chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: the vaccine may be already expired at the moment of vaccination; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number ED2EN, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th January 2018, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 29th January 2018, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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: 10-Aug-2022 Reporter's comments: A medical assistant provided a lot number of Boostrix vaccine because a patient was administered with the vaccine and the vaccine might be already expired at the moment of vaccination. The consent to follow up was granted. Additional Supportive Information: As patient received expired vaccine, which led to expired vaccine used.
Sex: M
Vaccine: DTAP
Symptoms: Extra dose administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Infanrix instead of Boostrix; Infanrix administered to patinet older than 10 YO; had 5 Dtaps prior to this shot.; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a adolescent male patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10th June 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Dtap vaccine (received 5 doses of Dtap vaccines prior to this shot).   On an unknown date, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered, inappropriate age at vaccine administration and extra dose administered. On an unknown date, the outcome of the wrong vaccine administered, inappropriate age at vaccine administration and extra dose 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: 10-Aug-2022 Reporter's comment: The patient already had 5 Dtaps vaccines prior to the shot. The nurse reported that the patient received Infanrix instead of Boostrix. The reporter consented to follow-up by email. Additional supportive information: The patient received Infanrix instead of Boostrix at inappropriate age after 5 Dtap vaccines, which led to wrong vaccine used and inappropriate age at vaccine administration and extra dose administered. In worst approach, inappropriate age at vaccine administration event was coded as patient was older than 10 years and for the same follow-up request was raised.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ABXD34AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 10th August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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: 10-AUG-2022 Reporter's comment: The nurse reported that a patient received a ten days expired dose of Bexsero. The reporter consented to follow up. Additional supportive information: The patient had received an expired dose of Bexsero, which led to expired vaccine used.
Sex: M
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: got another dose in June before waiting 6 months.; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a male patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS VACCINE ACELLULAR + TETANUS VACCINE TOXOID (INFANRIX).   On 18th June 2022, the patient received the 4th dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 18th June 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short 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: 11-AUG-2022 Reporter's Comments: The nurse practitioner reported that a patient was on a catch up schedule and received a 3rd dose of Infanrix in March and got another dose in June before waiting 6 months. The reporter consent to follow up. The HCP (Health care professional) did not had the patient details and HCP believed the dose was given on 18th June 2022. Additional supportive information: The patient received the Infanrix dose earlier than the recommended interval, which led to shortening of vaccination schedule.
Sex: U
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: dose expired 2 days before administration; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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: 11-Aug-2022 Reporter's comment: The pharmacist intern reported that Twinrix was administered a patient (unknown data) and the dose had expired 2 days before the administration date (vaccine lot number and expiration date unknown, vaccination date unknown). The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. Additional supportive information: The patient received an expired dose of Twinrix, which led to expired vaccine used. The case was linked with case US2022116460, reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2022116460:Same reporter
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Administered after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 21-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number TR292, expiry date 3rd November 2025) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th August 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 12-Aug-2022 Reporter's comment: The medical assistant stating that refrigerator temperature log indicated out of range temperatures for Boostrix.   The lowest recorded was 3.7 degrees Celsius and the highest was 9.2 degrees Celsius one day before the vaccination (for 48 minutes).   This case is for 1 out of 10 linked patients reported by same reporter. Additional supportive information: The patient received Boostrix after temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2022118616:Same reporter. US-GSK-US2022118615:Same reporter. US-GSK-US2022118614:Same reporter. US-GSK-US2022118613:Same reporter. US-GSK-US2022118612:Same reporter. US-GSK-US2022118572:Same reporter. US-GSK-US2022118571:Same reporter. US-GSK-US2022118570:Same reporter. US-GSK-US2022118569:Same reporter.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Administered after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 28-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number TR292, expiry date 3rd November 2025) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th August 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 12-Aug-2022 Reporter's comment: The medical assistant stating that refrigerator temperature log indicated out of range temperatures for Boostrix.   The lowest recorded was 3.7 degrees Celsius and the highest was 9.2 degrees Celsius one day before the vaccination (for 48 minutes).   This case is for 2 out of 10 linked patients reported by same reporter. Additional supportive information: The patient received Boostrix after temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2022118568:Same reporter. US-GSK-US2022118570:Same reporter. US-GSK-US2022118571:Same reporter. US-GSK-US2022118572:Same reporter. US-GSK-US2022118612:Same reporter. US-GSK-US2022118613:Same reporter. US-GSK-US2022118614:Same reporter. US-GSK-US2022118615:Same reporter. US-GSK-US2022118616:Same reporter.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Administered after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 51-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number TR292, expiry date 3rd November 2025) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th August 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 12-Aug-2022 Reporter's comment: The medical assistant stating that refrigerator temperature log indicated out of range temperatures for Boostrix.   The lowest recorded was 3.7 degrees Celsius and the highest was 9.2 degrees Celsius one day before the vaccination (for 48 minutes).   This case is for 3 out of 10 linked patients reported by same reporter. Additional supportive information: The patient received Boostrix after temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2022118568:Same reporter. US-GSK-US2022118569:Same reporter. US-GSK-US2022118572:Same reporter US-GSK-US2022118570:Same reporter. US-GSK-US2022118571:Same reporter. US-GSK-US2022118616:Same reporter. US-GSK-US2022118615:Same reporter. US-GSK-US2022118614:Same reporter. US-GSK-US2022118613:Same reporter.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Administered after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 41-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number TR292, expiry date 3rd November 2025) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th August 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 12-Aug-2022 Reporter's comment: The medical assistant stating that refrigerator temperature log indicated out of range temperatures for Boostrix.   The lowest recorded was 3.7 degrees Celsius and the highest was 9.2 degrees Celsius one day before the vaccination (for 48 minutes).   This case is for 4 out of 10 linked patients reported by same reporter. Additional supportive information: The patient received Boostrix after temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2022118569:Same reporter. US-GSK-US2022118568:Same reporter. US-GSK-US2022118571:Same reporter. US-GSK-US2022118572:Same reporter. US-GSK-US2022118612:Same reporter. US-GSK-US2022118613:Same reporter. US-GSK-US2022118614:Same reporter. US-GSK-US2022118615:Same reporter. US-GSK-US2022118616:Same reporter.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Administered after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 40-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number TR292, expiry date 3rd November 2025) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th August 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 12-Aug-2022 Reporter's comment: The medical assistant stating that refrigerator temperature log indicated out of range temperatures for Boostrix.   The lowest recorded was 3.7 degrees Celsius and the highest was 9.2 degrees Celsius one day before the vaccination (for 48 minutes).   This case is for 5 out of 10 linked patients reported by same reporter. Additional supportive information: The patient received Boostrix after temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2022118612:Same reporter. US-GSK-US2022118569:Same reporter. US-GSK-US2022118572:Same reporter US-GSK-US2022118570:Same reporter. US-GSK-US2022118568:Same reporter. US-GSK-US2022118571:Same reporter. US-GSK-US2022118614:Same reporter. US-GSK-US2022118615:Same reporter. US-GSK-US2022118616:Same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Administered after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a adult female patient who received Herpes zoster (Shingrix) (batch number LG3B4, expiry date 8th April 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 12-Aug-2022 Reporter's comment: The medical assistant stating that refrigerator temperature log indicated out of range temperatures for Shingrix.   The lowest recorded was 3.7 degrees Celsius and the highest was 9.2 degrees Celsius on 7th August 2022 (for 48 minutes).   This case is for 6 out of 10 linked patients reported by same reporter. Additional supportive information: The patient received Shingrix after temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2022118569:Same reporter. US-GSK-US2022118570:Same reporter. US-GSK-US2022118568:Same reporter. US-GSK-US2022118572:Same reporter. US-GSK-US2022118612:Same reporter. US-GSK-US2022118613:Same reporter. US-GSK-US2022118614:Same reporter. US-GSK-US2022118615:Same reporter. US-GSK-US2022118616:Same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Administered after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a adult female patient who received Herpes zoster (Shingrix) (batch number LG3B4, expiry date 8th April 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 12-Aug-2022 Reporter's comment: The medical assistant stating that refrigerator temperature log indicated out of range temperatures for Shingrix.   The lowest recorded was 3.7 degrees Celsius and the highest was 9.2 degrees Celsius on 7th August 2022 (for 48 minutes).   This case is for 7 out of 10 linked patients reported by same reporter. Additional supportive information: The patient received Shingrix after temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2022118568:Same reporter. US-GSK-US2022118569:Same reporter. US-GSK-US2022118570:Same reporter. US-GSK-US2022118571:Same reporter. US-GSK-US2022118616:Same reporter US-GSK-US2022118615:Same reporter US-GSK-US2022118614:Same reporter US-GSK-US2022118613:Same reporter US-GSK-US2022118612:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Administered after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a adult female patient who received Herpes zoster (Shingrix) (batch number LG3B4, expiry date 8th April 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 12-Aug-2022 Reporter's comment: The medical assistant stating that refrigerator temperature log indicated out of range temperatures for Shingrix.   The lowest recorded was 3.7 degrees Celsius and the highest was 9.2 degrees Celsius on 7th August 2022 (for 48 minutes).   This case is for 8 out of 10 linked patients reported by same reporter. Additional supportive information: The patient received Shingrix after temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2022118570:Same reporter. US-GSK-US2022118568:Same reporter. US-GSK-US2022118613:Same reporter. US-GSK-US2022118572:Same reporter US-GSK-US2022118612:Same reporter. US-GSK-US2022118571:Same reporter. US-GSK-US2022118569:Same reporter. US-GSK-US2022118616:Same reporter. US-GSK-US2022118615:Same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Administered after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a adult male patient who received Herpes zoster (Shingrix) (batch number LG3B4, expiry date 8th April 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 12-Aug-2022 Reporter's comment: The medical assistant stating that refrigerator temperature log indicated out of range temperatures for Shingrix.   The lowest recorded was 3.7 degrees Celsius and the highest was 9.2 degrees Celsius on 7th August 2022 (for 48 minutes).   This case is for 9 out of 10 linked patients reported by same reporter. Additional supportive information: The patient received Shingrix after temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2022118614:Same reporter. US-GSK-US2022118570:Same reporter. US-GSK-US2022118568:Same reporter. US-GSK-US2022118613:Same reporter. US-GSK-US2022118572:Same reporter US-GSK-US2022118612:Same reporter. US-GSK-US2022118571:Same reporter. US-GSK-US2022118569:Same reporter. US-GSK-US2022118616:Same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Administered after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a adult male patient who received Herpes zoster (Shingrix) (batch number LG3B4, expiry date 8th April 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 12-Aug-2022 Reporter's comment: The medical assistant stating that refrigerator temperature log indicated out of range temperatures for Shingrix.   The lowest recorded was 3.7 degrees Celsius and the highest was 9.2 degrees Celsius on 7th August 2022 (for 48 minutes).   This case is for 10 out of 10 linked patients reported by same reporter. Additional supportive information: The patient received Shingrix after temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2022118614:Same reporter. US-GSK-US2022118570:Same reporter. US-GSK-US2022118615:Same reporter. US-GSK-US2022118568:Same reporter. US-GSK-US2022118613:Same reporter. US-GSK-US2022118612:Same reporter. US-GSK-US2022118569:Same reporter. US-GSK-US2022118571:Same reporter. US-GSK-US2022118572:Same reporter
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 11feb2022, 2nd 14mar2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 71-year-old male patient who received Herpes zoster (Shingrix) (batch number 2NT5L, expiry date 12th May 2023) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 14th March 2022, the patient received the 2nd dose of Shingrix. On 14th March 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 12-AUG-2022 Reporter's comment: The registered pharmacist reported that the patient received second dose of Shingrix 31 days later the first dose of Shingrix. The pharmacist inquired should they revaccinate the patient. The doses not two months apart. Registered pharmacist confirmed the second dose was administered at their facility but not the first dose.  The reporter did not consent to follow up. Additional Supportive Information: The patient received second dose of Shingrix, earlier than the recommended interval, which led to shortening of vaccination schedule.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: expired Bexsero dose administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB36AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 11th August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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: 12-AUG-2022 Reporter's Comments: The medical assistant called to inquire about how to proceed. The medical assistant reported that an expired Bexsero dose was administered to the patient. The medical assistant confirmed that the vaccine was administered in their facility. The reporter did not consent to follow up. Additional Supportive Information: Expired Bexsero dose was administered to the patient which led to expired vaccine used.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Twinrix on 16-Jun-2022, Heplisav-B 22-Jul-2022; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 62-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (HEPLISAV-B) and HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 12-Aug-2022 Reporter's comment: The pharmacist reported that a patient received one dose of Twinrix and a dose of Heplisav-B. The reporter consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Twinrix (for Hepatitis-A), which led to incomplete course of vaccination.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Thrombosis
Clinical narrative: INJECTION SITE SWELLING; THROMBOSIS IN LEFT ARM; This spontaneous report received from a patient concerned a 63 year old female of an unspecified race and ethnicity. Initial information was processed along with the additional information received on 16-AUG-2022. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 total administered on 01-APR-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drug included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for drug used for unknown indication. Age at time of vaccination 63 years old. No concomitant medications were reported.  On APR-2021, the patient experienced thrombosis (Blood clot) in left arm. On JUN-2022, the patient experienced injection site swelling. The latency between covid-19 vaccine and swelling was reported as 14 months. On an unspecified date in 2021, the patient experienced pain from blood clot in left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable, and action taken with adalimumab was not reported. The patient recovered from injection site swelling on JUN-2022, and the outcome of thrombosis in left arm was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220826101-covid-19 vaccine ad26.cov2.s- Thrombosis in left arm. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered related.
Age: 0.67
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product leakage
Clinical narrative: No adverse event; Large size fluid leaked out on baby's skin immediately after first shot; vaccine leaked out and might not have received a full dose; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT LEAKAGE (Large size fluid leaked out on baby's skin immediately after first shot), INCORRECT DOSE ADMINISTERED (vaccine leaked out and might not have received a full dose) and NO ADVERSE EVENT (No adverse event) in an 8-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2022, the patient experienced PRODUCT LEAKAGE (Large size fluid leaked out on baby's skin immediately after first shot) and INCORRECT DOSE ADMINISTERED (vaccine leaked out and might not have received a full dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT LEAKAGE (Large size fluid leaked out on baby's skin immediately after first shot), INCORRECT DOSE ADMINISTERED (vaccine leaked out and might not have received a full dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drugs were not reported. It was reported that the baby was crying as soon as the HCP held in arm, even before injection and had no other side effects. It was also reported that after receiving the vaccine, a large size fluid leaked-out on patient's skin. Treatment medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Felt sick) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Felt sick) and CHILLS (Chills). At the time of the report, MALAISE (Felt sick) and CHILLS (Chills) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medications were reported. No treatment information was provided. Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (administer the vaccine to two patients, after leaving  it at a room temperature on the 19Jul2022) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 prophylaxis. No Medical History information was reported. On 20-Jul-2022 at 9:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2022 at 9:30 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (administer the vaccine to two patients, after leaving  it at a room temperature on the 19Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (administer the vaccine to two patients, after leaving  it at a room temperature on the 19Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for POOR QUALITY PRODUCT ADMINISTERED (administer the vaccine to two patients, after leaving  it at a room temperature on the 19Jul2022).  This case contains information on 2nd of two pediatric patients as described by the reporter.  No concomitant medications were provided. HCP had a temperature excursion of 24 hours at room temperature of a vial for the 6 months to 5 years of age on 20-Jul-2022 they administer the vaccine to two patients, after leaving it at a room temperature on the 19Jul2022. It was unknown if the vial was initially stored in the refrigerator. Date and time vial was first punctured is 19Jul2022 at 9:45am. Vial did not undergo any temperature excursions. The vial was stored in Room temperature post puncture. Amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was 24hours. It was unknown, the vial was exposed to room temperature for more than 24 hours. No treatment information was given.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator 14-Jul-2022 morning and was on refrigerator the entire time.; No adverse event; Vial was in refrigerator all the time prior to administration; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vial was in refrigerator all the time prior to administration), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 14-Jul-2022 morning and was on refrigerator the entire time.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056A22A) for COVID-19 prophylaxis. No Medical History information was reported. In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vial was in refrigerator all the time prior to administration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 14-Jul-2022 morning and was on refrigerator the entire time.) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vial was in refrigerator all the time prior to administration), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 14-Jul-2022 morning and was on refrigerator the entire time.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Vial was in refrigerator all the time prior to administration) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 14-Jul-2022 morning and was on refrigerator the entire time.). No concomitant medications were reported. It was reported that the patient received expired booster dose of vaccine in between 22-Jul-2022 to 02-Aug-2022. Number of doses and vials that were affected were 8 doses from 2 vials. The vial was initially stored in the refrigerator on 14-Jul-2022. The vial did not undergo any temperature excursions. The vial was in refrigerator throughout the entire time. No treatment details was reported.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered greater then 12 hours post puncture), PRODUCT STORAGE ERROR (The vial was stored at room temperature post puncture/vial exposed to room temperature for about 24 hours) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B22A) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Pfizer booster) on 06-Nov-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2022 at 9:30 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2022 at 9:30 AM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered greater then 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored at room temperature post puncture/vial exposed to room temperature for about 24 hours) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered greater then 12 hours post puncture), PRODUCT STORAGE ERROR (The vial was stored at room temperature post puncture/vial exposed to room temperature for about 24 hours) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered greater then 12 hours post puncture) and PRODUCT STORAGE ERROR (The vial was stored at room temperature post puncture/vial exposed to room temperature for about 24 hours). No relevant concomitant medications were reported. Date the vial was initially stored in the refrigerator was 04-Aug-2022. Date and time vial was first punctured was 10-Aug-2022 at 9:06 AM. The vial was stored at room temperature post puncture. The vial did not undergo any temperature excursions. The vial was exposed to room temperature range (8° to 25°C equals to 46° to 77°F) for about 24 hours. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time; No adverse event; Vial was in refrigerator all the time prior to administration; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vial was in refrigerator all the time prior to administration), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056A22A) for COVID-19 prophylaxis. No Medical History information was reported. In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vial was in refrigerator all the time prior to administration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vial was in refrigerator all the time prior to administration), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Vial was in refrigerator all the time prior to administration) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time). Case was created for 3rd of 8 adult patients. No concomitant medication was reported by reporter. Total 2 vials and 8 doses were affected. Vial did not undergo any temperature excursion and were in refrigerator the entire time. 4 patients were administered on 22-Jul-2022 and 4 patients on 2-Aug-2022. No treatment medication was reported by reporter.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vial was in refrigerator all the time prior to administration), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056A22A) for COVID-19 prophylaxis. No Medical History information was reported. In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vial was in refrigerator all the time prior to administration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was in refrigerator the entire time) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vial was in refrigerator all the time prior to administration), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was in refrigerator the entire time) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Vial was in refrigerator all the time prior to administration) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was in refrigerator the entire time). This case was created for 4th of 8 adult patients by the reporter. No concomitant medications were provided by the reporter. Total 2 vials and 8 doses were affected. Vial did not undergo any temperature excursion and the vial was initially stored in refrigerator on 14-Jul-2022 and the vial were in refrigerator the entire time. 4 patients were administered on 22-Jul-2022 and 4 patients on 2-Aug-2022. No treatment information were provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took second booster dose a month early) and NO ADVERSE EVENT (No adverse event) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took second booster dose a month early). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took second booster dose a month early) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took second booster dose a month early). No concomitant medication information was provided. Patient was given a Moderna COVID-19 booster shot today. They had given her second booster thinking this was first. They found out later that this patient has already received their first booster. This in turn meant they gave her Moderna COVID-19 second booster dose a month early. Most patient information and vaccination information was unknown. The patient did not experienced any side effects. There was no allergies. No COVID positive test or diagnosis. Expiration of the first Moderna COVID-19 vaccine was reported as unknown. Lot number of the second Moderna COVID-19 vaccine was reported as unknown. Expiration of the second Moderna COVID-19 vaccine was reported as unknown. Lot number of the first Moderna COVID-19 booster vaccine was reported as unknown. Expiration of the first Moderna COVID-19 booster vaccine was reported as unknown. Lot number of the second Moderna COVID-19 booster vaccine was reported as unknown. Expiration of the second Moderna COVID-19 booster vaccine was reported as unknown. No treatment medication were provided.