chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Accidental underdose, Product complaint, Regurgitation
Clinical narrative: Tasted very bad, appeared oily; Not able to swallow full dose; Not able to swallow full dose; This non-serious case was reported by a nurse via sales rep and described the occurrence of regurgitation of medication in a 9-week-old male patient who received Rota (Rotarix lyophilized formulation) (batch number SKBYL9YN) for prophylaxis. This case was associated with a product complaint.   On 17-APR-2023, the patient received Rotarix lyophilized formulation. On 17-APR-2023, less than a day after receiving Rotarix lyophilized formulation, the patient experienced regurgitation of medication (Verbatim: Not able to swallow full dose) and accidental underdose (Verbatim: Not able to swallow full dose). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: Tasted very bad, appeared oily). The outcome of the regurgitation of medication was not reported and the outcome of the accidental underdose and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.  It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator 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: 21-APR-2023 and 25-APR-2023 The patient was not able to swallow full dose of Rotarix liquid due to spitting out. It was observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth. The patient did not receive a second dose.  The patient made face as if it tasted too bad to swallow. The patient previously had used Rotarix vial presentation and had no problems. The reporter agreed to follow up from GlaxoSmithKline.  The patient was not able to swallow full dose of Rotarix liquid due to spitting out and observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth , which led to accidental underdose and pharmaceutical product complaint. This was 1 of 12 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR059808:Same reporter US-GSK-US2023AMR059807:Same reporter US-GSK-US2023AMR059645:Same reporter US-GSK-US2023AMR059644:Same reporter US-GSK-US2023AMR058971:Same reporter US-GSK-US2023AMR060400:Same reporter US-GSK-US2023AMR060460:Same reporter US-GSK-US2023AMR060463:Same reporter US-GSK-US2023AMR060491:Same reporter US-GSK-US2023AMR060460:Same reporter US-GSK-US2023AMR060400:Same reporter US-GSK-US2023AMR059808:Same reporter US-GSK-US2023AMR060497:Same reporter US-GSK-US2023060947:Same reporter. FU1 - deleted US-GSK-US2023AMR058971:Same reporter
Age: 0.25
Sex: M
Vaccine: RV1
Symptoms: Accidental underdose, Product complaint, Regurgitation
Clinical narrative: Not able to swallow full dose; Tasted very bad, appeared oily; SWALLOW FULL DOSE DUE TO SPITTING OUT; This non-serious case was reported by a nurse via sales rep and described the occurrence of regurgitation of medication in a 3-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number SKBYL9YN) for prophylaxis. This case was associated with a product complaint.   On 07-APR-2023, the patient received Rotarix lyophilized formulation. On 07-APR-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced accidental underdose (Verbatim: Not able to swallow full dose) and pharmaceutical product complaint (Verbatim: Tasted very bad, appeared oily). In APR-2023, the patient experienced regurgitation of medication (Verbatim: SWALLOW FULL DOSE DUE TO SPITTING OUT). The outcome of the regurgitation of medication was not reported and the outcome of the accidental underdose and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.     It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator 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: 21-APR-2023 The patient was not able to swallow full dose of Rotarix liquid due to spitting out. It was observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth. The patient did not receive a second dose.  The patient made face as if it tasted too bad to swallow. The patient previously had used Rotarix vial presentation and had no problems. The reporter agreed to follow up from GlaxoSmithKline.  The patient was not able to swallow full dose of Rotarix liquid due to spitting out and observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth, which led to accidental underdose and pharmaceutical product complaint. This was 1 of 12 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR058971:Same reporter US-GSK-US2023AMR059644:Same reporter US-GSK-US2023AMR059645:Same reporter US-GSK-US2023AMR059807:Same reporter US-GSK-US2023AMR059808:Same reporter US-GSK-US2023AMR060400:Same reporter US-GSK-US2023AMR060460:Same reporter US-GSK-US2023AMR060463:Same reporter US-GSK-US2023AMR060476:Same reporter US-GSK-US2023AMR060491:Same reporter US-GSK-US2023AMR060516:Same reporter US-GSK-US2023AMR060516:Same reporter US-GSK-US2023060947:Same reporter. FU1 - deleted US-GSK-US2023AMR058971:Same reporter
Age: 0.42
Sex: M
Vaccine: RV1
Symptoms: Accidental underdose, Product complaint, Regurgitation
Clinical narrative: Not able to swallow full dose; Tasted very bad, appeared oily; SWALLOW FULL DOSE DUE TO SPITTING OUT; This non-serious case was reported by a nurse via sales rep and described the occurrence of regurgitation of medication in a 5-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number SKBYL9YN) for prophylaxis. This case was associated with a product complaint.   On 12-APR-2023, the patient received Rotarix lyophilized formulation. On 12-APR-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced accidental underdose (Verbatim: Not able to swallow full dose) and pharmaceutical product complaint (Verbatim: Tasted very bad, appeared oily). In APR-2023, the patient experienced regurgitation of medication (Verbatim: SWALLOW FULL DOSE DUE TO SPITTING OUT). The outcome of the regurgitation of medication was not reported and the outcome of the accidental underdose and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.     It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator 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: 21-APR-2023 The patient was not able to swallow full dose of Rotarix liquid due to spitting out. It was observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth. The patient did not receive a second dose.  The patient made face as if it tasted too bad to swallow. The patient previously had used Rotarix vial presentation and had no problems. The reporter agreed to follow up from GlaxoSmithKline.  The patient was not able to swallow full dose of Rotarix liquid due to spitting out and observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth, which led to accidental underdose and pharmaceutical product complaint. This was 1 of 12 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR058971:Same reporter US-GSK-US2023AMR059644:Same reporter US-GSK-US2023AMR059645:Same reporter US-GSK-US2023AMR059807:Same reporter US-GSK-US2023AMR059808:Same reporter US-GSK-US2023AMR060400:Same reporter US-GSK-US2023AMR060460:Same reporter US-GSK-US2023AMR060463:Same reporter US-GSK-US2023AMR060476:Same reporter US-GSK-US2023AMR060491:Same reporter US-GSK-US2023AMR060497:Same reporter US-GSK-US2023AMR060497:Same reporter US-GSK-US2023060947:Same reporter. FU1 - deleted US-GSK-US2023AMR058971:Same reporter
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 59-year-old patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number 57GJ2) for prophylaxis.   On 27-JAN-2023, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap Vaccine, the patient experienced incorrect storage of drug (Verbatim: Received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 62-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 01-MAR-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incorrect storage of drug (Verbatim: Received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: 3rd Singrix given; Shingrix given instead of Twinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number YC5Y7, expiry date 25-OCT-2024) for prophylaxis.   On 17-APR-2023, the patient received the 3rd dose of Shingrix (left deltoid). On 17-APR-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: 3rd Singrix given) and wrong vaccine administered (Verbatim: Shingrix given instead of Twinrix). The outcome of the extra dose administered and wrong vaccine administered were unknown.   Additional Information: GSK Receipt Date: 18-APR-2023 The medical assistant reported on 18th April 2023 that patient received a 3rd dose of Shingrix by mistake when Twinrix was supposed to be given due to ending of names sound similar. The reporter wanted to know do GlaxoSmithKline have safety information. The Vaccine Administration Facility is the same as Primary Reporter. The patient was given Shingrix instead of Twinrix which led to wrong vaccine administered. The patient received 3rd dose of Shingrix which led to extra dose administered. This case was identified as duplicate of US2023056786. Case US2023056786 was deleted and all the future correspondence will be added in the present case US2023056785 which stands as a case of record for this patient. The reporter did not consent to follow-up.; Sender's Comments:  US-GSKCCFUS-Case-01680571_AE-94793:FU 1 -Deleted
Sex: U
Vaccine: VARZOS
Symptoms: Intercepted product prescribing error
Clinical narrative: has received a few prescriptions to repeat Shingrix series; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in an unspecified number of patients who did not received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (The patients had already completed the Shingrix series).   On an unknown date, the patient did not receive Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced intercepted drug prescribing error (Verbatim: has received a few prescriptions to repeat Shingrix series). The outcome of the intercepted drug prescribing error was unknown.   Additional Information: GSK Receipt Date: 19-APR-2023. The pharmacist stated that her pharmacy had received a few prescriptions to repeat Shingrix series in patients that had already completed the series.   The pharmacist reported that she believed the patients are usually around 3 years out from completion of the series.   The pharmacist did not had any patient information at the time of reporting.   She did not known the number of patients, she stated that they receive a couple here and there, it's an occasional thing.   No repeat doses had been administered. The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Muscle spasms, Nausea
Clinical narrative: nausea; muscle spasms in arms, legs, thumb, felt like collapse; Injection site pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included rash.   On 18-APR-2023 09:30, the patient received Shingrix (intramuscular, unknown deltoid). On 18-APR-2023, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: Injection site pain). On 18-APR-2023 16:30, the patient experienced muscle spasm (Verbatim: muscle spasms in arms, legs, thumb, felt like collapse). On 19-APR-2023, the patient experienced nausea (Verbatim: nausea). The patient was treated with ibuprofen (Motrin). The outcome of the injection site pain, muscle spasm and nausea were not resolved.   It was unknown if the reporter considered the injection site pain, muscle spasm and nausea to be related to Shingrix.     It was unknown if the company considered the injection site pain, muscle spasm and nausea to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-APR-2023 The reporter was the patient, received vaccine yesterday at 9:30 am at her pharmacy. Seven hours after vaccination at 4:30pm the patient experienced muscle spasms in her arms and legs and felt like she would collapse due to the spasms. On the day of reporting the patient had muscle spasms in her thumb. In the evening, prior to the GSK receipt date, the patient had pain at the injection site which was not recovered. On the day of reporting, the patient had nausea, which was not recovered. The pharmacist advised the patient to take treatment with Motrin for pain. No more details was report. The reporter consented to follow up. This case is linked with US2023057558, for the same reporter.; Sender's Comments:  US-GSK-US2023057558:Same reporter
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Electromyogram normal, Feeling abnormal
Clinical narrative: she is miserable; legs started burning, knees burning down to ankles, Still burning; This non-serious case was reported by a consumer via call center representative and described the occurrence of burning sensation in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 04-MAR-2023, the patient received the 1st dose of Shingrix (right arm). In MAR-2023, 3 days after receiving Shingrix, the patient experienced burning sensation (Verbatim: legs started burning, knees burning down to ankles, Still burning). On an unknown date, the patient experienced feeling miserable (Verbatim: she is miserable). The patient was treated with gabapentin and capsaicin (Capsaicin Cream). The outcome of the burning sensation was not resolved and the outcome of the feeling miserable was not reported.   It was unknown if the reporter considered the burning sensation and feeling miserable to be related to Shingrix.     It was unknown if the company considered the burning sensation and feeling miserable to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-APR-2023 and  21-APR-2023  The patient received Shingrix and after three days legs started burning, burning in both knees all the way down to ankles. They were still burning and cause her to feel this 24 hours a day. It was very hard on her. The patient turn 81 next month. her internist prescribed that she take gabapentin 300mg three times daily. Every week the dosage increases. So far it was not helping at all. The burning was not subsided, and she was miserable. On 20th April 2023 the patient went neurologist and did eletromicrogram, result showed nerves were okay. Today (on the day of reporting), the patient reported that the burning was not as bad but still was burning all the time. The patient begun to use Capsaicin cream for the burning and continuing the use of Gabapentin, which was not helpful. The patient would see internist on coming Tuesday. The patient did not pan on getting the second dose of Shingrix. The reporter consented to follow up.
Age: 59.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired Twinrix administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 59-year-old female patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 01-JAN-2023) for prophylaxis.   On 18-APR-2023, the patient received the 2nd dose of Twinrix. On 18-APR-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: Expired Twinrix administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-APR-2023 The Nurse reported that patient received their second dose of Twinrix and the dose was expired. The reporter consented to follow up. The patient received an expired dose of Twinrix, which led to expired vaccine used.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 19/Sep/2022, no 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received first dose on 19 September 2022).   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: 1st dose 19/Sep/2022, no 2nd dose 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: 19-Apr-2023 The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive second dose of Twinrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patients come after 6 months for their 2nd doses; This non-serious case was reported by a other health professional via sales rep and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patients did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patients experienced incomplete course of vaccination (Verbatim: Patients come after 6 months for their 2nd doses). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 19-Apr-2023 The reporter would like information around the 2nd doses Shingrix data outside of the 2 to 6 months interval. The patients were coming back after 6 months for their 2nd doses of Shingrix and the nursing team wants to know  if the series must be re-started. The vaccine administration facility was the same as primary reporter. No additional information available and unknown if follow up was permissible. Till the time of reporting, the patients did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: patient received 3 doses of Shingrix; This non-serious case was reported by a physician via sales rep and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an  unknown date) and Shingrix (2nd dose received on an  unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: patient received 3 doses of Shingrix). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 20-APR-2023 The sales representative submitted the following via system for a physician that if a patient received 3 doses of Shingrix, what should be done and was there anything that they should look out for? The reporter consented to follow up with sales representative for more information. The patient received 3 doses of Shingrix, which led to extra dose administered.
Age: 0.83
Sex: U
Vaccine: HIBV
Symptoms: Extra dose administered, Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Hiberix was administered to a 10 month old patient; Hiberix was administered to a 10 month old patient; This non-serious case was reported by a medical representative via call center representative and described the occurrence of inappropriate age at vaccine administration in a 10-month-old patient who received Hib (Hiberix) for prophylaxis.   Previously administered products included Hiberix (patient had already finished the Hiberix series and received final dose on 06 January 2023).   On 19-APR-2023, the patient received Hiberix. On 19-APR-2023, an unknown time after receiving Hiberix, the patient experienced inappropriate age at vaccine administration (Verbatim: Hiberix was administered to a 10 month old patient) and drug dose administration interval too short (Verbatim: Hiberix was administered to a 10 month old patient). The outcome of the inappropriate age at vaccine administration and drug dose administration interval too short were unknown.   Additional Information: GSK receipt date: 19-Apr-2023 and 20-Apr-2023 The patient accidently administered an extra dose of Hib vaccine(unknown). The patient had already finished the Hiberix series, and received final dose on 06 January 2023.  The representative did not have any additional patient information, and did not have the vaccine lot number or expiration date. The representative reported the vaccine facility was located in zip code. The medical information would be following up with the healthcare provider to provide requested medical information.  Any updates to adverse event obtained would be sent to safety in a separate email. The adverse event came in via afterhours voicemail by sales representative. There were no other information available. The 10 months patient accidently received an extra dose of Hiberix vaccine which led to inappropriate age at vaccine administration and drug dose administration interval too short.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pain
Clinical narrative: injection site soreness; Achiness at bed time; chills; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19-APR-2023, the patient received the 2nd dose of Shingrix. On 19-APR-2023, immediately after receiving Shingrix, the patient experienced injection site pain (Verbatim: injection site soreness), pain (Verbatim: Achiness at bed time) and chills (Verbatim: chills). The outcome of the injection site pain, pain and chills were not resolved.   It was unknown if the reporter considered the injection site pain, pain and chills to be related to Shingrix.     It was unknown if the company considered the injection site pain, pain and chills to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-APR-2023 The patient self-reported this case. The patient asked about side effects of Shingrix.  The injection site soreness began shortly after the injection and the chills and achiness began at bedtime last night. They continued on the day of reporting. The reporter did not consent to follow-up.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Menveo without reconstitution; Only liquid portion was administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA732A, expiry date 31-OCT-2023) for prophylaxis.   On 18-APR-2023, the patient received Menveo. On 18-APR-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Menveo without reconstitution) and inappropriate dose of vaccine administered (Verbatim: Only liquid portion was administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 20-APR-2023 The pharmacist reported that a patient received a dose of Menveo without reconstitution, only the liquid portion was administered. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. The patient received Menveo liquid portion only without reconstitution, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 15.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Interchange of vaccine products
Clinical narrative: 1st dose of bexsero, 2nd dose trumenba; This non-serious case was reported by a physician via call center representative and described the occurrence of interchange of vaccine products in a 15-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On 07-MAR-2023, the patient received the 1st dose of Bexsero. On 07-APR-2023, the patient received TRUMENBA. On an unknown date, an unknown time after receiving Bexsero, the patient experienced interchange of vaccine products (Verbatim: 1st dose of bexsero, 2nd dose trumenba). The outcome of the interchange of vaccine products was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 14-MAR-2023 The physician reported that a patient received a dose of Bexsero followed up with Trumenba.  No symptoms were reported. The reporter did not have date of birth, lot and expiry at the time of report.  The reporter consented to follow-up via any route. The patient received Bexsero and then Trumenba, which led to interchange of vaccine products. This case was linked with case US2023058295, reported by same reporter.; Sender's Comments:  US-GSK-US2023058295:Same reporter/Other patient
Sex: F
Vaccine: MENB, MENB
Symptoms: Interchange of vaccine products
Clinical narrative: 1st dose of bexsero, 2nd dose trumenba; This non-serious case was reported by a physician via call center representative and described the occurrence of interchange of vaccine products in a 15-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On 07-MAR-2023, the patient received the 1st dose of Bexsero. On 07-APR-2023, the patient received TRUMENBA. On an unknown date, an unknown time after receiving Bexsero, the patient experienced interchange of vaccine products (Verbatim: 1st dose of bexsero, 2nd dose trumenba). The outcome of the interchange of vaccine products was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-APR-2023 The reporter reported that the patient received one dose of Bexsero vaccine on 7th March 2023 and followed up with Trumenba vaccine on 7th April 2023. The patient did not had symptoms. The vaccine administration facility was the same as primary reporter. This case had been linked with US2023058294 by same reporter for different patient.  The patient was administered with Trumenba vaccine after Bexsero, which led to interchange of vaccine products.; Sender's Comments:  US-GSK-US2023058294:Same reporter/Other patient
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Vaccine adjuvant without active component; Received vaccine adjuvant without active component; 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 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 477X5, expiry date 27-MAY-2024) for prophylaxis.   On 20-APR-2023, the patient received the 1st dose of Shingrix. On 20-APR-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Vaccine adjuvant without active component) and inappropriate dose of vaccine administered (Verbatim: Received vaccine adjuvant without active component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 20-APR-2023 The reporter reported that the patient received Shingrix vaccine adjuvant without active component. The reporter did consent to follow up. The reporter gave by error Shingrix adjuvant portion only ,which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case had been linked with US2023058300 and US2023AMR058824 by same reporter for different patient.; Sender's Comments:  US-GSK-US2023058300:Same reporter/Other patient US-GSK-US2023AMR058824:Same reporter/Batch case
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose not received yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 2nd March 2022).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 2nd dose not received yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 20-APR-2023 The patient was self-reported this case. The patient reported that he did not received second dose of Shingrix vaccine but planned to receive the vaccine. The patient did not reported anything else. The reporter did not consent to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Vaccine adjuvant without active component; Received vaccine adjuvant without active component; 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 56-year-old male patient who received Herpes zoster (Shingrix) (batch number 477X5, expiry date 27-MAY-2024) for prophylaxis.   On 20-APR-2023, the patient received the 1st dose of Shingrix. On 20-APR-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Vaccine adjuvant without active component) and inappropriate dose of vaccine administered (Verbatim: Received vaccine adjuvant without active component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 20-APR-2023 The reporter reported that the patient received Shingrix vaccine adjuvant without active component. The reporter did consent to follow up. The reporter gave by error Shingrix adjuvant portion only ,which led to inappropriate preparation of medication and inappropriate dose of vaccine administered This case had been linked with US2023058298 and US2023AMR058824 by same reporter for different patient.; Sender's Comments:  US-GSK-US2023058298:Same reporter/Other patient US-GSK-US2023AMR058824:Same reporter/Batch case
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Adult received Pediatric dose; Adult received Pediatric dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 24-year-old female patient who received HBV (Engerix B pediatric) (batch number 25N39, expiry date 16-MAR-2024) for prophylaxis.   On 19-APR-2023, the patient received Engerix B pediatric. On 19-APR-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Adult received Pediatric dose) and adult use of a child product (Verbatim: Adult received Pediatric dose). 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: 20-Apr-2023 The pharmacist asked that how to proceed. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. An adult patient received an pediatric dose of Engerix-B, which led to underdose and adult use of a child product.
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 21 month old received Kinrix; 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 21-month-old female patient who received DTPa-IPV (Kinrix) (batch number G9N2M, expiry date 14-APR-2024) for prophylaxis.   On 19-APR-2023, the patient received Kinrix. On 19-APR-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 21 month old received Kinrix). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 20-APR-2023 The nurse reported inadvertent administration of Kinrix to a 21 month old child.  The vaccine administration facility was the same as primary reporter.  The date of outcome listed as 20th April 2023 was date first reported to GSK.  No additional adverse event details were available at that time per reporter. The reporter consented to follow up. The 21 month old patient received Kinrix, which led to inappropriate age at vaccine administration.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 2018, 2nd in 2022; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose around 2018).   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 drug dose administration interval too long (Verbatim: 1st dose 2018, 2nd in 2022). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 20-Apr-2023 The nurse called to inform that a patient received the 2nd dose in 2022. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient received the 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: Possible late dose, more than 6 months; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date).   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: Possible late dose, more than 6 months). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 20-Apr-2023 The physician reported that possible late dose of Shingrix greater than 6 months. No additional adverse event details were available. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Age: 0.83
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: 10 month old received Kinrix; Received Kinrix instead of 3rd DTap-IPV; 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 10-month-old male patient who received DTPa-IPV (Kinrix) (batch number 25zh4, expiry date 27-OCT-2024) for prophylaxis.   On 20-APR-2023, the patient received Kinrix. On 20-APR-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 10 month old received Kinrix) and inappropriate schedule of vaccine administered (Verbatim: Received Kinrix instead of 3rd DTap-IPV). The outcome of the inappropriate age at vaccine administration and inappropriate schedule 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: 20-APR-2023 The nurse stated that a patient inadvertently received Kinrix for their third dose of DTaP and IPV.  The reporter consented to follow up via email. The 10 month old patient received Kinrix instead of third dose of DTaP and IPV, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered.
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered
Clinical narrative: accidently administered a 4th dose of Pediarix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 10-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 25L32, expiry date 28-MAR-2025) for prophylaxis.   On 19-APR-2023, the patient received the 4th dose of Pediarix. On 19-APR-2023, an unknown time after receiving Pediarix, the patient experienced extra dose administered (Verbatim: accidently administered a 4th dose of Pediarix). The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-APR-2023 The reporter was medical assistant. The reporter was consented to follow up via email or phone.  The patient was accidently administered a 4th dose of Pediarix, which led to extra dose administered.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Possible late 2nd dose of Shingrix; This non-serious case was reported by a physician via sales rep and described the occurrence of inappropriate schedule of vaccine administered in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On 20-APR-2023, the patient received the 2nd dose of Shingrix. On 20-APR-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: Possible late 2nd dose of Shingrix). The outcome of the inappropriate schedule of vaccine administered was unknown.   Additional Information: GSK Receipt Date: 20-APR-2023 The physician reported possible late 2nd dose of Shingrix.  The vaccine administration facility was the same as primary reporter. The sales representative reported on behalf of physician.  No additional adverse event details available. The patient received possible late 2nd dose of Shingrix, which led to inappropriate schedule of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the 1st dose in June 2022 and has not yet returned to get the 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in June 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: received the 1st dose in June 2022 and has not yet returned to get the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 20-APR-2023 The reporter asked if received one dose of Shingrix and did not go back/ not yet returned to get the 2nd dose of Shingrix, how did you proceed. The reporter consented to follow up via email. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 39.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Pediatric dose given to adult; Pediatric dose given to adult; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 39-year-old female patient who received HAV (Havrix 720) (batch number 2X2EJ, expiry date 14-OCT-2024) for prophylaxis.   On 20-APR-2023, the patient received the 1st dose of Havrix 720. On 20-APR-2023, an unknown time after receiving Havrix 720, the patient experienced underdose (Verbatim: Pediatric dose given to adult) and adult use of a child product (Verbatim: Pediatric dose given to adult). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 21-APR-2023 The reporter was a medical assistant. The reporter reported that the adult patient received pediatric dose of Havrix vaccine. The reporter did consent to follow up. The adult patient was administered a pediatric dose of Havrix, which led to underdose and adult use of a child product. This case had been linked with US2023058972 by same reporter for different patient.; Sender's Comments:  US-GSK-US2023058972:Same reporter
Age: 6.0
Sex: U
Vaccine: TDAP, TDAP
Symptoms: Incomplete course of vaccination, Product administered to patient of inappropriate age
Clinical narrative: 6 year old received Dtap; TDap at 7 year old, now 10 year old 2nd dose not yet; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 10-year-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   Previously administered products included TDap (1st dose received on an unknown date at 7 year old).   On an unknown date, the patient received Boostrix and the 2nd dose of Tdap Vaccine. On an unknown date, an unknown time after receiving Boostrix and not applicable after receiving Tdap Vaccine, the patient experienced inappropriate age at vaccine administration (Verbatim: 6 year old received Dtap) and incomplete course of vaccination (Verbatim: TDap at 7 year old, now 10 year old 2nd dose not yet). The outcome of the inappropriate age at vaccine administration and incomplete course of vaccination were unknown.   Additional Information: GSK Receipt Date: 21-APR-2023 The healthcare professional reported that for a patient on a catch up schedule, given a Dtap at 6 years old, and then TDap at 7 years old.  The reporter wanted to verify TDap is appropriate to give again at the age recommended at 10 years old however centers for disease control catch up schedule states 7 year old can get TDap. The patient received a dose of Boostrix at an inappropriate age, which led to inappropriate age at vaccine administration. Till the time of reporting, the patient did not receive 2nd dose of TDap, which led to incomplete course of vaccination.
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired Twinrix administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 64-year-old female patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 01-JAN-2023) for prophylaxis.   On 20-MAR-2023, the patient received Twinrix. On 20-MAR-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: Expired Twinrix administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-APR-2023 The reporter called to report that an expired dose of Twinrix was accidentally given to a patient and wished to know how to proceed.  The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  The reporter called to report that an expired dose of Twinrix was accidentally given to a patient, which led to expired vaccine used.