chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: pox lesion; temperature excursion; This spontaneous report was received from a registered nurse concerning an 11-year-old male with no pre-existing allergies, birth defects, or medical conditions. There was no illness at the time of vaccination. There was no concomitant medication.  On 16-AUG-1996, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength and dose were not provided; Lot# was 617260/0563D and expiration date was not reported but upon internal validation as 01-NOV-1997) subcutaneously for prophylaxis.   On an unknown date (reported as subsequently), the patient developed approximately 20-30 apparent pox lesions per telephone report from the mother. There were no relevant diagnostic tests or laboratory data. There were no adverse events following prior vaccination. The outcome was reported as recovered.  It was also noted that the patient's brother developed varicella after vaccination with varicella virus vaccine live (oka/merck) (VARIVAX) (WAES # 0503USA00122).  Follow up information was received from a medical assistant on 09-APR-2021. On 07-APR-2021, the patient was vaccinated varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and route were not provided; lot# was T017685 and expiration date was 21-MAY-2022; lot# was T027303 and expiration date was 12-AUG-2022; lot# was T010311 and expiration date was 24-MAR-2022; lot# was T017681 and expiration date was 21-MAY-2022) involved a temperature excursion for prophylaxis (product storage error). The administered dose involved in a temperature excursion at - 58 degree Fahrenheit (F) to 5 degree F (9.5 F) for 0 hours 45 minutes 0 seconds and 11 degree F for 1 hour 0 minutes 0 seconds. There was a previous temperature excursion at 9.5 degree F for 0 hours 45 minutes 0 seconds. It was detected by a data logger.  This is one of the 7 cases received from the same reporter.; Sender's Comments:  US-009507513-2104USA002475: US-009507513-2104USA002470: US-009507513-2104USA003265: US-009507513-2104USA003268: US-009507513-2104USA003266: US-009507513-2104USA003267:
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Abdominal discomfort, Asthenia, Weight decreased
Clinical narrative: Both GARDASIL and GARDASIL 9 are being added as products to th.is case as the subject of the email states "GARDASIL/GARDASIL 9" however in the body of the email only GARDASIL is mentioned.; had reactions such as weight loss, weakness, and stomach issues.; had reactions such as weight loss, weakness, and stomach issues.; had reactions such as weight loss, weakness, and stomach issues.; This spontaneous report was received from an employee referring to a female patient of unknown age. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were unknown.   In 2006 (reported as 15 years ago), the patient started therapy with rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (also reported as Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL)) (strength, dose, route, batch/lot# and expiration date were unknown) for prophylaxis (product name confusion).   In 2006 (reported as 15 years ago), the patient had severe reactions such as weight loss, weakness, and stomach issues. The patient went to "many doctors" and "tried everything to resolve her issues." The patient has sought medical attention and received the treatment. It was unknown if any lab diagnostic/study was performed. The outcome of all the events was unknown. The causality assessments between the suspect vaccine and all the events were related by the reporter.
Age: 1.5
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE.; Patient was inadvertently administered expired MMRll Vaccine on 03/18/2021.; This spontaneous report was received from a nurse referring to an 18 months old patient of unknown gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported.  On 18-MAR-2021, the patient was inadvertently administered expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA) (M-M-R II) (lot # S007813, expiry date: 14-MAR-2021, strength, route and dose were not reported) for prophylaxis (expired product administered). No additional adverse event.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Nervous system disorder
Clinical narrative: neurological issues; Information has been received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 15-FEB-2016 (at approximately 64 years old), the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequently, the pt was treated by providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: neurological issues. The outcome of the event was unknown.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: temperature excursion on GARDASIL 9; No other adverse events - No signs or symptoms reported; Information has been received from a registered nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL for prophylaxis, lot# 1687293 and expiration date reported as 25-AUG-2022, but upon internal validation was established as 30-APR-2023 (route of administration not reported). No adverse events were reported.  On an unknown date, the vaccine underwent a temperature excursion of 47.1 Fahrenheit degree for 13 minutes. No previous temperature excursions were reported. The call was not placed because a digital data logger.  This is one of several reports received from the same reporter. 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: 1687293; expirationdate: 30-APR-2023; 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; Sender's Comments:  US-009507513-2103USA005285: US-009507513-2104USA003211: US-009507513-2104USA003212: US-009507513-2104USA003213: US-009507513-2104USA003214: US-009507513-2104USA003215: US-009507513-2104USA003216: US-009507513-2104USA003217: US-009507513-2104USA003218: US-009507513-2104USA003219: US-009507513-2104USA003220: US-009507513-2104USA003221: US-009507513-2104USA003222: US-009507513-2104USA003223: US-009507513-2104USA003224: US-009507513-2104USA003225: US-009507513-2104USA003196: US-009507513-2104USA003197: US-009507513-2104USA003198: US-009507513-2104USA003199: US-009507513-2104USA003200: US-009507513-2104USA003201: US-009507513-2104USA003202: US-009507513-2104USA003203: US-009507513-2104USA003204: US-009507513-2104USA003205: US-009507513-2104USA003206: US-009507513-2104USA003210: US-009507513-2104USA003208: US-009507513-2104USA003209:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: temperature excursion on GARDASIL 9; No other adverse events - No signs or symptoms reported; Information has been received from a registered nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL for prophylaxis, lot# 1687293 and expiration date reported as 25-AUG-2022, but upon internal validation was established as 30-APR-2023 (route of administration not reported). No adverse events were reported.  On an unknown date, the vaccine underwent a temperature excursion of 47.1 Fahrenheit degree for 13 minutes. No previous temperature excursions were reported. The call was not placed because a digital data logger.  This is one of several reports received from the same reporter. 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: 1687293; expirationdate: 30-APR-2023; 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; Sender's Comments:  US-009507513-2103USA005285: US-009507513-2104USA003211: US-009507513-2104USA003212: US-009507513-2104USA003213: US-009507513-2104USA003214: US-009507513-2104USA003215: US-009507513-2104USA003216: US-009507513-2104USA003217: US-009507513-2104USA003218: US-009507513-2104USA003219: US-009507513-2104USA003220: US-009507513-2104USA003221: US-009507513-2104USA003222: US-009507513-2104USA003223: US-009507513-2104USA003224: US-009507513-2104USA003225: US-009507513-2104USA003196: US-009507513-2104USA003197: US-009507513-2104USA003198: US-009507513-2104USA003199: US-009507513-2104USA003200: US-009507513-2104USA003201: US-009507513-2104USA003202: US-009507513-2104USA003203: US-009507513-2104USA003204: US-009507513-2104USA003205: US-009507513-2104USA003206: US-009507513-2104USA003210: US-009507513-2104USA003207: US-009507513-2104USA003209:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: temperature excursion on GARDASIL 9; No other adverse events - No signs or symptoms reported; Information has been received from a registered nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL for prophylaxis, lot# 1687293 and expiration date reported as 25-AUG-2022, but upon internal validation was established as 30-APR-2023 (route of administration not reported). No adverse events were reported.  On an unknown date, the vaccine underwent a temperature excursion of 47.1 Fahrenheit degree for 13 minutes. No previous temperature excursions were reported. The call was not placed because a digital data logger.  This is one of several reports received from the same reporter. 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: 1687293; expirationdate: 30-APR-2023; 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; Sender's Comments:  US-009507513-2103USA005285: US-009507513-2104USA003211: US-009507513-2104USA003212: US-009507513-2104USA003213: US-009507513-2104USA003214: US-009507513-2104USA003215: US-009507513-2104USA003216: US-009507513-2104USA003217: US-009507513-2104USA003218: US-009507513-2104USA003219: US-009507513-2104USA003220: US-009507513-2104USA003221: US-009507513-2104USA003222: US-009507513-2104USA003223: US-009507513-2104USA003224: US-009507513-2104USA003225: US-009507513-2104USA003196: US-009507513-2104USA003197: US-009507513-2104USA003198: US-009507513-2104USA003199: US-009507513-2104USA003200: US-009507513-2104USA003201: US-009507513-2104USA003202: US-009507513-2104USA003203: US-009507513-2104USA003204: US-009507513-2104USA003205: US-009507513-2104USA003206: US-009507513-2104USA003210: US-009507513-2104USA003207: US-009507513-2104USA003208:
Age: 0.25
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional AE reported; patient was given an expired ROT ATEQ vaccine; a temperature excursion; This spontaneous report was received from a nurse and refers to a 3-month-old patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 13-APR-2021, the patient received incorrectly stored and expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1660957with expiration date on 07-APR-2021, orally (exact dose was not reported) for prophylaxis. The vaccine underwent the temperature excursion of 61.1 degrees Fahrenheit for 4 hours and 30 minutes on 09-APR-2021. No previous excursion occurred. The digital data logger was not involved. No adverse events were reported.
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, Injection site extravasation, Injection site haemorrhage
Clinical narrative: Accidental underdose; blood came out of the injection site/same thing happened; liquid and blood came out of the injection site/another Engerix-B dose/12April2021/same thing happened; . This case was reported by a nurse via call center representative and described the occurrence of injection site hemorrhage in a 1-month-old female patient who received HBV (Engerix B pediatric) (batch number 2H575, expiry date 12th September 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B pediatric (Received dose of Engerix B on 5th April 2021, for tolerance refer case US2021082203).   On 12th April 2021, the patient received the 2nd dose of Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 12th April 2021, immediately after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced injection site hemorrhage and injection site leaking. On an unknown date, the patient experienced accidental underdose. Rechallenge with Engerix B pediatric was positive. On an unknown date, the outcome of the injection site hemorrhage, injection site leaking and accidental underdose were unknown.   It was unknown if the reporter considered the injection site hemorrhage and injection site leaking to be related to Engerix B pediatric and Engerix B 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 follow: This case was reported by a nurse. As per the CDC (Center for Disease Control and Prevention) recommendation, the patient was revaccinated with a dose of Engerix B pediatric. During vaccination, a small amount of blood and liquid came out of injection site again. The reporter initially contacted CDC because they were concerned the patient did not receive the full dose of vaccine and the same thing happened again, which led to accidental underdose. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021082203:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: wife got vaccinated / got shingles anyway/Suspected vaccination failure; shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 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 case was reported by the patient's spouse. The age at vaccination was not reported. The patient got vaccinated and she got shingles anyway. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, event onset time and laboratory confirmation for shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: a box / was left with 2 vials of antigen /believes the adjuvant portion was only administered; a box / was left with 2 vials of antigen /believes the adjuvant portion was only administered; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The nurse reported that during monthly inventory found out that a box of Shingrix was left with vial of antigen and believes the adjuvant portion was only administered to patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The nurse wanted to know if patient required to be revaccinated. The reporter consented to follow up. No further information was reported. This case had been linked with US2021084235, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021084235:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: had 3 lyophilized parts of the vaccine and no "diluents" / suspect /patients got the liquid adjuvant only; had 3 lyophilized parts of the vaccine and no "diluents" / suspect /patients got the liquid adjuvant only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The reporter was a pharmacy student. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The reporter stated that the patient might had been administered only the liquid adjuvant portion of the Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated that they had lyophilized part of the vaccine and no diluent, so they suspect that patient got the liquid adjuvant only. The reporter consented to follow up by email as HCP had no details at time of reporting. This case had been linked with US2021084246 and US2021AMR084959, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021084246:same reporter US-GLAXOSMITHKLINE-US2021AMR084959:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: had 3 lyophilized parts of the vaccine and no "diluents" / suspect /patients got the liquid adjuvant only; had 3 lyophilized parts of the vaccine and no "diluents" / suspect /patients got the liquid adjuvant only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The reporter was a pharmacy student. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The reporter stated that the patient might had been administered only the liquid adjuvant portion of the Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated that they had lyophilized part of the vaccine and no diluent, so they suspect that patient got the liquid adjuvant only. The reporter consented to follow up by email as HCP had no details at time of reporting. This case had been linked with US2021084246 and US2021AMR084958, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR084958:same reporter US-GLAXOSMITHKLINE-US2021084246:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure during pregnancy, Incorrect dose administered, Product preparation issue
Clinical narrative: Pricked herself with the adjuvant liquid only; Inappropriate dose of vaccine administered; May have been exposed to the adjuvant / Patient is in her first trimester; This prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. The patient's last menstrual period was on an unknown date and estimated date of delivery was 9th February 2021. The patient received Shingrix at an unknown time during the pregnancy. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication, inappropriate dose of vaccine administered and vaccine exposure during pregnancy. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and vaccine exposure during pregnancy were unknown. The pregnancy was ongoing.  Additional details were provided as follows: The age at vaccination was not reported. The patient pricked herself with the adjuvant liquid only, which led to inappropriate preparation of medication, inappropriate dose of vaccine administered and vaccine exposure during pregnancy. The patient's approximate due date was 9th Ferbruary 2021. The reporter consented to follow up.   Follow-up information was received on 15th April 2021: After completion of all the follow up attempts the case was considered as pregnancy lost to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: gave the wrong patient a Shingrix /  had already received two doses; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received on an unknown date 1 and half years before the date of reporting).   On 14th April 2021, the patient received the 3rd dose of Shingrix. On 14th April 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The nurse gave the wrong patient a Shingrix on the day of reporting but the patient in question had already received two doses, which led to extra dose administration. The reporter wished to remain anonymous but consented to follow up via email.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: a box / was left with 2 vials of antigen /believes the adjuvant portion was only administered; a box / was left with 2 vials of antigen /believes the adjuvant portion was only administered; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The reporter during monthly inventory found out that a box of Shingrix was left with 2 vials of antigen and believed that the adjuvant portion was only administered to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter asked if to revaccinate the patient. No other details of patient, vaccine or date was available. The reporter consented to follow up. This case has been linked with US2021AMR084838 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR084838:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was at room temperature for an undetermined amount of time / uncertain about the exact temperature or duration; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a adult patient who received Herpes zoster (Shingrix) (batch number 7354R, expiry date 15th November 2022) for prophylaxis.   On 13th April 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: The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient brought Shingrix into the office from her pharmacy and vaccine was at room temperature for an undetermined amount of time which led to incorrect storage of drug. The vaccine was administered to patient. The reporter was asked was the vaccine efficacy affected, would we still consider this as Shingrix shot 1. Vaccine extended stability data provided but health care professional was uncertain about the exact temperature or duration. The health care professional  declined to provide patient demographics. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: has first dose over one year ago, do patient / need 2nd dose"; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 8th January 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.2  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting ,the patient did not received the 2nd dose of shingrix, which led to incomplete course of vaccination. The reporter also inquired that, if the patient need to repeat 2 doses again or only 2nd dose would enough. During the chat,the reporter did not have information regarding batch number and expiry date. The reporter consented to follow up via email.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: had 3 lyophilized parts of the vaccine and no "diluents" / suspect /patients got the liquid adjuvant only; had 3 lyophilized parts of the vaccine and no "diluents" / suspect /patients got the liquid adjuvant only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The reporter was a pharmacy student. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The reporter stated that the patient might had been administered only the liquid adjuvant portion of the Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated that they had lyophilized part of the vaccine and no diluent, so they suspect that patient got the liquid adjuvant only. The reporter consented to follow up by email as HCP had no details at time of reporting. This was 1 of 3 linked cases, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR084958:same reporter US-GLAXOSMITHKLINE-US2021AMR084959:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: first Shingrix vaccination / on 12/15/2019 / second Shingrix vaccination / 4/14/2021 / did not receive second vaccination within recommended dosing schedule due to COVID exposure concerns during the pandemic; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 15th December 2019, in left arm).   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: The patient reported for himself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient had not received 2nd dose of Shingrix vaccination, as within recommended dosing schedule due to COVID exposure concerns during the pandemic. The reporter did not wish to provide any details other than his name and date of birth, vaccination site, his health care professional detail. The reporter did not consent to follow up
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: A mistake was made while withdrawing diluent for reconstitution; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate reconstitution technique in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate reconstitution technique. On an unknown date, the outcome of the inappropriate reconstitution technique was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as per vaccine indication. The pharmacist reported being short two vials of Shingrix diluent because a mistake was made while withdrawing diluent for reconstitution, which led to inappropriate reconstitution technique. The pharmacist did not provide lot numbers or expiration dates. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: patient could receive a possible third dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 29th September 2020) and Shingrix (2nd dose received on 21st December 2020).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient claimed that she had not received the 2nd dose of Shingrix yet, but the pharmacist stated that the facility had a record that the patient got the 1st and 2nd dose of Shingrix. The health care professional wondered if there was information about giving a 3rd dose of Shingrix to a patient since the patient could receive a possible 3rd dose of Shingrix, which led to extra dose administered. The health care professional called to request information about giving a 3rd dose to the patient. The reporter did not consent to follow up. Note: This case was conservatively kept valid with event extra dose administered as it was not clear if the patient had received the 3rd dose or not.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose / on September 30th 2019 / second dose / not / administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on 30th September 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received 1st dose of Shingrix at primary reporter's facility. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not want to provide lot number/expiration date. The reporter did not consent to follow up.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain
Clinical narrative: INTENSIFIED BODY ACHES; CHILLS; NAUSEA; This spontaneous report received from a patient concerned a 35 year old female. The patient's weight was 160 pounds, and height was 62 inches. The patient's concurrent conditions included coconut allergy, alcohol user, and non-smoker. The patient was not pregnant at the time of reporting. The patient had no history of drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042a21a, expiry: 21-JUN-2021) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced intensified body aches. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, intensified body aches, and nausea. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Photopsia, Vitreous floaters
Clinical narrative: FLASHING LIGHT ON RIGHT EYE; DUST PARTICLE/ FLOATERS; PAIN IN RIGHT ARM; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included degenerative arthritis at right hip, high triglycerides, and pinched nerve on left of the neck above the shoulders, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: 25/MAY/2021) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 31-MAR-2021, the subject experienced pain in right arm. On 10-APR-2021, the subject experienced dust particle/ floaters. On 12-APR-2021, the subject experienced flashing light on right eye. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in right arm on 02-APR-2021, and the outcome of dust particle/ floaters and flashing light on right eye was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Throat tightness
Clinical narrative: BRUISE  IN LEFT ARM/ ABOVE LEFT EYE; THROAT CONSTRICTION; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, non-smoker, penicillin allergy, and allergic to latex, and other pre-existing medical conditions included patient had history of severe allergies. The patient experienced drug allergy when treated with azithromycin, and diphenhydramine hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced bruise in left arm/ above left eye. On 02-APR-2021, the subject experienced throat constriction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from throat constriction on 03-APR-2021, and had not recovered from bruise in left arm/ above left eye. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: HEADACHE; FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and fever was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: UNUSUAL SIDE EFFECT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN Expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced unusual side effect. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unusual side effect was not reported. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia, Tremor
Clinical narrative: SEVERE UNCONTROLLABLE SHAKING; SEVERE UNCONTROLLABLE CHILLS; A LITTLE FEVER; BAD HEADACHE; This spontaneous report received from a patient concerned a 52 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced severe uncontrollable chills. On 09-APR-2021, the subject experienced a little fever. On 09-APR-2021, the subject experienced bad headache. On 09-APR-2021, the subject experienced severe uncontrollable shaking. Laboratory data included: Body temperature (NR: not provided) 100.5 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe uncontrollable chills, a little fever, bad headache, and severe uncontrollable shaking on 11-APR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Swelling face, Swollen tongue
Clinical narrative: NUMBNESS OF  TONGUE; SWOLLEN LEFT SIDE OF FACE; NUMBNESS OF LEFT SIDE OF FACE; SWOLLEN TONGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had taken an antihistamine one hour prior to injection.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced numbness of tongue. On 06-APR-2021, the subject experienced swollen left side of face. On 06-APR-2021, the subject experienced numbness of left side of face. On 06-APR-2021, the subject experienced swollen tongue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the numbness of tongue, swollen left side of face, numbness of left side of face and swollen tongue was not reported. This report was non-serious.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance
Clinical narrative: KNEE HURT; BARELY WALK; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included pollen allergy, no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included fexofenadine hydrochloride. On 13-APR-2021, the subject experienced knee hurt. On 13-APR-2021, the subject experienced barely walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from knee hurt, and barely walk. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Chills, Headache
Clinical narrative: ANXIETY; CHILLS; THROBBING HEADACHES; This spontaneous report received from a parent concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 12-APR-2021, the subject experienced anxiety. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced throbbing headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the throbbing headaches, chills and anxiety was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Platelet count, Ultrasound Doppler
Clinical narrative: DEEP VEIN THROMBOSIS; This spontaneous report received from a patient concerned a 46 year old male. Initial information was received and processed with additional information received on 15-APR-2021.  The patient's weight and height were not reported. Patient's medical history included insomnia for which he took klonopin occasionally. Patient was non-smoker.  Patient's body fat was reported as 6% The patient received vaccination with Janssen COVID-19 VACCINE (covid-19 vaccine ad26.cov2.s) (suspension for injection, route of admin intramuscular, batch number: Unknown) dose was not reported, administered on 14-MAR-2021 13:00 in left arm for prophylactic vaccination. Batch number was not reported, will be requested. No concomitant medication was reported as patient reported not taking any medication at the time of the event. Patient' did not have any blood work done since taking the vaccine.  On 23-FEB-2021, platelet count was 206.  On 05-APR-2021, the patient was diagnosed with deep vein thrombosis. Patient reported that after 2 weeks of vaccination, he experienced pain in left calf muscle for 2-3 days. Physician sent the patient for doppler scan for his leg. Patient was diagnosed with deep vein thrombosis. Treatment medications included: Eliquis (apixaban). Patient was prescribed apixaban 20 mg a day for a week and continue with it 10 mg a day for 2.5 months.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of deep vein thrombosis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: A 46-year-old man was diagnosed with deep venous thrombosis (DVT) in his left leg 21 days after vaccine. There was no relevant medical history or concomitant medications, he is a nonsmoker, and there is no family history of thrombosis. Nineteen days before vaccine his platelet count was normal at 206,000 and no laboratory work has been performed since then. The patient was treated with Eliquis. Idiopathic DVTs often are followed by an extensive workup to identify the cause, and the patient is reaching out to his physician to discuss further. Based on information currently available, company causality is considered possibly related.