chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 62-year-old female patient who received HAV (Havrix) (batch number 72T95, expiry date 9th August 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th October 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 7th October 2022, unknown after receiving Havrix and Havrix 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: 07-OCT-2022 Reporter's Comments: The reporter reported that they inadvertently administered an expired Havrix dose to a patient.  Pharmacist called to inquire how to proceed. The reporter did not consent to follow-up. Additional Supportive Information: The vaccine was already expired and was administered to the patient, which led to expired vaccine used.
Sex: U
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Twinrix in Oct 2021, and received Engerix-B and Hep A (Merck) for the 2nd dose a month later; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received 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.   Previously administered products included Twinrix (received 1st dose in Oct 2021), Engerix B (2nd dose received on unknown date in November 2021) and Hepatitis A (2nd dose received on unknown date in November 2021).   On an unknown date, the patient did not receive the 3rd 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 incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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: 07-Oct-2022 Reporter's comment: The registered pharmacist stated that a patient received their first dose of Twinrix in Oct 2021, and received Engerix B and Hepatitis A (Merck) for the 2nd dose a month later.  The reporter asked whether the patient should still get the Twinrix, how could we proceed. Health-care professional did not had patient demographics and did not had any vaccine information to provide (Lot, expiry date). The consent to follow-up was requested to follow up via mail.  Additional Supportive Information: Till the time of reporting, the patient did not receive 3rd dose of Twinrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Expired Flulaval administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a female patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2021-2022 season) (batch number 77AJ9, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th October 2022, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On 7th October 2022, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval 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: 07-OCT-2022 Reporter's comments: The Healthcare Professional (HCP) had administered Flulaval expired dose to a patient. The reporter did not consent to follow-up. Additional supportive information: The patient had received an expired dose of FluLaval Quadrivalent, which led to expired vaccine used.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only the grey vial was given; Only the grey vial was given; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA732A, expiry date 31st October 2023) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, 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: 07-OCT-2022 Reporter's comment: The reporter stated that he/she was working in a doctor's office.  Someone in their office used a Menveo vaccine, only the grey vial medication was given.  The reporter asked did they have to give the patient both vials together or could they just give them the red vial. The reporter did not know which of the patient's didn't get the red vial. The reporter went to give one and found the mistake. They did not know when it happened. The reporter found the extra red top yesterday (day before reporting) when he/she took out a red and a grey top to use. The reporter stated that only one bottle (red) left in the box. So it could be one of 3 patients. The reporter consented to follow-up via mail. Additional Supportive Information: The patient received only the grey vial of the vaccine, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Amnesia, Aphasia, Mental status changes, Pain in extremity
Clinical narrative: Sore arm; altered mental status; Anomic Aphasia; short term memory loss; This case was reported by a consumer via call center representative and described the occurrence of mental status changes in a 66-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9ZK5T, expiry date 7th October 2024) for prophylaxis.   On 26th September 2022, the patient received Boostrix. On 26th September 2022, less than a day after receiving Boostrix, the patient experienced mental status changes, aphasia and short-term memory loss. On 29th September 2022, the patient experienced pain in arm. On an unknown date, the outcome of the mental status changes, aphasia and short-term memory loss were unknown and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the mental status changes, aphasia, short-term memory loss and pain in arm to be related to Boostrix.     Additional Information: GSK Receipt Date: 07-OCT-2022 Reporter's Comment: The reporter stated that the patient received a dose of Boostrix and then experienced a sore arm for 2 to 3 days, altered mental status, anomic aphasia, and short term memory loss. The reporter consented to follow. Additional supportive information: As the onset date of event pain in arm was reported before administration of vaccine, however it was captured as 29 Sep 2022 conservatively
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: vaccine of Havrix is given expired; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix adult) (batch number unknown, expiry date 21st August 2022) for prophylaxis.   On an unknown date, the patient received the 1st dose of Havrix adult. On an unknown date, unknown after receiving Havrix adult, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 07-Oct-2022 Reporter's comment: The reporter was from an Health-care professional office.  The reporter stated that if a vaccine of Havrix was given expired, was there a need to administer that 1st dose again.  No additional information was provided.  The caller disconnected.  Not all information was available.  The caller disconnected and agent returned call to medical facility but was unable to reconnect with reporter to obtain additional information.  The adverse event would be filed with limited information.  The request was raised for the follow up with Health-care professional office to complete adverse event information and follow up with medical information for vaccines. The consent to follow-up was granted. Additional Supportive Information: The patient received expired dose of Havrix, which led to expired vaccine used.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis, Swelling
Clinical narrative: Enlarged knuckles; increased arthralgia in knuckles; This case was reported by a consumer via call center representative and described the occurrence of finger arthritis in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd August 2022, the patient received the 1st dose of Shingrix. In August 2022, less than 2 weeks after receiving Shingrix, the patient experienced finger arthritis and arthralgia. On an unknown date, the outcome of the finger arthritis and arthralgia were not recovered/not resolved.   It was unknown if the reporter considered the finger arthritis and arthralgia to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-Oct-2022 Reporter's comment: The case was self reported by the patient.  The patient received first dose of Shingrix on right arm. The patient reported that while removing wedding ring from ring finger on right hand because it felt snug approximately a week to a week and half after receiving dose.  The patient reported that when they attempted to put their wedding ring back on, they were unable to get it past the middle knuckle due to the knuckle being enlarged.  The patient reported that they were trying to put on ring on the left ring finger and noticed the left middle knuckle was also enlarged.  The patient located rings purchased for index finger to see if it would go past the middle knuckle on index finger.  The patient confirmed ring for index finger would not go past the middle knuckle on their right hand.  The patient reported the rest of their fingers are not swollen; only the middle knuckles.  The patient would take wedding ring into jewelry to confirm the size, which was size 6.  The patient reported jewelry confirmed size and measured around middle knuckle and advised size was now 6 and three quarters.  The patient reported that the weigh was less than they did when rings were purchased, so they feel know the enlargement of their middle knuckles was not due to weight gain.  The patient visited to seeing a rheumatologist a couple of months after receiving first dose of Shingrix.  The patient did not have rheumatoid arthritis.  The patient reported that increased arthralgia in the knuckles, since receiving first dose of Shingrix.  The reporter did not consent to follow-up. This case has been linked to the US2022AMR146029 case reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR146029:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Social problem
Clinical narrative: Did not return for 2nd dose likely due to Covid quarantine; Did not return for 2nd dose likely due to Covid quarantine; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received two and a half years prior to the reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem and quarantine. On an unknown date, the outcome of the social problem and quarantine were unknown.   Additional Information: GSK Receipt Date: 10-OCT-2022 Reporter's Comment: The reporter stated that, a patient received first dose of Shingrix two and a half years ago and, likely due to covid quarantine, did not return for dose 2. No further details were provided on call. The reporter was in a hurry to get off phone but consented to follow up. The reporter consented to follow up
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Unreconstituted Rotarix diluent only; Unreconstituted Rotarix diluent only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 7H9CH, expiry date 8th July 2023) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 7th October 2022, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 7th October 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, 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.   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: 10-OCT-2022 Reporter's Comment: The reporter was a office manager. The reporter reported that the patient received unreconstituted Rotarix vaccines diluent portion only. No symptoms reported. The reporter consented to follow up.  Additional supportive information: The reporter gave by error Rotarix diluent portion only ,which led to inappropriate preparation of medication and inappropriate dose of vaccine administered
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number h2pe2, expiry date 19th May 2023) for prophylaxis.   On 23rd June 2022, the patient received the 1st dose of Shingrix. On 4th October 2022, 103 days after receiving Shingrix, the patient experienced shingles. The patient was treated with antivirals nos. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 11-Oct-2022 Reporter's comment: The pharmacist reported that the patient received the first dose of Shingrix on 23rd June 2022 and approximately on 4th October 2022 (exact date was not recorded by pharmacist) started with shingle symptoms.  The pharmacist mentioned that the patient was taking antiviral medication at that moment (for shingles).  The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Herpes zoster oticus, Pain, Rash, Vaccination failure
Clinical narrative: completed series, developed shingles/ Suspected vaccination failure; shingles rash on ear; pain radiating to side of head; Shingles rash; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (on back).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) and the 1st dose of Shingrix. On an unknown date, between 5 and 7 months after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), herpes zoster otitis externa (serious criteria GSK medically significant), radiating pain and rash. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the herpes zoster otitis externa, radiating pain and rash were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, herpes zoster otitis externa, radiating pain and rash to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 11-Oct-2022 Reporter's comment: This case was self-reported by the patient.  The patient had completed two doses of Shingrix series about six to twelve months ago from reporting. The patient received 2nd dose of Shingrix on arm. About five or six months after completing the series the patient developed a shingles rash on his ear that was recovered. The patient also had pain radiating to the side of head at that time that was recovered. After recovering, the patient again developed pain and shingles rash on ear that was recovered.  The dermatologist saw and diagnosed shingles.  The patient had nothing else to report.  This report consented to follow up.  Additional Supportive Information: This case was considered as vaccination failure since the details regarding laboratory confirmation of shingles was unknown at the time of reporting.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site discolouration, Injection site erythema
Clinical narrative: slight discoloration around the injection site; itching near the injections site; 8 cm erythematous circle around the site of injection. It got worse; fatigue; chills; headache; This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st July 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In July 2022, 24 hrs after receiving Shingrix, the patient experienced injection site erythema, fatigue, chills and headache. On an unknown date, the patient experienced injection site discoloration and injection site itching. On an unknown date, the outcome of the injection site erythema, injection site itching, fatigue, chills and headache were recovered/resolved and the outcome of the injection site discoloration was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site discoloration, injection site itching, fatigue, chills and headache to be related to Shingrix.  Additional Information: GSK Receipt Date: 11-OCT-2022 Reporter's Comment: The reporter was stating that, she had a patient that got their Shingrix vaccine at the end of July 2022.She stated that, about 24 hours post vaccine, the patient had fatigue, chills, and a headache that lasted for about one day. She also stated that, about 24 hours later the patient developed an 8 cm erythematous circle around the site of injection. The patient stated that, she received her Shingrix about two and one-half months ago.  She experienced redness and itching near the injections site.  The size of the area was 4 inches x 2 inches.  It was bothersome and lasted a long time. She stated that, it got worse over the next few weeks and then started to fade. She reported the patient still had slight discoloration around the injection site. She had been left with a discoloration in her arm.  The reporter stated that, she had a picture of the redness which was taken a day after the vaccine which she would be happy to share reporter gave consent to follow up with healthcare professional (pharmacy). The reporter did not consent to follow-up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: slight discoloration around the injection site; itching near the injections site; 8 cm erythematous circle around the site of injection. It got worse; fatigue; chills; headache; This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st July 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In July 2022, 24 hrs after receiving Shingrix, the patient experienced injection site erythema, fatigue, chills and headache. On an unknown date, the patient experienced injection site discoloration and injection site itching. On an unknown date, the outcome of the injection site erythema, injection site itching, fatigue, chills and headache were recovered/resolved and the outcome of the injection site discoloration was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site discoloration, injection site itching, fatigue, chills and headache to be related to Shingrix.  Additional Information: GSK Receipt Date: 11-OCT-2022 Reporter's Comment: The reporter was stating that, she had a patient that got their Shingrix vaccine at the end of July 2022.She stated that, about 24 hours post vaccine, the patient had fatigue, chills, and a headache that lasted for about one day. She also stated that, about 24 hours later the patient developed an 8 cm erythematous circle around the site of injection. The patient stated that, she received her Shingrix about two and one-half months ago.  She experienced redness and itching near the injections site.  The size of the area was 4 inches x 2 inches.  It was bothersome and lasted a long time. She stated that, it got worse over the next few weeks and then started to fade. She reported the patient still had slight discoloration around the injection site. She had been left with a discoloration in her arm.  The reporter stated that, she had a picture of the redness which was taken a day after the vaccine which she would be happy to share reporter gave consent to follow up with healthcare professional (pharmacy). The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 04May2022, 2nd not yet; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (received first dose on 4th May 2021 which batch number 93FR9  and expiry date 29th April 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 11-Oct-2022 Reporter's comment: The nurse asked for information about the administration of Shingrix second dose to a patient. The reporter asked if they could administer the second dose or it needed to start over with the vaccination. The reporter consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose two years ago, 2nd not received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (received a dose of Shingrix two 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: 11-Oct-2022 Reporter's comment: The pharmacist reported that the patient never got the second dose. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Age: 64.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 64-year-old male patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th October 2022, the patient received the 1st dose of Havrix and Havrix Pre-Filled Syringe Device. On 11th October 2022, unknown after receiving Havrix and Havrix 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: 11-Oct-2022 Reporter's comment: The registered nurse reported that the patient received 1st dose of an expired Havrix vaccine.  The reporter consented to follow up.  The vaccine administration facility was the same as primary reporter. Additional Supportive Information: The patient was administered an expired dose of Havrix, which led to expired vaccine used.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Shingrix administered without reconstitution; Shingrix administered without reconstitution; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 51-year-old male patient who received Herpes zoster (Shingrix) (batch number E42J2, expiry date 10th July 2023) for prophylaxis.   On 10th October 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 10th October 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 11-Oct-2022 Reporter's comment: The clinic director of operations reported that the patient was seen in office one day before the reporting day for Shingrix administration (the first of a two part series).  The suspension component was drawn and injected into patient's right deltoid without first reconstituting the antigen component. No adverse reaction was noted. The patient was then administered a properly reconstituted dose on the same day. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient received Shingrix vaccine without antigen component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2 years since first shot; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (received first 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: 11-Oct-2022 Reporter's comment: The pharmacist reported that the patient was late for their second dose of Shingrix. The reporter asked during the chat that if about 2 years since a first Shingrix shot, did they have to start series over or just get the second shot. The online transcript did not save. The reporter declined to provide additional information die to being busy. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive second shot of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: st dose more than 6 months ago, 2nd not recived; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 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: 12-OCT-2022 Reporter's Comment: The reporter was patient's friend. The patient did not receive the second dose of Shingrix and it had been longer than six months since his first dose of Shingrix. The reporter stated that he was going to try and convince the patient to receive the second dose. 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.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Incomplete course of vaccination, Local reaction, Myalgia, Swelling
Clinical narrative: first vaccine in 2019, pharmacy would not administer 2nd; Large 15 cm local reaction; Swelling; Chills; Myalgias; This case was reported by a physician via call center representative and described the occurrence of local reaction in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number NZ4ZJ, expiry date unknown) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included psoriasis. Concomitant products included secukinumab (Cosentyx).   In August 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced local reaction, swelling, chills, myalgia and incomplete course of vaccination. The patient was treated with paracetamol (Tylenol) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the local reaction, swelling, chills and myalgia were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the local reaction, swelling, chills and myalgia to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-OCT-2022 Reporter's Comment: The reporter was a patient and also pediatrician. The reporter reported that she received Shingrix vaccine. The reporter stated that the patient had large 15 cm local reaction and swelling associated with chills and myalgia for 2 days. The patient received Tylenol and Benadryl as a treatment. The patient returned to receive the 2nd dose the pharmacy was not administered the 2nd dose because of her symptoms. The patient primary care provider was also advised to not receive the 2nd dose. The patient stated that she was concerned as she was not fully protected and she was interested to receive the second dose. The reporter did 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.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Injection site pain, Swelling
Clinical narrative: Fatigue; swelling, below vaccine site; redness, below vaccine site; Soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th October 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 10th October 2022, less than a day after receiving Shingrix, the patient experienced injection site pain. On 11th October 2022, the patient experienced fatigue, swelling and erythema. On an unknown date, the outcome of the injection site pain and fatigue were recovered/resolved and the outcome of the swelling and erythema were recovering/resolving.   It was unknown if the reporter considered the injection site pain, fatigue, swelling and erythema to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-OCT-2022 Reporter's Comment: The reporter was a patient. The patient received Shingrix vaccine and on that evening patient experienced soreness at the injection site that had resolved. The patient reported that on 11th October 2022 1 day after received Shingrix vaccine the patient experienced fatigue that had resolved and patient experienced swelling and redness below the vaccination site but not at the injection site. The patient stated that the redness and swelling was still present, but she stated that it was appears to be getting better. The patient did not want to give any further demographics and did not had any further information about the vaccine  itself. The reporter did not consent to follow up. Additional supportive information: The outcome of swelling and redness captured as recovering as per narrative.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Burning sensation, Ear pain, Extra dose administered, Herpes zoster, Neuralgia
Clinical narrative: first and second dose, experiencing internal Shingles/Suspected vaccination failure; Internal shingles; Nerve pain from jaw to ear; Burning from jaw to ear; receiving third dose of Shingrix; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   In August 2022, the patient received the 3rd dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In August 2022, unknown after receiving Shingrix and not applicable after receiving Shingrix and Shingrix, the patient experienced extra dose administered. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, post herpetic neuralgia and burning sensation. On an unknown date, the outcome of the vaccination failure and extra dose administered were unknown and the outcome of the shingles was recovered/resolved and the outcome of the post herpetic neuralgia and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia and burning sensation to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 12-OCT-2022 Reporter's Comment: The reporter was a patient. The reporter reported that the patient received first and second dose of Shingrix approximately three years ago prior to the reporting. The reporter stated that the patient recently experienced a case of internal shingles, resulting in healthcare professional who was unaware of patient was previously fully vaccinated, he recommended to receive Shingrix vaccine, once Shingles resolved. The patient received 3rd dose of Shingrix vaccine 2 months prior to the reporting. The reporter reported that the internal shingles consisted of burning and nerve pain from the jaw to the ear. The patient advised their shingles had resolved but they continue to experience nerve pain and burning from their jaw to the ear. The reporter did not consent to follow up. Additional supportive information: This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting. The patient received extra dose of Shingrix in error, which led to extra dose administered.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain in jaw, Post herpetic neuralgia, Vaccination failure
Clinical narrative: first and second dose, experiencing internal Shingles/Suspected vaccination failure; Internal shingles; Nerve pain from jaw to ear; Burning from jaw to ear; receiving third dose of Shingrix; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   In August 2022, the patient received the 3rd dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In August 2022, unknown after receiving Shingrix and not applicable after receiving Shingrix and Shingrix, the patient experienced extra dose administered. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, post herpetic neuralgia and burning sensation. On an unknown date, the outcome of the vaccination failure and extra dose administered were unknown and the outcome of the shingles was recovered/resolved and the outcome of the post herpetic neuralgia and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia and burning sensation to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 12-OCT-2022 Reporter's Comment: The reporter was a patient. The reporter reported that the patient received first and second dose of Shingrix approximately three years ago prior to the reporting. The reporter stated that the patient recently experienced a case of internal shingles, resulting in healthcare professional who was unaware of patient was previously fully vaccinated, he recommended to receive Shingrix vaccine, once Shingles resolved. The patient received 3rd dose of Shingrix vaccine 2 months prior to the reporting. The reporter reported that the internal shingles consisted of burning and nerve pain from the jaw to the ear. The patient advised their shingles had resolved but they continue to experience nerve pain and burning from their jaw to the ear. The reporter did not consent to follow up. Additional supportive information: This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting. The patient received extra dose of Shingrix in error, which led to extra dose administered.
Age: 51.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Asthenia, Diarrhoea, Fatigue, Feeling abnormal, Headache
Clinical narrative: tingling in both hands ( left more than right),; she feels tired; Feels with  no energy; headache that has not resolved; pain at both injection sites in hands(left and right arms); She "didn't sleep well last night; now left hand "feels funny; diarrhea; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   The patient's past medical history included shingles.   On 11th October 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and Flu vaccine (intramuscular). On 11th October 2022, less than a day after receiving Shingrix and Flu vaccine, the patient experienced injection site pain, insomnia and headache. On 12th October 2022, the patient experienced tingling, tiredness and loss of energy. In October 2022, the patient experienced abnormal sensation of limbs and diarrhea. On an unknown date, the outcome of the injection site pain, abnormal sensation of limbs, headache, tiredness and loss of energy were not recovered/not resolved and the outcome of the insomnia, tingling and diarrhea were recovered/resolved.   It was unknown if the reporter considered the injection site pain, insomnia, tingling, abnormal sensation of limbs, headache, diarrhea, tiredness and loss of energy to be related to Shingrix and Flu vaccine.   Additional Information: GSK receipt date: 12-OCT-2022 Reporters comment:  The patient received the first dose of shingrix and flu vaccine and experienced insomnia,pain at both injection sites,tingling in both hands left more than right, left hand feels funny. The patient stated that headache that was not resolved, and diarrhea. She states she called in from work today(day of reporting)because she feels tired and with no energy. The reporter did not consent to follow-up. Additional Supportive information: As per source document the flu shot was administered, since this case was about Shingrix, but in narrative was not mentioned the Flu shot so as conservative approach Flu vaccine coded because this flu shot was administered and narrative describes both injection sites.
Age: 51.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site pain, Insomnia, Paraesthesia, Sensory disturbance
Clinical narrative: tingling in both hands ( left more than right),; she feels tired; Feels with  no energy; headache that has not resolved; pain at both injection sites in hands(left and right arms); She "didn't sleep well last night; now left hand "feels funny; diarrhea; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   The patient's past medical history included shingles.   On 11th October 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and Flu vaccine (intramuscular). On 11th October 2022, less than a day after receiving Shingrix and Flu vaccine, the patient experienced injection site pain, insomnia and headache. On 12th October 2022, the patient experienced tingling, tiredness and loss of energy. In October 2022, the patient experienced abnormal sensation of limbs and diarrhea. On an unknown date, the outcome of the injection site pain, abnormal sensation of limbs, headache, tiredness and loss of energy were not recovered/not resolved and the outcome of the insomnia, tingling and diarrhea were recovered/resolved.   It was unknown if the reporter considered the injection site pain, insomnia, tingling, abnormal sensation of limbs, headache, diarrhea, tiredness and loss of energy to be related to Shingrix and Flu vaccine.   Additional Information: GSK receipt date: 12-OCT-2022 Reporters comment:  The patient received the first dose of shingrix and flu vaccine and experienced insomnia,pain at both injection sites,tingling in both hands left more than right, left hand feels funny. The patient stated that headache that was not resolved, and diarrhea. She states she called in from work today(day of reporting)because she feels tired and with no energy. The reporter did not consent to follow-up. Additional Supportive information: As per source document the flu shot was administered, since this case was about Shingrix, but in narrative was not mentioned the Flu shot so as conservative approach Flu vaccine coded because this flu shot was administered and narrative describes both injection sites.
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Aphasia, Chills, Feeding disorder, Headache
Clinical narrative: Barely able to speak; So much Pain; Chills; Headache; Stomach ache; Bedridden; was not able to eat; This case was reported by a consumer via call center representative and described the occurrence of chills in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th October 2022, the patient received the 1st dose of Shingrix. On 8th October 2022, 2 days after receiving Shingrix, the patient experienced chills, headache and stomach pain. On 12th October 2022, the patient experienced pain. In October 2022, the patient experienced bedridden and unable to eat. On an unknown date, the patient experienced aphasia. On 10th October 2022, the outcome of the unable to eat was recovered/resolved. On an unknown date, the outcome of the chills, pain and aphasia were not recovered/not resolved and the outcome of the headache and stomach pain were recovering/resolving and the outcome of the bedridden was recovered/resolved.   It was unknown if the reporter considered the chills, headache, stomach pain, bedridden, unable to eat, pain and aphasia to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-OCT-2022 Reporter's Comment: The reporter was a wife of the patient. The reporter reported that the patient received Shingrix vaccine. On 8th October 2022 after 2 days of received Shingrix vaccine the patient experienced chills, headache and a stomach ache. The reporter stated that the patient was bedridden until the Monday (10th October 2022), when the symptoms seemed to resolved. The reporter stated that the patient was not able to eat anything after received vaccine until Monday, 10th October 2022. The reporter reported that the patient felt well enough to complete some yardwork on Tuesday (11th October 2022). On 11th October 2022 the patient went out on the road as they are truck driver and on 12th October 2022 the patient was again experienced chills and pain the reporter stated that the patient had so much pain they were required to pull off of the road to lie down. The reporter reported that the patient was barely able to speak. The reporter did not provide the patient's demographics as they were attending to the emergency. The reporter did not consent to follow up.