chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 6/13/2019, 2nd dose 2/18/2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 13th June 2019).   On 18th February 2022, the patient received the 2nd dose of Shingrix. On 18th February 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient received the 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. The reporter wanted to inquire and report on how to proceed with Shingrix series, would the patient need to receive 2 doses or an additional dose. The reporter was unable to provide vaccine details. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose Sep2019, no 2nd dose yet / 1st 2 years ago; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in September 2019, intramuscularly).   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 self reported by the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The patient received Shingrix 2 years ago and was asking what should be done. The reporter did not have lot number, expiry date and date of administration for the first dose of Shingrix. The reporter consented to follow up with Healthcare professional. However, had very limited Healthcare professional contact information.
Sex: M
Vaccine: VARZOS
Symptoms: Syringe issue, Underdose
Clinical narrative: didn't receive full dose; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a male patient who received Herpes zoster (Shingrix) (batch number 42cm4, expiry date 11th June 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced underdose. On an unknown date, the outcome of the underdose was unknown.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The reporter stated that while administering Shingrix the syringe broke and some vaccine was lost and the patient did not receive full dose, which led to underdose. The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: sore arm; Headache; fever; chills; upset stomach; fatigue; vomited once; soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th February 2022 18:30, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th February 2022, 1 days after receiving Shingrix, the patient experienced pain in arm, headache, fever, chills, upset stomach, fatigue, vomiting and injection site pain. On an unknown date, the outcome of the pain in arm, vomiting and injection site pain were recovered/resolved and the outcome of the headache, fever, chills, upset stomach and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, headache, fever, chills, upset stomach, fatigue, vomiting and injection site pain to be related to Shingrix.  Additional details were reported as follows: The patient received a dose of Shingrix and next day experienced sore arm, headache, fever, chills, upset stomach, fatigue and he vomited once. The soreness in his arm had resolved, but he was still experiencing all the other symptoms listed till the time of reporting. Consent to follow up was granted.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: sore arm; Headache; fever; chills; upset stomach; fatigue; vomited once; soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th February 2022 18:30, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th February 2022, 1 days after receiving Shingrix, the patient experienced pain in arm, headache, fever, chills, upset stomach, fatigue, vomiting and injection site pain. On an unknown date, the outcome of the pain in arm, vomiting and injection site pain were recovered/resolved and the outcome of the headache, fever, chills, upset stomach and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, headache, fever, chills, upset stomach, fatigue, vomiting and injection site pain to be related to Shingrix.  Additional details were reported as follows: The patient received a dose of Shingrix and next day experienced sore arm, headache, fever, chills, upset stomach, fatigue and he vomited once. The soreness in his arm had resolved, but he was still experiencing all the other symptoms listed till the time of reporting. Consent to follow up was granted.
Age: 64.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: administered dose, expiration of 08Feb2022; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 64-year-old male patient who received HAB (Twinrix) (batch number DK23D, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th February 2022, the patient received the 1st dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 17th February 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient was administered an expired dose of Twinrix, which led to expired vaccine used. At the time of reporting, the dose had not been repeated.  The Vaccine administration facility was the same as Primary reporter. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose a little over a year ago; This case was reported by a pharmacist 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 over a year ago, from the day of reporting).   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, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The reporter was not sure what the recommendations were for dosing now. No additional details were provided on voicemail. The reporter consented to follow up. Due to to time difference, specialist was unable to make callback and hence, no additional information was available.
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: Overdose
Clinical narrative: received the full 1 milliliter dose; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 18-year-old male 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 February 2022, the patient received Havrix 1 ml and Havrix Pre-Filled Syringe Device. In February 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The patient received a 1ml dose of Havrix instead of 0.4 ml dose which led to overdose and inappropriate age at vaccine administration. Consent to follow up was denied. This case was linked to US2022031545 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022031545:same reporter
Age: 15.0
Sex: M
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: 15 year old patient received the full 1 milliliter dose; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 15-year-old male 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 February 2022, the patient received Havrix 1 ml and Havrix Pre-Filled Syringe Device. In February 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated a 15 year old patient received the full 1 milliliter dose of Havrix this weekend, which led to overdose. The recommended dose for this age was 0.4 milliliter.  The reporter was requesting information regarding potential side effects of the over dose and recommendations for next steps.  The reporter stated that she already reported this event to VAERS. The reporter had not provided additional details. The reporter did not consent to follow-up. The case had been linked to US2022031543, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022031543:same reporter
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: Patient received expired dose; Was 1st dose of dtap; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 15-month-old male patient who received DTPa (Infanrix) (batch number unknown, expiry date 6th February 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st February 2022, the patient received the 1st dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 21st February 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used and inappropriate age at vaccine administration. On an unknown date, the outcome of the expired vaccine used and inappropriate age at vaccine administration 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 medical assistant reported that a patient received an expired dose of Infanrix which was already expired in 6th February 2022, which led to expired vaccine used.  The health care professional indicated it was first dose of dtap received at the age of 15 month, which led to inappropriate age at vaccine administration. The lot number was not provided. The reporter consented to follow up.
Age: 10.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 10 year old was administered PEDIARIX; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 10-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 5N259, expiry date 5th October 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th February 2022, the patient received Pediarix (intramuscular) .5 ml and Pediarix Pre-Filled Syringe Device. On 17th February 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received Pediarix in left deltoid. The patient received Pediarix at the age of 10 years, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2019, no 2nd dose yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 88-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in year 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, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter did not consent to follow up.
Sex: M
Vaccine: HIBV
Symptoms: Haemophilus test, Therapeutic response decreased, Viral titre decreased
Clinical narrative: low tiers for Hiberix; This case was reported by a nurse via call center representative and described the occurrence of therapeutic response decreased in a 46-year-old male patient who received Hib (Hiberix) for prophylaxis.   Concurrent medical conditions included asplenia.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The asplenic patient had low titers for Hiberix, which led to decreased therapeutic response. No lot number and expiration date provided. No vaccination date provided. The Vaccine Administration Facility is the same as Primary Reporter The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: did not receive the second dose at 6 months; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 22nd November 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 Doctor of medicine. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The reporter asked if the patient should still receive the second dose or do they have to restart the series. The reporter consentd to follow up via postal.
Age: 39.0
Sex: U
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: asked for a shingles vaccine despite needing a varicella vaccine; patient is 39 year old and was administered Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 39-year-old 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 wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The pharmacist reported that a 39-years-old patient asked for a shingles vaccine despite needing a varicella vaccine and the patient would be going to travel which he was administered with Shingrix, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Mobility decreased, Spondylitis
Clinical narrative: arthritis in spine/worsening of arthritis in spine; worsening of arthritis in spine; could not sit up; This case was reported by a consumer via call center representative and described the occurrence of spondylarthritis in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included spondylarthritis (had severe arthritis in spine prior to dose).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced spondylarthritis, condition aggravated and mobility decreased. The patient was treated with steroids nos (Steroid Shot (Nos)) and prednisone. On an unknown date, the outcome of the spondylarthritis was not recovered/not resolved and the outcome of the condition aggravated and mobility decreased were unknown.   It was unknown if the reporter considered the spondylarthritis, condition aggravated and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received Shingrix a few months ago from reporting date.  The patient reported that received her dose on a Thursday and on Friday, she could not sit up due to the worsening of her arthritis in her spine.  The patient went to see her physician the following Monday where she received a steroid shot and prednisone dose pack and she continued to experience arthritis of her back. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose in 2018, never got second; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1t dose received on 26th February 2018, batch number FJ57S, expiry date unknown).   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 patient got her first dose on shingrix back in 2018 and she never got the second dose, which led to incomplete course of vaccination. The reporter asked if 4 years was too long because all literature says over 6 months they do not have to repeat the first dose. The reporter consented to follow up.
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received a first dose on 04-aug-2021 and the second dose 23-nov-2021; This case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too long in a 54-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 on 4th August 2021).   On 23rd November 2021, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 23rd November 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 details were provided as follows: The age at vaccination was unknown. The patient received second dose later than the recommended interval, which led to lengthening of vaccination schedule. No further events were reported. The reporter agreed to be contacted for follow-up. The Vaccine Administration Facility is the same as Primary Reporter.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental overdose
Clinical narrative: received 1st within 10 minutes, given 2nd; This case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 23J2S, expiry date unknown) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 21st February 2022, the patient received the 2nd dose of Shingrix .5 ml. On 21st February 2022, unknown after receiving Shingrix, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose was unknown.  Additional details were provided as follows: The pharmacy student reported that, the patient received her 1st dose of Shingrix and within 10 minutes, was accidentally given a 2nd dose, which led to accidental overdose. No symptoms reported. The reporter did not have the expiration date at the time of report. The other reporter (Clinic director) also reported about same patient, the reporter did not have lot number but provided with NDC TPA160-82311. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022031607:FU1 - Deleted
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Experiencing tiredness and fatigue; This case was reported by a pharmacist via call center representative and described the occurrence of tiredness in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 7797J, expiry date 12th May 2023) for prophylaxis.   On 16th February 2022, the patient received the 1st dose of Shingrix. In February 2022, less than a week after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was not recovered/not resolved.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix vaccine and was now experiencing tiredness and fatigue. The vaccine administration facility was the same as primary reporter. No further information reported. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hives that lasted for 5 days and resolved.; This case was reported by a consumer via call center representative and described the occurrence of hives in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2021, the patient received the 1st dose of Shingrix. In November 2021, immediately after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was recovered/resolved.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and experienced hives almost immediately after the dose. The hives lasted for 5 days and resolved. The reporter did not consent to follow-up.
Age: 17.0
Sex: M
Vaccine: HEPA
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: 17 year old male received an adult 1.0 ml dose of Havrix; 17 year old male received an adult 1.0 ml dose of Havrix; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 17-year-old male patient who received HAV (Havrix adult) (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 16th February 2022, the patient received the 1st dose of Havrix adult 1 ml and Havrix Pre-Filled Syringe Device. On 16th February 2022, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child 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 case was reported by Clinical Supervisor. The patient received an adult dose of Havrix, which led to overdose and adult product administered to child. No symptoms were reported. The reporter consented to follow up.
Sex: U
Vaccine: MMRV, MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: component of Menveo reconstituted with the MMR varicela vaccine diluent; component of Menveo reconstituted with the MMR varicela vaccine 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 Men ACWY-CRM NVS (Menveo) (batch number amva604a, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included MMRV VACCINE for prophylaxis.   On 17th February 2022, the patient received Menveo and MMRV VACCINE. On 17th February 2022, 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 details were provided as follows: The age at vaccination was not reported. The patient was inadvertently administrated a dose of the lyophilized component of Menveo reconstituted with the MMR varicella vaccine diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No further events were reported. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Note: The start date of Menveo conservatively captured as 17th February 2022 as there is a discrepancy.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: administrated reconstituted with sterile water; administrated reconstituted with sterile water; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 5f3t5, expiry date 26th May 2023) for prophylaxis.   On 18th February 2022, the patient received Shingrix. On 18th February 2022, 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 details were provided as follows: The patient inadvertently administrated the lyophilized component of Shingrix reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No further events were reported. The reporter agreed to be contacted for follow-up The Vaccine Administration Facility was the same as Primary Reporter.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Eyelid rash, Herpes zoster, Rash pruritic, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles outbreak; rash on head/itchy rash; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In February 2022, more than 2 years after receiving Shingrix and Shingrix, the patient experienced suspected vaccination failure (serious criteria GSK medically significant), shingles and itchy rash. On an unknown date, the outcome of the suspected vaccination failure was unknown and the outcome of the shingles and itchy rash were recovered/resolved.   It was unknown if the reporter considered the suspected vaccination failure, shingles and itchy rash to be related to Shingrix and Shingrix.  Additional details were reported as follows: The reporter was the patient. The age at vaccination was not reported. The patient received both doses of Shingrix in 2019. The patient experienced shingles outbreak approximately 2 weeks before the date of reporting.  The patient had a rash on right eyelid and on the head, and rash was itchy. In February 2022, rash, accompanying itch resolved and shingles were resolved. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were not unknown at the time of reporting. The reporter did not consent to follow-up. This case has been linked to US2022031562, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022031562:Same reporter.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles outbreak; rash on head/itchy rash; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In February 2022, more than 2 years after receiving Shingrix and Shingrix, the patient experienced suspected vaccination failure (serious criteria GSK medically significant), shingles and itchy rash. On an unknown date, the outcome of the suspected vaccination failure was unknown and the outcome of the shingles and itchy rash were recovered/resolved.   It was unknown if the reporter considered the suspected vaccination failure, shingles and itchy rash to be related to Shingrix and Shingrix.  Additional details were reported as follows: The reporter was the patient. The age at vaccination was not reported. The patient received both doses of Shingrix in 2019. The patient experienced shingles outbreak approximately 2 weeks before the date of reporting.  The patient had a rash on right eyelid and on the head, and rash was itchy. In February 2022, rash, accompanying itch resolved and shingles were resolved. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were not unknown at the time of reporting. The reporter did not consent to follow-up. This case has been linked to US2022031562, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022031562:Same reporter.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Eyelid rash, Herpes zoster, Rash pruritic, Vaccination failure
Clinical narrative: Shingles outbreak after receiving both doses/Suspected vaccination failure; Shingles outbreak; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient was reporter's family friend. The age at vaccination was not reported. The patient experienced shingles outbreak after receiving both doses of Shingrix. No demographics provided for the patient. The caller did not consent to follow-up. This case was considered as suspected vaccination failure as details regarding the time to onset and laboratory test confirmation for shingles were unknown at the time of reporting. The case was linked with case US2022031561, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022031561:Same reporter.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shingles outbreak after receiving both doses/Suspected vaccination failure; Shingles outbreak; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient was reporter's family friend. The age at vaccination was not reported. The patient experienced shingles outbreak after receiving both doses of Shingrix. No demographics provided for the patient. The caller did not consent to follow-up. This case was considered as suspected vaccination failure as details regarding the time to onset and laboratory test confirmation for shingles were unknown at the time of reporting. The case was linked with case US2022031561, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022031561:Same reporter.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: throbbing pain in her upper body; This case was reported by a consumer via call center representative and described the occurrence of throbbing pain in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th October 2021, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced throbbing pain. On an unknown date, the outcome of the throbbing pain was not recovered/not resolved.   It was unknown if the reporter considered the throbbing pain to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine (didn't remember which arm) and few days later she experienced throbbing pain in her upper body that was still continues (on and off) today (day of reporting). The patient stated that she had been to the ER x 2 since then. ER (emergency room) visit required. No further information reported. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the 1st dose of Shingrix 2 years ago; 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 (received 1st dose 2 years ago from the date of reporting, before Covid pandemic).   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, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. At the time of reporting, the patient wanted the 2nd dose. The reporter did not have the patient's date of birth or the exact date of vaccination. The reporter consented to follow up.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: a dose of Menveo/ Fluarix on February 19th 2022 and  second dose on February 21st 2022; dose of Bexsero on February 19th 2022 and  second dose on February 21st 2022; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA568A, expiry date 31st May 2022) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) (batch number ABXB29BA, expiry date 30th June 2022) for prophylaxis, meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 3xe27, expiry date 30th June 2022) for prophylaxis and flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included Men ACWY-CRM NVS (Menveo), Men B NVS (Bexsero) and Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season).   On 21st February 2022, the patient received the 2nd dose of Menveo, the 2nd dose of Bexsero, Bexsero Pre-Filled Syringe Device, the 2nd dose of Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 21st February 2022, unknown after receiving Menveo, Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device and not applicable after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced extra dose administered and drug dose administration interval too short. On an unknown date, the outcome of the extra dose administered and drug dose administration interval too short 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 patient received 2nd dose of Menveo and Fluarix Quadrivalent 2021-2022 season, which led to extra dose administered and 2nd dose of Bexsero, earlier than the recommended schedule which led to shortening of vaccination schedule. The reporter did not consent to follow-up. The Vaccine Administration Facility is the same as Primary Reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022032526:case deleted US-GLAXOSMITHKLINE-US2022032527:case deleted
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: administrated an expire dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number unknown, expiry date 15th January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th February 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 16th February 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient was inadvertently administrated an expired dose of Kinrix, which led to expired vaccine used.  No further events were reported.  The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Received dose 1 on 10-feb-2021, she forgot to get dose 2; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 10th February 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided 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 Shingrix, which led to incomplete vaccination schedule. The reporter asked if it was safe to get 2nd dose at the time of reporting.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Hot flush, Incomplete course of vaccination, Influenza like illness
Clinical narrative: extreme chills; hot flashes intermittently; has not yet gotten her second vaccine; minor flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In July 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. 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 influenza-like symptoms, chills, hot flashes and incomplete course of vaccination. On an unknown date, the outcome of the influenza-like symptoms, chills and hot flashes were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the influenza-like symptoms, chills and hot flashes to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and experienced minor flu like symptoms for about 3 days. The following 4-10 days post vaccine, she had extreme chills and hot flashes intermittently. All of her symptoms had resolved. The patient was unsure if she made a visit to the hospital during the time she was experiencing the chills and hot flashes.  Till the time of reporting the patient did not receive 2nd dose of Shingrix because was wary of the side effects, which led to incomplete course of vaccination. Spoke per content and referred to HCP(health care professional). The reporter consented to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose a year ago, no 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 male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose over a year ago from the date of reporting).   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, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. No more information provided by the reporter. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2019, has not received the 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 20th October 2019, batch number 3HT5J, expiry date 26h January 2022 in left deltoid).   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, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter consented to follow up.