chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Took the vaccine and still got the shingles/Suspected vaccination failure; Still 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.   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: 30-Sept-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient took the vaccine and still got the shingles. 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, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure/Received the 2 Shingrex shots and still got shingles; Still got shingles/it was quite painful but about a month; It was quite painful; 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), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 30-Sept-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient received the 2 Shingrix shots and still got shingles this past spring. It was quite painful, but only lasted for about a month. The patient thought that it would have been worse if he/she had not gotten 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. As per the verbatim, 'It was quite painful, but only lasted for about a month', outcome and duration for shingles event was captured as recovered same as pain, considering that patient was explaining the shingles in brief.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the shot and still got it/Suspected vaccination failure; Still got it; 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: 01-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient agreed and stated that had the shot and still got them. The patient mentioned that no more fake, money making shots for him/her. 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: F
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Herpes zoster, Hypersensitivity, Pain
Clinical narrative: Allergic reaction; Large painful blister; Painful blisters, hurt/ very painful shingles; Burned so bad; This case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2022, the patient received Shingrix. In September 2022, 1 day after receiving Shingrix, the patient experienced allergic reaction, blister, pain and burning sensation. On an unknown date, the outcome of the allergic reaction, blister, pain and burning sensation were recovering/resolving.   The reporter considered the allergic reaction, blister, pain and burning sensation to be possibly related to Shingrix.     Additional Information: GSK Receipt Date: 24-SEP-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The reporter stated that patient had Shingrix vaccine 2 weeks ago. Patient reported never had chicken pox however day after vaccine broke out in large painfull blisters on upper abdomen that hurt and burned badly. The breakouts began to dry up now. The reporter reported shingles was very painful. Follow-up would not possible, as no contact, details were available. This case had been linked with US2022AMR138575, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR138575:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: What if a patient gets a third shot?; 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 (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st and 2nd dose received on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 24-SEP-2022 Reporter's Comment: This case was reported by the consumer via interactive digital media. The reporter asked what if the patient received third dose of Shingrix vaccine. The reporter wanted to know what if patient gets a third shot. Additional Supportive Information: The patient received a third dose of Shingrix vaccine, which led to extra dose administered.  The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd Bexsero vaccine 3 weeks later; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 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.   Concomitant products included MENINGOCOCCAL B VACCINE (BEXSERO).   On an unknown date, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short 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: 26-SEP-2022 Reporter's comment: The reporter asked if a patient had 1st Bexsero then came back and got 2nd Bexsero vaccine 3 weeks later did the patient need to come for another Bexsero due to getting the 2nd vaccine too early. Additional Supportive Information: The patient received 2nd dose of Bexsero earlier than the recommended interval, which led to shortening of vaccination schedule. This case had been linked with case US2022001236, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022001236:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: hives appeared all over my body; itched like crazy, went to the ER; This case was reported by a consumer via interactive digital media and described the occurrence of hives 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 hives and pruritus. On an unknown date, the outcome of the hives and pruritus were unknown.   It was unknown if the reporter considered the hives and pruritus to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-SEP-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient had the vaccine and hives appeared all over his/her body.  It had been itched like crazy and had went to the Emergency Room (ER).  The reporter stated that he/she had remembered when his/her friends had shingles. The pain and suffering they went through, it sounded to be unbearable. He/She never wanted to experience that kind of pain, which had made him/her wanted to learn more about this painful, blistering rash.  He/She had educated himself/herself about the risk for developing shingles, especially for people 50 years or older, and what she could do for the prevention. Additional supportive information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Pain in extremity, Pruritus
Clinical narrative: arm area was so sore; arm  area was red; arm area was inflamed; arm area was very itchy; 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 an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm, erythema of extremities, inflammation localized and itchy upper limbs. On an unknown date, the outcome of the pain in arm, erythema of extremities, inflammation localized and itchy upper limbs were unknown.   It was unknown if the reporter considered the pain in arm, erythema of extremities, inflammation localized and itchy upper limbs to be related to Shingles vaccine.     Additional Information: GSK receipt date: 25-September-2022 Reporter's comment:  Patient reported that had arm area was sore and red, also had inflamed and very itchy. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: It was painful; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In September 2022, the patient received the 1st dose of Shingles vaccine. In September 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-SEP-2022 Reporters comment: This case was reported by a consumer via interactive digital media.  The patient received shingles vaccine last week and it was painful.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Made me feel crappy; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell 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 feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   The reporter considered the feeling unwell to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-SEP-2022 Reporter's Comments: The patient self-reported this case via interactive digital media. The patient received first shot and made him/her feel crappy. Additional Supportive Information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Big area in arm hurts/ arm hurst so bad/ most painful shot ever; 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 an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-Sep-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient needed the shot and had got his/her first one most painful shot which he/she ever had for which the patient arm hurts so bad. There was a big area in arm hurts. Additional supportive information: The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: Constant nerve damage pain is gone; This case was reported by a consumer via interactive digital media and described the occurrence of unexpected therapeutic effect in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had been dealing with shingles for 35 years) and nerve pain. Previously administered products included Shingles vaccine (got the one shot solution about 5 years ago and it did not work).   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 unexpected therapeutic effect. On an unknown date, the outcome of the unexpected therapeutic effect was unknown.   Linked case(s) involving the same patient: US2022AMR139444   Additional Information: GSK Receipt Date: 25-SEP-2022 and 27-SEP-2022 Reporter's Comment: This case was reported by patient via interactive digital media. The patient just got first dose of the new two shot treatment and he/she could already told that it was working.  The patient would get the second shot in 3 months.  The patient would highly recommend it.  The patient had a constant nerve damage pain in the area where his/her shingles would come up and it was gone. The patient asked what was the shingles. The patient did not thought he/she reached out to GlaxoSmithKline. The patient had just been tried to told people who were suffering his/her experience. The patient reported that Acyclovir to get to temporary remission and now patient had gotten his/her first shot. The one shot offered a few years back did not work for him/her. Additional supportive information: This case had been linked with case US2022AMR139444, reported by the same reporter. The follow-up would not possible, as no contact, details were available.; Sender's Comments:  US-GSK-US2022AMR139444:same patient
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: Make me sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-SEP-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient stated that Just received his/her second shot, hope it did not make sick like the first shot, but better than getting shingles as his/her doctor says. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: suffering searing pain from raw nerve endings, pain; This case was reported by a consumer via interactive digital media and described the occurrence of nerve pain 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, more than 2 years after receiving Shingles vaccine, the patient experienced nerve pain. On an unknown date, the outcome of the nerve pain was not recovered/not resolved.   It was unknown if the reporter considered the nerve pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 24-SEP-2022 Reporter's comment: The patient self-reported this case via interactive digital media. The patient received doses both vaccines 4 years ago and was still suffering searing pain from raw nerve endings. The patient stated that he/she wished it was for weeks but over one year later he/she was still suffering searing pain from raw nerve endings. The patient also stated that his/her doctors still had not figured out to stop the pain. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: expired vaccines inadvertently administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number T93SR, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra 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: 27-SEP-2022 Reporter's Comments: The medical assistant reported there were 2 boxes of Fluarix that left over from last year which was expired on June 2022. The three vaccines from it was inadvertently administered to 3 patients. The vaccine administration facility was the same as Primary Reporter No other details were available.  The reporter did not consent to follow up. The case was linked with US2022138666 and US2022AMR139388 reported same reporter. Additional Supportive Information: The patient received an expired dose of Fluarix, which led to expired vaccine used.; Sender's Comments:  US-GSK-US2022138666:Same reporter US-GSK-US2022AMR139388:Same reporter
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: expired vaccines inadvertently administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number T93SR, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra 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: 27-SEP-2022 Reporter's Comments: The medical assistant reported there were 2 boxes of Fluarix that left over from last year which was expired on June 2022. The three vaccines from it was inadvertently administered to 3 patients. The vaccine administration facility was the same as Primary Reporter No other details were available.  The reporter did not consent to follow up. The case was linked with US2022138666 and US2022AMR139387 reported same reporter. Additional Supportive Information: The patient received an expired dose of Fluarix, which led to expired vaccine used.; Sender's Comments:  US-GSK-US2022138666:Same reporter US-GSK-US2022AMR139387:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: it wiped me out; This case was reported by a consumer via interactive digital media and described the occurrence of malaise 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 malaise. On an unknown date, the outcome of the malaise was unknown.   It was unknown if the reporter considered the malaise to be related to Shingles vaccine.  Linked case(s) involving the same patient: US2022AMR140151   Additional Information: GSK Receipt Date: 28-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient stated that, he/she was wiped out. Additional Supportive Information: The follow up would not possible as no contact details were available. For tolerance of 2nd dose, refer case US2022AMR140151; Sender's Comments:  US-GSK-US2022AMR140151:Same reporter  2nd dose
Sex: M
Vaccine: COVID19, TDAP, VARZOS
Symptoms: Chills, Muscular weakness, Swelling
Clinical narrative: Shiver; Swelling; Weakness in legs; This case was reported by a nurse via sales rep and described the occurrence of shivers in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis and COVID-19 VACCINE (COVID VACCINE) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix, dTpa vaccine and COVID VACCINE. On an unknown date, 2 days after receiving Shingrix and unknown after receiving dTpa vaccine, the patient experienced shivers, swelling and lower extremities weakness of. On an unknown date, the outcome of the shivers, swelling and lower extremities weakness of were unknown.   It was unknown if the reporter considered the shivers, swelling and lower extremities weakness of to be related to Shingrix and dTpa vaccine.     Additional Information: GSK receipt date: 14-Sept-2022 Reporter's comment: The patient was of 59-60. The patient had symptoms includes shiver, swelling and weakness in leg, two days after Shingrix. The patient also had dtap vaccine Covid shot. The reporter only had a concern because of weakness in the legs. No hospitalization or treatment was needed. The reporter consented to follow-up.
Sex: F
Vaccine: UNK
Symptoms: Gastrointestinal disorder, Vomiting
Clinical narrative: Vomiting; GI issues; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number AS5RM, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th August 2022, the patient received Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On 28th August 2022, less than a day after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced vomiting and gastrointestinal disorder. On an unknown date, the outcome of the vomiting and gastrointestinal disorder were unknown.   It was unknown if the reporter considered the vomiting and gastrointestinal disorder to be related to Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra 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.   Additional Information: GSK Receipt Date: 24-SEP-2022 Reporter's Comment:  The patient received Fluarix vaccine and had vomiting and gastrointestinal(GI) issues later that evening. It was related to the patient. This was an after hours voicemail left on 24th September 2022 at 13:29 EST, received on 26th September 2022. A call was made one call back attempt to the caller to get more details, and also a voicemail was left that would probably call her for more information since all she left was a phone number. Do not know if the reporter was a healthcare professional or consumer. Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2022, the patient received the 1st dose of Shingrix. In September 2022, less than 2 weeks after receiving Shingrix, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was not recovered/not resolved.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.     Additional Information: GSK Receipt Date: 26-SEP-2022 Reporter's Comments: The patient self-reported this case. She received her first Shingrix dose about two weeks ago.  She experienced diarrhea soon after and it was lasted two weeks (diarrhea, not recovered).  She was an appointment with her physician to provide a stool sample and rule out other causes.  She was nothing else to report.  The reporter was consented to follow up with physician. Additional Supportive Information:  This case has been linked with the case US2022137996 reported by same reporter.; Sender's Comments:  US-GSK-US2022137996:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2022, the patient received the 1st dose of Shingrix. In September 2022, less than 2 weeks after receiving Shingrix, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was recovered/resolved.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.     Additional Information: GSK Receipt Date: 26-SEP-2022 Reporter's Comments: The reporter was the patient's wife.  The patient had his first Shingrix dose about 2 weeks ago. The patient developed diarrhea soon after and it resolved after two days. Nothing else was reported.  The reporter declined to provide DOB (Date of birth). The reporter did not consent to follow up. Additional Supportive Information:  This case has been linked with case US2022137993 reported by same reporter.; Sender's Comments:  US-GSK-US2022137993:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: 1st dose on Oct/Nov2021, 2nd not received/ Inappropriate Schedule of Vaccine; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received intramuscularly in October or November of 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK Receipt Date: 26-SEP-2022 Reporter's comment: The patient self-reported this case. The patient reported that he received his 1st Shingrix vaccine in October or November of 2021.  The patient also stated that he had not yet received their second Shingrix vaccine. (Inappropriate Schedule of Vaccine). The patient did not give permission to contact HCP (Health Care Professional). 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. This case had been linked with case US2022AMR138448, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR138448:Same reporter/ wife case
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 10sep2020, 2nd never; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (First dose received on 10 Sep 2020). Concurrent medical conditions included blood pressure (the patient takes blood pressure medication for prevention.).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 26-SEP-2022 Reporter's Comment: The medical assistant reporter that the patient received first dose of Shingrix. The patient never got second dose.  The Patient was not immunocompromised and taking blood pressure medication for prevention.  The reporter did not consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 2021, never had her 2nd dose; 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 (1st dose received in October 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: 26-SEP-2022 Reporter's Comments: The patient self-reported this case. The patient received first dose of Shingrix, but never receive her second dose. The reporter did not wish to provider her date of birth.  The patient indicates she would get the second dose. VAERS detail was reported for 1st dose. The reporter 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.
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Fall, Head injury, Intensive care, Loss of consciousness
Clinical narrative: fell, stay in the ICU for 2 days; hit head, stay in the ICU for 2 days; episodes of passing out; nausea; dizziness; This case was reported by a consumer via call center representative and described the occurrence of fall in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th May 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced fall (serious criteria hospitalization), head injury (serious criteria hospitalization), passed out (serious criteria hospitalization and GSK medically significant), nausea and dizziness. On an unknown date, the outcome of the fall, head injury, passed out, nausea and dizziness were not recovered/not resolved.   It was unknown if the reporter considered the fall, head injury, passed out, nausea and dizziness to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-SEP-2022 Reporter's Comments: The patient self-reported this case. The patient received 2 doses of Shingrix. He received his first dose on 19th May 2022 and his second dose on 15th September 2022. He stated that after his first dose, he experienced dizziness, nausea, and episodes of passing out. He also stated that he fell and hit his head on the concrete which resulted in having to stay in the ICU (Intensive Care Unit) for 2 days. He was admitted to the hospital on 16th August 2022 The symptoms were not resolved.  The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: fell, stay in the ICU for 2 days; hit head, stay in the ICU for 2 days; episodes of passing out; nausea; dizziness; This case was reported by a consumer via call center representative and described the occurrence of fall in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th May 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced fall (serious criteria hospitalization), head injury (serious criteria hospitalization), passed out (serious criteria hospitalization and GSK medically significant), nausea and dizziness. On an unknown date, the outcome of the fall, head injury, passed out, nausea and dizziness were not recovered/not resolved.   It was unknown if the reporter considered the fall, head injury, passed out, nausea and dizziness to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-SEP-2022 Reporter's Comments: The patient self-reported this case. The patient received 2 doses of Shingrix. He received his first dose on 19th May 2022 and his second dose on 15th September 2022. He stated that after his first dose, he experienced dizziness, nausea, and episodes of passing out. He also stated that he fell and hit his head on the concrete which resulted in having to stay in the ICU (Intensive Care Unit) for 2 days. He was admitted to the hospital on 16th August 2022 The symptoms were not resolved.  The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Ophthalmic herpes zoster
Clinical narrative: She has not yet received her second Shingrix dose; developed shingles in eye; This case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 4th February 2022, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient did not receive the 2nd dose of Shingrix. In August 2022, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the patient experienced incomplete course of vaccination. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the ophthalmic herpes zoster was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR140062   Additional Information: GSK Receipt Date: 27-SEP-2022 Reporter's Comment: The reporter was a patient. The reporter reported that the patient received Shingrix vaccine on unknown arm. The reporter stated that the patient experienced Shingles in her eye in early august 2022. The reporter stated that last week the patient started Valacyclovir for 10 days to treat the shingles. The patient had not received her second dose of Shingrix Yet. The reporter nothing had else to report. The reporter declined to provide contact information and demographics. The reporter did not consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. This case had been linked with US2022AMR140062 reported by same reporter for same patient.; Sender's Comments:  US-GSK-US2022AMR140062:same reproter, same patient
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 05/2021, 2nd not received; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in May 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: 27-Sept-2022 Reporter's comment: The patient was over 50 years of age. Medical physician called to inquired that how to proceed with Shingrix series. The reporter reported that the patient never came back for the second dose. The reporter was unable to provide full vaccine and patient details. 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.
Sex: F
Vaccine: FLUX
Symptoms: Cough, Dyspnoea
Clinical narrative: ended up in the hospital for 9 days; She mentions coughing and being winded recently; She mentions coughing and being winded recently; This case was reported by a consumer via call center representative and described the occurrence of hospitalization in a 70-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Co-suspect products included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (Trelegy Ellipta) inhalation powder for product used for unknown indication and fluticasone fur+umeclidinium+vilanterol ellipta dry powder inhaler device (Trelegy Ellipta Dry Powder Inhaler Device) inhaler (batch number Unk, expiry date unknown) for product used for unknown indication.   Concurrent medical conditions included asthma (patient was a long time user of inhaler and had a history of asthma). Concomitant products included montelukast sodium (Singulair) and levosalbutamol hydrochloride (Xopenex).   On an unknown date, the patient received Flu vaccine, Trelegy Ellipta (inhaled) 1 puff(s) once daily (1 puff(s) daily) and Trelegy Ellipta Dry Powder Inhaler Device. On an unknown date, unknown after receiving Flu vaccine, Trelegy Ellipta and Trelegy Ellipta Dry Powder Inhaler Device, the patient experienced hospitalization (serious criteria hospitalization), cough and breathlessness. Trelegy Ellipta was continued with no change. On an unknown date, the outcome of the hospitalization, cough and breathlessness were unknown.   It was unknown if the reporter considered the hospitalization, cough and breathlessness to be related to Flu vaccine, Trelegy Ellipta and Trelegy Ellipta Dry Powder Inhaler Device. 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: 27-SEP-2022 Reporter's comments: The reporter reported that she was a long-time user of inhaler. She stated that she was on singulair and xopenex as well and has a history of asthma. She stated that she had received a flu shot over 5 years ago from reporting and ended up in the hospital for 9 days after getting vaccine.  She did not remember if she was on TRELEGY at that time.  She mentioned of having coughing and being winded recently.  The reporter had consented to follow-up. Additional supportive information: The time taken to onset for event - cough and breathlessness was conservatively captured as more than 2 years.
Age: 72.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 72-year-old female patient who received HAB (Twinrix) (batch number X239D, expiry date 7th August 2022) 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 27th September 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 27th September 2022, unknown after receiving Twinrix and Twinrix 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: 28-Sept-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Twinrix, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2y ago, 2nd not received; 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 (received 1st dose about 2 years ago).   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: 28-Sept-2022 Reporter's comment: The patient was the reporter. The patient never receive 2nd shot. The patient provided limited information.  The patient did not want to answer any further questions.  Did not get an opportunity to ask for doctor of medicine (MD) contact information as the patient wanted to get off the phone. Additional supportive information: Till the time of reporting, the patient did not receive 2nd shot of Shingrix, which led to incomplete course of vaccination.
Age: 0.17
Sex: F
Vaccine: UNK
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 2 month old pt was administered Fluarix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 9XL7N, expiry date 30th June 2023) for prophylaxis.   On 27th September 2022, the patient received Fluarix Quadrivalent 2022-2023 season. On 27th September 2022, unknown after receiving Fluarix Quadrivalent 2022-2023 season, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 27-Sept-2022 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter gave permission for follow-up but declined to provide her last name. Additional supportive information: The patient received Fluarix QIV at inappropriate age, which led to inappropriate age at vaccine administration.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 25Apr2019, 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 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 25th April 2019 with batch number 2YN4S and expiry date 9th July 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: 28-Sept-2022 Reporter's comment: The pharmacist reported that the patient was not  immunocompromised received only one dose of Shingrix and never got the 2nd dose. The vaccine administration facility was the same as primary reporter. The reporter consented 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.
Sex: F
Vaccine: VARZOS
Symptoms: Bladder cancer, Chemotherapy
Clinical narrative: bladder cancer; This case was reported by a consumer via call center representative and described the occurrence of bladder cancer in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, several days after receiving Shingrix, the patient experienced bladder cancer (serious criteria GSK medically significant). The patient was treated with chemotherapy, nos (Chemotherapy). On an unknown date, the outcome of the bladder cancer was not recovered/not resolved.   It was unknown if the reporter considered the bladder cancer to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-SEP-2022 Reporter's Comments: The caller was the patient stating that she got her first Shingrix vaccine in November 2021.  The patient states that shortly after the vaccine, she was diagnosed with bladder cancer. The patient had not received 2nd dose yet due to chemo treatment but does plan on getting the second vaccine. The patient declined to give any further demographic information.  The reporter did not consent to follow up. Additional supportive information: Note: The 2nd dose was not coded due to medical reason.