chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shot / got the shingles/Suspected vaccination failure; got the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient was reporter's son's father-in-law.                                  The age at vaccination was not reported. The patient did not wanted shingles, so he got Shingle shot and it cost him 400 dollars. The patient got the shingles anyway. The reporter stated that the Shingles shot did not always work. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Periarthritis
Clinical narrative: arm was red; arm experienced pain; Frozen Shoulder; This case was reported by a nurse via call center representative and described the occurrence of erythema of extremities in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2021, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 6 months after receiving Shingrix, the patient experienced erythema of extremities, pain in arm and frozen shoulder. The patient was treated with non-drug therapy (Physical Therapy). On an unknown date, the outcome of the erythema of extremities, pain in arm and frozen shoulder were unknown.   It was unknown if the reporter considered the erythema of extremities, pain in arm and frozen shoulder to be related to Shingrix.  Additional details were provided as follows: The nurse self reported for herself. The age at vaccination was not reported. The patient received 1st dose of Shingrix last year at her pharmacy in her right deltoid and was due for her 2nd dose at her doctor's office. The patient reported that when she received the 1st dose, her arm was red and experienced pain that might have contributed to her developing a frozen shoulder (date unknown), patient was receiving physical therapy for this. The patient wanted to know if she could receive the 2nd dose in her thigh. The patient was given medical disclaimer and referred to health care professional. Patient wanted further information on alternative site of administration of Shingrix. The patient was transferred to Medical Information. The reporter consented to follow up. The patient declined to provide HCP details.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pruritus, Skin exfoliation, Varicella
Clinical narrative: chicken pox; 2 blisters, one on forehead and one on upper right arm; itchy spot; skin is peeling; This case was reported by a consumer via call center representative and described the occurrence of chickenpox in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th November 2021, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. In November 2021, 24 hrs after receiving Shingrix, the patient experienced chickenpox, blister, pruritus and skin peeling. On an unknown date, the outcome of the chickenpox, blister, pruritus and skin peeling were not recovered/not resolved.   It was unknown if the reporter considered the chickenpox, blister, pruritus and skin peeling to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The patient had received the Shingrix vaccine in her upper left arm.  The reporter reported that 24 hours after the vaccination, she developed 2 blisters (one on her forehead and one on her upper right arm).  The reporter stated that both her PCP (primary care physician) and her dermatologist told her it was chicken pox.  The caller stated the two spots were still itchy and the skin was peeling and they had not resolved over the past 2 months. The reporter was given consent to contact her and her healthcare professional but she did not had her physician's information available during the call. The reporter did not have the lot or expiration date of the vaccine administered. The reporter consented to follow up.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received 2nd dose today, received 1st dose more than 6 months ago; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on October 2020).   On 21st January 2022, the patient received the 2nd dose of Shingrix. On 21st January 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient self-reported the case. The patient received 2nd dose later than the recommended time interval, which led to lengthening of vaccination schedule. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in 2018 but has NOT received 2nd; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter called on behalf of a patient and was a caregiver to the patient. The patient received first dose of Shingrix in 2018 but had not received the second dose till the time of reporting, which led to incomplete course of vaccination. The reporter did not give a consent to follow-up with HCP (health care professional). Therefore, HCP contact information was not collected. The reporter did not provide the following information: lot or expiry date, patient's initials, date of birth, gender, the date and route of administration, and dose. This case has been linked to US2019120355, reported by the sam e reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019120355:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Administered Shingrix reconstituted with other diluents.; Administered Shingrix reconstituted with other diluents.; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) (batch number X54CN, expiry date unknown) for prophylaxis.   On 21st January 2022, the patient received Shingrix. On 21st January 2022, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient had been administered Shingrix reconstituted with diluents other than the AS01B adjuvanted suspension provided, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered . The reporter did not consent to follow-up. The reporter provided limited information regarding patient.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Diluent was administered; Diluent was administered; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA581A, expiry date 31st January 2023) for prophylaxis.   On 20th January 2022, the patient received Menveo. On 20th January 2022, 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 details were provided as follows: The reported stated that, Menveo diluent was administered only to patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No side effects reported. The reporter consented to follow up via email.
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number 30Z45, expiry date 15th January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th January 2022, the patient received Kinrix (intramuscular) and Kinrix Pre-Filled Syringe Device. On 17th January 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported but it could be 3 or 4 years. The patient inadvertently received an expired dose of Kinrix in the right thigh, which led to expired vaccine used. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Off label use, Pain
Clinical narrative: dose while they had active shingles; Fatigued; achy; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles.   On 21st January 2022, the patient received the 2nd dose of Shingrix. In January 2022, less than a week after receiving Shingrix, the patient experienced fatigue and pain. On 21st January 2022, the patient experienced off label use. On an unknown date, the outcome of the fatigue and pain were not recovered/not resolved and the outcome of the off label use was unknown.   It was unknown if the reporter considered the fatigue and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 79 or 80 years. The reporter called on behalf of a neighbor. Neighbor was the patient. The patient received a second dose of Shingrix while he had an active case of shingles., which led to off label use. The patient was feeling fatigued and achy.  The reporter provided very limited information, did not provide consent to follow-up with HCP (health care professional). Therefore, HCP contact information was not collected. Also the reporter did not provide initials and date of birth of the patient, lot/exp date, dose, route of administration, and an email address of acknowledgment letter and also no contact information either of herself. The reporter did not consent to follow-up.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: expired dose was given; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 12-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number C5JL7, expiry date 28th November 2021) for prophylaxis.   On 3rd January 2022, the patient received Boostrix. On 3rd January 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: Medical Assistant called to report that, an expired Boostrix dose was given to the patient by error, which led to expired vaccine used. The reporter consented to follow up by email.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 2019, 2nd dose on 24Jan2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number G4PY5, expiry date 15th April 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 29th September 2019).   On 24th January 2022, the patient received the 2nd dose of Shingrix. On 24th January 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient received a late 2nd dose of Shingrix, which led to lengthening of vaccination schedule. The reporter consented to follow up. The reporter did not have the lot/expiry of the 1st dose.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash
Clinical narrative: Generalized rash; "some blisters" throughout; This case was reported by a nurse via call center representative and described the occurrence of rash in a 56-year-old female patient who received SHINGRIX for prophylaxis. On 5th October 2021, the patient received the 1st dose of SHINGRIX. On 6th October 2021, 1 days after receiving SHINGRIX, the patient experienced rash and blister. On 20th October 2021, the outcome of the rash and blister were recovered/resolved. It was unknown if the reporter considered the rash and blister to be related to SHINGRIX. Additional details were reported as follows: The patient received a dose of SHINGRIX and next day experienced generalized rash on both arms. The patient described some blisters throughout. The patient was not evaluated by a health care professional for the reaction at the time and was back on the office for dose two. The nurse wanted to know if it was safe for her to get the second dose after this reaction. The reporter was provided medical advise disclaimer and was provided information on adverse event reports on clinical trials per (package insert) PI. HCP requested more information, provided warm transfer to (medical information) MI for further assistance. Consent to follow up was denied.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, Intercepted product prescribing error
Clinical narrative: Prescription requesting a 3rd and 4th dose; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 27th March 2018) and Shingrix (2nd dose received on 29th June 2018).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted drug prescribing error. On an unknown date, the outcome of the intercepted drug prescribing error was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter received a prescription from the Doctor requesting a 3rd and 4th (planned dose not administered yet) dose of Shingrix for the patient who already received a 1st and 2nd dose of Shingrix in 2018, which led to intercepted drug prescribing error. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose 35 days apart; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a female patient who received Herpes zoster (Shingrix) (batch number G4py5, expiry date unknown) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 6th January 2022, the patient received the 2nd dose of Shingrix. On 6th January 2022, unknown after receiving Shingrix, 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.  Additional details were reported as follows: Age at vaccination was not reported. The patient received a dose of Shingrix on 1st December 2021 and second dose 35 days later on 6th Jan 2022 which led to shortening of vaccination schedule. Consent to follow up was granted.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2 years ago, never received second.; This case was reported by a pharmacist 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 (received a dose of Shingrix 2 years ago.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: Age at vaccination was not applicable for this report. The patient received a dose of Shingrix 2 years before the reporting and did not receive second dose. Till the time of reporting, the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination. Consent to follow up was granted.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021012475:Same reporter
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: received expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number XG52X, expiry date 28th November 2021) for prophylaxis.   On 21st January 2022, the patient received the 2nd dose of Shingrix. On 21st January 2022, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were reported as follows: The patient received second dose of Shingrix on 21st January 2022 which was expired on 28th November 2021, which led to expired dose administration. Consent to follow up was granted.
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Maladministration after the expiration date; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number 3dz45, expiry date 15th January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th January 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 25th January 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. On 25th January 2022, the patient received a Kinrix vaccine which was expired on 15th January 2022, which led to expired vaccine used. The reporter consented to follow up.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Patient was administered an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number 4CL44, expiry date 24th January 2022) for prophylaxis.   On 25th January 2022, the patient received Engerix B. On 25th January 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported a patient was administered an expired dose of the Engerix-B vaccine,which led to expired vaccine used. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Gave diluent portion only; Gave diluent portion only; Gave diluent portion only and a replacement dose; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 49NM5, expiry date 6th April 2023) for prophylaxis.   On 23rd January 2022, the patient received the 1st dose of Shingrix. On 23rd January 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication, inappropriate dose of vaccine administered and underdose. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and underdose were unknown.  Additional details were provided as follows: The age at vaccination was not reported. On 23rd January 2022, reporter gave by error Shingrix diluent portion only ,which led to inappropriate preparation of medication and inappropriate dose of vaccine administered  After this, she gave other shot of a correctly reconstituted Shingrix vaccine on the same day,which led to underdose. This was patient´s Shingrix first dose. The reporter did not consent to follow-up.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 2018, 2nd dose 12Oct2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 7742Z, expiry date 25th March 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 9th November 2018).   On 12th October 2021, the patient received the 2nd dose of Shingrix. On 12th October 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows:  The reporter stated that a patient received the first dose of Shingrix on 9th November 2018 and the second dose on 12th October 2021, which led to lengthening of vaccination schedule. The lot and expiration was not available for the first dose, but the lot and expiration of dose 2 was as follows: 7742Z, 25th March 2023 .  The reporter noted the lot number was difficult to read, so it might not be accurate, but that was what the numbers appear to be.  The reporter consented to follow up from safety.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Ear swelling
Clinical narrative: chills; swelling behind her left ear; This case was reported by a consumer via call center representative and described the occurrence of chills in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th July 2021, the patient received the 1st dose of Shingrix. On 15th July 2021, less than a day after receiving Shingrix, the patient experienced chills. On 16th July 2021, the patient experienced ear swelling. On an unknown date, the outcome of the chills and ear swelling were recovered/resolved.   It was unknown if the reporter considered the chills and ear swelling to be related to Shingrix.  Additional details were reported as follows: Age at vaccination was not reported. The patient received a dose of Shingrix on 15th July 2021 and same night experienced chills which resolved after one night. Next morning the patient noticed some swelling behind her left ear which looked like a "big mosquito bite which she treated with a warm compress and 5 days later it resolved. Consent to follow up was denied.
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: received a dose that had expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received HBV (Engerix B) (batch number N234J, expiry date 21st January 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th January 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 26th January 2022, unknown after receiving Engerix B and Engerix B 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 details were provided as follows: The age at vaccination was unknown. Medical assistant reported that a patient received an expired dose of Engerix B, which led to expired vaccine used. The Vaccine Administration Facility was the same as Primary Reporter. The reporter did not consent to follow-up.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose after two weeks of first; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number C3455, expiry date 30th March 2023) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 27th October 2021, the patient received the 2nd dose of Shingrix. On 27th October 2021, unknown after receiving Shingrix, 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.  Additional details were provided as follows: The reporter stated that a patient was immunocompetent went to get the second dose of Shingrix after two week of the first dose, which led to shortening of vaccination schedule. On 20th January 2022 the patient asked for the record and then they realized the situation. The reporter wanted to know how to proceed.  The reporter consented to follow up.
Sex: U
Vaccine: HEPA
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd shot 2 & 1/2 years after the 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 HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device injection syringe for prophylaxis.   Previously administered products included Havrix (received 1st dose on an unknown date 2 and half years ago).   On an unknown date, the patient received the 2nd dose of Havrix and hepatitis A vaccine pre-filled syringe device. On an unknown date, unknown after receiving Havrix and hepatitis A vaccine 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 was provided as follow: The age at vaccination was not applicable for this report. The reporter enquired that could a patient receive their second shot 2 and 1/2 years after the first shot of Havrix. Till the time of reporting patient did not receive 2nd dose of Havrix vaccine, which led to incomplete course of vaccination. No further details were provided via form; specialist submitting all details available. The reporter consented to follow up.
Age: 9.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired dose given; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 9-year-old female patient who received HBV (Engerix B) (batch number 73h93, expiry date 10th January 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th January 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 26th January 2022, unknown after receiving Engerix B and Engerix B 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 details were reported as follows: Medical assistance reported that On 26th January 2022, the patient received dose of Engerix B that was already expired on 10th January 2022, which led to expired vaccine used. No adverse event was reported. The reporter consented to follow up.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Dyspnoea, Injection site pain
Clinical narrative: Dizziness when he stands up; Shortness of breath; Soreness at the 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 male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th January 2022, the patient received the 1st dose of Shingrix (intramuscular). In January 2022, less than a week after receiving Shingrix, the patient experienced injection site pain. On 26th January 2022, the patient experienced dizziness and shortness of breath. On an unknown date, the outcome of the injection site pain and shortness of breath were recovered/resolved and the outcome of the dizziness was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, dizziness and shortness of breath to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient himself.  The patient had soreness at the injection site that lasted about a day. During the afternoon of 26th January 2022 he started having dizziness when he stands up and shortness of breath. The reporter had nothing else to report. Consent to follow up was requested.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose Sep/2021, has not received any other dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 53-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (received 1st dose of Engerix B on 28th September 2021).   On an unknown date, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B 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 details were provided as follows: The age at vaccination was not applicable for this report. The patient received a dose of Engerix B. Till the time of reporting, the patient did not receive any subsequent doses, which led to incomplete course of vaccination. The reporter was requesting a recommendation regarding whether the patient should restart the series or next steps.  Provided caller number to medical informer and warm transferred call.  No additional events were provided by the caller. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 24Oct2019, 2nd dose 27Jan2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) (batch number 55R33, expiry date 19th May 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 24th October 2019.).   On 27th January 2022, the patient received the 2nd dose of Shingrix. On 27th January 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient received a late 2nd dose of Shingrix, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Patient was administered an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 63-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number c7734, expiry date 14th June 2021) for prophylaxis.   On 27th January 2022, the patient received the 1st dose of Boostrix. On 27th January 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: Nurse reported that a patient was administered an expired dose of Boostrix vaccine inadvertently, which led to expired vaccine used. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: one dose on 2020, 2nd still not given; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix in 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: Age at vaccination was not reported. The patient received a dose of Shingrix in 2020. Till the time of reporting, the patient never received second dose, which led to incomplete course of vaccination. Consent to follow up was granted.
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Received an expired dose; This case was reported by a consumer via call center representative and described the occurrence of expired vaccine used in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th January 2022, the patient received the 1st dose of Shingrix. On 24th January 2022, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient self-reported this case. The patient received the Shingrix which was already expired, which led to expired vaccine used. The agent could not get additional information to file adverse event as the caller was not responding. The agent could not ask for the consent to follow-up with health care professional. .
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose between 2 and 3 years ago; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose between 2 and 3 years ago from reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The physician was looking for guidance because his patient who received 1st dose between 2 and 3 years ago. The reporter reported that the patient was not immunocompromised. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led incomplete course of vaccination. The reporter did not consent to follow-up. Note- There is discrepancy regarding age of patient query was raised for the same and meanwhile 68 years was captured as age of patient as narrative.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: one dose 4 years ago, 2nd not given; This case was reported by a pharmacist 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 (received 1st dose on an unknown date 4 years ago from reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow-up.
Sex: F
Vaccine: MENB
Symptoms: Incorrect route of product administration
Clinical narrative: SC administration instead of IM; This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a adolescent female 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.   On an unknown date, the patient received Bexsero (subcutaneous) and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  This case was reported by a nurse via call center representative and described the occurrence of wrong route of administration in a adolescent female 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.   On an unknown date, the patient received Bexsero (subcutaneous) and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong route of administration. On an unknown date, the outcome of the wrong route of administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter called to report that a teenager received Bexsero vaccine subcutaneous instead of intramuscular, which led to wrong route of administration  The reporter did not have any further details about this situation at the moment of the call. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: didn't get the second shot until 8-9 months later; This case was reported by a other health professional 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 of Shingrix 8-9 months ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: Age at vaccination was not reported. The patient received a dose of Shingrix and did not receive second dose until 8 to 9 months later. The patient wanted to know if it was still effective or repeat vaccine was suggested. The consent to follow up was granted.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received Hiberix reconstituted with diluent other than supplied; received Hiberix reconstituted with diluent other than supplied; 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 Hib (Hiberix) (batch number FJ4FX, expiry date 7th January 2023) for prophylaxis.   In January 2022, the patient received Hiberix. In January 2022, unknown after receiving Hiberix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient might have received Hiberix reconstituted with diluent other than supplied, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The registered nurse reported that, when pulling out the box of Hiberix noticed that there was 1 diluent of Hiberix without use so she presumed the powder portion was reconstituted with other diluent. There was 1 patient who received Hiberix last week from the day of reporting, but she was not sure if that really happened. The reporter did not have patient's demographics. No Lot number and expiration date were provided regarding diluent portion that was found without the powder vial. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: had not yet received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 9th September 2018, batch number:dd43m and expiry date:9th September 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The reporter agreed to be contacted for follow-up.
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: big red rash on her arm; big red rash on her arm; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 92-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st January 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 28th January 2022, 7 days after receiving Shingrix, the patient experienced red rash and rash. On an unknown date, the outcome of the red rash and rash were not recovered/not resolved.   It was unknown if the reporter considered the red rash and rash to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient stated that she received the first dose of Shingrix and on the day of reporting she noticed a big red rash on her arm. No Lot number or Expiration date was known for the vaccine. The rash had not resolved as she just noticed it on the day of reporting. The patient wanted to know if she should receive the second dose. The patient was referred to her healthcare professional and provided medical disclaimer. The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: arm was really sore; could barely move it; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 2LC3P, expiry date unknown) for prophylaxis.   On 27th July 2021, the patient received the 2nd dose of Shingrix. In July 2021, less than a day after receiving Shingrix, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient stated her left arm was really sore and she could barely move arm, for the first two days after receiving 2nd dose of Shingrix. The reporter stated that, the patient had a bit more mobility in the left arm after the first two days, but mobility was still very restricted and remained same. The patient tried routinely stretching the left arm and using a heating pad to relive the pain and restricted mobility, to no available. The reporter consented to follow-up.