chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 via call center representative and described the occurrence of incorrect storage of drug in a 64-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 03-JAN-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
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 via call center representative and described the occurrence of incorrect storage of drug in a 63-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 04-JAN-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
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 60-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 11-JAN-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
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 50-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 11-JAN-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
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 59-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 17-JAN-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
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 55-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 18-JAN-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
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 53-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 20-JAN-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
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 50-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 23-JAN-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
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 55-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 24-JAN-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
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 65-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 24-JAN-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
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: OK to get another Shangrix, even if we got it 6 years ago; This non-serious case was reported by a consumer and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 6 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: OK to get another Shangrix, even if we got it 6 years ago). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 19-APR-2023 The case was reported by patient. The reporter stated that six years ago patient had a shingles vaccination but we did not remember which one or where she got the shingles vaccination.  The reporter stated that it was okay to get another Shingrix, even if it was Shingrix that she received six years ago. The reporter also asked how many years after having Shingrix and the booster she need to get the series again or it would give permanent immunity to shingles. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The case had been linked to US2023AMR058073, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023AMR058073:Same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: OK to get another Shangrix, even if we got it 6 years ago; This non-serious case was reported by a consumer 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 (received 1st dose of Shingrix 6 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: OK to get another Shangrix, even if we got it 6 years ago). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 19-APR-2023 The case was reported by patient's wife. The reporter stated that six years ago patient had a shingles vaccination but we did not remember which one or where we got the shingles vaccination.  The reporter stated that it was okay to get another Shingrix, even if it was Shangrix that he received six years ago. The reporter also asked how many years after having Shingrix and the booster he need to get the series again or it would give permanent immunity to shingles. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The case had been linked to US2023AMR058045, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023AMR058045:Same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: 2 diluent mixed as single dose; 2 diluent mixed and administered; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: 2 diluent mixed as single dose) and inappropriate dose of vaccine administered (Verbatim: 2 diluent mixed and administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 19-APR-2023 The reporter stated that 2 doses of Shingrix diluent mixed and given instead of 1 of each of the 2 parts.  No adverse events were reported when nurse followed up with patient.  The dose was repeated. The reporter stated that 2 doses of Shingrix diluent mixed and given instead of 1 of each of the 2 parts, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
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 via call center representative and described the occurrence of incorrect storage of drug in a 81-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 03-FEB-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-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 via call center representative 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 24-JAN-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-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 via call center representative and described the occurrence of incorrect storage of drug in a 63-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 25-JAN-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-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 via call center representative and described the occurrence of incorrect storage of drug in a 58-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 30-JAN-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-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 via call center representative and described the occurrence of incorrect storage of drug in a 55-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 31-JAN-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-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 via call center representative and described the occurrence of incorrect storage of drug in a 57-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 31-JAN-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-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 via call center representative and described the occurrence of incorrect storage of drug in a 61-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 01-FEB-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-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 via call center representative 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 30-JAN-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-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 25-JAN-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 Shingles vaccine temperature excursion was exposed and patient received unstable vaccine, which led to incorrect storage of drug. This case was 1 of 169 cases for the patient reported by same reporter. The reporter did consent to follow up. This case had been linked with US2023054677 and US2023AMR055743 by same reporter for different patient.; 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 57-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 27-JAN-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
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 60-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 07-FEB-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 Shingles vaccine temperature excursion was exposed and patient received unstable vaccine, which led to incorrect storage of drug. This case was 1 of 169 cases for the patient reported by same reporter. The reporter did consent to follow up. This case had been linked with US2023054677 and US2023AMR055743 by same reporter for different patient.; 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 64-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 06-FEB-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
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 81-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 03-FEB-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: 1.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: 15 month old got Kinrix; Patient received Kinrix as their 3rd dose; 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 15-month-old male patient who received DTPa-IPV (Kinrix) (batch number G9N2M, expiry date 14-APR-2024) for prophylaxis.   Previously administered products included Pentacel (dose received on 22th April 2022) and Vaxelis (dose received on 23rd February 2023).   On 24-MAR-2023, the patient received Kinrix. On 24-MAR-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 15 month old got Kinrix) and inappropriate schedule of vaccine administered (Verbatim: Patient received Kinrix as their 3rd dose). 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 14-APR-2023 The reporter reported that the 15 months old patient received Kinrix vaccine due for DTaP and IPV as their third dose. The reporter did consent to follow up. The patient received Kinirix who was younger than the indicated age which led to inappropriate age at vaccine administration. The patient received Kinirix as a third dose of DTaP and IPV series which led to inappropriate schedule of vaccine administered.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, IPV
Symptoms: Incorrect dose administered
Clinical narrative: Pediarix and Ipol given on same day; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 4-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 9552X, expiry date 26-OCT-2024) for prophylaxis.   Co-suspect products included POLIO VACCINE (IPOL) for prophylaxis.   On 13-APR-2023, the patient received Pediarix and IPOL. On 13-APR-2023, an unknown time after receiving Pediarix, the patient experienced overdose (Verbatim: Pediarix and Ipol given on same day). The outcome of the overdose 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: 18-APR-2023 The reporter was a clinic manager. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up via postal. The patient received Pediarix and Ipol Polio vaccine on the same day, which led to overdose.
Sex: M
Vaccine: MENB
Symptoms: Circumstance or information capable of leading to medication error, Product administered to patient of inappropriate age
Clinical narrative: Consider administering Bexsero to a 62 YO; Consider administering Bexsero to a 62 YO; 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 62-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient did not receive Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: Consider administering Bexsero to a 62 YO) and circumstance or information capable of leading to medication error (Verbatim: Consider administering Bexsero to a 62 YO). The outcome of the inappropriate age at vaccine administration and circumstance or information capable of leading to medication error 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: 14-APR-2023 The reporter did not consent to follow-up. No vaccine details or date because event had not happened yet. No initials for the patient reported. The nurse was considering administering the patient with Bexero at the age of 62 years, which led to inappropriate age at vaccine administration and circumstance or information capable of leading to medication error.
Sex: U
Vaccine: VARZOS
Symptoms: Product dose omission issue, Social problem
Clinical narrative: Several patients miss the 2nd dose due to COVID-19 pandemic; This non-serious case was reported by a other health professional via call center representative and described the occurrence of social problem in an unspecified number of patients 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 received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced social problem (Verbatim: Several patients miss the 2nd dose due to COVID-19 pandemic). The outcome of the social problem was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The pharmacy technician stated that at the time of reporting, the reporter did not had any of the patient/ dosing information available. The reporter did not want her personal information in database, but states it is fine to follow-up with a pharmacist if needed by fax, phone, or mail. The reporter consented to follow-up. The case was linked with case US2023AMR055920, reported by same reporter. The several patients missed the 2 to 6 months dosing window for the second dose due to Covid-19 pandemic, which led to social problem.; Sender's Comments:  US-GSK-US2023AMR055920:Same reporter.
Age: 56.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: expired Havrix administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 56-year-old male patient who received HAV (Havrix) (batch number H4H53, expiry date 30-JAN-2023) for prophylaxis.   On 14-APR-2023, the patient received Havrix. On 14-APR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: expired Havrix administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-APR-2023 The reporter reported that expired Havrix administered. The reporter given consent for safety follow up. The reporter reported that expired Havrix administered, which led to expired vaccine used.
Sex: U
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: hurts during injection; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced injection site pain (Verbatim: hurts during injection). The outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the injection site pain to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-APR-2023 The reporter asked if information on why Bexsero hurts during injection
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Pain in extremity
Clinical narrative: sore arm; 2nd dose not administered yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the did not receive 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm (Verbatim: sore arm) and incomplete course of vaccination (Verbatim: 2nd dose not administered yet). The outcome of the pain in arm and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.   It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-APR-2023 The reporter reported that at least one patient was late for their second dose of Shingrix due to a sore arm.  The reporter declined to provide more information. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only  adjuvant portion; received only  adjuvant portion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: received only  adjuvant portion) and inappropriate dose of vaccine administered (Verbatim: received only  adjuvant portion). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 17-APR-2023 The pharmacist reported a patient received only the adjuvant portion of the Shingrix vaccine The reporter consented to follow up.  The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case is linked with US2023AMR056653, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR056653:same reporter
Age: 76.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 5/18/2022, 2nd dose on 4/11/2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 76-year-old female patient who received HAB (Twinrix) (batch number H3SG9, expiry date 03-JAN-2025) for prophylaxis.   Previously administered products included Twinrix (received first dose on 18th May 2022 of lot number: lot number: 4F3YY and expiration date: 1st January 2023).   On 11-APR-2023, the patient received the 2nd dose of Twinrix. On 11-APR-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose on 5/18/2022, 2nd dose on 4/11/2023). 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: GSK receipt date: 17-Apr-2023 The pharmacist wants to know how to proceed with Twinrix third dose. The reporter consented to follow-up by email. The patient received second dose of Twinrix later than the recommended interval, which led to lengthening of vaccine schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose a year ago, forgot to get 2nd; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received first dose one year ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose a year ago, forgot to get 2nd). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date:17-APR-2023 The reporter stated that the patient forgot to get second dose.  The reporter asked that how did she know if she has immunity or there was a lab test she can do since missed the window for second dose. The management requested for submission. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to Incomplete course of vaccination.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only adjuvant administered; Only adjuvant administered; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate dose of vaccine administered in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number XL7RB, expiry date 05-AUG-2024) for prophylaxis.   On 28-MAR-2023, the patient received the 1st dose of Shingrix (left arm). On 28-MAR-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered (Verbatim: Only adjuvant administered) and inappropriate preparation of medication (Verbatim: Only adjuvant administered). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK Receipt Date: 18-APR-2023 The reporter reported regarding the maladministration of the Shingrix adjuvant to the patient. The sales rep shared HCP´s contact information and mentioned that HCP wanted to know when they could give a proper reconstituted dose of Shingrix. The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at injection site, admitted to the hospital; This serious case was reported by a other health professional via call center representative and described the occurrence of injection site cellulitis in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In MAR-2023, the patient received Shingrix (intramuscular, unknown deltoid). In MAR-2023, 6 days after receiving Shingrix, the patient experienced injection site cellulitis (Verbatim: Cellulitis at injection site, admitted to the hospital) (serious criteria hospitalization). The patient was treated with antibiotics nos (Antibiotics Iv (Drug Name Unknown)). The outcome of the injection site cellulitis was resolved.   It was unknown if the reporter considered the injection site cellulitis to be related to Shingrix.     It was unknown if the company considered the injection site cellulitis to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-APR-2023 The reporter who was physician's office manager reported that a patient received shingrix in early March 2023 and 6 days after vaccination she developed cellulitis at the injection site (cellulitis, recovered).  The patient was admitted to the hospital for a few days and was treated with IV antibiotics. No further information was reported. The reporter gave consent to follow-up.; Sender's Comments:  US-GSK-US2023056835:Same reporter
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose: pre-covid, 2nd dose: 18-APR-2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number 9372K, expiry date 05-AUG-2024) for prophylaxis.   Previously administered products included Shingrix (1st dose received in pre covid  (february or march)).   On 18-APR-2023, the patient received the 2nd dose of Shingrix. On 18-APR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose: pre-covid, 2nd dose: 18-APR-2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 18-APR-2023 Lot number and expiration was for the second shot of the vaccine series.  The reporter consented to follow up. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: M
Vaccine: VARZOS
Symptoms: Rectal haemorrhage
Clinical narrative: Rectal bleeding; This serious case was reported by a consumer via call center representative and described the occurrence of rectal bleeding in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-MAR-2023, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced rectal bleeding (Verbatim: Rectal bleeding) (serious criteria GSK medically significant). The outcome of the rectal bleeding was not resolved.   It was unknown if the reporter considered the rectal bleeding to be related to Shingrix.     It was unknown if the company considered the rectal bleeding to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-APR-2023. The consumer reported that he had a Shingrix vaccination administered at the first of March 2023.  The consumer reported that he was now having rectal bleeding.   No further information was known. The reporter did not consent to follow up. The consumer declined to provide consent, Doctor of medicine name, phone number, as well, his date of birth and address.   The reporter stated that he did not want his information out there.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Accidental exposure to product, Exposure via skin contact, Incorrect dose administered, Syringe issue
Clinical narrative: vaccine leaked out; vaccine leaked out on patient's arm; vaccine leaked out on patient's arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 53-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number B32NG, expiry date 13-JUN-2025) for prophylaxis.   On 19-APR-2023, the patient received the 1st dose of Boostrix. On 19-APR-2023, an unknown time after receiving Boostrix, the patient experienced incomplete dose administered (Verbatim: vaccine leaked out), exposure via skin contact (Verbatim: vaccine leaked out on patient's arm) and inadvertent exposure to vaccine (Verbatim: vaccine leaked out on patient's arm). The outcome of the incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine were unknown.   Additional Information: GSK receipt date: 19-Apr-2023 The pharmacist was wondering if they need to revaccinate the patient. The reporter consented to follow-up. The patient was recently injected with Boostrix but the vaccine leaked out on the patient's arm which led to incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine.