chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Expired product administered, Injection site erythema, Injection site swelling, Product storage error
Clinical narrative: swelling and redness around the injection site; swelling and redness around the injection site; expired vaccine administered; temperature excursion; This spontaneous report was received from a pharmacist referring to a 66-years-old male patient. The patient's medical history, drug allergies, previous drug reactions, concurrent conditions, and concomitant medications were not reported.  On 18-MAY-2020, the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) underwent a temperature excursion (product storage error) reported with a maximum temperature achieved above 47 Fahrenheit degrees "(82 F)" for a timeframe of 15 hours.  On 24-JUL-2020, the patient was vaccinated by a trained pharmacist with the improperly stored vaccine of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscular injection in the right arm, frequency reported as once (dose not reported, lot # R011632 which was confirmed to be valid for pneumococcal vaccine, polyvalent (23-valent) and expiration date reported and validated as 02-FEB-2020) for prophylaxis (expired product administered). On the same day, the patient was vaccinated with diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (ADACEL) intramuscular injection in the left arm (dose not reported, lot number C5661AA and with an expiration date reported as 08-AUG-2020) for an indication not provided.  On 25-JUL-2020, the patient experienced swelling and redness around the injection site (vaccination site swelling and vaccination site erythema) that lasted 3 or 4 days, therefore, on an unspecified date in July 2020, the patient recovered from the events. No product quality complaint was reported.  The reporter considered the events vaccination site swelling and vaccination site erythema to be attributable to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and to the administration of the expired vaccine. The causal relationship between diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (ADACEL) and the events was not provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R011632; expirationdate: 02-FEB-2020; deviceage and unit: 0 ; operatorofdevice: Pharmacist; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 1.83
Sex: M
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; temperature excursion for VARIVAX and MMR II; This spontaneous report was received from an office manager referring to a 22-month-old male patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.       On 30-SEP-2020, two vaccines varicella virus vaccine live (oka/merck)(VARIVAX) (lot# T003706 with expiration date 30-JAN-2022) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot# S029454 with expiration date 19-SEP-2021) had temperature excursion. The temperature excursion was -14.27 C for 20 minutes.   On 01-OCT-2020, the patient was vaccinated with both vaccines (dose details, frequency and route were unknown) for prophylaxis (product storage error). No additional adverse event was reported.       There was no previous temperature excursion. Data logger was involved.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: Temperature excursion; Information has been received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with a hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis, lot number 1637651 with expiration date in 09-JUN-2022 (dose, route of administration, strength and anatomical location not reported) that underwent a temperature excursion.  The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was stored at a temperature of 35.6 degrees Fahrenheit (°F) for the time frame of 3 hours and 15 minutes. There was a previous temperature excursion and the call was because of a data logger. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637651; expirationdate: 09-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: The patient did not exhibit any negative signs or symptoms related to the administration; Administration of an expired PNEUMOVAX 23 vaccine; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age or gender. The patient's concurrent and historical conditions, as well as concomitant medications were not reported.  On 07-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, strength, route and anatomical location were not reported), lot # S026366 with expiration date of 17-SEP-2020 (expired product administered), for prophylaxis. It was reported that the patient did not exhibit any negative signs or symptoms related to the vaccination. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S026366; expirationdate: 17-SEP-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability.
Sex: U
Vaccine: MMR
Symptoms: Generalised onset non-motor seizure
Clinical narrative: Generalized nonconvulsive epilepsy; Literature Report: Information has been received from the authors of a published literature article, title as stated above regarding to a child patient of an unknown gender. No information was provided regarding the patient's medical history, concurrent conditions and concomitant therapies.  On an unknown date, the patient was vaccinated with at least the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) to prevent measles (dose, vaccination scheme, route of administration, anatomical injection site, lot number and expiration date were not reported).  On an unknown date, the patient experienced generalized non-convulsive epilepsy (generalised onset non-motor seizure). At the time of the report, the outcome of the event was not reported.  The authors considered that the event generalised onset non-motor seizure was considered to be related to suspect vaccine as this event was considered a rare consequence of routine childhood measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccination.  Upon internal review, the event generalised onset non-motor seizure was determined to be medically significant.   A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports received from the same reporter. Sender's Comments:  US-009507513-2010USA001144:
Sex: U
Vaccine: MMR
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: Generalized convulsive epilepsy; Literature Report.   Information has been received from the authors of a published literature article, title as stated above regarding to a child patient of an unknown gender. No information was provided regarding the patient's medical history, concurrent conditions and concomitant therapies.  On an unknown date, the patient was vaccinated with at least the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) to prevent measles (dose, vaccination scheme, route of administration, anatomical injection site, lot number and expiration date were not reported).  On an unknown date, the patient experienced generalised convulsive epilepsy (generalised tonic-clonic seizure). At the time of the report, the outcome of the event was not reported.  The authors considered that the event generalised tonic-clonic seizure was considered to be related to suspect vaccine as this event was considered a rare consequence of routine childhood measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccination.  Upon internal review, the event generalised tonic-clonic seizure was determined to be medically significant.   A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports received from the same reporter (MARRS# 2010USA001144).; Sender's Comments:  US-009507513-2010USA001144:
Sex: U
Vaccine: MMR
Symptoms: Partial seizures
Clinical narrative: Localization-related (focal) (partial) epilepsy and epileptic syndromes with simple partial seizures; Literature Report.   Information has been received from the authors of a published literature article, title as stated above regarding to a child patient of an unknown gender. No information was provided regarding the patient's medical history, concurrent conditions and concomitant therapies.  On an unknown date, the patient was vaccinated with at least the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) to prevent measles (dose, vaccination scheme, route of administration, anatomical injection site, lot number and expiration date were not reported).  On an unknown date, the patient experienced localization-related (focal) (partial) epilepsy and epileptic syndromes with simple partial seizures (partial seizures). At the time of the report, the outcome of the event was not reported.  The authors considered that the event partial seizures was considered to be related to suspect vaccine as this event was considered a rare consequence of routine childhood measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccination.  Upon internal review, the event partial seizures was determined to be medically significant.   A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports received from the same reporter (MARRS# 2010USA001144).; Sender's Comments:  US-009507513-2010USA001144:
Sex: U
Vaccine: MMR
Symptoms: Seizure
Clinical narrative: Other Seizure; Literature Report:   Information has been received from the authors of a published literature article, title as stated above regarding to a child patient of an unknown gender. No information was provided regarding the patient's medical history, concurrent conditions and concomitant therapies.  On an unknown date, the patient was vaccinated with at least the first dose of M-M-R II to prevent measles (dose, vaccination scheme, route of administration, anatomical injection site, lot number and expiration date were not reported).  On an unknown date, the patient experienced other seizure. At the time of the report, the outcome of the event was not reported.  The authors considered that the event seizure was considered to be related to suspect vaccine as this event was considered a rare consequence of routine childhood M-M-R II vaccination.  Upon internal review, the event seizure was determined to be medically significant.   A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports received from the same reporter.  Sender's Comments:  US-009507513-2010USA001144:
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness, Syncope
Clinical narrative: passed out; fainted; This spontaneous report was received from a physician assistant (PA) via a company employee referring to a female child patient of unknown detailed age (reported as 11 (units not reported)). Information about pertinent medical history, drug reactions/allergies and concomitant medication was unknown.  On 17-SEP-2020 (reported as 3 weeks ago), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose detail, route, lot # and expiration date were not reported) for prophylaxis.  The patient was not be made to wait the 15 minutes after received the vaccine, and she stood up, passed out and fainted. The patient did not seek medical attention and no treatment was given for the events. The patient had recovered from the events. The causality assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.   Upon internal review, the events of passed out and fainted were determined to be medically significant.
Sex: F
Vaccine: MENB
Symptoms: Headache, Mobility decreased, Pyrexia
Clinical narrative: temp of 100.5; headache; Could barely move her arms and legs; This case was reported by a other health professional via sales rep and described the occurrence of fever in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, 1 day after receiving Bexsero, the patient experienced fever, headache and mobility decreased. On an unknown date, the outcome of the fever, headache and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the fever, headache and mobility decreased to be related to Bexsero.  Additional details were as follows: The age at vaccination was not reported, but it could be 17 year or 18 year. It was reported that patient received the 1st Bexsero vaccine few months ago and the next day of vaccination patient expereinced temp of 100.5 degree F , headache and could barely move her arms and legs and the events subsided after the 48 hrs. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR201424:2nd dose
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chemotherapy, Incomplete course of vaccination, Neoplasm malignant, Surgery
Clinical narrative: many months of chemo; surgery; This case was reported by a consumer via call center representative and described the occurrence of cancer in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd May 2019, the patient received the 1st dose of Shingrix. On 15th May 2019, 13 days after receiving Shingrix, the patient experienced surgery. On an unknown date, the patient experienced cancer (serious criteria GSK medically significant). The patient was treated with chemotherapy, nos (Chemotherapy). Shingrix was discontinued. On an unknown date, the outcome of the cancer and surgery were unknown.   It was unknown if the reporter considered the cancer and surgery to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient's husband. The patient got the first dose of Shingrix and she had a surgery on 15th May 2020 and she had many months of chemo due to the surgery which she started in July 2019 and ended in November.  She was advised by her doctor to not get the second dose of Shingrix.  The reporter did not consent to follow-up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dyspnoea, Pyrexia
Clinical narrative: Fever; Shortness of Breath; Chills; This case was reported by a consumer via call center representative and described the occurrence of fever in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th October 2020, the patient received the 1st dose of Shingrix (intraparietal). On 8th October 2020, 1 days after receiving Shingrix, the patient experienced fever, shortness of breath and chills. On an unknown date, the outcome of the fever, shortness of breath and chills were recovered/resolved.   It was unknown if the reporter considered the fever, shortness of breath and chills to be related to Shingrix.  Additional details were reported as follows: The patient experienced Fever, Chills, and Shortness of Breath.  These symptoms lasted approximately four hours and then resolved. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: experiencing muscle pain in the injection arm; This case was reported by a pharmacist via call center representative and described the occurrence of injection site muscle pain in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site muscle pain. On an unknown date, the outcome of the injection site muscle pain was recovered/resolved.   It was unknown if the reporter considered the injection site muscle pain to be related to Shingrix.  Additional details were provided as follows: The age vaccination was not reported. The patient was vaccinated with 1st dose of Shingrix and experinced muscle pain in the injection arm. The reporter was patient. The reporter consent to follow up. This case was 1 of 4 cases reported by same patient. This case was linked with case US2020AMR202100 by patient link.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020201572:same reporter US-GLAXOSMITHKLINE-US2020201576:same reporter US-GLAXOSMITHKLINE-US2020201578:same reporter US-GLAXOSMITHKLINE-US2020AMR202100:same reporter
Age: 17.0
Sex: U
Vaccine: MENB
Symptoms: Headache, Neck pain, Pyrexia
Clinical narrative: patient developed fever, headache and sore neck within 24 hours of injection; patient developed fever, headache and sore neck within 24 hours of injection; patient developed fever, headache and sore neck within 24 hours of injection; This is a spontaneous report from a contactable physician.  A 17-year-old patient of an unspecified gender received the first dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration, on an unspecified date at a single dose for immunization.  The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient developed fever, headache and sore neck within 24 hours of injection. The patient never had a headache like that before.  The outcome of fever and sore neck was recovered on an unspecified date and of headache was recovering.  The physician was unsure whether it was related to Trumenba or not. Added that quite a few of his patients develop headache and fever post injection.   The batch/lot number for the vaccine, TRUMENBA, was not provided and will be requested during follow up.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Sick for weeks; Initial information was received on 07-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves patient (gender unspecified) who was sick for weeks (malaise), while received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick for weeks (malaise) (unknown latency, non-serious event) following the administration of INFLUENZA VACCINE.  No laboratory data was provided   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on lot number.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 07-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves patient (unknown demographics) who experienced flu (influenza), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) unknown latency following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for influenza.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sick; Initial information was received on 07-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a patient (age and gender unspecified) who was sick (malaise), when received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (malaise) (unknown latency, non-serious event) following the administration of INFLUENZA VACCINE. The patient was sick for 3 months and then 2 months   No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: patient had worse flu ever after receiving the flu shot; Initial information received on 07-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non health care professional.  This case involves a patient (age and gender not reported) who experienced worse flu (influenza), while he/she received vaccine INFLUENZA VACCINE.  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination  On an unknown date, the patient developed non-serious worse flu (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  Case Detail: Product name was not provided. Since this was a public post on the Sanofi flu shot campaign The Race for 200M, it was assumed that consumer was referring to the Sanofi flu vaccine.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was not reported.  There will be no information available on batch number for this case.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: a partial dose of Fluzone High Dose was given to patient, No AE; syringe leaked from end of syringe where needle is attached, hub area while injecting, no AE; Initial information was received on 23-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 65-years-old female patient who was administered with partial dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] (lot UJ456AA, expiry date: 30-Jun-2022) via an intramuscular route in left deltoid for prophylactic vaccination (underdose and syringe issue) on 23-Sep-2020.  Medical history, past medical treatments, vaccinations and family history were not provided. Patient had no concomitant medications.  It was a case of vaccine underdose and syringe leak. It was reported that partial dose of Fluzone HD was given to patient, as much as half the vaccine may not have been administered because it ran out of the hub area where the needle was connected, just prior to injecting into patient's skin  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: the ActHib dilute did not get refrigerated when arrived, Dilute was left outside of refrigeration for several days and exposed to room temperature (75 F)/No AE; Initial information received on 24-Sep-2020 regarding an unsolicited valid non-serious case received from the other health care professional.  This case involves an unknown age female patient.  It was reported that HIB (PRP/T) VACCINE [ACT-HIB] (Lot Number: u6789ab, expiration date: 21-Oct-2021) dilute did not get refrigerated when arrived. Dilute was left outside of refrigeration for several days and exposed to room temperature (75 Fahrenheit) (Product storage error).  Medical history, medical treatment, vaccination, concomitant therapy and family history were not provided.  This was a potential medication error case due to incorrect product storage.  It was unknown whether the vaccine was administered or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.08
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: A 5 week old patient received Daptacel, no AE; Initial information was received on 24-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 5 week old male patient who received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number not reported, form: single dose vial) via unknown route in unknown administration site for prophylactic vaccination on an unknown date (product administered to patient of inappropriate age).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency same day)  The reporter asked whether the vaccination is counted as a valid.   At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on lot number.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: received an Act HIB vaccine, but it was later discovered that the diluent of that vaccine had already expired with no adverse event; Initial information received on 24-Sep-2020 regarding an unsolicited valid non-serious case received from a Health care professional.  This case was linked to case 2020SA263460.  This case involves a 12 months old male patient who received a 0.5 ml fourth dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB], (single dose vial) (lot: UJ114AAA, expiry date: 24-Aug-2020) once via Intramuscular route on right thigh, on 03-Sep-2020.  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medication included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13).  It was an actual medication error due to the expired product administered. It was reported that a patient received an Act HIB vaccine, but it was later discovered that the diluent of that vaccine had already expired. (latency on the same day)  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: received an ActHIB vaccine, but it was later discovered that the diluent of that vaccine had already expired with no adverse event; Initial information received on 24-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case was linked to case 2020SA263869.  This case involves a 12 months old male patient who received a 0.5 ml once fourth dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB], single dose vial (lot: UJ114AAA, expiry date: 24-Aug-2020, vaccination site not reported), via Intramuscular route, on 02-Sep-2020.  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medication included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13)  It was an actual medication error due to the expired product administered. It was reported that a patient received an Act HIB vaccine, but it was later discovered that the diluent of that vaccine had already expired. (latency- on the same day)  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 38.0
Sex: M
Vaccine: FLUX
Symptoms: Lymphadenopathy, Sensitive skin
Clinical narrative: swollen lymph node under armpits on both sides; sensitive skin under armpits on both sides; Initial information was received on 29-Sep-2020 regarding an unsolicited valid non-serious case from a consumer or other non-professional.  This case involves a 38-year-old male patient who experienced swollen lymph node and sensitive skin under armpits on both sides (lymphadenopathy and sensitive skin), while he received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On 28-Sep-2020 around 11:00 am, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an intramuscular route at the right deltoid for prophylactic vaccination.  On 29-Sep-2020, the patient developed a non- swollen lymph node and sensitive skin under armpits on both sides (lymphadenopathy and sensitive skin), 1 day following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.   It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was unknown for all reported events.   There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: She said they give this vaccine to pregnant women with no AE; Initial information received on 09-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age female patient who was exposed to vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (exposure during pregnancy). Data regarding this pregnancy were received prospectively. The date of last menstrual period was not reported.  The estimated due date was not reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, (unknown latency) the patient was exposed to dose of suspect INFLUENZA QUADRIVAL A-B VACCINE prefilled syringe [lot UJ471AB and Expiration date unknown] via unknown route in unknown administration site for prophylactic vaccination (exposure during pregnancy) with no adverse event.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Not Applicable.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: tiredness; This case was reported by a pharmacist via call center representative and described the occurrence of tiredness in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (for the tolerability of 1st dose, refer case US2020201575 reported for same patient).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was recovered/resolved.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient experienced tiredness after the second dose of Shingrix. The reporter consented to follow up. This case has been linked with US2020201572, US2020201576, US2020201578 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020201572:same reporter US-GLAXOSMITHKLINE-US2020201576:same reporter US-GLAXOSMITHKLINE-US2020201578:same reporter US-GLAXOSMITHKLINE-US2020201572:same reporter US-GLAXOSMITHKLINE-US2020201576:same reporter US-GLAXOSMITHKLINE-US2020201578:same reporter US-GLAXOSMITHKLINE-US2020201575:same reporter
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Injection site erythema
Clinical narrative: inch diameter ring around my injection; FATIGUE /tiredness; headache; chills; chills like the flu.; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 54-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd October 2020, the patient received the 1st dose of Shingrix. On 3rd October 2020, 1 days after receiving Shingrix, the patient experienced fatigue, headache, chills and flu like symptoms. On 8th October 2020, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown and the outcome of the fatigue, headache, chills and flu like symptoms were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, fatigue, headache, chills and flu like symptoms to be related to Shingrix.  Additional details were provided as follows:  This case was reported by patient itself. The patient had bad headache fatigue tiredness and chills like the flu symptoms. At the time of reporting, the symptoms pretty much went away. The 4 inch diameter ring around injection site was very red.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Pain in extremity, Peripheral swelling
Clinical narrative: Bump / Red and raised; Bump / Red and raised; Pain at his thigh; exhausted; This case was reported by a consumer via call center representative and described the occurrence of exhaustion in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (in last 5 years had shingles 20 times). Concomitant products included etanercept (Embrel).   On 30th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 2nd October 2020, 2 days after receiving Shingrix, the patient experienced exhaustion. On 5th October 2020, the patient experienced pain in thigh. On 7th October 2020, the patient experienced local swelling and redness of legs. On an unknown date, the outcome of the exhaustion, pain in thigh, local swelling and redness of legs were unknown.   It was unknown if the reporter considered the exhaustion, pain in thigh, local swelling and redness of legs to be related to Shingrix.  Additional details were provided as follows: The patient had a history of shingles in the last 5 years having had shingles 20 times but it was limited to the same spot on his thigh. The patient had not been taking his Embrel for 3 weeks once he started again in May, he experienced four breakouts of shingles on the back of his left thigh. The patient received the 1st dose of Shingrix in left arm and by 2nd October he was exhausted. On 4th October 2020, the patient took his Embrel medication. On 5th October 2020, 5 days after vaccination the patient had pain at his thigh. The pain he experienced was not a blistering breakout but on 7th October 2020, 7 days after vaccination he had a bump where he initially had the breakout and it was red and raised but could barely be seen on his left thigh. The back of left thigh is where he was experiencing the single bump at the time of reporting. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: She felt tingling all over her body / in her lower back and face; pain when the vaccine was injected; she could feel the vaccine move down her arm across her chest and head and down the other arm; her arm hurt; This case was reported by a consumer via call center representative and described the occurrence of tingling in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th September 2020, the patient received the 1st dose of Shingrix. In September 2020, less than 2 weeks after receiving Shingrix, the patient experienced pain in arm. On 24th September 2020, the patient experienced tingling, pain and feeling abnormal. On an unknown date, the outcome of the tingling was not recovered/not resolved and the outcome of the pain was recovered/resolved and the outcome of the feeling abnormal was unknown and the outcome of the pain in arm was recovering/resolving.   It was unknown if the reporter considered the tingling, pain, feeling abnormal and pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient felt pain when vaccine was injected and she experienced the vaccine moved down her arm across her chest and head and down the other arm and she also felt tingling all over her body.  It was reported that when she was busy doing things like gardening, she did not notice it as much but was feeling the tingling in her lower back and face. She also said her arm hurt for a few days before resolving.  The reporter consented to follow up.
Age: 57.0
Sex: F
Vaccine: FLUC3, VARZOS
Symptoms: Blister
Clinical narrative: break out on her chin that were blisters; This case was reported by a pharmacist via call center representative and described the occurrence of blister in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 73T27, expiry date 9th September 2022) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUCELVAX QUADRIVALENT) for prophylaxis.   On 21st September 2020, the patient received the 1st dose of Shingrix (intramuscular) and FLUCELVAX QUADRIVALENT. In September 2020, less than a week after receiving Shingrix, the patient experienced blister. On an unknown date, the outcome of the blister was unknown.   It was unknown if the reporter considered the blister to be related to Shingrix.  Additional details were provided as follows: The patient received the Shingrix vaccine and a Flucelvax Quadrivalent vaccine. Three to four days later, she had a break out on her chin that were blisters. The reporter consented to follow up.
Age: 59.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently approximately 64-year-old patient of unknown gender. Medical history, concurrent conditions and concomitant medications were not provided.  On or about 02-DEC-2016, the patient was administered the zoster vaccine live (ZOSTAVAX) (dose, route of administration, site of administration and lot # were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unknown date (reported as subsequently), the patient was treated by a provider for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX): herpes zoster. The patient claimed damages as a result of: injury to themselves. The outcome of the event was not provided.  The lawyer considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: We were both sick the whole winter.; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received the 1st dose of Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows:  This case reported by patient herself (wife). The age at vaccination was not reported. The patient received flu shot and experienced sick (whole winter). This case had been linked to the case US2020AMR202143 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR202143:Same reporter
Sex: M
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: We were both sick the whole winter.; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows:  This case was referred to patient's husband. The age at vaccination was not reported. The patient received flu shot and experienced sick (whole winter). This case had been linked to the case US2020AMR202139 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR202139:Same reporter
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Incomplete course of vaccination, Mobility decreased, Pain in extremity, Pruritus
Clinical narrative: itching and scaling on his head; rash of some sort; scaling on his head; difficult to move his arm; 10-JUL-2019 first dose; arm pain; headache/lasted 2 months; This case was reported by a consumer via call center representative and described the occurrence of headache in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included migraine.   On 10th July 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 10th July 2019, several hours after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm. On 11th July 2019, the patient experienced headache. On an unknown date, the patient experienced pruritus, rash, skin scaly, mobility decreased and incomplete course of vaccination. On an unknown date, the outcome of the headache, pruritus, rash, skin scaly, mobility decreased and incomplete course of vaccination were unknown and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the headache, pain in arm, pruritus, rash, skin scaly and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had headache and lasted 2 months.   The patient had arm pain and it was difficult to move his arm.  The patient started to had some itching and scaling on his head and recently noticed that it may be a rash of some sort. Till date the patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.