chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: TYP
Symptoms: No adverse event, Product storage error
Clinical narrative: Kept the vaccines in ice packs while traveling but the ice got melted by the time, she reach the destination; A spontaneous report was received from the nurse and patient's husband on 11JUL2022. It described a 51-year-old female patient who "kept the vaccines in ice packs while traveling but the ice got melted by the time, she reaches the destination" (PT: Product storage error). The patient received the oral Vivotif capsule (typhoid vaccine live oral Ty21A) for travelling. It was reported that the patient got the oral 8-day typhoid vaccine recommended as one pill every other day. Furthermore, it was reported that while traveling she kept the vaccines in the insulated pack with ice, but the ice got melted by the time she reached the destination, and she did not note the exact temperature reading and thought it was still cool. It was mentioned that the vaccine within icepacks was not completely defrosted. Additionally, it was reported that the patient did not develop any side effects after consuming the Vivotif dose on an unknown date. The outcome of the reported event was unknown.  Lot number was unknown as threw away the packaging.  Action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: A 51-year-old  consumer kept the vaccines in ice packs while traveling but the ice got melted by the time, she reached the destination (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error. The case is considered non serious as per medical assessment.; Sender's Comments: A 51-year-old  consumer kept the vaccines in ice packs while traveling but the ice got melted by the time, she reached the destination (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error. The case is considered non serious as per medical assessment.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Patient left Vivotif dose out for 3 hours unrefrigerated; A spontaneous report was received from other health care professional on 12JUL2022. It described a female patient (unknown age) who "left Vivotif dose out for 3 hours unrefrigerated" (PT: Product storage error). The patient took the Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that the patient took the first dose of Vivotif after she left the dose out unrefrigerated for 3 hours. The outcome of the reported event was unknown.  Action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a patient left Vivotif dose out for 3 hours unrefrigerated (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a patient left Vivotif dose out for 3 hours unrefrigerated (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error. The case is considered non serious as per medical assessment.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Has never healed shingles vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 03-Aug-2022 Reporter comment: This case was reported by a patient via interactive digital media. The patient (husband) received the vaccine three year ago. The patient had never healed shingles vaccine. Follow-up would not possible, as no contact details were available. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Flushing, Myalgia
Clinical narrative: fatigue; muscle aches; face is flushed; This case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 1st August 2022, the patient received the 2nd dose of Shingles vaccine. In August 2022, less than a week after receiving Shingles vaccine, the patient experienced fatigue, muscle pain and facial flushing. On an unknown date, the outcome of the fatigue, muscle pain and facial flushing were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, muscle pain and facial flushing to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 02-Aug-2022. Reporter's Comments: The case was reported by the consumer via interactive digital media. The patient got his/her second shingles shot yesterday and had fatigue, muscle aches and his/her face was flushed but don't had hives. The patient wanted to know how long would this last. The follow-up could not be possible as no contact details were available
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: give a Bexsero and it expired 3 days ago; This case was reported by a consumer via interactive digital media and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number unknown, 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 3rd August 2022, the patient received Bexsero. On 3rd August 2021, the patient started Bexsero Pre-Filled Syringe Device. On 3rd August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device and unknown after starting 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: 03-Aug-2022 Reporter's Comments: The reporter reported the case via interactive digital media. The reporter stated that they had a nurse just gave a Bexsero vaccine and it expired the end of July, 3 days before date of reporting. The reporter's doctor would like to know if this was considered invalid. Additional Supportive Information: The patient was administered with Bexsero vaccine, which was already expired, which led to expired vaccine used. The follow-up would not possible as no contact details were available. This case has been linked with the case US2022AMR115313, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR115313:Same reporter
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: give a Bexsero and it expired 3 days ago; This case was reported by a consumer via interactive digital media and described the occurrence of expired vaccine used in an unspecified number of patients who received Men B NVS (Bexsero) (batch number unknown, expiry date 31st August 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 3rd August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 3rd 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: 03-Aug-2022 Reporter's Comments: The reporter reported the case via interactive digital media. The reporter stated that they had a nurse just gave a Bexsero vaccine and it expired the end of July, 3 days before date of reporting. The reporter's doctor would like to know if this was considered invalid. Additional Supportive Information: The patient was administered with Bexsero vaccine, which was already expired, which led to expired vaccine used. The follow-up would not possible as no contact details were available. This case has been linked with the case US2022AMR115273, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR115273:Same reporter
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: got 2nd dose after 6 months past the 1st; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose 0.5 ml received in November 2019 on an unknown arm).   On 27th July 2022, the patient received Shingrix .5 ml. On 27th July 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.     Additional Information: Additional Information: GSK Receipt Date: 02-AUG-2022. Reporter's Comments: The case was reported by patient's wife. The patient was vaccinated with Shingrix at an unknown arm. The patient got his 2nd Shingrix vaccine greater than 6 months past the first vaccine. The reporter did not want to give any further demographics or details and did not had any information about the vaccine itself. The reporter did not consent to follow up. No HCP for follow up. Additional Supportive Information: The patient received 2nd dose shingrix late than recommended interval, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration, Loss of consciousness, Seizure
Clinical narrative: Seizure; Loss of consciousness; 1st dose of Boostrix in 2014 and received a 2nd dose in 2021; This case was reported by a pharmacist via call center representative and described the occurrence of seizure in a 60-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Previously administered products included Boostrix (1st dose received in 2014).   On an unknown date, the patient received the 2nd dose of Boostrix. On an unknown date, less than 2 years after receiving Boostrix, the patient experienced seizure (serious criteria GSK medically significant), loss of consciousness (serious criteria GSK medically significant) and drug dose administration interval too short. On an unknown date, the outcome of the seizure, loss of consciousness and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the seizure and loss of consciousness to be related to Boostrix.     Additional Information: GSK Receipt Date: 02-Aug-2022 Reporter's comment: The patient received the 2nd dose of Boostrix in 2021. The patient had a seizure with loss of consciousness after the 2nd dose. The pharmacist asked was there any data available on an increase in adverse events if vaccinated too soon (since the patient received the 2nd dose 7 years after the first instead of 9 to 10 years). The pharmacist did not have any additional information to provide, stated that she had sent this information from another person who really just needed a question to be asked. She also stated that this had been reported to VAERS and therefore declined follow up. The patient did not consent to follow-up. Additional supportive information: The patient received the 2nd dose earlier than the recommended interval, which led to shortening of vaccination schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Shingrix adjuvant without antigen component; Shingrix adjuvant without antigen component; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced 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: 03-Aug-2022 Reporter's comment: The reporter was the Healthcare professional (nurse).  The patient received Shingrix adjuvant without antigen component (inappropriate Reconstitution Technique).   The reporter had nothing else to report.  The Vaccine Administration Facility was the same as Primary Reporter. The consent to follow up was given. Additional Supportive Information: The patient received Shingrix adjuvant without antigen component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 5.0
Sex: M
Vaccine: HEP
Symptoms: Accidental overdose, Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: 5 YO wasgiven  adult dose; 5 YO wasgiven  adult dose; 5 YO wasgiven 4th dose; This case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 5-year-old male patient who received HBV (Engerix B adult) (batch number TB3KN, expiry date 3rd December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st August 2022, the patient received the 4th dose of Engerix B adult 1 ml and Engerix B Pre-Filled Syringe Device. On 1st August 2022, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced accidental overdose, adult product administered to child and extra dose administered. On an unknown date, the outcome of the accidental overdose, adult product administered to child 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: 3-Aug-2022 Reporter's comment: The patient was accidentally given an adult dose of Engerix-B for his fourth dose at age of 5 years. The reporter did'nt had anything else to report. The reporter consented to follow up. Additional supportive information: The patient received an adult dose of Engerix B at age of 5 years, which led to the accidental overdose and adult product administered to child. The patient received fourth dose of Engerix B at age of 5 years, which led to Extra dose administered.
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Gotten the Dtap instead of the Tdap; Gotten the Dtap instead of the Tdap/Received the one for children instead of adult vaccine; This case was reported by a consumer via call center representative and described the occurrence of wrong vaccine administered in a adult male patient who received DTPa (DTaP vaccine) for prophylaxis.   On an unknown date, the patient received DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 03-Aug-2022 Reporter's comment: The reporter was patient's wife. The reporter stated that the patient might had got the Dtap instead of the Tdap. The reporter believed that the patient received the one for children instead of adult vaccine. The reporter did not consent to follow-up. Additional Supportive Information: The patient received Dtap instead of the Tdap, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity
Clinical narrative: Felt unwell; Sore arm; This case was reported by a consumer via call center representative and described the occurrence of unwell in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th March 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 11th March 2022, 1 days after receiving Shingrix, the patient experienced unwell and pain in arm. On an unknown date, the outcome of the unwell and pain in arm were recovered/resolved.   It was unknown if the reporter considered the unwell and pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 03-AUG-2022 Reporter's Comments: The reporter was the patient's wife stating that her husband got his first Shingrix vaccine. The reporter stated that on the following day patient had a sore arm and felt unwell in general for a few days.  The patient had recovered from these symptoms.  The reporter did not consent to follow-up.  This was report of 2nd patient out of 2 patients. Additional Supportive Information:  This case was linked with US2022114895 reported by same reporter.; Sender's Comments:  US-GSK-US2022114895:Same reporter. Patient 1
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Incorrect dose administered, Product preparation issue, Rash
Clinical narrative: Shingles; rash getting worse; Only diluent administered; Only Shingrix diluent portion; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th April 2022, the patient received the 1st dose of Shingrix. On 25th April 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown and the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.     Additional Information: GSK receipt date: 3-Aug-2022 Reporter's comment: The pharmacist called to report that the immunocompetent patient developed shingles after received only Shingrix diluent portion. The rash was getting worse as the patient stated. The reporter consented to follow-up by email. Additional supportive information: The patient received only Shingrix diluent portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: 106 degree Fever and went to the ER; This case was reported by a physician via call center representative and described the occurrence of fever in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB28AA, expiry date 30th June 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 14th December 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, less than 9 months after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional Information: GSK Receipt Date: 03-AUG-2022 Reporter's comments: The Healthcare Professional (HCP) reported that the patient had experienced a 106 degree fever and went to the Emegency room (ER) after receiving the 1st dose of Bexsero.  The reporter had also asked that did they had recommendations on administering the 2nd dose of Bexsero based off this reaction.  The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up however the healthcare professional was called and a voice message (VM) was left to call back the medical inquirer (MI).
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Accidental exposure to product, Exposure via skin contact, Incorrect dose administered, Product complaint, Syringe issue
Clinical narrative: medication leaked out from syringe; most of dose ended up on patient's thigh; most of dose ended up on patient's thigh; syringe issue; pharmaceuutic product complaint; This case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a 12-month-old female patient who received Hib (Hiberix) (batch number BA975, expiry date unknown) for prophylaxis.   On 1st August 2022, the patient received Hiberix .5 ml. On 1st August 2022, unknown after receiving Hiberix, the patient experienced incomplete dose administered, exposure via skin contact, inadvertent exposure to vaccine, syringe issue and pharmaceutical product complaint. On an unknown date, the outcome of the incomplete dose administered, exposure via skin contact, inadvertent exposure to vaccine, syringe issue and pharmaceutical product complaint were unknown.   Linked case(s) involving the same patient:  US2022115404   Additional Information: GSK Receipt Date: 03-Aug-2022 Reporter's Comments: The reporter calling about Hiberix.  A patient was to receive dose and when giving the dose the medication leaked out from the syringe out of the hub of the needle that was connected to the syringe.  So, there must had been a defect in the connection and most of the dose ended up on the patient's outside of the thigh versus inside of the thigh. The syringe might have a defect and that was the reason of the leaking. The reporter informed that he/she could be reached between the hours of 8:30 and 5. Health care professional (HCP) did not provide any patient details, date of birth, lot number, or expiration date of product.   HCP provided contact for follow-up. Additional Supportive Information: Hiberix was administered incompletely since the syringe leaked, which led to incomplete dose administered, exposure via skin contact, inadvertent exposure to vaccine, syringe issue and pharmaceutical product complaint.; Sender's Comments:  US-GSK-US2022115404:FU2 - Deleted
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, HEP, MENB, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: Patient received one of these vx after excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men B NVS (Bexsero) 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, DTPa (Reduced antigen) (Boostrix) for prophylaxis, HBV (Engerix B) for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero, Bexsero Pre-Filled Syringe Device, Boostrix, Engerix B, Infanrix, Infanrix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Menveo, Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero, Bexsero Pre-Filled Syringe Device, Boostrix, Engerix B, Infanrix, Infanrix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Menveo, Pediarix and Pediarix 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: 04-AUG-2022 Reporter's comment: The nurse reported that the following vaccines were exposed to freezing temperatures included Bexsero, Boostrix, Engerix B, Infanrix, Kinrix, Menveo, Pediarix. On 22nd July 2022, vaccines were exposed to a lowest temperature of minus 10.7 Degree Celsius for 1 hour and 9 minutes.  The health care professional believed that there was patient that received one of these vaccines after this excursion.  The health care professional was trying to figure out who was the patient involved as well as the vaccine. The reporter consented to follow up by email. Additional Supportive Information: The nurse reported that the Bexsero, Boostrix, Engerix B, Infanrix, Kinrix, Menveo, Pediarix vaccines were exposed to temperature excursion which led to incorrect storage of drug.
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: dose on 04Aug2022, had an expiration date of 31Jul2022; 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 ABXB34AA, 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 4th August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 4th 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: 04-Aug-2022 Reporter's Comments: Medical Assistant reported 18-year-old female patient was administered a dose of Bexsero on 4th August 2022, which had an expiration date of 31st July 2022.  At the time of reporting, dose had not been The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter. Additional Supportive Information: The patient was administered with Bexsero vaccine, which was already expired, which led to expired vaccine used.
Age: 15.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Bexsero that already expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 15-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB39AC, 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 4th August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 4th 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: 04-Aug-2022 Reporter's Comments: Registered nurse reported on 4th August 2022 that patient received on 4th August 2022, a dose of Bexsero that had already expired on 31st July 2022. The reporter did not consent to follow-up. The Vaccine Administration Facility is the same as Primary Reporter. Additional Supportive Information: The patient was administered with Bexsero vaccine, which was already expired, which led to expired vaccine used.
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: expired Bexsero administered; 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 Men B NVS (Bexsero) (batch number unknown, 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 4th August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 4th 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: 04-AUG-2022 Reporter's Comment: The reporter was a pharmacy intern. The reporter reported that the patient was received expired Bexsero vaccine. The reporter did not had the patients gender, date of birth and the lot at the time of report. The reporter did consent to follow-up. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Age: 34.0
Sex: F
Vaccine: VARZOS
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: pregnant patient got Shingrix; 34YO patient got Shingrix; This prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a 34-year-old female patient who received Herpes zoster (Shingrix) (batch number AC4CK, expiry date 14th September 2023) for prophylaxis.   On 4th August 2022, the patient received Shingrix. The patient's last menstrual period was on an unknown date and estimated date of delivery was 16th December 2022. The patient received Shingrix at an unknown time during the pregnancy. On 4th August 2022, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown. The pregnancy was ongoing.  Additional Information: GSK Receipt Date: 04-AUG-2022 Reporter's Comments: The patient received Shingrix by mistake and wanted to know about the risks and adverse events for Shingrix while being pregnant. The patient was 12 weeks and 5 days pregnant at the time of reporting. The reporter consented to follow up. Additional Supportive Information: The patient received Shingrix while being pregnant, which led to vaccine exposure during pregnancy. The patient received vaccine earlier than the recommended age, which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: Menveo administered after freezing exposure; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA690A, expiry date 31st October 2022) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, 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: 4-Aug-2022 Reporter comment: The pharmacist reported three patients received Menveo that had been stored in the freezer. The reporter gave consent to follow up. Reporter did not want medical information to store information in medical information database. Additional Supportive Information: The reporter stated that three patients received Menveo that had been stored in the freezer, which led to incorrect storage of product. This is 1 of the 3 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022115428:Same reporter. Patient 1 US-GSK-US2022AMR115729:Same reporter. Patient 2
Age: 18.0
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 18-year-old male 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 4th August 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 4th 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: 04-AUG-2022. Reporter's Comments: The reporter states that an expired dose of Bexsero was administered to the patient.  The reporter consent to follow up via postal. Additional Supportive Information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st Engerix B 7Jan2019, 2nd 14Mar2019; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 38-year-old female patient who received HBV (Engerix B) (batch number GR55T, expiry date unknown) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On 14th March 2019, the patient received the 2nd dose of Engerix B. On 14th March 2019, unknown after receiving Engerix B, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 04-AUG-2022 Reporter's Comments: The patient received 1st dose of Engerix B on 7th January 2019. The patient received two doses of Engerix-B (both with same lot ) and a dose of Heplisav B on 1st August 2022. The reporter consent to follow up. Additional Supportive Information: The patient received 2nd dose of Engerix-B later than the recommended interval, which led to lengthening of the vaccine schedule.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administered the Menveo liquid component only; Administered the Menveo liquid component only; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA690A, expiry date 31st October 2022) 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: 04-Aug-2022 Reporter's Comments: Registered Nurse (RN) reported they inadvertently administered the Menveo liquid component only without the lyophilized component to a patient. RN unsure who the one patient was or when the dose was administered. RN mentioned thought the dose was administered on a day in between 8th July 2022 to 3rd August 2022. No additional details provided. The reporter consented to follow up. HCP provided contact for follow-up. Additional Supportive Information: The patient inadvertently administered with Menveo liquid component only without the lyophilized component to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 62.0
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Received a dose of Engerix B instead of Havrix; Patient had already completed the Hep B series; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 62-year-old male patient who received HBV (Engerix B) (batch number 7B2YL, expiry date 25th February 2024) for prophylaxis.   On 2nd August 2022, the patient received the 4th dose of Engerix B. On 2nd August 2022, unknown after receiving Engerix B, the patient experienced wrong vaccine administered and extra dose administered. On an unknown date, the outcome of the wrong vaccine administered and extra dose administered were unknown.    Additional Information: GSK Receipt Date: 04-AUG-2022 Reporter's Comments: The nurse reported that the patient was supposed to receive a dose of Havrix but instead was given a dose of Engerix B. The reporter stated that the patient had already completed the Hepatitis B series. The reporter consent to follow up. Additional Supportive Information: The patient received Engerix B instead of Havrix vaccine, which led to wrong vaccine administered. The patient received extra Engerix B dose, which led to extra dose administered.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose end of Jan2022, no 2nd dose yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 26th January 2022).   On an unknown date, the patient received 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: 04-AUG-2022 Reporter's Comments: The patient reported that received first dose of Shingrix at the end of January of 2022 (26th January to be exact) and having not yet received the second dose. The patient had realized that gone past the 2-6 month window to get the second shot. The patient asked that was that ok or did they have to start over again. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, patient did not receive the 2nd dose of vaccine which led to incomplete course of vaccination.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Maternal exposure before pregnancy, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; ANGIOEDEMA; VACCINE EXPOSURE BEFORE PREGNANCY; This spontaneous pregnancy report received from a physician via another pharmaceutical company (Pfizer) concerned a 40 year old pregnant female. The patient's height, and weight were not reported. The patient's concurrent conditions included: wheat allergy (rash). The patient was pregnant at the time of event reporting with Gravida 1. The patient received first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805018 expiry: unknown) dose was not reported, 1 total administered on 19-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 38 years old. On 19-MAR-2021, the patient experienced vaccine exposure before pregnancy (Dose number in series 1). The patient received second dose of non-company suspect vaccine elasomeran (Moderna covid-19 vaccine) (Dose number in series 2) (form of admin, and route of admin were not reported, batch number: 006D21A expiry: unknown) dose was not reported, administered on 10-NOV-2021 for covid-19 prophylaxis. Concomitant medications included dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol, and guaifenesin/pseudoephedrine hydrochloride. It was reported that patient's last menstrual period was on 25-NOV-2021 and expected delivery date was on 01-SEP-2022. On an unspecified date, the patient experienced suspected covid-19 infection (Dose number in series 2). The patient received non-company co-suspect drug Paxlovid (form of administration not reported, oral, batch number, and expiry date were not reported) dose was not reported, administered from 22-JUL-2022 to 24-JUL-2022 for treatment of COVID-19. On 24-JUL-2022 (on day 3 of Paxlovid treatment course) the patient experienced angioedema (tongue swelling, skin erythema, and muscle heaviness) (Dose number in series 2). The outcome of pregnancy was not reported. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable and with Paxlovid was not reported. The patient had not recovered from angioedema, and the outcome of suspected covid-19 infection and vaccine exposure before pregnancy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220804040- covid-19 vaccine ad26.cov2.s-Angioedema.  The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related(Latency between event occurrence and vaccination was more than 16 months, also event occurrence was more related with administration of co-suspect drug - Paxlovid )
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: This spontaneous report received from a patient via a company representative via social media (J&J Corporate) concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient's were previously treated with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose not reported, 1 total,  administered on an unspecified date for covid-19 prophylaxis. It was unknown if patients experienced any adverse event after covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient's received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the people were dropping off like flies until they got all these vaccinations and booster shots (dose number in series 2). It was reported that: "People that I know are dropping off like flies that were in good health until they got all these vaccinations and booster shots." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of people that know are dropping off like flies until they got all these vaccinations and booster shots was not reported. This report was non-serious. This case is a duplicate of 20220809692. Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This spontaneous report received from a consumer via social media via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 in total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, it was reported that. "Facts I know a nurse an plenty of ppl fully vaxed that's died regardless....so... On an unspecified date, the patient died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This report was associated with product quality complaint: 90000245172.; Sender's Comments: V0-20220809549-covid-19 vaccine ad26.cov2.s-Died. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: M
Vaccine: COVID19
Symptoms: Hot flush, Joint swelling, Pain
Clinical narrative: This spontaneous report received from a patient via other manufacturer concerned an adult male. The patient's height, and weight were not reported. The patient's concurrent conditions included: ankylosing spondylitis. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) dose, start therapy date were not reported, 1 total, administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. Non-company suspect drugs included: Humira (adalimumab) (solution for injection in pre-filled pen, citrate free, subcutaneous, batch number 1160837, expiry: unknown) dose, frequency and therapy dates were not reported for ankylosing spondylitis. On an unspecified date, the patient experienced swollen joints, hot flashes, and pain (Dose number in series 1). The patient additionally received booster dose of non-company suspect vaccine included: Moderna (elasomeran) (Dose number in series 2) (form of admin not reported, intramuscular, batch number: unknown, expiry: unknown) (1 in 1 Once) dose, start therapy date were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with booster dose of Moderna (elasomeran) covid-19 vaccine (Dose number in series 2). It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab, and elasomeran was not reported. The patient recovered from hot flashes, and the outcome of swollen joints and pain was not reported. This report was non-serious.