chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: late 2nd dose; This 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 58-year-old female patient who received HAB (Twinrix) (batch number J477Y, expiry date 20th May 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis and HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX) for prophylaxis.   On 27th September 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 3rd July 2022, the patient received the 1st dose of TWINRIX. On 27th September 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: Additional Information: GSK Receipt Date: 28-SEP-2022 Reporter's Comment: The health care professional reported a patient received a late 2nd dose of twinrix. On 3rd July 2022 the patient received 1st dose of Twinrix. The vaccine administration facility was the same as the primary reporter. The reporter did consent to follow up. Additional supportive information: The patient received 2nd dose of Twinrix late than recommended time frame, which led to lengthening of vaccination schedule.
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash erythematous, Skin irritation
Clinical narrative: Constantly itching- all over; red rash-irritation from scratching  around neck; red rash-irritation from scratching  around neck; This case was reported by a consumer via call center representative and described the occurrence of generalized pruritus in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included heart attack (2 heart attacks) and difficulty breathing (breathing problems in the last 3 years).   On 22nd June 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 25th June 2022, 3 days after receiving Shingrix, the patient experienced generalized pruritus, red rash and skin irritation. The patient was treated with medication unknown (Cream (Medication Unknown)). On an unknown date, the outcome of the generalized pruritus was not recovered/not resolved and the outcome of the red rash and skin irritation were recovered/resolved.   It was unknown if the reporter considered the generalized pruritus, red rash and skin irritation to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-SEP-2022 Reporter's Comment:  The patient received first dose of Shingrix and 3 days later he experienced constant itching all over body, that was still ongoing. The reporter also mentioned he had red rash like irritation from scratching around neck. The reporter stated that he went to health care professional, and they ordered cream, but it did not help.  Medical disclaimer provided.  The reporter referred to health care professional, medical information phone number provided. Spoke per content. The reporter consented to follow up.
Age: 6.0
Sex: M
Vaccine: UNK
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness at Injection site; Swelling at injection site, big and more pronounced than usual; injection site hot to touch; This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 6-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 9249L, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th September 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. In September 2022, less than a week after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced injection site erythema, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site warmth were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site warmth to be related to FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra 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: 28-SEP-2022 Reporter's comment: GlaxoSmithKline field representative called GlaxoSmithKline to report an adverse event from an HCP office. HCP reported there was redness and swelling at the injection site. HCP reported the area was big and more pronounced than usual. HCP reported the injection site was hot to touch. Consented to follow up.
Sex: U
Vaccine: RV1
Symptoms: Incorrect route of product administration
Clinical narrative: Rotarix was injected instead of oral administration; This case was reported by a physician via call center representative and described the occurrence of inappropriate route of vaccination in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate route of vaccination. On an unknown date, the outcome of the inappropriate route 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: 28-SEP-2022 Reporter's comment: The physician asked for information about the wrong administration of Rotarix to the patient.  The reporter reported that Rotarix was injected instead of being administered via oral.  Since the physician was not at his office, and he was notified about this situation by a nurse. The reporter did not provide any data about the patient and the vaccine that was administered. The reporter consented to follow up. Additional Supportive Information: The patient received dose of Rotarix lyophilized which was injected instead of being administered via oral, which led to inappropriate route of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 2020, never received the 2nd.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 10th September 2020 from batch number G4HX3 with expiry date 13th May 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 29-SEP-2022 Reporter's Comments: The pharmacist reported that the patient never received the second dose of Shingrix. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The VAERS details reported for the first dose of Shingrix. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. This case has been linked to the US2022AMR141306 case reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR141306:Same reporter
Age: 56.0
Sex: F
Vaccine: TTOX, VARZOS
Symptoms: Hypoaesthesia, Muscle spasms
Clinical narrative: Numbness in hand and legs; Cramps in hands and legs; This case was reported by a consumer via call center representative and described the occurrence of numbness in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included tetanus vaccine for prophylaxis.   On 8th April 2022, the patient received the 1st dose of Shingrix (intramuscular) and tetanus vaccine at an unknown dose and frequency. On an unknown date, between 1 and 2 months after receiving Shingrix, the patient experienced numbness and cramp. The patient was treated with magnesium (Magnesium Powder). On an unknown date, the outcome of the numbness and cramp were unknown.   It was unknown if the reporter considered the numbness and cramp to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-Sep-2022 Reporter's comment: This case was self reported by the patient.  The patient reported that received first dose of Shingrix vaccine on left arm. The patient was also administered with Tet vaccine in the right arm on the same day when patient got the Shingrix vaccine.  The patient reported that 1 or 2 months after the vaccine had numbness and cramps in hands and legs.  The patient reported that it was from below the knee.  The patient reported that using Magnesium powder and this had helped.  No all information was available.  Lot and expiration date were unknown.  No additional information was provided.  The reporter did not consent to follow up.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only the liquid diluent portion of Menveo used.; Only the liquid diluent administered; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA722Z, expiry date 31st August 2023) for prophylaxis. This case was associated with a product complaint.   On 29th September 2022, the patient received Menveo. On 29th September 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 29-SEP-2022 Reporter's Comment: The reporter reported that a possible 7 patients having received only the liquid diluent portion of Menveo. The reporter consented to follow up. Additional Supportive Information: The reporter reported that a possible 7 patients having received only the liquid diluent portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This was 1 of 7 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2022140222:Same reporter- Patient 2 US-GSK-US2022140223:Same reporter- Patient 3 US-GSK-US2022140225:Same reporter- Patient 4 US-GSK-US2022140231:Same reporter- Patient 5 US-GSK-US2022140233:Same reporter- Patient 6 US-GSK-US2022140243:Same reporter- Patient 7
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product complaint, Product preparation issue
Clinical narrative: Pharmaceutical product complaint; Only the liquid diluent portion of Menveo used; Only the liquid diluent administered; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA722Z, expiry date 31st August 2023) for prophylaxis. This case was associated with a product complaint.   On 29th September 2022, the patient received Menveo. On 29th September 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt Date: 29-SEP-2022 Reporter's Comment: The reporter reporting a possible 7 patients having received only the liquid diluent portion of Menveo. The reporter consented to follow up. Additional Supportive Information: The reporter reporting a possible 7 patients having received only the liquid diluent portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This was 1 of 7 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2022140220:Same reporter- Patient 1 US-GSK-US2022140223:Same reporter- Patient 3 US-GSK-US2022140225:Same reporter- Patient 4 US-GSK-US2022140231:Same reporter- Patient 5 US-GSK-US2022140233:Same reporter- Patient 6 US-GSK-US2022140243:Same reporter- Patient 7
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Pharmaceutical product complaint; Only  liquid diluent portion of Menveo used; Only the liquid diluent administered; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA27Z, expiry date 31st August 2023) for prophylaxis. This case was associated with a product complaint.   On 29th September 2022, the patient received Menveo. On 29th September 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt Date: 29-SEP-2022 Reporter's Comment: The reporter reported a possible 7 patients having received only the liquid diluent portion of Menveo. The reporter consented to follow up. Additional Supportive Information: The patient received only the liquid diluent portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This was 1 of 7 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2022140220:Same reporter- Patient 1 US-GSK-US2022140222:Same reporter- Patient 2 US-GSK-US2022140225:Same reporter- Patient 4 US-GSK-US2022140231:Same reporter- Patient 5 US-GSK-US2022140233:Same reporter- Patient 6 US-GSK-US2022140243:Same reporter- Patient 7
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Shingrix administered after temperature excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 29-SEP-2022 Reporter's Comment: The reporter was a pharmacist. The reporter reported that the patient received Shingrix vaccine. The reporter stated that the Shingrix vaccine was exposed down to 28 Fahrenheit for 8 hours, the reporter stated that there was no prior excursions. The reporter reported that the 8 patients were administered temperature exposed Shingrix vaccines. The reporter asked about Shingrix stability and wanted to know any recommendation on revaccination. The reporter was unable to provide patient details. The reporter did not consent to follow up. Additional supportive information: The Shingrix vaccine temperature was exposed upto 28 Fahrenheit for 8 hours, which led to incorrect storage of drug. This case was 1 of 8 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2022140227:Same reporter US-GSK-US2022140234:Same reporter US-GSK-US2022140236:Same reporter US-GSK-US2022140237:Same reporter US-GSK-US2022140239:Same reporter US-GSK-US2022140240:Same reporter US-GSK-US2022140241:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Shingrix administered after temperature excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 29-SEP-2022 Reporter's Comment: The registered pharmacist reported that the patient received a dose of Shingrix vaccine, and which was exposed down to 28 Fahrenheit for 8 hours. The reporter stated that there were no prior excursions. The reporter asked about Shingrix stability and wanted to know any recommendation on revaccination. The reporter was unable to provide any vaccine or patient details at this moment. The reporter did not consent to follow up. Additional supportive information: The patient received a dose of Shingrix vaccine, and which was exposed down to 28 Fahrenheit for 8 hours, which led to incorrect storage of drug. This case was one of 8 cases reported by same reporter.; Sender's Comments:  US-GSK-US2022140235:Same reporter US-GSK-US2022140227:Same reporter US-GSK-US2022140234:Same reporter US-GSK-US2022140237:Same reporter US-GSK-US2022140239:Same reporter US-GSK-US2022140240:Same reporter US-GSK-US2022140241:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Shingrix administered after temperature excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 29-SEP-2022 Reporter's Comment: The registered pharmacist reported that the patient received a dose of Shingrix vaccine, and which was exposed down to 28 Fahrenheit for 8 hours. The reporter stated that there were no prior excursions. The reporter asked about Shingrix stability and wanted to know any recommendation on revaccination. The reporter was unable to provide any vaccine or patient details at this moment. The reporter did not consent to follow up. Additional supportive information: The patient received a dose of Shingrix vaccine, and which was exposed down to 28 Fahrenheit for 8 hours, which led to incorrect storage of drug. This case was one of 8 cases reported by same reporter.; Sender's Comments:  US-GSK-US2022140236:Same reporter US-GSK-US2022140235:Same reporter US-GSK-US2022140227:Same reporter US-GSK-US2022140234:Same reporter US-GSK-US2022140239:Same reporter US-GSK-US2022140240:Same reporter US-GSK-US2022140241:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: exposed down to 28 F, administered; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 29-SEP-2022 Reporter's Comment: The registered pharmacist reported that the patient received a dose of Shingrix vaccine, and which was exposed down to 28 Fahrenheit for 8 hours. The reporter stated that there were no prior excursions. The reporter asked about Shingrix stability and wanted to know any recommendation on revaccination. The reporter was unable to provide any vaccine or patient details at this moment. The reporter did not consent to follow up. Additional supportive information: The patient received a dose of Shingrix vaccine, and which was exposed down to 28 Fahrenheit for 8 hours, which led to incorrect storage of drug. This case was one of 8 cases reported by same reporter.; Sender's Comments:  US-GSK-US2022140237:Same reporter US-GSK-US2022140236:Same reporter US-GSK-US2022140235:Same reporter US-GSK-US2022140227:Same reporter US-GSK-US2022140234:Same reporter US-GSK-US2022140240:Same reporter US-GSK-US2022140241:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: exposed down to 28 F, administered; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 29-SEP-2022 Reporter's Comment: The registered pharmacist reported that the patient received a dose of Shingrix vaccine, and which was exposed down to 28 Fahrenheit for 8 hours. The reporter stated that there were no prior excursions. The reporter asked about Shingrix stability and wanted to know any recommendation on revaccination. The reporter was unable to provide any vaccine or patient details at this moment. The reporter did not consent to follow up. Additional supportive information: The patient received a dose of Shingrix vaccine, and which was exposed down to 28 Fahrenheit for 8 hours, which led to incorrect storage of drug. This case was one of 8 cases reported by same reporter.; Sender's Comments:  US-GSK-US2022140236:Same reporter US-GSK-US2022140239:Same reporter US-GSK-US2022140237:Same reporter US-GSK-US2022140235:Same reporter US-GSK-US2022140240:Same reporter US-GSK-US2022140227:Same reporter US-GSK-US2022140234:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: exposed down to 28 F, administered; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 29-SEP-2022 Reporter's Comment: The registered pharmacist reported that the patient received a dose of Shingrix vaccine, and which was exposed down to 28 Fahrenheit for 8 hours. The reporter stated that there were no prior excursions. The reporter asked about Shingrix stability and wanted to know any recommendation on revaccination. The reporter was unable to provide any vaccine or patient details at this moment. The reporter did not consent to follow up. Additional supportive information: The patient received a dose of Shingrix vaccine, and which was exposed down to 28 Fahrenheit for 8 hours, which led to incorrect storage of drug. This case was one of 8 cases reported by same reporter.; Sender's Comments:  US-GSK-US2022140239:Same reporter US-GSK-US2022140237:Same reporter US-GSK-US2022140235:Same reporter US-GSK-US2022140236:Same reporter US-GSK-US2022140241:Same reporter US-GSK-US2022140234:Same reporter US-GSK-US2022140227:Same reporter
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product complaint, Product preparation issue
Clinical narrative: Pharmaceutical product complaint; Only  liquid diluent portion of Menveo used; Only the liquid diluent administered; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA722Z, expiry date 31st August 2023) for prophylaxis. This case was associated with a product complaint.   On 29th September 2022, the patient received Menveo. On 29th September 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt Date: 29-SEP-2022 Reporter's Comment: The reporter reporting a possible 7 patients having received only the liquid diluent portion of Menveo. The reporter consented to follow up. Additional Supportive Information: The reporter reporting a possible 7 patients having received only the liquid diluent portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This was 1 of 7 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2022140220:Same reporter- Patient 1 US-GSK-US2022140223:Same reporter- Patient 3 US-GSK-US2022140222:Same reporter- Patient 2 US-GSK-US2022140231:Same reporter- Patient 5 US-GSK-US2022140233:Same reporter- Patient 6 US-GSK-US2022140243:Same reporter- Patient 7
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product complaint, Product preparation issue
Clinical narrative: Pharmaceutical product complaint; Only liquid diluent portion of Menveo used; Only the liquid diluent administered; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA722Z, expiry date 31st August 2023) for prophylaxis. This case was associated with a product complaint.   On 29th September 2022, the patient received Menveo. On 29th September 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt Date: 29-SEP-2022 Reporter's Comment: The reporter reporting a possible 7 patients having received only the liquid diluent portion of Menveo. The reporter consented to follow up. Additional Supportive Information: The reporter reporting a possible seven patients having received only the liquid diluent portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This was 1 of 7 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2022140220:Same reporter- Patient 1 US-GSK-US2022140222:Same reporter- Patient 2 US-GSK-US2022140225:Same reporter- Patient 4 US-GSK-US2022140223:Same reporter- Patient 3 US-GSK-US2022140233:Same reporter- Patient 6 US-GSK-US2022140243:Same reporter- Patient 7
Age: 34.0
Sex: M
Vaccine: UNK
Symptoms: Accidental exposure to product, Exposure via skin contact, Incorrect dose administered
Clinical narrative: unsure received any of the vaccine; squirted on patient's arm; squirted on patient's arm; This case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a 34-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th September 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 28th September 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact 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: 29-Sep-2022 Reporter's comment: The healthcare professionals reported that needle felt blocked and the Flulaval squirted on the patient's arm.  The healthcare professionals was unsure if patient received any of the vaccine. The healthcare professionals stated that no issue with the PFS, they had notified the manufacturer of the needles due to previous issues.  There was no product quality complaint noted. The reporter consented to follow up. The follow-up was not possible as per the process convention. Additional Supportive Information: The needle felt blocked and the Flulaval squirted on the patient's arm, which led to incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product complaint, Product preparation issue
Clinical narrative: Pharmaceutical product complaint; Only  liquid diluent portion of Menveo used; Only the liquid diluent administered; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA722Z, expiry date 31st August 2022) for prophylaxis. This case was associated with a product complaint.   On 29th September 2022, the patient received Menveo. On 29th September 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt Date: 29-SEP-2022 Reporter's Comment: The reporter reporting a possible 7 patients having received only the liquid diluent portion of Menveo. The reporter consented to follow up. Additional Supportive Information: The reporter reporting a possible seven patients having received only the liquid diluent portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This was 1 of 7 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2022140220:Same reporter- Patient 1 US-GSK-US2022140231:Same reporter- Patient 5 US-GSK-US2022140222:Same reporter- Patient 2 US-GSK-US2022140225:Same reporter- Patient 4 US-GSK-US2022140223:Same reporter- Patient 3 US-GSK-US2022140243:Same reporter- Patient 7
Age: 17.0
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered, Incorrect dose administered, Product preparation issue
Clinical narrative: Pharmaceutical product complaint; 7 patients having received only the liquid diluent portion of Menveo; 7 patients having received only the liquid diluent portion of Menveo; 7 patients had received only the liquid diluent portion of Menveo; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old patient who received Men ACWY-CRM NVS (Menveo) (batch number amva722z, expiry date 31st August 2022) for prophylaxis. This case was associated with a product complaint.   On 29th September 2022, the patient received Menveo. On 29th September 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication, inappropriate dose of vaccine administered and expired vaccine used. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered, expired vaccine used and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt Date: 29-Sep-2022 Reporter's comment: The nurse reported that a possible 7 patients had received only the liquid diluent portion of Menveo.  The healthcare professional consents to safety team for follow up. These case was 7 out of 7 patient. The consent to follow up was granted. Additional Supportive Information: The nurse reported that a possible 7 patients had received only the liquid diluent portion of Menveo, which led to inappropriate preparation of medication, inappropriate dose of vaccine administered and expired vaccine used.; Sender's Comments:  US-GSK-US2022140223:Same reporter- Patient 3 US-GSK-US2022140233:Same reporter- Patient 6 US-GSK-US2022140231:Same reporter- Patient 5 US-GSK-US2022140222:Same reporter- Patient 2 US-GSK-US2022140225:Same reporter- Patient 4 US-GSK-US2022140220:Same reporter- Patient 1
Sex: U
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: received only one dose a year ago; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (The  patient who received only one dose of Twinrix a year ago.).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-SEP-2022 Reporter's Comments: The reporter stated that a patient who received only one dose of Twinrix a year prior to the reporting. The reporter did not consent to follow-up. Additional Supportive Information: The did not received 2nd dose which lead to incomplete course of vaccination.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: COVID-19, Incomplete course of vaccination
Clinical narrative: delayed in second dose due to covid infection; she developed COVID/Covid infection; This case was reported by a consumer via call center representative and described the occurrence of covid-19 in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 23rd March 2022, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. In July 2022, 4 months after receiving Shingrix, the patient experienced covid-19. On an unknown date, the patient experienced incomplete course of vaccination. The patient was treated with antivirals for systemic use (nos) (Oral Antivirals Nos). On an unknown date, the outcome of the covid-19 was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.     Additional Information: GSK receipt date: 29-Sept-2022 Reporter's comment: The patient had received a dose of Shingrix and about four months later she developed Covid infection which was treated with an oral antiviral. The patient mentioned that she has not yet received her second dose of Shingrix.  The patient had nothing else to report. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination. The second dose of coded as suspect with incomplete course of vaccination event as real event's outcome was reported as recovered.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Arthralgia, Back pain, Chills, Cough, Fatigue
Clinical narrative: Coughing; fingers joints hurt, joint pain; headache; Back hurts; Chills; pain; Fever; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of cough in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID-19 BOOSTER) for prophylaxis.   On 28th September 2022, the patient received Flu vaccine and COVID-19 BOOSTER. In September 2022, less than a week after receiving Flu vaccine, the patient experienced cough, pain in joint involving hand, headache, back pain, chills, pain, fever and fatigue. The patient was treated with guaifenesin (Mucinex). On an unknown date, the outcome of the cough, pain in joint involving hand, headache, back pain, chills, pain, fever and fatigue were recovering/resolving.   It was unknown if the reporter considered the cough, pain in joint involving hand, headache, back pain, chills, pain, fever and fatigue to be related to Flu vaccine.     Additional Information: GSK Receipt Date: 29-SEP-2022 Reporter's comment: The patient self-reported this case. The patient received dose of Flu and Covid booster shot and experienced coughing, fingers joints hurt, headache, back hurts, chills and pain. The patient also experienced fatigue, joint pain and fever. The patient took Mucinex to alleviate the cough.  The patient felt better today (on the day of reporting). Reporter provided limited information. The reporter did not consent to follow-up. Note: As the patient felt better today(day of reporting), outcome of all events captured accordingly. Additional supportive information:  It was unknown if the reporter considered the cough, pain in joint involving hand, headache, back pain, chills, pain, fever and fatigue to be related to Covid booster vaccine.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Coughing; fingers joints hurt, joint pain; headache; Back hurts; Chills; pain; Fever; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of cough in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID-19 BOOSTER) for prophylaxis.   On 28th September 2022, the patient received Flu vaccine and COVID-19 BOOSTER. In September 2022, less than a week after receiving Flu vaccine, the patient experienced cough, pain in joint involving hand, headache, back pain, chills, pain, fever and fatigue. The patient was treated with guaifenesin (Mucinex). On an unknown date, the outcome of the cough, pain in joint involving hand, headache, back pain, chills, pain, fever and fatigue were recovering/resolving.   It was unknown if the reporter considered the cough, pain in joint involving hand, headache, back pain, chills, pain, fever and fatigue to be related to Flu vaccine.     Additional Information: GSK Receipt Date: 29-SEP-2022 Reporter's comment: The patient self-reported this case. The patient received dose of Flu and Covid booster shot and experienced coughing, fingers joints hurt, headache, back hurts, chills and pain. The patient also experienced fatigue, joint pain and fever. The patient took Mucinex to alleviate the cough.  The patient felt better today (on the day of reporting). Reporter provided limited information. The reporter did not consent to follow-up. Note: As the patient felt better today(day of reporting), outcome of all events captured accordingly. Additional supportive information:  It was unknown if the reporter considered the cough, pain in joint involving hand, headache, back pain, chills, pain, fever and fatigue to be related to Covid booster vaccine.
Age: 55.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Incorrect dose administered, Injection site erythema, Product preparation issue
Clinical narrative: redness at injection site/localized reaction at injection site; only gave adjuvant portion; only gave adjuvant portion; This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 55-year-old male patient who received Herpes zoster (Shingrix) (batch number NF442, expiry date 5th October 2022) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) for prophylaxis.   On 27th September 2022, the patient received Shingrix and FluLaval Quadrivalent 2022-2023 season. On 27th September 2022, less than a day after receiving Shingrix and FluLaval Quadrivalent 2022-2023 season, the patient experienced injection site erythema, inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the injection site erythema, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix and FluLaval Quadrivalent 2022-2023 season.   Additional Information: GSK Receipt Date: 29-SEP-2022 and 30-SEP-2022 Reporter's Comment: The reporter reported that, one of our nurse was giving a Shingrix vaccine and only gave vial, adjuvant portion of the vaccine. we had reported it within our health system.  The patient experienced a localized reaction and redness at injection site. The reporter reported administration of Flulaval at same time as Shingrix vaccine in a different arm.  The reporter consented to follow up. Additional Supportive Information: The reporter reported that, one of our nurse was giving a Shingrix vaccine and only gave vial, adjuvant portion of the vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No Adverse event; administered 0.25ml of the Moderna bivalent booster dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (administered 0.25ml of the Moderna bivalent booster dose) and NO ADVERSE EVENT (No Adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 05-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (administered 0.25ml of the Moderna bivalent booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (administered 0.25ml of the Moderna bivalent booster dose) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        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 ACCIDENTAL UNDERDOSE (administered 0.25ml of the Moderna bivalent booster dose).    No concomitant medications were reported.  Pharmacy technician reported to administered 0.25ml of the Moderna bivalent booster dose to a patient on 05-Oct-2022. Lot number was 057F22A and expiration date (30 days use by) 24-Nov-2022.  No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: No adverse Event; Nurse is not sure which vial administered 60 days ago; This spontaneous case was reported by a nurse and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Nurse is not sure which vial administered 60 days ago) and NO ADVERSE EVENT (No adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051C22A) for COVID-19 vaccination.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Nurse is not sure which vial administered 60 days ago). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse Event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Nurse is not sure which vial administered 60 days ago) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        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 CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Nurse is not sure which vial administered 60 days ago).    No concomitant medications was reported.  Reporter states that one of their nurses gave a vaccine about 60 days ago, After 31-AUG-2022, but she placed the wrong label on the record.  No treatment information was provided.   Reporter did not allow further contact