chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The patient had the shingles shot but got shingles anyway. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles, within 2 weeks; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a 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 weeks after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received Shingles shot and within 2 weeks experienced shingles. The patient said he/she did not want anymore shots. The follow up could not be possible as no contact details were reported.
Sex: F
Vaccine: DTAP
Symptoms: Laboratory test abnormal, Pertussis, Pyrexia, Vaccination failure
Clinical narrative: DPT shot, probably the pertussis/ suspected vaccination failure; probably the pertussis; had a temp of over 105; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received DTPa (DTaP vaccine) for prophylaxis.   On an unknown date, the patient received DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), pertussis (serious criteria GSK medically significant) and fever. On an unknown date, the outcome of the vaccination failure, pertussis and fever were unknown.   The reporter considered the vaccination failure, pertussis and fever to be related to DTaP vaccine.  Additional details were provided as follows: This case was reported by patient's parent. The age at vaccination was not reported. The patient had a temperature of over 105 degree F from the DPT shot. The reporter stated that they said it was probably the pertussis. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for pertussis and time to onset were unknown.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix 2 years ago; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date 2 years 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 provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked if the patient needs to restart or just give the second dose at the moment of reporting. The follow-up would not possible as no contact details were available.
Age: 46.0
Sex: M
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: Fluarix exposed to freezing temperature was administrated; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 46-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number LZ4N2, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix 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 provided were as follows: The health care professional called and reported that a Fluarix QIV that was exposed to freezing temperature was administrated to a patient, which led to incorrect storage of drug. No symptoms or further details were reported. The reporter agreed to follow-up. This case was 1 of 8 case reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR215097:different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215096:different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215095:different patient, same reporter US-GLAXOSMITHKLINE-US2021214412:different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215093:different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215098:different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215092:different patient, same reporter
Age: 31.0
Sex: F
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: Fluarix exposed to freezing temperature was administrated; This case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 31-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number LZ4N2, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix 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 provided were as follows: The health care professional called and reported that a Fluarix QIV that was exposed to freezing temperature was administrated to a patient, which led to incorrect storage of drug. No symptoms or further details were reported. The reporter agreed to follow-up. This case was 1 of 8 case reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR215096:different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215097:different patient, same reporter US-GLAXOSMITHKLINE-US2021214412:different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215094:different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215098:different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215092:different patient, same reporter US-GLAXOSMITHKLINE-US2021AMR215093:different patient, same reporter
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Product storage error
Clinical narrative: Fluarix was administrated and person is also PREGNANT.; Fluarix exposed to freezing temperature was administrated; This prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number LZ4N2, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Fluarix Quadrivalent 2021-2022 season at an unknown time during the pregnancy. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced vaccine exposure during pregnancy and incorrect storage of drug. On an unknown date, the outcome of the vaccine exposure during pregnancy and incorrect storage of drug were unknown. The pregnancy was ongoing.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details provided were as follows: The health care professional called and reported that a Fluarix QIV that was exposed to freezing temperature was administrated to a patient, which led to incorrect storage of drug. The patient was pregnant at the time of vaccination which led to vaccine exposure during pregnancy. No symptoms or further details were reported. The reporter agreed to follow-up. This case was 1 of 8 case reported by the same reporter.
Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: Fluarix exposed to freezing temperature was administrated; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 32-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number LZ4N2, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix 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 provided were as follows: The health care professional called and reported that a Fluarix QIV that was exposed to freezing temperature was administrated to a patient, which led to incorrect storage of drug. No symptoms or further details were reported. The reporter agreed to follow-up. This case was 1 of 8 case reported by the same reporter.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Fluarix exposed to freezing temperature was administrated; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 26-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number LZ4N2, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix 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 provided were as follows: The health care professional called and reported that a Fluarix QIV that was exposed to freezing temperature was administrated to a patient, which led to incorrect storage of drug. No symptoms or further details were reported. The reporter agreed to follow-up. This case was 1 of 8 case reported by the same reporter.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site discolouration, Insomnia, Product administration error
Clinical narrative: injection site has a discoloration (yellow/green); had trouble sleeping; fatigued; received Flu shot at the same time and in the same arm as Shingrix; This case was reported by a consumer via call center representative and described the occurrence of injection site discoloration in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   In September 2021, the patient received the 1st dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2021-2022 season (intramuscular). In September 2021, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced difficulty sleeping, fatigue and product administration error. On an unknown date, the patient experienced injection site discoloration. On an unknown date, the outcome of the injection site discoloration was not recovered/not resolved and the outcome of the difficulty sleeping and fatigue were recovered/resolved and the outcome of the product administration error was unknown.   It was unknown if the reporter considered the injection site discoloration, difficulty sleeping and fatigue to be related to Shingrix and Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were provided as follows: This case was reported by the patient himself. The age at vaccination was not reported. The patient had received the first dose of Shingrix vaccine a few weeks ago (end of September 2021) could not remember exact date, in the left arm. The patient also received the Flu shot at the same time injection site a few inches lower than Shingrix injection site, which led to product administration error. The patient stated that same night he had trouble sleeping and was fatigued the next day. The reporter stated that several weeks after vaccination, he noticed the injection site had a 2x4 inch rectangle of discoloration (yellow/green) near Shingrix injection site. The reporter consented to follow up. This case was linked with US2021210528, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021210528:same reporter
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Condition aggravated, Fatigue, Rash
Clinical narrative: Tiredness; Achy joints; rash on feet, torso, chest, and arms; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included rash (the past 30 years, he gets a similar rash that goes away after 3 to 4 days).   On 8th October 2021, the patient received the 1st dose of Shingrix (intramuscular). On 9th October 2021, 1 days after receiving Shingrix, the patient experienced tiredness, joint pain and rash. On 11th October 2021, the outcome of the tiredness and joint pain were recovered/resolved. On an unknown date, the outcome of the rash was recovering/resolving.   It was unknown if the reporter considered the tiredness, joint pain and rash to be related to Shingrix.   Additional details were reported as follows: This case reported by the patient for himself. The patient was received Shingrix vaccine and next day he felt tiredness and achy joints, that resolved a couple days later. The patient also reported that the next day after receiving the Shingrix vaccine he experienced a rash on the bottom of his feet, across his torso, chest, and both arms. The patient also stated that the rash was not itchy and it was pretty much faded. The patient mentioned that prior shingrix vaccine he didn't think about rash because every time he got any virus for the past 30 years, he got a similer rash that goes away after 3 to 4 days. The patient was not sure if this rash was related to shingrix vaccine. The reporter did not consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not received second dose yet.; This case was reported by a pharmacist 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 vaccine (1st dose received in 2018).   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 time of reporting, the patient had not received the second dose, which led to incomplete course of vaccination. The Vaers details were reported for 1st dose of Shingrix. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose 18 months ago; This case was reported by a pharmacist 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 vaccine (1st dose received about 18 months 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 had not received second dose of Shingrix, which led to incomplete course of vaccination. The Vaers details were reported for 1st dose. The reporter consented to follow-up via email.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: itchy rash on both arms; Rash (not itchy); This case was reported by a consumer via call center representative and described the occurrence of rash in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th September 2021, the patient received the 1st dose of Shingrix (intramuscular). On 29th September 2021, 2 days after receiving Shingrix, the patient experienced rash. On 2nd October 2021, the patient experienced itchy rash. The patient was treated with steroids nos (Steroid (Not Specified)). On an unknown date, the outcome of the rash was recovered/resolved and the outcome of the itchy rash was not recovered/not resolved.   It was unknown if the reporter considered the rash and itchy rash to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for himself. The patient received shingrix vaccine and 2 days later he developed a rash(not itchy) on right side of face, all around neck to the top of shoulders. The patient stated it had  cleared up since. The patient also reported that around 5 days after the vaccine he developed an itchy rash on both arms (left arm worse than right arm). The patient had not recovered from rash on arms and called his Primary Care Physician.  The patient stated they prescribed him some pills to take, one was a steroid and the other he wasn't sure what type of medicine it was. The patient stated he would go see his dermatologist soon.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose in January of 2021; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix vaccine (1st dose received in January 2021).   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. The pharmacist inquired about if it was okay for the patient to receive their second dose on the day of reporting and till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. The reporter did not consent for follow-up. No additional information was provided.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Grip strength decreased, Muscular weakness, Musculoskeletal disorder, Pain in extremity
Clinical narrative: couldn't grip anything; hand weakness; hand pain; loss of function of her hand; This case was reported by a consumer via call center representative and described the occurrence of grip strength decreased in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th August 2021, the patient received the 1st dose of Shingrix. On 28th August 2021, 2 days after receiving Shingrix, the patient experienced grip strength decreased, hands weakness of, pain in hand and upper extremity dysfunction. On an unknown date, the outcome of the grip strength decreased, hands weakness of, pain in hand and upper extremity dysfunction were recovered/resolved.   It was unknown if the reporter considered the grip strength decreased, hands weakness of, pain in hand and upper extremity dysfunction to be related to Shingrix.  Additional details were reported as follows; This case was reported by the patient for herself. The patient received Shingrix vaccine and 2 days later developed left hand weakness, left hand pain,  the patient couldn't grip anything in her left hand and reported loss of function of her hand.  The reporter consented to follow-up. This case is linked with US2021AMR213144, reported by the same reporter for the 2nd episode.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR213144:same reporter
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Muscular weakness, Musculoskeletal disorder, Pain in extremity
Clinical narrative: couldn't grip anything; hand weakness; hand pain; loss of function of her hand; This case was reported by a consumer via call center representative and described the occurrence of grip strength decreased in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th August 2021, the patient received the 1st dose of Shingrix. On 28th August 2021, 2 days after receiving Shingrix, the patient experienced grip strength decreased, hands weakness of, pain in hand and upper extremity dysfunction. On an unknown date, the outcome of the grip strength decreased, hands weakness of, pain in hand and upper extremity dysfunction were recovered/resolved.   It was unknown if the reporter considered the grip strength decreased, hands weakness of, pain in hand and upper extremity dysfunction to be related to Shingrix.  Additional details were reported as follows; This case was reported by the patient for herself. The patient received Shingrix vaccine and 2 days later developed left hand weakness, left hand pain,  the patient couldn't grip anything in her left hand and reported loss of function of her hand.  The reporter consented to follow-up. This case is linked with US2021AMR213144, reported by the same reporter for the 2nd episode.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR213144:same reporter
Sex: U
Vaccine: HEPA
Symptoms: Incomplete course of vaccination
Clinical narrative: has not received dose two.; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Hepatitis A vaccine for prophylaxis.   Previously administered products included Hepatitis A vaccine (1st dose (manufacturer unknown) received 10 years ago from reporting date).   On an unknown date, the patient received the 2nd dose of Hepatitis A vaccine. On an unknown date, unknown after receiving Hepatitis A vaccine, 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 had not received dose two, which led to incomplete course of vaccination. The physician did not decline or consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Product dispensing error, Recalled product administered
Clinical narrative: received doses that were impacted by the voluntary recall; received doses that were impacted by the voluntary recall; This case was reported by a pharmacist via call center representative and described the occurrence of recalled drug administered in a patient who received Herpes zoster (Shingrix) (batch number 9LH3Y, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.  Additional details were reported as follows: This case was reported by the pharmacist. The age at vaccination was not applicable. The pharmacist reported that several patients in the clinic received doses that were impacted by the voluntary recall and she asked if they need to be revaccinated, which led to recalled drug administered and drug dispensing error. No further details provided on the call. Specialist neglected to note potential event during call, and thus limited details were obtained and specialist neglected to ask whether safety had permission to follow up. This case is linked to the case US2021AMR213388 and US2021AMR213387, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR213388:same reporter US-GLAXOSMITHKLINE-US2021AMR213387:same reporter
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administration of Kinrix to 13 month old.; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 13-month-old female patient who received DTPa-IPV (Kinrix) (batch number 237C4, expiry date 17th January 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd September 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 23rd September 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 reported as follows: This case was reported by the nurse. The nurse reported administration of Kinrix to 13 month old, which led to inappropriate age at vaccine administration. The reporter consented to follow-up. The case has been linked with US2021AMR054797, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR054797:same reporter
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Gastrointestinal disorder, Musculoskeletal discomfort, Nausea, Syncope
Clinical narrative: fainted; diarrhea; vomiting; nausea; Knees buckled; severe gastrointestinal effects; This case was reported by a consumer via call center representative and described the occurrence of fainting in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 8 hrs after receiving Shingrix, the patient experienced fainting (serious criteria GSK medically significant), diarrhea, vomiting, nausea, discomfort in joints and gastrointestinal disorder. On an unknown date, the outcome of the fainting, diarrhea, vomiting, nausea, discomfort in joints and gastrointestinal disorder were recovered/resolved.   It was unknown if the reporter considered the fainting, diarrhea, vomiting, nausea, discomfort in joints and gastrointestinal disorder to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. 2 weeks ago, from reporting date, the patient received 1st dose of Shingles and 8 hours after vaccination experienced knees buckled, fainted, and had severe gastrointestinal effects including nausea, vomiting and diarrhea. The patient did not provide vaccine facility details and enquired if he should receive 2nd dose of Shingles vaccine. The patient also enquired if he could have the flu vaccine at the same time as the shingles vaccine.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: fainted; diarrhea; vomiting; nausea; Knees buckled; severe gastrointestinal effects; This case was reported by a consumer via call center representative and described the occurrence of fainting in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 8 hrs after receiving Shingrix, the patient experienced fainting (serious criteria GSK medically significant), diarrhea, vomiting, nausea, discomfort in joints and gastrointestinal disorder. On an unknown date, the outcome of the fainting, diarrhea, vomiting, nausea, discomfort in joints and gastrointestinal disorder were recovered/resolved.   It was unknown if the reporter considered the fainting, diarrhea, vomiting, nausea, discomfort in joints and gastrointestinal disorder to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. 2 weeks ago, from reporting date, the patient received 1st dose of Shingles and 8 hours after vaccination experienced knees buckled, fainted, and had severe gastrointestinal effects including nausea, vomiting and diarrhea. The patient did not provide vaccine facility details and enquired if he should receive 2nd dose of Shingles vaccine. The patient also enquired if he could have the flu vaccine at the same time as the shingles vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: haven't received the second dose yet; This case was reported by a pharmacist 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 24th August 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 information was provided as follow: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter enquired should they start all over or just give her the second shot. The reporter consented to follow up. No further details provided on web form. This case had been linked with US2021213497, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021213497:same reporter
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Guillain-Barre syndrome
Clinical narrative: difficulty breathing; potential signs and symptoms of Guillain-Barre syndrome; This case was reported by a pharmacist via call center representative and described the occurrence of difficulty breathing in a 92-year-old female patient who received Herpes zoster (Shingrix) (batch number 5P9DR, expiry date 20th March 2023) for prophylaxis.   On 13th October 2021, the patient received Shingrix. On 13th October 2021, less than a day after receiving Shingrix, the patient experienced difficulty breathing (serious criteria hospitalization) and guillain barre syndrome (serious criteria hospitalization and GSK medically significant). On 14th October 2021, the outcome of the difficulty breathing and guillain barre syndrome were recovered/resolved.   It was unknown if the reporter considered the difficulty breathing and guillain barre syndrome to be related to Shingrix.  Additional details were provided as follows: The patient had received Shingrix vaccine on and 1 to 2 hours later experienced difficulty breathing and potential signs and symptoms of Guillain-Barre syndrome.  The patient was admitted to the hospital for observation. The reporter consented to follow up.
Sex: U
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: received a hepatitis b vaccine instead of flulaval; This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a patient who received Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that during a vaccine clinic a patient mistakenly received a hepatitis b vaccine instead of FluLaval, which led to wrong vaccine administered. During call, the reporter had no information regarding the patient. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose 15Nov2019, has not received second dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 15th November 2019, batch number SKBMBP52).   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 the pharmacy technician. 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. The reporter was not sure about the batch number, no expiration date. The reporter consented to follow up via email.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose May 2020, how to proceed with 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 21-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (received 1st dose on an unknown date in May 2020).   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, 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 received 2nd dose, which led to incomplete course of vaccination. The pharmacist enquired how to process with vaccination schedule before administering 2nd dose. The pharmacist did not have lot number or expiration date of 1st dose. The reporter consented to follow up.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose 2019, second dose not given; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 30-year-old female 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.   Previously administered products included Twinrix (received 1st dose on unknown date in 2019).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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 information was provided as follow: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Twinrix vaccine, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Late 2nd dose, 1st on 10-SEP-2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 10th September 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 at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix and was late, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never got shot #2; This case was reported by a pharmacist 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 Zostavax (prior vaccination with Zostavax) and shingrix (received 1st dose on an unknown date, 1 year ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist did not want to share the patient's date of birth. The patient got the Shingrix shot 1 years ago but never got shot, which led to incomplete course of vaccination. The pharmacist did not have any further information since the first shot was not given at her pharmacy.
Age: 61.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administration; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 61-year-old female 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.   Previously administered products included Twinrix (received 1st dose on 10th October 2021).   On 10th September 2021, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 10th September 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, 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.   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 reported as follows: The patient received 2nd dose of Twinrix later than the recommended schedule, which led to lengthening of vaccination schedule. The patient has not received 3rd dose. The reporter did not consent to follow-up.
Age: 47.0
Sex: M
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: Fluarix exposed to freezing temperature was administrated; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 47-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number LZ4N2, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix 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: It was reported that the Fluarix QIV that was exposed to freezing temperature was administrated to the patient, which led to incorrect storage of drug.  No symptoms or further details were reported.  The reporter agreed to be contacted for follow-up. This is one of eight cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR215097:Original Case : US2021214412 US-GLAXOSMITHKLINE-US2021AMR215096:Original Case : US2021214412 US-GLAXOSMITHKLINE-US2021AMR215095:Original Case : US2021214412 US-GLAXOSMITHKLINE-US2021AMR215094:Original Case : US2021214412 US-GLAXOSMITHKLINE-US2021AMR215093:Original Case : US2021214412 US-GLAXOSMITHKLINE-US2021AMR215098:Original Case : US2021214412 US-GLAXOSMITHKLINE-US2021AMR215092:Original Case : US2021214412
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Lot of people who took 2nd shot have been sick for 3 and 4 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Lot of people who took 2nd shot have been sick for 3 and 4 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Lot of people who took 2nd shot have been sick for 3 and 4 days). At the time of the report, VACCINATION COMPLICATION (Lot of people who took 2nd shot have been sick for 3 and 4 days) outcome was unknown.            No concomitant medications were mentioned. No treatment details were reported.   This case was linked to MOD-2021-348466 (Patient Link).
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Eye pain, Hypoaesthesia, Nausea, Paraesthesia
Clinical narrative: With Dose #1, within 24 hours of receiving the dose on 9/10/21 at 4:00pm, I had extremity numbness from my elbows to my fingertips, my knees to my toes, along with tingling in my extremities along with my face and nose tingling as well, I had nausea and diarrhea.  With Dose #2 within 2 hours of receiving the dose on 9/30/21 at 6:45pm, i had continued extremity numbness and tingling along with my face and nose, as well as sharp pains in the center of my eyes, nausea, and vomiting.   It is 10/20/21 and those symptoms have remained.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: With Dose #1, within 24 hours of receiving the dose on 9/10/21 at 4:00pm, I had extremity numbness from my elbows to my fingertips, my knees to my toes, along with tingling in my extremities along with my face and nose tingling as well, I had nausea and diarrhea.  With Dose #2 within 2 hours of receiving the dose on 9/30/21 at 6:45pm, i had continued extremity numbness and tingling along with my face and nose, as well as sharp pains in the center of my eyes, nausea, and vomiting.   It is 10/20/21 and those symptoms have remained.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Head discomfort, SARS-CoV-2 test, Sinus congestion, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; LITTLE DIZZY FEELING; PRESSURE ON FOREHEAD; HEAD CONGESTION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On OCT-2021, the patient experienced suspected covid-19 infection. On OCT-2021, the patient experienced little dizzy feeling. On OCT-2021, the patient experienced pressure on forehead. On OCT-2021, the patient experienced head congestion. On 09-OCT-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection on OCT-2021, and the outcome of little dizzy feeling, pressure on forehead and head congestion was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.