chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: have shingles,  had a vaccination and got it anyway/ suspected vaccination failure; 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 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: 21-Jun-2022. Reporter's Comments: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. It was reported that patient had vaccination still patient had shingles at the time of reporting. The follow up would not be possible as contact details were not provided. Additional supportive information: 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 for herpes zoster were unknown.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Using all the diluent to reconstitute the lyophilized powder and not just 0.6mL.; Using all the diluent to reconstitute the lyophilized powder and not just 0.6mL.; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in an unknown number of patients who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, 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: 22-JUN-2022 Reporter's comment: The reporter stated that there was not a specific patient, but general population at department of health. The reporter stated that when reconstituting Hiberix, site had been using all the diluent to reconstitute the lyophilized powder and not just 0.6mL. They had been doing this for a long time. They recently caught this error and had corrected it. Additional Supportive Information: when reconstituting Hiberix, site had been using all the diluent to reconstitute the lyophilized powder and not just 0.6mL which led to inappropriate preparation of medication and inappropriate dose of vaccine administered
Sex: M
Vaccine: MEN, MENB
Symptoms: Interchange of vaccine products
Clinical narrative: accidentally gave another brand of men b for second dose; This case was reported by a consumer via interactive digital media and described the occurrence of interchange of vaccine products in a male patient who received Men B NVS (Bexsero) 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 and MENINGOCOCCAL B VACCINE for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero, Bexsero Pre-Filled Syringe Device and the 2nd dose of MENINGOCOCCAL B VACCINE. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products 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: 22-JUN-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The reporter stated that their son's doctor accidentally gave him another brand of Meningococcal B for his 2nd dose. The reporter enquired duration to get the Bexsero 2nd dose and was it safe. Additional Supportive Information: The patient received Bexsero followed by Meningococcal B vaccine other brand, which led to interchange of vaccine products. No follow-up was possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Inadvertently took a 3rd shot the 2nd one 4 years ago; This case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date) and Shingles vaccine (2nd dose received 4 years ago).   On 22nd June 2022, the patient received the 3rd dose of Shingles vaccine. On 22nd June 2022, unknown after receiving Shingles vaccine, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 22-JUN-2022 Reporter's Comments: This case reported by consumer via interactive digital media. The patient self-reported this case. The patient inadvertently took a third shingles shot 15 minutes before reporting.  The patient forgot that he or she had taken the second one 4 years ago and asked that what he or she should do. Follow-up would not be possible as no contact details available. Additional supportive information: The patient received 3rd dose of Shingles vaccine which led to extra dose administered.
Age: 90.0
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: took 2 shots, took the third one; This case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 90-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (Took 2 shingles shots 4 years ago).   On 22nd June 2022, the patient received the 3rd dose of Shingles vaccine. On 22nd June 2022, unknown after receiving Shingles vaccine, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional Information: GSK Receipt Date: 22-JUN-2022 Reporter's Comments: This case was reported by a consumer. The reporter stated that he/she had inadvertently took a third shingles shot. The reporter stated that he/she forgot that he/she had taken the second one 4 years ago (from the day of reporting) and the third one 15 minutes ago. The reporter enquired the further course of action and the duration does the shingles last. Additional Supportive Information: The patient received the third dose of Shingles vaccine, which led to extra dose administered.
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash papular
Clinical narrative: Has large patch of red bumps from wrist to his elbow on the same arm as injection; Has large patch of red bumps from wrist to his elbow on the same arm as injection; This case was reported by a consumer via interactive digital media and described the occurrence of red rash in a male 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 red rash and papular rash. On an unknown date, the outcome of the red rash and papular rash were recovered/resolved.   It was unknown if the reporter considered the red rash and papular rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 22-JUN-2022 Reporter's comments: The case was reported via interactive digital media. The reporter was patient's wife. The patient experienced large patch of red bumps from his wrist to his elbow on the same arm as injection after receiving 2nd dose of Shingrix, but patient felt fine. The reporter asked was it fine.
Sex: F
Vaccine: HEPAB
Symptoms: Fatigue
Clinical narrative: Extreme fatigue; This case was reported by a consumer and described the occurrence of fatigue in a female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was not recovered/not resolved.   It was unknown if the reporter considered the fatigue to be related to Twinrix and Twinrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022AMR096836   Additional Information: GSK Receipt Date: 15-JUN-2022 Reporter's Comments: Patient experienced extreme fatigue after the 1st twinrix dose received, but did not see a physician for it as patient wrote it off to the rigors of physical trainin; however, the fatigue did not go away even after being in less physical environments. Additional supportive information: For tolerance to the 2nd dose refer US2022AMR096836; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR096836:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Rash
Clinical narrative: blisters; Rash all over; This case was reported by a consumer via interactive digital media and described the occurrence of blister 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 blister and generalized rash. On an unknown date, the outcome of the blister and generalized rash were unknown.   It was unknown if the reporter considered the blister and generalized rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 23-JUN-2022 Reporter's Comments: This case was received from patient via interactive digital media. The patient got blisters and rash all over after vaccine. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Got a rash with blisters all over; This case was reported by a consumer via interactive digital media and described the occurrence of blistery rash 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 blistery rash. On an unknown date, the outcome of the blistery rash was not recovered/not resolved.   It was unknown if the reporter considered the blistery rash to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 23-JUN-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had the shingles vaccine and got the rash with blisters all over.  The patient wanted to know was that normal. Additional Supportive Information: The follow up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Influenza, Myalgia
Clinical narrative: flu; muscle pain; weakness; This case was reported by a consumer via interactive digital media and described the occurrence of influenza 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 influenza, muscle pain and weakness. On an unknown date, the outcome of the influenza, muscle pain and weakness were unknown.   It was unknown if the reporter considered the influenza, muscle pain and weakness to be related to Shingrix.     Additional Information: GSK Receipt Date: 23-JUN-2022 Reporter's Comments: This case was received from patient's cousin via interactive digital media. The reporter stated that the patient develops flu, severe muscle pain & weakness after receiving the vaccine. The reporter want to know how long can it last. The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Patient experienced extensive arm redness in the vaccinated arm; This case was reported by a other health professional via sales rep and described the occurrence of erythema of extremities in a male 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 erythema of extremities. On an unknown date, the outcome of the erythema of extremities was recovered/resolved.   It was unknown if the reporter considered the erythema of extremities to be related to Shingrix.     Additional Information: GSK Receipt Date: 23-JUN-2022 Reporter's Comments: The physician described that a patient at their clinic had experienced extensive arm redness in his vaccinated arm following his dose of Shingrix. His condition led to a visit with his physician. The condition did resolve over some time, and the patient was given the second dose of Shingrix without incident. No further information regarding the patient event was available at time of this report. The local GlaxoSmithKline vaccines representative would be collecting further information from the reporter on 24th June 2022, if possible. The reporter was consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: longer than six months from first dosage.; 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 1st dose on an unknown date).   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: 23-JUN-2022 Reporter's Comments: This case was reported by patient via interactive digital media. The patient asked should he/she take second dosage of Shingrix if it had been longer than six months from first dosage. 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: F
Vaccine: VARZOS
Symptoms: Headache, Illness, Peripheral swelling
Clinical narrative: swollen arm when she received the Shingrix shot; headache; felt sick; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of peripheral swelling (received flu vaccine on an unknown date and experienced swollen arm refer case US2022096941).   In December 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced swelling arm, headache and sickness. On an unknown date, the outcome of the swelling arm, headache and sickness were recovered/resolved.   It was unknown if the reporter considered the swelling arm, headache and sickness to be related to Shingrix.     Linked case(s) involving the same patient: US2016018882, US2022096941, US2022AMR097788, US2022AMR097795   Additional Information: GSK Receipt Date: 23-JUN-2022 Reporter's Comments: The case was self-reported by the patient. The patient received first dose of Shingrix into unknown arm and had swollen arm, headache and felt sick. The side effects lasted one day. The reporter did not consent to follow up. This was one of four cases, reported by the same reporter. Additional Supportive Information: For tolerance of 2nd dose, refer case US2022AMR097795.; Sender's Comments:  US-GSKCCFUS-Case-01417054_AE-81514: US-GLAXOSMITHKLINE-US2022096943:Same reporter US-GLAXOSMITHKLINE-US2022AMR097632:Same reporter US-GLAXOSMITHKLINE-US2016018882:Same patient, same reporter US-GLAXOSMITHKLINE-US2022AMR097788:Same patient, same reporter US-GLAXOSMITHKLINE-US2022096943:Same reporter US-GLAXOSMITHKLINE-US2022096941:Same patient, same reporter US-GLAXOSMITHKLINE-US2022AMR097632:Same reporter US-GLAXOSMITHKLINE-US2022AMR097795:Same patient, same reporter
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Malaise, Peripheral swelling
Clinical narrative: swollen arm; headache; felt sick; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included flu vaccine with an associated reaction of peripheral swelling (On every October of every year the patient received flu vaccine refer case US2022096941.), flu vaccine with an associated reaction of peripheral swelling (On Oct 2021 the patient received flu vaccine refer case US2022AMR097788.) and Shingrix with an associated reaction of headache (On Dec 2020 the patient received 1st dose of Shingrix refer case US2022AMR097791).   In June 2021, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced swelling arm, headache and sickness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the swelling arm, headache and sickness were recovered/resolved.   It was unknown if the reporter considered the swelling arm, headache and sickness to be related to Shingrix.     Linked case(s) involving the same patient:  US2022096941, US2022AMR097788, US2022AMR097791   Additional Information: GSK Receipt Date: 23-JUN-2022 Reporter's Comments: The patient had a swollen arm when she received the Shingrix shot. It was on the same arm where she received the injection.  When the patient received the second dose of Shingrix, she had worse side effects than when receiving the first dose: felt sick, had a headache. The side effects lasted one day. The reporter did not gave consent to follow up. Additional Supportive Information: This is 1 of the 4 cases reported by the reporter.; Sender's Comments:  US-GSKCCFUS-Case-01417054_AE-81514: US-GLAXOSMITHKLINE-US2022096943:Same reporter US-GLAXOSMITHKLINE-US2022AMR097632:Same reporter US-GLAXOSMITHKLINE-US2016018882:Same patient, same reporter US-GLAXOSMITHKLINE-US2022AMR097788:Same patient, same reporter US-GLAXOSMITHKLINE-US2022096941:Same patient, same reporter US-GLAXOSMITHKLINE-US2022AMR097791:Same patient, same reporter US-GLAXOSMITHKLINE-US2022AMR097632:Same reporter US-GLAXOSMITHKLINE-US2022096943:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Headache, Heart rate increased, Myalgia
Clinical narrative: elevated heart rate; extreme muscle soreness; Cold Chills; all of a sudden becomes super cold; mild headache off and on; sinus congestion off and on; This case was reported by a consumer via interactive digital media and described the occurrence of heart rate increased in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In June 2022, the patient received Shingles vaccine. In June 2022, less than 2 weeks after receiving Shingles vaccine, the patient experienced heart rate increased, muscle soreness, chills, coldness general, headache and sinus congestion. On an unknown date, the outcome of the heart rate increased, muscle soreness, chills and coldness general were unknown and the outcome of the headache and sinus congestion were not recovered/not resolved.   It was unknown if the reporter considered the heart rate increased, muscle soreness, chills, coldness general, headache and sinus congestion to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 24-JUN-2022 Reporter's Comments: The case was reported via interactive digital media. The reporter was patient's wife. The patient got the vaccine last week and had elevated heart rate, extreme muscle soreness, cold chills and all of a sudden becomes super cold, mild headache off and on and sinus congestion off and on.
Sex: M
Vaccine: VARZOS
Symptoms: Sinus congestion
Clinical narrative: elevated heart rate; extreme muscle soreness; Cold Chills; all of a sudden becomes super cold; mild headache off and on; sinus congestion off and on; This case was reported by a consumer via interactive digital media and described the occurrence of heart rate increased in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In June 2022, the patient received Shingles vaccine. In June 2022, less than 2 weeks after receiving Shingles vaccine, the patient experienced heart rate increased, muscle soreness, chills, coldness general, headache and sinus congestion. On an unknown date, the outcome of the heart rate increased, muscle soreness, chills and coldness general were unknown and the outcome of the headache and sinus congestion were not recovered/not resolved.   It was unknown if the reporter considered the heart rate increased, muscle soreness, chills, coldness general, headache and sinus congestion to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 24-JUN-2022 Reporter's Comments: The case was reported via interactive digital media. The reporter was patient's wife. The patient got the vaccine last week and had elevated heart rate, extreme muscle soreness, cold chills and all of a sudden becomes super cold, mild headache off and on and sinus congestion off and on.
Sex: U
Vaccine: VARZOS
Symptoms: Cough, Nasopharyngitis, Pyrexia
Clinical narrative: Constant cough; feeling like I have cold; feeling feverish; 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 22nd June 2022, the patient received Shingrix. On 23rd June 2022, 1 days after receiving Shingrix, the patient experienced fever and cold. On 24th June 2022, the patient experienced cough. On an unknown date, the outcome of the fever, cough and cold were not recovered/not resolved.   It was unknown if the reporter considered the fever, cough and cold to be related to Shingrix.  Additional Information: GSK Receipt Date: 26-JUN-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient was feeling feverish since 23rd June, a constant cough and he or she had been feeling like he/she had cold for the last two days before the date of reporting.  The reporter wanted to know if this was normal. Additional Supportive Information: The follow up would not possible as no contact details were available. Note: The year of vaccination and onset date was considered as 2022 from narrative.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a 77-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 24th June 2022, the patient received Shingles vaccine. In June 2022, less than a week after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   The reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-JUN-2022 Reporter's Comments: This case was reported by patient's mate via interactive digital media. The reporter reported that the patient had pain from the Shingles vaccine which was received yesterday (the day before reporting). The reporter asked what he/she should do. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Swelling; redness; This case was reported by a consumer via interactive digital media and described the occurrence of swelling in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 24th June 2022, the patient received the 2nd dose of Shingrix. In June 2022, less than a week after receiving Shingrix, the patient experienced swelling and redness. On an unknown date, the outcome of the swelling and redness were not recovered/not resolved.   It was unknown if the reporter considered the swelling and redness to be related to Shingrix.     Additional Information: GSK Receipt Date: 26-JUN-2022 Reporter's Comments: This case was received from patient's cousin via interactive digital media. The patient had Shingrix shot on Friday and the swelling and redness seem worse on the date of reporting than before. The patient asked if it was normal. The follow-up would not possible as no contact details were available.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm hurt a little; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Covid 19 vaccine with an associated reaction of pain in extremity.   On 9th December 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, 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 Shingrix.     Linked case(s) involving the same patient:  US2022066333   Additional Information: GSK Receipt Date: 27-JUN-2022 Reporter's Comments: The patient self-reported this case. The patient received 1st dose of Shingrix and had no reaction other than her arm hurt a little more compared to the Covid 19 vaccine. The patient gave permission to contact her primary care doctor. Additional Supportive Information: For tolerance of 2nd dose refer case US2022066333, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022066333:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: tired; This case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a 62-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 21st June 2022, the patient received the 2nd dose of Shingles vaccine. On 22nd June 2022, 1 days after receiving Shingles vaccine, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was not recovered/not resolved.   It was unknown if the reporter considered the tiredness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 24-JUN-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient reported that she was a healthy person and received second dose of Shingles vaccine Tuesday afternoon (the day before reporting) and felt horribly tired all day on Wednesday (the day before reporting) and then on Thursday she felt okay and then today (Friday) on the day of reporting she really tired again. The reporter asked would this tired feeling subside soon.  Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Infection, Intercepted product prescribing error
Clinical narrative: possible infection; doctor says should receive a 3rd Shingrix dose; This case was reported by a consumer via interactive digital media and described the occurrence of infection 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 Shingrix and Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced infection and intercepted drug prescribing error. On an unknown date, the outcome of the infection and intercepted drug prescribing error were unknown.   It was unknown if the reporter considered the infection to be related to Shingrix.     Additional Information: GSK Receipt Date: 24-JUN-2022 Reporter's Comments: The case was reported by patient via interactive digital media. The patient reported that his/her doctor said he/she should receive a 3rd Shingrix dose because of signs of a possible infection. Additional Supportive Information: The doctor said the patient should receive a 3rd Shingrix dose, which led to intercepted drug prescribing error. Follow up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: She's exhibit pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a 77-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 24th June 2022, the patient received Shingles vaccine. In June 2022, less than a week after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-JUN-2022 Reporter's Comments: This case was received from patient's mate via interactive digital media. The reporter stated that the patient yesterday receive the Shingles vaccine and she had exhibit pain. What should he/she should do. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the shot still got them/Suspected vaccination failure; still got them; 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: 24-June-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the shot and still got them. 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.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/Fully vaccinated for shingles/vaccine hasn't stopped my outbreaks/This is the third time I have gotten; broken out with shingles/currently broken out again/vaccine hasn't stopped my outbreaks/This is the third time I have gotten; 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.   The patient's past medical history included shingles (had broken out with shingles a few times a year for years) and blister. Concurrent medical conditions included scar (have had scars on his/her side from blisters).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than 2 years 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 Information: GSK receipt date: 24-June-2022 Reporter's comment: The case was reported by the patient via interactive digital media. The patient was broken out with shingles a few times a year for years.  The patient had scars on his/her side from the blisters.  The patient was fully vaccinated for shingles last year but the patient was currently broken out again.  The vaccine had not stopped the outbreaks at all.  This was the third time the patient had gotten them since the shots. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. Note: As there is no contact details available due which it was not possible to confirm whether scars on my side from the blisters was occurred before or after the vaccinations, therefore conservatively it was captured under medical condition as narrative chronology.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Felt like I'm carrying a golf ball under my arm it is so painful; 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 23rd June 2022, the patient received the 1st dose of Shingles vaccine. In June 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 not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-JUN-2022 Reporter's Comments: This case was reported by patient via interactive digital media. The patient reported that three days ago (the day before reporting) he/she received a dose of Shingles vaccine, for two days patient felt like he/she carried a golf ball under arm, it was so painful. The patient reported that it should be cleared up in the next day or so. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/Got the shot in 2017, I came down with shingles in 2021; Shingles in 2021 were in my mouth; 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: 26-June-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had received a shingles shot in 2017 and came down with shingles in 2021 and they were in his/her mouth. The patient stated that worst thing ever. The patient stated that he/she would never have a vaccine for anything again. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza
Clinical narrative: I felt like a slight case of flu for just one day after 1st and 2nd shot; This case was reported by a consumer via interactive digital media and described the occurrence of flu in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of influenza (1st dose received on an unknown date, for tolerance refer case US2022AMR098889).   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 flu. On an unknown date, the outcome of the flu was recovered/resolved.   It was unknown if the reporter considered the flu to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-Jun-2022 Reporters comment: This case was reported by the patient via interactive digital media The patient received a dose of shingles vaccine and experienced slight case of flu for 1 day. The patient thought it was worth it, not to get shingles. Follow up was not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR098889:Same Reporter
Sex: M
Vaccine: VARZOS
Symptoms: Death, Guillain-Barre syndrome
Clinical narrative: died; GBS as a side effect, and died; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death 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 unknown cause of death (serious criteria death and GSK medically significant) and guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the guillain barre syndrome was unknown. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death and guillain barre syndrome to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-JUN-2022 Reporter's Comment: This case was reported by a patient's son/daughter via interactive digital media. The patient got the Shingles vaccine and got Guillain Barre syndrome (GBS) as a side effect. The patient was died. Additional Supportive Information: The follow up would not possible as no contact details were available.; Reported Cause(s) of Death: Unknown cause of death
Sex: F
Vaccine: VARZOS
Symptoms: Blood disorder, Death
Clinical narrative: The shot gave my mother a blood disorder that killed her; This case was reported by a consumer via interactive digital media and described the occurrence of blood disorder 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 blood disorder (serious criteria death). On an unknown date, the outcome of the blood disorder was fatal. The reported cause of death was blood disorder.   The reporter considered the blood disorder to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-Jun-2022 Reporters comment: The case was reported by patient's child via interactive digital media. The shot gave the patient a blood disorder that killed her. The vaccine for them killed the patient. Additional Supportive Information: The follow up was not possible as no contact details were available.; Reported Cause(s) of Death: Blood disorder
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/had the vaccine but came with shingles; 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: 27-June-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the vaccine but still came down with shingles. The patient stated that be sure to get your shingles shot. 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.
Sex: U
Vaccine: COVID19, VARZOS
Symptoms: Herpes zoster, Immune system disorder, Vaccination failure
Clinical narrative: caused immune system to work overtime; suspected vaccination failure/had last shot, got shingles; shingles//had last shot, got 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.   Co-suspect products included COVID-19 VACCINE (COVID-19 BOOSTER) for prophylaxis.   The patient's past medical history included shingles (had shingles ).   In February 2022, the patient received Shingles vaccine. On an unknown date, the patient received COVID-19 BOOSTER. In June 2022, less than 5 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced immune system disorder. On an unknown date, the outcome of the vaccination failure, shingles and immune system disorder were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and immune system disorder to be related to Shingles vaccine.     Additional Information: GSK receipt date: 24-June-2022 Reporter's comment: The case was reported by the patient via interactive digital media. The patient had the last shot for shingles in February and 4 days ago the reporting date, the patient got shingles. The patient stated that going with it would be a lot worse then if the patient not had the vaccine, because it was not even one-fourth as bad as the patient had it the first time. After speaking with the physician, the patient believed that the Covid booster caused his/her immune system to work overtime (had major reaction) causing a shingles flair. The patient stated that the shingles was horrid. Additional supportive information: The reporter considered the shingles and immune system disorder to be related to Covid 19 booster. 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. Note: As it was unknown whether the patient had received the Covid booster before or after the Shingles vaccine and there is no contact details were available, therefore case was conservatively processed considering Covid booster as suspect product.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: suspected vaccination failure/had all the shots, they still pop up on me; they still pop up on me; Burning; Itching; 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), shingles, burning sensation and pruritus. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the burning sensation and pruritus were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, burning sensation and pruritus to be related to Shingles vaccine.     Additional Information: GSK receipt date: 24-June-2022 Reporter's comment: The case was reported by the patient via interactive digital media. The patient stated that the so sorry for the loss. The patient had all the shots and they still pop up on him/her every few months. The patient started medication as soon as the burning and itching started and it stopped them. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure/took the shot then got shingles; shingles//took the shot then got shingles; He said it hurts; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 25-June-2022 Reporter's comment: The case was reported by the patient's friend via interactive digital media. The patient took the shot then got shingles, it never leave the body, shows up every once in a while and the patient said that it hurts. The reporter could not saw nothing on this video. 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.