chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site warmth
Clinical narrative: Painful arm; Hot to touch arm; Red arm; Flu like symptoms; Received 2 shots 3 months apart; Some site reaction; This case was reported by a other health professional via call center representative and described the occurrence of injection site reaction in a 57-year-old male patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2021-2022 season) (batch number 579C9, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   Concomitant products included Flu Seasonal QIV (FluLaval Quadrivalent 2021-2022 season).   On 21st February 2022, the patient received FluLaval Quadrivalent 2021-2022 season, Flulaval Tetra Pre-Filled Syringe Device and PNEUMONIA VACCINE. On 21st February 2022, less than a day after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced injection site reaction, influenza-like symptoms and extra dose administered. On 23rd February 2022, the patient experienced injection site pain, injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site reaction and influenza-like symptoms were recovered/resolved and the outcome of the injection site pain, injection site warmth, injection site erythema and extra dose administered were unknown.   It was unknown if the reporter considered the injection site reaction, injection site pain, injection site warmth, injection site erythema and influenza-like symptoms to be related to FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra 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 details were provided as follows: The patient received FluLaval Quadrivalent 2021-2022 season and Pneumonia vaccine on an unknown same arm. The patient received 2nd dose of FluLaval Quadrivalent 2021-2022 season, which led to extra dose administered. After receiving FluLaval Quadrivalent 2021-2022 season, the patient developed some site reaction and flu like symptoms at the end of day which was resolved in 24 hrs. The patient was also complained of painful hot to touch and red arm. The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter. It was unknown if the reporter considered the injection site reaction, injection site pain, injection site warmth, injection site erythema and influenza-like symptoms to be related to Pneumonia vaccine.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administered only the liquid component; Administered only the liquid component; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) 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 details were provided as follows: The age at vaccination was not reported. The reporter reported that, they might have administered only the liquid component of Menveo to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered, but they were not completely sure. The reporter stated that, they had narrow down to 5 patients, no data available for any of them when asked but provided with vaccination dates and lot, patient 1 was vaccinated on 29th October 2021 with batch number AMAA589A, patient 2 was vaccinated on 18th November 2021 with batch number AMVA589A, patient 3 was vaccinated on 26th November 2021 with batch number AMUA589A, patient 4 and 5 were vaccinated on 16th December 2021 with batch number AMAA589A. No further details were provided. The reporter consented to follow up. Note- As we do not have any confirmation which patient was involved out of these 5 patients, vaccine start date and batch number was not captured in the case.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Itching on belly; Redness on belly; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 24th February 2022, 4 days after receiving Shingrix, the patient experienced pruritus and erythema. On an unknown date, the outcome of the pruritus and erythema were not recovered/not resolved.   It was unknown if the reporter considered the pruritus and erythema to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine on left deltoid 4 days ago from reporting date and experienced itching and redness on her belly today (day of reporting). The patient did not have lot number or expiration date for the vaccine.  The reporter also wanted to know if it could cause shingles. The reporter did not consent to follow-up.
Sex: U
Vaccine: RV1
Symptoms: Inappropriate schedule of product administration
Clinical narrative: up to 8 months to receive both doses; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in an unspecified number of patients who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator 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 details were provided as follows: The age at vaccination was not reported. The reporter stated that, they were given guidance that, the patients had up until 8 months to receive both doses of Rotarix, but she read in the prescribing information that, both doses must be administered by the time the patients were 24 weeks.  The reporter stated that, since they were initially given guidance on patients receiving both doses by 8 months of age, some patients had been received Rotarix outside of the timeframe recommended in the prescribing information, which led to lengthening of vaccination schedule. The reporter consented to follow up. No patient demographics were available at the time of reporting The reporter consented to follow up via postal.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Incorrect dose administered, Product complaint, Syringe issue
Clinical narrative: Product Complaint; leaked out from lock and syringe; leaked out from lock and syringe; This case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB37AA, expiry date 31st July 2022) for prophylaxis. This case was associated with a product complaint.   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 February 2022, the patient received the 2nd dose of Bexsero (intramuscular) 1 dosage form(s) and Bexsero Pre-Filled Syringe Device. On 3rd February 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incomplete dose administered and syringe leak. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the incomplete dose administered, syringe leak 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 details were provided as follows: The reporter reported that, she was administering a dose of Bexsero from a pre filled syringe and the liquid leaked out from between the luer lock and syringe barrel when she depressed the plunger to give the dose and the patient did not get the dose which led to incomplete dose administered. The defect was discovered in the process of administering and the needle was in the patient but there was a leak and unknown if any went into the patient.  The leak was between luer lock device and the syringe barrel.  The needle was put on immediately before administration.  The size of gauge needle used was 25G x 1 inch.  blister and/or carton was not damaged.  No visible luer lok damage was noted.  The needle which was used was available and would be returned with product.  No apparent damage or breakage was noted on the syringe barrel. No picture would be emailed in.  Suspect syringe would be returned to GlaxoSmithKline by healthcare professional.  The reporter would call back with information on the patient to whom the vaccine was administered because she did not have that information available.  Consent did not ask because the healthcare professional was reporter and the patient was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered only the adjuvant; administered only the adjuvant; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 70-year-old 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 details were provided as follows: The age at vaccination was not reported. The patient was administered only the adjuvant part of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow up. The reporter did not want follow up as it did not happen at her pharmacy and she had no other details.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Headache
Clinical narrative: sporadic episodes of dizziness; tired; headache; 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 22nd January 2022, the patient received the 2nd dose of Shingrix (intramuscular). In January 2022, less than a week after receiving Shingrix, the patient experienced tiredness, headache and dizziness. On an unknown date, the outcome of the tiredness and headache were recovered/resolved and the outcome of the dizziness was not recovered/not resolved.   It was unknown if the reporter considered the tiredness, headache and dizziness to be related to Shingrix.  Additional details were provided as follows: The patient self reported this case. The patient received dose of Shingrix vaccine and for two days after the vaccination, she felt tired and had a headache. About three days after vaccination she experienced sporadic episodes of dizziness. The dizziness continued to come and go. Sometimes the dizziness occurred during yoga, sometimes when she lied down in bed, and sometimes when she sat up. The patient had an appointment with her physician next week.  The reporter consents to follow up with physician but can't remember the spelling of her last name or contact information.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: stored in the freezer and vaccinated; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Herpes zoster (Shingrix) (batch number 4N2AB, expiry date 10th February 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Nurse reported that, by mistake they had stored Shingrix in the freezer, which led to incorrect storage of drug and some patients were vaccinated as well. No data was available from patients or vaccination dates. The reporter consented to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pain in arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th September 2021, the patient received the 1st dose of Shingrix (intramuscular) 0.5 ml. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient reported case for herself. The reporter reported that she received dose of Shingrix and had since been experiencing pain in her arm. No lot number or expiration date was known for the vaccine. The pain continued and had not resolved. The reporter did not consent to follow-up. The reporter declined to provide HCP information.
Age: 64.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: administered an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 64-year-old female patient who received HAB (Twinrix) (batch number DQ23D, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th February 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 25th February 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received an expired dose of Twinrix, which led to expired vaccine used. The reporter consented to follow up.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Laboratory test abnormal, Pain, Pruritus, Rash
Clinical narrative: first and second dose, developed shingles/Suspected vaccination failure; shingles; rash; pain; itching; bleeding lesions on his skin; bleeding lesions on his skin; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 8th April 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 29th January 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, 2 years 10 months after receiving Shingrix and more than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash, pain, pruritus, skin lesion and skin bleeding. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, rash, pain, pruritus, skin lesion and skin bleeding were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash, pain, pruritus, skin lesion and skin bleeding to be related to Shingrix and Shingrix.  Additional details were provided as follows: The case was reported by the patient. The patient recently had developed the shingles rash with pain and itching (Lack of Effect).  The patient also reported that the rash was causing bleeding lesions on his skin.  This issue had developed 2 years and 10 months after receiving the 2 dose Shingrix series. No lot or expiration dates were known for either vaccine.  The patient wished to be contacted via email for any follow up. This case was considered as suspected vaccination failure as detail regarding laboratory test confirming shingles were unknown at the time of reporting.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Skin haemorrhage, Skin lesion, Vaccination failure
Clinical narrative: first and second dose, developed shingles/Suspected vaccination failure; shingles; rash; pain; itching; bleeding lesions on his skin; bleeding lesions on his skin; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 8th April 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 29th January 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, 2 years 10 months after receiving Shingrix and more than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash, pain, pruritus, skin lesion and skin bleeding. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, rash, pain, pruritus, skin lesion and skin bleeding were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash, pain, pruritus, skin lesion and skin bleeding to be related to Shingrix and Shingrix.  Additional details were provided as follows: The case was reported by the patient. The patient recently had developed the shingles rash with pain and itching (Lack of Effect).  The patient also reported that the rash was causing bleeding lesions on his skin.  This issue had developed 2 years and 10 months after receiving the 2 dose Shingrix series. No lot or expiration dates were known for either vaccine.  The patient wished to be contacted via email for any follow up. This case was considered as suspected vaccination failure as detail regarding laboratory test confirming shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose of series on 30Sep2020, but did not receive second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (might received 1st dose on 30th September 2020).   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 details were provided as follows: The age at vaccination was not applicable for this report. Pharmacist reported that, the patient presented to the pharmacy with a prescription for 2 dose Shingrix series.   Records indicated that, the patient might have received 1st dose of series already on 30th September 2020, but patient did not receive second dose.   Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. Pharmacist stated that, the record was from a clinic and did not include a lot number or expiration date, so she was not completely sure the dose was administered.   She would follow up with the clinic to verify. The reporter consented to follow up.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Patient received expired dose; 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 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 24th February 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 24th February 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 without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient received an expired dose of Havrix, which led to expired vaccine used. This was all the data that was provided by the healthcare professional. The reporter consented to follow up.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: Has not received the second dose; Active Herpes Zoster; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 9th July 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 9th July 2020, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional details were reported as follows: The age at vaccination was not applicable for 2nd dose of Shingrix. The first dose was administered at a different facility so pharmacist did not have the lot number or expiration date information.  The reporter reported that on the same day of vaccination, patient was diagnosed with shingles and till the time of reporting did not receive the second dose, which led to incomplete course of vaccination. The reporter gave permission for follow-up.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Given only the liquid adjuvant portion; Given only the liquid adjuvant portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 60-year-old male patient who received SHINGRIX (batch number D4PA4, expiry date unknown) for prophylaxis.   On 16th February 2022, the patient received Shingrix. On 16th February 2022, 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 details were provided as follows: The patient might have been given only the liquid adjuvant portion of the Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered but it was not known for certain.   At the time of reporting, repeat dose had not been administered. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022036014:Same reporter
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Freezed dose administered; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received HBV (Engerix B) (batch number 39a3l, expiry date 23rd February 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B 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 without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that, a freeze dose of Engerix-B was inadvertently administrated to one or two patients, which led to incorrect storage of drug.  The healthcare professional had no details on the exact amount or patients or date of administration at the time of reporting but agreed to be contacted for follow up through provided email address.  No further events were reported. The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Both doses on 9/15/19 and 6/08/20; 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 Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 15th September 2019).   On 8th June 2020, the patient received the 2nd dose of Shingrix. On 8th June 2020, 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 details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix, later than the recommended schedule, which led to lengthening of vaccination schedule. The reporter enquired if the patient should get a 3rd dose. The reporter disconnected before call center representative was able to gather additional information about the patient or obtain permission for follow up.  Email address was provided.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, Product complaint, Syringe issue
Clinical narrative: Product Complaint; did not receive full dose; liquid shot out of the side of the syringe; This case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a 10-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number NK45F, expiry date 30th June 2022) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd February 2022, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 23rd February 2022, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incomplete dose administered and syringe leak. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the incomplete dose administered, syringe leak 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 details were provided as follows: The reporter stated that, they had 3 cracked prefilled syringes of the Fluarix.  The crack or breakage observed on the barrel of the syringe. The reporter stated that, she was administering Fluarix to the patient and once she injected into the patient's arm, the liquid shot out of the side of the syringe, which was cracked.  She stated that, the patient did not receive the full dose as it was wasted, which led to incomplete dose administered.  She claimed none of the medication touched the patient as it shot out into the air. She was unsure how much was leftover as the syringe was discarded.  They only had one of the syringes to return as the other was discarded. The defect was discovered on an unknown site. It was unknown if healthcare professional preparing or administering vaccine was a new or experienced use. It was unknown if the package or carton or blister tray damaged upon receipt. There was no any evidence of leakage or product in package or carton. The product was still present in the syringe at the time of reporting. Full demographics for patient was unavailable.  The reporter did not consent to follow up.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Expired Drug Used; This case was reported by a other health professional via sales rep and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA462A, expiry date 31st October 2021) for prophylaxis.   On 25th February 2022, the patient received Menveo. On 25th February 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient received an expired dose of Menveo, which led to expired vaccine used. The reporter did not consent to follow-up. The PQC was ruled out because it was discovered the wholesaler provided the expired product to the healthcare professional recently.
Sex: U
Vaccine: MENB
Symptoms: Intercepted product prescribing error
Clinical narrative: Patient outside approved age with prescription; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 29-year-old 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.   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 intercepted drug prescribing error. On an unknown date, the outcome of the intercepted drug prescribing error was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Pharmacist reported that, the patient had a prescription for Bexsero and was over 25 years of age, which led to intercepted drug prescribing error. The reporter did not consent to follow-up.
Age: 29.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: expired vaccine administrated; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 29-year-old female patient who received HAB (Twinrix) (batch number dk23d, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th February 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 27th February 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that, on 27th February 2022 an expired vaccine dose was administrated to the patient. No further events were reported. The reporter agreed to be contacted follow-up. The Vaccine Administration Facility is the same as Primary Reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillan-Barre syndrome after Shingrix; This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 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 guillain barre syndrome (serious criteria medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient reported that she was diagnosed with Guillan-Barre syndrome after taking the Shingrix vaccine. The reporter did not consent to follow-up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Chills, Constipation, Injection site pain, Injection site swelling
Clinical narrative: pain at the injection site; swelling at the injection site; low grade fever; chills; constipation; abdominal pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th February 2022, the patient received the 1st dose of Shingrix. On 26th February 2022, 1 days after receiving Shingrix, the patient experienced injection site pain, injection site swelling, low grade fever, chills, constipation and abdominal pain. On an unknown date, the outcome of the injection site pain, injection site swelling, low grade fever and chills were recovered/resolved and the outcome of the constipation was not recovered/not resolved and the outcome of the abdominal pain was unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, low grade fever, chills, constipation and abdominal pain to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix vaccine in left arm. On the next morning, she woke up with pain and swelling at injection site, a few hours later she reported low grade fever and chills. The patient also experienced constipation (not resolved) and abdominal pain.  The patient was referred to HCP (health care professional).  The reporter did not consent to follow-up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: pain at the injection site; swelling at the injection site; low grade fever; chills; constipation; abdominal pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th February 2022, the patient received the 1st dose of Shingrix. On 26th February 2022, 1 days after receiving Shingrix, the patient experienced injection site pain, injection site swelling, low grade fever, chills, constipation and abdominal pain. On an unknown date, the outcome of the injection site pain, injection site swelling, low grade fever and chills were recovered/resolved and the outcome of the constipation was not recovered/not resolved and the outcome of the abdominal pain was unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, low grade fever, chills, constipation and abdominal pain to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix vaccine in left arm. On the next morning, she woke up with pain and swelling at injection site, a few hours later she reported low grade fever and chills. The patient also experienced constipation (not resolved) and abdominal pain.  The patient was referred to HCP (health care professional).  The reporter did not consent to follow-up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site scab
Clinical narrative: scab at the injection site; Shoulder pain; This case was reported by a consumer via call center representative and described the occurrence of injection site scab in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th December 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In December 2021, 3 days after receiving Shingrix, the patient experienced injection site scab and shoulder pain. On an unknown date, the outcome of the injection site scab was not recovered/not resolved and the outcome of the shoulder pain was unknown.   It was unknown if the reporter considered the injection site scab and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received dose Shingrix vaccine into her left arm muscle and a few days after the injection experienced scab at the injection site and shoulder pain.  The scab was still there as of today(day of reporting). The reporter did not have the lot number or expiration date of the vaccine administered. The patient gave consent to contact her HCP (health care professional). The reporter consented to follow-up. GSK note- there was discrepancy in reported information. The Time to Onset was provided as 3 days in structured filed but in narrative, it is mentioned as few days after vaccination event started. TTO is captured as per structured field.
Sex: U
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: given an 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 HAB (Twinrix) (batch number DK23D, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th February 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 25th February 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter called and informed that, on 25th February 2022, the patient was given an expired dose of Twinrix. No details from patient available. The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose in 2019, second in 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 10th September 2019).   On 19th January 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 19th January 2021, 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 details were provided as follows: The reporter called on behalf of the patient. The patient received second dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule. The reporter gave a consent to follow-up with himself for follow-up. The reporter did not have lot or expiry date for the second dose of Shingrix.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Patient received a expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number H9Y52, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th February 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 28th February 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received an expired dose of Kinrix, which led to expired vaccine used. The patient seek advice. The reporter consented to follow up.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Patient inadvertently received expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number Z9MZ2, expiry date 31st December 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th January 2022, the patient received the 2nd dose of Kinrix (intramuscular) and Kinrix Pre-Filled Syringe Device. On 26th January 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient inadvertently received expired dose of Kinrix in the left thigh, which led to expired vaccine used. No further information reported. The reporter consented to follow-up.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only injected the liquid component; Only injected the liquid component; 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) 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 details were provided as follows: The age at vaccination was not reported. The patient received only the liquid component of the Menveo vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter asked should she give the entire vaccine again. The vaccine administration facility was the same as primary reporter. The reporter stated that they could follow up with her though the patient was her colleagues but they were at same practice. No other details available. The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Upper arm probably sore from previous shot; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter would like to know if hip can be used instead of upper arm. Further prompted reporter why alternative site, reporter mentioned patient that probably sore from previous shot.  This was 2nd shot of Shingrix. No other information was available.  The reporter did not consent to follow-up.
Age: 76.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: an expired dose fo Twinrix was administrated; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 76-year-old male patient who received HAB (Twinrix) (batch number dk23d, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th February 2022, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 25th February 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter reported that an expired dose of Twinrix was administrated to a patient, which led to expired vaccine used. No further events were reported.  The reporter agreed to be contacted for follow-up.