chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Pyrexia
Clinical narrative: fever/develop fever; Afib; This serious case was reported by a physician via sales rep and described the occurrence of fever in a male 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 fever (Verbatim: fever/develop fever) (serious criteria hospitalization) and atrial fibrillation (Verbatim: Afib) (serious criteria hospitalization and GSK medically significant). The outcome of the fever and atrial fibrillation were resolved.   It was unknown if the reporter considered the fever and atrial fibrillation to be related to Shingrix.     It was unknown if the company considered the fever and atrial fibrillation to be related to Shingrix.   Additional Information: GSK receipt date: 16-AUG-2023 The patient had Shingrix in combo with other vaccines.  The patient went to hospital spent several days there, released and was now ok.  The hospital refused to say it was vaccine related. (Rest was unknown). The reporter did not agreed to follow up from GlaxoSmithKline (GSK).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Product administered to patient of inappropriate age, Vaccination failure
Clinical narrative: get shingles even after the vaccine/ Suspected vaccination failure; Shingles; patients were female and not yet 50; This serious case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a adult female 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 vaccination failure (Verbatim: get shingles even after the vaccine/ Suspected vaccination failure) (serious criteria medically significant), shingles (Verbatim: Shingles) and inappropriate age at vaccine administration (Verbatim: patients were female and not yet 50). The outcome of the vaccination failure and inappropriate age at vaccine administration were unknown and the outcome of the shingles was not reported.   The reporter considered the vaccination failure and shingles to be possibly related to Shingrix.     The company considered the vaccination failure and shingles to be possibly related to Shingrix.   Additional Information: Receipt date: 16-AUG-2023 The patient was in late 40s. The reporter asked if the vaccine itself could cause a case of Shingles. Reporter stated that she had three patients still get shingles even after the vaccine and discussed that might be a possibility at some point, but she indicated that she believed it might had been a result of the vaccine itself. The reporter discussed that the adverse events that include flu-like symptoms including myalgia, fatigue, headache, shivering and fever and when asked if these might had been the symptoms that the patient experienced, she stated no, and stated what they experienced, was indeed a case of shingles. Reporter discussed that the indication was for patients over 50 years. The reporter did consent to follow up. The patient below 50 years received Shingrix, which led to inappropriate age at vaccine administration. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory details were unknown at a time of reporting. This case was 1 of 3 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR112314:same reporter US-GSK-US2023AMR112313:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Product administered to patient of inappropriate age, Vaccination failure
Clinical narrative: get shingles even after the vaccine / Suspected vaccination failure; Shingles; 2 of the patients were female and not yet 50; This serious case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a adult female 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 vaccination failure (Verbatim: get shingles even after the vaccine / Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and inappropriate age at vaccine administration (Verbatim: 2 of the patients were female and not yet 50). The outcome of the vaccination failure and inappropriate age at vaccine administration were unknown and the outcome of the shingles was not reported.   The reporter considered the vaccination failure and shingles to be possibly related to Shingrix.     The company considered the vaccination failure and shingles to be possibly related to Shingrix.   Additional Information: GSK Receipt date: 16-AUG-2023 The patient was in late 40s. The reporter asked if the vaccine itself could cause a case of Shingles. Reporter stated that she had three patients still get shingles even after the vaccine and discussed that might be a possibility at some point, but she indicated that she believed it might had been a result of the vaccine itself. The reporter discussed that the adverse events that include flu-like symptoms including myalgia, fatigue, headache, shivering and fever and when asked if these might had been the symptoms that the patient experienced, she stated no, and stated what they experienced, was indeed a case of shingles. Reporter discussed that the indication was for patients over 50 years. The reporter did consent to follow up. The patient below 50 years received Shingrix, which led to inappropriate age at vaccine administration. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory details were unknown at a time of reporting. This case was 1 of 3 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR112288:same reporter US-GSK-US2023AMR112314:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Impaired work ability, Neck pain, Pain, Rash
Clinical narrative: Suspected vaccination failure; I got shingles from the shingles vaccine; Neck pain; rash; not able to work for days; pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (patient's mother had shingles ).   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I got shingles from the shingles vaccine), neck pain (Verbatim: Neck pain), pain (Verbatim: pain), rash (Verbatim: rash) and inability to work (Verbatim: not able to work for days). The outcome of the vaccination failure and shingles were unknown and the outcome of the neck pain, rash and inability to work were resolved and the outcome of the pain was resolved (duration 5 months).   The reporter considered the vaccination failure, shingles, neck pain, pain, rash and inability to work to be possibly related to Shingrix.  The company considered the vaccination failure, shingles, neck pain, pain, rash and inability to work to be possibly related to Shingrix.   Additional Information: GSK Receipt Date: 17-AUG-2023 This case was reported by a patient via interactive digital media. The patient got shingles from the shingles vaccine. The patient was not aware of getting it because of his/her active, healthy lifestyle but that was not the case at all. The reporter stated that little did she knew, shingles varies from person to person. For her, it stated with four days of neck pain. The pain kept getting worse. Then a rash developed and her doctor diagnosed her with shingles. The pain was so intense that she was not able to work for days. Even after the rash went away, she had pain that lasted for five months. She wish that she would not have waited to learn more about shingles. The reporter thought that the event might had been related to the drug. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: Suspected vaccination failure; I got shingles from the shingles vaccine; Neck pain; rash; not able to work for days; pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (patient's mother had shingles ).   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I got shingles from the shingles vaccine), neck pain (Verbatim: Neck pain), pain (Verbatim: pain), rash (Verbatim: rash) and inability to work (Verbatim: not able to work for days). The outcome of the vaccination failure and shingles were unknown and the outcome of the neck pain, rash and inability to work were resolved and the outcome of the pain was resolved (duration 5 months).   The reporter considered the vaccination failure, shingles, neck pain, pain, rash and inability to work to be possibly related to Shingrix.  The company considered the vaccination failure, shingles, neck pain, pain, rash and inability to work to be possibly related to Shingrix.   Additional Information: GSK Receipt Date: 17-AUG-2023 This case was reported by a patient via interactive digital media. The patient got shingles from the shingles vaccine. The patient was not aware of getting it because of his/her active, healthy lifestyle but that was not the case at all. The reporter stated that little did she knew, shingles varies from person to person. For her, it stated with four days of neck pain. The pain kept getting worse. Then a rash developed and her doctor diagnosed her with shingles. The pain was so intense that she was not able to work for days. Even after the rash went away, she had pain that lasted for five months. She wish that she would not have waited to learn more about shingles. The reporter thought that the event might had been related to the drug. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Age: 16.0
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: 16 YO the adult dosing of Engerix-B; 16 YO the adult dosing of Engerix-B; This non-serious case was reported by a physician via call center representative and described the occurrence of overdose in a 16-year-old male patient who received HBV (Engerix B adult) for prophylaxis.   On 14-AUG-2023, the patient received Engerix B adult. On 14-AUG-2023, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: 16 YO the adult dosing of Engerix-B) and inappropriate age at vaccine administration (Verbatim: 16 YO the adult dosing of Engerix-B). The outcome of the overdose and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date: 14-AUG-2023 On the day of reporting, the reporter had a situation where he/she gave a 16 year old the adult dosing of Engerix-B, which led to inappropriate age at vaccine administration and overdose. The reporter wondered if there was any recommendations on the wrong dosing from the manufacturer. The reporter will transfer over to Medical Information.
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations
Clinical narrative: develop palpitations after Shingrix shot; This non-serious case was reported by a physician via sales rep and described the occurrence of palpitation in a female 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 palpitation (Verbatim: develop palpitations after Shingrix shot). The outcome of the palpitation was not reported.   It was unknown if the reporter considered the palpitation to be related to Shingrix.     It was unknown if the company considered the palpitation to be related to Shingrix.   Additional Information: GSK Receipt date: 16-AUG-2023 A physician reported that he/she had a patient who develop palpitations after Shingrix shot and went to hospital. The reporter did not agree to follow up.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error, Product preparation issue
Clinical narrative: only received the diluent and not the powder of 2 vial Menveo; only received the diluent and not the powder of 2 vial Menveo; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a adolescent male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: only received the diluent and not the powder of 2 vial Menveo) and inappropriate dose of vaccine administered (Verbatim: only received the diluent and not the powder of 2 vial Menveo). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 16-Aug-2023 The patient was coming in on 17th August 2023 to get entire vaccine. The reporter consented to follow-up. The patient only received the diluent and not the powder of 2 vial of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain
Clinical narrative: Chest pain; This non-serious case was reported by a physician via sales rep and described the occurrence of chest pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced chest pain (Verbatim: Chest pain). The outcome of the chest pain was not reported.   It was unknown if the reporter considered the chest pain to be related to Shingrix.   It was unknown if the company considered the chest pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-AUG-2023 The reporter reported that the patient received Shingrix vaccine and experienced severe chest pain. The reporter consented to follow up.
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: administration of an expired Bexsero dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXC05AA, expiry date 31-MAR-2023) for prophylaxis.   On 06-JUL-2023, the patient received Bexsero. On 06-JUL-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: administration of an expired Bexsero 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: 14-AUG-2023 The pharmacist reported that the administration of an expired Bexsero dose to a patient. The reporter asked for guidance on this situation. The reporter consented to follow up. The patient received a Bexsero vaccine which was already expired, which led to expired vaccine used.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain
Clinical narrative: She has pain; A 4" raised red area around the injection site which began on 8-13-2023; She had a headache the first day; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12-AUG-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm) .5 ml. On 12-AUG-2023, less than a day after receiving Shingrix, the patient experienced headache (Verbatim: She had a headache the first day). On 13-AUG-2023, the patient experienced injection site pain (Verbatim: She has pain) and injection site erythema (Verbatim: A 4" raised red area around the injection site which began on 8-13-2023). On 13-AUG-2023, the outcome of the headache was resolved (duration 1 day). The outcome of the injection site pain and injection site erythema were not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema and headache to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site erythema and headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-AUG-2023 The patient reported that she received her first Shingrix vaccine and had a headache the first day that resolved the next day. The patient had pain and a 4" raised red area around the injection site which has not resolved.  The patient reported that the raised red area did appear to be lessening today. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain
Clinical narrative: Fatigue; soreness 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 pain in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included sinus disorder (sinus issues).   On 09-AUG-2023, the patient received the 1st dose of Shingrix. On 10-AUG-2023, 1 days after receiving Shingrix, the patient experienced injection site pain (Verbatim: soreness at injection site) and injection site erythema (Verbatim: redness at injection site). On 13-AUG-2023, the patient experienced fatigue (Verbatim: Fatigue). The outcome of the injection site pain and injection site erythema were unknown and the outcome of the fatigue was not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema and fatigue to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site erythema and fatigue to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-AUG-2023 The patient reported that she received the first dose of Shingrix.  She experienced soreness and redness at the injection site.  She felt fatigued all day and this fatigue had continued to occur intermittently since that time.  She stated that it comes in waves daily. The reporter did not consent to follow-up.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Pain, Rash, Rash pruritic
Clinical narrative: Itchy (rash); Painful rash; This non-serious case was reported by a other health professional via call center representative and described the occurrence of itchy rash in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number 5YP3L, expiry date 31-JAN-2026) for prophylaxis.   On 10-AUG-2023 15:00, the patient received the 1st dose of Bexsero. On 11-AUG-2023 15:00, 1 days after receiving Bexsero, the patient experienced itchy rash (Verbatim: Itchy (rash)). In AUG-2023, the patient experienced pain (Verbatim: Painful rash). The outcome of the itchy rash was resolving and the outcome of the pain was resolved.   It was unknown if the reporter considered the itchy rash and pain to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   It was unknown if the company considered the itchy rash and pain to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-AUG-2023 The reporter sated that a patient experienced a rash all over the body after the administration of Bexsero.  The rash developed later that day or the next day. The reporter stated that the patient called yesterday and reported that was patient was feeling better and the rash was not itchy or painful anymore. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up via postal.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Fall, Hypoaesthesia, Myalgia
Clinical narrative: pain in her left hip; pain in her thigh; muscle pain in her left hip and leg; left knee and lower left leg became numb; pain in her upper back; fall twice; This non-serious case was reported by a consumer via call center representative and described the occurrence of upper back pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-MAR-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm) .5 ml. On 04-MAR-2023, 1 days after receiving Shingrix, the patient experienced upper back pain (Verbatim: pain in her upper back). On 05-MAR-2023, the patient experienced muscle pain (Verbatim: muscle pain in her left hip and leg) and numbness of lower extremities (Verbatim: left knee and lower left leg became numb). In MAR-2023, the patient experienced fall (Verbatim: fall twice). On an unknown date, the patient experienced pain in hip (Verbatim: pain in her left hip) and pain in thigh (Verbatim: pain in her thigh). In MAY-2023, the outcome of the numbness of lower extremities was resolved. The outcome of the upper back pain, muscle pain, pain in hip and pain in thigh were not resolved and the outcome of the fall was not reported.   It was unknown if the reporter considered the upper back pain, muscle pain, numbness of lower extremities, fall, pain in hip and pain in thigh to be related to Shingrix.     It was unknown if the company considered the upper back pain, muscle pain, numbness of lower extremities, fall, pain in hip and pain in thigh to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-AUG-2023 The patient received her 1st Shingrix vaccine and 24 hours after she had pain in her upper back. 48 hours after receiving her Shingrix vaccine she developed severe muscle pain in her left hip and leg and her left knee and lower left leg became numb. The numbness caused her to fall twice.  The numbness in her left leg resolved after 2 and half months.  The patient still (at the time of reporting) had pain in her left hip and thigh and upper back. The reporter did not consent to follow-up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: pain in her left hip; pain in her thigh; muscle pain in her left hip and leg; left knee and lower left leg became numb; pain in her upper back; fall twice; This non-serious case was reported by a consumer via call center representative and described the occurrence of upper back pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-MAR-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm) .5 ml. On 04-MAR-2023, 1 days after receiving Shingrix, the patient experienced upper back pain (Verbatim: pain in her upper back). On 05-MAR-2023, the patient experienced muscle pain (Verbatim: muscle pain in her left hip and leg) and numbness of lower extremities (Verbatim: left knee and lower left leg became numb). In MAR-2023, the patient experienced fall (Verbatim: fall twice). On an unknown date, the patient experienced pain in hip (Verbatim: pain in her left hip) and pain in thigh (Verbatim: pain in her thigh). In MAY-2023, the outcome of the numbness of lower extremities was resolved. The outcome of the upper back pain, muscle pain, pain in hip and pain in thigh were not resolved and the outcome of the fall was not reported.   It was unknown if the reporter considered the upper back pain, muscle pain, numbness of lower extremities, fall, pain in hip and pain in thigh to be related to Shingrix.     It was unknown if the company considered the upper back pain, muscle pain, numbness of lower extremities, fall, pain in hip and pain in thigh to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-AUG-2023 The patient received her 1st Shingrix vaccine and 24 hours after she had pain in her upper back. 48 hours after receiving her Shingrix vaccine she developed severe muscle pain in her left hip and leg and her left knee and lower left leg became numb. The numbness caused her to fall twice.  The numbness in her left leg resolved after 2 and half months.  The patient still (at the time of reporting) had pain in her left hip and thigh and upper back. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose in 2020; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 31 October 2020).   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: received the first dose in 2020). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 15-AUG-2023 The pharmacist called in to request the information about the usage of Shingrix in a patient who received the first dose in 2020 and wished to get the second dose in 2023.  Partial information about patient, event and vaccine provided. Till the date of reporting, the patient did not receive 2nd dose which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Pharmacist reports the patient only received the first dose of the Shingrix series; This non-serious case was reported by a pharmacist 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 first dose of Shingrix in October 2020).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Pharmacist reports the patient only received the first dose of the Shingrix series). The outcome of the incomplete course of vaccination was unknown.   Additional Information: Receipt Date: 15-AUG-2023 The pharmacist stated that in October 2020 patient received the only first dose of Shingrix series. Exact date, lot number or expiration date was not provided. Till the time of reporting patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: given a dose of Shingrix reconstituted with a sterile diluent; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number 6R5XF, expiry date 22-AUG-2025) for prophylaxis.   In JUL-2023, the patient received the 1st dose of Shingrix. In JUL-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: given a dose of Shingrix reconstituted with a sterile diluent). The outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt date: 15-AUG-2023 A nurse reported that a patient was accidentally given a dose of Shingrix reconstituted with a sterile diluent 3 weeks ago from reporting and wanted to know how to proceed. The vaccine administration facility was the same as primary reporter. The patient received Shingrix reconstituted with a sterile diluent which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: administration of an expired Hiberix dose to a patient.; 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 female patient who received Hib (Hiberix) (expiry date 27-JUL-2023) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: administration of an expired Hiberix dose to a patient.). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 15-AUG-2023 The healthcare professional called to ask for information regarding the administration of an expired Hiberix dose to a patient.  The healthcare professional asked if there was a grace period to administer a repeat dose. The reporter did not provide patient initials, patient age nor lot number of the Hiberix vaccine. The reporter consented to follow up. The patient received Hiberix beyond the expiration date, which led to expired vaccine used.
Sex: F
Vaccine: HEP
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: instead of receiving a pediatric dose, the patient received an adult dose; received the 3rd dose of Engerix-B, but instead of receiving a pediatric dose, the patient received an adult dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 5-year-old female patient who received HBV (Engerix B adult) (batch number NJG23) for prophylaxis.   On 14-AUG-2023, the patient received the 3rd dose of Engerix B adult. On 14-AUG-2023, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: instead of receiving a pediatric dose, the patient received an adult dose) and adult product administered to child (Verbatim: received the 3rd dose of Engerix-B, but instead of receiving a pediatric dose, the patient received an adult dose). The outcome of the overdose and adult product administered to child were unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: Receipt Date: 15-AUG-2023 A nurse practitioner called to inform that a 5-year-old patient received the 3rd dose of Engerix-B, but instead of receiving a pediatric dose, the patient received an adult dose, which led to overdose and adult product administered to child. The vaccine administration facility is the same as primary reporter. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Shingrix late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 15-NOV-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: Shingrix late second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: Receipt Date: 16-AUG-2023 Pharmacist was looking for information about late second dose of Shingrix and the efficacy data for one dose only. They had patient that their first dose was 2 years ago from reporting. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. This case was 1 of 2 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2023111553:same reporter, 2nd case
Age: 99.0
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: late second dose of Shingrix and the efficacy data for one dose only; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 103-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on March 10, 2020).   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: late second dose of Shingrix and the efficacy data for one dose only). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 16-AUG-2023 The pharmacist intern was looking for information about late 2nd dose of Shingrix and the efficacy data for one dose only.  The patient received the 1st dose was 2 years ago. Till the date of reporting the patient did not receive 2nd dose, which led to incomplete course of vaccination. The reporter did not consent to follow-up. This case is linked with US2023111503, US2023AMR111828, by same reporter.; Sender's Comments:  US-GSK-US2023AMR111828:secand case created for second patient US-GSK-US2023111503:same reporter, 2nd case
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: supposed to be a second Shingrix vaccine in 2 to 6 months from the first to complete the series; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (In 2019, received the first dose 0.5ml intramuscularly in an unknown arm).   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: supposed to be a second Shingrix vaccine in 2 to 6 months from the first to complete the series). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 16-AUG-2023 The reporter reported that her husband received her first Shingrix vaccine sometime in 2019 and he nowfinds out from the pharmacy that there was supposed to be a second Shingrix vaccine in 2 to 6 months from the first to complete the series. The reporter did not consent to follow up. The reporter reported that till the time of reporting the patient had not received the 2nd dose of Shingrix vaccine, which lead to incomplete course of vaccination. This case had been linked to the case US2023111556 reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2023111556:Same reporter, different patient
Age: 11.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: incorrect vaccine being administered/ maladministration of Kinrix to an 11 year old patient. Kinrix was administered instead of Tdap; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received DTPa-IPV (Kinrix) (batch number C472T, expiry date 31-MAR-2024) for prophylaxis.   On 22-JUL-2023, the patient received Kinrix. On 22-JUL-2023, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: incorrect vaccine being administered/ maladministration of Kinrix to an 11 year old patient. Kinrix was administered instead of Tdap). 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: 16-AUG-2023 The nurse reported that the patient was administered the incorrect vaccine. Kinrix was administered instead of the TDAP (Boostrix). No symptoms had been reported due to the incorrect vaccine being administered. The reporter consented to follow up. The patient was given Kinrix instead of Boostrix which led to wrong vaccine administered.; Sender's Comments:  US-GSK-US2023111519:
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: pharmacist called to inform that a patient that received the first dose of Shingrix back in December 2018 hadn't received the second dose 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 adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the 1st dose of Shingrix back in December 2018).   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: pharmacist called to inform that a patient that received the first dose of Shingrix back in December 2018 hadn't received the second dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 16-AUG-2023 The reporter called to inform that a patient had not received the second dose of Shingrix yet. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 7.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Extra dose administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: received Kinrix vaccine instead of boostrix; 7 year old received Kinrix vaccine instead of boostrix; received Kinrix vaccine instead of boostrix/Last completed schedule with Kinrix was on 15 November 2019; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 7-year-old female patient who received DTPa-IPV (Kinrix) (batch number F5492) for prophylaxis.   Previously administered products included Kinrix (Last completed schedule with Kinrix was on 15th November 2019).   On 09-AUG-2023, the patient received Kinrix. On 09-AUG-2023, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: received Kinrix vaccine instead of boostrix), inappropriate age at vaccine administration (Verbatim: 7 year old received Kinrix vaccine instead of boostrix) and extra dose administered (Verbatim: received Kinrix vaccine instead of boostrix/Last completed schedule with Kinrix was on 15 November 2019). The outcome of the wrong vaccine administered, inappropriate age at vaccine administration and extra dose administered were unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: Receipt Date: 16-AUG-2023 The reporter reported that a 7 year old received Kinrix vaccine instead of Boostrix, which led to wrong vaccine administered, inappropriate age at vaccine administration and extra dose administered. The reporter consented to follow up.
Sex: U
Vaccine: FLU4, TDAP
Symptoms: Product storage error
Clinical narrative: received Flulaval after a temperature excursion/temperature excursion for Boostrix vaccines; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 7PE77) and (batch number N742D) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   In NOV-2022, the patient received FluLaval Quadrivalent 2022-2023 season. On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving FluLaval Quadrivalent 2022-2023 season and Boostrix, the patient experienced incorrect storage of drug (Verbatim: received Flulaval after a temperature excursion/temperature excursion for Boostrix vaccines). The outcome of the incorrect storage of drug was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2023111537   Additional Information: Receipt Date: 16-AUG-2023 The reporter stated that cold temperatures had been going on for months the lowest temperature was 30.4°F.  Between October to December 2022 total 30 patient received the Flulaval QIV season 22-23 after a temperature excursion. Flulaval QIV SEASON 22-23 with lot number 7PE77 was administered during November 2022. Lot number UT7715AA were not a GSK vaccine lot number. Same temperature excursion for Boostrix vaccines was reported but no data was available for the Boostrix scenarios. The patient received Flulaval QIV SEASON 22-23 and Boostrix below temperature excursion which led to incorrect storage of drug. The reporter consented to follow up. This is 1 of 30 linked report, reported by same reporter for different patients.
Sex: M
Vaccine: HEPA
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: patient that is 2 years 4 months old, received and adult dose; patient that is 2 years 4 months old, received and adult dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 28-month-old male patient who received HAV (Havrix 1440 adult) (batch number 95DB2, expiry date 13-DEC-2024) for prophylaxis.   On 17-JUL-2023, the patient received Havrix 1440 adult (intramuscular, right side). On 17-JUL-2023, an unknown time after receiving Havrix 1440 adult, the patient experienced overdose (Verbatim: patient that is 2 years 4 months old, received and adult dose) and adult product administered to child (Verbatim: patient that is 2 years 4 months old, received and adult dose). The outcome of the overdose and adult product administered to child were unknown.   This report is mad without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: Receipt date: 17-Aug-2023 Medical assistant and the administrator calling to report that a patient that was 2 years 4 months old, received and adult dose of Havrix. The reporter consented to follow-up. A pediatric patient received an adult dose of Havrix, which led to overdose and adult product administered to child.
Age: 95.0
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Shingrix: did not receive 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 97-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 24th July 2021 from lot number 9727R and expiry date 27th January 2023).   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: Shingrix: did not receive 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 18-AUG-2023 The reporter reported that the patient never received 2nd dose of Shingrix vaccine. The reporter wanted to know if patient need to restart the series. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 16.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: patient received an expired dose of Boostrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (expiry date 15-JUL-2023) for prophylaxis.   On 21-AUG-2023, the patient received Boostrix. On 21-AUG-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: patient received an expired dose of Boostrix). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 21-AUG-2023 The reporter could not provide the lot number for the product.  No additional information was provided. The reporter consented to follow up. The reporter reported that the patient received an expired dose of Boostrix, which led to expired vaccine used.
Age: 5.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient 6 months-5 years of age received a Moderna Covid19 bivalent Vaccine from the pink cap (10 mcg) instead of blue cap (25 mcg); This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient 6 months-5 years of age received a Moderna Covid19 bivalent Vaccine from the pink cap (10 mcg) instead of blue cap (25 mcg)) and NO ADVERSE EVENT (No adverse event) in a 5-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 216K22A and 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 18-May-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 17-Jun-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 10 microgram. In 2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient 6 months-5 years of age received a Moderna Covid19 bivalent Vaccine from the pink cap (10 mcg) instead of blue cap (25 mcg)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient 6 months-5 years of age received a Moderna Covid19 bivalent Vaccine from the pink cap (10 mcg) instead of blue cap (25 mcg)) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient 6 months-5 years of age received a Moderna Covid19 bivalent Vaccine from the pink cap (10 mcg) instead of blue cap (25 mcg)).    The route of administration of suspect Moderna bivalent dose 1 and 2 was reported.  Concomitant medication was not reported.  Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:same reporter