chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/had the shot and still got the shingles; shingles/had the shot and still got the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 26-June-2022 Reporter's comment: The case was received from the patient's friend via interactive digital media. The patient had the shot and still got the shingles. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: Had 3 shingles vaccines, had shingles/Suspected vaccination failure; Had 3 shingles vaccines, had shingles; Had 3 shingles vaccines; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 26-June-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had three shingles vaccines and then had the worst case of shingles ever lol. Additional supportive information: The patient received 3 doses of Shingles vaccine, wghich led to extra dose administered. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd shot too early; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's Comments: This case was received via interactive digital media. The patient received 2nd shot too early. Additional supportive Information: The patient received 2nd early than recommended interval, which led to shortening of vaccination schedule. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Neck pain
Clinical narrative: stiff/sore neck; stiff/sore neck; This case was reported by a consumer via interactive digital media and described the occurrence of neck pain in a 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 neck pain and stiff neck. On an unknown date, the outcome of the neck pain and stiff neck were unknown.   It was unknown if the reporter considered the neck pain and stiff neck to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's Comments: This case was received via interactive digital media. The reporter stated that could one side effect of Shingrix be a stiff/sore neck. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-Jun-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient was the reporters mother. The reporter stated that the patient did get shingles after the Shingles shot and that the patient never had shingles until she got the Shingles vaccine. Additional Supportive Information: This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available.
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient received a diluted dose due to inappropriate reconstitution; Patient received a diluted dose due to inappropriate reconstitution; This case was reported by a nurse via call center representative and described the occurrence of inappropriate reconstitution technique in a 6-month-old female patient who received Hib (Hiberix) (batch number 5229L, expiry date unknown) for prophylaxis.   On 10th June 2022, the patient received Hiberix. On 10th June 2022, unknown after receiving Hiberix, the patient experienced inappropriate reconstitution technique and incorrect dose administered. On an unknown date, the outcome of the inappropriate reconstitution technique and incorrect dose administered were unknown.   Additional Information: GSK Receipt Date: 21-Jun-2022 Reporters comment: The reporter consented to follow up. Additional Supportive Information: The patient received a diluted dose of the hiberix vaccine which led to the inappropriate reconstitution technique and incorrect dose administered. This case is one of 2 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022095702:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms 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 influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-JUN-2022 Reporter's Comments: The case was self reported by the patient. The patient received a dose of Shingrix vaccine and experienced flu-like symptoms. The reporter disconnected the call abruptly and agent was unable to collect any further information including HCP (health care professional) contact information and patients DOB (date of birth), address and consent to contact. AE (adverse event) filed. Spoke from content. Additional supportive Information: This case has been linked with case US2022AMR096275 reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR096275:Same reporter, different patient
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Electric shock sensation, Pain
Clinical narrative: Sharp electrical pains on her side; This case was reported by a consumer via call center representative and described the occurrence of pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2022, the patient received the 2nd dose of Shingrix. On 16th June 2022, less than a month after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-Jun-2022. Reporter's Comments: The reporter was patient's husband who advised his wife (patient) received her second dose of Shingrix about a month ago from reporting and 5 days ago from the day of reporting, she developed sharp electrical pains on her side.  The symptom had not yet resolved.  The consent was not provided to follow-up.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Havrix was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st June 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 21st June 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-Jun-2022 Reporters comment: The healthcare professional reported that an expired Havrix was administered to a patient. No reactions reported. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up by email. Additional Supportive Information: The patient received expired dose of Havrix which led to expired vaccine used.
Age: 69.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Underdose
Clinical narrative: 2nd and 3rd dose with a half dose; pediatric dose administered to adult; Drug dose administration interval too long; 2nd and 3rd dose with a half dose; pediatric dose administered to adult; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 69-year-old male patient who received HBV (Engerix B) (batch number j7h4d, expiry date 7th April 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) (batch number 333m, expiry date 23rd March 2022) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (received full dose on an unknown date).   On 7th April 2022, the patient received the 3rd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 23rd September 2021, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 23rd September 2021, not applicable after receiving Engerix B and Engerix B Pre-Filled Syringe Device and unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On 7th April 2022, the patient experienced underdose, adult use of a child product and drug dose administration interval too long. On an unknown date, the outcome of the underdose, adult use of a child product, drug dose administration interval too long, underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-Jun-2022 Reporters comment: The patient received 2nd and 3rd dose of Engerix B which were half of the dose. The half dose was because it was the pediatric dose of Engerix B. No adverse event was reported. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up. Additional Supportive Information: The patient received half dose of Engerix-B at second and third vaccination, which led to the underdose and adult use of a child product. The patient received 3rd dose of Engerix B later than the recommended schedule which led to lengthening of vaccination schedule.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: mixed the powder vial with a sterile diluent; Wrong diluent Menveo given to adolescent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a adolescent 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 wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 22-Jun-2022 Reporters comment: The patient received a dose of Menveo where the powder vial was mixed with sterile diluent instead of the liquid contents in the second vial that was sent with the kit. The reporter consented to follow up. Additional Supportive Information: The patient received Menveo which was not mixed correctly that led to the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact
Clinical narrative: accidently stuck with the needle, syringe contained SHINGRIX adjuvant; accidently stuck with the needle, syringe contained SHINGRIX adjuvant; This case was reported by a pharmacist via call center representative and described the occurrence of accidental occupational exposure to product in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 35l52, expiry date 6th July 2023) for prophylaxis.   On 16th June 2022, the patient received Shingrix. On 16th June 2022, unknown after receiving Shingrix, the patient experienced accidental occupational exposure to product and exposure via skin contact. On an unknown date, the outcome of the accidental occupational exposure to product and exposure via skin contact were unknown.   Additional Information: GSK Receipt Date: 22-JUN-2022 Reporter's Comment: Health Care Professional was the reporter who stated that after drawing up the Shingrix adjuvant from the vial, she accidently stuck herself with the needle. The syringe only contained the Shingrix adjuvant. The adjuvant was disposed of and was not used. The reporter did not consent to follow-up. Additional supportive information:  The HCP (Health Care Professional) stated that after drawing up the Shingrix adjuvant from the vial, she accidently stuck herself with the needle, which led to accidental occupational exposure to product and exposure via skin contact.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: pt vaccinated with an expired dose; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   On 22nd June 2022, the patient received Havrix. On 22nd June 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 22-JUN-2022 Reporter's Comment: Gastroenterologist reported that the patient was vaccinated today (day of reporting) with an expired dose of Havrix.  The reporter consented to follow-up. Additional Supportive Information:  The patient received a dose of Havrix vaccine which was already expired, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st shot on 5 Jun-2018, 2nd dose not yet administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (the patient received the first dose on 5th June 2018).   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: 22-JUN-2022 Reporter's Comments: The reporter gave 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 This case had been linked with US2019117629, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019117629:Same reporter
Age: 32.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: dose that was reconstituted with a sterile water diluent; pt received a dose that was reconstituted with a sterile water diluent; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 32-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA658A, expiry date 31st January 2023) for prophylaxis.   On 20th June 2022, the patient received Menveo. On 20th June 2022, unknown after receiving Menveo, the patient experienced inappropriate dose of vaccine administered and wrong solution used in drug reconstitution. On an unknown date, the outcome of the inappropriate dose of vaccine administered and wrong solution used in drug reconstitution were unknown.   Additional Information: GSK Receipt Date: 22-JUN-2022 Reporter's Comments: The patient received a dose of Menveo that was reconstituted with a sterile water diluent vs the MenCYW-135 liquid conjugate vaccine component. The Vaccine Administration Facility was the same as Primary Reporter. Outside phone number for GlaxoSmithKline Medical Information given for future reference and warm transfer provided. The reporter gave consent to follow up. Additional supportive Information: The patient received a dose of Menveo that was reconstituted with a sterile water diluent which led to inappropriate dose of vaccine administered and wrong solution used in drug reconstitution.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered
Clinical narrative: receive 2 doses on 2020 and then 2 more doses on 2022; receive 2 doses on 2020 and then 2 more doses on 2022; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (patient received 1st dose on 24th June 2020) and Shingrix (patient received 2nd dose on 3rd September 2020).   On 15th June 2022, the patient received the 4th dose of Shingrix. On 16th March 2022, the patient received the 3rd dose of Shingrix. On 16th March 2022, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced extra dose administered. On 15th June 2022, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered and extra dose administered were unknown.    Additional Information: GSK Receipt Date: 22-JUN-2022 Reporter's Comments: The reporter wanted to receive guidance.  The reporter stated that a patient received 2 more additional doses of Shingrix in 2022. The reporter gave consent to follow up by mail. Additional Supportive Information: The patient received 2 additional doses of Shingrix, which led to extra dose administered.; Sender's Comments:  US-GLAXOSMITHKLINE-US2018110009:Same reporter
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered using two different batches; administered using two different batches; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 2-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number M4AR7, expiry date 6th July 2023) and (batch number 5BC7N, expiry date 11th July 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 22nd June 2022, the patient received Rotarix lyophilized formulation. On an unknown date, the dose was an unknown dose. On 22nd June 2022, the patient started Rotarix Oral Applicator Device. On 22nd June 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, 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.   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: 22-June-2022 Reporter's comment: A nurse reported that the Rotarix vaccine was administered to a patient using an approved diluent from a batch with a powder of another batch of Rotarix. The reporter consented to follow-up. Additional supportive information: The patient received the Rotarix vaccine which was reconstituted using two different batches of Rotarix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: vaccinated with expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a male patient who received HAV (Havrix) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   On 22nd June 2022, the patient received Havrix. On 22nd June 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 22-JUN-2022 Reporter's Comments: The reporter stated that a patient was vaccinated with an expired dose of Havrix. The reporter gave consent to follow up. Additional Supportive Information: The patient received dose of Havrix which was already expired in 24th May 2022 which lead to Expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Inappropriate schedule of vaccine administration; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in Jun 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: 22-Jun-2022 Reporter's comments: The patient had not received dose two at the moment of the report. The reporter gave consent 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.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Vaccine reconstituted with sterile water; administration of mixed powder vial with a sterile diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) (batch number x3p72, expiry date 7th November 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 23-June-2022 Reporter's comment: Medical assistance reported that a patient was administrated with Shingrix.  The vaccine was reconstituted with sterile water.  The Vaccine Administration Facility was the same as Primary Reporter. No adverse event was reported. No patient's identifiers was provided. No vaccination date was provided. The reporter consented to follow up.  Additional supportive information: The patient was administrated with Shingrix which was reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: administration of three months expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA648A, expiry date 31st March 2022) for prophylaxis.   On 20th June 2022, the patient received Menveo. On 20th June 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 Information: GSK receipt date: 23-June-2022 Reporter's comment: A nurse reported a maladministration of Menveo as a patient received a three months expired dose of Menveo. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Menveo, which led to expired vaccine used.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, Incorrect route of product administration
Clinical narrative: received expired dose; received dose, Left thigh; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 2-year-old male patient who received HAV (Havrix) (batch number ZJ3G3, expiry date 12th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd June 2022, the patient received the 2nd dose of Havrix and Havrix Pre-Filled Syringe Device. On 22nd June 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used and intramuscular formulation administered by other route. On an unknown date, the outcome of the expired vaccine used and intramuscular formulation administered by other route 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: 23-June-2022 Reporter's comment: The health care professional reported that the patient received an expired dose of Havrix one day before the reporting, in left thigh.  With dose 2 asymptomatic results were reported.  The reporter had more questions regarding how to proceed.  Medical information, phone number and warm transfer were provided. The reporter consented to follow up. Additional supportive information: The patient received an expired dose of Havrix on left thigh, which led to expired vaccine used and intramuscular formulation administered by other route.
Age: 18.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Interchange of vaccine products
Clinical narrative: first Bexsero, gave Trumenba instead of second dose; This case was reported by a consumer via call center representative and described the occurrence of interchange of vaccine products in a 18-year-old male 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 and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   Concomitant products included MENINGOCOCCAL B VACCINE (BEXSERO).   On an unknown date, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 21st June 2022, the patient received TRUMENBA. On 21st June 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products 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: 23-JUN-2022 Reporter's Comment: The patient's mother reported this case. The nurse mistakenly gave Trumenba instead of a second dose of Bexsero to the patient. The reporter had nothing else to report. The reporter consented to follow-up. Might follow up with prescriber. Additional supportive information: The patient mistakenly received Trumenba instead of a second dose of Bexsero, which led to Interchange of vaccine products.
Age: 47.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 47-year-old male patient who received Herpes zoster (Shingrix) (batch number 5A9GE, expiry date 3rd June 2023) for prophylaxis. On 9th June 2022, the patient received Shingrix (subcutaneous). On 9th June 2022, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown. Additional Information: GSK Receipt Date: 23-JUN-2022. Reporter's Comment: The reporter was medical assistant. The reporter stated that, The patient was administered with a dose of Shingrix subcutaneously instead of Intramuscular. The reporter reported that patient had no additional symptoms. Warm transferred HCP to medical information for further guidance and provided adverse event reference number. The reporter consented to follow up. Additional Supportive Information: The patient received dose of Shingrix subcutaneously instead of Intramuscular, which led to intramuscular formulation administered by other route.
Age: 60.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received a dose which expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 60-year-old female patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd June 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 22nd June 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-JUN-2022 Reporter's Comments: The pharmacist reported that inadvertently patient received a dose of Havrix which was already expired. Lot number was provided by the agent who initially took the pharmacist's call before the initial call was disconnected. The reporter consented to follow up. Additional Supportive Information: The use of Havrix dose which was already expired on 18th June 2022, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 6 month mark missed between doses; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix 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 incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.    Additional Information: GSK Receipt Date: 23-JUN-2022 Reporter's Comments: The patient missed the 6 month mark between dose . This query came in via chat, user abandon chat before any further details were obtained. The reporter did not consent to follow up. Additional Supportive Information: Till the time of reporting, the patient had not receive the 2nd dose of Shingrix, which led to incomplete course  of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm hurt a lot; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 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 Information: GSK Receipt Date: 23-Jun-2022 Reporter's Comments: The patient was over the age of 50 years. The patient received 1st dose of Shingrix about 2 years ago in 2020. The patient held off getting the 2nd dose because her because her arm hurt a lot after that first dose. The reporter did not have patient date of birth and vaccination information like date, lot and expiry. The reporter consented to follow up via mail.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: receiving accidentally a 3 dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 71-year-old male patient who received Herpes zoster (Shingrix) (batch number ZG744, expiry date 28th August 2023) for prophylaxis.   Previously administered products included Shingrix (patient received 1st dose of Shingrix on 20th December 2021). Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 15th June 2022, the patient received the 3rd dose of Shingrix. On 15th June 2022, unknown after receiving Shingrix , the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 23-JUN-2022 Reporter's Comments: The reporter stated that the patient receiving accidentally a 3rd dose of Shingrix. The reporter gave consent to follow up. Additional Supportive Information: The patient received 3rd dose which lead to Extra dose administered.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient wants her 2nd dose, states she had her 1st dose in 2018; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On 11st May 2018 the patient received 1st dose of Shingrix. batch no9V, expiry date 25th April 2019).   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: 23-JUN-2022 Reporter's Comments: The registered pharmacist stated that a patient wanted her second dose of Shingrix and received her first dose in 2018.  The reporter gave consent to follow up. Additional supportive Information: Till the time of reporting, the patient did not want to receive 2nd dose of Shingrix, which led to Incomplete course of vaccination.
Sex: U
Vaccine: MNQ
Symptoms: Accidental exposure to product, Exposure via eye contact
Clinical narrative: administrator had an eye exposure; administrator had an eye exposure; This case was reported by a nurse via call center representative and described the occurrence of accidental occupational exposure to product in an administrator who was administering Men ACWY-CRM NVS (Menveo) to a patient for prophylaxis.  On 22nd June 2022, the patient received Menveo. On 22nd June 2022, unknown after receiving Menveo, the patient experienced accidental occupational exposure to product and exposure via eye contact. On an unknown date, the outcome of the accidental occupational exposure to product and exposure via eye contact were unknown.   Additional Information: GSK Receipt Date: 23-JUN-2022 Reporter's Comment: Nurse reported that an administrator had an eye exposure to the Menveo liquid component. The reporter consented to follow-up. Additional supportive information: The administrator had an eye exposure to the Menveo liquid component, which led to accidental occupational exposure to product and exposure via eye contact.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Aspiration joint, Bedridden, Injection site pain, Joint swelling
Clinical narrative: joint swelling; pain radiated to his shoulders; whole body pain; arm pain radiated to his shoulders, down the opposite arm/opposite arm pain; pain in the arm of the vaccination site; bedridden; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included covid-19. Concomitant products included prednisone.   On 14th April 2022, the patient received the 2nd dose of Shingrix. On 14th April 2022, less than a day after receiving Shingrix, the patient experienced injection site pain (serious criteria hospitalization). On 15th April 2022, the patient experienced shoulder pain (serious criteria hospitalization), general body pain (serious criteria hospitalization) and pain in arm (serious criteria hospitalization). On an unknown date, the patient experienced swollen joints (serious criteria hospitalization) and bedridden (serious criteria hospitalization). On an unknown date, the outcome of the injection site pain, shoulder pain, general body pain and pain in arm were unknown and the outcome of the swollen joints was not recovered/not resolved and the outcome of the bedridden was recovered/resolved.   It was unknown if the reporter considered the injection site pain, shoulder pain, general body pain, pain in arm, swollen joints and bedridden to be related to Shingrix.   Additional Information: GSK Receipt Date:23-JUN-2022 Reporter's Comment: The case was reported by the patient. The patient received Shingrix and on the day of the vaccination he had pain in the arm of the vaccination site.  The reporter stated that, the next day the arm pain radiated to his shoulders, down the opposite arm, then whole body pain. The patient stated that, later he developed joint swelling which made him bedridden for two weeks. The patient stated that, the pain and swelling progressed until he was required to be hospitalized for five days.  The patient stated that, his knee required joint aspiration five times. One day after receiving Shingrix, the patient experienced shoulder pain, general body pain and pain in arm. Less than 2 months after receiving Shingrix, the patient experienced swollen joints and bedridden.  ER (emergency room) visit required.  The reporter consented to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: joint swelling; pain radiated to his shoulders; whole body pain; arm pain radiated to his shoulders, down the opposite arm/opposite arm pain; pain in the arm of the vaccination site; bedridden; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included covid-19. Concomitant products included prednisone.   On 14th April 2022, the patient received the 2nd dose of Shingrix. On 14th April 2022, less than a day after receiving Shingrix, the patient experienced injection site pain (serious criteria hospitalization). On 15th April 2022, the patient experienced shoulder pain (serious criteria hospitalization), general body pain (serious criteria hospitalization) and pain in arm (serious criteria hospitalization). On an unknown date, the patient experienced swollen joints (serious criteria hospitalization) and bedridden (serious criteria hospitalization). On an unknown date, the outcome of the injection site pain, shoulder pain, general body pain and pain in arm were unknown and the outcome of the swollen joints was not recovered/not resolved and the outcome of the bedridden was recovered/resolved.   It was unknown if the reporter considered the injection site pain, shoulder pain, general body pain, pain in arm, swollen joints and bedridden to be related to Shingrix.   Additional Information: GSK Receipt Date:23-JUN-2022 Reporter's Comment: The case was reported by the patient. The patient received Shingrix and on the day of the vaccination he had pain in the arm of the vaccination site.  The reporter stated that, the next day the arm pain radiated to his shoulders, down the opposite arm, then whole body pain. The patient stated that, later he developed joint swelling which made him bedridden for two weeks. The patient stated that, the pain and swelling progressed until he was required to be hospitalized for five days.  The patient stated that, his knee required joint aspiration five times. One day after receiving Shingrix, the patient experienced shoulder pain, general body pain and pain in arm. Less than 2 months after receiving Shingrix, the patient experienced swollen joints and bedridden.  ER (emergency room) visit required.  The reporter consented to follow up.
Age: 68.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: pt received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 68-year-old male patient who received HAB (Twinrix) (batch number 75C72, expiry date 13th June 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 23rd June 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 23rd June 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 Information: GSK Receipt Date: 23-JUN-2022 Reporter's Comment: The public health nurse reported that on day of reporting, a patient received an expired dose of Twinrix. The vaccine was expired on 13th June 2022. The reporter consented to follow-up. Additional Supportive Information: The patient received a dose of Twinrix vaccine which was already expired, which led to expired vaccine used.
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: administered 2nd dose too early, 1st dose on 10May2022, 2nd dose administered 23Jun2022; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 16-year-old female patient who received HAV (Havrix) (batch number 532H4, expiry date 21st August 2022) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX).   On 23rd June 2022, the patient received the 2nd dose of Havrix. On 23rd June 2022, unknown after receiving Havrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 23-JUN-2022 Reporter's Comment: The reporter declined to give patient's initials. The patient was administered her second dose of Havrix vaccine too early.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The patient received 2nd dose of Havrix earlier than the recommended schedule, which led to shortening of vaccination schedule.
Age: 25.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: pt 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 25-year-old female patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   On 23rd June 2022, the patient received Havrix. On 23rd June 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 23-JUN-2022 Reporter's comments: A medical assistant reported that the patient received an expired dose of Havrix. The reporter consented to follow up. Additional supportive information: The patient received Havrix which was expired on 18th June 2022, which led to expired vaccine used.