chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU4
Symptoms: Syringe issue, Underdose
Clinical narrative: content leaked out, other dose administered; plunger issue/syringe leak/looked like the plunger was loose/content leaked out; Pharmaceutical product complaint; This case was reported by a other health professional via sales rep and described the occurrence of accidental underdose in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number 9722R, expiry date unknown) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced accidental underdose, syringe issue and pharmaceutical product complaint. On an unknown date, the outcome of the accidental underdose, syringe issue and pharmaceutical product complaint 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: 25-OCT-2022 Reporter's Comment: The reporter reported that the patient received a dose of Flulaval pre filled syringe where the vaccine ran out while she was depressing the plunger. The one nurse shared that it looked like it leaked out below the where you attach the syringe. The reporter started to report this as a quality issue at the GRC, case #01528098, on 13th October 2022. At that time, the reporter had limited information and it was not clear if this happened while the nurses were preparing the vaccine dose or while they were administering the dose. The reporter finally received feedback from the nurses that administered the vaccines, and they shared that the incidents happened while they were administering the vaccines.  The nurses said that it looked like the plunger was loose. Two times the vaccine contents leaked out of the top and 2 times the vaccine contents leaked out of the bottom.  The nurses shared that each time they felt that the patient did not receive any of the dose and it was a failed attempt, so they threw the dose away and administered another dose. The reporter shared that the patient did not have any reaction to the dose given. Although the patient did not have reactions to the vaccine dose given, the reporter reporting this in case it falls into the category of maladministration. The reporter did not consent to follow up. This was two of four cases, reported by the same reporter. Additional Supportive Information: The vaccine leaked out and had plunger issue, looked like the plunger was loose and other dose was administered, which led to accidental underdose, syringe issue and pharmaceutical product complaint.; Sender's Comments:  US-GSK-US2022AMR154589:Same Reporter US-GSK-US2022AMR154684:Same Reporter US-GSK-US2022AMR154685:Same Reporter
Sex: U
Vaccine: FLU4
Symptoms: Accidental underdose, Product complaint, Syringe issue
Clinical narrative: content leaked out, other dose administered; plunger issue/syringe leak/looked like the plunger was loose/content leaked out; Pharmaceutical product complaint; This case was reported by a other health professional via sales rep and described the occurrence of accidental underdose in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number 9722R, expiry date unknown) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced accidental underdose, syringe issue and pharmaceutical product complaint. On an unknown date, the outcome of the accidental underdose, syringe issue and pharmaceutical product complaint 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: 25-OCT-2022 Reporter's Comment: The reporter reported that the patient received a dose of Flulaval pre filled syringe where the vaccine ran out while she was depressing the plunger. The one nurse shared that it looked like it leaked out below the where you attach the syringe. The reporter started to report this as a quality issue at the GRC, case #01528098, on 13th October 2022. At that time, the reporter had limited information and it was not clear if this happened while the nurses were preparing the vaccine dose or while they were administering the dose. The reporter finally received feedback from the nurses that administered the vaccines, and they shared that the incidents happened while they were administering the vaccines.  The nurses said that it looked like the plunger was loose. Two times the vaccine contents leaked out of the top and 2 times the vaccine contents leaked out of the bottom.  The nurses shared that each time they felt that the patient did not receive any of the dose and it was a failed attempt, so they threw the dose away and administered another dose. The reporter shared that the patient did not have any reaction to the dose given. Although the patient did not have reactions to the vaccine dose given, the reporter reporting this in case it falls into the category of maladministration. The reporter did not consent to follow up. This was three of four cases, reported by the same reporter. Additional Supportive Information: The vaccine leaked out and had plunger issue, looked like the plunger was loose and other dose was administered, which led to accidental underdose, syringe issue and pharmaceutical product complaint.; Sender's Comments:  US-GSK-US2022AMR154683:Same reporter US-GSK-US2022AMR154589:Same reporter US-GSK-US2022AMR154685:Same reporter
Sex: U
Vaccine: FLU4
Symptoms: Accidental underdose, Product complaint, Syringe issue
Clinical narrative: content leaked out, other dose administered; plunger issue/syringe leak/looked like the plunger was loose/content leaked out; Pharmaceutical product complaint; This case was reported by a other health professional via sales rep and described the occurrence of accidental underdose in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number 9722R, expiry date unknown) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced accidental underdose, syringe issue and pharmaceutical product complaint. On an unknown date, the outcome of the accidental underdose, syringe issue and pharmaceutical product complaint 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: 25-OCT-2022 Reporter's Comment: The reporter reported that the patient received a dose of Flulaval pre filled syringe where the vaccine ran out while she was depressing the plunger. The one nurse shared that it looked like it leaked out below the where you attach the syringe. The reporter started to report this as a quality issue at the GRC, case #01528098, on 13th October 2022. At that time, the reporter had limited information and it was not clear if this happened while the nurses were preparing the vaccine dose or while they were administering the dose. The reporter finally received feedback from the nurses that administered the vaccines, and they shared that the incidents happened while they were administering the vaccines. The nurses said that it looked like the plunger was loose. Two times the vaccine contents leaked out of the top and 2 times the vaccine contents leaked out of the bottom. The nurses shared that each time they felt that the patient did not receive any of the dose and it was a failed attempt, so they threw the dose away and administered another dose. The reporter shared that the patient did not have any reaction to the dose given. Although the patient did not have reactions to the vaccine dose given, the reporter reporting this in case it falls into the category of maladministration. The reporter did not consent to follow up. This was four of four cases, reported by the same reporter. Additional Supportive Information: The vaccine leaked out and had plunger issue, looked like the plunger was loose and other dose was administered, which led to accidental underdose, syringe issue and pharmaceutical product complaint.; Sender's Comments:  US-GSK-US2022AMR154683:Same reporter US-GSK-US2022AMR154684:Same reporter US-GSK-US2022AMR154589:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: had 2 shots 7 months apart; This case was reported by a contact via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date ).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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: 25-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient received 2 shingles vaccination 7 months apart. Additional supportive information: The patient received 2nd dose of Shingles vaccine later than the recommended interval, which led to lengthening of vaccine schedule. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st shot  Aug2019, 2nd 25Oct2022; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a 81-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine  (received first dose in August 2019).   On 25th October 2022, the patient received the 2nd dose of Shingles vaccine. On 25th October 2022, unknown after receiving Shingles vaccine, 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: 26-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient asked that because of the long time between shots should he/she get a third one and if so, when should get it. Additional supportive information: The patient received the second dose of Shingles vaccine later than the recommended interval, which led to lengthening of vaccine schedule. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: wasn't old enough, and got it.; This case was reported by a consumer via interactive digital media and described the occurrence of inappropriate age at vaccine administration in a female 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 inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 26-Oct-2022 Reporter's comment: The case was received from the patient's parent via interactive digital media. The reporter reported that the day he/she got the shot, the patient, who was not old enough, got the vaccine. Additional supportive information: The patient received a dose of Shingles vaccine at inappropriate age, which led to inappropriate age at vaccine administration. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Arm is red where I got the vx; Arm is swollen where I got the vx; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that his/her arm was red and swollen where he/she received his/her first vaccine. Additional supportive information: Follow-up would not possible as no contact details were available.
Age: 63.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 63-year-old male patient who received HAV (Havrix adult) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   On 24th October 2022, the patient received Havrix adult. On 24th October 2022, unknown after receiving Havrix adult, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 24-OCT-2022 Reporter's comment : The reporter reported administering expired Havrix to patient today (on the day of reporting). The reporter had consented to follow up. Additional supportive information: The patient had received an expired dose of Havrix adult, which had led to expired vaccine used. This case was linked with US2022153062 which was reported by same reporter.; Sender's Comments:  US-GSK-US2022153062:same reporter
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: administering expired Havrix; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 64-year-old female patient who received HAV (Havrix 720 adult) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th October 2022, the patient received Havrix 720 adult and Havrix Pre-Filled Syringe Device. On 24th October 2022, unknown after receiving Havrix 720 adult 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: 24-OCT-2022 Reporter's comment : reported administering expired Havrix to patient today (on the date of reporting). The reporter consented to follow-up. Additional supportive information: The patient had received an expired dose of Havrix 720 adult, which had led to expired vaccine used. This case had been linked with case US2022153119, reported by the same reporter.; Sender's Comments:  US-GSK-US2022153119:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: tired; sore; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced tiredness and pain. On an unknown date, the outcome of the tiredness and pain were recovered/resolved.   It was unknown if the reporter considered the tiredness and pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 24-Oct-2022 Reporter's comment: This case was self reported by the patient. The patient experienced sore and tired the day after receiving first Shingrix dose (adverse event sore, tired was recovered).  Nothing else was reported. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2020, 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 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose into unknown arm in 2020 (0.5 ml) ).   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: 24-OCT-2022 Reporter's comment: The case was self-reported by the patient. The patient reported that she had not gotten her second dose of Shingrix yet. The patient was planning on getting her second vaccine.  The patient did not remember which arm she got the vaccine or have any further information about the vaccine itself. The reporter did not consent 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.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received 1st dose 10/16/2021, 2nd not administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (The patient received 1st dose of Shingrix on 16th OCT 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: 24-OCT-2022 Reporter's Comment: The reporter stated that the patient never returned back over the weekend to get 2nd dose.  The reporter also stated that 2nd dose had not been administered at time of call. No additional data available. The reporter give consent to follow up. Additional Supportive Information: The patient had not received 2nd dose which led to incomplete course of vaccination. This case is linked with US2022153074 reported by the same reporter.; Sender's Comments:  US-GSK-US2022153074:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose  2-3 years 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 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date about 2 to 3 years ago prior to reporting).   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: 24-OCT-2022 Reporter's comment: The case was self-reported by the patient. The pharmacy where shot was administered indicated to patient that the record had been archived. Till the time of reporting, the patient did not receive the second dose of Shingrix. The reporter consented to follow up. The details given for first dose. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. This was 1 of 2 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2022153130:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2-3years 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 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 to 3 years ago prior to the reporting).   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: 24-OCT-2022 Reporter's Comment: The reporter was the patient's husband. The patient was at home at the time of the reporting, but she did not come on the phone. The pharmacy where the shot was administered to the patient that the record was archived in that the patient had yet to receive the 2nd dose of Shingrix vaccine. The detail was reported for 1st dose. The reporter indicated that the patient gave consent to the follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. This case had been linked with US2022153129 by same reporter for different patient.; Sender's Comments:  US-GSK-US2022153129:Same reporter
Sex: U
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Twinrix was administered in 2 doses administered in 2017, 3rd dose was today on 10/24/22; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose in 2017) and Twinrix (received 2nd dose in 2017).   On 24th October 2022, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 24th October 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, 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.   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: 24-Oct-2022 Reporter's comment: The pharmacist reported that the 3rd dose was today (on the day of reporting). The health-care professional was unable to provide any adverse event details today.  The health-care professional consented to follow up by safety team. The consent to follow-up was granted. Additional Supportive Information: The patient received 3rd dose of Twinrix later than recommended time interval, which led to lengthening of vaccination schedule.
Age: 0.17
Sex: F
Vaccine: HEP, HEP
Symptoms: Overdose
Clinical narrative: Engerix B and Recombivax HB administered same day; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 2-month-old female patient who received HBV (Engerix B pediatric) (batch number yy2r3, expiry date 12th May 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis and HEPATITIS B VACCINE (RECOMBIVAX HB) for prophylaxis.   On 24th October 2022, the patient received the 2nd dose of Engerix B pediatric (intramuscular) .5 ml, Engerix B Pre-Filled Syringe Device and the 1st dose of RECOMBIVAX HB. On 24th October 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 25-Oct-2022 Reporter's comment: The medical assistant stated that she gave an extra dose of the hepatitis B vaccine to a 2 month old.  The reporter stated that she gave the RECOMBIVAX HB vaccine that had hepatitis B in it and then gave Engerix B as well on the same day.   It was also recommended that a hepatitis B vaccine be given at 0 and 1 month so the patient was late for the vaccine. Did not consent to follow-up. Additional supportive information: The patient received Engerix B in right thigh and Recombivax HB on the same day, which led to overdose. As vaccination date was not reported for 1st dose of Engerix-B, therefore medication error drug dose administration interval too long was not coded.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2020, 2nd not yet; This case was reported by a other health professional via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2020).   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: 25-OCT-2022 Reporter's comment:  The reporter reported that they have a patient that was not received the 2nd dose of Shingrix since 2020.  The reporter was consented to follow up. Additional Supportive Information:  Till the time of reporting the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination.
Sex: M
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Bexsero administered instead of Engerix-b; Bexsero administered to a 9 months-old; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 9-month-old male patient who received Men B NVS (Bexsero) (batch number 3YB52, expiry date 30th April 2024) 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 an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, 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.   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: 25-OCT-2022 Reporter's comments: A health care professional reported that the patient had received a Bexsero dose, but he was intended to receive an Engerix-b dose. The reporter had consented to follow-up. Additional supportive information: A 9 month old patient had received a dose of Bexsero instead of Engerix-b, which had led to wrong vaccine administered and inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received 2nd dose one year after 1st dose; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received approximately one year ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 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: GSK Receipt Date: 25-OCT-2022 Reporter's Comments: The caller reported patient receiving second dose of Shingrix approximately one year after receiving the first dose. The reporter did not consent to follow up. Additional Supportive Information: The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of the vaccine schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose in February 2018 and the 2nd dose in November 2018; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in February 2018).   In November 2018, the patient received the 2nd dose of Shingrix. In November 2018, 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: GSK receipt date: 25-OCT-2022 Reporters comment: The reporter was patient she herself reported that had both Shingrix vaccines in 2018, she had her second dose after 6 months from the date of the first dose. No additional information was provided. Lot and expiry date not available for either vaccine. Additional Supportive information: The patient received 2nd dose later than recommended interval, which led to lengthening of vaccination schedule.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administration of Kinrix to a 4 month-old; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 9th November 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th October 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 25th October 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 25-Oct-2022 Reporter's comment: Nurse called to ask information about the administration of Kinrix to 4 month old patient. The reporter asked for safety information as well as how to proceed with this patient. The reporter consented to follow-up. Additional supportive information: The patient received a dose of Kinrix at inappropriate age, which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: administrated with expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number unknown, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th October 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 25th October 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-OCT-2022 Reporter's Comments: The reporter reported that a patient was administrated with an expired dose of Boostrix and the vaccine expired on 30th September 2022.  No adverse event was reported. No patient's identifiers provided, no lot number and expiration date were provided. The reporter was consented to follow up. Additional supportive information: The vaccine was already expired and was administered to the patient, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Miliaria
Clinical narrative: developing a prickly heat rash on chest and arms a few days after getting the first shingrix dose; This case was reported by a consumer via call center representative and described the occurrence of heat rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2022, the patient received the 1st dose of Shingrix. In October 2022, several days after receiving Shingrix, the patient experienced heat rash. On an unknown date, the outcome of the heat rash was not recovered/not resolved.   It was unknown if the reporter considered the heat rash to be related to Shingrix.     Additional Information: GSK receipt date: 26-OCT-2022 Reporters comment:  The patient received the first dose of shingrix and then developed a prickly heat rash on chest and arms a few days after received the first shingrix dose.  No other information reported to the agent by the patient.  The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose Mar2019, 2nd not yet; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in March 2019).   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: 26-OCT-2022 Reporter's comment: The pharmacy intern reported that the patient had not received a second dose of Shingrix yet. The health care professional wanted to be anonymous. The reporter consented to follow up by email. 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: 17.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero Administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB58AA, expiry date 30th September 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 October 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 4th October 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: 26-OCT-2022 Reporter's Comment: The reporter reported that, the maladministration of Bexsero after the expiration date to the patient.  The reporter consented to follow up. Additional Supportive Information: The reporter reported that, the maladministration of Bexsero after the expiration date to the patient, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: injection site reaction; This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th October 2022, the patient received Shingrix. In October 2022, less than a week after receiving Shingrix, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown.   It was unknown if the reporter considered the injection site reaction to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-OCT-2022 Reporter's Comment: The reporter reported a patient received Shingrix and developed an injection site reaction.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The case had been linked to US2021199863,reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021199863:Same reporter
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered liquid conjugate only; administered liquid conjugate only; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a adolescent male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA710A, expiry date 30th April 2023) 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: 27-OCT-2022 Reporter's Comment: The reporter reported that, a patient was administered the liquid conjugate portion of Menveo only. The reporter consented to follow up via email. Additional Supportive Information: The reporter reported that, a patient was administered the liquid conjugate portion of Menveo only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 47.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: vaccinated with expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 47-year-old male patient who received HAV (Havrix) (batch number Y29KL, expiry date 21st February 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th October 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 26th October 2022, 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: 27-OCT-2022 Reporter's comment: Nurse reported that the patient was vaccinated with expired dose of Havrix. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via email. Additional Supportive Information:  The patient received a dose of Havrix which was already expired, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: only one Shingrix injection in 10/11/2021; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 11th 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: 27-OCT-2022 Reporter's comment: The reporter asked if a patient had only one Shingrix injection in 11th October 2021, what was the best way to proceed. The reporter also asked if one more injection or start series over. The reporter consented to follow-up via-postal. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of vaccine, which led to Incomplete course of vaccination.
Age: 66.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: expired dose was administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 66-year-old male patient who received HAV (Havrix) (batch number Ha9y9, expiry date 17th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th October 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 24th October 2022, 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: 27-OCT-2022 Reporter's comment: Pharmacist reported that an expired dose of Havrix was administered to the patient. The reporter declined to provide information besides the age and gender of the patient.  Expiration date was from salesforce. The reporter did not consent to follow-up. Additional Supportive Information: The patient received a dose of Havrix which was already expired, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Fridge was few degrees cooler; This case was reported by a consumer via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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: 27-OCT-2022 Reporter's comment: The patient self-reported this case. The patient received dose of a shingles vaccine in August. Patient reports was being told by the pharmacy later on afterwards that the pharmacy found out that the refrigerator holding the shingles vaccine was a few degrees cooler for half an hour. The patient disconnected from the call so no further information could be obtained.  It was also unknown what shingles vaccine the patient was referring to. The reporter did not consent to follow-up. Additional Supportive Information: The patient received dose of shingles vaccine that was few degrees cooler for half an hour, which led to Incorrect storage of drug. Year of vaccine administration was not reported hence vaccination date was not captured in the case.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Fully vaccinated, then shingles/Suspected vaccination failure; Two episode of shingles; This case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 27th October 2022, unknown after receiving Shingrix and Shingrix, 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 Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 27-OCT-2022 Reporter's Comment: The reporter was medical assistant. The reporter reported that, patient experienced vaccine inefficacy twice after being fully vaccinated.  The reporter was unable to provide any adverse event information at this time.  The reporter consented to follow up with safety team. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT IN LEG; This spontaneous report received from a consumer (Patient's wife) concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown and expiry: unknown) dose was not reported, 01 total administered, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clot in leg and he prescribed with Xarelto and. Ultrasound test was scheduled to determine if the blood clot was dissolved. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with rivaroxaban was not reported. The outcome of blood clot in leg was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20220621170.; Sender's Comments: V0: 20221052932-blood clot in leg. The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.