chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: painful shots; 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.   Previously administered products included Covid vaccine (received on an known date).   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. 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: The patient self reported the case. The age at vaccination was not reported. The patient had Shingles shot in the beginning of last year and those were some painful shots and with seriously tough side effects however, patient glad to have those. The patient mother and older sister both had Shingles in their 50s. The patient stated that compared to this shot, Covid vaccine was a breeze. The follow up would not be possible as no contact details were available. For tolerance to 2nd dose, refer case US2021AMR191192.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR191192:same reporter
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster, Neuralgia, Vaccination failure
Clinical narrative: got the new double shot this year, I have shingles; shingles; burning feeling; nerve 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 (the patient had shingles shot several years ago).   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine and 8 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, burning sensation and nerve pain. On an unknown date, the outcome of the vaccination failure, shingles, burning sensation and nerve pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, burning sensation and nerve pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The reporter stated that he/she had the shingles shot several years ago. Then got the new double shot this year. 8 months later the patient had shingles on the side of foot.  The patient went to doctor after about 2 weeks as he/ she thought it was poison ivy until the burning feeling started. Turns out the burning feeling was nerve pain along the nerve running down the side of his/her foot to where the shingles was on the side of foot near toes.  The physician confirmed it was shingles and said thankfully the patient got the shot or patient most likely would have had a severe case.  The patient was shocked with his diagnosis as shingles was the last thing that would have ever crossed His/her mind because the patient had both the old vaccine and the 2 dose new vaccine. The patient stated that vaccines aren't 100% but offer much greater protection This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: got the shot, I have it again/ suspected vaccination failure; I have it again; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles 15 years ago).   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: This case was self-reported by the patient. The age at vaccination was not reported. The patient had shingles fifteen years ago and got the shot when it was over. The patient again got shingles after the shot and made doctor's appointment before it got worse. The patient thought he/she was safe.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles on 08/28/2021 after first dose; This case was reported by a consumer and described the occurrence of shingles in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (11 cases of shingles occurred before the vaccine in the past 8 years), shingles (occurred on 9th July 2021, refer case US2021190982) and breast cancer.   On 8th July 2021, the patient received the 1st dose of Shingrix. On 28th August 2021, 51 days after receiving Shingrix, the patient experienced shingles. The patient was treated with acyclovir. 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: This case was reported by the patient herself. The patient mentioned that she had 11 cases of shingles in past 8 years. Out of 11 cases, 4 cases of shingles occurred before Shingrix and that occurred during chemotherapy treatment due to breast cancer. The patient received Shingrix on the right deltoid (National drug code number 58160-0823-11) at the pharmacy. The patient again had a case of shingles last weekend from reporting date and again took a week regimen of acyclovir. The patient had been getting shingles on the same spot each time (upper left hip). The current state of shingles was that they were drying up and becoming smaller in size but were not completely resolved. The reporter gave a consent to follow-up with healthcare professional. However, she did not have a phone/fax number and an email address to healthcare professional. She did not have her personal email address. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021190982:Same reporter.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles on 07/09/2021 after first dose; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (4 cases of shingles occurred before the vaccine in the past 8 years), chemotherapy (due to breast cancer) and breast cancer.   On 8th July 2021, the patient received the 1st dose of Shingrix. In July 2021, less than a day after receiving Shingrix and acyclovir, the patient experienced shingles. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The patient mentioned that she had 11 cases of shingles in past 8 years. Out of 11 cases, 4 cases of shingles occurred before Shingrix and that occurred during chemotherapy treatment due to breast cancer. The patient received Shingrix on the right deltoid at the pharmacy. On 9th July 20021, within 14 hours after vaccination, the patient broke into shingles. Healthcare professional prescribed her acyclovir and shingles cleared up.  The patient had been getting shingles on the same spot each time (upper left hip) and her healthcare professional prescribes acyclovir each time she breaks out into shingles. The reporter gave a consent to follow-up with healthcare professional.  However, she did not have a phone/fax number and an email address to healthcare professional.  She did not have her personal email address. The reporter consented to follow-up. For tolerance of shingles 2nd outbreak, refer case US2021AMR191247, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR191247:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity
Clinical narrative: shingles in left leg, having symptoms again; severe pain in leg; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (11 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 shingles and leg pain. On an unknown date, the outcome of the shingles and leg pain were unknown.   It was unknown if the reporter considered the shingles and leg 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 had a very bad case of shingles down my left leg. The patient received dose of Shingles vaccine and started having symptoms again a week and a half ago from reporting. The patient stated that the pain in his/her leg was as severe the shingles was 11 years ago. The patient was on a non-viral prescription and he/she could have the shot again. The patient could not wait to get that shot next week. The patient stated no Covid shot for him/her. The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got vaccinated, still got shingles / suspected vaccination failure; shingles/ flares up; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) 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 reporter was patient's wife. The age at vaccination was not reported. The patient got vaccinated but still got shingles, but just a light case flares up every now and then. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: Very sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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 patient self reported this case. Age at vaccination was not reported. The patient received dose of Shingles vaccine and felt very sick for 2 days. The patient said he/she would never get another vaccine again.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got vaccine and broke out with shingles / Suspected vaccination failure; shingles for the 14th time; 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 case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient got vaccine and broke out with shingles for the 14th time. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure, Vaccine positive rechallenge
Clinical narrative: 've had them 5 times. Had the shot several years ago and it didn't help/suspected vaccination failure; shingles; seems to keep the pain away; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had them 5 times and had the shot several years ago and it did not help, refer case US2021AMR191936. The patient had the new shot and improved that which the patient had a reaction to. The patient said the best thing was, the patient had found to use when you first feel shingles starting was to put blue kote on them. It seems to keep the pain away and helps them heal quicker, blue kote worked for the patient. No contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR191936:same patient same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: has had them since getting the shot / Suspected vaccination failure; has had them over 40 times; 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 case details were reported as follows: The reporter was patient's friend. The age at vaccination was not reported. The patient has had shingles over 40 times since getting the shot. The reporter would take his or her chances of getting them again without the shot. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  Concurrent medical conditions included epstein-barr virus infection and immune disorder (nos).   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 days after receiving Shingles vaccine, 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 Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient for himself/herself. The age at vaccination was not reported. The patient received shingles vaccine and 3 days later had a huge outbreak going down the left side of his/her back, then it crossed the midline and covered his/her entire back and butt. The patient stated its been 4 years now and the shingles had never gone completely away. The patient stated if you had an Epstein Barr, you are at risk with this vaccine and other immune issues could cause it to had harsh reactions also. The patient stated good luck in vaccine injury court getting any help either. The follow up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Diarrhoea, Fatigue
Clinical narrative: Stomach pain; Diarrhea; Tiredness; Weakness; This case was reported by a consumer Shingrix GSK and described the occurrence of stomach pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th August 2021, the patient received Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced stomach pain, diarrhea, tiredness and weakness. On an unknown date, the outcome of the stomach pain, diarrhea, tiredness and weakness were not recovered/not resolved.   It was unknown if the reporter considered the stomach pain, diarrhea, tiredness and weakness to be related to Shingrix.  Additional details were provided as follows: The reporter was wife of the patient. The age at vaccination was not reported. The patient got the Shingrix vaccine on 28th August 2921 and since then he had been experiencing stomach pain, diarrhea and tiredness/weakness off and on.  Note: Discrepancy is present regarding year of the vaccination was reported as 2921 but has been conservatively added as 2021 as 2921 is a future date and seems to be typo error, hence considered as 28th August 2021.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: got the shot, shingles / suspected vaccination failure; shingles; it hurts; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles 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 case details were reported as follows: The reporter was patient's wife. The age at vaccination was not reported. The patient got the shot to but he had shingles and it hurts. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: pain at injection site; This case was reported by a consumer via Shingrix GSK and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received the 2nd dose of Shingrix vaccine and experienced pain at injection site. The patient was enquiring if he/she could take Tylenol or Ibuprofen to relieve pain at injection site. Follow-up would not be possible as no contact details available.
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: cellulitis; This case was reported by a consumer via other manufacturer and described the occurrence of cellulitis in a male 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 cellulitis (serious criteria GSK medically significant). On an unknown date, the outcome of the cellulitis was unknown.   The reporter considered the cellulitis to be related to Shingrix.  Additional details were provided as follows: This case was reported by patients wife. The age at vaccination was not reported. The patient got cellulitis from Shingrix not at the injection site.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: took the shots, shingles kept coming back/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure 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 reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient took the 2 Shingles shots and the shingles kept coming back and coming back. 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: U
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Back pain, Dysstasia, Herpes zoster, Hypoaesthesia
Clinical narrative: shingles; couldn't stand; couldn't sit and had to be on my left side; stomach hurts; numbness in stomach; not much back pain; This case was reported by a consumer via media and described the occurrence of shingles in a 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, 3 weeks after receiving Shingles vaccine, the patient experienced shingles, difficulty in standing, mobility decreased, stomach pain, numbness and back pain. On an unknown date, the outcome of the shingles, difficulty in standing, mobility decreased, stomach pain, numbness and back pain were unknown.   It was unknown if the reporter considered the shingles, difficulty in standing, mobility decreased, stomach pain, numbness and back pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported The patient had 2nd dose of the shingles vaccine then 3 weeks later the patient had the shingles.  The patient could not stand or sit and had to be on left side. Now the right side of stomach was completely numb and hurts. The back not so much. This stuff was bad.
Sex: U
Vaccine: VARZOS
Symptoms: Mobility decreased
Clinical narrative: shingles; couldn't stand; couldn't sit and had to be on my left side; stomach hurts; numbness in stomach; not much back pain; This case was reported by a consumer via media and described the occurrence of shingles in a 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, 3 weeks after receiving Shingles vaccine, the patient experienced shingles, difficulty in standing, mobility decreased, stomach pain, numbness and back pain. On an unknown date, the outcome of the shingles, difficulty in standing, mobility decreased, stomach pain, numbness and back pain were unknown.   It was unknown if the reporter considered the shingles, difficulty in standing, mobility decreased, stomach pain, numbness and back pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported The patient had 2nd dose of the shingles vaccine then 3 weeks later the patient had the shingles.  The patient could not stand or sit and had to be on left side. Now the right side of stomach was completely numb and hurts. The back not so much. This stuff was bad.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blister, Condition aggravated, Herpes zoster, Injected limb mobility decreased
Clinical narrative: got shingrix, small area on my forearm that blistered, would have gotten a lot worse without the shot / suspected vaccination failure; tingling nerve type pain; tingling; shut my arm DOWN; small area on my forearm that blistered; 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 (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Family History) (husband had shingles on his ankle to knee and some on his thigh after Christmas last year).   On an unknown date, the patient received Shingrix. In January 2021, less than 9 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, nerve pain, tingling and arm discomfort. On an unknown date, the outcome of the vaccination failure, nerve pain and arm discomfort were unknown and the outcome of the shingles was recovered/resolved and the outcome of the tingling was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, nerve pain, tingling and arm discomfort to be related to Shingrix.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient got shingrix a couple of years ago before COVID showed up. The patient's husband had shingles on his ankle to knee and some on his thigh after Christmas last year. In January, patient had a small area on her forearm that blistered a bit. It lasted about 3 to 4 weeks but did not grow or hurt. The only thing the patient still had is a tingling nerve type pain that shoots down that arm from my shoulder. It happens sometimes 4 times a day and sometimes once a week. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule and laboratory test confirmation were unknown at the time of reporting. The follow up was not required.
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort, Neuralgia, Pain, Pain in extremity, Paraesthesia
Clinical narrative: got shingrix, small area on my forearm that blistered, would have gotten a lot worse without the shot / suspected vaccination failure; tingling nerve type pain; tingling; shut my arm DOWN; small area on my forearm that blistered; 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 (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Family History) (husband had shingles on his ankle to knee and some on his thigh after Christmas last year).   On an unknown date, the patient received Shingrix. In January 2021, less than 9 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, nerve pain, tingling and arm discomfort. On an unknown date, the outcome of the vaccination failure, nerve pain and arm discomfort were unknown and the outcome of the shingles was recovered/resolved and the outcome of the tingling was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, nerve pain, tingling and arm discomfort to be related to Shingrix.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient got shingrix a couple of years ago before COVID showed up. The patient's husband had shingles on his ankle to knee and some on his thigh after Christmas last year. In January, patient had a small area on her forearm that blistered a bit. It lasted about 3 to 4 weeks but did not grow or hurt. The only thing the patient still had is a tingling nerve type pain that shoots down that arm from my shoulder. It happens sometimes 4 times a day and sometimes once a week. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule and laboratory test confirmation were unknown at the time of reporting. The follow up was not required.
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: got shingrix, small area on my forearm that blistered, would have gotten a lot worse without the shot / suspected vaccination failure; tingling nerve type pain; tingling; shut my arm DOWN; small area on my forearm that blistered; 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 (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Family History) (husband had shingles on his ankle to knee and some on his thigh after Christmas last year).   On an unknown date, the patient received Shingrix. In January 2021, less than 9 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, nerve pain, tingling and arm discomfort. On an unknown date, the outcome of the vaccination failure, nerve pain and arm discomfort were unknown and the outcome of the shingles was recovered/resolved and the outcome of the tingling was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, nerve pain, tingling and arm discomfort to be related to Shingrix.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient got shingrix a couple of years ago before COVID showed up. The patient's husband had shingles on his ankle to knee and some on his thigh after Christmas last year. In January, patient had a small area on her forearm that blistered a bit. It lasted about 3 to 4 weeks but did not grow or hurt. The only thing the patient still had is a tingling nerve type pain that shoots down that arm from my shoulder. It happens sometimes 4 times a day and sometimes once a week. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule and laboratory test confirmation were unknown at the time of reporting. The follow up was not required.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure, Vaccine positive rechallenge
Clinical narrative: suspected vaccination failure; the second time was light easier; 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.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. Rechallenge with Shingles vaccine was positive. 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 patient had reported for him/herself. The age at vaccination was not reported. The patient stated that, before receiving Shingles vaccine, shingles case was not good. After receiving Shingles vaccine, the patient got shingles. The patient stated that, Shingles vaccine helped. Shingles was light, easier and not as painful. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation of shingles were not provided. For the toleance of 1st dose, refer linked case US2021AMR192426. This was 1 of 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR192426:1st dose, same patient same reporter US-GLAXOSMITHKLINE-US2021AMR192711:Original Case : US2021AMR179087
Sex: U
Vaccine: COVID19, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had shingles vaccine, I got shingles / suspected vaccination failure; shingles; Shingles was just awful.; 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 COVID-19 VACCINE (COVID19 VACCINE) for prophylaxis.   The patient's past medical history included chickenpox (Had chickenpox when young).   On an unknown date, the patient received Shingles vaccine and the 2nd dose of COVID19 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 case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had chickenpox when young. The patient had Shingles vaccine about 5 years before reporting and 3rd day after 2nd COVID19 vaccine, patient got a severe case of shingles on the same side of my vaccine. Shingles was just awful. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Localised infection, Near death experience, Peripheral swelling, Scab
Clinical narrative: died twice and was brought back; had huge blisters all over me; have numerous scars.; This case was reported by a consumer via media and described the occurrence of near death experience in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included allergy.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced near death experience (serious criteria GSK medically significant and life threatening), blister and scar. On an unknown date, the outcome of the near death experience and blister were unknown and the outcome of the scar was not recovered/not resolved.   It was unknown if the reporter considered the near death experience, blister and scar to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not  reported. The patient got the Shingles vaccine, took a reaction, died twice and was brought back, and had huge blisters all over and still had numerous scars. After receiving Tuberculosis (TB) vaccine, arm swelled up 3 times bigger and got blood poisoning. Twice after that when tested for employment at a hospital, the patient had the same reaction.  Booster vaccine (unknown name vaccine) had to have it 3 times, scabbed up and arm became infected all 3 times. The patient have horrible allergies. The patient said not a fan of vaccines. No contact details were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Scar, Sepsis
Clinical narrative: died twice and was brought back; had huge blisters all over me; have numerous scars.; This case was reported by a consumer via media and described the occurrence of near death experience in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included allergy.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced near death experience (serious criteria GSK medically significant and life threatening), blister and scar. On an unknown date, the outcome of the near death experience and blister were unknown and the outcome of the scar was not recovered/not resolved.   It was unknown if the reporter considered the near death experience, blister and scar to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not  reported. The patient got the Shingles vaccine, took a reaction, died twice and was brought back, and had huge blisters all over and still had numerous scars. After receiving Tuberculosis (TB) vaccine, arm swelled up 3 times bigger and got blood poisoning. Twice after that when tested for employment at a hospital, the patient had the same reaction.  Booster vaccine (unknown name vaccine) had to have it 3 times, scabbed up and arm became infected all 3 times. The patient have horrible allergies. The patient said not a fan of vaccines. No contact details were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: shingles hot deathly ill; This case was reported by a consumer via interactive digital media and described the occurrence of illness in a 60-year-old 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 illness. On an unknown date, the outcome of the illness was unknown.   It was unknown if the reporter considered the illness to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient's parent. The age at vaccination was not reported. The reporter reported his/her daughter had deadly ill side effect with Shingles shot. No contact details were available. The case had been linked with US2021AMR192577 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR192577:Original Case : US2021AMR179087
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shingles and she had all the vaccines/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.   Co-suspect products included COVID-19 VACCINE (COVID-19 VACCINE UNKNOWN) for prophylaxis.   The patient's past medical history included chickenpox (when the patient was young).   On an unknown date, the patient received Shingles vaccine and the 2nd dose of COVID-19 VACCINE UNKNOWN. On an unknown date, unknown after receiving Shingles vaccine and an unknown time after receiving COVID-19 VACCINE UNKNOWN, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had Shingles vaccine about 5 years ago from the date of reporting and 3rd day after 2nd COVID19 vaccine, the patient got a severe case of shingles on the same side of vaccine. The patient shingles was just awful. 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: Herpes zoster
Clinical narrative: Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles 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 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 patient self reported this case. Age at vaccination was not reported. The patient received dose of Shingles vaccine and experienced shingles. It was a light case but the doctor recommended to patient that he/she get the better shingles shot. The patient hoped people will get the shot. The shingles was terrible and the patient hoped they never get them. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Not the typical fainting and syncope; This case was reported by a nurse via call center representative and described the occurrence of syncope in an unspecified number of patients who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced syncope (serious criteria GSK medically significant). The action taken with Menveo was unknown. On an unknown date, the outcome of the syncope was unknown.   It was unknown if the reporter considered the syncope to be related to Menveo.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The reporter routinely administers Menveo and had the demonstrated wealth of experience with the vaccine. On 2nd August, the they began administering Menveo under a new lot number. The reporter stated that they were alarmed not only at the unusual high rate of adverse event but also the degree and severity of the adverse event where they had not previously witnessed before. These adverse events were documented in the product prescribing information and included over time after the product launch. There was no change in the health care professional administering Menveo and no change in the syringe or needle. The reporter stated  that this had not just been your typical adverse reaction of syncope. The reporter had work within the immunization program for 7 years and had never seen these types of reactions. They had all been completely different than your typical fainting and syncope. This case is one of the 4 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021167017:Same reporter. Patient 1 atypical case. US-GLAXOSMITHKLINE-US2021AMR167723:Same reporter. Patient 2 atypical case. US-GLAXOSMITHKLINE-US2021AMR167724:Same reporter. Patient 3 atypical case.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles 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 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 case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient got the one shot and had the shingles now. The patient requested to take the new vaccine as it was not a fun. The follow up was not required.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: incomplete course of vaccinationhad the first shot about 5 years ago but never had the second dose; This case was reported by a consumer via 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 (received 1st dose on an unknown date about 5 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: This case was self-reported by the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not received second dose, which led to incomplete course of vaccination. The patient enquired if he/she need to start over.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a consumer via Shingrix GSK and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The case was reported by the consumer for himself/herself. The age at vaccination was not reported. The patient reported that, he/she had the Shingrix shot and within a few days the patient developed a few shingle spots. The patient asked was this normal.