chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: TYP
Symptoms: Product residue present
Clinical narrative: Last capsule of Vivotif came out in his stools; A spontaneous report was received from a pharmacist on 08NOV2023 regarding a male patient of unknown age whose "last capsule of Vivotif came out in his stools" (PT: Product residue present). The patient took Vivotif (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that patient noticed that his last capsule of Vivotif came out in his stools. Reportedly, the pharmacist did not know if the capsule was open, but he believed that the capsule was "in one part".  The outcome of the reported event was unknown, at the time of this report.  The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a patient was on Vivotif and last capsule of Vivotif came out in his stools (product residue present). It was reported that the patient believed that the capsule was in one part. Considering the case information, the causality of the above event is assessed as possible. The case is considered non serious as per medical assessment.; Sender's Comments: Company comment: It was reported that a patient was on Vivotif and last capsule of Vivotif came out in his stools (product residue present). It was reported that the patient believed that the capsule was in one part. Considering the case information, the causality of the above event is assessed as possible. The case is considered non serious as per medical assessment.
Sex: M
Vaccine: TYP
Symptoms: Product residue present
Clinical narrative: Capsule had passed in the stool; A spontaneous report was received on 09NOV2023 from male patient of unknown age whose "capsule had passed in the stool" (PT: Product residue present). The patient took Vivotif (Typhoid vaccine live oral Ty21A; route: oral; lot number: unknown) for an immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that the patient was prescribed typhoid medication and had doses properly. The patient took last dose of Vivotif and after 45 minutes, the capsule had passed in the stool. Further, the patient had no issues with the prior doses and wasn't experiencing any nausea or diarrhea or anything.  The outcome of the reported event was unknown.    The action taken with Vivotif with respect to the reported event not applicable.    No additional information was reported.  Company comment: It was reported that a patient took last dose of Vivotif and after 45 minutes capsule had passed in the stool (product residue present). Considering the case information, the causality of the above event is assessed as possible. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a patient took last dose of Vivotif and after 45 minutes capsule had passed in the stool (product residue present). Considering the case information, the causality of the above event is assessed as possible. The case is considered non serious as per medical assessment.
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Nausea
Clinical narrative: Nausea; Abdominal pain; A spontaneous report was received from pharmacist on 16NOV2023 regarding a 40-year-old female patient who experienced "abdominal pain" (PT: Abdominal pain) and "nausea" (PT: Nausea). The patient took Vivotif (Typhoid vaccine live oral Ty21A; route: oral; lot number: 3003851) for an immunisation.   The patient's medical history, concomitant medications, or allergies were not reported.   It was reported that patient experienced abdominal pain and nausea after taking the first dose of Vivotif.  The outcome of the reported events was unknown.   The action taken with Vivotif with respect to the reported events was unknown.   No additional information was reported.  Company comment: It was reported that a patient experienced abdominal pain and nausea after taking the first dose of Vivotif. Further information regarding the events is limited. Hence, in view of strong temporal association, the causality of the above events is assessed as possibly related to Vivotif.; Sender's Comments: It was reported that a patient experienced abdominal pain and nausea after taking the first dose of Vivotif. Further information regarding the events is limited. Hence, in view of strong temporal association, the causality of the above events is assessed as possibly related to Vivotif.
Sex: M
Vaccine: TYP
Symptoms: Intentional dose omission
Clinical narrative: Neglected to take the final two doses; A spontaneous report was received from other healthcare professional on 20NOV2023 regarding a male patient of unknown age who "neglected to take the final two doses" (PT: Intentional dose omission). The patient took Vivotif (Typhoid vaccine live oral Ty21A; lot number: unknown) for an immunisation.   The patient's medical history, concomitant medications, or allergies were not reported.   It was reported that patient took the first two doses of Vivotif on 12NOV2023 and 14NOV2023 and then neglected to take the final two doses.  The outcome of the reported events not applicable.    The action taken with Vivotif with respect to the reported event was not applicable.    No additional information was reported.  Company comment: It was reported that a consumer took the first two doses of Vivotif on 12NOV2023 and 14NOV2023 and then neglected to take the final two doses (intentional dose omission). The causality of intentional dose omission is assessed as not applicable to Vivotif considering the nature of the event.; Sender's Comments: It was reported that a consumer took the first two doses of Vivotif on 12NOV2023 and 14NOV2023 and then neglected to take the final two doses (intentional dose omission). The causality of intentional dose omission is assessed as not applicable to Vivotif considering the nature of the event.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: injection site reactions; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of injection site reaction in an unspecified number of patients 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 injection site reaction (Verbatim: injection site reactions). The outcome of the injection site reaction was not reported.   It was unknown if the reporter considered the injection site reaction to be related to Shingrix.     It was unknown if the company considered the injection site reaction to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-NOV- 2022 The pharmacist stated that some patient experienced injection site reaction and might decide not to receive the second dose. The reporter did not agree to follow up from GlaxoSmithKline.   Upon internal review the case was updated on 20-NOV-2023. This case was initially processed as invalid, however upon significant follow-up received on 10-NOV-2023, case became valid and it was missed to add appropriate significant follow-up tracking, due to which regulatory reports had not been scheduled. The case was amended for error correction. Summary of Changes: Significant amendment tracking added with description as error correction, Shingrix dose number added and narrative updated.
Sex: F
Vaccine: RVX
Symptoms: Erythema, Injection site pruritus, Pain
Clinical narrative: itching at vaccine site; Continued pain; redness; This non-serious case was reported by a consumer and described the occurrence of injection site itching in a 68-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Concurrent medical conditions included depression, anxiety, blood pressure high and herpes virus infection. Concomitant products included duloxetine hydrochloride (Cymbalta), bupropion hydrochloride (Wellbutrin), trazodone hydrochloride (Trazodone) and losartan potassium (Losartin).   On 08-NOV-2023, the patient received RSV vaccine. On 09-NOV-2023, 1 days after receiving RSV vaccine, the patient experienced injection site itching (Verbatim: itching at vaccine site), pain (Verbatim: Continued pain) and erythema (Verbatim: redness). The outcome of the injection site itching, pain and erythema were not resolved.   It was unknown if the reporter considered the injection site itching, pain and erythema to be related to RSV vaccine.   It was unknown if the company considered the injection site itching, pain and erythema to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 11-NOV-2023 The reporter was consumer. The patient received RSV vaccine and had continued pain, redness and itching at vaccination site. The reporter consent to follow up.
Sex: U
Vaccine: DTAPIPV, MMRV
Symptoms: Diarrhoea, Injection site rash
Clinical narrative: Diarrohoea; Injection site rash; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of diarrhea in a patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included Proquad (batch number X018581, expiry date 01-MAY-2025) for prophylaxis.   On 27-OCT-2023, the patient received Kinrix and Proquad. On 27-OCT-2023, less than a day after receiving Kinrix, the patient experienced diarrhea (Verbatim: Diarrohoea) and injection site rash (Verbatim: Injection site rash). On 30-OCT-2023, the outcome of the diarrhea and injection site rash were resolved (duration 3 days).   It was unknown if the reporter considered the diarrhea and injection site rash to be related to Kinrix.     It was unknown if the company considered the diarrhea and injection site rash to be related to Kinrix.   Additional Information: GSK receipt date: 08-NOV-2023 Employee called on behalf of HCP to report potential adverse event. Reporter stated patient was administered with Proquad and Kinrix, then experienced diarrhea and a rash on injection site later that day (on the day of vaccination). Reporter stated patient experienced symptoms for 3 days. Patient went to HCP for follow up. HCP stated diarrhea may be caused by separate virus that was not known at the time and may not have been from Proquad. It was unknown if the reporter considered the injection site rash to be related to Proquad. The reporter consented to follow up.
Sex: U
Vaccine: RVX
Symptoms: Influenza, Nervousness
Clinical narrative: feeling like flu symptoms; little nervous; This non-serious case was reported by a consumer via call center representative and described the occurrence of flu symptoms in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Concurrent medical conditions included fibromyalgia and immune system disorder.   On 08-NOV-2023, the patient received RSV vaccine. On 10-NOV-2023, 2 days after receiving RSV vaccine, the patient experienced flu symptoms (Verbatim: feeling like flu symptoms). In NOV-2023, the patient experienced nervous (Verbatim: little nervous). The outcome of the flu symptoms was not resolved and the outcome of the nervous was not reported.   It was unknown if the reporter considered the flu symptoms and nervous to be related to RSV vaccine.     It was unknown if the company considered the flu symptoms and nervous to be related to RSV vaccine.   Additional Information: GSK Receipt date: 11-NOV-2023 The patient had the RSV vaccine three days ago, the next day it was fine then two days later the patient was feeling like flu symptoms and it continued and until Saturday. On Friday and Saturday the patient felt like flu symptoms. The reporter asked if it was normal to have flu symptoms. The patient was little nervous and had a low immune system and fibromyalgia. The reporter was double checking. The patient didn't have any extra extra pains. The patient was feeling like coming down with the flu.
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: swollen arm for 2 weeks; This non-serious case was reported by a consumer via call center representative and described the occurrence of swelling arm 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 swelling arm (Verbatim: swollen arm for 2 weeks). The outcome of the swelling arm was resolved (duration 2 weeks).   It was unknown if the reporter considered the swelling arm to be related to Shingrix.     It was unknown if the company considered the swelling arm to be related to Shingrix.   Additional Information: GSK Receipt date: 12-NOV-2023 It was reported that patient had swollen arm for 2 weeks after the Shingrix vaccine. The reporter stated that the latest covid vaccine was doing the same and questioned what do these 2 have in common.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: her 2nd Shingrix, as it has been more than 6 months since her first.; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose more than 6 months ago).   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: her 2nd Shingrix, as it has been more than 6 months since her first.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 13-NOV-2023 The patient called about getting her 2nd Shingrix, as it had been more than 6 months since her first. VAERS details provided corresponding to the 1st dose and the case is an incomplete course of vaccination.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: pregnant patient in the 3nd trimester was administered Arexvy; pregnant patient in the 3nd trimester was administered Arexvy; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a 31-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   In OCT-2023, the patient received Arexvy. In OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: pregnant patient in the 3nd trimester was administered Arexvy). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant patient in the 3nd trimester was administered Arexvy). The outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date-13-NOV-2023 The pharmacist reported that the pregnant patient who was in the third trimester was administered Arexvy vaccine two weeks ago at an inappropriate age, which led to vaccine exposure during pregnancy and inappropriate age at vaccine administration. The reporter consented to follow up
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose not received 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 male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received in September 2021).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: 2nd dose not received yet). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 13-NOV-2023 The pharmacist reported on November 13th 2023 that patient received the first dose of Twinrix on September 2021 and the second dose was not administered yet. The reporter did not consent to follow up. The vaccine administration facility is the same as primary reporter. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: adult patient received pediatric dose of ENGERIX-B; adult patient received pediatric dose of ENGERIX-B; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 25-year-old female patient who received HBV (Engerix B pediatric) (batch number DD7K7, expiry date 31-MAR-2024) for prophylaxis.   On 06-NOV-2023, the patient received Engerix B pediatric 10 ug. On 06-NOV-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: adult patient received pediatric dose of ENGERIX-B) and adult use of a child product (Verbatim: adult patient received pediatric dose of ENGERIX-B). The outcome of the underdose and adult use of a child product 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: 13-NOV-2023 The reporter was a certified medical assistant. adult patient received pediatric dose of Engerix-B, which led to underdose and adult use of a child product. The reporter consented to follow up.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: patient was administered an expired dose of Havrix by someone else on Friday; 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 patient who received HAV (Havrix) (batch number H4H53, expiry date 30-JAN-2023) for prophylaxis.   On 10-NOV-2023, the patient received Havrix. On 10-NOV-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: patient was administered an expired dose of Havrix by someone else on Friday). 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: The Pharmacist reported that the patient had administered expired vaccine of havrix . The reported that vaccine expired in January 2023. The caller declined to provide more information. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: administration of an expired Shingrix dose to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a male patient who received Herpes zoster (Shingrix) (batch number PY3VD, expiry date 25-SEP-2023) for prophylaxis.   On 13-NOV-2023, the patient received the 2nd dose of Shingrix. On 13-NOV-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: administration of an expired Shingrix dose to a patient). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 13-NOV-2023 The nurse called and reported regarding the administration of an expired Shingrix dose to the patient, which led to expired vaccine used. She reported that it was the second dose of the series.  The health care professional had asked what was the recommended interval between the expired dose and the repeated dose.  The reporter had consented to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Shingrix possible late second dose/ received Shingrix first dose on 2021; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 47AY2, expiry date 26-SEP-2025) for prophylaxis.   Previously administered products included Shingrix (In 2021, received first dose).   On 13-NOV-2023, the patient received the 2nd dose of Shingrix. On 13-NOV-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Shingrix possible late second dose/ received Shingrix first dose on 2021). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 13-NOV-2023 A pharmacist had an immunocompetent patient whose doctor stated that patient received Shingrix first dose in 2021, however pharmacist did not have any records on that. The doctor recommended to start over the series. The pharmacist had just given a Shingrix dose on the day of reporting. The reporter consented to follow up. The patient received the second dose of Shingrix later than recommended schedule, which led to lengthening of vaccine schedule.
Sex: M
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: administration of Havrix after the vaccines were exposed to freezing temperatures and administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 3-year-old male patient who received HAV (Havrix) (batch number Y3ME2, expiry date 23-FEB-2025) for prophylaxis.   On 06-NOV-2023, the patient received Havrix. On 06-NOV-2023, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: administration of Havrix after the vaccines were exposed to freezing temperatures and administered). The outcome of the incorrect storage of drug 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: 13-NOV-2023 The reporter contacted GlaxoSmithKline via phone and inquiring about Havrix and what information was available about the administration of Havrix after the vaccines were exposed to freezing temperatures and administered, which led to incorrect storage of vaccine. They gave partial information about vaccines, patient and event.  The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Sex: M
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Dose given after exposure to freezing temperature; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 1-year-old male patient who received HAV (Havrix) (batch number Y3ME2, expiry date 23-FEB-2025) for prophylaxis.   On 08-NOV-2023, the patient received Havrix. On 08-NOV-2023, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: Dose given after exposure to freezing temperature). The outcome of the incorrect storage of drug 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: 13-NOV-2023 The reporter inquired about Havrix and what information was available about the administration of Havrix after the vaccines were exposed to freezing temperatures and administered, which led to incorrect storage of drug. They gave partial information about vaccines, patient and event. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: F
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: the vaccines were exposed to freezing temperatures and administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 1-year-old female patient who received HAV (Havrix) (batch number Y3ME2, expiry date 23-FEB-2025) for prophylaxis.   On 08-NOV-2023, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: the vaccines were exposed to freezing temperatures and administered). The outcome of the incorrect storage of drug 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: 13-Nov-2023 A health care professional contacted GlaxoSmithKline via phone inquiring about Havrix and what information was available about the administration of Havrix after the vaccines were exposed to freezing temperatures and administered.  The reporter gave partial information about vaccines, patient and event.  The Vaccine Administration Facility was the same as Primary Reporter. The patient received a dose of Havrix after temperature excursion, which led to incorrect storage of drug.
Sex: F
Vaccine: RSV
Symptoms: Product preparation error
Clinical narrative: patient received the adjuvant only of Arexvy; patient received the adjuvant only of Arexvy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate dose of vaccine administered in a female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number T3N4M, expiry date 05-MAR-2025) for prophylaxis.   On 13-NOV-2023, the patient received Arexvy. On 13-NOV-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate dose of vaccine administered (Verbatim: patient received the adjuvant only of Arexvy) and inappropriate preparation of medication (Verbatim: patient received the adjuvant only of Arexvy). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK Receipt Date: 13-NOV-2023 The pharmacist reported the patient received only adjuvant of Arexvy which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient got dose one of Shingrix in November of 2022 and has not received dose two.; 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 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix in November 2022).   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: patient got dose one of Shingrix in November of 2022 and has not received dose two.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 13-NOV-2023 Pharmacy intern reported that the patient had not received dose two of Shingrix. The healthcare professional could not provide the lot number and expiration date or exact date of vaccination. The reporter 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.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received Engerix-B first dose on May 16th 2023 and 2nd dose on Nov 13th 2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 32-year-old female patient who received HBV (Engerix B) (batch number 9kg23, expiry date 10-FEB-2025) for prophylaxis.   Previously administered products included Engerix B (1st dose received on 16th May 2023).   On 13-NOV-2023, the patient received the 2nd dose of Engerix B. On 13-NOV-2023, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: patient received Engerix-B first dose on May 16th 2023 and 2nd dose on Nov 13th 2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date:13-Nov-2023 The reporter was a pharmacy intern. The patient received 2nd dose of Engerix-B late than recommended time frame, which led to lengthening of vaccination schedule. The reporter asked if need to restart the series. The reporter did consent to follow up.
Age: 0.5
Sex: F
Vaccine: MNQ, MMR, MNQ, RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: six months old was given the single vial presentation of Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number 27PE9, expiry date 31-DEC-2024) for prophylaxis.   On 13-NOV-2023, the patient received the 1st dose of Menveo. On 13-NOV-2023, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: six months old was given the single vial presentation of Menveo). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 13-NOV-2023 Nurse reported that a patient who was six months old was given the single vial presentation of Menveo for their first dose, which led to inappropriate age at vaccine. The reporter consented to follow up.
Age: 0.5
Sex: F
Vaccine: MNQ, MMR, MNQ, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: six months old was given the single vial presentation of Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number 27PE9, expiry date 31-DEC-2024) for prophylaxis.   On 13-NOV-2023, the patient received the 1st dose of Menveo. On 13-NOV-2023, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: six months old was given the single vial presentation of Menveo). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 13-NOV-2023 Nurse reported that a patient who was six months old was given the single vial presentation of Menveo for their first dose, which led to inappropriate age at vaccine. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: three doses of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number PF222, expiry date 16-AUG-2025) for prophylaxis.   On 10-NOV-2023, the patient received the 3rd dose of Shingrix. On 10-NOV-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: three doses of Shingrix). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date:13-NOV-2023 The pharmacist contacted and inquired about Shingrix and what information was available about the safety data available about the safety of three doses of Shingrix. Partial information about patient, vaccine and event was given. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter. The patient received 3rd dose of Shingrix, which led to extra dose administered.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Product preparation error
Clinical narrative: gave the adjuvant only of the Shingrix vaccine; gave the adjuvant only of the Shingrix vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26-OCT-2023, the patient received Shingrix. On 26-OCT-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: gave the adjuvant only of the Shingrix vaccine) and inappropriate dose of vaccine administered (Verbatim: gave the adjuvant only of the Shingrix vaccine). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 14-NOV-2023 The healthcare professional called to report that one of their staff gave the adjuvant only of the Shingrix vaccine to a patient which led to to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: inadvertently administered an expired Boostrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired drug used in a 70-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2G3PH, expiry date 27-OCT-2023) for prophylaxis.   On 06-NOV-2023, the patient received Boostrix. On 06-NOV-2023, an unknown time after receiving Boostrix, the patient experienced expired drug used (Verbatim: inadvertently administered an expired Boostrix). The outcome of the expired drug used was unknown.   Additional Information: GSK Receipt Date: 14-NOV-2023 The registered nurse called to inquire how to proceed, if the dose was still good The patient was inadvertently administered a Boostrix on 6th November 2023, which was expired on 27th October 2023, Which led to expired vaccine used. The reporter did not consent to follow-up from safety
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Dysstasia, Gait disturbance, Hypoaesthesia, Magnetic resonance imaging abnormal
Clinical narrative: nerve damage on one; Loosing balance/ not walking normal/ wobbling from side to side was trying to be sturdy but could not walk/ would not stand up; numbness; tingling of the feet/ sensation on the feet/ sensation on right leg from foot to ankle and it went to the left leg it got worse got to the calf (expanding and contracting) upto the thighs; This serious case was reported by a consumer via call center representative and described the occurrence of peripheral nerve injury in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (on an unknown date received 1st dose  No issues with Dose 1).   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 peripheral nerve injury (Verbatim: nerve damage on one) (serious criteria GSK medically significant), balance difficulty (Verbatim: Loosing balance/ not walking normal/ wobbling from side to side was trying to be sturdy but could not walk/ would not stand up), numbness in feet (Verbatim: numbness) and tingling of extremity (Verbatim: tingling of the feet/ sensation on the feet/ sensation on right leg from foot to ankle and it went to the left leg it got worse got to the calf (expanding and contracting) upto the thighs). The outcome of the peripheral nerve injury, balance difficulty and numbness in feet were unknown and the outcome of the tingling of extremity was not resolved.   It was unknown if the reporter considered the peripheral nerve injury, balance difficulty, numbness in feet and tingling of extremity to be related to Shingrix.     It was unknown if the company considered the peripheral nerve injury, balance difficulty, numbness in feet and tingling of extremity to be related to Shingrix.   Additional Information: GSK receipt date: 14-NOV-2023 The patient reported that he received 2nd dose of Shingrix in the month of September or October and 20 minutes to half an hour of the shot at the grocery store he felt a sensation on the feet, loosing balance, numbness, as if its going to sleep, was not walking normal.  On Saturday same symptoms during the day so sat and relaxed.  On Thursday while walking he had sensation on right leg from foot to ankle and it went to the left leg it got worse got to the calf (expanding and contracting) upto the thighs.  Try to put foot down would not stand up with use of cane was woobling from side to side was trying to be sturdy but could not walk.  Next day called physician send to therapist got MRI found nerve damage on one other 2 are ok.  No probelm with upper body only lower body.  As if now (at the time of reporting) still had tingling of the feet and getting acclimated to it.  The patient had no issues with Dose 1. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia, Peripheral nerve injury, Walking aid user
Clinical narrative: nerve damage on one; Loosing balance/ not walking normal/ wobbling from side to side was trying to be sturdy but could not walk/ would not stand up; numbness; tingling of the feet/ sensation on the feet/ sensation on right leg from foot to ankle and it went to the left leg it got worse got to the calf (expanding and contracting) upto the thighs; This serious case was reported by a consumer via call center representative and described the occurrence of peripheral nerve injury in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (on an unknown date received 1st dose  No issues with Dose 1).   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 peripheral nerve injury (Verbatim: nerve damage on one) (serious criteria GSK medically significant), balance difficulty (Verbatim: Loosing balance/ not walking normal/ wobbling from side to side was trying to be sturdy but could not walk/ would not stand up), numbness in feet (Verbatim: numbness) and tingling of extremity (Verbatim: tingling of the feet/ sensation on the feet/ sensation on right leg from foot to ankle and it went to the left leg it got worse got to the calf (expanding and contracting) upto the thighs). The outcome of the peripheral nerve injury, balance difficulty and numbness in feet were unknown and the outcome of the tingling of extremity was not resolved.   It was unknown if the reporter considered the peripheral nerve injury, balance difficulty, numbness in feet and tingling of extremity to be related to Shingrix.     It was unknown if the company considered the peripheral nerve injury, balance difficulty, numbness in feet and tingling of extremity to be related to Shingrix.   Additional Information: GSK receipt date: 14-NOV-2023 The patient reported that he received 2nd dose of Shingrix in the month of September or October and 20 minutes to half an hour of the shot at the grocery store he felt a sensation on the feet, loosing balance, numbness, as if its going to sleep, was not walking normal.  On Saturday same symptoms during the day so sat and relaxed.  On Thursday while walking he had sensation on right leg from foot to ankle and it went to the left leg it got worse got to the calf (expanding and contracting) upto the thighs.  Try to put foot down would not stand up with use of cane was woobling from side to side was trying to be sturdy but could not walk.  Next day called physician send to therapist got MRI found nerve damage on one other 2 are ok.  No probelm with upper body only lower body.  As if now (at the time of reporting) still had tingling of the feet and getting acclimated to it.  The patient had no issues with Dose 1. The reporter consented to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles
Clinical narrative: Blisters formed around injection site; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site blisters in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number h379C) for prophylaxis.   On 13-NOV-2023, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid). On 14-NOV-2023, 1 days after receiving Shingrix, the patient experienced injection site blisters (Verbatim: Blisters formed around injection site). The outcome of the injection site blisters was not resolved.   It was unknown if the reporter considered the injection site blisters to be related to Shingrix.     It was unknown if the company considered the injection site blisters to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-Nov-2023 The reporter reported that the patient received Shingrix vaccine and experienced blisters around her injections site. The reporter did consent to follow up.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: a patient who received 2 doses of Arexvy vaccine.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 70-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number EP5FD, expiry date 07-DEC-2024) and (batch number 9R25L, expiry date 21-MAR-2025) for prophylaxis.   Concomitant products included RSV vaccine prot. subunit PreF3 (Arexvy).   On 14-NOV-2023, the patient received the 2nd dose of Arexvy. On 14-NOV-2023, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: a patient who received 2 doses of Arexvy vaccine.). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 14-NOV-2023 The pharmacist requested data regarding potential adverse effects for a patient who received 2 doses of Arexvy vaccine. The patient received 1st dose on 08-SEP-2023 and 2nd dose on 14-NOV-2023, which led to extra dose administered. The reporter consented to follow up.
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix as the first dose in an unvaccinated patient; Kinrix as the first dose in an unvaccinated patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-year-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Additional patient notes included did not had any prior history of vaccines.   On an unknown date, the patient received the 1st dose of Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix as the first dose in an unvaccinated patient) and inappropriate dose of vaccine administered (Verbatim: Kinrix as the first dose in an unvaccinated patient). The outcome of the inappropriate age at vaccine administration and inappropriate dose of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 15-Nov-2023 A pharmacist contacted GlaxoSmithKline via phone and inquiring about Kinrix and what information was available about the administration of Kinrix in a patient that comes from another country and did not had any prior history of vaccines.  The call dropped and a callback was made but the reporter did not answer the phone. The Vaccine Administration Facility was the same as Primary Reporter. An unvaccinated patient received a dose of Kinrix at an inappropriate age, which led to inappropriate age at vaccine administration and inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Delirium, Fatigue, Neuralgia
Clinical narrative: felt delirious; he had chills; fatigue; neuralgia; This serious case was reported by a consumer via call center representative and described the occurrence of delirium in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31-OCT-2023, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced delirium (Verbatim: felt delirious) (serious criteria GSK medically significant), chills (Verbatim: he had chills), fatigue (Verbatim: fatigue) and neuralgia (Verbatim: neuralgia). The outcome of the delirium, chills, fatigue and neuralgia were resolved.   It was unknown if the reporter considered the delirium, chills, fatigue and neuralgia to be related to Shingrix.     It was unknown if the company considered the delirium, chills, fatigue and neuralgia to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-NOV-2023 The patient that hours later he had chills, fatigue, neuralgia, and felt delirious.  The next day his symptoms subsided.  Referred him to health care professional (HCP), MI phone number provided. The reporter did not consent to follow-up.
Age: 25.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Pharmacist calling to report an adverse event involving a 25 year old patient who was inadvertently administered an expired dose of MMR II.  Pharmacist stated that the MMR II dose had a labeled expiration date of 7/15/2023, and was administered today; This spontaneous report was received from a pharmacist and refers to a 25-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 09-NOV-2023, the patient was vaccinated with an expired dose of measles, mumps, and rubella (WISTAR RA 27-3) virus vaccine, live (M-M-R II) injection, therapy type: rHA, two dose series, lot #U022316, expiration date: 15-JUL-2023, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). Pharmacist confirmed no report of symptoms or medical concerns at this time from patient involved (No adverse event). Pharmacist stated they were unaware if the dose administered was the first dose the patient has received.  No additional information provided regarding this adverse event.