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: had the shot and 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.   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 shot and still got the shingles and had them really bad. 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: When you get the vaccine.then get shingles/Suspected Vaccination failure; get 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. As per the patient, when you get the vaccine, then you would get shingles and you were contagious and the gave shingles to others. 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: Condition aggravated, 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.   The patient's past medical history included shingles (Family History) (patient's sister in law had several times before receiving shot).   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 patient self reported the case. The age at vaccination was not reported. The patient stated that, the patients sister in law had never had chickenpox but she had shingles several times before she got the shot. The patient commented that, the shot does not keep one from getting the shingles ( if they once had chicken pox) but so they want get a severe case of shingles. The patient received the vaccine and 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 herpes zoster were not provided. This case has been linked to US2021AMR179072, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR179072:same reporter, master case
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had the shot and just recently got them anyway/had the shot a few years ago and just recently came down with the shingles/Suspected Vaccination Failure; shingles; painfull/ 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, several 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 was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional case details were reported as follows: The case was reported by the patient for himself/herself. The age at vaccination was not reported. The patient had the Shingles shot a few years ago from the date of reporting and just recently came down with the shingles and it was very painful and still suffering from them and the patient still had pain from them. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: shot twice and at 89 years old l got the shingles/ got the shot four years ago and now I got the shingles/Suspected Vaccination Failure; shingles; pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 89-year-old 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, more 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 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 and Shingles vaccine.  Additional case details were reported as follows: The case was reported by the patient for himself/herself. The age at vaccination was not reported. The patient got the shot twice four years ago from reporting date and now before reporting the patient got the shingles and the pain was so bad and was in lot of pain, and on third week the pain pills also did not work. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; pain; uncomfortable; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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, pain and discomfort. On an unknown date, the outcome of the vaccination failure, shingles, pain and discomfort were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and discomfort to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient got the shingle vaccine and still got shingles. He was in a lot of pain and uncomfortable for a long time. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles/ I got shingles twice after the shot; 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: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient got shingles twice after the shot. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: sick; This case was reported by a consumer via  interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Moderna with an associated reaction of pain (received Moderna on an unknown date).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 3 months after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient got Shingles shot two and half month back of reporting date and felt little sick. The patient said Shingles shot was not as bad as modern.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Loss of personal independence in daily activities, Pain, Pyrexia
Clinical narrative: painful; fever; Had long time ago. Had one shot but never again; was in bed for four days; This case was reported by a consumer and described the occurrence of pain 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 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced pain, fever, activities of daily living impaired and incomplete course of vaccination. On an unknown date, the outcome of the pain, fever, activities of daily living impaired and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the pain, fever and activities of daily living impaired to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received 1st dose long time ago and was painful, he/she got sick had fever and was in bed for 4 days. Till the time of reporting, the patient did not received 2nd dose, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: headache; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 23rd August 2021, the patient received Shingles vaccine. In August 2021, less than a week after receiving Shingles vaccine, the patient experienced headache. On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache 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 and experienced big headache now but mentioned that, it was worth it to prevent shingles The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 24th August 2021, the patient received Shingles vaccine. On 24th August 2021, less than a day after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported the case for herself/himself. The age at vaccination was not reported. The patient received shingle shot on the day of reporting and experienced sore arm. 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 preparation of medication 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 preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received a dose of the Shingrix adjuvant only without the lyophilized antigen, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No symptoms reported. The reporter was not in the office at the time of report and did not have any of the patients information at that time. The reporter consented to follow up. This case was 1 of 12 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR179302:Same reporter US-GLAXOSMITHKLINE-US2021AMR179303:Same reporter US-GLAXOSMITHKLINE-US2021AMR179304:Same reporter US-GLAXOSMITHKLINE-US2021AMR179305:Same reporter US-GLAXOSMITHKLINE-US2021AMR179306:Same reporter US-GLAXOSMITHKLINE-US2021AMR179301:Same reporter US-GLAXOSMITHKLINE-US2021AMR179300:Same reporter US-GLAXOSMITHKLINE-US2021AMR179307:Same reporter US-GLAXOSMITHKLINE-US2021AMR179298:Same reporter US-GLAXOSMITHKLINE-US2021AMR179299:Same reporter US-GLAXOSMITHKLINE-US2021178442:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: Suspected Vaccination failure; had it couple years ago some doesn't go away; scratch my back; 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 pruritus. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient got Shingles vaccine and experienced shingles couple of years ago and thought some doesn't go away. The patient stated that if only someone could scratch his/her back. 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 was linked with case US2021AMR179447, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR179447:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; had it couple years ago some doesn't go away; 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 was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient got Shingles vaccine couple of years ago and thought some experienced shingles which doesn't go away. 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 was linked with case US2021AMR179434, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR179434:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; didn't stop the outbreaks; 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 himself/herself.  The age at vaccination was not reported. The patient received Shingles vaccine and it did not stop the outbreaks. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure; got the very painful shingles; very painful shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), 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 case was reported by the patient's wife. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got the very painful shingles. The reporter stated that, they let him know they lingered after many, many months of having them. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation of shingles were not provided.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR180191:Same reporter
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 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 age at vaccination was not applicable. The reporter had worked at a retirement center. At retirement center, everyone who got Shingles vaccine got shingles. The follow-up would not possible as no contact details were available. 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 unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Death, Paralysis
Clinical narrative: Death; received the Vaccination and paralyzed her. Not long after she died; This case was reported by a consumer via media and described the occurrence of unknown cause of death 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 unknown cause of death (serious criteria death and GSK medically significant) and paralysis (serious criteria disability and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the paralysis was unknown. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine. The reporter considered the paralysis to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported for the reporter's friend and ex-coworker. The age at vaccination was not reported. The patient received Shingles vaccine and it paralyzed her.  Not long after that, the patient died.  The reporter suggested to research and have conversations with the doctor.  Reporter stated that, everyone reacted differently from every medication.; Reported Cause(s) of Death: Unknown cause of death
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; almost debilitating; really bad; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, asthenia and feeling bad. On an unknown date, the outcome of the vaccination failure, shingles, asthenia and feeling bad were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, asthenia and feeling bad to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient's wife The age at vaccination was not reported. The patient had both the shots and few months ago experienced shingles and was felling bad and was debilitating. This case was considered as suspected vaccination failure as details regarding, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Apparent life threatening event, Near death experience
Clinical narrative: nearly killed me; This case was reported by a consumer via media and described the occurrence of near death experience 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 near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was unknown.   The reporter considered the near death experience to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The patient reported that Shingles vaccine nearly killed him/her. The patient experienced horrible side effects.
Age: 25.0
Sex: M
Vaccine: HEP
Symptoms: Condition aggravated, Hepatitis A antibody abnormal, Inappropriate schedule of product administration, Therapeutic response decreased
Clinical narrative: Low titers after first series / as a child; First dose March 4 2021 / Second dose March 18 2021; This case was reported by a nurse via call center representative and described the occurrence of therapeutic response decreased in a 25-year-old male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device injection syringe for prophylaxis and HBV (Engerix B) (batch number 74em4, expiry date 20th December 2022) for prophylaxis.   Concomitant products included HBV (Engerix B).   On an unknown date, the patient received Engerix B and hepatitis B vaccine pre-filled syringe device. On 18th March 2021, the patient received the 2nd dose of Engerix B. On 18th March 2021, not applicable after receiving Engerix B and hepatitis B vaccine pre-filled syringe device, unknown after receiving Engerix B and an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too short. On an unknown date, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased 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 age at vaccination was not reported. The patient as a child had low titers after receiving the first series of Engerix-b, which led to therapeutic response decreased. Now patient started with second series of Engerix B and received 1st dose on 4th March 2021. The patient received 2nd dose earlier than recommended schedule, which led to shortening of vaccination schedule. No known side effect was reported. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021173207:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face, Swollen tongue
Clinical narrative: facial Swelling; tongue Swelling; This case was reported by a pharmacist via call center representative and described the occurrence of facial swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included autoimmune disorder. Concurrent medical conditions included food allergy.   On 16th August 2021, the patient received Shingrix (intramuscular). On 17th August 2021, 1 days after receiving Shingrix, the patient experienced facial swelling and swollen tongue. The patient was treated with benadryl (nos) (Benadryl) and antihistamine (Antihistamines). On an unknown date, the outcome of the facial swelling and swollen tongue were unknown.   It was unknown if the reporter considered the facial swelling and swollen tongue to be related to Shingrix.  Additional details were provided as follows: Pharmacist stated patient was approximately 52 years old. The pharmacist stated that patient was administered Shingrix vaccine in left deltoid muscle and one day after the vaccination the patient had facial and tongue swelling. On 18th August 2021,the patient called to pharmacist to report events but pharmacist believed event had been progressing since 17th August 2021. The patient was being treated with benadryl and antihistamines. The Pharmacist was calling from home and did not have vaccine lot number/expiration date. The reporter consented to follow up. The HCP (Health care professional) gave permission to follow-up.
Sex: U
Vaccine: FLU4
Symptoms: Hypersensitivity
Clinical narrative: Allergic Reaction; This case was reported by a physician via call center representative and described the occurrence of allergic reaction in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2013-2014) 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 an unknown date, the patient received FluLaval Tetra 2013-2014 and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, less than a year after receiving FluLaval Tetra 2013-2014 and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction 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 provided as follows: The age at vaccination was not reported. The physician reported that she had patient who had an allergic reaction to FluLaval vaccine in 2013. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the liquid portion / adjuvant only.; received only the liquid portion / adjuvant only.; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication 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 preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The medical assistant stated that, the patient had received only the liquid portion of the shingrix, they did not reconstituted with the powder. which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No further data reported. The the medical assistant states that a husband and wife were in the office and one of them received only a partial dose of the shingrix for dose 2 of the series. They had no way of determining which patient (the husband or wife) received the adjuvant only. They intend to revaccinate both patients in four weeks time. No further details were provided at the time of this call, and the medical assistant rushed off the line at the end of the medical discussion. No further details provided. The reporter consented to follow up.
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Urticaria
Clinical narrative: redness at the injection site; hives; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 17th August 2021, the patient received Boostrix (intramuscular) .5 ml. In August 2021, less than a week after receiving Boostrix, the patient experienced hives. On 18th August 2021, the patient experienced injection site erythema. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site erythema and hives were recovered/resolved.   It was unknown if the reporter considered the injection site erythema and hives to be related to Boostrix.  Additional details were provided as follows: The case was reported by the patient's friend. The age at vaccination was not reported. The reporter declined to provide demographic information and did not have many details. The patient received Boostrix on a Tuesday in unnown arm and next day after the vaccination patient had some redness at the injection site. On Friday or Saturday of the same week the patient had hives. The patient took Benadryl tablets and the hives resolved within days. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: received in 2017 the complete schedule. In 2020 had shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax with an associated reaction of herpes zoster.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the 1st case of shingles after the Zostavax vaccine. In 2017, about 4 years prior to the reporting, the patient received the complete vaccination schedule of Shingrix vaccine (the 2 doses 6 months apart) and in 2020, she had the mild case of shingles. The patient wanted to know if it was possible to get Shingrix twice in a lifetime. The different health care professionals (HCPs) told the patient different things and the last one said that it was not possible to get the Shingrix twice and refused to vaccinate the patient. The physician recommended revaccination after 5 years from the last Shingrix shot. The reporter was rushing to get off the phone and was looking for a yes or no to the question she asked about Shingrix booster dose. Upon asking the questions to document safety report, the reporter asked if she could get off the phone and thus, no vaccine information was provided at the time of the call. The reporter did not consent to follow up with the health care professional and therefore, did not collect the health care professional contact information. The reporter did not consent to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Skin exfoliation
Clinical narrative: Topical reaction. Injection site eruption; skin came off; This case was reported by a physician via call center representative and described the occurrence of injection site eruption in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st July 2021, the patient received the 1st dose of Shingrix. In July 2021, 3 days after receiving Shingrix, the patient experienced injection site eruption and skin peeling. On an unknown date, the outcome of the injection site eruption and skin peeling were unknown.   It was unknown if the reporter considered the injection site eruption and skin peeling to be related to Shingrix.  Additional details were provided as follows: The patient experienced minor local reaction after first dose of Shingrix. Topical reaction below the site of injection 4 inches down a little eruption, tiny and skin came off.  The patient stated that it was nothing big, small area, probably from the site of injection.  The patient experienced adverse event on day 3 after vaccine. The patient was not going to take 2nd vaccination. The reporter did not consent to follow-up. This case was been linked with the case US2021177362 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021177362:same reporter
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Overdose
Clinical narrative: Boostrix to the same patient twice on the same day; Boostrix to the same patient twice on the same day; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 11-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis and dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 2nd dose of Boostrix, Boostrix Pre-Filled Syringe Device, the 1st dose of Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device and not applicable after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced overdose and overdose. On an unknown date, the outcome of the overdose and overdose were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse manager stated that a certified medical assistants gave Boostrix to the same patient twice on the same day, which led to overdose. The reporter stated  that the patient had a twin and therefore the vaccine was administered to the same patient. This happened about 3 weeks ago and the child was fine. No additional patient demographics or vaccine details (lot, exp) available at time of call. The reporter consented to follow up via email.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, IPV
Symptoms: Incorrect dose administered
Clinical narrative: administrated Pediarix and a single dose of IPV at the same time; This case was reported by a physician via call center representative and described the occurrence of overdose in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 4977t, expiry date 5th September 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and POLIOMYELITIS VACCINE INACTIVATED (IPV (INACTIVATED POLIO VACCINE)) for prophylaxis.   On 23rd August 2021, the patient received the 3rd dose of Pediarix, Pediarix Pre-Filled Syringe Device and IPV (INACTIVATED POLIO VACCINE). On 23rd August 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient reported that 6 month old male patient was administrated Pediarix and a single dose of IPV at the same time, which led to overdose for inactivated polio component. The vaccines were administrated on the same day.  The dose of Pediarix was meant to be a third dose. The injections were given each one in different legs. The HCP believed the single dose IPV was from the brand SANOFI  but was not sure. No further events were reported. The reporter agreed to be contacted for follow up through email.