chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: no additional AE's; temperature excursion / temperature 34.1 F; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, current conditions nor concomitant therapies provided.  On 02-FEB-2021, 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), dose/frequency reported as 1 (unit not provided), lot # 1687292, expiration date 25-AUG-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in temperature of 34.1 degrees Fahrenheit (F) for 4 hours and 15 minutes. Previous temperature excursions were reported as follows: 34.8 F for 45 minutes and 34.7 F for 2 hours and 45 minutes (dates not provided). Digital data logger was involved. The patient was reported to be asymptomatic, no adverse events (AE's) were reported.  This is one of several reports 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: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA007278: US-009507513-2104USA007277: US-009507513-2104USA007276: US-009507513-2104USA007270:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: no additional AE's; temperature excursion / temperature 34.1 F; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, current conditions nor concomitant therapies provided.  On 04-FEB-2021, 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), dose/frequency reported as 1 (unit not provided), lot # 1687292, expiration date 25-AUG-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in temperature of 34.1 degrees Fahrenheit (F) for 4 hours and 15 minutes. Previous temperature excursions were reported as follows: 34.8 F for 45 minutes and 34.7 F for 2 hours and 45 minutes (dates not provided). Digital data logger was involved. The patient was reported to be asymptomatic, no adverse events (AE's) were reported.  This is one of several reports 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: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA007278: US-009507513-2104USA007277: US-009507513-2104USA007276: US-009507513-2104USA007270:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: no additional AE's; temperature excursion / temperature 34.1 F; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, current conditions nor concomitant therapies provided.  On 08-FEB-2021, 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), dose/frequency reported as 1 (unit not provided), lot # 1687292, expiration date 25-AUG-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in temperature of 34.1 degrees Fahrenheit (F) for 4 hours and 15 minutes. Previous temperature excursions were reported as follows: 34.8 F for 45 minutes and 34.7 F for 2 hours and 45 minutes (dates not provided). Digital data logger was involved. The patient was reported to be asymptomatic, no adverse events (AE's) were reported.  This is one of several reports 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: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA007278: US-009507513-2104USA007277: US-009507513-2104USA007276: US-009507513-2104USA007270:
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: No other AE's; temperature excursion on RECOMBIV AX that was administered.; This spontaneous report was received from the medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 22-APR-2021, the patient was vaccinated with improperly stored Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) 1 time dose (lot numbers reported as T004378 and T022566; expiration dates established upon internal validation as 07-MAR-2022 and 03-NOV-2022, respectively) (exact dose, route of administration and anatomical location were not provided), for prophylaxis. Administered dose of vaccine experienced temperature excursion of 48.2 degrees Fahrenheit for 2 hours. There was no adverse event reported. Data logger was not involved. There were no previous excursions reported.  This is one of three reports received from the same reporter.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE's; temperature excursion on RECOMBIV AX that was administered.; This spontaneous report was received from the medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 22-APR-2021, the patient was vaccinated with improperly stored Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) 1 time dose (lot numbers reported as T004378 and T022566; expiration dates established upon internal validation as 07-MAR-2022 and 03-NOV-2022, respectively) (exact dose, route of administration and anatomical location were not provided), for prophylaxis. Administered dose of vaccine experienced temperature excursion of 48.2 degrees Fahrenheit for 2 hours. There was no adverse event reported. Data logger was not involved. There were no previous excursions reported.  This is one of three reports received from the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Vaccination failure
Clinical narrative: I got the shot / and I got shingles / Suspected vaccination failure; I got the shot / and I got shingles; When I had my heart surgery my immune system was weakend; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included cardiac operation.   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), shingles and decreased immune responsiveness. On an unknown date, the outcome of the vaccination failure, shingles and decreased immune responsiveness were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and decreased immune responsiveness to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported the case for himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The reporter mentioned that, getting the vaccine helps but did not always prevent them. The patient got the Shingles shot when he/she had his/her heart surgery his/her immune system was weakend and he/she got shingles. The reporter mentioned that, he/she did not suffer as bad as his/her mom did, she got them, so do not get a false sense of security thinking you would never get them. 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. The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; Shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included chemotherapy.   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 the case for herself/himself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient got the shingles after the shot. The reporter mentioned that, seeing so many said shingles shortly after was a clue. 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. Follow-up would not possible, as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR093045:same reporter (Invalid case)
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult 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 age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient got Shingles vaccine and experienced shingles. 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: Herpes zoster, Vaccination failure
Clinical narrative: Got the vaccination it cost $200 that was years ago now and I still have shingles/ suspected vaccination failure; I still have shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult 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 was unknown and the outcome of the shingles was not recovered/not resolved.   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 self reported the case. The age group was not reported but was selected as adult as per vaccine indication. The age at vaccination was not reported. The patient got the vaccination that was years ago before the reporting date and the patient still had shingles at the time of reporting. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Several months after receiving my shingles shot, I got shingles/Suspected vaccination failure; Several months after receiving my shingles shot, I got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several months 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: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. Several months after receiving Shingles shot, the patient got shingles. The patient was told that a small percentage would still get them after receiving the shot. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR093211:Same reporter. Invalid-Hearsay case.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Swelling, Vaccine positive rechallenge
Clinical narrative: Even after the 2nd shot, I still have remnants of sore bumps; Even after the 2nd shot, I still have remnants of sore bumps; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on unknown date and refer case id US2021AMR093225).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain and local swelling. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain and local swelling were unknown.   It was unknown if the reporter considered the pain and local swelling to be related to Shingles vaccine.  Additional details were provided as follow: The case was reported by the consumer itself. The age at vaccination was not applicable for this report. The patient received 2nd dose of shingles vaccine on an unknown date. The patient experienced same events pain and local swelling. No further information was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose of Shingrix on 5-24-18 / unable to receive the second dose because of shortage; This case was reported by a consumer via and described the occurrence of product supply issue in a 54-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 24th May 2018.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.  Additional details were provided as follow: This case was reported by the patient itself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient was unable to receive the second dose because of the shortage, which led to product supply issue. The patient asked could he/she get the 2nd dose or was it too late, and do he/she need to restart the series. No further information was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Nerve injury, Pain, Vaccination failure
Clinical narrative: Had the shingles shot and a few years later I got the shingles on my face/Suspected vaccination failure; Had the shingles shot and a few years later I got the shingles on my face; The blow torch pain is unbelievable; Now I am dealing with nerve damage; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and nerve damage. On an unknown date, the outcome of the vaccination failure, shingles, pain and nerve damage were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and nerve damage to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by patient. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient had shingles shot and a few years later he/she got the shingles on face. The patient stated that the blow torch pain was unbelievable and now he/she was dealing with nerve damage caused by the shingles. The patient still would recommend others to get the shot and asked to do not put it off. This case was considered as suspected vaccination failure as details regarding vaccination schedule and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort, Pain
Clinical narrative: I recently got the vaccine. It hurt; It's worth the minor discomfort; This case was reported by a consumer via  interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had Shingles when he/she was 15 and it was so painful he/she thought he/she would die).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain and discomfort. On an unknown date, the outcome of the pain and discomfort were unknown.   It was unknown if the reporter considered the pain and discomfort to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient got Shingles vaccine and experienced pain and discomfort.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: Had the shot three times and still gets it/Suspected vaccination failure; Had the shot three times and still gets it; Had the shot three times; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 3rd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The reported this case for his/her uncle. The age at vaccination was not reported. The patient received 3 doses of shingles vaccine and still experienced shingles. As per global schedule of shingles vaccine only 2 doses were recommended however patient received total 3 doses of vaccine, which led to extra dose administration. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received her first dose over a year ago / not / received her second dose.; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received in left arm, over a year ago from reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of the Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only the adjuvant portion was given to patient; only the adjuvant portion was given to patient; This case was reported by a other health professional and described the occurrence of inappropriate preparation of medication in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th March 2021, the patient received Shingrix. On 19th March 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details 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 reporter informed that, the patient had received an incomplete dose of Shingrix and was vaccinated with only the adjuvant portion (diluent), was given to patient which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. After noticing this, a valid dose was given on the other arm, on the same day. The reporter also mentioned that, this complete dose was given too soon as per IAC (Individual Accountability and Conduct) guidelines. The reporter declined any patient information and just requested to have the recommendations mentioned. No other data was collected. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose of Shingrix on 14Feb2020 / not received the second dose yet; This case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose recieved on 14th February 2020, batch number 3N7F2, expiry date 25th March 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of the Shingrix, which led to incomplete course of vaccination. The patient had received 1st dose of Shingrix at primary reporter's facility. The reporter consented to follow up via email
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose 37 days apart form first dose. First dose was 3/16/2021 / second dose was 4/22/2021; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number AP545, expiry date 25th January 2023) for prophylaxis.   Concurrent medical conditions included blood pressure. Concomitant products included Herpes zoster (Shingrix).   On 22nd April 2021, the patient received the 2nd dose of Shingrix. On 22nd April 2021, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were reported as follows: The nurse was looking for guidance because there was a patient that received Shingrix second dose 37 days apart form first dose. The patient received 2nd dose of Shingrix, before than the recommended interval, which led to shortening of vaccination schedule. The patient was not immunocompromised and he was taking 3 different medications for blood pressure. The reporter did not consent to follow up.
Sex: U
Vaccine: HEPAB
Symptoms: Product storage error
Clinical narrative: administration of a Twinrix vaccine stored at freezing temperatures; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th April 2021, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that Twinrix vaccine stored at freezing temperatures and administered to a patient, which led to incorrect storage of drug. The reporter had no further information on the patient nor the expiration or lot number of the product. No further events were reported. The reporter did not consent to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose 4/26/21, first dose was in may 2018; This case was reported by a nurse and described the occurrence of drug dose administration interval too long in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included SHINGRIX (1st dose received in May 2018).   On 26th April 2021, the patient received the 2nd dose of Shingrix. On 26th April 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional case details were reported as follows: The patient received 2nd dose of vaccine later than the recommended schedule, which led to lengthening of vaccination schedule. The reporter asked whether this dose would be counted as valid or the series need to be restarted. The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received dose two of Shingrix one month after dose one; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number AP545, expiry date 25th January 2023) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 26th April 2021, the patient received the 2nd dose of Shingrix. On 26th April 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The reporter did not provide lot number or expiration date for dose one of Shingrix. The Patient received 2nd dose of Shingrix one month after dose one which led to shortening of vaccination schedule. The patient consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This case was reported by a consumer and described the occurrence of flu like symptoms in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of shingrix 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 flu like symptoms. On an unknown date, the outcome of the flu like symptoms was recovered/resolved.   It was unknown if the reporter considered the flu like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient's wife reported that the patient received dose of Shingrix in 2019. After the vaccination the patient had flu like symptoms for few days. The reporter stated that she had a lot of friends who had gotten some side effects with the second dose. No additional details were provided. The reporter did not consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR093183:Friends' case
Sex: F
Vaccine: HEPAB
Symptoms: Product storage error
Clinical narrative: Patient was administered a dose / exposed to a freezing temperature; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 60-year-old female patient who received HAB (Twinrix) (batch number 3597P, expiry date 12th March 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows:  The age at vaccination was not reported.  The Pharmacist reported a patient was administered a dose of Twinrix after it had been exposed to a freezing temperature of negative 8 degrees Celsius, which led to incorrect storage of drug. The reporter consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient could not take the second dose / on time / not able to go to the facility; This case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 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 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 group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not applicable for this report. The pharmacist reported that the patient could not take the 2nd dose of Shingrix on time due to the patient was not able to go to the facility, which led to incomplete course of vaccination. The healthcare professional declined provide more information. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Looking for / financial assistance with / second dose / had the first dose years ago; This case was reported by a consumer and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose years 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 reported as follows: This case was reported by patient herself. The age at vaccination was not applicable for this report. The patient had been told by her PCP (primary care physician) that she needs the 2nd dose and till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient was looking for information concerning financial assistance with getting her 2nd dose. The reporter consented to follow up.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Feeling abnormal, Malaise, Paraesthesia
Clinical narrative: TINGLING SENSATION IN SPINE TO CRANIUM; BALANCE DISORDER; ODD FEELING; GENERAL MALAISE; This spontaneous report received from a patient concerned a 55 year old female. 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, every 1 total from 08-MAR-2021 to 08-MAR-2021 on right arm for prophylactic vaccination. The batch number was requested. No concomitant medications were reported. On 08-MAR-2021, the patient experienced tingling sensation in spine to cranium, balance disorder, odd feeling, and general malaise. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling sensation in spine to cranium, balance disorder, odd feeling, and general malaise on 15-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Pain
Clinical narrative: BODY ACHES; FELT HOT; BAD HEADACHE; 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 was not reported, administered on 08-APR-2021 10:30 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 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced felt hot. On 08-APR-2021, the subject experienced bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, felt hot, and bad headache on 10-APR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Influenza like illness, Pain in extremity
Clinical narrative: PAIN IN UPPER LEG; FLU-LIKE SYMPTOMS; COLD SWEATS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included testosterone replacement therapy, and concurrent conditions included hereditary familial cardiovascular risks.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. Concomitant medications included acetylsalicylic acid, and testosterone. On APR-2021, the subject experienced flu-like symptoms. On APR-2021, the subject experienced cold sweats. On an unspecified date, the subject experienced pain in upper leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu-like symptoms, cold sweats and pain in upper leg was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Blood glucose abnormal, COVID-19, Diarrhoea
Clinical narrative: CONFIRMED COVID 19; DIZZINESS; VOMITING; LOSS OF TASTE; LOSS OF SMELL; DIARRHEA; FEVER; HYSTERECTOMY; 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 concurrent conditions included diabetes, hypertension, alcohol use, seasonal allergy, and nonsmoker, and other pre-existing medical conditions included the patient had no history of drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 and expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. Concomitant medications included metformin for diabetes, amlodipine for hypertension, acetylsalicylic acid, ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride, dulaglutide, ergocalciferol, hydrochlorothiazide, and lisinopril. On APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) negative. On 09-APR-2021, the subject experienced hysterectomy. On 10-APR-2021, the subject experienced dizziness. On 10-APR-2021, the subject experienced vomiting. On 10-APR-2021, the subject experienced loss of taste. On 10-APR-2021, the subject experienced loss of smell. On 10-APR-2021, the subject experienced diarrhea. On 10-APR-2021, the subject experienced fever. Laboratory data included: Blood sugar abnormal (NR: not provided) not reported. On 13-APR-2021, the subject experienced confirmed covid 19. Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on 13-APR-2021, had not recovered from dizziness, loss of taste, loss of smell, fever, and diarrhea, and the outcome of confirmed covid 19 and hysterectomy was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be voided (did not meet pqc criteria) based on the PQC evaluation/investigation performed.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Hysterectomy, Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: CONFIRMED COVID 19; DIZZINESS; VOMITING; LOSS OF TASTE; LOSS OF SMELL; DIARRHEA; FEVER; HYSTERECTOMY; 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 concurrent conditions included diabetes, hypertension, alcohol use, seasonal allergy, and nonsmoker, and other pre-existing medical conditions included the patient had no history of drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 and expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. Concomitant medications included metformin for diabetes, amlodipine for hypertension, acetylsalicylic acid, ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride, dulaglutide, ergocalciferol, hydrochlorothiazide, and lisinopril. On APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) negative. On 09-APR-2021, the subject experienced hysterectomy. On 10-APR-2021, the subject experienced dizziness. On 10-APR-2021, the subject experienced vomiting. On 10-APR-2021, the subject experienced loss of taste. On 10-APR-2021, the subject experienced loss of smell. On 10-APR-2021, the subject experienced diarrhea. On 10-APR-2021, the subject experienced fever. Laboratory data included: Blood sugar abnormal (NR: not provided) not reported. On 13-APR-2021, the subject experienced confirmed covid 19. Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on 13-APR-2021, had not recovered from dizziness, loss of taste, loss of smell, fever, and diarrhea, and the outcome of confirmed covid 19 and hysterectomy was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be voided (did not meet pqc criteria) based on the PQC evaluation/investigation performed.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Genital rash, Haematochezia, Headache
Clinical narrative: BLOOD IN STOOL; RASH ON FANNY; CHILLS; FEVER; HEADACHE; BODY ACHES; BACK ACHE; This spontaneous report received from a parent concerned a 23 year old, female. The patient's height, and weight were not reported. The patient had no known allergies.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, one total, administered on 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 11-APR-2021, the patient had body aches, chills, fever, headache and backache (low back pain). On 12-APR-2021, Monday, she felt better but experienced backache again on 13-APR-2021, Tuesday and felt better later that day. On 14-APR-2021, at night she had weird rash on fanny and also had lower back pain. On 15-APR-2021 morning, she had blood in stool and again experienced backache (pain in the lower back).  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, fever, and headache on 13-APR-2021, and had not recovered from back ache, rash on fanny, and blood in stool. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210432632-Covid-19 vaccine ad26.cov2.s -Blood in stool. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: BLOOD IN STOOL; RASH ON FANNY; CHILLS; FEVER; HEADACHE; BODY ACHES; BACK ACHE; This spontaneous report received from a parent concerned a 23 year old, female. The patient's height, and weight were not reported. The patient had no known allergies.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, one total, administered on 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 11-APR-2021, the patient had body aches, chills, fever, headache and backache (low back pain). On 12-APR-2021, Monday, she felt better but experienced backache again on 13-APR-2021, Tuesday and felt better later that day. On 14-APR-2021, at night she had weird rash on fanny and also had lower back pain. On 15-APR-2021 morning, she had blood in stool and again experienced backache (pain in the lower back).  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, fever, and headache on 13-APR-2021, and had not recovered from back ache, rash on fanny, and blood in stool. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210432632-Covid-19 vaccine ad26.cov2.s -Blood in stool. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 60.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Pain in extremity
Clinical narrative: ARM PAIN; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 100 kilograms, and height was not reported. The patient's concurrent conditions included primary pulmonary hypertension. 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 13-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up The patient received macitentan (form of admin unknown, oral, batch number: ZE019B0101 expiry: UNKNOWN) 10 mg, 1 time, therapy dates were not reported for an unspecified indication. Non-company suspect drugs included: epoprostenol sodium (intravenous, batch number: MM248M0101 expiry: 30/JUN/2022, form of admin was not reported) 20 mg, frequency, and therapy dates were not reported for an unspecified indication. Concomitant medications included warfarin non-company for drug used for unknown indication, and riociquat non-company. On an unspecified date, the subject experienced arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of macitentan was not changed. The outcome of arm pain was not reported. This report was non-serious.