chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: administrated /an expired dose/on June 29 2021/ expired on May 30 2021.; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received DTPa (Infanrix) (batch number j947t, expiry date 30th May 2021) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Infanrix (received 1st four doses, on an unknown date).   On 29th June 2021, the patient received the 5th dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 29th June 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 nurse reported that, the patient received dose of Infanrix  which was expired on 30th May 2021, which led to expired vaccine used. No adverse event was reported. The vaccine was provided on another facility.  The reporter did not consent to follow-up.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was administrated with an expired dose of Pediarix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa-HBV-IPV (Pediarix) (batch number unknown, expiry date 14th June 2021) 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 June 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 17th June 2021, unknown after receiving Pediarix and Pediarix 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 are as follows: The age at vaccination was not reported. Medical assistance reported that, the patient was administered with an expired dose of pediarix on 17th June 2021 which led to expired vaccine used. No adverse event was reported. No patient's identifiers was provided. No LOT number was provided. The reporter did not consented to follow- up.
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Tremor
Clinical narrative: woke up today shaky; and felt like he was going to pass out.; This case was reported by a consumer via call center representative and described the occurrence of tremor in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th June 2021, the patient received Shingrix. On 30th June 2021, 2 days after receiving Shingrix, the patient experienced tremor and felt faint. On an unknown date, the outcome of the tremor and felt faint were unknown.   It was unknown if the reporter considered the tremor and felt faint to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient's wife. The age at vaccination was not reported. The reporter stated that, the patient received Shingrix vaccine and on a day of reporting, woke up shaky and felt like he was going to pass out. Initially reporter consented to follow up, however on 5th July 2021, reporter denied to provide further contact details.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient/didn´t received Shingrix 2nd dose/1st dose was given more than 6 months ago.; This case was reported by a nurse 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 6th months ago of reporting 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 reported as follows: This case was reported by a nurse. Age at vaccination was not applicable for this report. The patient did not received second dose of shingrix till the time of reporting, which led to incomplete course of vaccination.  the reporter consented to follow up
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: got vaccinated in his left arm/ and developed a rash on both of his wrists 2-3 days ago; This case was reported by a consumer via call center representative and described the occurrence of rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th June 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 2 weeks 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 were provided as follows: Age at vaccination was not reported but it could be 73 or 74 years. The patient received Shingrix and experienced a rash on both of his wrists, 2 to 3 days ago of reporting date. The rash that had not resolved. No further information reported. The reporter consented to follow up.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Decreased appetite
Clinical narrative: had poor appetite; 4 month old patient received Kinrix; received Kinrix instead of dose 2 of Pentacel; This case was reported by a nurse via call center representative and described the occurrence of appetite impaired in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number PP9L5, expiry date 16th October 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, less than 5 months after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced appetite impaired, inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the appetite impaired was recovered/resolved and the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   It was unknown if the reporter considered the appetite impaired to be related to Kinrix and Kinrix 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: Nurse practitioner reported a 4 month old patient received Kinrix instead of dose 2 of Pentacel and the patient had poor appetite for a couple days but it had resolved, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose / on 18 Jun 2019 and did not receive any further doses; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 18th June 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 medical assistant reported that, till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose / on October 22 2020 / did not received 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 patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 22nd October 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: No patient's identifiers provided. 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. No lot number and expiration date provided for 1st dose. No adverse event was reported. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Late for / second dose / first dose was / on September 5 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 5th September 2019, batch number 3rn95, expiry date 6 December 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 course of vaccination. No adverse event was reported. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix on 8/18/2018 / had not yet received the second dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on 18th August 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were 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. No further events were reported. The health care professional agreed to be contacted for follow up. The reporter did not consent to follow-up.
Age: 13.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: her teenage daughter has been given Shingrix / by accident at the pharmacy; This case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 13-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd June 2021, the patient received the 1st dose of Shingrix (intramuscular). On 23rd June 2021, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional case details were reported as follows: This case was reported by patient's mother. The teenage daughter was given Shingrix vaccine by accident at the pharmacy, which led to inappropriate age at vaccine administration.   No side effects were reported. The reporter did not have the last name of health care professional, mailing address, fax number, or an email address.  The reporter did not know the phone number to the pharmacy where the vaccine was given.  The reporter gave her personal email address. The reporter did not know the lot number/expiration date or the dose of the vaccine. The reporter consented to follow up with patient's health care professional.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: did not receive 2nd dose of Shingrix for greater than 6 months; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 92-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2018 with batch number m77b4 and expiry date 2nd October 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 did not receive 2nd dose of Shingrix for more than 6 months after 1st dose, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Incorrect dose administered, Incorrect route of product administration, Product preparation error
Clinical narrative: Was given / after being reconstituted with sterile diluent; Was given / after being reconstituted with sterile diluent; Administration was intravenous instead of oral; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number AP7JT, expiry date 3rd May 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 2nd July 2021, the patient received Rotarix lyophilized formulation (intravenous) and Rotarix Oral Applicator Device. On 2nd July 2021, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced wrong solution used in drug reconstitution, inappropriate dose of vaccine administered and inappropriate route of vaccination. On an unknown date, the outcome of the wrong solution used in drug reconstitution, inappropriate dose of vaccine administered and inappropriate route of vaccination 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 Rotarix vaccine was given to the patient after being reconstituted with sterile diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered   The administration was intravenous instead of oral, which led to inappropriate route of vaccination. No further details were provided. The reporter consented to follow up.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, Incorrect dose administered, Product preparation issue
Clinical narrative: partial dose. Liquid portion of Menveo was given; partial dose. Liquid portion of Menveo was given; given on 1st july 2021 and this was the second dose; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA439A, expiry date 31st August 2022) for prophylaxis.   Previously administered products included Menveo (received 1st dose on an unknown date).   On 1st July 2021, the patient received the 2nd dose of Menveo. On 1st July 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication, inappropriate dose of vaccine administered and extra dose administered. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and extra dose administered were unknown.  Additional details were provided as follows: The patient received liquid portion of Menveo this was the second dose in the series first dose was given properly, which led to inappropriate preparation of medication, inappropriate dose of vaccine administered and extra dose administered. HCP wanted to know if the patient had to be vaccinated again after the second dose was a partial dose. The reporter consented to follow up.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: (Infanrix XG942 Exp 08/22/2022) was administered by error in the left deltoid of an 11-year-old patient instead of a Tdap vaccine.; (Infanrix XG942 Exp 08/22/2022) was administered by error in the left deltoid of an 11-year-old patient instead of a Tdap vaccine.; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received DTPa (Infanrix) (batch number XG942, expiry date 22nd August 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th June 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 30th June 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, 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.   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 reporter was a healthcare professional representative. The reporter was a medical assistant and vaccine coordinator The patient received DTaP vaccine by error in the left deltoid instead of a Tdap vaccine, which led to wrong vaccine administered and inappropriate age at vaccine administration. No additional adverse event was reported. The reporter consented to follow up.  The reporter provided consent to follow up with healthcare professional.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Injection site haemorrhage
Clinical narrative: bleeding from the injection site immediately after the administration; This case was reported by a pharmacist via call center representative and described the occurrence of injection site hemorrhage in a 30-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 33AT7, expiry date 7th November 2022) for prophylaxis.   On an unknown date, the patient received Boostrix (intramuscular). On an unknown date, immediately after receiving Boostrix, the patient experienced injection site hemorrhage. On an unknown date, the outcome of the injection site hemorrhage was unknown.   It was unknown if the reporter considered the injection site hemorrhage to be related to Boostrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Boostrix on left deltoid and experienced bleeding from the injection site immediately after the administration. The reporter consented to follow up.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, Exposure during pregnancy
Clinical narrative: Use of Fluarix in pregnancy at 32 weeks / expired on June 30, 2021; Use of Fluarix in pregnancy at 32 weeks; This prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 27-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number YT5K7, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd July 2021, the patient received Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Fluarix Quadrivalent 2020-2021 season at an unknown time during the pregnancy. On 2nd July 2021, unknown after receiving Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used and vaccine exposure during pregnancy. On an unknown date, the outcome of the expired vaccine used and vaccine exposure during pregnancy were unknown. The pregnancy was ongoing.   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 Fluarix in pregnancy at 32 weeks and the vaccine was expired on 30th June 2021, which led to expired vaccine used and vaccine exposure during pregnancy. The reporter consented to follow up.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: administered an expired Boostrix; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 43-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number TG597, expiry date 9th March 2021) for prophylaxis.   On 5th July 2021, the patient received Boostrix. On 5th July 2021, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional information was provided as follows: On 5th July 2021, the patient was been inadvertently administered by expired dose of Boostrix which was expired on 9th March 2021. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first Shingrix/12-07-2019/is planning on receiving the second Shingrix; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 81-year-old female patient who received Herpes zoster (Shingrix) for an unknown indication.   Previously administered products included Shingrix (first dose received on 7th 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 information was 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 patient was planning on receiving the second Shingrix vaccine soon.  The reporter did not consent to follow up.
Sex: M
Vaccine: HEPA
Symptoms: Incomplete course of vaccination
Clinical narrative: got his first dose of Havrix in Oct2019 and never received a 2nd dose; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 59-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.   Previously administered products included Havrix (received 1st dose in October 2019).   On an unknown date, the patient received the 2nd dose of Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The case was 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 Havrix as per the vaccination schedule, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Fatigue
Clinical narrative: Extreme shoulder Pain / extends from her shoulder down to her elbow; Tired; This case was reported by a consumer via call center representative and described the occurrence of arthralgia in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th May 2021, the patient received the 1st dose of Shingrix (intramuscular). On 25th May 2021, less than a day after receiving Shingrix, the patient experienced arthralgia and tiredness. On an unknown date, the outcome of the arthralgia was not recovered/not resolved and the outcome of the tiredness was recovered/resolved.   It was unknown if the reporter considered the arthralgia and tiredness to be related to Shingrix.  Additional details were reported as follows; This case was reported by a consumer. The patient received her first dose of shingrix. Post that, the patient experienced feeling tired and extreme shoulder pain. The patient stated that, the shoulder pain never stopped and now seems to be getting worse. The pain extended from her shoulder down to her elbow. The patient consented to follow up.
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia
Clinical narrative: Extreme shoulder Pain / extends from her shoulder down to her elbow; Tired; This case was reported by a consumer via call center representative and described the occurrence of arthralgia in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th May 2021, the patient received the 1st dose of Shingrix (intramuscular). On 25th May 2021, less than a day after receiving Shingrix, the patient experienced arthralgia and tiredness. On an unknown date, the outcome of the arthralgia was not recovered/not resolved and the outcome of the tiredness was recovered/resolved.   It was unknown if the reporter considered the arthralgia and tiredness to be related to Shingrix.  Additional details were reported as follows; This case was reported by a consumer. The patient received her first dose of shingrix. Post that, the patient experienced feeling tired and extreme shoulder pain. The patient stated that, the shoulder pain never stopped and now seems to be getting worse. The pain extended from her shoulder down to her elbow. The patient consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix in August of 2020./has not yet received their second dose; This case was reported by a consumer 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 in August 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 not recovered/not resolved.  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. Limited demographics were obtained. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received Shingrix on 30Jun2020/ not have a history of her getting the 2nd dose.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 30th June 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 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 consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 18May2019/ received the first dose of Shingrix/ 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 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 18th May 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 return to receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received his first Shingrix  vaccine about 8 months ago/has not received the second dose yet.; This case was reported by a consumer 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 (0.5 ml) 8 months ago from reporting 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 reported as follows: This case was reported by patient himself. 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. No HCP (healthcare professional) information was provided. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: past due for dose two / received dose one / in August on 2019 / have not received dose two; This case was reported by a consumer 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 in August 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No additional details were reported. The case was linked with case US2021AMR148564 reporter by same reporter. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR148564:Same reporter
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site swelling
Clinical narrative: Injection was given / in right arm  / had redness / at the injection site / have resolved; Injection was given / in right arm / swelling at the injection site / have resolved; administered injection / via subcutaneous route instead of intramuscular route / was given 28Jun2021 in right arm; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number TP943, expiry date 28th January 2023) for prophylaxis.   On 28th June 2021, the patient received the 1st dose of Shingrix (subcutaneous). On 28th June 2021, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema and injection site swelling were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix vaccine in the right arm subcutaneously instead of intramuscular, which led to intramuscular formulation administered by other route. The patient called back to the office on 1st July 2021 to report she had redness and swelling at the injection site. The reporter granted permission for follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose / in May 2019 and has not received the second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in May 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 are as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient had not received her 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient received the first dose / on 06-Jan-2020 and 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 female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 6th January 2020).   On 6th January 2020, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: a 3rd dose / was administered to a / patient. At the time of the report / patient has not reported any issues; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 79-year-old male patient who received Herpes zoster (Shingrix) (batch number DA9Rz, expiry date 30th September 2022) for prophylaxis.   On 6th July 2021, the patient received Shingrix. On 6th July 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The pharmacist reported that the patient received 3rd dose of Shingrix, which led to extra dose administered. At the time of the reporting, the patient did not report any issue. No information about 1st and 2nd dose was reported. The reporter consented to follow up.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Pain in extremity
Clinical narrative: First / vaccine September 2020 / had arm pain; First / vaccine September 2020 / has not gotten the second; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received the 1st dose of Shingrix (intramuscular). 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 pain in arm and incomplete course of vaccination. On an unknown date, the outcome of the pain in arm and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follow: The age at vaccination was not applicable for 2nd dose of Shingrix.. The patient received first dose of shingrix and experienced arm pain. Till the time of reporting, the patient did not receive her second dose of Shingrix, which led to incomplete course of vaccination. The patient did not consent to follow-up
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site pain, Injection site reaction, Pain in extremity
Clinical narrative: Local reaction at the injection site / swelling/horrible reaction after vaccination; Local reaction at the injection site / severe pain/horrible reaction after vaccination; Terrible reaction in her arm / it was very very painful; This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included mastectomy bilateral and lymph node excision.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, injection site pain and pain in arm. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain and pain in arm were recovered/resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain and pain in arm to be related to Shingrix.  Additional details were reported as follows: This case was reported by a nurse. Patient identifiers other than gender were not provided. Date of first dose, batch number nor expiration date was provided. The patient developed a local reaction at the injection site which included swelling and severe pain. Patient had a terrible reaction in her arm. She had severe swelling. Her entire arm swelled up from her upper arm and it was very very painful and took a long time to go down. Vaccination was done in a different facility.  The second dose had not been administered yet and nurse wanted to verify if there was any other injection site apart from the arm.  Patient had a double mastectomy and lymph nodes removed and patient thought that might have contributed to her reaction in her arm.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose of Pediarix was administered / 2 days apart from the first dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number T4Y35, expiry date 28th November 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included DTPa-HBV-IPV (Pediarix).   On 6th July 2021, the patient received the 2nd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 6th July 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, 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.   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 1st dose on 4th July 2021 on right thigh. The pharmacist reported that the 2nd dose of Pediarix was administered to a female patient 2 days apart from the first dose, which led to shortening of vaccination schedule. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination, Rash
Clinical narrative: Experienced a rash on the lower extremities; Had recently experienced a Shingles episode; decided not to receive the second dose until today; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 7th February 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced rash, shingles and incomplete course of vaccination. On an unknown date, the outcome of the rash, shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the rash and shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported for the 1st dose. The age at the vaccination was not applicable for the 2nd dose. No patient or vaccine data was available. The patient experienced a rash on the lower extremities, after that decided not to receive the second dose until today when wanted to receive it but had recently (more than 2 years) experienced a Shingles episode. Till now patient didn't receive second dose of vaccine which led to incomplete course of vaccination. Consented to follow up.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Patient / received Boostrix / after / exposed to a temperature of negative 12 degrees Celsius; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 12-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9L39Z, expiry date 8th October 2021) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th June 2021, the patient received Boostrix (intramuscular) and Boostrix Pre-Filled Syringe Device. On 30th June 2021, unknown after receiving Boostrix and Boostrix 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 details were reported as follows: The nurse reported that, the patient inadvertently received Boostrix through route in the left deltoid after the Boostrix was exposed to a temperature of negative 12 degree Celsius, which led to incorrect storage of drug. The reporter consented to follow up.
Age: 38.0
Sex: F
Vaccine: VARZOS
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: First dose / to a 38 year old / patient / Planed to be administrated on the same day of the call; Prescription and administration of a first dose of Shingrix to a 38 year old; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 38-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th July 2021, the patient received the 1st dose of Shingrix. On 6th July 2021, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration and off label use. On an unknown date, the outcome of the inappropriate age at vaccine administration and off label use were unknown.  Additional details were reported as follows: The pharmacist reported that the patient had prescription and administration of a dose of Shingrix to a 38 year old patient, which led to inappropriate age at vaccine administration and off label use. The patient was planed to be administrated on the day of reporting. No further events were reported.  The reporter did not consent nor decline follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose of Shingrix on 10/10/2020/ not yet received the second; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 27th October 2020 from batch number 5cb4k with expiry date 23rd August 2022).   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 provided as follows: The pharmacist was called to report the late second dose of shingrix. Till the time of reporting patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No further events were reported. Health care provider declined to be contacted for follow-up. The reporter did not consented to follow-up.