chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: VARlVAX was given to a patient after the temperature excursion occurred; no AE; This spontaneous report was received from an office manager and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.  On 13-JUL-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot: T032315, expiration date: 22-SEP-2022, for prophylaxis, 1 time dose (exact dose and route of administration were not provided).  The varicella virus vaccine live (oka/merck)(VARIVAX) experienced temperature excursion of -9.3 degree Celsius for 42 minutes. Previous temperature excursion was not detected. The digital data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: The consumer said he thinks a couple of doses were administered after a temperature excursion but he was not sure; No other AE; This spontaneous report was received from a physician referring to an unknown number of patients whose age and gender were not specified. No information was provided regarding the patients' pertinent medical history, concurrent conditions, concomitant medication, drug reactions or allergies.  On an unknown date, a temperature excursion involving Hepatitis A Vaccine, Inactivated (VAQTA) (lot number T033304, verified as valid for syringe formulation, with an expiration date reported and validated as 02-APR-2022) occurred. The doses of Hepatitis A Vaccine, Inactivated (VAQTA) were improperly stored at a temperature of 0.5 degrees Celsius for 20 minutes, 1.7 degrees Celsius for 50 minutes, and 1.2 degrees Celsius for 10 minutes. There wasn't a previous temperature excursion, and this was called because of a data logger.  The reporter thought that, after experiencing the temperature excursion, a couple of doses of Hepatitis A Vaccine, Inactivated (VAQTA) were administered to the patients for prophylaxis, but he was not sure (administered dose, dose number, vaccination scheme frequency, route of administration, and anatomical location of vaccination were not reported) (product storage error). No other adverse events (AE) were reported.  This case was considered non-valid due to the lack of patients' identifiers. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T033304; expirationdate: 02-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient has not experienced any adverse events; 3 year old male patient was administered PNEUMOVAX23 by mistake; the physician who placed the order for pneumococcal vaccination entered it in the system as PNEUMOVAX23, when he should have entered PREVNAR 13; This spontaneous report was received from a medical assistant and refers to a 3-year-old male patient. The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  It was reported that on an unknown date in 2021, the physician who placed the order for pneumococcal vaccination entered it in the system as  pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) when he should had entered pneumococcal vaccine conj 7v (CRM197) (PREVNAR) (Product prescribing error). On 06-JUL-2021, the patient was vaccinated with a unspecified dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # T036820 with expiration date 01-JUL-2022, at a dose of 0.5 milliliter one dose, for prophylaxis, as this was the vaccine the physician had ordered (Wrong product administered). The error was caught by the office until a billing audit. The patient had not experienced any adverse events or reported any complaints related to the administration. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T036820; expirationdate: 01-JUL-2022; deviceage and unit: 0; malfunction: Unknown; deviceusage: Unknown; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; a dose of GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age or gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions, concomitant medication, and drug reactions or allergies.  On an unknown date, a temperature excursion involving HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot number T030746, verified as valid for syringe formulation, with an expiration date reported and validated as 16-MAR-2023) occurred. The HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was improperly stored at a temperature of 49.69 degrees Fahrenheit for 1 hour and 24 minutes. There was no previous temperature excursion, and this was called because of a data logger. On 19-JUL-2021, following the temperature excursion, a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was administered to the patient for prophylaxis (administered dose, dose number, vaccination scheme frequency, route of administration, and anatomical location of vaccination were not reported) (product storage error). No additional adverse events (AE) were reported. 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: T030746; expirationdate: 16-MAR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: A medical assistant reported VARlVAX was administered after undergoing a temperature excursion.; This spontaneous report has been received from a Medical Assistant and refers to a 4-years old patient of unspecified gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On 15-JUL-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) as prophylaxis (lot number T035400, that was verified to be valid, with an expiration date reported and established upon internal validation as 16-OCT-2022) (concentration, dose number, vaccination scheme frequency, route and anatomical site of administration were not provided). It was reported that the vaccine was administered after underwent a temperature excursion of 0.4 degrees Celsius (+ 0.4 ° C) with a time frame of 13 hours and 10 minutes, which was detected by data logger (product storage error). No previous temperature excursions were reported.  This is one of several reports received from  the same reporter.; Sender's Comments:  US-009507513-2107USA007000: US-009507513-2107USA007007: US-009507513-2107USA006981: US-009507513-2107USA007009: US-009507513-2107USA007049: US-009507513-2107USA006957: US-009507513-2107USA007004:
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: A medical assistant reported VARIVAX was administered after undergoing a temperature excursion; This spontaneous report has been received from a Medical Assistant and refers to a 4-years old patient of unspecified gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On 19-JUL-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) as prophylaxis (lot number T028310, that was verified to be valid, with an expiration date reported and established upon internal validation as 20-AUG-2022) (concentration, dose number, vaccination scheme frequency, route and anatomical site of administration were not provided). It was reported that the vaccine was administered after underwent a temperature excursion of 0.4 degrees Celsius (+ 0.4 ° C) with a time frame of 13 hours and 10 minutes, which was detected by data logger (product storage error). No previous temperature excursions were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2107USA006887: US-009507513-2107USA007000: US-009507513-2107USA007007: US-009507513-2107USA006981: US-009507513-2107USA007009: US-009507513-2107USA007049: US-009507513-2107USA007004:
Sex: M
Vaccine: HPV9
Symptoms: Unevaluable event
Clinical narrative: got the third dose of GARDASIL 9/The primary care Doctor tells the patient to go and get a fourth dose one week later.; The primary care Doctor tells the patient to go and get a fourth dose one week later.; The Pharmacist did not give the patient the fourth dose due to reading the prescribing information.; no additional adverse events; This spontaneous report was received from a pharmacist and refers to a currently 24-year-old male patient. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On an unknown dates (between the patient's 15 and 18 years of old), the patient was vaccinated with the first and the second doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, lot #, expiration date, route and site of administration were not reported) for prophylaxis. On an unspecified date, he received a titer for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) at his doctors office and got the third dose of the vaccine (dose, lot #, expiration date, route and site of administration were not reported) for prophylaxis. The doctor told the patient to go and get the fourth dose one week later, however the pharmacist did not give him the fourth dose due to reading the prescription information. No additional adverse event was reported.
Sex: F
Vaccine: HPV9
Symptoms: No adverse event
Clinical narrative: she is older than 45 years old; No additional AE reported; This spontaneous report was received from a female patient of an unknown exact age (older than 45-year-old), who reported on herself. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On an unknown date, the patient who was older than 45-year-old, was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), for prophylaxis (dose, lot #, expiration date, route and site of administration were not reported). No additional adverse event was reported.
Sex: F
Vaccine: VARCEL
Symptoms: Accidental exposure to product, Wrong technique in product usage process
Clinical narrative: No additional AE reported; exposure (spray) into her eye; exposure (spray) into her eye while drawing it up out of vile today,; This spontaneous report as received from an administrator a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 22-JUL-2021, while drawing varicella virus vaccine live (oka/merck) (VARIVAX) (0.5 ml, lot # and expiration date were not provided) up out of vile, it sprayed into her eye. It was stated that she did not feel discomfort at all and there was no pain or irritation or redness noted. They flushed the eye out in the eye wash station per their office protocol. It was reported that a physician was seeing her (sought medical attention) and they were calling poison control as well to consult. It was unknown, if the patient received any treatment for the events. No adverse effects were reported. Her present status was reported as not recovered.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: No additional AEs; A dose of MMR II was mistakenly given by intramuscular route instead of subcutaneous route; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On 23-JUL-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # T006167 with an expiration date on 19-FEB-2022) at a dose of 0.5 milliliters by intramuscular route for prophylaxis  (strength, and anatomical location were not reported) instead of the subcutaneous route (incorrect route of product administration).         No additional adverse events were reported.
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: Administration of a pediatric dose to an adult patient; No adverse events reported; This spontaneous report was received from a nurse concerning an adult patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with hepatitis b vaccine (recombinant) thimerosal-free (RECOMBIVAX HB), 0.5 ml dose, lot number S002769 with expiration date 04-NOV-2021 for prophylaxis (strength and route of administration were not provided).  The nurse confirmed that the dose received by this adult patient was a pediatric dose (incorrect dose administered). No adverse events or product quality complaints (PQC) were reported.  At the reporting time, the patient's outcome was unknown. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S002769; expirationdate: 04-NOV-2021; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 33.0
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: no symptoms reported/No additional AEs reported; 33 year old patient received dose of PROQUAD; This spontaneous report was received from a nurse who refers to a 33-year-old patient of an unknown gender. Information regarding the patient's drug reactions or allergies, concomitant therapies and pertinent medical history was not provided. On 23-JUL-2021, the 33-year-old patient was vaccinated with measles (+) mumps (+) rubella (+) varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 05 milliliter, subcutaneously, for prophylaxis, lot # T030944, which has been verified to be valid, expiry date was not reported, but upon internal validation was established as 09-MAR-2022 (formulation, concentration, dose number, frequency were not reported). No additional adverse event was reported. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration
Clinical narrative: first shingles vaccine on 1-8-2020. I got shingles 6 months later.; I had my first shingles vaccine on 1-8-2020./ I got my second shingles vaccine today; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 8th January 2020, the patient received the 1st dose of Shingrix. On 20th July 2021, the patient received the 2nd dose of Shingrix. On 20th July 2021, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced shingles. On an unknown date, the outcome of the shingles and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced Shingles 6 months later. The patient received 2nd dose today (day of reporting), which led to drug dose administration interval too long. The pharmacist recommended a third vaccine but GlaxoSmithKline information did not. The reporter confused at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: Due to COVID / second dose / 7 months and one week after the first; This case was reported by a consumer via interactive digital media and described the occurrence of social problem 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 social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: This case was reported by patient for herself/himself. The age at vaccination was not reported. The patient due to COVID had to took his/her second dose of Shingrix vaccine 7 months and one week after the first dose which led to social problem. The reporter asked whether his/her immunization good or do he/she need to restart the series.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: it's been more than 6 months since you got the first dose, you should get the second dose as; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date more than 6 months 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: This case was reported by patient herself/himself. The age at vaccination was not applicable for this report. Till the time of reporting patient had not yet received second dose of Shingrix which led to incomplete course of vaccination. The reporter asked if the second dose was given 8 months after the first dose does it rendered the procedure invalid. The reporter also asked the vaccine still effective if the second dose was received after 6 months.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination, Ophthalmic herpes zoster
Clinical narrative: I've had twice now / into my right eye...; I've had twice now on top of my head; Incomplete course of vaccination; This case was reported by a consumer via interactive digital media and described the occurrence of ophthalmic herpes zoster 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 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), shingles and incomplete course of vaccination. On an unknown date, the outcome of the ophthalmic herpes zoster and shingles were not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient himself/herself. The age at vaccination was not reported. The patient stated he/she received the 1st dose of Shingles vaccine and the patient had shingles twice and at the time of reporting on top of head and into right eye. The reporter stated that he/she hated it and the 2nd time got shingles was year later. Till the time of reporting the patient did not receive the 2nd dose of Shingles vaccine,which led to incomplete corse of vaccination. The reporter asked anything I could do help.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: had an extra powder left / not sure if just liquid cyw / was administered / what would happen / if they administered only the cyw component; had an extra powder left / not sure if just liquid cyw / was administered / what would happen / if they administered only the cyw component; This case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that in office had an extra powder left with Menveo in their box and reporter not sure this was just liquid CYW of Menveo vaccine was administered by patient which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter said that in same office they had drawn up a CYW and were about to mix with A' component, but the patient decided then not to get the vaccine. The reporter wanted to know that what would happened and if there was any information from GSK if patient administered only the CYW component. No other information provided by reporter. The reporter told if they found out vaccine was administered to a patient they would report information.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: COVID-19, Illness, Incomplete course of vaccination
Clinical narrative: Covid / very ill / hospitalized; very ill; perhaps / shouldn't do the second dose / patient was six month post first dose / was unsure about finishing the series; This case was reported by a nurse via sales rep and described the occurrence of covid-19 in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced covid-19 (serious criteria hospitalization), illness (serious criteria hospitalization) and incomplete course of vaccination. On an unknown date, the outcome of the covid-19 and illness were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   The reporter considered the covid-19 and illness to be unrelated to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shngrix last year from the date of reporting. After receiving Shingrix, the patient had covid. The reporter was unsure of the order of events and which was first or second.  She said that, the patient became very ill and ended up hospitalized.  Because of the timing of the vaccine being so close to the illness, she said that, the hospital provider had told that, the patient that perhaps they should not do the second dose of Shingrix.  When the patient was six-month post first dose, she was healthy and said that, the patient was unsure about finishing the series.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The sales representative told that, he/she legally needed to report the possible adverse event.  The reporter said that, she did not believe that, her illness and hospitalization was due to the vaccine and did not want anyone to reach out. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness/at the injection site; swelling at the injection site; This case was reported by a nurse via sales rep and described the occurrence of injection site erythema 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 injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details provided were as follows: Age at vaccination was not reported. The patient received shingrix vaccination and complained of redness and swelling at the injection site. The reporter was not able to collect any more information. The reporter did not consented to follow-up.
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Pediatric patients be given Havrix Adult Dose; Pediatric patients be given Havrix Adult Dose; This case was reported by a other health professional via sales rep and described the occurrence of overdose in a 14-year-old male patient who received HAV (Havrix adult) (batch number EK59B, expiry date 20th November 2020) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   It was unknown if the reporter considered the overdose and adult product administered to child to be related to Havrix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the pediatric patient received Havrix adult dose, which led to overdose and adult product administered to child. The reporter consented to follow up. This was 2 of 4 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR159012:Same reporter US-GLAXOSMITHKLINE-US2021AMR158998:Same reporter US-GLAXOSMITHKLINE-US2021AMR159013:Same reporter
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Pediatric patients be given Havrix Adult Dose; Pediatric patients be given Havrix Adult Dose; This case was reported by a other health professional via sales rep and described the occurrence of overdose in a 2-year-old male patient who received HAV (Havrix adult) (batch number EK59B, expiry date 20th November 2020) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the pediatric patient received Havrix adult dose, which led to overdose and adult product administered to child. The reporter consented to follow up. This was 4 of 4 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR159011:Same reporter US-GLAXOSMITHKLINE-US2021AMR159013:Same reporter US-GLAXOSMITHKLINE-US2021AMR158998:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got shingles; This case was reported by a consumer via 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: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. The patient reported that, it was not 100 percent effective. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Multiple sclerosis, Multiple sclerosis relapse
Clinical narrative: The shot took my MS our off remission!; This case was reported by a consumer via interactive digital media and described the occurrence of multiple sclerosis relapse in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included multiple sclerosis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced multiple sclerosis relapse (serious criteria GSK medically significant). On an unknown date, the outcome of the multiple sclerosis relapse was unknown.   The reporter considered the multiple sclerosis relapse to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient reported that, the shingles shot took his/her multiple sclerosis out off remission.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; had shingles twice; This case was reported by a consumer via media and described the occurrence of 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 are as follows: The age at vaccination was not reported. The patient had shingles twice and have had the vaccine. The patient stated so much for that and vaccine did not help him/ her. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: rash at injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st July 2021, the patient received the 1st dose of Shingrix. In July 2021, less than a week after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was not recovered/not resolved.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix 4 days ago and had a rash at injection site.  The reporter asked did the patient need to report to a doctor.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Been vaccinated / still got shingles/Suspected Vaccination failure; got shingles; This case was reported by a consumer via 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 reported as follows: The age at vaccination was not reported. The patient been vaccinated several years ago and still got shingles last year.  At the time of reporting this would be better to get. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Immediate post-injection reaction, Peripheral swelling
Clinical narrative: next day she was tired; next day she was / sleepy; her arm became  itchy; her arm became  / red; her arm became  / warm; her arm became  / swollen; Itchy rash; chills; This case was reported by a consumer via call center representative and described the occurrence of itchy upper limbs in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th July 2021, the patient received the 1st dose of Shingrix (intramuscular). On 17th July 2021, immediately after receiving Shingrix, the patient experienced itchy upper limbs, erythema of extremities, skin warm, swelling arm, itchy rash and chills. On 18th July 2021, the patient experienced tiredness and sleepiness. On an unknown date, the outcome of the itchy upper limbs, erythema of extremities, skin warm, swelling arm and itchy rash were not recovered/not resolved and the outcome of the chills, tiredness and sleepiness were recovered/resolved.   It was unknown if the reporter considered the itchy upper limbs, erythema of extremities, skin warm, swelling arm, itchy rash, chills, tiredness and sleepiness to be related to Shingrix.  Additional details were reported as follows: The reporter was the patient.  The patient received Shingrix in right arm and arm became itchy, red, warm and swollen shortly thereafter.  The patient experienced chills the same evening and next day the patient was tired and sleepy.  The reporter was referred to health care professional. The reporter did not consent to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash pruritic, Skin warm, Somnolence
Clinical narrative: next day she was tired; next day she was / sleepy; her arm became  itchy; her arm became  / red; her arm became  / warm; her arm became  / swollen; Itchy rash; chills; This case was reported by a consumer via call center representative and described the occurrence of itchy upper limbs in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th July 2021, the patient received the 1st dose of Shingrix (intramuscular). On 17th July 2021, immediately after receiving Shingrix, the patient experienced itchy upper limbs, erythema of extremities, skin warm, swelling arm, itchy rash and chills. On 18th July 2021, the patient experienced tiredness and sleepiness. On an unknown date, the outcome of the itchy upper limbs, erythema of extremities, skin warm, swelling arm and itchy rash were not recovered/not resolved and the outcome of the chills, tiredness and sleepiness were recovered/resolved.   It was unknown if the reporter considered the itchy upper limbs, erythema of extremities, skin warm, swelling arm, itchy rash, chills, tiredness and sleepiness to be related to Shingrix.  Additional details were reported as follows: The reporter was the patient.  The patient received Shingrix in right arm and arm became itchy, red, warm and swollen shortly thereafter.  The patient experienced chills the same evening and next day the patient was tired and sleepy.  The reporter was referred to health care professional. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Herpes zoster, Product supply issue, Scab
Clinical narrative: Shingles; crusts 1x1 inches; colored pink; due to supply issues he could not get the second dose; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles, crust, erythema and product supply issue. The patient was treated with cortisone (non-proprietary) (Cortisone 10). On an unknown date, the outcome of the shingles, crust and erythema were recovering/resolving and the outcome of the product supply issue was unknown.   It was unknown if the reporter considered the shingles, crust and erythema to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient's spouse. The reporter stated that the patient received the first Shingrix vaccine in 2018 but due to supply issues he could not get the second dose. The nurse reported that male patient till the time of reporting due to out of stock of the vaccine second dose has been not yet receive which led to product supply issue. The patient received first dose of Shingrix in 2018 and developed shingles describes as crusts 1 by 1 inches, colored pink, no pustules. The patient administered corticoids and applied bandages every day reduced the symptoms after a week.  No other information was provided as patient identifiers, no lot number nor expiration date. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021157381:Same reporter, FU, deleted from database US-GLAXOSMITHKLINE-US2021157377:FU2 deleted
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 21st July 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In July 2021, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details provided were as follows: The reporter was patient's mother. Age at vaccination was not reported. The patient got the second dose of the Shingrix vaccine, a day before reporting and next morning at 2 am he started having a fever. The reporter did not consented to follow-up.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Contusion, Hypokinesia, Paraesthesia, Pruritus
Clinical narrative: local itching; local / bruising; was in bed all day; tingling in his arm/ tingling sensation all over; joints are sore; This case was reported by a consumer via call center representative and described the occurrence of tingling of extremity in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number TP943, expiry date 28th January 2023) for prophylaxis.   On 20th July 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In July 2021, less than a week after receiving Shingrix, the patient experienced tingling of extremity and soreness of joint. On 21st July 2021, the patient experienced movements reduced. On 22nd July 2021, the patient experienced localized itching and contusion. On an unknown date, the outcome of the tingling of extremity, soreness of joint, localized itching and contusion were not recovered/not resolved and the outcome of the movements reduced was unknown.   It was unknown if the reporter considered the tingling of extremity, soreness of joint, localized itching, contusion and movements reduced to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient himself. The patient had received 2nd dose of Shingrix vaccine in the right arm and had tingling in his arm, tingling sensation all over, his joints are sore and he was in bed all day on next day of vaccination and 2 day after receiving Shingrix, he had local itching and bruising. The reporter consented to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Shingrix/ was exposed at room temperature for 900 hours; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 7Z29K, expiry date unknown) for prophylaxis.   On 2nd July 2021, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: Pharmacist reported that the patient was administered Shingrix which was exposed to room temperature for 900 hours, which led to incorrect storage of drug. No information about expiration date was provided. The reporter consented to follow up by fax. This case was linked with US2021159292, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021159292:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Off label use
Clinical narrative: Physician wrote intentional prescription for a patient less than 50 years old to receive Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of off label use in a 32-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes zoster.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced off label use. On an unknown date, the outcome of the off label use was unknown.  Additional details provided were as follows: Pharmacist reported that physician wrote intentional prescription for a patient less than 50 years old to receive Shingrix vaccine due to patient's medical history of herpes zoster virus which led to off label use. Vaccine had not yet been administered. Pharmacist did not provided date of birth but stated that the patient's current age was 32 years. Reporter consented to follow up. Pharmacist provided permission for follow-up.
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Incorrect route of product administration
Clinical narrative: administered Boostrix  subcutaneously/administered Menveo subcutaneously; This case was reported by a physician via call center representative and described the occurrence of intramuscular formulation administered by other route in a 12-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number BR352, expiry date 27th August 2022) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis and Men ACWY-CRM NVS (Menveo) (batch number AMVA371A, expiry date 31st July 2021) for prophylaxis.   On 2nd December 2020, the patient received Boostrix (subcutaneous), Boostrix Pre-Filled Syringe Device and Menveo (subcutaneous). On an unknown date, unknown after receiving Boostrix, Boostrix Pre-Filled Syringe Device and Menveo, 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 provided were as follows: Age at vaccination was not reported. On 23rd July 2021, physician reported that female patient was administered Boostrix and Menveo subcutaneously instead of intramuscularly which led to Intramuscular formulation administered by other route. Reporter did not consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021159306:FU DELETED
Sex: F
Vaccine: VARZOS
Symptoms: Product prescribing error
Clinical narrative: 45 year old /has a medical order to receive Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of drug prescribing error in a 45-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug prescribing error. On an unknown date, the outcome of the drug prescribing error was unknown.  Additional details were provided as follows: The age at vaccination was not applicable. The pharmacist reported that the 45 year old patient had a medical order to receive Shingrix and the vaccine had not been administered, which led to drug prescribing error. The reporter consented to follow up.