chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shingles shot/ still got the shingles/suspected vaccination failure; still got the shingles/ his were worse; 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 details were reported as follows: The age at vaccination was not reported. The patient received Shingles shot and experienced shingles. 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. This case linked with US2021AMR151351, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR151351:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: If a patient had first Shingrix shot in 2018 do they need to restart series?; This case was reported by a other health professional via  interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2018).   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 to this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter wanted to know they need to restart series or not.  The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got two shot and still feel the it everyday / suspected vaccination failure; I got two shot and still feel the it everyday; This case was reported by a consumer via (Facebook) 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 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 patient had reported the case for himself/herself. The age at vaccination was not reported. The patient mentioned that, he/she got two Shingles shot and still feel them every day. This case was considered as suspected vaccination failure since the details regarding, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. Follow-up would not be possible, as no contact details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose of Shingrix in 2018/do they just need to get 2nd dose to complete the series?; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2018).   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 to this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter wanted to know patient need to restart the series or do they just need to get 2nd dose to complete the series. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; YES ! I had the shot and I have them now; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; My cousin has had the shot and had them three times..twice after the shot....; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows. The patient had reported for his/her cousin. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.    This was 1 of 3 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR151420:Same reporter. Reporter's case. US-GLAXOSMITHKLINE-US2021AMR151421:Same reporter. Other people's case.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspect vaccination failure; got them after my second vaccine/still have them under my left arm and breast; 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.   In March 2021, the patient received the 2nd dose of Shingles vaccine. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 5 months after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional details were provided as follows. The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still had them under his/her left arm and breast, and it was horrific. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.    This case had been linked with case US2021AMR151371, reported for the patient's husband.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Supected vaccination failure; now dealing with the shingles; pain is overwhelming; 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, 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. The patient received Shingles shots 2 years ago from the date of reporting. After receiving Shingles vaccine, the patient was dealing with shingles at the time of reporting. The patient stated that, the pan was overwhelming, and the shots did nothing for him/her. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization and laboratory confirmation were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Laboratory test, Pain, Rash, Vaccination failure
Clinical narrative: Suspected vaccination failure; I broke out the very next day oñ the left chest area....hello shingles; The pain before the break out was terrible / ended up in the E.R; I got a rash to come back right away; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and rash. The patient was treated with calamine + zinc oxide (Calamine Lotion). On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown and the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and rash to be related to Shingles vaccine.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. The patient stated that, the pain before the breakout was terrible and he/she ended up in emergency room. They ran tests to saw if the patient was having a heart attack. The patient was told to see his/her P C D the next day and he could find nothing and said he thought, might be the patient was going to break out with shingles. He/she got a rash to come back right away. The patient broke out the very next day on the left chest area. The patient went back and was given some medications that he said would give the patient a lighter case. The patient stated that, from what he/she had saw from other people's cases of the breakout phase, he/she was very lucky, it was very light. The patient used calamine lotion on them and once they broke out. The pain was about over. The patient suggested to get the shot and said might be you be one of the lucky ones that it would work for. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided. This was 1 of 3 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR151406:Same reporter. Cousin's case. US-GLAXOSMITHKLINE-US2021AMR151421:Same reporter. Other people's case.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; From what I have see from other people's cases of the breakout phase...; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The age at vaccination was not reported. After receiving Shingles vaccine, the unspecified number of patient's had shingles breakout. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.   This was 1 of 3 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR151406:Same reporter. Cousin's case. US-GLAXOSMITHKLINE-US2021AMR151420:Same reporter. Reporter's case.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I got the shingles vaccine and 2 weeks later I got shingles??; 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 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 patient self reported the case. The age at vaccination was not reported. The patient received the shingles vaccine and 2 weeks later got shingles. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; I feel an onset/ the shingles from flaring up; This case was reported by a consumer via interactive digital media and (Facebook) 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. The patient was treated with valaciclovir hydrochloride (Valacyclovir). 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 patient had reported for him/herself. The age at vaccination was not reported. The patient stated that, he/she got Shingles vaccine, but it did not help. The patient's physician told him/her that, it was only effective in about 60 percent of people. The physician put him/her on Valacyclovir 1 gm. When the patient felt an onset, he/she took 2 tablets.  It had stopped the shingles from flaring up. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; My patient / got shingles; This case was reported by a other health professional via interactive digital media 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 reporter stated that, after receiving Shingrxi, the patient got singles. The reporter asked if the patient needed a booster. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Sex: M
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: nonviable after a temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a child male patient who received HAV (Havrix) (batch number 5575N, expiry date 19th June 2022) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional case details were reported as follows: The age at vaccination was not reported. The patient was given a dose of Havrix that was deemed nonviable after a temperature excursion, which led to incorrect storage of drug.  No symptoms reported. The reporter consented to follow up. This case was 1st of 9 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021142812:same reporter US-GLAXOSMITHKLINE-US2021142813:same reporter US-GLAXOSMITHKLINE-US2021142815:same reporter US-GLAXOSMITHKLINE-US2021142816:same reporter US-GLAXOSMITHKLINE-US2021142817:same reporter US-GLAXOSMITHKLINE-US2021142818:same reporter US-GLAXOSMITHKLINE-US2021AMR151443:same reporter US-GLAXOSMITHKLINE-US2021AMR151445:same reporter US-GLAXOSMITHKLINE-US2021AMR151444:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort, Influenza like illness
Clinical narrative: I got flu like symptoms for 2 days after/It was uncomfortable; This case was reported by a consumer via media and described the occurrence of influenza-like symptoms 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, less than a month after receiving Shingles vaccine, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.  It was unknown if the reporter considered the influenza-like symptoms to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient himself/herself. The patient reported that got first dose of shingles vaccine a month ago. After vaccination patient experienced flu like symptoms which was recovered in 2 days. Patient stated that It was uncomfortable but getting shingles was much worse patient heard so worth it.
Sex: F
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: nonviable after a temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a female patient who received HAV (Havrix) (batch number ABXB28AA, expiry date 30th June 2022) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were reported as follows: The age at vaccination was not reported. The patient was given a dose of Havrix that was deemed nonviable after a temperature excursion, which led to incorrect storage of drug.  No symptoms were reported. This is one of the several cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021142812:same reporter US-GLAXOSMITHKLINE-US2021142813:same reporter US-GLAXOSMITHKLINE-US2021142815:same reporter US-GLAXOSMITHKLINE-US2021142816:same reporter US-GLAXOSMITHKLINE-US2021142817:same reporter US-GLAXOSMITHKLINE-US2021142818:same reporter US-GLAXOSMITHKLINE-US2021AMR151436:same reporter US-GLAXOSMITHKLINE-US2021AMR151444:same reporter US-GLAXOSMITHKLINE-US2021AMR151445:same reporter US-GLAXOSMITHKLINE-US2021142817:
Sex: F
Vaccine: MENB
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: nonviable after a temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a female patient who received Men B NVS (Bexsero) (batch number ABXB28AA, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.    This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not reported. The patient was twin. The patient was given a dose of Bexsero that was deemed nonviable after a temperature excursion, which led to incorrect storage of drug.  No symptoms were reported. This is one of the several cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021142812:same reporter US-GLAXOSMITHKLINE-US2021142813:same reporter US-GLAXOSMITHKLINE-US2021142815:same reporter US-GLAXOSMITHKLINE-US2021142816:same reporter US-GLAXOSMITHKLINE-US2021142817:same reporter US-GLAXOSMITHKLINE-US2021142818:same reporter US-GLAXOSMITHKLINE-US2021AMR151443:same reporter US-GLAXOSMITHKLINE-US2021AMR151436:same reporter US-GLAXOSMITHKLINE-US2021AMR151445:same reporter US-GLAXOSMITHKLINE-US2021142817:
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pain, Pain in extremity
Clinical narrative: Very sore arm.; Chills; Horrible body ache; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 9th July 2021, the patient received the 1st dose of Shingles vaccine. On 10th July 2021, 1 days after receiving Shingles vaccine, the patient experienced pain in arm, chills and general body pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the pain in arm, chills and general body pain were unknown.   It was unknown if the reporter considered the pain in arm, chills and general body pain to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for himself /herself. The age at vaccination was not reported. The patient received first dose of shingles vaccine and experienced horrible body ache,chills and very sore arm. On the day of reporting ,the patient was not good at all. The patient took Tylenol and slept for 4 hours.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Hubby and I got a sore arm; Hubby and I got / some tiredness for a couple of day; This case was reported by a consumer via media and described the occurrence of pain in arm 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 pain in arm and tiredness. On an unknown date, the outcome of the pain in arm and tiredness were recovered/resolved.   It was unknown if the reporter considered the pain in arm and tiredness to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received shingles vaccine and experienced sore arm and some tiredness for a couple of days. At the time of reporting, the patient was fine and it was a time for patient's second shot. The reporter stated that they do not want to get shingles. No other information was reported. This case is linked to case US2021AMR151468, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR151468:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Hubby and I got a sore arm; Hubby and I got / some tiredness for a couple of day; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a male 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 pain in arm and tiredness. On an unknown date, the outcome of the pain in arm and tiredness were recovered/resolved.   It was unknown if the reporter considered the pain in arm and tiredness to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient's partner. The age at vaccination was not reported. The patient received shingles vaccine and experienced sore arm and some tiredness for a couple of days. At the time of reporting, the patient was fine and it was a time for his second shot. The reporter stated that they do not want to get shingles. No other information was reported. This case is linked to case US2021AMR151464, reported by same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR151464:Same reporter
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Neuropathy peripheral, Vaccination failure
Clinical narrative: Suspected vaccination failure; neuropathy; shingles. Mild case; had blisters; 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 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), neuropathy (serious criteria GSK medically significant), shingles and blister. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the neuropathy and blister were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, neuropathy, shingles and blister 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. After receiving Shingles vaccine, the patient got mild singles. Till the time of reporting, the patient still had blisters and neuropathy. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: received the vaccine and still got shingles/Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received shingles vaccine and still experienced shingles. 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: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: that needed hurts me so bad n my arm sore; This case was reported by a consumer via media and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (patient's 41 years old daughter got the shingles).   In July 2021, the patient received the 1st dose of Shingles vaccine. In July 2021, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by patient herself. The age at vaccination was not reported. The patient's daughter got shingles and was so much in pain, able to hardly sleep and eat. The reporter stated that shingles were contagious and her daughter had rash. Hence patient's daughter advised her to took shingles vaccine. The patient got 1st dose of vaccine a week before reporting day that hurts the patient so bad and her arm was sore like the she had the covid shot. The patient would get the other shot in September 2021.  The reporter stated that it still bothors her a little bit that her daughter told her that it hurt like labor pains that's the worst pain ever.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shingles shot but got them anyway / Suspected Vaccination failure; got the shingles shot but got them anyway; 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 details were provided as follows:  This case was reported by patient's wife. The age at vaccination was not reported. The patient got the Shingles shot but got shingles anyway. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: I got the shot and got a very mild case / suspected vaccination failure; got a very mild case; it was so painful??; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows:  The patient had reported the case for himself/herself. The age at vaccination was not reported. The patient got the shot and got a very mild case of shingles and it was so painful. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible, as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: only effected was sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by patient herself. The age at vaccination was not reported. The patient received Shingrix and had sore arm. The patient stated that its was better than getting shingles. The patient was planned to receive 2nd dose in September 2021. This case was linked with US2021AMR151908 and US2021AMR151907, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR151908:Same reporter US-GLAXOSMITHKLINE-US2021AMR151907:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: sore arm; was red / for few days; swollen / for few days; This case was reported by a consumer via (Facebook )  interactive digital media and described the occurrence of pain in arm in a male 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 pain in arm, erythema and swelling. On an unknown date, the outcome of the pain in arm, erythema and swelling were unknown.   It was unknown if the reporter considered the pain in arm, erythema and swelling to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The reporter was the patients wife. The patient received 1st dose of shingles and experienced sore arm ,redness and swollen for few days. No further information was reported. The follow up was not possible as no contact details were provided. This case has been linked with US2021AMR151903 and US2021AMR151908 , reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR151903:Same reporter US-GLAXOSMITHKLINE-US2021AMR151908:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: complained how sore her arm was; This case was reported by a consumer via (Facebook ) interactive digital media and described the occurrence of pain in arm 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 pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The reporter was the patients sister. The patient received dose of shingles vaccine and experienced sore arm . No further information was reported. The follow up was not possible as no contact details were provided. This case has been linked with US2021AMR151907 and US2021AMR151903, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR151907:Same reporter US-GLAXOSMITHKLINE-US2021AMR151903:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Drug ineffective, Herpes zoster, Pruritus, Swelling
Clinical narrative: Second shot . Two weeks later / shingles / Still breaking out with a spot here and there; Little bumps; Little bumps itching like crazy; Prescribed / valacyclovir. Still breaking out with a spot here and there; This case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included valaciclovir hydrochloride (Valacyclovir) unknown for shingles.   On an unknown date, the patient received the 2nd dose of Shingrix and Valacyclovir at an unknown dose and frequency. On an unknown date, 2 weeks after receiving Shingrix and not applicable after starting Valacyclovir, the patient experienced shingles, swelling, pruritus and lack of drug effect. The action taken with Valacyclovir was unknown. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the swelling, pruritus and lack of drug effect were unknown.   It was unknown if the reporter considered the shingles, swelling, pruritus and lack of drug effect to be related to Shingrix and Valacyclovir.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 2nd dose of shingrix vaccine and experienced 2 weeks later shingles, little bumps and itching. The patient thought the shot was going to prevent out breaks of shingles. The doctor prescribed the valacyclovir for shingles but Still breaking out with a spot which led to lack of drug effect. The reporter consent to follow up was Unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: 3rd shot of Shingrix; This case was reported by a consumer via Shingrix GSK and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received 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 reporter was the patient. The patient received 3rd dose of Shingrix, which led to extra dose administered.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: received an expired dose of Bexsero; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABX769AA, expiry date 31st July 2020) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th November 2020, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 17th November 2020, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional case details were reported as follows: The patient received an expired dose of Bexsero. The reporter consented to follow up.   Follow-up received from Nurse on 12th July 2021 as follows: VAERS details were captured. No further details provided.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Insomnia, Migraine, Pain
Clinical narrative: has trouble sleeping; weakness; body aches; felt fatigue; has had migraines just about everyday after vaccine; This case was reported by a consumer and described the occurrence of migraine in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix (intramuscular). In April 2019, 1 day after receiving Shingrix, the patient experienced migraine. On 6th June 2021, the patient experienced weakness, general body pain and fatigue. On an unknown date, the patient experienced difficulty sleeping. Shingrix was discontinued. On an unknown date, the outcome of the migraine, weakness, general body pain and fatigue were not recovered/not resolved and the outcome of the difficulty sleeping was unknown.   It was unknown if the reporter considered the migraine, difficulty sleeping, weakness, general body pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced migraines just about everyday after vaccine and had trouble sleeping. From 6th June 2021 until the morning of reporting day patient felt fatigue, body aches, and weakness. The patient did not get her second dose because of the side effects she experienced with first dose. The reporter consented to follow up.
Sex: U
Vaccine: TDAP
Symptoms: Incorrect dose administered, Syringe issue, Underdose
Clinical narrative: Patient received the incomplete booster dose of Boostrix; This case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 28th June 2021, the patient received Boostrix. On 28th June 2021, unknown after receiving Boostrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The registered nurse reported that the patient received the incomplete booster dose of Boostrix since when taking the syringe from the vial, part of the liquid leaked, which led to incomplete dose administered. No patient's identifiers and no vaccine information were reported. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Peripheral swelling
Clinical narrative: she was fatigued.; her arm was swollen; This case was reported by a consumer via call center representative and described the occurrence of fatigue 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 fatigue and swelling arm. On an unknown date, the outcome of the fatigue and swelling arm were unknown.   It was unknown if the reporter considered the fatigue and swelling arm to be related to Shingrix.  Additional details were provided are as follows: The case was reported for reporter's friend. The age at vaccination was not reported. It was reported that the patient just received Shingrix vaccine and experienced her arm was swollen and was fatigued. The reporter refused to provide any information and stated she would encourage her patient to call GlaxoSmithKline to report symptoms.  The patient was referred to her health care professional. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose was administrated on June 24 2019 / 2nd dose was no administrated; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 24th June 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist stated that, a patient is late for the second dose of Shingrix. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No adverse event was reported. No patient's identifiers provided. No lot number and expiration date provided for 1st dose.  The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First / dose in 2019 / has not yet received the second / will get / soon; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No health care professional information available. The patient would get the second dose soon, and would not restart the vaccine series, per content. Patient did not wish to give complete demographics.  The reporter did not consent to follow up.