chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the worst case of shingles/Suspected vaccination failure; Had the worst case of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of 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, more than 2 years 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 Information: GSK Receipt Date: 05-Oct-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received the Shingles vaccine four years ago from reporting. The patient experienced the worst case of shingles last spring form bellybutton to spine on left side. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The follow up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site pain, Vaccination failure
Clinical narrative: I've had both doses. I had shingles/suspected vaccination failure; dose 2, some soreness in the injection site/dose 1, some soreness in the injection site; had shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), injection site pain and shingles. On an unknown date, the outcome of the vaccination failure, injection site pain and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, injection site pain and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 6-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had both doses of Shingrix vaccine for shingles and had shingles. The patient had no side effects, some soreness in the injection site, that's it. The patient stated that you did not want them, get vaxxed. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/I have a mild case now. I've had both shingles vaccines; mild case. It is NOT fun; This case was reported by a consumer via interactive digital media and described the occurrence of 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. The patient was treated with valaciclovir hydrochloride (Valtrex). 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 Information: GSK receipt date: 6-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient have had both shingles vaccine and had a mild case now. The patient stated that Valtrex was clearing them up. The patient stated that it was not fun, even in a mild case, get the shots. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/Got shots 2years ago, now it returned; now suddenly it returns ad bad as before; This case was reported by a consumer via interactive digital media and described the occurrence of 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. In October 2022, more than 2 years 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 Information: GSK receipt date: 6-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the shots two years ago and now suddenly it returns as bad as before.  The physician also could not understand why he/she got them again. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. Time to onset was considered as more than 2 years as patient got the shots 2 years ago and now had the shingles.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/Had vaccine 5 years ago and got shingles; shingles on my back; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, more than 2 years 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 Information: GSK receipt date: 7-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had vaccine 5 years ago and got the shingles last year on his/her back. The reporter denied to follow-up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got vaccine, had severe case of shingles/Suspected vaccination failure; severe shingles; This case was reported by a consumer via interactive digital media and described the occurrence of 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 Information: GSK receipt date: 7-Oct-2022 Reporter's comment: The case was received from the patient's friend via interactive digital media. The patient's friend reported that the patient never had shingles but after getting the shingles vaccination, had sever case of the shingles. The case was linked with case US2022AMR144803 reported by same reporter for different patient. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR132558:Same reporter US-GSK-US2022AMR144803:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got vaccine, had severe case of shingles/Suspected vaccination failure; severe shingles; This case was reported by a consumer via interactive digital media and described the occurrence of 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 Information: GSK receipt date: 7-Oct-2022 Reporter's comment: The case was received from the patient's friend via  interactive digital media. The patient's friend reported that the patient never had shingles but after getting the shingles vaccination, had sever case of the shingles. The case was linked with case US2022AMR144790 reported by same reporter for different patient. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR144790:Same reporter US-GSK-US2022AMR132558:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: 202.2 fever; chills; This case was reported by a consumer via interactive digital media and described the occurrence of fever 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, 1 day after receiving Shingles vaccine, the patient experienced fever and chills. On an unknown date, the outcome of the fever and chills were unknown.   It was unknown if the reporter considered the fever and chills to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 01-Oct-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient experienced 102.2 fever with chills normal the day after the second shingles shot. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: fever (202.2 F); chills; This case was reported by a consumer via call center representative and described the occurrence of fever 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 fever and chills. On an unknown date, the outcome of the fever and chills were not recovered/not resolved.   It was unknown if the reporter considered the fever and chills to be related to Shingrix.     Additional Information: GSK Receipt Date: 01-OCT-2022 Reporter's comment: This case was reported by the patient's wife via interactive digital media. Reporter stated that how long can fever and chills last after second shot.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Waited little too long as about 6 months since 1st; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (The patient received 1st dose of shingles vaccine on an unknown date).   On 1st October 2022, the patient received the 2nd dose of Shingles vaccine. On 1st October 2022, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.       Additional Information: GSK Receipt Date: 01-OCT-2022 Reporter's Comment: This case was reported by a patient via  interactive digital media. The patient stated that, he/she waited a little too long as about 6 months since his/her first shot of shingles vaccine. The patient stated that, hopefully he/she was good. The patient further stated that, they said he/she might have to get 2 more close together but he/she was not sure insurance would cover.  This scared the hell out of him/her more than covid. Additional Supportive Information: The patient received 2nd dose of shingles vaccine later than the recommended schedule which led to lengthening of vaccination schedule. The follow up would not possible as no contact details were available. Since the exact  interval of administration was not clear and just is stated about 6 months being conservative  drug dose administration interval too long was coded.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Pain, Tenderness
Clinical narrative: redness at the injection site; Tenderness of the injected arm; redness below injection site; soreness below injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th September 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site pain, erythema of extremities and pain localized. On 3rd October 2022, the outcome of the injection site erythema, injection site pain, erythema of extremities and pain localized were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain, erythema of extremities and pain localized to be related to Shingrix.   Additional Information: GSK Receipt Date:01-OCT-2022 and 03-OCT-2022 Reporter's Comment: The patient Shingrix administered to unspecified arm.  The patient wanted to know if it was common to have redness and soreness at and 2 -3 below the injection site. The patient stated that, it was still sore and red at the above locations. The reporter did not have the lot number of the Shingrix which was administered. But did provide the contact information for the pharmacy where the shot was administered reporter gave consent for safety to reach out to his doctor though he mentioned that, he had not seen the new doctor yet as he had to recently switch doctors. The patient stated that, he looked at his arm this morning (3rd October 2022) and it looked fine.  There was no redness at the injection site or below the injection site (anymore). Also the tenderness (soreness) of the injected arm had resolved.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: arm that ached several days/ Arm being little sore; neck pain; low grade fever; chills; fatigue; This case was reported by a other health professional via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of no adverse event (received 1st dose on an unknown date, it was good). Concurrent medical conditions included immunocompromised (the patient had low immune system).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm, neck pain, low grade fever, chills and fatigue. On an unknown date, the outcome of the pain in arm, neck pain, low grade fever, chills and fatigue were recovered/resolved.   It was unknown if the reporter considered the pain in arm, neck pain, low grade fever, chills and fatigue to be related to Shingles vaccine.     Additional Information: GSK receipt date: 01-OCT-2022 Reporter's comment: This case was reported by a consumer via interactive digital media. The patient said his/her insurance paid for both 100 percents. His/her first injection was all good.  The patient received second injection was arm that ached for several days and into his/her neck on that side.  The patient had low grade fever and chills and fatigue but not bad enough to keep from working.  Besides the arm being a little sore. All symptoms were gone within 36 hours including the neck pain.  The patient was low immune system and his/her doctor recommended it.  The patient was said glad did it.  The patient said had several patients with shingles and they were in so much pain. Additional supportive information: Follow up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Swelling
Clinical narrative: Large red bump on arm getting worse; This case was reported by a consumer via interactive digital media and described the occurrence of local swelling 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 local swelling. On an unknown date, the outcome of the local swelling was not recovered/not resolved.   It was unknown if the reporter considered the local swelling to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 01-OCT-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient had a large red bump on his/her arm post vaccine that's keeps getting worse. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash after vaccination; This case was reported by a consumer via interactive digital media and described the occurrence of rash 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 rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 02-OCT-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and experienced rash after the vaccination. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Severe muscle pain; This case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was unknown.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 02-OCT-2022 Reporter's comment: This case was reported by the patient's via interactive digital media. The reporter stated that he/she had experienced severe muscle pain. Additional supportive information: Follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: 202.2 fever; chills; This case was reported by a consumer via interactive digital media and described the occurrence of fever 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, 1 day after receiving Shingrix, the patient experienced fever and chills. On an unknown date, the outcome of the fever and chills were unknown.   It was unknown if the reporter considered the fever and chills to be related to Shingrix.     Additional Information: GSK Receipt Date: 01-OCT-2022 Reporter's Comment: This case was reported by patient via interactive digital media. The patient received second dose of Shingrix and one day after vaccination experienced 102.2 fever with chills and wanted was it normal. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.     Additional Information: GSK Receipt Date: 03-OCT-2022 Reporter's Comment: This case was reported via interactive digital media. The reporter asked how many days after getting Shingrix shot was it normal to get fever.  Additional supportive information: The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: Is allergic; This case was reported by a consumer via interactive digital media and described the occurrence of allergy 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 allergy. On an unknown date, the outcome of the allergy was unknown.   It was unknown if the reporter considered the allergy to be related to Shingrix.     Additional Information: GSK Receipt Date: 02-OCT-2022 Reporter's Comment: This case was reported by a patient's husband via interactive digital media. The reporter reported that he could not found any information on this drug.  The reporter's wife was allergic to the Shingrix vaccine and she was suffering horribly. The reporter asked could GSK tell him more please. Additional supportive information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on July2018, 2nd not received; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the 1st dose in July 2018).   On an unknown date, the patient did not receive 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 Information: GSK receipt date: 03-OCT-2022 Reporters comment: This case was reported by a patient via interactive digital media. The patient not received the second dose of Shingrix. Additional Supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose 11 months after 1st dose; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 03-OCT-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received his/her 2nd dose of Shingrix 11 months after the first. The patient asked as about the revaccination. Additional Supportive Information: The patient received 2nd dose of Shingrix 11 months after the first, which led to lengthening of vaccination schedule. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm is a little sore; 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.   Previously administered products included Shingles vaccine (received 1st dose of shingles vaccine on an unknown date).   On 1st October 2022, the patient received the 2nd dose of Shingles vaccine. In October 2022, 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 Information: GSK Receipt Date: 05-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient stated that, he/she was very fortunate that, his/her insurance paid 100 percent of both shots of shingles and received the second one the day before reporting and arm was a little sore but manageable.  The patient further stated that, he/she highly recommend receiving the vaccine it was better than having the virus. Additional Supportive Information: The follow up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR142018:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Dyspnoea, Heart rate increased, Insomnia, Limb discomfort, Mobility decreased
Clinical narrative: fever; sharp Pain; heavy arm (can not move nor touch at all); heavy arm/ arm discomfort; swelling of the throat; couldnt sleep; difficulty breathing, shallow and fact, need to sit up to breath; Weaken arm, dropped dishes many times; fast heartbeat; This case was reported by a consumer via call center representative and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, pain, mobility decreased, heaviness in arm, throat swelling, insomnia, difficulty breathing, weakness of arms and heartbeats increased. The patient was treated with budesonide + formoterol (Symbicort Turbuhaler) and other anti-asthmatics, inhalants (Asthma Inhaler (Nos)). On an unknown date, the outcome of the fever, pain, mobility decreased, heaviness in arm and insomnia were unknown and the outcome of the throat swelling, difficulty breathing, weakness of arms and heartbeats increased were recovered/resolved.   It was unknown if the reporter considered the fever, pain, mobility decreased, heaviness in arm, throat swelling, insomnia, difficulty breathing, weakness of arms and heartbeats increased to be related to Shingrix.     Additional Information: GSK Receipt Date: 04-OCT-2022 Reporter's Comment: The patient self-reported this case  The patient got 1st Shingrix shot on 14th March (year unspecified). The patient was wondering whether to take 2nd shot or not as he/she had strong side effects after 1st shot, beside fever. The patient got Shingrix shot at 10:45 am and in afternoon the patient had sharp pain and heavy arm (could not move nor touch at all) swelling of the throat (the patient took Symbicort Turbuhaler, asthma inhaler, then it became okay)  At night the patient could not sleep due to difficulty breathing (shallow and fact breathing) and need to sit up to breath fast heartbeat. Next morning no more difficult on breathing and heartbeat was normal. The patient experienced weaken arm (dropped dishes many times) for more than one month. The patient experienced pain, mobility decreased, heaviness in arm and insomnia, throat swelling, difficulty breathing less than day after receiving Shingrix.  The patient asked would please give him/her advise, whether he/she should take 2nd shot or not.
Sex: U
Vaccine: VARZOS
Symptoms: Muscular weakness, Pain, Pharyngeal swelling, Pyrexia
Clinical narrative: fever; sharp Pain; heavy arm (can not move nor touch at all); heavy arm/ arm discomfort; swelling of the throat; couldnt sleep; difficulty breathing, shallow and fact, need to sit up to breath; Weaken arm, dropped dishes many times; fast heartbeat; This case was reported by a consumer via call center representative and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, pain, mobility decreased, heaviness in arm, throat swelling, insomnia, difficulty breathing, weakness of arms and heartbeats increased. The patient was treated with budesonide + formoterol (Symbicort Turbuhaler) and other anti-asthmatics, inhalants (Asthma Inhaler (Nos)). On an unknown date, the outcome of the fever, pain, mobility decreased, heaviness in arm and insomnia were unknown and the outcome of the throat swelling, difficulty breathing, weakness of arms and heartbeats increased were recovered/resolved.   It was unknown if the reporter considered the fever, pain, mobility decreased, heaviness in arm, throat swelling, insomnia, difficulty breathing, weakness of arms and heartbeats increased to be related to Shingrix.     Additional Information: GSK Receipt Date: 04-OCT-2022 Reporter's Comment: The patient self-reported this case  The patient got 1st Shingrix shot on 14th March (year unspecified). The patient was wondering whether to take 2nd shot or not as he/she had strong side effects after 1st shot, beside fever. The patient got Shingrix shot at 10:45 am and in afternoon the patient had sharp pain and heavy arm (could not move nor touch at all) swelling of the throat (the patient took Symbicort Turbuhaler, asthma inhaler, then it became okay)  At night the patient could not sleep due to difficulty breathing (shallow and fact breathing) and need to sit up to breath fast heartbeat. Next morning no more difficult on breathing and heartbeat was normal. The patient experienced weaken arm (dropped dishes many times) for more than one month. The patient experienced pain, mobility decreased, heaviness in arm and insomnia, throat swelling, difficulty breathing less than day after receiving Shingrix.  The patient asked would please give him/her advise, whether he/she should take 2nd shot or not.
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Near death experience
Clinical narrative: made the patient deathly ill with flu within 2 hours after; This case was reported by a consumer and described the occurrence of near death experience in a 61-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, less than a day after receiving Flu vaccine, the patient experienced near death experience (serious criteria GSK medically significant). On an unknown date, the outcome of the near death experience was unknown.   The reporter considered the near death experience to be related to Flu vaccine.     Linked case(s) involving the same patient: US2022GSK143658   Additional Information: GSK Receipt Date: 26-SEP-2022 Reporter's Comment: The reporter reported that the patient received a dose of Flu vaccine and vaccine made the patient deathly ill within 2 hours after vaccination. This case had been linked with US2022GSK143658 reported by same reporter.; Sender's Comments:  US-GSK-US2022GSK143658:
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose Dec2021, forgot to get 2nd; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on December 2021).   On an unknown date, the patient did not receive 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 Information: GSK receipt date: 03-OCT-2022 Reporter's comment: The patient self reported the case. Patient reported that he forgot to get the 2nd dose. Patient inquired when should get the 2nd shingles vaccine.  Not all information was available. No additional information was provided for this first dose (lot or site of injection). Patient consented to follow up with HCP, but did not have the information available at the moment. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 3.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: expired Kinrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 3-year-old female patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd October 2022, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 3rd October 2022, unknown after receiving Kinrix and Kinrix 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 Information: GSK Receipt Date: 03-OCT-2022 Reporter's Comment: The reporter from a pediatric office reported an expired dose of Kinrix was administered to a patient.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The reporter from a pediatric office reported an expired dose of Kinrix was administered to a patient, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Shingrix only adjuvant used; Only adjuvant administration; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 299J9, expiry date 1st July 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 03-OCT-2022 Reporter's comment: A health care professional reported that a female patient received only the adjuvant of Shingrix. The reporter was consented to follow up. Additional Supportive Information: The patient received only the adjuvant of Shingrix, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 3 years ago, 2nd not received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received over 3 years ago prior to the reporting).   On an unknown date, the patient did not receive 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 Information: GSK Receipt Date: 03-OCT-2022 Reporter's Comment:  The reporter reported that the patient received first dose of Shingrix vaccine over 3 years ago and 2nd dose not received yet. The vaccine administration facility was the same as the primary reporter. The reporter did consent to follow up via mail. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. VAERS details provided corresponded to the 1st dose as the 2nd dose had not been administered yet.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles on front head (still); This case was reported by a nurse via call center representative and described the occurrence of shingles in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 9cr25, expiry date 24th September 2023) for prophylaxis.   On 27th September 2022, the patient received Shingrix. On 29th September 2022, 2 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 03-OCT-2022 Reporter's Comments: The nurse reported that a patient was administrated with Shingrix and developed shingles on the front head. The patient continued with shingles. The reporter consented to follow up.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: gave adjuvant without reconstituting it; gave adjuvant without reconstituting it; This case was reported by a nurse via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 53-year-old male patient who received Herpes zoster (Shingrix) (batch number DN74H, expiry date 10th July 2023) for prophylaxis.   On 3rd October 2022, the patient received the 1st dose of Shingrix. On 3rd October 2022, unknown after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK Receipt Date: 03-OCT-2022 Reporter's comment: Nurse practitioner stated that a medical assistant accidentally given the adjuvant portion of the vaccine to the patient without reconstituting it on the day of reporting. This would had been patient's first dose in the series. The reporter had consented to follow-up. Additional supportive information: The patient had accidentally received the adjuvant portion of the vaccine only without reconstituting it, which led to inappropriate dose of vaccine administered and inappropriate preparation of medication.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose on March 9 2022, has not yet received second; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (had received her first dose of Shingrix on March 9 2022).   On an unknown date, the patient did not receive 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 Information: GSK Receipt Date: 03-OCT-2022 Reporter's comment: The patient reported that he did not receive the 2nd dose yet. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: 1st dose Dec2021, 2nd not yet; shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In December 2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. In August 2022, between 7 and 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 04-OCT-2022 Reporter's Comments: The reporter was the healthcare professional who was reporting on behalf of a patient.  The patient experienced shingles and had not yet received her second dose of Shingrix. The reporter did not consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 18Nov2019, 2nd on 10Jun2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 80-year-old male patient who received Herpes zoster (Shingrix) (batch number Y44ZT, expiry date 10th July 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 18th November 2019).   On 10th June 2022, the patient received the 2nd dose of Shingrix. On 10th June 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 04-OCT-2022 Reporter's Comment: The reporter stated that a patient received a late second dose of Shingrix. The reporter asked should they get another dose. The reporter did not consent to follow up. Additional supportive information: As patient received late 2nd dose of Shingrix which led to lengthening of vaccination schedule.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received 3 doses. 3rd dose 12 months after 1st; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 52-year-old male patient who received Herpes zoster (Shingrix) (batch number 47S82, expiry date 20th May 2024) for prophylaxis.   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 Information: GSK receipt date: 04-OCT-2022 Reporters comment: The patient received three doses of Shingrix and third dose was administered 12 months after the 1st dose. The first two doses were administered considering the correct schedule. The reporter consent to follow-up. Additional Supportive information: The patient received 3rd dose of Shingrix, which led to extra dose administered.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose years ago, 2nd not yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received couple of years ago, prior to the pandemic from the date of reporting).   On an unknown date, the patient did not receive 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 Information: GSK Receipt Date: 06-OCT-2022 Reporter's comment: The patient self-reported this case. The patient had not yet received his second dose of Shingrix. The details were reported for 1st dose. The reporter gave consented to follow-up with health care professional (pharmacy) Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to Incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Possible cellulitis in patients after SHINGRIX; This case was reported by a other health professional via sales rep and described the occurrence of cellulitis in an unspecified number of patients 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.   It was unknown if the reporter considered the cellulitis to be related to Shingrix.  Additional Information: GSK Receipt Date: 06-OCT-2022 Reporter's Comment: The reporter wanted to know how common incidence of cellulitis in patients was after receiving Shingrix. The reporter consented to follow up. Additional Supportive Information: This case was conservatively kept valid with event cellulitis as it was not clear if it was medical inquiry or reporter wanted to report event, clarification had been raised.