chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: had a sore arm for 3 days; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a 70-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (1st dose received 5 to 6 months prior to the 2nd dose, refer case US2021AMR103055).   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 in arm. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient itself. The age at vaccination was not reported. The patient had 2nd dose of Shingles and had a sore arm for 3 days, that was it. The patient was happy that it was a lifetime vaccine and stated no problems at all. The follow up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR103055:same reporter, same patient, same vaccine, different dose (1st dose)
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles / expecting it to be mild. If this is mild I do not want to see the real strength; nothing I can compare it with. Plain awful; This case was reported by a consumer via media and described the occurrence of 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, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient.  The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication.   Three years before the date of reporting, the patient received Shingles vaccine and now experienced shingles. The patient was expecting it to be mild and if this was mild do not want to see the real strength. The patient reported there was nothing can compare it with, plain awful. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule and laboratory test confirmation for shingles infection were unknown. Note: event pain was captured in the case because it seem that there is typo error because it was reported as plain awful instaed of pain awful.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: I've had all three vaccines and still got shingles/Suspected vaccination failure; shingles; I've had all three vaccines; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st 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 provided as follows: The case was reported by patient itself. 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 got Shingles after vaccination. The patient had received 3 vaccines which led to Extra dose administered. This case was considered as suspected vaccination failure as details regarding laboratory confirmation and time to onset of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shingles shot / got shingles / suspected vaccination failure; got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a 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) 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. The patient received Shingles vaccine and couple years later got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming herpes zoster 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: I got the shingles after I got my vaccine / Suspected Vaccination failure; I got the shingles after I got my vaccine; 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 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. The patient experienced shingles after he/she got his/her Shingles vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB
Symptoms: Electroencephalogram, Muscle spasms
Clinical narrative: Muscle spasms in his upper torso / involuntary muscles spasms / still having them; This case was reported by a consumer via call center representative and described the occurrence of muscle spasm in a 16-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included MCV4 vaccine with an associated reaction of no adverse event (received dose 1 on unknown date with no problems).   On 7th May 2021 15:30, the patient received the 1st dose of Bexsero (intramuscular). On 7th May 2021, the patient started Bexsero Pre-Filled Syringe Device. On 7th May 2021 15:30, the patient received Menveo (intramuscular). On 7th May 2021 18:30, 3 hrs after receiving Bexsero, Bexsero Pre-Filled Syringe Device and Menveo, the patient experienced muscle spasm. On an unknown date, the outcome of the muscle spasm was not recovered/not resolved.   The reporter considered the muscle spasm to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the reporter considered the muscle spasm to be related to Menveo. 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 case was reported by the mother of the patient. The reporter claimed that her son had no health issues and was perfectly healthy before receiving  the Menveo booster shot for college. This was his last meningitis vaccine for college. The patient got Bexsero and Menveo both in the left arm. The reporter said about 3 hours after the shot the patient started having the involuntary muscle spasms, it affected his upper torso. The reporter said if he was standing up he was fine but if he sat or lounged or laid down he was prone to it, spasms looked like he was having a seizure. The patient could talk through it, no cognitive loss, appetite was fine. The reporter said they had been to the pediatrician and to the emergency room regarding this. On the day of reporting they had an EEG test done at the neurologist and they had not received the results. She offered to send a video of what it looked like. The patient's condition till the time of reporting remained unchanged. The reporter said that the physician's did not think that the MCV-4 (Meningococcal ACWY) vaccine was the one which was causing the muscle spasms since he had already had dose 1 before with no issues. The reporter was asked if she had the lot number/expiration date of the Bexsero she said no. It was the Bexsero that the reporter believed was causing the muscle spasms. Note: The reporter did not have the trade name of MCV-4 (Meningococcal ACWY) but she thought it might have been made by Pfizer, therefore it might have been GSK's product Menveo.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB
Symptoms: Electroencephalogram, Injection related reaction, Tic
Clinical narrative: Muscle spasms in his upper torso / involuntary muscles spasms / still having them; This case was reported by a consumer via call center representative and described the occurrence of muscle spasm in a 16-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included MCV4 vaccine with an associated reaction of no adverse event (received dose 1 on unknown date with no problems).   On 7th May 2021 15:30, the patient received the 1st dose of Bexsero (intramuscular). On 7th May 2021, the patient started Bexsero Pre-Filled Syringe Device. On 7th May 2021 15:30, the patient received Menveo (intramuscular). On 7th May 2021 18:30, 3 hrs after receiving Bexsero, Bexsero Pre-Filled Syringe Device and Menveo, the patient experienced muscle spasm. On an unknown date, the outcome of the muscle spasm was not recovered/not resolved.   The reporter considered the muscle spasm to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the reporter considered the muscle spasm to be related to Menveo. 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 case was reported by the mother of the patient. The reporter claimed that her son had no health issues and was perfectly healthy before receiving  the Menveo booster shot for college. This was his last meningitis vaccine for college. The patient got Bexsero and Menveo both in the left arm. The reporter said about 3 hours after the shot the patient started having the involuntary muscle spasms, it affected his upper torso. The reporter said if he was standing up he was fine but if he sat or lounged or laid down he was prone to it, spasms looked like he was having a seizure. The patient could talk through it, no cognitive loss, appetite was fine. The reporter said they had been to the pediatrician and to the emergency room regarding this. On the day of reporting they had an EEG test done at the neurologist and they had not received the results. She offered to send a video of what it looked like. The patient's condition till the time of reporting remained unchanged. The reporter said that the physician's did not think that the MCV-4 (Meningococcal ACWY) vaccine was the one which was causing the muscle spasms since he had already had dose 1 before with no issues. The reporter was asked if she had the lot number/expiration date of the Bexsero she said no. It was the Bexsero that the reporter believed was causing the muscle spasms. Note: The reporter did not have the trade name of MCV-4 (Meningococcal ACWY) but she thought it might have been made by Pfizer, therefore it might have been GSK's product Menveo.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Social problem
Clinical narrative: did not receive the second dose because of COVID precautions; This case was reported by a pharmacist and described the occurrence of social problem in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received 1st dose on 28th December 2019.).   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 follow: The case was reported by a pharmacist. The patient did not receive the second dose due to COVID precaution which led to social problem. The pharmacist did not provide lot number and expiration date of first dose of Shingrix. No further information was provided. The reporter consented to follow up.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site extravasation, Underdose
Clinical narrative: a drop of vaccine came out of the skin; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 52-year-old male patient who received Herpes zoster (Shingrix) (batch number 7Y359, expiry date 15th November 2022) for prophylaxis.   On 24th March 2021, the patient received the 1st dose of Shingrix. On 24th March 2021, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.  Additional details were provided as follows: The pharmacist reported that, the patient received Shingrix vaccine at their pharmacy and a drop of vaccine came out of the skin after administration, which led to accidental underdose. The pharmacist asked does the patient need to be revaccinated. No further information reported. The reporter consented to follow up.
Age: 2.0
Sex: F
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: expire powder of Menveo (expiration date July 2020); This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 2-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA175A, expiry date 31st July 2020) for prophylaxis.   On 6th May 2021, the patient received Menveo. On 6th May 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient had taken an expired powder of Menveo and liquid portion was not expired which led to expired vaccine used. The reporter had limited information about lot numbers and expiration date on the vials and was not sure if accurate information was provided. The reported batch number AMVA1758 did not exist and was updated to AMVA175A as per sales data sheet review. The reporter did not consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental underdose, Malabsorption from administration site
Clinical narrative: vaccine liquid did not go through the patient's arm/ more than 50%  was administered; This case was reported by a pharmacist and described the occurrence of accidental underdose in a female patient who received Herpes zoster (Shingrix) (batch number PK5B9, expiry date 15th November 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 11th May 2021, the patient received the 2nd dose of Shingrix. On 11th May 2021, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.  Additional details were provided as follows: The age at vaccination was not reported. No patients data provided. The patient while receiving dose of Shingrix moved and some of the vaccine liquid did not go through the patient arm and more than 50 percent of vaccine was administered but there was no way to know for sure, which led to accidental underdose It was administered on the same day as reported. The reporter consented follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient received 1st dose / between September and October, 2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix between September and October 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.  Additional details were provided as follows: The age at vaccination was not applicable. The reporter stated the patient was 65 years and older but did not specify. Till the time of reporting the patient did not receive the 2nd dose which led to incomplete course of vaccination. No further details of patient or vaccine were provided. No further details were reported. The reporter did not consent to follow up. This is 1 of the 5 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021102193:Same reporter US-GLAXOSMITHKLINE-US2021102195:Same reporter US-GLAXOSMITHKLINE-US2021102197:Same reporter US-GLAXOSMITHKLINE-US2021102198:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose / between September and October, 2020 / didn't receive the 2nd dose; This case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in between September and October, 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.  Additional details were provided as follow: The patient was 65 years and older but did not specify. The age at vaccination was not applicable for this report. The patient did not receive the 2nd dose till the time of the call, which led to Incomplete course of vaccination. No further details of patient or vaccine were provided. The reporter did not consented to follow up. This is 1 of the 5 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021102194:Same reporter US-GLAXOSMITHKLINE-US2021102193:Same reporter US-GLAXOSMITHKLINE-US2021102195:Same reporter US-GLAXOSMITHKLINE-US2021102198:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: Patient received 1st dose between September and October, 2020 and didn't receive the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received between September and October, 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.  Additional details were reported as follows: The age of the patient was 65 years and older. The age at vaccination was not applicable for this report. The patient did not receive the 2nd dose till the time of reporting, which led to incomplete course of vaccination. No further details of patient or vaccine were provided. The reporter did not consent to follow-up. This is 1 of the 5 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021102194:Same reporter US-GLAXOSMITHKLINE-US2021102193:Same reporter US-GLAXOSMITHKLINE-US2021102197:Same reporter US-GLAXOSMITHKLINE-US2021102198:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: 1st dose / between September and October, 2020 / didn't receive the 2nd dose; This case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix between September and October 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.  Additional details were reported as follows: The patient was 65 years and older but did not specify. The age at vaccination was not applicable for this report. Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. No further details of patient or vaccine were provided. The reporter did not consent to follow up. This is 1 of the 5 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021102194:Same reporter US-GLAXOSMITHKLINE-US2021102197:Same reporter US-GLAXOSMITHKLINE-US2021102193:Same reporter US-GLAXOSMITHKLINE-US2021102195:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: stored Shingrix vaccine in the freezer for a while / administered after being exposed to freezing temperatures / might be 18 patients related; This case was reported by a other health professional via sales rep and described the occurrence of incorrect storage of drug 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 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 group was not reported but was selected as adult as per vaccine indication. GSK representative reported that an Office manager from a medical facility mentioned  that they had stored Shingrix vaccine in the freezer for a while. And that these vaccines were administered to around 18 patients after being exposed to freezing temperatures, which led to incorrect storage of drug. No further information was available. The reporter consented to follow up.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, Product storage error
Clinical narrative: inadvertently administered the vaccines that were stored outside of normal range; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number DE7TB, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd April 2021, the patient received FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Tetra 2020-2021 season and Flulaval Tetra 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 clinical supervisor called in to check stability of Flulaval vaccine stored at minimum 29 degree F temperatures for 48 hours. The clinical supervisor reported that the patient was inadvertently administered Flulaval tetra vaccine that was stored outside of normal range and needed to be discarded, which led to incorrect storage of drug. The reporter was unable to provide additional details. This case is one of 5 cases,reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021102718:Same reporter US-GLAXOSMITHKLINE-US2021102717:Same reporter US-GLAXOSMITHKLINE-US2021102720:Same reporter US-GLAXOSMITHKLINE-US2021102721:Same reporter
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Administered the vaccines that were stored outside of normal range; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2EC5G, expiry date 13th January 2023) for prophylaxis.   On 2nd April 2021, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, 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 clinical supervisor called in to check stability of Boostrix vaccine stored at minimum 29 degree F temperatures for 48 hours. The clinical supervisor reported that the patient was inadvertently administered Boostrix vaccine that was stored outside of normal range and needed to be discarded, which led to incorrect storage of drug. The reporter was unable to provide additional details. The reporter did not consent to follow up. This case is one of 5 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021102716:Same reporter US-GLAXOSMITHKLINE-US2021102720:Same reporter US-GLAXOSMITHKLINE-US2021102721:Same reporter
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Administered the vaccines that were stored outside of normal range; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received HAV (Havrix) (batch number N592C, expiry date 12th June 2022) for prophylaxis.   On 2nd April 2021, the patient received Havrix. On an unknown date, unknown after receiving Havrix, 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 reporter was a clinical supervisor. The age at vaccination was not reported. The patient received Havrix vaccine which was stored at minimum 29 Fahrenheit temperatures for 48 hours, which led to incorrect storage of drug. The reporter stated that the vaccine was inadvertently administered which was stored outside of normal range and needed to be discarded. The reporter was unable to provide additional vaccine and patient details. The reporter did not consent to follow up. This case was 1 of the 5 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021102721:Same reporter US-GLAXOSMITHKLINE-US2021102720:Same reporter US-GLAXOSMITHKLINE-US2021102716:Same reporter US-GLAXOSMITHKLINE-US2021102717:Same reporter
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: vaccines (Boostrix, Flulaval, Havrix) stored at minimum 29 Fahrenheit temperatures for 48 hours / administered the vaccines that were stored outside of normal range; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number DE7TB, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd April 2021, the patient received FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Tetra 2020-2021 season and Flulaval Tetra 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 clinical supervisor called in to check stability of Flulaval vaccine stored at minimum 29 degree F temperatures for 48 hours. The clinical supervisor reported that the patient was inadvertently administered Flulaval tetra vaccine that was stored outside of normal range and needed to be discarded, which led to incorrect storage of drug. The reporter was unable to provide additional details. This case is one of 5 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021102717:Same reporter US-GLAXOSMITHKLINE-US2021102720:Same reporter US-GLAXOSMITHKLINE-US2021102718:Same reporter US-GLAXOSMITHKLINE-US2021102716:Same reporter
Sex: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre syndrome; This case was reported by a pharmacist via call center representative and described the occurrence of guillain barre syndrome in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced guillain barre syndrome after receiving a flu vaccine dose. The reporter stated that the patient did not know what brand of vaccine she received prior to onset of Guillain-Barre syndrome. The reporter consented to follow up via email. No further information was available.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 11th November 2020, less than 2 weeks after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   The reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix in left arm and experienced flu like symptoms that resolved the next day. The reporter did not consent to follow up. For tolerance of 2nd dose, refer case US2021AMR102990, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR102990:Same reporter
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2020, the patient received the 1st dose of Shingrix (intramuscular). On 9th May 2021, between 4 and 6 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but could be 69 or 70 years. Patient got her first Shingrix vaccine and was scheduled to get her next vaccine tomorrow from the day of reporting but got Shingles 3 days ago. The reporter did not consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: had first dose of Shingrix in 2019. Never had second dose (Inappropriate schedule of vaccine).; 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 (1st dose received in the year 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. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Believes she received the first Shingrix vaccine March 13, 2019 / Not sure if she received the second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 13th March 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 did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The patient was not sure if she received only one vaccine or if she received the second dose in the vaccine series as she was unable to verify with her pharmacy. It was unclear if this was an inappropriate schedule of vaccine, as the customer could not verify the details. The reporter did not consent to follow up.  Note: Possibly invalid case, but kept valid with worst case if the dose was not received since the patient was confused and called to report AE.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: 23 years old received a dose of pediatrix Engerix-B; 23 years old received a dose of pediatrix Engerix-B; This case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 23-year-old female patient who received HBV (Engerix B pediatric) (batch number 722KC, expiry date 6th April 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th May 2021, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 11th May 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced adult use of a child product and underdose. On an unknown date, the outcome of the adult use of a child product and underdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Medical assistant reported that a 23 years old patient received a dose of pediatrix Engerix-B, which led to adult use of child product and underdose. The reporter consent to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Hepatic steatosis, Thrombosis, Ultrasound scan
Clinical narrative: BLOOD CLOT IN LEFT LEG/MUSCLE IN LEG TIGHTENED UP/CHARLEY HORSE LIKE/LEFT THIGH STILL HURT; FATTY LIVER; This spontaneous report received from a patient 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. Concomitant medications included ustekinumab used for unknown indication.  On an unspecified date, the patient experienced blood clot in left leg/muscle in leg tightened up/charley horse like/left thigh still hurt, and had a fatty liver a few weeks ago and was hospitalized. The patient stated that she took the vaccine of covid-19 three weeks ago and developed a left leg blood clot and had muscle in leg tightened up (real tight) like charley horse. Then, she went to the PCP (primary care physician) who told her for the valley imaging an ultrasound laboratory test which discovered the clot. On 30-APR-2021, the patient got admitted to the hospital and was discharged on 02-MAY-2021. The patient was hospitalized for two days. Treatment medications (dates unspecified) included: apixaban and she was doubled up on eliquis (apixaban) for blood clot in left leg. On the day of report, she stated that left thigh hurt still ongoing. (The patient have a colonoscopy laboratory test on 09-JUN-2021). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot in left leg/muscle in leg tightened up/charley horse like/left thigh still hurt and fatty liver was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210506567 -COVID-19 VACCINE AD26.COV2.S- Blood clot in left leg/Muscle in leg tightened up/Charley horse like/Left thigh still hurt, Fatty liver. 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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominoplasty, Influenza like illness, Mammoplasty, Pain in extremity, SARS-CoV-2 test
Clinical narrative: TUMMY TUCK; BREAST IMPLANT; FLU LIKE SYMPTOMS; SORE ARM; This spontaneous report received from a patient concerned a 38-year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included mild asthma. Patient was non-alcoholic, and non-smoker. From an unknown date, the patient was taking birth control (unspecified). 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: 1808609, and expiry: 09-JUN-2021) dose was not reported, administered on 22-MAR-2021 at 12:26 for prophylactic vaccination to left arm. No concomitant medications were reported.  On 23-MAR-2021, the next day after vaccination, she had Flu like symptoms like fever (not too high, body feels warm), chills, light cough, arm was sore and boy aches for the whole next day. On 23-MAR-2021, she had a COVID 19 test because she was travelling to other country and the test came back negative. On 16-APR-2021, about 3 weeks later, she had major surgeries including Tummy Tuck and Breast Implant. She thought she was taking a big risk especially after hearing on the news about blood clots. Her surgeries went well with no complications. She didn't have any symptoms of blood clots. She was now recovering from the surgeries and was doing great so far. She wanted her case to be useful for Janssen to help with research. She was willing to share the documents and reports from her surgeries if needed. Patient does not have a PCP (primary care physician) at that time. Laboratory data included: COVID-19 virus test (NR: not provided) as negative.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, and sore arm on 24-MAR-2021, and was recovering from breast implant, and tummy tuck. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210506581-Covid 19 Vaccine- Tummy Tuck and Breast Implant. 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).
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Death, Extra dose administered
Clinical narrative: DEATH; STROKE; EXTRA DOSE ADMINISTERED; This spontaneous report received from a consumer via social media concerned a male 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 and expiry: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient administered extra dose and had a bad stroke within 12 hours of the 2nd dose. Later, the patient died. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on an unspecified date, and the outcome of extra dose administered was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20210506977- Covid-19 vaccine ad26.cov2.s- Death, Stroke. 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).; Reported Cause(s) of Death: STROKE
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Laboratory test, Thrombosis
Clinical narrative: DEATH; BLOOD CLOT; This spontaneous report received from a health care professional concerned a 66 year old White and not Hispanic or Latino female. Initial information received from the health care professional on 05-MAY-2021 was processed with additional information obtained from live follow up with health care professional on 06-MAY-2021. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, diabetes, high cholesterol, non smoker, non alcohol user and other pre-existing medical conditions included no known allergies, no drug abuse or illicit drug use. Lab work was done 3-4 months ago, the results of which were unavailable. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: Unknown) dose was not reported, 1 total, administered on 10-APR-2021 possibly left arm for prophylactic vaccination. Unspecified concomitant medications were reported. On 28-APR-2021, the patient developed right leg pain and right leg swelling also began around this time as well. On 04-MAY-2021, the patient died from blood clot. An autopsy was not performed. The reporter stated that the patient's death was related to Janssen covid-19 vaccination and blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of blood clot on 04-MAY-2021. This report was serious (Death).; Sender's Comments: V0:20210509157-JANSSEN COVID-19 VACCINE- Death, blood clot - These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.; Reported Cause(s) of Death: BLOOD CLOT
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac arrest, Cardiac stress test, Catheterisation cardiac, Computerised tomogram
Clinical narrative: CARDIAC ARREST DURING ANESTHESIA FOR A SCHEDULED HEART SURGERY; ATRIAL FIBRILLATION; This spontaneous report received from a patient concerned a 70 year old White and Hispanic or Latino male. The patient's height, and weight were not reported. The patient's past medical history included general anesthesia.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: not reported) dose 1 total, administered on 06-MAR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 2021, the patient experienced atrial fibrillation. On 02-APR-2021,the patient went to the hospital for ablation of atrial fibrillation and experienced cardiac arrest during anesthesia for a scheduled heart surgery. Patient heart was stopped suddenly but cardiologist were able to revive patient .Patient had tested for Catheterization of heart ,CAT scan and stress test for heart prior 2-3 weeks before heart surgery. All the test were normal .On 02-APR-2021,After an event ,Patient was hospitalized for 5 days. The surgery for heart was pending.  On MAR-2021, Laboratory data included: CAT scan (NR: not provided) normal, Cardiac catheterization (NR: not provided) normal, and Stress test (NR: not provided) normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cardiac arrest during anesthesia for a scheduled heart surgery on APR-2021, and the outcome of atrial fibrillation was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0. 20210512607-COVID-19 VACCINE AD26.COV2.S-Cardiac arrest, Atrial fibrillation. 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)