chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: she gave an expired Kinrix vaccine to a patient; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number Yz97n, expiry date 26th August 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st August 2022, the patient received the 1st dose of Kinrix (intramuscular) .5 ml and Kinrix Pre-Filled Syringe Device. On 31st August 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 by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-AUG-2022 The nurse stated that she gave an expired Kinrix vaccine to a patient. She did not report that the patient was experiencing any side effects. The reporter did not consent to follow-up. Additional supportive information: The patient had received an expired dose of Kinrix, which led to expired vaccine used.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 01Nov2021 2nd, 31Aug2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number MS5HC, expiry date 8th July 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 1st November 2021 with batch number:2NT5L and expiry date:12th May 2023).   On 31st August 2022, the patient received the 2nd dose of Shingrix. On 31st August 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 31-Aug-2022 Reporters comment: The pharmacist reported that patient did not receive second dose until 31Aug2021. The reporter consent to follow-up. Additional Supportive information: The patient received second dose of Shingrix later than recommended interval, which led to lengthening of vaccine schedule.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: First dose on 15Mar2021, 2nd dose on 14Jul2022; Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 2-year-old female patient who received HAV (Havrix) (batch number 5575N, expiry date 19th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix (received 1st dose on 15th March 2021).   On 14th July 2022, the patient received the 2nd dose of Havrix and Havrix Pre-Filled Syringe Device. On 14th July 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long and expired vaccine used. On an unknown date, the outcome of the drug dose administration interval too long and expired vaccine used 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: 31-AUG-2022 Reporter's comment: The nurse reported that a second dose of Havrix was given to the patient and it was already expired. The Vaccine Administration Facility was the same as primary reporter.  The reporter consented to follow up. Additional Supportive Information: The patient received the second dose of Havrix later than the recommended interval which was already expired, which led to lengthening of vaccination schedule and expired vaccine used.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Asthenia, Hypoacusis, Impaired work ability, Incomplete course of vaccination
Clinical narrative: Problems with vision; Problems with hearing; Joint pain; Muscle pain; Rashes; Weakness; Lost the ability to use hands properly; Patient did not receive 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of abnormal vision in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included ZOSTAVAX (received in April 2011) and ZOSTAVAX (received in March 2013).   On 7th October 2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced abnormal vision, hearing impaired, joint pain, muscle pain, rash, weakness, inability to work and incomplete course of vaccination. On an unknown date, the outcome of the abnormal vision, hearing impaired, joint pain, muscle pain, rash, weakness, inability to work and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the abnormal vision, hearing impaired, joint pain, muscle pain, rash, weakness and inability to work to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-AUG-2022 Reporter's comment: The patient's husband reported this case. The patient received first dose of Shingrix vaccine and experienced problems with her vision, hearing, she had joint and muscle pain, rashes and weakness. The patient also had lost the ability to use her hands properly. The reporter did not consented to 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 has been linked with case US2022126202, reported by the same reporter. As it was unknown that there was any medical reason due to which patient did not receive the 2nd dose, therefore 2nd dose was coded as suspect and linked with incomplete course of vaccination.; Sender's Comments:  US-GSK-US2022126202:Same reporter
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Musculoskeletal disorder, Myalgia, Rash, Visual impairment
Clinical narrative: Problems with vision; Problems with hearing; Joint pain; Muscle pain; Rashes; Weakness; Lost the ability to use hands properly; Patient did not receive 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of abnormal vision in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included ZOSTAVAX (received in April 2011) and ZOSTAVAX (received in March 2013).   On 7th October 2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced abnormal vision, hearing impaired, joint pain, muscle pain, rash, weakness, inability to work and incomplete course of vaccination. On an unknown date, the outcome of the abnormal vision, hearing impaired, joint pain, muscle pain, rash, weakness, inability to work and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the abnormal vision, hearing impaired, joint pain, muscle pain, rash, weakness and inability to work to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-AUG-2022 Reporter's comment: The patient's husband reported this case. The patient received first dose of Shingrix vaccine and experienced problems with her vision, hearing, she had joint and muscle pain, rashes and weakness. The patient also had lost the ability to use her hands properly. The reporter did not consented to 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 has been linked with case US2022126202, reported by the same reporter. As it was unknown that there was any medical reason due to which patient did not receive the 2nd dose, therefore 2nd dose was coded as suspect and linked with incomplete course of vaccination.; Sender's Comments:  US-GSK-US2022126202:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Not received second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 7th October 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK Receipt Date: 31-AUG-2022 Reporter's Comments: The had not received his second dose at the time of the call. 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.; Sender's Comments:  US-GSK-US2022126195:Same reporter
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Infanrix administered to a 11 y/o patient; Received Infanrix instead of Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old female patient who received DTPa (Infanrix) (batch number 49TM, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th August 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 17th August 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-AUG-2022 Reporter's comment: Healthcare Professional (HCP) reported that while the patient was 11 years old, the patient had received the Infanrix instead of the Boostrix. No reactions were reported. The vaccine administration facility was the same as primary reporter. The reporter had consented to follow-up by email. Additional supportive information: A 11 years old patient had received Infanrix instead of the Boostrix which led to inappropriate age at vaccine administration and wrong vaccine administered.
Sex: U
Vaccine: DTAPIPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: a dose of expired Kinrix was administered to a patient.; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa-IPV (Kinrix) (batch number unknown, expiry date 26th August 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th August 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 30th August 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 by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 31-AUG-2022 Reporter's comment: Healthcare Professional (HCP) reported that an expired dose of Kinrix was administered to a patient on day before the reporting day. No details for adverse event, either lot number or patient details were available at the time of chat but the reporter consented to follow up via email. Additional supportive information: The patient had received an expired dose of Kinrix, which led to expired vaccine used.
Age: 48.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired Havrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 48-year-old female patient who received HAV (Havrix adult) (batch number 72T95, expiry date 9th August 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st August 2022, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On 31st August 2022, unknown after receiving Havrix 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: 31-AUG-2022 Reporter's Comments: The reporter was the office manager.  The reporter reported accidentally administered expired Havrix to a patient which was expired on 9th August 2022.  The reporter reported patient had not reported any adverse reactions. The reporter consent to follow up. Additional Supportive Information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Muscular weakness
Clinical narrative: Muscle weakness in both legs; Numbness in both feet; This case was reported by a consumer via call center representative and described the occurrence of muscle weakness lower limb in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced muscle weakness lower limb and numbness in feet. On an unknown date, the outcome of the muscle weakness lower limb and numbness in feet were not recovered/not resolved.   It was unknown if the reporter considered the muscle weakness lower limb and numbness in feet to be related to Shingrix.     Additional Information: GSK Receipt Date: 01-SEP-2022 Reporter's Comment: The reporter was a patient. The reporter reported that the patient received Shingrix vaccine 2 or 3 months ago. The reporter stated that after received Shingrix vaccine the patient experienced muscle weakness in both legs and numbness in both feet.  The reporter stated that it had been progressively getting worse for the past 2 to 3 months and had not resolved. The reporter did consent to follow up.
Age: 95.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: 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 95-year-old female patient who received Men B NVS (Bexsero) (batch number AVXB39AB, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st September 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 1st September 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: 01-Sept-2022 Reporter's comment: The follow-up permission was not requested during the call, later, agent will email Safety Team with health care professional's details and follow-up confirmation. The reporter did not consent to follow-up. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Age: 22.0
Sex: F
Vaccine: HEPAB
Symptoms: Serology test, Therapeutic response decreased
Clinical narrative: low tiers; This case was reported by a pharmacist via call center representative and described the occurrence of therapeutic response decreased in a 22-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased 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: 1-Sep-2022 Reporter's Comment: Pharmacist reported that a patient had low tiers.  The patient was administrated with Twinrix 22 years ago. No adverse event was reported. No patient's identifiers, no lot number and expiration date and no vaccination date were provided. The reporter did not consent to follow-up.  Additional Supportive Information: The patient received Twinrix and had low tiers, which led to therapeutic response decreased.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Nausea
Clinical narrative: Nausea; Dizziness; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st August 2022, the patient received the 1st dose of Shingrix. On 1st September 2022, 1 days after receiving Shingrix, the patient experienced nausea and dizziness. On an unknown date, the outcome of the nausea and dizziness were not recovered/not resolved.   It was unknown if the reporter considered the nausea and dizziness to be related to Shingrix.     Additional Information: GSK Receipt Date: 01-SEP-2022 Reporter's Comment: The reporter was a patient's husband. The reporter reported that the patient received Shingrix vaccine. On the day of reporting, she started to experience nausea and dizziness. Symptoms had not resolved. Did not consent to follow-up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Food intolerance, Headache, Injection site pain, Injection site urticaria
Clinical narrative: Pain at injection site; Welt at injection site; Severe Stomach pain; Headache; Unable to go about daily activities; having to resume their normal diet slowly, due to the severity of the stomach pain; Slight fever; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 592RY, expiry date 31st August 2023) and (batch number 5392T, expiry date 31st August 2023) for prophylaxis.   Previously administered products included Shingrix vaccine with an associated reaction of injection site pain (1st dose received on 16 June 2022 for the tolerance of the 1st dose, refer linked case US2022AMR127400).   On 24th August 2022, the patient received the 2nd dose of Shingrix. On an unknown date, the dose was an unknown dose. In August 2022, less than a day after receiving Shingrix, the patient experienced fever, activities of daily living impaired and food intolerance. On 24th August 2022, the patient experienced stomach pain and headache. On an unknown date, the patient experienced injection site pain and injection site wheal. Rechallenge with Shingrix was positive. On 25th August 2022, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the injection site pain, injection site wheal, stomach pain and headache were recovered/resolved and the outcome of the activities of daily living impaired was unknown and the outcome of the food intolerance was recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site wheal, stomach pain, fever, headache, activities of daily living impaired and food intolerance to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR127400   Additional Information: GSK Receipt Date: 01-SEP-2022 Reporter's Comment: The reporter was a patient. The reporter reported that the patient received Shingrix vaccine, the lot number of adjuvant was 5392T and expiration date 31st August 2023. The reporter stated that after received Shingrix vaccine the patient experienced severe stomach pain around 1 or 2 in the morning, the stomach pain was so severe as they were unable to do their daily activities, reporter reported that had to resume their normal diet slowly due to the severity of the stomach pain. patient had fever in the middle of the same night and lasted approximately 12 hours, patient started headache after 7-8 hours of received vaccine and lasted for 2-3 days.  The reporter reported that pain at the injection site and a welt at below the injection site, that has since resolved. The reporter did consent to follow up. Additional supportive information: for the tolerance of the 1st dose, refer linked case US2022AMR127400, reported by same reporter; Sender's Comments:  US-GSK-US2022AMR127400:Same reporter
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Pyrexia, Urticaria
Clinical narrative: Pain at injection site; Welt at injection site; Severe Stomach pain; Headache; Unable to go about daily activities; having to resume their normal diet slowly, due to the severity of the stomach pain; Slight fever; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 592RY, expiry date 31st August 2023) and (batch number 5392T, expiry date 31st August 2023) for prophylaxis.   Previously administered products included Shingrix vaccine with an associated reaction of injection site pain (1st dose received on 16 June 2022 for the tolerance of the 1st dose, refer linked case US2022AMR127400).   On 24th August 2022, the patient received the 2nd dose of Shingrix. On an unknown date, the dose was an unknown dose. In August 2022, less than a day after receiving Shingrix, the patient experienced fever, activities of daily living impaired and food intolerance. On 24th August 2022, the patient experienced stomach pain and headache. On an unknown date, the patient experienced injection site pain and injection site wheal. Rechallenge with Shingrix was positive. On 25th August 2022, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the injection site pain, injection site wheal, stomach pain and headache were recovered/resolved and the outcome of the activities of daily living impaired was unknown and the outcome of the food intolerance was recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site wheal, stomach pain, fever, headache, activities of daily living impaired and food intolerance to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR127400   Additional Information: GSK Receipt Date: 01-SEP-2022 Reporter's Comment: The reporter was a patient. The reporter reported that the patient received Shingrix vaccine, the lot number of adjuvant was 5392T and expiration date 31st August 2023. The reporter stated that after received Shingrix vaccine the patient experienced severe stomach pain around 1 or 2 in the morning, the stomach pain was so severe as they were unable to do their daily activities, reporter reported that had to resume their normal diet slowly due to the severity of the stomach pain. patient had fever in the middle of the same night and lasted approximately 12 hours, patient started headache after 7-8 hours of received vaccine and lasted for 2-3 days.  The reporter reported that pain at the injection site and a welt at below the injection site, that has since resolved. The reporter did consent to follow up. Additional supportive information: for the tolerance of the 1st dose, refer linked case US2022AMR127400, reported by same reporter; Sender's Comments:  US-GSK-US2022AMR127400:Same reporter
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Product storage error, Respiratory disorder
Clinical narrative: Administration of Improperly Stored Vaccine; Respiratory Illness; This case was reported by a consumer via call center representative and described the occurrence of respiratory disorder in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (received 1st dose on 4th March 2022). Concomitant products included PEDIARIX.   On 12th July 2022, the patient received the 3rd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 28th July 2022, 16 days after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced respiratory disorder. On an unknown date, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the respiratory disorder was not recovered/not resolved and the outcome of the incorrect storage of drug was unknown.   It was unknown if the reporter considered the respiratory disorder to be related to Pediarix and Pediarix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 01-Sept-2022 Reporter's comment: The member of public reported that the patient (her grandson) received third dose of Pediarix vaccine and the family then received a message that the vaccine had not been properly stored, that the temperature monitoring system had not been working for the past 3 months and was not discovered until 9th May 2022.   The message stated that the office wanted to repeat the dose of the vaccine, but the reporter was concerned about this because the patient has had a respiratory illness for the past 5 weeks. The reporter did not had the lot number information for any doses. The reporter was unsure if the health care professional office reported this event, could potentially be a duplicate. The reporter stated that she was unsure about giving permission for follow-up and did not knew the health care professional's information. Additional supportive information: The patient received the third dose after temperature excursion, which led to incorrect storage of drug.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered
Clinical narrative: Patient received 4th dose of Pediarix; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 6-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number X9HF4, expiry date 25th March 2024) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st September 2022, the patient received the 4th dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 1st September 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered 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: 01-Sept-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received 4th dose of Pediarix, which led to extra dose administered.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only adjuvant portion administered; Only adjuvant portion administered; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number 39YM7, expiry date 1st September 2023) for prophylaxis.   On 26th August 2022, the patient received the 1st dose of Shingrix. On 26th August 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 Information: GSK receipt date: 01-Sept-2022 Reporter's comment: The pharmacist stated that  a pharmacy intern administered the adjuvant portion only to a patient.  The patient was administered a properly reconstituted dose on the same day as the non-reconstituted dose. The reporter consented to follow-up via postal. Additional supportive information: The patient received only adjuvant portion of the vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Mobility decreased, Pain, Vaccination failure
Clinical narrative: Full vaccination / shingles/ suspected vaccination failure; Shingles; Pain is climbing up spine, cannot get out of bed; cannot get out of bed; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (in November 2021).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In August 2022, less than 9 months after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, radiating pain and mobility decreased. The patient was treated with acyclovir. On an unknown date, the outcome of the vaccination failure, shingles, radiating pain and mobility decreased were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, radiating pain and mobility decreased to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 01-Sep-2022 Reporter's comment: The reporter was the patient.  The patient stated that she completed her full vaccination for Shingrix about 6- 8 months ago and about 10 days ago, she came down with shingles.  This was the second time she had shingles. The first time was in November 2021 before she received Shingrix.  The patient stated that this time the shingles was worse.    The pain was climbing up her spine, she can not get out of bed.  The patient was prescribed acyclovir for treatment. The reporter consent to follow up. Additional supportive information: This case was considered as suspected vaccination failure since details regarding laboratory conformation of shingles was not given at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 16Nov2018, 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 92-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 16th November 2018 with batch number ey93j).   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: 01-Sept-2022 Reporter's comment: The health care professional asked that the patient could get 2nd shot or need to restart the series. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive 2nd shot of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: DTAP, DTAPIPV, FLU4, HEP, HEPA, MENB, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: patients may have received vaccines after temperature excursion; 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 Flu Seasonal QIV (FluLaval Quadrivalent) for prophylaxis.   Co-suspect products included DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAV (Havrix) for prophylaxis, HBV (Engerix B) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, Men B NVS (Bexsero) for prophylaxis, meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent, Infanrix, Infanrix Pre-Filled Syringe Device, Havrix, Engerix B, Boostrix, Kinrix, Kinrix Pre-Filled Syringe Device, Bexsero, Bexsero Pre-Filled Syringe Device and Menveo. On an unknown date, unknown after receiving FluLaval Quadrivalent, Infanrix, Infanrix Pre-Filled Syringe Device, Havrix, Engerix B, Boostrix, Kinrix, Kinrix Pre-Filled Syringe Device, Bexsero, Bexsero Pre-Filled Syringe Device and Menveo, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 01-Sept-2022 Reporter's comment: The pharmacist with the department of health reported that from 28th May 2022 until the end of June 2022 there was no temperature recording data from a fridge were Flulaval, Infanrix, Havrix, Engerix-B, Boostrix, Kinrix, Bexsero and Menveo were stored in a vaccination site.  The reporter reported that there might had been a temperature excursion during that time and patients might had received vaccines after a temperature excursion. The reporter consented to follow-up. Additional supportive information: The patients might had received the vaccines after a temperature excursion, which led to incorrect storage of drug.
Age: 1.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: SHINGRIX administered to a child; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old female patient who received Herpes zoster (Shingrix) (batch number 75B29, expiry date 24th August 2023) for prophylaxis.   On 30th August 2022, the patient received Shingrix. On 30th August 2022, unknown after receiving Shingrix, 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: 01-SEP-2022 Reporter's Comment: The reporter reported that the child patient received Shingrix vaccine. The reporter consented to follow up. Additional supportive information: The reporter reported that the 1 year child patient received Shingrix vaccine, which led to Inappropriate age of vaccine administration.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st Twinrix on 01FEB22, 2nd and 3rd dose not administered; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 1st February 2022 with batch number 93KF5) and Hepatitis B vaccine (received a dose of Hepatitis B vaccine (Manufacture unknown) on 2nd March 2022).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 01-Sept-2022 Reporter's comment: The health care professional reported that the patient received 1st dose of Twinrix then received a Hepatitis B vaccine (manufacture unknown). The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Twinrix (incomplete for hepatitis A), which led to incomplete course of vaccination
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient did not receive 2nd dose; This case was reported by a other health professional 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 (received 1st dose on 13th December 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: 01-Sept-2022 Reporter's comment: The health care professional from physician's office reported that the patient never receive 2nd dose. 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.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: Adult dose of Engerix-B to a 18 y/o; Adult dose of Engerix-B to a 18 y/o; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 18-year-old female patient who received HBV (Engerix B adult) (batch number 39PZ2, expiry date 7th September 2023) and (batch number L9Y4G, expiry date 5th April 2024) for prophylaxis.   On 13th June 2022, the patient received Engerix B adult. On an unknown date, the dose was an unknown dose. On 13th June 2022, unknown after receiving Engerix B adult, the patient experienced overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the overdose and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 01-SEP-2022 Reporter's Comment: The reporter reported that, administration of an adult dose of Engerix-B to a 18 y/o patient and a paediatric dose on 26th July 2022.  The patient had not experienced any adverse effects. The reporter consented to follow up. Additional Supportive Information: The reporter reported that, administration of an adult dose of Engerix-B to a 18 y/o patient, which led to overdose and inappropriate age of vaccine administration. There were 2 batch numbers were reported for suspect, so it was not clear if it was given for 1st and 2nd dose, conservatively captured for suspect.
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received an 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 adult male patient who received HAV (Havrix) (batch number 3F349, expiry date 9th August 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, 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: 02-Sep-2022 Reporter's Comment: The reporter reported that a patient received an expired dose of Havrix vaccine. The reporter consented to follow up. Additional Supportive Information: The patient received an expired dose of Havrix vaccine which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: two doses "years apart", two years since dose two; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date).   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: 2-Sep-2022 Reporter's Comment: The patient who was over 65 at the moment of this report received two doses of Shingrix years apart and that it had been two years since dose two. The reporter consented to follow up. Additional Supportive Information: The patient received two doses of Shingrix years apart and that it´s been two years since dose two, which led to drug dose administration interval too long.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: adjuvant only, forgot  powder portion; only adyuvant administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd September 2022, the patient received Shingrix. On 2nd September 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 Information: GSK Receipt Date: 02-SEP-2022 Reporter's Comment: The reporter reported that, a patient was given only adjuvant of Shingrix and forgot the powder portion. The vaccine administration facility was the same as primary reporter. No other details were available. The reporter did not consent to follow-up. Additional Supportive Information: The patient received only adjuvant of Shingrix and forgot the powder portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 0.42
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 6 MO was administered Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old male patient who received DTPa-IPV (Kinrix) (batch number B75MY, expiry date 15th June 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd November 2019, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 22nd November 2019, 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: 2-Sep-2022 Reporter's Comments: The nurse reported that going back through old records from 3 years ago and noted that a 6 month old patient was administered a dose of Kinrix. The vaccine administration facility was the same as primary reporter. The reporter give consent to follow up. Additional Supportive Information: The reporter stated 6-month-old patient was administered a dose of Kinrix which led to inappropriate age at vaccine administration.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Expired Boostrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 5e43j, expiry date 30th August 2022) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd September 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 2nd September 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: 02-SEP-2022  Reporter's Comment: The reporter was medical assistant. The reporter reported that, a patient received a expired dose of Boostrix. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  Additional Supportive Information: The reporter reported that, a patient received a expired dose of Boostrix, which led to expired vaccine used.