chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Social problem
Clinical narrative: COVID restrictions / impeded her / to receive the second dose on time; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 82-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles with an associated reaction of limb operation (1st dose received on October 2019, refer case US2021086465).   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 social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at the vaccination was not applicable. Till the time of reporting patient had hand surgery and COVID restrictions began which  impeded her ability to receive the second dose on time which led to social problem. The patient was referred back to her health care professional. No further information was provided. Consented to follow up was unknown This case has been linked with case US2021086467, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021086467:Same reporter US-GLAXOSMITHKLINE-US2021086465:Same reporter. US-GLAXOSMITHKLINE-US2021086467:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; got the shingles anyhow; This case was reported by a consumer via (facebook) 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 patient's sister. The age at vaccination was not reported. The patient received Shingles vaccine and experience shingles. The reporter stated Vaccine did not help her sister got the shingles anyhow. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; 15 people / experienced shingles; This case was reported by a consumer via media and described the occurrence of  suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received Shingles vaccine and experienced shingles. 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. This case was one of the 16 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR088476: US-GLAXOSMITHKLINE-US2021AMR088499: US-GLAXOSMITHKLINE-US2021AMR088499: US-GLAXOSMITHKLINE-US2021AMR088498:Original Case : US2021AMR088476 US-GLAXOSMITHKLINE-US2021AMR088500:Original Case : US2021AMR088476
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; I had both of my shingle shots and have shingles now; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, 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 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 and Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient had both shingle shots and had shingles at the time of reporting. The patient did have a milder case because the patient had both shots. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation was not reported. No further information would be available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: My friends husband got shingles from the shot/Suspected Vaccination failure; My friends husband got shingles from the shot; This case was reported by a consumer 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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter's friends husband got shingles from the shot. Te reporter stated that the patient was older then. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting. No further information would be available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the shots. Still got shingles/Suspected vaccination failure; Got the shots. Still got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. Despite of receiving shots, the patient experienced shingles, but was it not the bad case. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting. No further information would be available.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction, Anxiety
Clinical narrative: Thought I was going to died had a bad. Reaction to the shot; This case was reported by a consumer via interactive digital media and described the occurrence of impending doom in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced impending doom. On an unknown date, the outcome of the impending doom was unknown.   It was unknown if the reporter considered the impending doom to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported the case for himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient had the shot, he/she thought he/she was going to died had a bad reaction to the shot. The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: I received the shingles vaccine and I still got shingles/suspected Vaccination failure; I received the shingles vaccine and I still got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient received the shingles vaccine and still got shingles. The reporter stated it was awful and hoped that he or she did not get them  again. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting. No further information would be available.
Sex: U
Vaccine: VARZOS
Symptoms: Bursitis, Limb discomfort, Mobility decreased
Clinical narrative: Bursitis / had to stretch daily to get my normal range of motion back; right arm took a long time to recover; This case was reported by a consumer via interactive digital media and described the occurrence of bursitis in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than 5 months after receiving Shingles vaccine, the patient experienced bursitis and arm discomfort. On an unknown date, the outcome of the bursitis and arm discomfort were recovered/resolved.   It was unknown if the reporter considered the bursitis and arm discomfort to be related to Shingles vaccine.  Additional details were provided as follows: Age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. The patient received 2nd dose of Shingles vaccine this year. The patient right arm took a long time to recover. Bursitis set in and the patient had to stretch daily to get his/her normal range of motion back. It literally took months
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: I got both shots / most hurtful of any shot I have ever had.; This case was reported by a consumer and described the occurrence of pain during injection in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced pain during injection. On an unknown date, the outcome of the pain during injection was recovered/resolved.   It was unknown if the reporter considered the pain during injection to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient got shingles shots and stated that it was most hurtful of any shot ever had. The case was linked with US2021AMR088678 reported by same reporter for 2nd dose.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR088678:same patient (2ND dose)
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Vaccine positive rechallenge
Clinical narrative: I got both shots / most hurtful of any shot I have ever had.; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain (1st dose received on an unknown date, refer case US2021AMR088664.).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient got Shingles vaccine and experienced pain. The patient reported that it was most hurtful of any shot ever had. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR088664:same patient (1st dose)
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Diarrhoea, Presyncope
Clinical narrative: pain all over my abdomen; lbm; I almost collapsed. My daughter brought me to ER; This case was reported by a consumer via interactive digital media and described the occurrence of abdominal pain in a female 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, less than 2 years after receiving Shingles vaccine, the patient experienced abdominal pain, loose bowel and presyncope. Shingles vaccine was discontinued. On an unknown date, the outcome of the abdominal pain, loose bowel and presyncope were recovered/resolved.   It was unknown if the reporter considered the abdominal pain, loose bowel and presyncope to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported the case for herself. The age at vaccination was not reported. The patient had first shot of the latest shingle vaccine 2 years ago from the reporting date and did not take the 2nd dose because she had the bad reaction. The patient had pain all over her abdomen and lbm (loose bowel movement). The patient was almost collapsed and her daughter brought her to ER (emergency room). The reporter mentioned that, her husband got the first and 2nd dose with no reaction at all. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: most horrific case of shingles,on my back and spine,I prayed to die ! Four months of hell !; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient received 1st dose of Shingles vaccine and soon after had the most horrific case of shingles on his/her back and spine. The patient prayed to die and stated it was as 4 months of hell. The patient stated soon after Covid started and he/she had both Covid shots, as of 3 weeks ago of reporting and now wanted to know when he/she could safely get shingles number 2 or do he/she need to start over. The patient had confusing answers from physicians and pharmacologists, so he/she asked for help. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Illness, Incomplete course of vaccination
Clinical narrative: I was soooo sick; didn't take the second injection / will NEVER take the 2 injection vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced sickness and incomplete course of vaccination. On an unknown date, the outcome of the sickness and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follow: The patient received 1st dose of shingles vaccine on an unknown date. The patient experienced sickness. The patient decided not to take 2 dose of shingles vaccine, which led to incomplete course of vaccination. No further information was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Ear pain, Herpes zoster, Herpes zoster oticus
Clinical narrative: Suspected vaccination failure; shingles in ear; shingles; burning in my ear; earache; blisters on my face and the lower part of my back; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In April 2021, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), herpes zoster otitis externa (serious criteria GSK medically significant), shingles, burning sensation, ear pain and blister. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the herpes zoster otitis externa, shingles, burning sensation, ear pain and blister were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, herpes zoster otitis externa, shingles, burning sensation, ear pain and blister to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. A week before the date of reporting, the patient experienced burning in ear and thought it was earache and went to physician who said it was shingles. At the time of reporting the patient was having blisters on face and lower part of back. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles in ear; shingles; burning in my ear; earache; blisters on my face and the lower part of my back; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In April 2021, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), herpes zoster otitis externa (serious criteria GSK medically significant), shingles, burning sensation, ear pain and blister. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the herpes zoster otitis externa, shingles, burning sensation, ear pain and blister were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, herpes zoster otitis externa, shingles, burning sensation, ear pain and blister to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. A week before the date of reporting, the patient experienced burning in ear and thought it was earache and went to physician who said it was shingles. At the time of reporting the patient was having blisters on face and lower part of back. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the shot now I hav the shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per vaccine indication. The patient had the shot and had shingles, the patient hope the shot helped but doubted it. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, event onset time and laboratory confirmation for shingles were unknown at the time of reporting. The information regarding consent to follow up was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second shot until February of 2021 / first shot in October of 2019 / a year and 4 months between the first and second shot; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 62-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received 1st dose on October 2019.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follow: This case was reported by consumer herself. The age at the vaccination was not applicable for this report. The patient was late for 2nd dose,  which lead to lengthing of vaccination schedule. The patient did not consent to follow-up. No further information was provided
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: Had it 2 times, got the vaccine, and got it one more time/ suspected vaccination failure; Had it 2 times, got the vaccine, and got it one more time.; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles 2 times).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but selected as adult as per the vaccine indication. The patient got the vaccine and got shingles one more time. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease(shingles) and laboratory test confiding shingles were unknown at the time of reporting.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: On base
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chest discomfort, Fatigue, Haemoptysis, Influenza like illness
Clinical narrative: Fever up to 102.6, body aches, extreme fatigue, coughing up blood (bright red), chest tightness, general malaise -Feels like the flu
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain
Clinical narrative: Fever up to 102.6, body aches, extreme fatigue, coughing up blood (bright red), chest tightness, general malaise -Feels like the flu
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Fatigue, Headache, Injection site pain
Clinical narrative: Day after vaccination:  fever of 101.9 , extreme pain below injection site, extreme fatigue, nausea, stomach pains, dizziness, extreme headache, and tremors in lower lip.  Second day after vaccination:  fever of 100.1 , extreme pain below injection site, extreme fatigue, nausea, stomach pains, dizziness, extreme headache, and tremors in lower lip.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Tremor
Clinical narrative: Day after vaccination:  fever of 101.9 , extreme pain below injection site, extreme fatigue, nausea, stomach pains, dizziness, extreme headache, and tremors in lower lip.  Second day after vaccination:  fever of 100.1 , extreme pain below injection site, extreme fatigue, nausea, stomach pains, dizziness, extreme headache, and tremors in lower lip.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lip pain, Lip swelling
Clinical narrative: Onset of symptoms  was around 12:30 am on 04/23/21. Symptoms began with lip pain followed  by the feeling of  puffiness around my lips , which then prompted me to look at them with a mirror. I  noticed not only were they swollen but they were also slightly red as well.  As of 3:36 am on 04/23/21 they are still swollen, painful and red.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; My brother got vacc and still got shingles; This case was reported by a consumer via  media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient got vaccination and still got shingles. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Itchy swollen red
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Scan
Clinical narrative: Day after receiving vaccine, left hand and left side of face to include the left side of inside of mouth started to tingle. Took Benadryl and it initially went away. The next day it came back and Benadryl did not work. Went to ER where they said it looked as if minor stroke had occurred.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen glands right side of throat.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Intermenstrual bleeding, Menstruation irregular
Clinical narrative: Menstrual irregularities including early bleeding, heavy bleeding, intense pain, spotting
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: Only got 1st vaccination / yet have shingles now; Only got 1st vaccination didn't get 2nd one; This case was reported by a consumer via  interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported for the 1st dose of Shingles vaccine. The age at vaccination was not applicable for the 2nd dose of Shingles vaccine. The age group was selected an an adult as per vaccine indication. The patient received the 1st dose of Shingles vaccine and experienced shingles now that was not good. Till the time of reporting patient had not receive the 2nd dose of Shingles vaccine, which led to incomplete course of vaccination. No further information reported.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nasopharyngitis, Nausea, Sleep disorder
Clinical narrative: I got the 1st shot of Covid Vaccine in the morning, during the evening symptoms have started:  nausea,  drowsiness, head pain, fatigue, classic cold symptoms, could not sleep through the night.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: I got the 1st shot of Covid Vaccine in the morning, during the evening symptoms have started:  nausea,  drowsiness, head pain, fatigue, classic cold symptoms, could not sleep through the night.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Arthralgia, Chills, Fatigue, Headache
Clinical narrative: 1. Aches/Pains muscular/joints  2. Slight fever with chills  3. Extreme Fatigue  4. Headache  5. Acute Tinnitus with hyperacusis
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperacusis, Influenza virus test, Laboratory test, Myalgia, Pyrexia
Clinical narrative: 1. Aches/Pains muscular/joints  2. Slight fever with chills  3. Extreme Fatigue  4. Headache  5. Acute Tinnitus with hyperacusis
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: 1. Aches/Pains muscular/joints  2. Slight fever with chills  3. Extreme Fatigue  4. Headache  5. Acute Tinnitus with hyperacusis
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: She got shingles after getting Shingrix/Suspected vaccination failure; She got shingles after getting Shingrix; This case was reported by a nurse via sales rep and described the occurrence of Suspected vaccination failure in a female 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 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.  Additional details were provided as follows: The age at vaccination was not reported. The patient got Shingles after vaccination. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory confirmation, time to onset of shingles were unknown at the time of reporting. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; I HAD THE SHOT AND STILL GOT THE SHINGLES.; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. It was reported that the patient had the shot and still got the shingles. This case was considered as suspected vaccination was failure since the details regarding dose number, time to onset and laboratory confirmation was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Had a horrible case / & I had the vaccine shot before; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/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 the patient. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient received Shingles vaccine and experienced horrible case which lasted for 5 months. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I ended up with shingles 2 weeks after my second shot; This case was reported by a consumer via (facebook)interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but captured as adult as per vaccine indication. The patient ended up with shingles after the 2nd dose of Shingles vaccine. The patient stated that they told him/her that there was no connection between the vaccine and event and to get well soon, shingles was not for sissies. The information regarding consent to follow up was not reported.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Had them not fun even after I had a shot; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient received Shingles vaccine and experienced shingles. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: I had the vaccine and got the shingles within a year/suspected vaccination failure; I had the vaccine and got the shingles within a year; they hurt; This case was reported by a consumer via media  and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a year 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 age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient had the vaccine and got the shingles within a year. The patient was shocked and stated that they hurt. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: became aware that he needed a second dose / received it on 01/02/2021; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose about 14 months before the time of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional 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 the 2nd dose of the vaccine, which led to incomplete course of vaccination. The reporter consented to follow up.   Follow up information was received from consumer on 20th April 2021: This case was reported by patient himself. The patient demographics were updated. On 30th November 2019, the patient received 1st dose (intramuscular) of Shingrix in left deltoid.  The patient was not aware that he needed to take 2nd dose, then he became aware. On 2nd January 2021, the patient received 2nd dose (intramuscular) of Shingrix in left deltoid, later then the recommended schedule, which led to lengthening of vaccination schedule. The patient went day before reporting to take another dose but was told that he did not need to restart the series. The patient called GlaxoSmithKline to confirm if this was true. The VAERS details were updated. The reporter did not consent to follow up.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site vesicles
Clinical narrative: Redness at site; Redness at site turned into burning; at site turned into burning then black with fluid filled blisters; fluid filled blisters which has now turned black; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 63-year-old male patient who received Herpes zoster (Shingrix) for injection site erythema, injection site pain, injection site blisters and injection site discoloration.   On 3rd April 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 6th April 2021, 3 days after receiving Shingrix, the patient experienced injection site erythema, injection site burning, injection site blisters and injection site discoloration. The patient was treated with cefalexin (Cephalexin) and steroid shot (nos). On an unknown date, the outcome of the injection site erythema, injection site burning, injection site blisters and injection site discoloration were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site burning, injection site blisters and injection site discoloration to be related to Shingrix.  Additional details were provided as follows: The reporter reported that patient received 1st dose of Shingrix by which patient experienced redness at site which turned into burning then black with fluid filled blisters,which are not resolved. The patient went to urgent care and emergency room and now has appointment with wound care specialist on 19-April-2021.  ER visit required. The HCP consented to followup.
Sex: M
Vaccine: VARZOS
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered
Clinical narrative: accidently gets 3 doses of shingrix; This case was reported by a other health professional via call center representative and described the occurrence of circumstance or information capable of leading to medication error in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced circumstance or information capable of leading to medication error. On an unknown date, the outcome of the circumstance or information capable of leading to medication error was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The physician's assistant asked if there were there any negative effects if a patient accidently gets 3 doses of Shingrix.  The reporter had a patient who insisted that he had only one dose and so he wanted a 2nd dose and they showed him a record of already receiving 2 doses, which was the circumstance or information capable of leading to medication error since there was a possibility of either an extra dose or possible underdose (inappropriate schedule). The reporter consented to follow up via email but declined to leave patient's initials
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 733D2, expiry date 25th October 2022) for prophylaxis.   On 12th April 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 14th April 2021, 2 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows:  The patient received 2nd dose of Shingrix vaccine and was seen by his healthcare professional and was diagnosed with Shingles. Till the time of reporting, the shingles was not resolved. The pharmacist did not have patient's healthcare professional information. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: HCP reports possibility of three doses of Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date) and Shingrix (received 2nd dose on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional details were provided as follows: The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The healthcare professional reported possibility of three doses of Shingrix for the patient, which led to extra dose administered. No further information was reported. Note: This case was conservatively kept valid with event extra dose administered as it was not clear if the patient had received extra dose or not.