chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the 2nd dose of Shingrix only 3 weeks apart from the first dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   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 short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received the 2nd dose of Shingrix only 3 weeks apart from the first dose, which led to shortening of vaccination schedule. Also mentioned this was very long before from day of reporting and that if they administer another 2nd dose to the patient that would be a late second dose. The healthcare professional did not have any vaccine data or dates, they were administered at another pharmacy. The reporter consented to follow up.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect product formulation administered
Clinical narrative: did not mix Shingrix adjuvant suspension into Lyophilized gE Antigen; patient received Shingrix adjuvant suspension only; This case was reported by a consumer via call center representative and described the occurrence of inappropriate preparation of medication in a 57-year-old male patient who received Herpes zoster (Shingrix) (batch number H4H34, expiry date 27th November 2021) for prophylaxis.   On 26th April 2021, the patient received Shingrix. On 26th April 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The case was reported by buyer who supplied Shingrix vaccine to the long term care facility.  As per the reporter, the registered Nurse did not mix Shingrix adjuvant suspension into Lyophilized AgE Antigen. The patient received Shingrix adjuvant suspension only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  The reporter did not have details regarding, in which arm vaccination was given, first or second dose and the patient's Heath care Professional. The reporter consented to follow up.
Age: 66.0
Sex: M
Vaccine: HEPAB, HEPAB, HEPAB
Symptoms: Blood test, Hepatitis A antibody positive, Hepatitis B antibody negative, Serology test, Therapy non-responder
Clinical narrative: Took a blood test / there were / no antibodies to Hep B (low titers); but no antibodies to Hep B (low titers); This case was reported by a consumer via call center representative and described the occurrence of therapy non-responder in a 67-year-old male patient who received HAB (Twinrix) (batch number 9RT94, expiry date 24th May 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, HAB (Twinrix) (batch number 3PP42, expiry date 16th March 2022) for prophylaxis, hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) (batch number H4A37, expiry date 18th October 2021) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th February 2020, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 17th September 2019, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 17th August 2019, the patient received the 1st dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 26th March 2021, 405 days after receiving Twinrix and Twinrix Pre-Filled Syringe Device, 556 days after receiving Twinrix and Twinrix Pre-Filled Syringe Device and 587 days after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced therapy non-responder and hepatitis b antibody negative. On an unknown date, the outcome of the therapy non-responder and hepatitis b antibody negative were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows:  The caller was patient himself. On 26th March 2021, the caller reports his HCP took a blood test and reported there were antibodies to Hep A, but no antibodies to Hep B (low titers), which led to therapy non-responder and hepatitis b antibody negative. The caller does not give permission to contact HCP. The reporter did not consent to follow up.
Age: 61.0
Sex: M
Vaccine: COVID19, VARZOS
Symptoms: Back pain, Pain, Pain in extremity, Pruritus, Rash
Clinical narrative: Sunburn-like pain on his back; Sunburn-like pain on his back; Rash on his back / patch-like rash on his back; Itching on his back; Left arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included TOZINAMERAN (COVID-19 VACCINE PFIZER) for prophylaxis.   Concomitant products included TOZINAMERAN (COVID-19 VACCINE PFIZER).   On 3rd March 2021, the patient received the 1st dose of Shingrix. On 8th April 2021, the patient received the 2nd dose of COVID-19 VACCINE PFIZER. On 4th March 2021, 1 days after receiving Shingrix, the patient experienced pain in arm. On 19th April 2021, the patient experienced pain burning, back pain, patchy rash and localised pruritus. The patient was treated with lidocaine, dermatologicals nos (Lotion) and ambiguous medication nos (Cortisone (Nos)). On 8th March 2021, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the pain burning, back pain, patchy rash and localised pruritus were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, pain burning, back pain, patchy rash and localised pruritus to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself. The patient was vaccinated with Shingrix in his left arm. The patient had left arm pain next day after vaccination with Shingrix. On 18th March 2021, the patient was vaccinated with 1st dose of Pfizer Covid vaccine in his right arm. On 8th April 2021, the patient was vaccinated with 2nd dose of Pfizer Covid vaccine in his right arm. On 19th April 2021, 1 days after receiving Pfizer Covid vaccine and 47 days after Shingrix vaccine, the patient experienced Sunburn-like pain, itching and rash on his back. On 26th April 2021, the patient experienced patch-like rash on his back. The patient used over the counter lotions, cortisone, and Lidocaine P. The patient did not receive his second Shingrix vaccination. The patient did not share any information except his name and date of birth. The lot number and expiration date of Shingrix vaccination was not known.  The reporter did not share if he received his vaccine at a pharmacy or his Heath Care Professional's office. The reporter did not consent to follow up. It was unknown if the reporter considered the back pain, pain burning, patchy rash and localized pruritus to be related to Pfizer Covid vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix more than 2 years ago on 17Feb2019 / not received the second dose; This case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on 17th February 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 details were reported as follows: The age at vaccination was not applicable for this report. The 1st dose was received more than 2 years ago from reporting date. Till the time of reporting, the patient did not receive the 2nd dose of the Shingrix, which led to incomplete course of vaccination. The patient had received 1st dose of Shingrix at primary reporter's facility. No vaccine data was reported. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st vaccine on 05/22/2018 and it in the pharmacy today for 2nd dose; This case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on 22nd May 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. On the day of reporting, the patient was in pharmacy to receive 2nd dose.  The reporter asked Medical Information to see if it was safe to administer 2nd dose or whether the patient had to restart the series. Till the time of reporting, the patient did not receive the 2nd dose of the Shingrix, which led to incomplete course of vaccination. The reporter did not had lot number and expiration date for 1st dose. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient had his 1st dose of Shingrix on 3/10/2019 / has not had a 2nd dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 10th March 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 details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient received 1st dose of Shingrix at primary reporter's facility.
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administration of a dose of Kinrix to an 18 month old patient; third dose in the series was Kinrix; 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 18-month-old female patient who received DTPa-IPV (Kinrix) (batch number H9Y52, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pentacel (received 1st dose of the DTPa series in 2019 at 2 months age) and Pediarix (received 2nd dose of the DTPa series on 25th August 2020 at 11 months of age).   On 26th April 2021, the patient received the 3rd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 26th April 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. The action taken with Kinrix Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was a medical assistant. The (18 month old) patient received Kinrix as 3rd dose of the DTPa series by mistake, which was led to inappropriate age at vaccination and wrong vaccine administered. Reporter consented to follow-up.
Age: 0.75
Sex: M
Vaccine: HEPA
Symptoms: Wrong product administered
Clinical narrative: Havrix was administered to a 9 months of age patient instead of Hiberix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 9-month-old male patient who received HAV (Havrix) (batch number Y4FL4, expiry date 28th January 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th April 2021, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 13th April 2021, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine 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 details were provided as follows:  The registered nurse reported that a dose of Havrix was administered to a patient instead of Hiberix, which led to wrong vaccine administered. The reporter consent to follow up.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: given an expired dose of Menveo / 27Apr2021 / expired in March 2021; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA268A, expiry date 31st March 2021) for prophylaxis.   On 27th April 2021, the patient received the 1st dose of Menveo. On 27th April 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient was given an expired dose of Menveo, expired on 31st March 2021, which led to expired vaccine used. No symptoms were reported. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received dose one of Shingrix in 2019 /is past due for dose two; 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 female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on an unknown date in 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 details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of the Shingrix, which led to incomplete course of vaccination. The patient was past due for dose two now. The reporter did not provide exact date of dose one.  The reporter did not had the lot number or expiration date to provide. The reporter consent to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Pain in extremity, Rash
Clinical narrative: rash / on her left arm; pain on her left arm; has not received her second dose of Shingrix; This case was reported by a consumer via call center representative and described the occurrence of rash in a 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.   On 1st September 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced rash, pain in arm and incomplete course of vaccination. On an unknown date, the outcome of the rash and pain in arm were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the rash and pain in arm to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported for the 1st dose.  The age at the vaccination was not applicable for 2nd dose. The patient received dose of Shingrix vaccine in left arm and experienced rash and pain on her left arm. Till the time of reporting patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient was told by her HCP to receive her 2 doses of Covid vaccine after her first dose of Shingrix. The patient was unsure of the type of Covid vaccine and specific dates but received 2 Covid vaccinations. The caller wished to remain anonymous and does not give permission to follow up. The patient did accept Medical Information telephone number to share with her health care professional. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: gap between dose 1 and dose 2 would be > 18 months; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 21st August 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 details were provided as follows: The age at vaccination was not applicable for this report. The reporter had a patient that was requesting that they complete her Shingrix series however, gap between dose 1 and dose 2 would be more than 18 months. Till the time of reporting, patient did not receive 2nd dose, which led to incomplete course of vaccination. The reporter was looking for safety and efficacy data and to determine if this dose would be appropriate. The reporter mentioned that, first shot for this female patient was not given at his pharmacy therefore he was not able to provide the lot number and expiration or the route of administration. The consent to follow-up was granted. This case had been linked with US2021094168, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021094168:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: the gap between dose 1 and dose 2 would be > 18 months; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 87-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 21st August 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 details were provided as follows: The case was reported by the pharmacist on behalf of patient's wife via web. The age at vaccination was not applicable for this report. The reporter had a patient that was requesting that they complete her Shingrix series however, gap between dose 1 and dose 2 would be more than 18 months. Till the time of reporting, patient did not receive 2nd dose, which led to incomplete course of vaccination. The reporter was looking for safety and efficacy data and to determine if this dose would be appropriate. The pharmacist explained that patient's wife told him that they both received the 1st dose on the same day. The consent to follow-up was granted. This case had been linked with US2021094169, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021094169:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose was given on 13Mar2020 / second dose had not been given yet; This case was reported by a pharmacist 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 on 13th March 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional case details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination. The reporter called for information regarding the completion of the dosing schedule for the Shingrix vaccine. The reporter did not have complete patient or vaccine information but could find it if enough time was available. The reporter consented to follow up by mail.
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic reactions; This case was reported by a physician via call center representative and described the occurrence of anaphylactic reaction in a 64-year-old 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 anaphylactic reaction (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylactic reaction was unknown.   It was unknown if the reporter considered the anaphylactic reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced anaphylatic reaction to Shingrix few years before the date of reporting, but does not remember when it happened. The patient would like to get Covid -19 vaccine and would like to know if it would safe or have similar preservatives as of Shingrix. No other details of vaccine were available at the time of reporting. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix on August 11th, 2019 / not received the second dose yet; This case was reported by a pharmacist 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 on 11th August 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 case details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of vaccine which led to incomplete course of vaccination. The reporter did not provide more information. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received 1st and only dose of Shingrix in 2018; This case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a 82-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 1st January 2018).   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 case details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: received only the first dose on Twinrix on December 2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 30-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 (1st dose received in December 2020).   On an unknown date, the patient received 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 case details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination. The patient was late for the second dose of Twinrix. No adverse event was reported. The vaccine lot number, vaccine expiration date and vaccination date was not provided. The VAERS information was reported for 1st dose of vaccine. The reporter consented to follow up.
Age: 13.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Interchange of vaccine products
Clinical narrative: received a dose of Menactra, March 2016 / 4 months later (07/13/2016) / dose of Menveo; This case was reported by a nurse via call center representative and described the occurrence of interchange of vaccine products in a 13-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included Menactra for prophylaxis.   On 13th July 2016, the patient received Menveo. In March 2016, the patient started Menactra at an unknown dose and frequency. On 13th July 2016, unknown after receiving Menveo, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products was unknown.  Additional details were reported as follows: The patient received dose of Menactra and 4 months later the patient received a dose of Menveo which led to interchange of vaccine products. All patient identifiers were reported.No Batch number or Expiration date reported when asked. No further clarifications. Consented to follow up. No further information was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose of Shingrix on Jan 2019 / second dose yesterday (April 26th, 2021); This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on January 2019).   On 26th April 2021, the patient received the 2nd dose of Shingrix. On 26th April 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule. No further information available. The patient did not consent to follow up.
Sex: M
Vaccine: COVID19, VARZOS
Symptoms: Dementia
Clinical narrative: had Shingrix and Covid vaccines and suddenly has Dementia; This case was reported by a consumer via call center representative and described the occurrence of dementia in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included covid-19 vaccine for prophylaxis.   On an unknown date, the patient received Shingrix and covid-19 vaccine at an unknown dose and frequency. On an unknown date, unknown after receiving Shingrix, the patient experienced dementia (serious criteria GSK medically significant). On an unknown date, the outcome of the dementia was not recovered/not resolved.   It was unknown if the reporter considered the dementia to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's friend. The patient had Shingrix and Covid vaccines and suddenly had dementia. It was unknown if the reporter considered the dementia to be related to covid-19 vaccine. The reporter had very few details. All information was not available. The reporter did not consent to follow-up.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Experienced rash; This case was reported by a physician via sales rep and described the occurrence of rash in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th December 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows:  The patient experienced rash after 1st dose but she did not report it . On 5th February 2021 and on 5th March 2021, patient received 1st dose and 2nd dose of Covid Moderna prior to 2nd Shingrix vaccination. The reporter did not have information about dose, route of administration, site of injection, lot number or expiration date and information about the patient such as demographics or telephone number. The reporter consent to follow up. This case has been linked with US2021AMR093961, reported for the 2nd dose of same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR093961:Same reporter.
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient / received / first dose / on 28Nov2020 and / second on 24Apr2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received HAB (Twinrix) (batch number 57E3G, expiry date 20th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 28th November 2020).   On 24th April 2021, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 24th April 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional information was provided as follows: The age at vaccination was not reported.  The reporter declined to provide patient data. The pharmacist reported that the patient received a late 2nd dose for Twinrix, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Sex: M
Vaccine: HEP
Symptoms: Accidental underdose, Syringe issue
Clinical narrative: Wiiggled / needle came out / attached a new needle and applied the remaining dose; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a male patient who received HBV (Engerix B pediatric) (batch number 7574E, expiry date 29th December 2022) for prophylaxis.   On 27th April 2021, the patient received the 1st dose of Engerix B pediatric. On 27th April 2021, unknown after receiving Engerix B pediatric, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.  Additional details were provided as follows: The patient didn't have a name at the time of the call. The reporter informed while administering the vaccine, the new born baby wiggled and the needle came out then the new needle was attached and applied the remaining vaccine. The reporter was sure some of the vaccine was lost but didn't know how much, which led to accidental underdose. The reporter did not say anything about the patient or the reporter getting in touch with the leaking vaccine. The reporter consented to follow up.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Hypersensitivity
Clinical narrative: Severe allergic reaction that led to a hospitalization; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 57-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2017-2018 season) (batch number DM9N3, expiry date 30th April 2018) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th October 2017, the patient received FluLaval Tetra 2017-2018 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Tetra 2017-2018 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced allergic reaction (serious criteria hospitalization). On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to FluLaval Tetra 2017-2018 season and Flulaval Tetra Pre-Filled Syringe Device.  This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The case was reported by the patient himself. The patient suffered from the severe allergic reaction that led to hospitalization. The reporter did not consent to follow up.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Incomplete course of vaccination
Clinical narrative: Red patch on his arm; Hot patch on his arm; This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced localized erythema and localized feeling of warmth. On an unknown date, the outcome of the localized erythema and localized feeling of warmth were unknown.   It was unknown if the reporter considered the localized erythema and localized feeling of warmth to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient for himself. Age of patient calculated by reported date of birth of patient and date of vaccination. Reporter stated that after receiving the 1st dose of Shingrix patient had experienced a red-hot patch on his arm. Till the time of reporting, the patient did not receive the 2nd dose of the Shingrix because of the Covid pandemic. The patient did not had the virus but did not got an appointment for the second Shingrix dose. All information was not available. The reporter consent to follow up. For 2nd dose refer linked case id US2021AMR094040.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR094040:Same reporter. US-GLAXOSMITHKLINE-US2021093365:Same reporter. Wife's case. 1st dose. US-GLAXOSMITHKLINE-US2021AMR094049:Same reporter. Wife's case. 2nd dose.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Influenza, Skin warm
Clinical narrative: red-hot patch on her arm; Hot patch; Flu symptoms that last one or two days; This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced localized erythema, feeling hot and flu symptoms. On an unknown date, the outcome of the localized erythema, feeling hot and flu symptoms were recovered/resolved.   It was unknown if the reporter considered the localized erythema, feeling hot and flu symptoms to be related to Shingrix.  Additional details were reported as follows: The case was reported by spouse of patient. The reporter stated that after receiving the 1st dose of Shingrix patient had experienced a red-hot patch on her arm and flu symptoms that lasted one or two days.  Till the time of reporting, the patient did not receive the 2nd dose of the Shingrix because of the Covid pandemic. The patient did not had the virus but did not get an appointment for the second Shingrix dose. The reporter inquired could the patient still get her 2nd dose. All information was not available. For the tolerance of 2nd dose refer US2021AMR094049 this case. This was 1 of 3 cases reported by same reporter. The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR094049:Same reporter. US-GLAXOSMITHKLINE-US2021AMR094040:Same reporter. Husband's case. 2nd dose. US-GLAXOSMITHKLINE-US2021093364:Same reporter. Husband's case. 1st dose.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient is over a year past due for dose two of Shingrix; This case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix. (1st dose received 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 details were provided as follows:  The age at vaccination was not applicable for this report. The age group was not reported but was captured as adult as per vaccine indication. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The pharmacist reports the patient was over a year past due for dose two of Shingrix. The healthcare professional did not provide any patient demographics, lot number, expiration date, or exact date of 1st dose of Shingrix. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: gets the first Shingrix/ in 2019 /waits until 2021 to ask for the 2nd; . This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 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 details were provided as follows:  The age at vaccination was not applicable for this report. The age group was not reported but was captured as adult as per vaccine indication. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The pharmacist asked for the 2nd Shingrix shot do they need to start the 2 dose series over again or should they just get the 2nd shot after 2 years had passed and not worry about it anymore. The reporter consent to follow up.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: administered on 02/04/2021.an expired dose 1 of kinrix (expired on 02/02/2021); 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 X2X42, expiry date 2nd February 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th February 2021, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 4th February 2021, 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 details were provided as follows: The patient received an expired dose of Kinrix vaccine. The reporter would like to know what was the grace period and if needs to revaccinate. The reporter consented to follow up.
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: vaccinated before the specified age; Kinrix received was the patient's 3rd dose of DTaP and IPV; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-month-old female patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included DTaP and IPV.   On 26th April 2021, the patient received the 3rd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 26th April 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule 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 details were provided as follows: The age at the vaccination was not reported. The patient received Kinrix and it was patient's 3rd dose of DTaP and IPV, but she was vaccinated before the specified age in the PI, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. No further details reported at the time of reporting. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: administered the Shingrix second dose with less than the recommended time; This case was reported by a pharmacist and described the occurrence of drug dose administration interval too short in a 73-year-old male patient who received Herpes zoster (Shingrix) (batch number 394KF, expiry date 14th October 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after receiving Shingrix, 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 details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix, less than the recommended time interval, which led to shortening of vaccination schedule. The health care provider asked for scheduled time for Shingrix to decide how to proceed with 2nd dose. The reporter consented to follow up. This case has been linked with US2021094192, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021094192:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix in 2019. Has not received a 2nd dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 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 details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The VAERS details reported for 1st dose of vaccine.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Havrix vaccines / exposed to freezing temperatures since 13Apr2021 until 26Apr2021 / might have administered the vaccines after the excursion; This case was reported by a other health professional via call center representative and described the occurrence of product storage error in a patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   In April 2021, 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 product storage error. On an unknown date, the outcome of the product storage error was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follow: The reporter was a clinic manager. The age at vaccination was not reported. The Havrix was exposed to freezing temperature since 13th April 2021 until 26th April 2021, which leads to product storage error. The reporter stated that they might had administered the vaccines after the excursion, they were not sure at the moment of reporting. The reporter consented to follow up via email. No further information was reported.