chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Subdural haematoma, Unresponsive to stimuli
Clinical narrative: Patient is a 60 y.o. male with a PMH of Bipolar, Anxiety/Depression, Chronic back pain (Morphine pump), HTN, PVD/Stent, CAD/MI, HLD, COPD, OSA, bladder cancer, anemia, and GERD who presented to facility on 12/28/2022 as a transfer from an facility with an Isodense Right Subdural Hematoma (Traumatic) and Acute-on-Chronic Hypoxic/Hypercarbic Respiratory Failure   The patient was admitted with Right SDH after a fall 3 days prior to admission in the setting of Xarelto, pletal and plavix use. His Xarelto was reversed with PCC and no surgical intervention was indicated. During his work-up his ECHO revealed an EF of 40% and he required low dose levophed to maintain goal MAP > 65. His hospital course was further complicated by acute on chronic respiratory failure due to COVID. He was requiring HHF during the day and BIPAP at night, he wears oxygen at home at baseline.  He was noted to have acute hypotension and hypoxia on 1/5/2023 around 21:05. He was unresponsive and noted to be in PEA. CPR was started, he was emergently intubated, ACLS rounds for > 20 minutes with no ROSC. A bedside ECHO showed hypodynamic cardiac function concerning for cardiogenic shock. Time of death 21:33 Family arrived to bedside and were updated.   Discharge Diagnoses:   Deceased
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Alcohol use, Blood magnesium, Cardiac flutter, Cardiac stress test normal, Chest discomfort
Clinical narrative: Email from VAERS only stated "Lot Number for Vaccine Number 1 is Missing" and I am not retyping all the information on this file that I already entered into the online system on 05FEB23. I have given all numbers and letters provided by the pharmacy on my COVID-19 Vaccination Record Card. If the number is still lacking, that is on the pharmacy unfortunately and VAERS will have to contact them to search through their records.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dizziness, Echocardiogram normal, Electrocardiogram, Electrocardiogram ambulatory normal, Lipids
Clinical narrative: Email from VAERS only stated "Lot Number for Vaccine Number 1 is Missing" and I am not retyping all the information on this file that I already entered into the online system on 05FEB23. I have given all numbers and letters provided by the pharmacy on my COVID-19 Vaccination Record Card. If the number is still lacking, that is on the pharmacy unfortunately and VAERS will have to contact them to search through their records.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Palpitations, Supraventricular tachycardia, Ventricular extrasystoles
Clinical narrative: Email from VAERS only stated "Lot Number for Vaccine Number 1 is Missing" and I am not retyping all the information on this file that I already entered into the online system on 05FEB23. I have given all numbers and letters provided by the pharmacy on my COVID-19 Vaccination Record Card. If the number is still lacking, that is on the pharmacy unfortunately and VAERS will have to contact them to search through their records.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Vaccination error
Clinical narrative: Email from VAERS only stated "Lot Number for Vaccine Number 1 is Missing" and I am not retyping all the information on this file that I already entered into the online system on 05FEB23. I have given all numbers and letters provided by the pharmacy on my COVID-19 Vaccination Record Card. If the number is still lacking, that is on the pharmacy unfortunately and VAERS will have to contact them to search through their records.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs were reported; Nurse reported that an expired VAQTA was given to a patient.  No additional AEs were reported, No further information provided.  No PQC.; This spontaneous report has been received from a nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.   On 23-JAN-2023, the patient was vaccinated with an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) intramuscular injection at a dose of 0.5 milliliter (ml) once as prophylaxis (lot number u012007 has been verified to be valid; expiration date reported and established as 18-JAN-2023) (expired product administered) (strength, route of administration, and anatomical location were not provided). No adverse effects were reported.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: A HCP called to report an AE. A patient received her third dose of GARDASIL 9 two months too early. No adverse effects were reported. The caller did not provide the date of administration so the AE onset date is marked as "Unknown". No additional inf; No adverse effects were reported; This spontaneous report as received from a medical assistant concerning a female patient of unknown age. The patient's concurrent conditions and medical history, as well as concomitant medications, were not provided.  On an unknown date, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # U039529, expiration date 09-AUG-2024)at a dose of 0.5 milliliter for prophylaxis. The reporter stated that the dose was received two months too early (inappropriate schedule of vaccine administration). No adverse event were reported.
Sex: F
Vaccine: HEPA
Symptoms: Injury associated with device, Skin laceration, Syringe issue
Clinical narrative: she was cut by the glass when the finger flange broke; HCP getting cut by the broken finger flange/ she was cut by the glass when the finger flange broke; which included "broken VAQTA/ a pre-filled syringe and the finger flange broke/ When she picked the VAQTA out of the tray the finger flange broke; This spontaneous report was received from a nurse, referring about herself as a female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 18-JAN-2023, after receiving a shipment of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (lot number W029899 was verified to be a valid number, expiration date: 16-MAY-2024), she went to store the product, when she picked the hepatitis a vaccine, inactivated (VAQTA) out of the tray the finger flange broke completely off (syringe issue); she was cut by the glass when the finger flange broke (skin laceration and injury associated with device), said it was "a thumb prick" and she needed to apply a band aid. The product was not administered. The reporter said she would set aside the product for retrieval.  At the time of reporting, the patient had recovered from the event.  The reporter did not provide a causal relationship between the events and the suspect vaccine.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: no additional AE's were reported.; patient that was administered to a patient after it expired.; the product also had a previous temperature excursion.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug allergies, reactions, or concomitant medications was not provided.  On 30-JAN-2023, the patient was vaccinated with an expired and improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23 SYRINGE (DEVICE)) injection (lot #U018309 had been verified to be a valid number; expiration date 08-JAN-2023, and upon internal validation established as the same date) for prophylaxis (dosage, vaccination scheme, frequency, route of administration, and anatomical site of injection were not reported). The administered dose of the vaccine was stored at an unknown temperature for an unknown time frame. There was not previous temperature excursion reported. There was no adverse effect reported.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; temperature excursion; This spontaneous report has been received from another reporter, concerning a 12-months-old male patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 29-DEC-2022, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, on left thigh (valid lot number W017343 [expiration date 13-DEC-2023]) (dose, vaccination scheme, and frequency were not provided) for prophylaxis, after a temperature excursion of 47.9 degrees Fahrenheit (F) for 47 minutes that occurred on 01-DEC-2022 (product storage error).  No additional adverse events (AE) were reported.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; HCP reporting VAQTA was administered after a temperature excursion; This spontaneous report has been received from a medical assistant, concerning a 12-months old male patient. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.   On 13-DEC-2022, the patient was vaccinated with improperly stored Hepatitis A Vaccine, Inactivated (VAQTA) intramuscular injection administered intramuscularly on the left thigh (lot number W023937 has been verified to be valid; expiration date reported and established as 06-DEC-2023) (strength and dose were not provided) (product storage error).  The administered dose of the vaccine was stored at a temperature of 47.9 degrees Fahrenheit (F), during a time frame of 47 minutes, as recorded by a digital data logger. There was no previous temperature excursion. There was no adverse effect reported.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other issues or concerns noted.; Medical assistance calling to report that a 2 month old female patient received an expired dose of ROTATEQ. NO PQC No follow letter Admin on 2/1/2023 No TE No other issues or concerns noted. LOT: 1742420 EXP:  Jan 31, 2023; This spontaneous report was received from a medical assistant and refers to a 2-month-old female patient.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 01-FEB-2023, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally as prophylaxis (lot number:1742420, expiration date: 31-JAN-2023; strength, dose, and frequency were not provided) (expired product administered).  No other issues or concerns were reported (no adverse event).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Arteriogram coronary abnormal, Arteriosclerosis, Arteriosclerosis coronary artery, Blood cholesterol increased
Clinical narrative: Funny taste in mouth after injection. A few hours later I felt like someone was poking my heart with a stick. It was a constant but not severe pain in a specific location in the area of my heart. The pain was consistent and lasted for about a month. After a month it came and went several times a day for about another month  and then became less frequent and tapered off in early December 2021, but I continue to have recurring pain in that region of my chest. I was in the process of moving at that time and made appointments with a new Doctor as soon as I arrived. Dr referred me to a Cardiology facility after she did an EKG. EKG showed a Right Bundle Branch block. Cardiology facility had me wear a monitor for 10 days in December 2021 and had me take a cardio stress test with ultrasound in January 2022. They then referred me to Hospital  for an MRI in March of 2022 and followed up with a Angio CT scan, also at Hospital in June of 2022. I have a Calcium score of 457 which is very high. I have told every cardiologist this story and only one has said I may have had myocarditis in 2021, but it would be impossible to know at this point. I am getting a second opinion at Clinic on May 5, 2023.   I have received two more boosters, both Moderna, the first on 5/31/2022, and the second (bivalent) on 10/10/22. Within a week of the 10/10/22 booster, I started having regular, multiple-times-a-day heart pain similar to what I experienced before, but less intense. I will file another report about that later. My heart pain has lessened significantly  and I almost never experience it. At this point I am afraid to get another booster.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Blood triglycerides increased, Bundle branch block right, Cardiac discomfort, Cardiac monitoring, Cardiac stress test
Clinical narrative: Funny taste in mouth after injection. A few hours later I felt like someone was poking my heart with a stick. It was a constant but not severe pain in a specific location in the area of my heart. The pain was consistent and lasted for about a month. After a month it came and went several times a day for about another month  and then became less frequent and tapered off in early December 2021, but I continue to have recurring pain in that region of my chest. I was in the process of moving at that time and made appointments with a new Doctor as soon as I arrived. Dr referred me to a Cardiology facility after she did an EKG. EKG showed a Right Bundle Branch block. Cardiology facility had me wear a monitor for 10 days in December 2021 and had me take a cardio stress test with ultrasound in January 2022. They then referred me to Hospital  for an MRI in March of 2022 and followed up with a Angio CT scan, also at Hospital in June of 2022. I have a Calcium score of 457 which is very high. I have told every cardiologist this story and only one has said I may have had myocarditis in 2021, but it would be impossible to know at this point. I am getting a second opinion at Clinic on May 5, 2023.   I have received two more boosters, both Moderna, the first on 5/31/2022, and the second (bivalent) on 10/10/22. Within a week of the 10/10/22 booster, I started having regular, multiple-times-a-day heart pain similar to what I experienced before, but less intense. I will file another report about that later. My heart pain has lessened significantly  and I almost never experience it. At this point I am afraid to get another booster.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiovascular disorder, Computerised tomogram coronary artery, Echocardiogram, Electrocardiogram abnormal, Hypercholesterolaemia
Clinical narrative: Funny taste in mouth after injection. A few hours later I felt like someone was poking my heart with a stick. It was a constant but not severe pain in a specific location in the area of my heart. The pain was consistent and lasted for about a month. After a month it came and went several times a day for about another month  and then became less frequent and tapered off in early December 2021, but I continue to have recurring pain in that region of my chest. I was in the process of moving at that time and made appointments with a new Doctor as soon as I arrived. Dr referred me to a Cardiology facility after she did an EKG. EKG showed a Right Bundle Branch block. Cardiology facility had me wear a monitor for 10 days in December 2021 and had me take a cardio stress test with ultrasound in January 2022. They then referred me to Hospital  for an MRI in March of 2022 and followed up with a Angio CT scan, also at Hospital in June of 2022. I have a Calcium score of 457 which is very high. I have told every cardiologist this story and only one has said I may have had myocarditis in 2021, but it would be impossible to know at this point. I am getting a second opinion at Clinic on May 5, 2023.   I have received two more boosters, both Moderna, the first on 5/31/2022, and the second (bivalent) on 10/10/22. Within a week of the 10/10/22 booster, I started having regular, multiple-times-a-day heart pain similar to what I experienced before, but less intense. I will file another report about that later. My heart pain has lessened significantly  and I almost never experience it. At this point I am afraid to get another booster.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: Funny taste in mouth after injection. A few hours later I felt like someone was poking my heart with a stick. It was a constant but not severe pain in a specific location in the area of my heart. The pain was consistent and lasted for about a month. After a month it came and went several times a day for about another month  and then became less frequent and tapered off in early December 2021, but I continue to have recurring pain in that region of my chest. I was in the process of moving at that time and made appointments with a new Doctor as soon as I arrived. Dr referred me to a Cardiology facility after she did an EKG. EKG showed a Right Bundle Branch block. Cardiology facility had me wear a monitor for 10 days in December 2021 and had me take a cardio stress test with ultrasound in January 2022. They then referred me to Hospital  for an MRI in March of 2022 and followed up with a Angio CT scan, also at Hospital in June of 2022. I have a Calcium score of 457 which is very high. I have told every cardiologist this story and only one has said I may have had myocarditis in 2021, but it would be impossible to know at this point. I am getting a second opinion at Clinic on May 5, 2023.   I have received two more boosters, both Moderna, the first on 5/31/2022, and the second (bivalent) on 10/10/22. Within a week of the 10/10/22 booster, I started having regular, multiple-times-a-day heart pain similar to what I experienced before, but less intense. I will file another report about that later. My heart pain has lessened significantly  and I almost never experience it. At this point I am afraid to get another booster.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Tem excursion of 47.9 F for 47 min on Dec. 1st 2022/ VAQTA administered after a temperature excursion.; This spontaneous report was received from a medical assistant and refers to a 2-year-old male patient.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 22-DEC-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot number W017343 was verified as valid, expiration date reported and upon internal review established as 13-DEC-2023, administered intramuscularly in the left thigh for prophylaxis (strength was not provided) after a temperature excursion that happened on 01-DEC-2022 at a temperature of 47.9 Fahrenheit degree for 47 minutes (product storage error). No additional adverse event reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2301USA009943:MSD
Age: 68.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired Twinrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 68-year-old female patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th January 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 27th January 2023, 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: 27-Jan-2023 Reporter's comment: The pharmacist stated a dose of Twinrix was dispensed to an assisted living facility where it was administered to a patient on the day of reporting.  The reporter was unsure which dose number in the series this was for the patient.   At the time of reporting, dose has not been repeated. The reporter gave permission for the follow-up. Additional supportive information: The patient received an expired dose of Twinrix, which led to expired vaccine used.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose a week apart from 1st dose; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number abxb37aa, 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.   Concomitant products included MENINGOCOCCAL B VACCINE (BEXSERO).   On 31st May 2022, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 31st May 2022, unknown after receiving Bexsero and Bexsero 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: 30-Jan-2023 Reporter's comment: The registered nurse reported that the another nurse administered the 2nd dose of Bexsero a week apart from 1st dose. The reporter consented to follow-up. Additional supportive information: The patient received the 2nd dose of Bexsero earlier than the recommended interval, which led to shortening of vaccination schedule.
Age: 30.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: administered an expired dose; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 30-year-old male patient who received HAB (Twinrix) (batch number P9LT9, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 2 doses on an unknown date).   On 30th January 2023, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 30th January 2023, 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: 30-Jan-2023 Reporter's comment: A physician reported at the time of reporting, the dose has not been repeated. The reporter gave permission for follow-up. Additional supportive information: The patient received an expired dose of Twinrix, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received 1st dose years ago, not sure if received 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose 2 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 30-Jan-2023  Reporter's comment: The pharmacist stated that she was not sure if the patient may had received the 2nd dose elsewhere but could not find it documented in the database. The reporter stated that she was getting this question more.  The reporter did not report any other patients who was late with the 2nd dose. The reporter did not know the exact date of the first dose. The reporter consented to follow-up via postal. The case was linked with case US2023AMR014484, reported by same reporter for different patients. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2023AMR014484:same reporter
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administered only the MenA component; Administered only the MenA component; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 37-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA791A, expiry date 31st January 2024) for prophylaxis.   On 30th January 2023, the patient received Menveo (intramuscular). On 30th January 2023, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 30-Jan-2023 Reporter's comment: The reporter called to reported that a staff member administered Menveo incorrectly. Only serogroup A (MenA lyophilized conjugate component (orange cap)) portion of Menveo was administered to the patient. They were asking what the next step should be and transferred to GlaxoSmithKline medical information line. The reporter consented to follow-up. Additional supportive information: The patient only received the  MenA lyophilized conjugate component (orange cap) without e MenCYW-135 liquid conjugate component (gray cap), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Received only the adjuvant; Received only the adjuvant; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 73-year-old male patient who received Herpes zoster (Shingrix) (batch number FB2BH, expiry date 26th January 2024) for prophylaxis.   On 30th January 2023, the patient received the 1st dose of Shingrix. On 30th January 2023, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 30-Jan-2023 Reporter's comment: The medical letter was read. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient was inadvertently given the adjuvant portion of Shingrix without reconstituting the lyophilized component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 19Oct2021, 2nd never; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 19th October 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 30-Jan-2023 Reporter's comment: A pharmacist was looking for additional information for patient who wants to received Shingrix second dose after recommended Shingrix schedule. The reporter declined for the follow-up. This is for 1 of 2 linked patients reported by same reporter. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2023014284:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 15Oct2021, 2nd never; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 84-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 15th October 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 30-Jan-2023 Reporter's comment: A pharmacist was looking for additional information for patient who wants to received Shingrix second dose after recommended Shingrix schedule. The reporter declined for the follow-up. This is for 2 of 2 linked patients reported by same reporter. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2023014279:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2 yars ago, 2nd not yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received Zostavax 5 to 7 years ago) and Shingrix (received first dose about 2 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 30-Jan-2023 Reporter's comment: The patient mentioned that she has not yet received her second dose, for unknown reason.  Nothing else was reported. The reporter declined to give name, date of birth. Did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Age: 54.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: 54 YO received pediatric dose; 54 YO received pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 54-year-old male patient who received HAV (Havrix 720) (batch number EP47E, expiry date 6th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th January 2023, the patient received the 1st dose of Havrix 720 and Havrix Pre-Filled Syringe Device. On 19th January 2023, unknown after receiving Havrix 720 and Havrix Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 30-Jan-2023 Reporter's comment: The medial assistant reported that the patient was inadvertently administered a pediatric dose.  This was the patient's first dose in the series.   At the time of reporting, the patient has not been re-dosed. The vaccine administration facility was the same as primary reporter. The reporter gave permission for follow-up. Additional supportive information: The adult patient received a pediatric dose of Havrix, which led to underdose and adult use of a child product.
Age: 58.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 58-year-old female patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th January 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 30th January 2023, unknown after receiving Havrix and Havrix 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: 30-Jan-2023 Reporter's comment: The medical assistant called to inquired that the patient need another one. The reporter did not consent to follow-up. Additional supportive information: The patient was inadvertently administered an expired dose of Havirx at their facility, which led to expired vaccine used.
Age: 62.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 62-year-old female patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   On 30th January 2023, the patient received Havrix. On 30th January 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 30-Jan-2023 Reporter's comment: No symptoms were reported. The reporter consented to follow-up via postal mail. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Age: 25.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Patient got an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 25-year-old female patient who received HAB (Twinrix) (batch number 4f3yy, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th January 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 19th January 2023, 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: 30-Jan-2023 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Twinrix, which led to expired vaccine used.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2020, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose in 2020).   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: 31-JAN-2023 Reporter's Comments: The pharmacist called reporting a patient received his first dose of Twinrix in 2020 and had not yet received dose 2. The reporter consented to follow up. No additional details to share as pharmacist was at home when she called. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only diluent was used; Only diluent was administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old patient who received Men ACWY-CRM NVS (Menveo) (batch number amxa762a, expiry date October 2024) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional Information: GSK Receipt Date: 31-JAN-2023 Reporter's Comments: HCP was the reporter.  The reporter mentioned that only the Menveo diluent (MenCYW-135) was administered to a patient. Minimal information available. The reporter consented to follow up. Additional Supportive Information: The patient received only nly the Menveo diluent was administered to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Expired Kinrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number PX27D, expiry date 17th January 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th January 2023, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 28th January 2023, unknown after receiving Kinrix and Kinrix 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: 31-JAN-2023 Reporter's Comments: HCP stated that an expired dose of Kinrix was administered to a patient. The reporter consented to follow up via postal. Additional Supportive Information: The patient received Kinrix, which was already expired.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 17Dec2020, 2nd not yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose on 17th December 2020 on an unknown arm).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 31-JAN-2023 Reporter's Comments: The patient stated that she got her first Shingrix vaccine 17th December 2020.  She had not gotten her second vaccine yet but plans on it. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 28.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 28-year-old female patient who received HAV (Havrix) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st January 2023, the patient received the 1st dose of Havrix and Havrix Pre-Filled Syringe Device. On 31st January 2023, unknown after receiving Havrix and Havrix 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: 31-JAN-2023 Reporter's Comments: Medical Assistant reported that a female 28 years old patient received an expired dose of Havrix on day of reporting. Initials for patient not provided when asked. The reporter consented to follow up via email.  The Vaccine Administration Facility is the same as Primary Reporter. Additional Supportive Information: The patient received Havrix, which was already expired.
Age: 47.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 47-year-old female patient who received HAV (Havrix 1440) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   On 31st January 2023, the patient received the 1st dose of Havrix 1440. On 31st January 2023, unknown after receiving Havrix 1440, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 31-JAN-2023 Reporter's Comments: Nurse reported 47-year-old female patient was administered a dose of Havrix on 31st January 2023, which had an expiration date of 30th January 2023. This was the patient's first dose in the series. At the time of reporting, the patient had not been re-dosed. The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter. Additional Supportive Information: The patient received Havrix, which was already expired.
Age: 44.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 44-year-old female patient who received HAV (Havrix) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st January 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 31st January 2023, unknown after receiving Havrix and Havrix 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: 31-JAN-2023 Reporter's Comments: A nurse reported that a female patient received an expired dose of havrix Additional Supportive Information: The patient received Havrix, which was already expired.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the liquid portion; received only the liquid portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number amva764a, expiry date 31st December 2023) for prophylaxis.   On 30th January 2023, the patient received the 1st dose of Menveo. On 30th January 2023, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and incorrect dose administered. On an unknown date, the outcome of the inappropriate preparation of medication and incorrect dose administered were unknown.   Additional Information: GSK Receipt Date: 31-JAN-2023 Reporter's Comments: The patient had accidentally received only the liquid portion of Menveo on 30th January 2023. They gave the vaccine details, patients detail and requested information about how to proceed.  She accepted follow-up and provided her e-mail address so that the medical information could be sent. The Vaccine Administration Facility was the same as Primary Reporter. The reporter mentioned it was incredibly difficult to make out what she was saying as there seemed to be a lot of background noise on the reporter's end.  She moved location without having to be asked to.  During the initial part of the call, she only mentioned that she was inquiring for a patient, but after that she mentioned another patient.  She also gave information for that other patient. Additional Supportive Information: The patient received only the liquid portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2023015039:Same reporter.