chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: 2 months later / only administered the lyophilized powder mixed with normal saline; Inappropriate dose of vaccine administered; received the 1st dose of adjuvant suspension only / 2 months later / only administered the lyophilized powder mixed with normal saline; received the 1st dose of adjuvant suspension only / 2 months later / only administered the lyophilized powder mixed with normal saline; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In April 2021, the patient received the 1st dose of Shingrix. In June 2021, the patient received the 2nd dose of Shingrix. In April 2021, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. In June 2021, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered, 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 reporter stated that, the patient received the 1st dose of adjuvant suspension only, and came back 2 months later and only administered the lyophilized powder mixed with normal saline. No adverse events reported by patient. This was 8 of 9 linked cases reported by same reporter for different patients. The reporter consented to follow up.   Follow up information received from sales representative on 25 June 2021: The reporter stated that, the health care professional mixed the adjuvant portion with saline solution and administrated it as a first dose and later reconstituted the powder portion with saline solution as second dose. The event inappropriate preparation of medication for 1st dose updated to wrong solution used in drug reconstitution as stated that the health care professional mixed the adjuvant portion with saline solution. The reporter did not know exact date, patient's involved and outcome.  No further events were reported. The reporter consented to follow up; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR138555:Same reporter US-GLAXOSMITHKLINE-US2021AMR138557:Same reporter US-GLAXOSMITHKLINE-US2021AMR138556:Same reporter US-GLAXOSMITHKLINE-US2021AMR138546:Same reporter US-GLAXOSMITHKLINE-US2021AMR138554:Same reporter US-GLAXOSMITHKLINE-US2021AMR138552:Same reporter US-GLAXOSMITHKLINE-US2021AMR138553:Same reporter US-GLAXOSMITHKLINE-US2021AMR138559:Same reporter US-GLAXOSMITHKLINE-US2021138628:FU1 deleted
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Malaise, Pain
Clinical narrative: reaction at the injection site/ with underlying hardness at the site; genera and malaise; large area of redness / at the site/ local reaction has gotten larger; with underlying hardness at the site; severe body aches; low grade fever; This case was reported by a consumer and described the occurrence of injection site reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date).   On 24th June 2021, the patient received the 2nd dose of Shingrix. On 24th June 2021, 12 hrs after receiving Shingrix, the patient experienced injection site reaction, malaise, general body pain, low grade fever, injection site erythema and injection site induration. On an unknown date, the outcome of the injection site reaction, injection site erythema and injection site induration were not recovered/not resolved and the outcome of the malaise, general body pain and low grade fever were recovered/resolved.   The reporter considered the injection site reaction, malaise, general body pain, low grade fever, injection site erythema and injection site induration to be possibly related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by patient's wife. The patient had taken second dose of Shingrix and had mild side effects and they thought might be a reaction at the injection site. After vaccination beginning about 12 hours patient had genera and malaise, Severe body aches and low grade fever. The patient had also developed a large area of redness with underlying hardness at the site. The patient symptoms resolved over about 2-3 days but local reaction had gotten larger.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: reaction at the injection site/ with underlying hardness at the site; genera and malaise; large area of redness / at the site/ local reaction has gotten larger; with underlying hardness at the site; severe body aches; low grade fever; This case was reported by a consumer and described the occurrence of injection site reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date).   On 24th June 2021, the patient received the 2nd dose of Shingrix. On 24th June 2021, 12 hrs after receiving Shingrix, the patient experienced injection site reaction, malaise, general body pain, low grade fever, injection site erythema and injection site induration. On an unknown date, the outcome of the injection site reaction, injection site erythema and injection site induration were not recovered/not resolved and the outcome of the malaise, general body pain and low grade fever were recovered/resolved.   The reporter considered the injection site reaction, malaise, general body pain, low grade fever, injection site erythema and injection site induration to be possibly related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by patient's wife. The patient had taken second dose of Shingrix and had mild side effects and they thought might be a reaction at the injection site. After vaccination beginning about 12 hours patient had genera and malaise, Severe body aches and low grade fever. The patient had also developed a large area of redness with underlying hardness at the site. The patient symptoms resolved over about 2-3 days but local reaction had gotten larger.
Sex: F
Vaccine: MEN
Symptoms: Feeding disorder, Throat irritation
Clinical narrative: had an allergic reaction to the second shot / their are negative side effects; put on meds that burnt her throat; put on meds that / left her unable to eat much for over a week; This case was reported by a consumer via media and described the occurrence of allergic reaction in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced allergic reaction, burn local and unable to eat. On an unknown date, the outcome of the allergic reaction and burn local were unknown and the outcome of the unable to eat was recovered/resolved.   It was unknown if the reporter considered the allergic reaction, burn local and unable to eat to be related to Meningococcal B vaccine.  Additional details were reported as follows: This case was reported by patient's parent. The age at vaccination was not reported. The patient had an allergic reaction to the second dose of vaccine. The patient ended up being put on medicines that burnt her throat and was unable to eat much for over a week. The reporter sated that even though this experience was rare but it still happened. The reporter stated that there were some negative side effects of vaccinations that also needs to be talked about. No other information was reported. Notes : No information about allergic medicines was reported and it was drug class hence medicines which were used to treat allergic reactions were only mentioned in additional details and was not captured as suspect in Argus for events throat burn and unable to eat much.
Sex: M
Vaccine: VARZOS
Symptoms: Loss of consciousness
Clinical narrative: passed out; This case was reported by a physician via sales rep and described the occurrence of passed out in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced passed out (serious criteria GSK medically significant). On an unknown date, the outcome of the passed out was recovered/resolved.   The reporter considered the passed out to be unrelated to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in the afternoon at the office.  At around 1 am at home, the patient passed out and an ambulance was called.  The patient refused to go to hospital as he felt better.  The physician had referred the patient to cardiologist for evaluation.  The reporter felt that it was not due to the Shingrix shot. The reporter consented to follow up. This case has been linked to US2021012440, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021012440:Same reporter
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain
Clinical narrative: flare up, and pain; felt like she had flu like symptoms / hospitalized monday / until tuesday; This case was reported by a consumer via other manufacturer and described the occurrence of influenza-like symptoms in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis. Concomitant products included lamotrigine, vitamin d, salbutamol sulfate (Proair Hfa), tiotropium bromide (Spiriva Respimat), budesonide + formoterol fumarate (Symbicort), roflumilast (Daliresp), duloxetine hydrochloride, hydrochlorothiazide, cyclobenzaprine hydrochloride, metformin hydrochloride (Metformin Er) and tofacitinib citrate (Xeljanz).   On 5th June 2021, the patient received Shingrix. On 5th June 2021, less than a day after receiving Shingrix and an unknown time after starting lamotrigine and vitamin d, the patient experienced influenza-like symptoms (serious criteria hospitalization). On 8th June 2021, the patient experienced exacerbation of pain (serious criteria hospitalization). The patient was treated with steroids nos (Steroids), tramadol and prednisone. On an unknown date, the outcome of the influenza-like symptoms and exacerbation of pain were unknown.   It was unknown if the reporter considered the influenza-like symptoms and exacerbation of pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient received Shingrix shot in the morning and in afternoon she felt like she had flu symptoms.  On 7th June 2021, the patient called the physician and was told to go the emergency room and was hospitalized. The patient was treated with intravenous steroids every 3 hours while at hospital. On 8th June 2021, 3 days after vaccination, the patient had flare up pain (5 out of 10) and was prescribed tramadol and Prednisone and was discharged. The reporter consented to follow up with her and prescriber. No additional information was reported.
Sex: U
Vaccine: DTP
Symptoms: Malaise, Pertussis, Vaccination failure
Clinical narrative: My kids got very ill from the pertussis in the DTP vaccine/ suspected vaccination failure; My patient got very ill from the pertussis; My patient's got very ill; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received DTP (A or W not known) (DTP vaccine) for prophylaxis.   On an unknown date, the patient received DTP vaccine. On an unknown date, unknown after receiving DTP vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), pertussis (serious criteria GSK medically significant) and unwell. On an unknown date, the outcome of the vaccination failure, pertussis and unwell were unknown.   It was unknown if the reporter considered the vaccination failure, pertussis and unwell to be related to DTP vaccine.  Additional information was provided as follows: The age at vaccination was not applicable for this report. The reporter's patients got very ill from the pertussis in the DTP vaccine. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis, Condition aggravated, Pain in extremity
Clinical narrative: experiencing shoulder problems / had shoulder pain; had sore arm for 2-3 days; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included arthritis.   On 18th April 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 18th April 2021, less than a day after receiving Shingrix, the patient experienced shoulder pain and pain in arm. On 21st April 2021, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the shoulder pain was not recovered/not resolved.   It was unknown if the reporter considered the shoulder pain and pain in arm to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient received her 1st dose of Shingrix in unknown arm and experienced sore arm for 2 to 3 days and recovered. The patient also had shoulder pain that had not recovered. The patient had already consulted with her healthcare professional regarding the shoulder pain and her healthcare professional said it was her arthritis. The patient did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021139680:same reporter - same patient - (FU1)
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received late 2nd dose of shingrix. DOSE 1:AUG 2019, DOSE 2: 06/25/2021.; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in August 2019).   On 25th June 2021, the patient received the 2nd dose of Shingrix. On 25th June 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 late than the recommended time interval which led to lengthening of vaccination schedule. No other detail of patient or vaccine available The reporter consented to follow up.
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity, Obstructive airways disorder
Clinical narrative: she had a severe allergic reaction to it; with her airways blocked; This case was reported by a other health professional via call center representative and described the occurrence of allergic reaction in a female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2019-2020 season) (batch number T9N35, expiry date 30th June 2020) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   In November 2019, the patient received Fluarix Tetra 2019-2020 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, less than 2 years after receiving Fluarix Tetra 2019-2020 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced allergic reaction and airways obstruction. On an unknown date, the outcome of the allergic reaction and airways obstruction were recovered/resolved.   It was unknown if the reporter considered the allergic reaction and airways obstruction to be related to Fluarix Tetra 2019-2020 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not reported. The patient experienced severe allergic reaction and her airways was blocked. At the time of reporting, the patient was recovered from reactions. The reporter did not consent nor declined follow up. No further information was provided.
Sex: M
Vaccine: VARZOS
Symptoms: Intercepted product prescribing error
Clinical narrative: prescription of the / vaccine to a 42 year old male patient; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted product prescribing error in a 42-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted product prescribing error. On an unknown date, the outcome of the intercepted product prescribing error was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The healthcare professional reported that the Shingrix was prescribed to the 42 years old patient and planned to be given, which led to intercepted product prescribing error. The reporter did not consent or not decline to follow up. No further events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: was only injected the adjuvant component of Shingrix; was only injected the adjuvant component of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, patient was only injected the adjuvant component of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No patient's identifiers provided. No lot number and expiration date provided. No adverse event was reported. The reporter did not consent to follow up. This case was linked with case US2019086074, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019086074:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Caller / developed a rash on her neck; 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.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not reported. The patient received Shingrix vaccine and developed rash on her neck. The reporter did not consented to follow up. No other information was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: A RN / gave / just the adjuvant of the Shingrix vaccine; A RN / gave / just the adjuvant of the Shingrix vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, patient was just the adjuvant of the Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow up.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose/given less than 2 months apart. First dose/ 05/30/2021 and second dose/ 06/29/2021.; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number X7Z52, expiry date 5th November 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 29th June 2021, the patient received the 2nd dose of Shingrix. On 29th June 2021, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On 29th June 2021, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The patient received 1st dose of Shingrix on 30th May 2021. The reporter stated that, second dose of Shingrix given less than 2 months apart to the patient, which led to shortening of vaccination schedule. The reporter consented to follow up.
Age: 0.75
Sex: F
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: patient received the diluent component of HIBERIX without the powder component; patient received the diluent component of HIBERIX without the powder component; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 9-month-old female patient who received Hib (Hiberix) (batch number FT775, expiry date 26th June 2022) for prophylaxis.   On 21st June 2021, the patient received Hiberix. On 21st June 2021, unknown after receiving Hiberix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The medical assistant reported that, pediatric female patient received the diluent component of HIBERIX without the powder component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient / received only the liquid component of Menveo vaccine; Patient / received only the liquid component of Menveo vaccine; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 15-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA419A, expiry date 31st August 2022) for prophylaxis.   On 29th June 2021, the patient received Menveo. On 29th June 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter stated that, patient who received only the liquid component of Menveo vaccine, it was administered on the same day as reported it. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Received only diluent ASO1B / without gE antigen reconstituted; Received only diluent ASO1B / without gE antigen reconstituted; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number br7b3, expiry date unknown) for prophylaxis.   On 24th June 2021, the patient received Shingrix. On 24th June 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 provided as follows: The reporter stated that, the patient received only diluent ASO1B from Shingrix vaccine without gE antigen reconstituted, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: got first dose /on 10/20/2019 /came /today to get second dose.; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose (0.5 ml) on 20th October 2019, intramuscularly in unknown arm).   On 30th June 2021, the patient received the 2nd dose of Shingrix. On 30th June 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 nurse stated that, the patient came into the office at the time of reporting to get the second dose of Shingrix later than the recommended interval, which led to lengthening of the vaccine schedule. No further information was reported The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: received a Shingrix /had a sore arm / is common side effect.; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old male 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 pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by the wife of the patient. The age at vaccination was not reported. The reporter initially called to inquire about the components used in the making of Shingrix vaccine, then she mentioned about her husband who received a Shingrix vaccine and experienced a sore arm.  The reporter inquired if the sore arm was common side effect. The reporter told that she had an appointment and therefore she must leave.  The reporter ended the conversation, therefore, unable to collect the following information, patient's initials, patient's full mailing address, lot/expiry date, route and date of administration, first or second dose, left or right arm, when did the symptom started, and if the symptom has been resolved or not. The reporter did not gave a consent to follow-up with health care professional, therefore, did not collect health care professional contact information.  The reporter mentioned that safety may reach out to her if there are any follow-up questions.  The reporter provided her email address. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Product dose omission issue
Clinical narrative: shot #1 on 17-Nov-2020 but has not yet received Shingrix shot #2; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose rceived on 17th November 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. 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 course of vaccination. The reporter consented to follow up. This case was linked with case US2021000082, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021000082:Same reporter
Age: 91.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Shingrix dose in question: Jan 1st 2019/ Shingrix confirmed dose: 4/7/2021; 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 91-year-old male patient who received Herpes zoster (Shingrix) (batch number 299BM, expiry date 10th October 2022) for prophylaxis.   Previously administered products included Shingrix (first dose received on 1st January 2019).   On 7th April 2021, the patient received the 2nd dose of Shingrix. On 7th 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 reported as follows: The pharmacy student was looking for information about Shingrix third dose because the patient may had received 2 doses of Shingrix but they were not 100 percent  sure and they were planning to give him a potentially Shingrix third dose. The patient's shingrix was 1st dose on 1st January 2019 (dose in question). There were no records about this shot. No lot number was available. The patient received a dose on 7th April 2021, which led to lengthening of vaccination schedule. At the moment of the call, the pharmacy student confirmed only one Shingrix dose given to this patient. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: received her 2 doses (2 months apart)  / 3 years ago / had an outbreak of shingles 9 months ago/suspected vaccination failure; received her 2 doses (2 months apart)  / 3 years ago / had an outbreak of shingles 9 months ago; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a adult 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 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than a year 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 age at vaccination was not reported. The reporter was the patient.   The patient received 2 doses 2 months apart of Shingrix 3 years ago and had an outbreak of shingles 9 months ago.  The reporter was inquiring if the patient should get another Shingrix vaccine.  The reporter did not consent to follow up. Limited information was obtained. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles and time to onset were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: got their first dose over a year ago and has not received the 2nd dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date a over 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. The health care professional asked if a patient got their first dose over a year ago and had not received the 2nd dose, did they need to restart the series. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the first dose /on 6/9/21 /on 6/23/21 received the second dose; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number MT7C9, expiry date 15th April 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 23rd June 2021, the patient received the 2nd dose of Shingrix. On 23rd June 2021, 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 details were provided as follows: The patient received 2nd dose of Shingrix, before than the recommended interval, which led to shortening of vaccination schedule. The reporter did not consented to follow up.
Age: 1.33
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: on Jul 1st 2021, an expired Infanrix dose/ exp. 10/23/2020/ was given; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-month-old male patient who received DTPa (Infanrix) (batch number CX59C, expiry date 23rd October 2020) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st July 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 1st July 2021, unknown after receiving Infanrix and Infanrix 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 dose of Infanrix which was already expired on 23rd October 2020, which led to expired vaccine used. The reporter stated that, this dose was not patient's 1st Dtap dose. The health care professional reported that she would call again to the patient in order to revaccinate. The reporter consent to follow up. Note : Since it was unknown when patient received 1st Dtap dose, it was mentioned only in narrative and was not captured as conmed or historical drug.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: On 22Jul2020, /received first / dose / did not return / to receive the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female 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 pharmacist stated that, the patient received first Shingrix dose, however did not return within the recommended time frame to receive the second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 39.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: given a dose of Havrix/ deemed nonviable after a temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 39-year-old male patient who received HAV (Havrix) (batch number N39BM, expiry date 31st 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 9th June 2021, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 9th June 2021, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made 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 patient was given a dose of Havrix that was deemed nonviable after a temperature excursion, which led to incorrect storage of drug.  No symptoms reported. The reporter consented to follow up. This case was 2nd from 6 case reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021142812:Same reporter US-GLAXOSMITHKLINE-US2021142818:Same reporter US-GLAXOSMITHKLINE-US2021142817:Same reporter US-GLAXOSMITHKLINE-US2021142816:Same reporter US-GLAXOSMITHKLINE-US2021142815:Same reporter
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: dose of Boostrix / that was/nonviable after an excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 11-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 5E43J, expiry date 30th August 2022) for prophylaxis.   On 18th June 2021, the patient received Boostrix. On 18th June 2021, unknown after receiving Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional case details were reported as follows: The patient was given a dose of Boostrix that was deemed nonviable after a temperature excursion, which led to incorrect storage of drug.  No symptoms reported. The reporter consented to follow up. This case was 3rd from 6 case reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021142817:Same reporter US-GLAXOSMITHKLINE-US2021142812:Same reporter US-GLAXOSMITHKLINE-US2021142816:Same reporter US-GLAXOSMITHKLINE-US2021142813:Same reporter US-GLAXOSMITHKLINE-US2021142818:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose / on 12/31/2019 and wants to get second dose / greater than 6 months since first dose.; 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 December 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 pharmacist stated that, the patient wanted to get second dose.It had been greater than 6 months since first dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 61.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received 2nd dose of twinrix late; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 61-year-old male patient who received HAB (Twinrix) (batch number 3y7nl, 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.   Previously administered products included Twinrix (1st dose received on 20th September 2020).   On 30th June 2021, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 30th June 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 reported as follows: This case was reported by a registered pharmacist. The patient received 2nd dose of Twinrix later then the recommended schedule, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: received his second / vaccine on June 26, 2018 / today he was diagnosed with Shingles/suspected Vaccination failure; today he was diagnosed with Shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 26th June 2018, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 1st dose of Shingrix. On 1st July 2021, 1101 days after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional information was provided as follows: The case was reported by patient himself. The age at vaccination was not reported. The patient stated that at the time of reporting, he was diagnosed with Shingles.  No Lot or Expiration date for the vaccine was known. This case was considered as suspected vaccination failure as details laboratory confirmation were unknown at the time of reporting.  The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Product dose omission issue
Clinical narrative: first dose of Shingrix 9 months ago / has not received dose two; 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 (1st dose received on an unknown date, 9 months 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 course of vaccination. The pharmacist refused to answer any questions.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 18 months ago / first Shingrix vaccine; 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 (1st dose received on an unknown date, 18 months 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. The pharmacist stated that, the patient did not return within the recommended time frame to receive the second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The pharmacist only had the gender of the patient no other information known at the time of call.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Developed a rash on his scalp and belt line; This case was reported by a consumer via call center representative and described the occurrence of rash in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th May 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 10th May 2021, less than a day after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details provided as follows: The patient reported this case for himself. The patient experienced rash on scalp and belt line. The reporter did not consent to follow-up.