chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Shot painful; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles 2 years ago).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient had the shingles 2 years ago it was horrible. The patient received a shot of Shingles vaccines and was painful. The follow-up could not be possible as no contact details were available. For tolerance of 2nd shot of Shingles vaccine, refer case US2021AMR197125.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR197125:Same reporter.
Sex: F
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 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 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 reporter was patient's friend. The age at vaccination was not reported. The patient got shingles and suffered the rest of her life after she got the shingles vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media (facebook) 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 reporter was patient. The age at vaccination was not reported. It was stated that the patient got shingles shots but still experienced shingles back in January. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: people who got shingles got the shingles shot-suspected vaccination failure; Shingles; This case was reported by a consumer and described the occurrence of Suspected vaccination failure in unspecified number of 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: This case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient only know the people  that who got the shingle shot got the shingles. The contact details were not reported hence follow up was not possible. This case considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: got the shots and got sick on both; 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.   The patient's past medical history included shingles (had for almost a year on the whole right side of head into neck).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient got the shot and got sick. The patient did not take medicine of any kind and at seventy three it could worried a person. The follow-up could not be possible as no contact details were available. For tolerance of 2nd shot refer case US2021AMR197147.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR197147:Same patient - 2nd dose
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: had my first shot a few years ago, second shot did not do it; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received a few years ago).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. The reporter Went to get the second shot, did not do it. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked why did the shots cost so much.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: got the two vaccines, they think it's shingles/suspected vaccination failure; shingles; stinging/ burning pain/ lots 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, couple of years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and stinging. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and stinging were recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles and stinging 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 had the 1st Shingles vaccination and then couple years later got the 2 Shingles vaccine and couple years later had stinging, burning pain and lots pain in the patient's left side. They thought it was Shingles on the inside been going on 3 months still there but lot better. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: got shingles shot and then 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, 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's friend. The age at vaccination was not reported. The reporter had heard of shingles had several flares very painful. The patient got the shingle shot and then got shingles. 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: Got vaccination, got shingles/Suspected vaccination failure; Got 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 self-reported this case. The age at vaccination was not reported. The patient got the vaccination, but got shingles anyway. 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, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; 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 case was reported by the consumer for herself/himself. The age at vaccination was not reported. The patient reported that, he/she got Shingles shot and got the shingles on his/her forehead, It was very painful. The patient said, he/she hope never get it again. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule, time to onset for event and laboratory confirmation for shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Got 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 reporter was known to the patient. The age at vaccination was not reported. The reporter stated that, he/she known the patient who got shingles after getting the Shingles vaccine.  The reporter said that, stop with the big pharma propaganda. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule, time to onset for event and laboratory confirmation for shingles were not provided. This is 1 of the 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR197941:Same reporter. Pt 2/3 US-GLAXOSMITHKLINE-US2021AMR197942:Same reporter. Pt 3/3
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shingles vaccine then she got shingles; shingles; This case was reported by a consumer via 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 case details were reported as follows:  The case was reported by patient's child. The age at vaccination was not reported. The patient received Shingles vaccines and then got Shingles. The reporter said no thanks. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Pain, Vaccination failure
Clinical narrative: got both shots, got shingles; shingles; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had painful shingles several years ago) and pain.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, 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, 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 case details were reported as follows:  The patient self-reported this case. The age at vaccination was not reported. The patient received both shots about 3 years before the day of reporting. The patient got shingles about 3 months before the day of reporting, but they were less painful. This case was considered as suspected vaccination failure since the details regarding confirmation of shingles were unknown at the time of reporting
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Headache
Clinical narrative: headache; upset stomach; This case was reported by a consumer via (Shingrix interactive digital media and described the occurrence of headache 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 headache and upset stomach. On an unknown date, the outcome of the headache and upset stomach were not recovered/not resolved.   It was unknown if the reporter considered the headache and upset stomach to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient asked was it ok to take Tylenol after getting the Shingrix shot, because the patient got a headache and upset stomach.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/Got the shot and in a few months got a horrible case of Shingles.; got a horrible case of 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.   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 provided were as follows: The case was reported by friend of the patient. Age at vaccination was not reported. The patient received a shot of Shingles vaccine several years ago and few months after experienced a case of Shingles. The patient was concerned that he might need another one. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible as no contact details available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: Got sick as a dog; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for herself/himself. The age at vaccination was not reported. The patient reported that, he/she got the Shingle shots and got sick as a dog. For the tolerance of other dose, refer case US2021AMR198024, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR198024:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Vaccine positive rechallenge
Clinical narrative: Got sick as a dog; This case was reported by a consumer and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of illness (received a dose on an unknown date and got sick as a dog, refer case US2021AMR198022).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. Rechallenge with Shingles vaccine was positive. 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: The case was reported by the consumer for herself/himself. The age at vaccination was not reported. The patient reported that, he/she got the Shingle shots and got sick as a dog.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR198022:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had shingles even with the vaccine/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 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 self-reported this case. The age at vaccination was not reported. The patient got shingles even with the vaccine, but it was a so called mild case and pain was terrible. 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/got the shot, got shingles; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in unspecified number of 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.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details provided were as follows: The age at vaccination was not applicable for this report. The patient reported that everybody he/she know that didn't have Shingles and then went and got the shot, afterwards got shingles. The reporter felt sorry for those who had shingles, but he/she just stated that there was probably a better way to prevent Shingles (boost immune systems) or herbal or allopathic medicine to deal with Shingles once he/she get it. The reporter reported that to everyone he/she know, the shot introduced into the body something that set shingles in motion and it erupted after the shot. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible as no contact details available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: have shingles, have shingles shot/Suspected vaccination failure; shingles; This case was reported by a consumer via (Shingrix GSK Chatbot) 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 reporter think he/she had shingles, and had the shingles shot. The reporter also asked how often he/she need the 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. No contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: feel like crud; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had Shingles vaccine which made him/her feel like crud for about 2 days. For tolerance of 1st dose refer case US2021AMR198037.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR198037:same reporter
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This case was reported by a consumer and described the occurrence of pain in arm in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (patient has had 3 episodes of shingles before getting her Shingrix vaccine; the severity of the shingles episodes decreased with every episode.).   In August 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The reporter was the spouse of the patient.  The patient had 3 episodes of shingles before getting her Shingrix vaccine and with every episode, the severity of the shingles episodes had decreased. The patient had the vaccine month ago from reporting date on the left arm and had a sore arm for almost a week. Lot and expiration dates were unknown. The reporter consented to follow-up and also gave consent to follow-up with health care professional.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast cancer female, Chemotherapy, Incomplete course of vaccination, Radiotherapy
Clinical narrative: Breast cancer; This case was reported by a consumer via call center representative and described the occurrence of breast cancer in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced breast cancer (serious criteria GSK medically significant). The patient was treated with chemotherapy, nos (Chemotherapy) and non-drug therapy (Radiation). On an unknown date, the outcome of the breast cancer was unknown.   It was unknown if the reporter considered the breast cancer to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for herself. The age at vaccination was not reported. The patient received Shingrix vaccine on left upper arm and was diagnosed with breast cancer for which she was under treatment chemotherapy and radiation. Due to this treatment patient was not able to receive second dose of shingrix within 2 to 6 months.  The patient did not state clearly that she was diagnosed after the vaccine, but she explained the events situation in order that it seems like she was diagnosed after the first dose of Shingrix. The patient don't have batch number and expiry date. The reporter gave a consent to follow-up with health care professional.
Sex: U
Vaccine: HEP
Symptoms: Wrong technique in product usage process
Clinical narrative: half the Adult dose instead of pediatric dose; This case was reported by a pharmacist via call center representative and described the occurrence of wrong technique in product usage process in an unspecified number of patients who received HBV (Engerix B adult) (batch number 39TZ2, expiry date 7th September 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th September 2021, the patient received Engerix B adult and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced wrong technique in product usage process. On an unknown date, the outcome of the wrong technique in product usage process was unknown.   It was unknown if the reporter considered the wrong technique in product usage process to be related to Engerix B adult and Engerix B 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 applicable for this report. The pharmacist reported that at least 20 young patients were given half of the adult dose of Engerix-B instead of a pediatric dose, which led to wrong technique in product usage process. Health care professional did not had information regarding the patients. The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: Chills; This case was reported by a consumer via call center representative and described the occurrence of chills in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th September 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 15th September 2021, 1 days after receiving Shingrix, the patient experienced chills. On an unknown date, the outcome of the chills was not recovered/not resolved.   It was unknown if the reporter considered the chills to be related to Shingrix.  Additional details were provided as follows: The patient experienced chills and asked how long the side effects typically last. The copy of package insert was offered.  The reporter did not consent to follow up. The reporter declined to provide health care professional information.
Age: 0.08
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 2 months old child received the vaccine; This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 2-month-old male patient who received DTPa-IPV (Kinrix) (batch number 24T2N, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th September 2021, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, 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 GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received dose of Kinrix in the left deltoid. The health care professional reported that, 2 months old patient received dose of Kinrix, which led to inappropriate age at vaccine administration. The reporter consented to follow up by phone.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: has not received the second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 12th August 2020, batch number 272M2, expiry date 7th December 2021).   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 consented to follow up. The VAERS details were reported for 1st dose of Shingrix.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling at injection site; Redness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 2-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) 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 14th September 2021, the patient received FluLaval Tetra 2020-2021 season (intramuscular) .5 ml and Flulaval Tetra Pre-Filled Syringe Device. On 15th September 2021, 1 days after receiving FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to FluLaval Tetra 2020-2021 season 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 reporter was the mother of the patient.  The patient received FluLaval Quadrivalent and 1 day later on the day of reporting, she had redness and swelling at the injection site.  The mother of the patient consented to follow up with the physician.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose before month 2; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number 4y2p4, expiry date 31st January 2023) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 15th September 2021, the patient received the 2nd dose of Shingrix. On 15th September 2021, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The registered nurse reported a patient received 2nd dose of shingrix less than the minimum recommended interval (before month 2), which led to shortening of vaccination schedule. The reporter confirmed that, the patient was not immunocompromised. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Got my 2nd dose yesterday and now I am feeling really bad; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Got my 2nd dose yesterday and now I am feeling really bad) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In September 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced VACCINATION COMPLICATION (Got my 2nd dose yesterday and now I am feeling really bad). At the time of the report, VACCINATION COMPLICATION (Got my 2nd dose yesterday and now I am feeling really bad) outcome was unknown.            Concomitant medication were not reported. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Product dose omission issue, Rash, Urticaria
Clinical narrative: hives minutes later; Breathing issues; Missed the recommended interval between doses/ she got the 1st Moderna covid-19 vaccine on January and didn't take the 2nd; Rash; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives minutes later), DYSPNOEA (Breathing issues), PRODUCT DOSE OMISSION ISSUE (Missed the recommended interval between doses/ she got the 1st Moderna covid-19 vaccine on January and didn't take the 2nd) and RASH (Rash) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced URTICARIA (hives minutes later), DYSPNOEA (Breathing issues), PRODUCT DOSE OMISSION ISSUE (Missed the recommended interval between doses/ she got the 1st Moderna covid-19 vaccine on January and didn't take the 2nd) and RASH (Rash). In January 2021, PRODUCT DOSE OMISSION ISSUE (Missed the recommended interval between doses/ she got the 1st Moderna covid-19 vaccine on January and didn't take the 2nd) had resolved. At the time of the report, URTICARIA (hives minutes later), DYSPNOEA (Breathing issues) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were provided.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (died) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.      No concomitant medications were provided. No treatment medications were provided.  Company Comment: This case concerns a male patient (unknown age) with no relevant medical history, who experienced the unexpected event of death of unknow cause. The event occurred unknown date after the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The event was considered related to the product per the reporter's assessment. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a male patient (unknown age) with no relevant medical history, who experienced the unexpected event of death of unknow cause. The event occurred unknown date after the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The event was considered related to the product per the reporter's assessment. The benefit-risk relationship of Spikevax is not affected by this report.; Reported Cause(s) of Death: unknown cause of death
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest discomfort, Dyspnoea, Hypoxia, Pulmonary embolism
Clinical narrative: Hypoxia; Pulmonary embolism; CONFIRMED COVID-19 INFECTION; Chest discomfort; Dyspnoea; SARS-CoV-2 test positive; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System, concerned a 84 year old female patient of unspecified race and ethnic origin. 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: 1802068 expiry: unknown) dose was not reported,1 total administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the patient had severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 ) test by nucleic acid amplification (NAA) micro sented which showed positive result with shortness of breath, confirmed covid-19 infection, confirmed clinical vaccination failure, chest discomfort, dyspnoea and hypoxemia diagnosed with pulmonary embolism (PE). She was hospitalized for the same on unspecified date and discharged on 15-APR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection, chest discomfort, dyspnoea, hypoxia, pulmonary embolism, sars-cov-2 test positive and confirmed clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000189960. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.  Additional information received from Central Complaint Vigilance department on 16-SEP-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V2: The additional information in this version is Product quality complaint investigation result. This doesnot alter causality of previously reported events  20210832756-Covid-19 vaccine ad26.cov2.s-hypoxia, pulmonary embolism, confirmed covid-19 infection, chest discomfort, dyspnoea, SARS-CoV-2 test positive. 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).  20210832756-Covid-19 vaccine ad26.cov2.s-Confirmed Clinical vaccination 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: 84.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: Hypoxia; Pulmonary embolism; CONFIRMED COVID-19 INFECTION; Chest discomfort; Dyspnoea; SARS-CoV-2 test positive; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System, concerned a 84 year old female patient of unspecified race and ethnic origin. 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: 1802068 expiry: unknown) dose was not reported,1 total administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the patient had severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 ) test by nucleic acid amplification (NAA) micro sented which showed positive result with shortness of breath, confirmed covid-19 infection, confirmed clinical vaccination failure, chest discomfort, dyspnoea and hypoxemia diagnosed with pulmonary embolism (PE). She was hospitalized for the same on unspecified date and discharged on 15-APR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection, chest discomfort, dyspnoea, hypoxia, pulmonary embolism, sars-cov-2 test positive and confirmed clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000189960. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.  Additional information received from Central Complaint Vigilance department on 16-SEP-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V2: The additional information in this version is Product quality complaint investigation result. This doesnot alter causality of previously reported events  20210832756-Covid-19 vaccine ad26.cov2.s-hypoxia, pulmonary embolism, confirmed covid-19 infection, chest discomfort, dyspnoea, SARS-CoV-2 test positive. 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).  20210832756-Covid-19 vaccine ad26.cov2.s-Confirmed Clinical vaccination 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