chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Pyrexia
Clinical narrative: Gastroesophageal reflux disease; fever; chills; stomach issues; numbness, elbow and thigh; constipation; severe stomach distension; This case was reported by a consumer and described the occurrence of gastroesophageal reflux disease in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced gastroesophageal reflux disease, fever, chills, gastrointestinal disorder, numbness, constipation and distended stomach. On an unknown date, the outcome of the gastroesophageal reflux disease, fever, chills, gastrointestinal disorder, numbness and constipation were unknown and the outcome of the distended stomach was not recovered/not resolved.   It was unknown if the reporter considered the gastroesophageal reflux disease, fever, chills, gastrointestinal disorder, numbness, constipation and distended stomach to be related to Shingles vaccine.  Additional details provided were as follows: Age at vaccination was not reported. The patient received a dose of Shingles vaccine and experienced fever, chills, stomach issues, numbness, constipation, severe stomach distention, numbness in elbow and thigh as well as GERD symptoms. The patient had none of these issues before taking the vaccine. It's almost a year later and not one doctor can help the patient with his/her severe stomach distention and I had spent countless monies on seeing almost every doctor on Island. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Immediate post-injection reaction
Clinical narrative: Had shingles immediately after, lasted for 7 months; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a month after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient's friend. The age at vaccination was not reported. the patient had got the shot and had shingles immediately after, It lasted for 7 months. GSK note -  the time to onset added as less than a month considering worst case approach, as immediate TTO seems to be incorrect.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Headache, Loss of personal independence in daily activities, Pain
Clinical narrative: feel horrible, Missed a day of work; fever, Missed a day of work; chills, Missed a day of work; body ache, Missed a day of work; headache, Missed a day of work; Missed a day of work; This case was reported by a consumer via interactive digital media and described the occurrence of feels awful in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feels awful, fever, chills, general body pain, headache and activities of daily living impaired. On an unknown date, the outcome of the feels awful was recovered/resolved and the outcome of the fever, chills, general body pain, headache and activities of daily living impaired were unknown.   It was unknown if the reporter considered the feels awful, fever, chills, general body pain, headache and activities of daily living impaired to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The patient glad that he/she got the vaccine, but it made the patient feel horrible for a couple days. The patient also experienced fever, chills, body aches, headache. The patient missed a day of work.  The patient was scared to go get the second one.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: feel horrible, Missed a day of work; fever, Missed a day of work; chills, Missed a day of work; body ache, Missed a day of work; headache, Missed a day of work; Missed a day of work; This case was reported by a consumer via interactive digital media and described the occurrence of feels awful in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feels awful, fever, chills, general body pain, headache and activities of daily living impaired. On an unknown date, the outcome of the feels awful was recovered/resolved and the outcome of the fever, chills, general body pain, headache and activities of daily living impaired were unknown.   It was unknown if the reporter considered the feels awful, fever, chills, general body pain, headache and activities of daily living impaired to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The patient glad that he/she got the vaccine, but it made the patient feel horrible for a couple days. The patient also experienced fever, chills, body aches, headache. The patient missed a day of work.  The patient was scared to go get the second one.
Sex: U
Vaccine: VARZOS
Symptoms: Induration
Clinical narrative: hard knot; This case was reported by a consumer via interactive digital media and described the occurrence of induration 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 induration. On an unknown date, the outcome of the induration was unknown.   It was unknown if the reporter considered the induration to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The reporter asked how long should a hard knot last after the Vaccine. No contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Herpes zoster, Vaccination failure
Clinical narrative: had both, got it again/ suspected vaccination failure; got it; big red mark on my scalp; This case was reported by a consumer viainteractive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and erythema. On an unknown date, the outcome of the vaccination failure, shingles and erythema were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and erythema to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had both Shingles shot and still got shingles physician said had shingles again no blisters n itching just a big red mark on scalp. The patient stated he/she vaccine did not always work. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the shot and got shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had the Shingles vaccine and got shingles.  The patient stated he/she had shingles 5 times and had them shingles again. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Illness, Vaccination failure
Clinical narrative: had shot still got shingles. I was in hospital\ Suspected vaccination failure; shingles; sickest I have ever been; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant), shingles (serious criteria hospitalization) and sickness (serious criteria hospitalization). On an unknown date, the outcome of the vaccination failure, shingles and sickness were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and sickness to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles shot and still got shingles. The patient was in hospital. The patient stated he/she had been battling shingles for little over two months. It has been the sickest ever been. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first Shingrix over a year ago; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose over a year ago).   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 case was reported by patient's sister. 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, which led to incomplete course of vaccination. The reporter asked that she could still get her 2nd dose or should she start over. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: delay between the first and second shots; This case was reported by a consumer via interactive digital media 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 (received first dose 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 drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated that there was delay between the first and second shots. The patient received second dose at interval longer than the recommended interval, which led to lengthening of vaccination schedule. The patient enquired if the third shot was needed.
Sex: U
Vaccine: FLU3, PPV
Symptoms: Asthenia, Chills, Feeling abnormal, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: GUILLAIN-BARRE LIKE SYNDROME; DIFFICULTY WALKING; UNSTABLE; FEVER; NAUSEA; CHILLS; WEAK; This spontaneous report has been received from the patient's sister via GlaxoSmithKline (GSK), regarding a 74-year-old male patient. Information regarding the patient's historical conditions, past drugs reactions or allergies, concurrent conditions or concomitant therapies was not provided.   Approximately in November 2020 (reported as "about a year ago"), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) as prophylaxis (formulation, dose, dose number, vaccination scheme frequency, route and anatomical location of administration, lot number and expiration date were not reported), and influenza vaccine (FLUZONE).   Consequently, when he received the vaccines, he experienced weakness (asthenia), chills, nausea, unstable (ill-defined disorder), difficulty walking (gait disturbance), fever (pyrexia) and Guillain-Barre like syndrome (reported as "similar reaction/symptoms"). However, it was not reported if test or studies were performed regarding the event. The outcome of the events was not provided.   The causality assessment between the events and was not provided.   Upon an internal review, the Guillain-Barre syndrome was determined to be medically significant.
Sex: U
Vaccine: FLU3, PPV
Symptoms: Ill-defined disorder, Nausea, Pyrexia
Clinical narrative: GUILLAIN-BARRE LIKE SYNDROME; DIFFICULTY WALKING; UNSTABLE; FEVER; NAUSEA; CHILLS; WEAK; This spontaneous report has been received from the patient's sister via GlaxoSmithKline (GSK), regarding a 74-year-old male patient. Information regarding the patient's historical conditions, past drugs reactions or allergies, concurrent conditions or concomitant therapies was not provided.   Approximately in November 2020 (reported as "about a year ago"), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) as prophylaxis (formulation, dose, dose number, vaccination scheme frequency, route and anatomical location of administration, lot number and expiration date were not reported), and influenza vaccine (FLUZONE).   Consequently, when he received the vaccines, he experienced weakness (asthenia), chills, nausea, unstable (ill-defined disorder), difficulty walking (gait disturbance), fever (pyrexia) and Guillain-Barre like syndrome (reported as "similar reaction/symptoms"). However, it was not reported if test or studies were performed regarding the event. The outcome of the events was not provided.   The causality assessment between the events and was not provided.   Upon an internal review, the Guillain-Barre syndrome was determined to be medically significant.
Age: 4.0
Sex: F
Vaccine: DTAP, DTAP, DTAP
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: is 7 yrs old and has only received 2 doses of the Dtap; First dose on 8/29/18 and 2nd on 2/19/2020. DOB: 18-NOV-2013; First dose on 8/29/18 and the 2nd on 2/19/2020.; First dose on 8/29/18 and 2nd on 2/19/2020. DOB: 18-NOV-2013; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old female patient who received DTPa (DTaP vaccine) for prophylaxis.   Co-suspect products included DTPa (DTaP vaccine) for prophylaxis and DTPa (DTaP vaccine) for prophylaxis.   On 29th August 2018, the patient received the 1st dose of DTaP vaccine. On 19th February 2020, the patient received the 2nd dose of DTaP vaccine. On an unknown date, the patient received the 3rd dose of DTaP vaccine. On 29th August 2018, unknown after receiving DTaP vaccine and not applicable after receiving DTaP vaccine and DTaP vaccine, the patient experienced inappropriate age at vaccine administration. On 19th February 2020, the patient experienced inappropriate age at vaccine administration and drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the inappropriate age at vaccine administration, inappropriate age at vaccine administration, drug dose administration interval too long and incomplete course of vaccination were unknown.  Additional details were provided as follows: The certified medical assistant reported that, 7 years and 11 month old patient received 2 doses of the Dtap, which led to inappropriate age at vaccine administration. The patient received 2nd dose of Dtap, later than the recommended schedule, which led to lengthening of vaccination schedule. Till the time of reporting, the patient did not receive 3rd dose of Dtap, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th July 2021, the patient received the 1st dose of Shingrix. In July 2021, less than a week after receiving Shingrix, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was recovered/resolved.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.  Additional details were provided as follows: The patient reported case for herself. She described that after she received her Shingrix vaccine.Within a week,she experienced diarrhea.She had not reported other symptoms. The limited information provided. She did not consent to follow-up.
Age: 16.0
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of product administration
Clinical narrative: Boostrix intra venous administration; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 16-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Boostrix (intravenous) and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.     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: Pharmacist reported that the patient was administered Boostrix via intravenous instead of intramuscular route, which lead to Incorrect route of vaccine administration. The reporter consented to follow up.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: vaccinated 7/7/2020. Other dose was administered 8/10/2021; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 12-year-old female patient who received  .   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number 237ZH, expiry date 1st April 2023) for prophylaxis and dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included DTPa (Reduced antigen) (Boostrix).   On 10th August 2021, the patient received the 2nd dose of Boostrix and Boostrix Pre-Filled Syringe Device. On 10th August 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The patient vaccinated  of with 1st dose of Boostrix on 7th July 2021.  Another dose was administered on 10th August 2021, which led to extra dose administered. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Palpitations, Pyrexia
Clinical narrative: Heart palpitations; Slight fever; Myalgia; This case was reported by a consumer via call center representative and described the occurrence of palpitation in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th November 2021, the patient received the 1st dose of Shingrix. On 6th November 2021, 1 days after receiving Shingrix, the patient experienced palpitation, fever and myalgia. On 7th November 2021, the outcome of the palpitation, fever and myalgia were recovered/resolved.   It was unknown if the reporter considered the palpitation, fever and myalgia to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received 1st dose of Shingrix and experienced heart palpitations, a slight fever, and myalgia the following day, starting between 4 and 5 am. The patient had not yet received the 2nd dose. The reporter did not consent to follow up.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: received expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 9-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number GF2DK, 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 13th September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 13th September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The patient received fluarix vaccine after its expiry date which led to the event expired vaccine used. The reporter did not consent to follow up. This is 1 of the 8 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021232194:Same reporter US-GLAXOSMITHKLINE-US2021232193:Same reporter US-GLAXOSMITHKLINE-US2021232202:Same reporter US-GLAXOSMITHKLINE-US2021232201:Same reporter US-GLAXOSMITHKLINE-US2021232197:Same reporter US-GLAXOSMITHKLINE-US2021232200:Same reporter US-GLAXOSMITHKLINE-US2021232198:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only with the diluent; received only with the diluent; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 43-year-old female patient who received Herpes zoster (Shingrix) (batch number PG35Z, expiry date 11th March 2023) 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 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 pharmacist reported that the patient received a dose of Shingrix vaccine only with the diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, Product complaint
Clinical narrative: Fluarix PFS, potentially be defected, made a spray; 10 or 15% of the vaccine made a spray; This case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a 9-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number ZG474, expiry date 30th June 2022) 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 10th November 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 10th November 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incomplete dose administered. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the incomplete dose administered and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the incomplete dose administered and pharmaceutical product complaint to be related to 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 information was provided as follows: The reporter stated that the vaccine could potentially be defected and, while he was injecting, 10 or 15 percent of the vaccine made a spray to the side of the patient which led to incomplete dose administered.  The reporter wasn't sure if the needle or syringe was the issue, he did not mention accidental exposure. Since, reporting day was the last day of the reporter in the pharmacy, he decided not to provide last name and requested a follow-up directly with the pharmacy by a call back.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error, Product preparation issue
Clinical narrative: only adjuvant was administered; only adjuvant was administered; 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 10th November 2021, the patient received Shingrix. On 10th November 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 provided were as follows: Age at vaccination was not reported. Pharmacist called on behalf of a doctor's office to report that a patient received the Shingrix vaccine prior to the vaccine being reconstituted, only adjuvant was administered, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The pharmacist would like to know if the patient need to receive the dose again. The pharmacist reported that this occurred on the reporting day and was unaware of any adverse events experienced by the patient. The pharmacist was unaware of the dose number and doctor's office did not provide any patient demographics. The pharmacist did not have patient demographic information or health care professional contact information apart from phone number. The reporter denied to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Shingrix reconstituted with other diluent.; Shingrix reconstituted with other diluent.; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) (batch number 4G94Z, expiry date 3rd February 2023) for prophylaxis.   In October 2021, the patient received Shingrix. In October 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient received Shingrix on 22nd October 2021 or 29th October 2021, with the powder component of Shingrix reconstituted with other diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not want to provide patients demographic data. The reporter consented to follow up. This case was one of the 8 cases reported by the same reporter.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received 3 doses, second 19-JUL-2021, third 08-NOV-2021; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 17th May 2021) and Shingrix (2nd dose received on 19th July 2021).   On 8th November 2021, the patient received the 3rd dose of Shingrix. On 8th November 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 reported as follows: Registered Nurse reported that a patient received 3 doses of the Shingrix vaccine and wanted to know if that was ok.  The patient received the 3rd dose of vaccines on 8th November 2021 which led to extra dose administered. The reporter did not consent to follow up.
Age: 48.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Received both doses and was under 50 y/o; Received both doses and was under 50 y/o; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 48-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 26th March 2019, the patient received the 2nd dose of Shingrix. On 24th December 2018, the patient received the 1st dose of Shingrix. On 24th December 2018, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On 26th March 2019, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate age at vaccine administration were unknown.  Additional details were reported as follows: A nurse reported that a 48 year old patient received the 1st dose and the 2nd dose of Shingrix which led to inappropriate age at vaccine administration.   The patient was wondering if 3rd dose was needed since she was under 50 years of age at time of vaccination. The reporter consented to follow up. The HCP did not want to provide the patient's DOB but did consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: experienced arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in extremity 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 pain in extremity. On an unknown date, the outcome of the pain in extremity was unknown.   It was unknown if the reporter considered the pain in extremity to be related to Shingrix.  Additional details provided were as follows: The case was reported by the patient's sister. Age at vaccination was not reported. The patient received a dose of Shingrix and experienced soreness in arm. The reporter gave limited information. The reporter did not consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: feels nauseous.; This case was reported by a consumer via call center representative and described the occurrence of nausea in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced nausea. The action taken with Shingrix was unknown. On an unknown date, the outcome of the nausea was not recovered/not resolved.   It was unknown if the reporter considered the nausea to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The case was reported by patient. Patient received her first dose of Shingrix  few days ago. Patient states that she feel nauseous till the time of reporting. The reporter did not consent to follow-up.
Age: 1.25
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: inadvertedly administrated Kinrix instead of Infanrix; Kinrix was administrated to 15 month old; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old male patient who received DTPa-IPV (Kinrix) (batch number 3dz45, expiry date 15th January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th November 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 12th November 2021, unknown after receiving Kinrix and Kinrix 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: 15 month old male patient was inadvertedly administrated Kinrix instead of Infanrix, which led to wrong vaccine administered and inappropriate age at vaccine administration. No further events were reported.  The reporter agreed to be contacted for follow- up.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Product administered at inappropriate site, Skin warm
Clinical narrative: received dose in his left triceps; is red; hot to the touch; This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a 55-year-old male patient who received Herpes zoster (Shingrix) (batch number K7T79, expiry date 14th April 2023) for prophylaxis.   On 10th November 2021, the patient received the 1st dose of Shingrix (intramuscular). On 10th November 2021, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. In November 2021, the patient experienced erythema and skin warm. On an unknown date, the outcome of the erythema was recovered/resolved and the outcome of the skin warm and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the erythema and skin warm to be related to Shingrix.  Additional details were provided as follows: The patient received the first dose of Shingrix in his left triceps, and it is now hot to the touch and red in appearance, which led to vaccine administered at inappropriate site. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 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 patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose a year ago).   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 reporter declined permission to collect information to create an account in our database. The reporter did not consent to follow up.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: expired dose engerix-B vaccination; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 2-month-old female patient who received HBV (Engerix B pediatric) (batch number HN5BA, expiry date 16th September 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th November 2021, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 12th November 2021, unknown after receiving Engerix B pediatric and Engerix B 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 expired dose of  engerix-B vaccination, which led to expired vaccine used. The reporter consented to follow up.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: dose of the Shingrix in 2018 / the second dose in 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 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient received 2nd dose in 2021, later than the recommended time interval, which led to lengthening of vaccination schedule. The reporter inquired if a third dose of Shingrix was recommended. The reporter did not consent to follow up.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: but has not yet received third dose; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 29-year-old male patient who received HAB (Twinrix adult) 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 adult (received 1st dose on 19th November 2020) and Twinrix adult (received 2nd dose on 20th December 2020).   On an unknown date, the patient received the 3rd dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional 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 3rd dose of Twinrix adult, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: pediatric dose of Engerix-B instead of an adult dose.; pediatric dose of Engerix-B instead of an adult dose.; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 61-year-old female patient who received HBV (Engerix B pediatric) (batch number L32D9, expiry date unknown) for prophylaxis.   On 12th November 2021, the patient received Engerix B pediatric. On 12th November 2021, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional details were provided as follows: The patient received pediatric dose of Engerix-B instead of an adult dose, which led to underdose and adult use of a child product. The reporter consented to followup.
Age: 1.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 12 months old patient received a dose of Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-month-old male patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd November 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 2nd November 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The medical assistant reported that, 12 months old male patient who received a dose of Kinrix, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: gave expired dose to a patient; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA32AB, expiry date 31st May 2021) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th November 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 11th November 2021, unknown after receiving Bexsero and Bexsero 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 medical assistant reported that a nurse gave an expired dose of Bexsero to a patient, which led to expired vaccine used. The reporter consented to follow up.
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received third dose in 4 months, instead of six; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in a male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on an unknown date) and Twinrix (received 2nd dose on an unknown date).   On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced 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: This case was reported by patient himself. The patient received third dose of Twinrix in 4 months, instead of 6 months, earlier than recommended interval, which led to shortening of vaccination schedule. No demographics provided. The reporter did not consent to follow-up.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Low grade fever; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever) and FATIGUE (Felt tired) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included Hysterectomy. Concomitant products included PIROXICAM (PAXIL [PIROXICAM]), ROPINIROLE HYDROCHLORIDE (REQUIP), MULTIVITAMIN [VITAMINS NOS], APPLE CIDER VINEGAR, ASTAXANTHIN, GINKGO BILOBA and WITHANIA SOMNIFERA (ASHWAGANDHA [WITHANIA SOMNIFERA]) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PYREXIA (Low grade fever) and FATIGUE (Felt tired). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 15-Mar-2021, PYREXIA (Low grade fever) and FATIGUE (Felt tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-072933, MOD-2021-378657 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Follow up received contains physician details and past procedure and patient demographic updated.