chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Product use in unapproved indication
Clinical narrative: Under 50 YO  prescription of Vx; Under 50 YO  prescription of Vx; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in an unspecified numbers of patients who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, [the patient experienced inappropriate age at vaccine administration (Verbatim: Under 50 YO  prescription of Vx) and drug use for unapproved indication (Verbatim: Under 50 YO  prescription of Vx). The outcome of the inappropriate age at vaccine administration and drug use for unapproved indication were unknown.   Additional Information: GSK receipt date: 07-MAR-2023  The pharmacist asked if there was any data on administering Shingrix to patients who were under 50 (not immunosuppressed or immunocompromised) with recurring shingles, which led to inappropriate age at vaccine administration and drug use for unapproved indication. The reporter stated that this question was not in regards to a specific patient but physician were writing orders to admin to patients who are under 50 with recurring shingles. No additional details as decision to file adverse event was made after call was disconnected.  Unknown if follow up was permissible due to this.
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Expired Kinrix adminsitered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number E2L53, expiry date 03-MAR-2023) for prophylaxis.   On 07-MAR-2023, the patient received Kinrix. On 07-MAR-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: Expired Kinrix administered). 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: 7-Mar-2023 The reporter opted out of follow-up. The reporter did not consent to follow-up. The patient received an expired dose of Kinrix, which led to expired vaccine used.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 20-year-old female patient who received Men B NVS (Bexsero) (batch number 59M3M, expiry date 28-FEB-2023) for prophylaxis.   On 07-MAR-2023, the patient received the 2nd dose of Bexsero. On 07-MAR-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired Bexsero administered).  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-MAR-2023 Practice Manager stated that one of the staff administered an expired dose of Bexsero to a patient.  The reporter consented to follow up via postal. Patient received a dose of Bexsero on 7th March 2023 which was expired on 28th February 2023, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: Feeling lousy; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling bad in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Covid 19 vaccine with an associated reaction of adverse drug reaction.   On 04-MAR-2023, the patient received the 1st dose of Shingrix (left arm). In MAR-2023, an unknown time after receiving Shingrix, the patient experienced feeling bad (Verbatim: Feeling lousy). The outcome of the feeling bad was not recovered/not resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingrix.   It was unknown if the company considered the feeling bad to be related to Shingrix.   Additional Information: GSK Receipt date: 08-MAR-2023 Reporter was a patient that received his dose of Shingrix  He was still feeling lousy today (on the day of reporting).  The patient said the side effects were worse than when he received his Covid-19 vaccine (unknown product).  The Covid-19 vaccine was received prior to receiving the Shingrix vaccine.  The patient disconnected the call before could ask any details about his adverse reactions and consent to follow up with HCP.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This non-serious 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 E2L54, expiry date 03-MAR-2023) for prophylaxis.   On 07-MAR-2023, the patient received Kinrix. On 07-MAR-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: received an expired dose).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- 08-MAR-2023. A nurse reported that a patient received an expired dose of Kinrix on 7-MAR-2023. The vaccine expired on 3-MAR-2023.  The reporter was consented to follow up via email. The patient received vaccine beyond the expiry date which led to expired vaccine used.
Age: 10.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 10-year-old female patient who received HAV (Havrix 720) (batch number EP47E, expiry date 06-FEB-2023) for prophylaxis.   On 06-MAR-2023, the patient received the 2nd dose of Havrix 720. On 06-MAR-2023, an unknown time after receiving Havrix 720, the patient experienced expired vaccine used (Verbatim: Expired Havrix administered). 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: 08-MAR-2023 The medical assistant reported that a patient was administered with a dose of expired Havrix vaccine. This was the second dose in the series for the patient.  At the time of reporting, the dose had not been repeated. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. HCP gave permission for follow-up. Patient received a dose of Havrix on 6th March 2023 which was expired on 6th February 2023, which led to expired vaccine used. This case is linked with US2023036748, reported by the same reporter.; Sender's Comments:  US-GSK-US2023036748:Same reporter
Age: 8.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 8-year-old female patient who received HAV (Havrix 720) (batch number EP47E, expiry date 06-FEB-2023) for prophylaxis.   On 06-MAR-2023, the patient received the 2nd dose of Havrix 720. On 06-MAR-2023, an unknown time after receiving Havrix 720, the patient experienced expired vaccine used (Verbatim: Expired Havrix administered). 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: 08-MAR-2023 The medical assistant reported that a patient was administered with a dose of expired Havrix vaccine. At the time of reporting, the dose had not been repeated. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. HCP gave permission for follow-up. Patient received a dose of Havrix on 6th March 2023 which was expired on 6th February 2023, which led to expired vaccine used. This case is linked with US2023036747, reported by the same reporter.; Sender's Comments:  US-GSK-US2023036747:Same reporter
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: Expired Pediarix administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 2-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number MK944, expiry date 05-MAR-2023) for prophylaxis.   On 08-MAR-2023, the patient received the 1st dose of Pediarix (left thigh). On 08-MAR-2023, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: Expired Pediarix administered). 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: 08-MAR-2023. The reporter reported that a patient received his dose of Pediarix on his left anterolateral thigh which was expired and mentioned that vaccine was stored properly prior to the event.  As per the reporter the 1st dose received of Pediarix was 2 weeks late, per the package insert dosing schedule of the 1st dose should be given at 2 months. Consent to follow up with HCP obtained. The patient received an expired dose of Pediarix, which led to expired vaccine used.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Erythema, Fatigue, Injection site erythema
Clinical narrative: Redness on arms and legs; Redness at injection site; Fatigue; General weakness; This non-serious case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number Y573z, expiry date 30-SEP-2023) for prophylaxis.   On 06-MAR-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 07-MAR-2023, 1 days after receiving Shingrix, the patient experienced injection site erythema (Verbatim: Redness at injection site), fatigue (Verbatim: Fatigue) and weakness (Verbatim: General weakness). On 08-MAR-2023, the patient experienced erythema of extremities (Verbatim: Redness on arms and legs). The outcome of the injection site erythema and erythema of extremities were not recovered/not resolved and the outcome of the fatigue and weakness were unknown.   The reporter considered the injection site erythema to be related to Shingrix. It was unknown if the reporter considered the fatigue, weakness and erythema of extremities to be related to Shingrix.     The company considered the injection site erythema to be related to Shingrix. It was unknown if the company considered the fatigue, weakness and erythema of extremities to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-MAR-2023. The nurse practitioner stated that she gave a patient first dose of Shingrix vaccine and the next day the patient experienced redness at the injection site, fatigue and general weakness. On the day of reporting 2 days after vaccination the patient experienced redness on both arms and legs. The patient did not complain of any itching or pain. The reporter did not indicate if the patient still had fatigue or weakness. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only liquid portion given; Only liquid portion given; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, [the patient experienced inappropriate preparation of medication (Verbatim: Only liquid portion given) and inappropriate dose of vaccine administered (Verbatim: Only liquid portion given). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 08-MAR-2023 The pharmacist reported that he sent 2 vials of Shingrix vaccine to a nursing home to be administered to a patient, but nurse gave only the liquid portion to the patient without mixing it. No additional information was provided. The reporter consented to follow up. The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Expired product used; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number E2L54, expiry date 03-MAR-2023) for prophylaxis.   On 08-MAR-2023, the patient received Kinrix. On 08-MAR-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: Expired product used). 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: 08-MAR-2023 The reporter reported that a expired dose of Kinrix was administered to a 4 year old male patient.  At the time of reporting, the dose had not been repeated. The reporter consented to follow up. The patient received an expire dose of Kinrix, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose March 2019 , 2nd not yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose in March 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose March 2019 , 2nd not yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 08-MAR-2023 The reporter called and reported that a patient received the first dose of Shingrix in March 2019 and wished to know if the patient could receive the second dose.  The information about the site or vaccine was not provided as it was unknown. The patient gave consent to follow up. Till the time of reporting, the patient did not receive the second dose of Shingrix which led to incomplete course of vaccination.
Age: 4.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This non-serious 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 HAV (Havrix) (batch number T57F3, expiry date 16-FEB-2023) for prophylaxis.   On 08-MAR-2023, the patient received Havrix. On 08-MAR-2023, an unknown time after receiving Havrix, [the patient experienced expired vaccine used (Verbatim: Expired Havrix administered).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:08-MAR-2023  Reporter's comment: The nurse reported that she/he gave expired vaccine of Havrix to patient. The adverse event contained all information provided. The reporter consented to follow up. Additional supportive information: The patient was administered with expired vaccine of Havrix which led to Expired vaccine used.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Papule
Clinical narrative: Bumps on legs and fore arms; This non-serious case was reported by a consumer via call center representative and described the occurrence of papule in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number XY22F) for prophylaxis.   In FEB-2023, the patient received the 1st dose of Shingrix (injection, left arm). In FEB-2023, 1 week after receiving Shingrix, the patient experienced papule (Verbatim: Bumps on legs and fore arms). The outcome of the papule was unknown.   It was unknown if the reporter considered the papule to be related to Shingrix.     It was unknown if the company considered the papule to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-MAR-2023 The patient self-reported this case. The patient received Shingrix about 3 weeks ago from reporting, most likely in his left arm, (he was not sure), and about 1 week to 10 days after receiving the Shingrix vaccine, he got bumps on his legs and forearms that popped. The reporter did not consent to follow up.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 23Aug2022, 2nd 21Sep2022; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 21-SEP-2022, the patient received the 2nd dose of Shingrix. On 21-SEP-2022, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: 1st dose 23Aug2022, 2nd 21Sep2022). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 8-Mar-2023 The vaccine administration facility was the same as primary reporter. The follow up by safety team accepted by health care professional. The reporter consented to follow-up. The patient received second dose of Shingrix earlier than the recommended interval, which led to shortening of vaccine schedule.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 5-year-old female patient who received HAV (Havrix) (batch number LY35X, expiry date 16-FEB-2023) for prophylaxis.   On 08-MAR-2023, the patient received Havrix. On 08-MAR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired Havrix administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 8-Mar-2023 A technician called in to report the administration of an expired Havrix dose to 2 patients. The reporter asked if she had to call back the patients in order to re-vaccinate them. Both patients had same initials. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient received an expired dose of Havrix, which led to expired vaccine used. The case was linked with case US2023036775, reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2023036775:Same reporter
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This non-serious 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 male patient who received HAV (Havrix) (batch number LY35X, expiry date 16-FEB-2023) for prophylaxis.   On 08-MAR-2023, the patient received Havrix. On 08-MAR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired Havrix administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 8-Mar-2023 A technician called in to report the administration of an expired Havrix dose to 2 patients. The reporter asked if she had to call back the patients in order to re-vaccinate them. Both patients had same initials. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient received an expired dose of Havrix, which led to expired vaccine used. The case was linked with case US2023036774, reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2023036774:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 5Nov2021, 2nd not yet; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 5th November 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose 5Nov2021, 2nd not yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 8-Mar-2023 The pharmacy technician asked that they need to restart the series or administer the 2nd dose now. The reporter consented to follow-up via postal. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash all over the body; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16-JAN-2023, the patient received the 2nd dose of Shingrix. In FEB-2023, 3 weeks after receiving Shingrix, the patient experienced rash (Verbatim: Rash all over the body). The outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.     It was unknown if the company considered the rash to be related to Shingrix.   Additional Information: GSK Receipt date: 09-Mar-2023 Pharmacist reported to VEARS that 3 weeks after Shingrix second dose the patient developed rash all over his body.  Patient´s doctor indicated a treatment with steroid, but the rash was still present with no improvement. Patient was not immunocompromised, and he was a Doctor as well. The reporter consented to follow up. The reporter did not have lot number, expiration date and patient´s DOB information were not available at the moment of reporting. HCP was driving to her work. The reporter was consented to follow-up by email.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: administered a dose diluted with saline water; administered a dose diluted with saline water; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA764A, expiry date 31-DEC-2023) for prophylaxis.   On 08-MAR-2023, the patient received Menveo. On 08-MAR-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: administered a dose diluted with saline water) and inappropriate dose of vaccine administered (Verbatim: administered a dose diluted with saline water). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 09-Mar-2023 The pharmacist called to inform that the patient inadvertently received a dose of Menveo diluted with saline water instead of with the approved diluent supplied.  The healthcare professional agreed to the follow up by the GSK team.  The reporter clarified that follow up could be via phone on Thursdays, since those days the healthcare professional would available in the facility. The patient inadvertently received a dose of Menveo diluted with saline water instead of with the approved diluent supplied, which led to wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose Oct2018, 2nd not yet, Didn't knowneed 2nd; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose in October 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix (intramuscular, unknown deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose Oct2018, 2nd not yet, Didn't knowneed 2nd). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 09-Mar-2023 The reporter was the patient.  The reporter reported the case via interactive digital media. He had not received the second dose yet. He did not realize a second dose was needed.  He planned to receive the second dose. Nothing else was reported. Did not consent to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. This case is 1 of 2 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2023037532:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in 2018, 2nd dose not given yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date in October 2018 intramuscularly).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose in 2018, 2nd dose not given yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 09-MAR-2023 The reporter was the patient's husband.  The patient had not received the second dose of Shingrix yet, which led to incomplete course of vaccination. She did not realized a second dose was needed.  The patient planned to receive the second dose.  Nothing else was reported. The reporter did not consent to follow-up. This case is linked with US2023037533, reported by same reporter.; Sender's Comments:  US-GSK-US2023037533:same reporter
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 1-year-old female patient who received HAV (Havrix) (expiry date 06-FEB-2023) for prophylaxis.  On 08-FEB-2023, the patient received Havrix. On 08-FEB-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired dose administered). 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: 09-MAR-2023 A healthcare professional (HCP) called to report that on 08 February 2023, a patient received a dose of Havrix that had expired on 06 February 2023. The vaccine administration facility was the same as primary reporter. The HCP did not had the lot number and when being asked if Havrix was the vaccine that was administered or not to which he said he believed so. The reporter had consented to follow-up. At the time of reporting, the patient received a dose of expired Havrix vaccine, which had led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose Jul2021, 2nd 07Mar2023; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose in July 2021).   On 07-MAR-2023, the patient received the 2nd dose of Shingrix. On 07-MAR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose Jul2021, 2nd 07Mar2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt date: 09-Mar-2023 Member of the public reporting she received 1st dose of Shingrix in July 2021 and second dose on 7th March 2021. The reporter consented to follow up via email. The patient received 2nd dose of shingrix on 7th March 2021, later than the recommended standard schedule, which led to lengthening of the vaccination schedule.
Age: 0.75
Sex: F
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 9 month received Bexsero; Received Bexsero instead of Hep B Vx; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-month-old female patient who received Men B NVS (Bexsero) (batch number 9F3X2, expiry date 31-MAR-2024) for prophylaxis.   On 07-MAR-2023, the patient received Bexsero. On 07-MAR-2023, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: 9 month received Bexsero) and wrong vaccine administered (Verbatim: Received Bexsero instead of Hep B Vx). The outcome of the inappropriate age at vaccine administration and wrong 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: 09-MAR-2023 The Office Lead reported that the 9 month old female patient was ordered to receive Hepatitis B vaccine and medical assistant inadvertently administered Bexsero vaccine. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. The patient received Bexsero who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter reported that, they were intending to administer Hepatitis B and inadvertently administered Bexsero instead of Hepatitis B, which led to wrong vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Local pain; Fever; This non-serious case was reported by a physician via call center representative and described the occurrence of pain localized in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain localized (Verbatim: Local pain) and fever (Verbatim: Fever). The outcome of the pain localized and fever were unknown.   It was unknown if the reporter considered the pain localized and fever to be related to Shingrix.     It was unknown if the company considered the pain localized and fever to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR038112   Additional Information: GSK Receipt date: 09-Mar-2023 The physician reported that he had received the Shingrix series.  After 1st dose he experienced common reactions such as fever and local pain.  The reporter consented to follow up email. For tolerance of 2nd dose refer linked case US2023AMR038112, reported by same reporter; Sender's Comments:  US-GSK-US2023AMR038112:Same reporter
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Bexsero administered instead of Menveo; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 14-year-old female patient who received Men B NVS (Bexsero) (batch number 94BS5, expiry date 31-MAR-2024) for prophylaxis.   On 09-MAR-2023, the patient received Bexsero. On 09-MAR-2023, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: Bexsero administered instead of Menveo). The outcome of the wrong vaccine administered 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: 09-MAR-2023 The reporter reported that the patient was supposed to receive a dose of Menveo but received Bexsero vaccine. The vaccine administration facility was the same as primary reporter. The reporter consent to follow up. The reporter reported that, they were intending to administer Menveo and inadvertently administered Bexsero instead of Menveo, which led to wrong vaccine administered.
Age: 3.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Boostrix given instead of Daptacel; Boostrix given to a 3-year-old; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 3-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9ZK5T, expiry date 07-OCT-2024) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: Boostrix given instead of Daptacel) and inappropriate age at vaccine administration (Verbatim: Boostrix given to a 3-year-old). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date: 9-Mar-2023 The reporter did not consent to follow-up. The patient received a dose of Boostrix instead of Daptacel at an inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Headache, Injection site bruising, Injection site erythema
Clinical narrative: Feeling of something caught in throat but nothing is there; Feeling tired; Nausea; Diarrhea; Fever, feverish; Headache; Swollen top lip (worsened); Bruising at injection site; Swelling at injection site; Rash at injection site; Redness at injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site bruising in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-MAR-2023, the patient received the 1st dose of Shingrix (intramuscular). On 04-MAR-2023, 1 days after receiving Shingrix, the patient experienced injection site bruising (Verbatim: Bruising at injection site), injection site swelling (Verbatim: Swelling at injection site), injection site rash (Verbatim: Rash at injection site) and injection site erythema (Verbatim: Redness at injection site). On 05-MAR-2023, the patient experienced tiredness (Verbatim: Feeling tired), nausea (Verbatim: Nausea), diarrhea (Verbatim: Diarrhea), fever (Verbatim: Fever, feverish), headache (Verbatim: Headache) and lip swelling (Verbatim: Swollen top lip (worsened)). On 06-MAR-2023, the patient experienced lump feeling in throat (Verbatim: Feeling of something caught in throat but nothing is there). . Thethe outcome of the lip swelling and lump feeling in throat were not recovered/not resolved.   It was unknown if the reporter considered the injection site bruising, injection site swelling, injection site rash, injection site erythema, tiredness, nausea, diarrhea, fever, headache, lip swelling and lump feeling in throat to be related to Shingrix.     It was unknown if the company considered the injection site bruising, injection site swelling, injection site rash, injection site erythema, tiredness, nausea, diarrhea, fever, headache, lip swelling and lump feeling in throat to be related to Shingrix.   Additional Information: GSK Receipt date: 09-Mar-2023 Patient was calling to report side effects from his Shingrix vaccine.  On March 4, 2023 he began noticing the bruising, swelling and rash at the injection site.  These symptoms ended a day or two ago, meaning approximately 7th March 2023.  On 5th March 2023 he began feeling tired, with nausea, diarrhea, fever and headache.  He also started noticing that his top lip was swollen on the right side. The nausea, tiredness, diarrhea, fever and headache are almost gone as of date of reporting, 9th March 2023, but the lip was more swollen than before. The reporter offered medical disclaimer, referred to HCP, offered after-call survey.   The reporter also offered MI number to pass along to his HCP, but he declined. The reporter consented to follow up.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling, Lip swelling, Nausea, Pyrexia
Clinical narrative: Feeling of something caught in throat but nothing is there; Feeling tired; Nausea; Diarrhea; Fever, feverish; Headache; Swollen top lip (worsened); Bruising at injection site; Swelling at injection site; Rash at injection site; Redness at injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site bruising in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-MAR-2023, the patient received the 1st dose of Shingrix (intramuscular). On 04-MAR-2023, 1 days after receiving Shingrix, the patient experienced injection site bruising (Verbatim: Bruising at injection site), injection site swelling (Verbatim: Swelling at injection site), injection site rash (Verbatim: Rash at injection site) and injection site erythema (Verbatim: Redness at injection site). On 05-MAR-2023, the patient experienced tiredness (Verbatim: Feeling tired), nausea (Verbatim: Nausea), diarrhea (Verbatim: Diarrhea), fever (Verbatim: Fever, feverish), headache (Verbatim: Headache) and lip swelling (Verbatim: Swollen top lip (worsened)). On 06-MAR-2023, the patient experienced lump feeling in throat (Verbatim: Feeling of something caught in throat but nothing is there). . Thethe outcome of the lip swelling and lump feeling in throat were not recovered/not resolved.   It was unknown if the reporter considered the injection site bruising, injection site swelling, injection site rash, injection site erythema, tiredness, nausea, diarrhea, fever, headache, lip swelling and lump feeling in throat to be related to Shingrix.     It was unknown if the company considered the injection site bruising, injection site swelling, injection site rash, injection site erythema, tiredness, nausea, diarrhea, fever, headache, lip swelling and lump feeling in throat to be related to Shingrix.   Additional Information: GSK Receipt date: 09-Mar-2023 Patient was calling to report side effects from his Shingrix vaccine.  On March 4, 2023 he began noticing the bruising, swelling and rash at the injection site.  These symptoms ended a day or two ago, meaning approximately 7th March 2023.  On 5th March 2023 he began feeling tired, with nausea, diarrhea, fever and headache.  He also started noticing that his top lip was swollen on the right side. The nausea, tiredness, diarrhea, fever and headache are almost gone as of date of reporting, 9th March 2023, but the lip was more swollen than before. The reporter offered medical disclaimer, referred to HCP, offered after-call survey.   The reporter also offered MI number to pass along to his HCP, but he declined. The reporter consented to follow up.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Sensation of foreign body
Clinical narrative: Feeling of something caught in throat but nothing is there; Feeling tired; Nausea; Diarrhea; Fever, feverish; Headache; Swollen top lip (worsened); Bruising at injection site; Swelling at injection site; Rash at injection site; Redness at injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site bruising in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-MAR-2023, the patient received the 1st dose of Shingrix (intramuscular). On 04-MAR-2023, 1 days after receiving Shingrix, the patient experienced injection site bruising (Verbatim: Bruising at injection site), injection site swelling (Verbatim: Swelling at injection site), injection site rash (Verbatim: Rash at injection site) and injection site erythema (Verbatim: Redness at injection site). On 05-MAR-2023, the patient experienced tiredness (Verbatim: Feeling tired), nausea (Verbatim: Nausea), diarrhea (Verbatim: Diarrhea), fever (Verbatim: Fever, feverish), headache (Verbatim: Headache) and lip swelling (Verbatim: Swollen top lip (worsened)). On 06-MAR-2023, the patient experienced lump feeling in throat (Verbatim: Feeling of something caught in throat but nothing is there). . Thethe outcome of the lip swelling and lump feeling in throat were not recovered/not resolved.   It was unknown if the reporter considered the injection site bruising, injection site swelling, injection site rash, injection site erythema, tiredness, nausea, diarrhea, fever, headache, lip swelling and lump feeling in throat to be related to Shingrix.     It was unknown if the company considered the injection site bruising, injection site swelling, injection site rash, injection site erythema, tiredness, nausea, diarrhea, fever, headache, lip swelling and lump feeling in throat to be related to Shingrix.   Additional Information: GSK Receipt date: 09-Mar-2023 Patient was calling to report side effects from his Shingrix vaccine.  On March 4, 2023 he began noticing the bruising, swelling and rash at the injection site.  These symptoms ended a day or two ago, meaning approximately 7th March 2023.  On 5th March 2023 he began feeling tired, with nausea, diarrhea, fever and headache.  He also started noticing that his top lip was swollen on the right side. The nausea, tiredness, diarrhea, fever and headache are almost gone as of date of reporting, 9th March 2023, but the lip was more swollen than before. The reporter offered medical disclaimer, referred to HCP, offered after-call survey.   The reporter also offered MI number to pass along to his HCP, but he declined. The reporter consented to follow up.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Incorrectly reconstituted dose, not sure; Incorrectly reconstituted dose given; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA751A, expiry date 30-NOV-2023) for prophylaxis.   On 24-FEB-2023, the patient received Menveo. On 24-FEB-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Incorrectly reconstituted dose, not sure) and inappropriate dose of vaccine administered (Verbatim: Incorrectly reconstituted dose given). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 09-Mar-2023 A nurse supervisor reported that the patient might have received an incorrectly reconstituted dose of Menveo on 24 February 203. The healthcare professional found an extra dose of the liquid component so nurse was not sure if the dose was correctly or incorrectly reconstituted. The healthcare professional consented to follow up via email. The patient received a received an incorrectly reconstituted dose of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 41.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 41-year-old male patient who received HAV (Havrix 1440) (batch number H4H53, expiry date 30-JAN-2023) for prophylaxis.   On 14-FEB-2023, the patient received the 2nd dose of Havrix 1440. On 14-FEB-2023, an unknown time after receiving Havrix 1440, the patient experienced expired vaccine used (Verbatim: Expired Havrix administered). 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: 9-Mar-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via postal. The patient received an expired dose of Havrix, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Passed the 6-month window without receiving 2nd dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Passed the 6-month window without receiving 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 9-Mar-2023 The medical assistant reported that a system audit had revealed a list of multiple patients that had received 1 dose of Shingrix and had potentially gone past the 6 month window without receiving a second dose.   The reporter was unsure of how many patients there were that were actually past due for second dose, she stated she had an 8 page list of patients to go through. The Vaccine Administration Facility was the same as Primary Reporter. The reporter gave permission for follow-up. Till the time of reporting, the patients did not receive the second dose of Shingrix, which led to incomplete course of vaccination.