chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Pediatric patients be given Havrix Adult Dose; Pediatric patients be given Havrix Adult Dose; This case was reported by a other health professional via sales rep and described the occurrence of overdose in a 18-year-old male patient who received HAV (Havrix adult) (batch number EK59B, expiry date 20th November 2020) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the pediatric patient received Havrix adult dose, which led to overdose and adult product administered to child. The reporter consented to follow up. This was 3 of 4 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR159012:Same reporter US-GLAXOSMITHKLINE-US2021AMR159011:Same reporter US-GLAXOSMITHKLINE-US2021AMR158998:Same reporter
Sex: U
Vaccine: COVID19, VARZOS, VARZOS
Symptoms: Ophthalmic herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure; corneal shingles in my right eye; very painful.; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and COVID 19 VACCINE for prophylaxis.   Previously administered products included Covid vaccine (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine, the 1st dose of Shingles vaccine and the 2nd dose of COVID 19 VACCINE. On an unknown date, several years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria medically significant), ophthalmic herpes zoster (serious criteria medically significant) and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient received both the doses of Shingles vaccine several years ago from the date of reporting. After receiving Shingles vaccine and 2nd dose of Covid vaccine, the patient got corneal shingles in his/her right eye. The patient reported that, it was very painful. It was unknown if the reporter considered the ophthalmic herpes zoster and pain to be probably related to Covid vaccine. This case was considered as suspected vaccination failure, since the details regarding laboratory confirmation were not provided.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Injection site pain, No adverse event, Product preparation issue
Clinical narrative: Vaccine hurt when originally being administered; Administered only the adjuvant/on 7/9; Administered only the adjuvant/on 7/9/Full dose/given 7/15; This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a 51-year-old male patient who received Herpes zoster (Shingrix) (batch number d4pa4, expiry date unknown) for prophylaxis.   On 9th July 2021, the patient received Shingrix. On 9th July 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided are as follows: The patient received only adjuvant component of Shingrix in his right deltoid, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The office gave a full dose of Shingrix in left deltoid on 15th July 2021. No adverse event was reported  but only mentioned it hurt during original vaccination. The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shingles from the shingle shot/ Suspect vaccination failure; Got shingles from the shingle shot; 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.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient got shingles from the shingle shot and was suffering beyond explanation. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the shot and have gotten the shingles twice/Suspected Vaccination failure; have gotten the shingles twice; 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 reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient after vaccination, gotten the shingles twice. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: already nine months from my first shot; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose nine months ago in 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 patient was the reporter. The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Was Shingrix originally a single dose; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in April 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 patient was the reporter. The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; had them 3 times; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided are as follows: The age at vaccination was not reported. The patient received Shingles vaccination and had shingles 3 times, once before vaccination and twice after vaccination. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I know 6 people that got the shot and then got shingles /Suspected vaccination failure; I know 6 people that got the shot and then got 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; The age at vaccination was not reported. The reporter stated that, the patient got the shot and then got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided. This case was 1 of 6 linked cases reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR161278:Same reporter. Pt 2/6 US-GLAXOSMITHKLINE-US2021AMR161279:Same reporter. Pt. 3/6 US-GLAXOSMITHKLINE-US2021AMR161280:Same reporter. Pt 4/6 US-GLAXOSMITHKLINE-US2021AMR161281:Same reporter. Pt 5/6 US-GLAXOSMITHKLINE-US2021AMR161282:Same reporter. Pt 6/6
Sex: U
Vaccine: DTP
Symptoms: Cyanosis, Near death experience, Seizure
Clinical narrative: almost died; convulsions; turned to blue; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a patient who received DTP (A or W not known) (DTP vaccine) for prophylaxis.   On an unknown date, the patient received DTP vaccine. On an unknown date, unknown after receiving DTP vaccine, the patient experienced near death experience (serious criteria GSK medically significant and life threatening), convulsion (serious criteria GSK medically significant and life threatening) and cyanosis (serious criteria life threatening). On an unknown date, the outcome of the near death experience, convulsion and cyanosis were unknown.   It was unknown if the reporter considered the near death experience, convulsion and cyanosis to be related to DTP vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. When the patient was baby, he/she almost died from the DTP shot.  The patient slipped into convulsions and turned to blue.  After that, pertussis part of the shot had left out because, that was protocol.  The patient stated that, not everyone should get the pertussis part of the shot.
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Injury, Pyrexia, Syncope
Clinical narrative: fainted; sweats; fever; sustained injury; This case was reported by a other health professional via sales rep and described the occurrence of faint in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced faint (serious criteria GSK medically significant), sweating, fever and injury. On an unknown date, the outcome of the faint, sweating, fever and injury were unknown.   It was unknown if the reporter considered the faint, sweating, fever and injury to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's daughter. The age at vaccination was not reported. After receiving Shingrix, the patient had sweats and fever and next day, she fainted and sustained injury.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; have gotten 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 (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, 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 Shingrix.  Additional details were provided as follows: This case was reported by patient him/herself. The age at vaccination was not reported. After receiving Shingrix, the patient got shingles, 3 times in the year of reporting. The patient asked, if he/she could get the vaccine again. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity
Clinical narrative: severe allergic reaction; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number AFLLA175AA, expiry date 30th June 2009) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was recovered/resolved.   The reporter considered the allergic reaction to be related to FluLaval Quadrivalent.  Additional details were provided as follows: This case was reported by patient herself. The age at vaccination was not reported. The patient reported that she had severe allergic reaction to Flulaval 2008-2009 season. The patient did not gave her email address or age or birth date. The patient thought that the adverse event was already reported. No further information was provided.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial pain, Herpes zoster, Nervous system disorder, Pruritus, Rash
Clinical narrative: he had both Shingrix vaccine/ Shingles episode on mid-May of this year 2021.; Shingles / shingles outbreak; an unusual very mild rash/rash was on the back-left side of the torso; itched/ itching at the left side of the face; pain on the left trigeminal nerve; Shingles nerve problems; still pain on the face; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In May 2021, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash, pruritus facial, trigeminal neuralgia, neurological disorder nos and facial pain. The patient was treated with gabapentin. On an unknown date, the outcome of the vaccination failure, rash, pruritus facial and trigeminal neuralgia were unknown and the outcome of the shingles was recovered/resolved and the outcome of the neurological disorder nos and facial pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash, pruritus facial, trigeminal neuralgia, neurological disorder nos and facial pain to be related to Shingrix and Shingrix.  Additional detaails were provided as follows: The reporter was the patient. The patient received both Shingrix shot as soon as the vaccine was available around 2017. The patient had the Zostavax vaccine before getting both doses of Shingrix. The patient had Shingles episode on mid-May of this year 2021. The reporter stated that, had an unusual very mild rash that he thought it was bug bites and it itched not painful. The patient reported the shingles rash was on the back-left side of the torso, itching at the left side of the face with pain on the trigeminal nerve, with no visible rash, only itching. The patient stated that the outbreak of the Shingles rash happened simultaneously at the same time the itching and pain on the left trigeminal nerve started. This trigeminal left nerve  was never an issue before. The patient reported, had been prescribed Gabapentin and will be starting a new anti-seizures medication. The reporter stated that, did not have Shingles now and only had shingles nerve problems and still pain on the face. The reporter stated that, no pain in the torso area. Not all information was available. Both dates of vaccination were unknown. Lot and expiration dates were unknown. The reporter consented to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic, Trigeminal neuralgia, Vaccination failure
Clinical narrative: he had both Shingrix vaccine/ Shingles episode on mid-May of this year 2021.; Shingles / shingles outbreak; an unusual very mild rash/rash was on the back-left side of the torso; itched/ itching at the left side of the face; pain on the left trigeminal nerve; Shingles nerve problems; still pain on the face; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In May 2021, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash, pruritus facial, trigeminal neuralgia, neurological disorder nos and facial pain. The patient was treated with gabapentin. On an unknown date, the outcome of the vaccination failure, rash, pruritus facial and trigeminal neuralgia were unknown and the outcome of the shingles was recovered/resolved and the outcome of the neurological disorder nos and facial pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash, pruritus facial, trigeminal neuralgia, neurological disorder nos and facial pain to be related to Shingrix and Shingrix.  Additional detaails were provided as follows: The reporter was the patient. The patient received both Shingrix shot as soon as the vaccine was available around 2017. The patient had the Zostavax vaccine before getting both doses of Shingrix. The patient had Shingles episode on mid-May of this year 2021. The reporter stated that, had an unusual very mild rash that he thought it was bug bites and it itched not painful. The patient reported the shingles rash was on the back-left side of the torso, itching at the left side of the face with pain on the trigeminal nerve, with no visible rash, only itching. The patient stated that the outbreak of the Shingles rash happened simultaneously at the same time the itching and pain on the left trigeminal nerve started. This trigeminal left nerve  was never an issue before. The patient reported, had been prescribed Gabapentin and will be starting a new anti-seizures medication. The reporter stated that, did not have Shingles now and only had shingles nerve problems and still pain on the face. The reporter stated that, no pain in the torso area. Not all information was available. Both dates of vaccination were unknown. Lot and expiration dates were unknown. The reporter consented to follow up.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Catheterisation cardiac, Chest pain, Condition aggravated, Coronary artery disease, Dyspnoea
Clinical narrative: received a cardiac catheterization; has not had his second dose; was diagnosed with / pericarditis; was diagnosed with minimal coronary disease; trouble breathing; sever chest pain; This case was reported by a nurse and described the occurrence of pericarditis in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included pericarditis, coronary disease, chronic lymphocytic leukemia and shingles.   On 10th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On 13th January 2020, 3 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pericarditis (serious criteria GSK medically significant), coronary disease, difficulty breathing and chest pain. On an unknown date, the patient experienced cardiac catheterization and incomplete course of vaccination. On an unknown date, the outcome of the pericarditis, chest pain and incomplete course of vaccination were not recovered/not resolved and the outcome of the coronary disease, difficulty breathing and cardiac catheterization were unknown.   It was unknown if the reporter considered the pericarditis, coronary disease, difficulty breathing, chest pain and cardiac catheterization to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient's wife. The age at vaccination was not applicable for 2nd dose reported. The patient received the 1st dose of Shingrix and 3 days later he had severe chest pain and trouble breathing. The patient went to the emergency department at that time, received a cardiac catheterization, was diagnosed with minimal coronary disease and pericarditis.  The patient had not received his 2nd dose of Shingrix till the time of reporting which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Pericarditis
Clinical narrative: received a cardiac catheterization; has not had his second dose; was diagnosed with / pericarditis; was diagnosed with minimal coronary disease; trouble breathing; sever chest pain; This case was reported by a nurse and described the occurrence of pericarditis in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included pericarditis, coronary disease, chronic lymphocytic leukemia and shingles.   On 10th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On 13th January 2020, 3 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pericarditis (serious criteria GSK medically significant), coronary disease, difficulty breathing and chest pain. On an unknown date, the patient experienced cardiac catheterization and incomplete course of vaccination. On an unknown date, the outcome of the pericarditis, chest pain and incomplete course of vaccination were not recovered/not resolved and the outcome of the coronary disease, difficulty breathing and cardiac catheterization were unknown.   It was unknown if the reporter considered the pericarditis, coronary disease, difficulty breathing, chest pain and cardiac catheterization to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient's wife. The age at vaccination was not applicable for 2nd dose reported. The patient received the 1st dose of Shingrix and 3 days later he had severe chest pain and trouble breathing. The patient went to the emergency department at that time, received a cardiac catheterization, was diagnosed with minimal coronary disease and pericarditis.  The patient had not received his 2nd dose of Shingrix till the time of reporting which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Intercepted product administration error
Clinical narrative: patient / 40 years old with a prescription to get vaccinated; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 40-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted drug prescribing error. On an unknown date, the outcome of the intercepted drug prescribing error was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The pharmacist inquired about the approved age of the Shingrix vaccine because he has a patient at his pharmacy that is 40 years old with a prescription to get vaccinated, which led to intercepted drug prescribing error. The pharmacist states was not planning on administering the vaccine initially and only wanted to verify. The reporter consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact, Incorrect dose administered
Clinical narrative: partial dose was received; amount of vaccine seen running down patient's arm and onto their foot; amount of vaccine seen running down patient's arm and onto their foot; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number KX52G, expiry date 1st December 2021) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced accidental underdose, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the accidental underdose, inadvertent exposure to vaccine and exposure via skin contact were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix and only a partial dose was received after the needle separated from the Tip-Lok syringe and a noticeable amount of vaccine seen running down patient's arm and onto their foot after administration which led accidental underdose, inadvertent exposure and exposure via skin contact. The reporter consent to follow up.
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: received Hiberix / dose expired; received Hiberix/ patient´s age/ 72; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 72-year-old female patient who received Hib (Hiberix) (batch number G4XX7, expiry date 20th May 2021) for prophylaxis.   On 23rd July 2021, the patient received Hiberix. On 23rd July 2021, unknown after receiving Hiberix, the patient experienced expired vaccine used and inappropriate age at vaccine administration. On an unknown date, the outcome of the expired vaccine used and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist stated that, the patient received already expired vaccine at the age of 72 years old, which led to expired vaccine used and inappropriate age at vaccine administration. The health care professional was not sure about the patient's age, mentioned it was 72, although it was explained that that was not the recommended age for the use of the vaccine. The reporter consented to follow up.
Age: 14.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: Kinrix was administrated instead of Boostrix to a 14 years old; Kinrix was administrated instead of Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 14-year-old female patient who received DTPa-IPV (Kinrix) (batch number hb7l7, expiry date 31st August 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th June 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 18th June 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. The action taken with Kinrix Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The medical assistance reported that, Kinrix was administrated instead of Boostrix to a 14 years old patient, which led to inappropriate age at vaccine administration and wrong vaccine administered. No adverse event was reported. The reporter consented to follow up.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Burning sensation, Herpes zoster, Rash, Rash erythematous
Clinical narrative: Suspected Vaccination failure; HCP confirmed Shingles / Developed shingles; Red spot on his right back / spread under his right armpit to his stomach; The redness has formed blisters on his stomach area; Spot gave him a burning sensation; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 10th November 2019, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, the patient received the 1st dose of Shingrix. On 23rd July 2021, 621 days after receiving Shingrix, unknown after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, red rash, blister and burning sensation. The patient was treated with valaciclovir hydrochloride (Valtrex) and analgesic, nos (Pain Medication). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, red rash, blister and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, red rash, blister and burning sensation to be related to Shingrix and Shingrix.  Additional details were provided as follows: The case was reported by the patient himself. The patient received the two doses of Shingrix and patient had shingles. The patient stated that on last friday before reporting date he noticed a red spot on his right back about the size of a silver dollar,the patient was working in yard so he thought he was bitten by an insect. On 25th July 2021,the red spot grew to the size of a basketball and spread under his right armpit to his stomach. The patient went to the HCP and the HCP confirmed it as Shingles. At the day of reporting the redness had formed blisters on his stomach area. The HCP started on patient valtrex and pain medications for treatment. The reporter stated that he developed shingles even though he received both doses of the Shingrix. The reporter did not consent to follow up. The reporter did not give permission to contact HCP. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: Suspected Vaccination failure; HCP confirmed Shingles / Developed shingles; Red spot on his right back / spread under his right armpit to his stomach; The redness has formed blisters on his stomach area; Spot gave him a burning sensation; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 10th November 2019, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, the patient received the 1st dose of Shingrix. On 23rd July 2021, 621 days after receiving Shingrix, unknown after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, red rash, blister and burning sensation. The patient was treated with valaciclovir hydrochloride (Valtrex) and analgesic, nos (Pain Medication). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, red rash, blister and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, red rash, blister and burning sensation to be related to Shingrix and Shingrix.  Additional details were provided as follows: The case was reported by the patient himself. The patient received the two doses of Shingrix and patient had shingles. The patient stated that on last friday before reporting date he noticed a red spot on his right back about the size of a silver dollar,the patient was working in yard so he thought he was bitten by an insect. On 25th July 2021,the red spot grew to the size of a basketball and spread under his right armpit to his stomach. The patient went to the HCP and the HCP confirmed it as Shingles. At the day of reporting the redness had formed blisters on his stomach area. The HCP started on patient valtrex and pain medications for treatment. The reporter stated that he developed shingles even though he received both doses of the Shingrix. The reporter did not consent to follow up. The reporter did not give permission to contact HCP. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Prostate cancer, Radiotherapy
Clinical narrative: prostate cancer; This case was reported by a pharmacist via call center representative and described the occurrence of prostate cancer in a 83-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd April 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced prostate cancer (serious criteria GSK medically significant). The patient was treated with non-drug therapy (Radio Therapy). On an unknown date, the outcome of the prostate cancer was unknown.   It was unknown if the reporter considered the prostate cancer to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received the 1st dose of Shingrix and less than 4 months after the vaccination the patient experienced prostate cancer. The patient was on radio therapy as treatment. The reporter consented to follow up. The pharmacist only knew that it was a new diagnosis for the patient. No further details provided. The pharmacist consented to follow up via letter in the mail.
Age: 7.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix given to a 7 years old patient; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received DTPa-IPV (Kinrix) (batch number JP55J5, expiry date 13th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th July 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 26th July 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 provided as follows: The 7 years old patient received Kinrix, which led to inappropriate age at vaccine administration. The reporter wanted to know if this dose was valid or if needs to re done it. The reporter consented to follow up. This case was linked with case US2021160427, reported by same reporter for different patient. .; Sender's Comments:  US-GLAXOSMITHKLINE-US2021160427:Same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: In 2018 /received the first /received the second /on/ Feb 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date in 2018).   In February 2021, the patient received the 2nd dose of Shingrix. In February 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided are as follows: The case was reported by pharmacist. The age at the vaccination was not reported. The patient received 2nd dose of Shingrix over the recommended dosing interval, which led to drug dose administration interval too long. The reporter consented to follow up. The email address was unavailable for the pharmacist.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Extra dose administered
Clinical narrative: patient had previously been given 3 doses of Bexsero.; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number A8X809A2, expiry date 21st May 2022) 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.   Previously administered products included bexsero (received first dose on 12th August 2020) and bexsero (received 2nd dose on 23rd September 2020).   On 21st June 2021, the patient received the 3rd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 21st June 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered 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 patient received had previously received 2 doses of Bexsero vaccine and now received the 3rd dose which led to extra dose administered. Reporter consented to follow-up via e-mail.
Sex: U
Vaccine: COVID19
Symptoms: Photophobia
Clinical narrative: PHOTOPHOBIA; This spontaneous report received from a patient concerned multiple patients. 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced photophobia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of photophobia 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.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID TEST POSITIVE; This spontaneous report received from a patient via a company representative 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, 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 23-JUL-2021, the subject experienced covid test positive. Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid test positive was not reported. This report was non-serious. This report was associated with product quality complaint: 90000187245 The suspected product quality complaint has been confirmed to be voided (no PQC was identified within the time period when complaint was reported) based on the PQC evaluation/investigation performed.; Sender's Comments: Medical assessment comment not required as per standard procedure as the case assessed non-serious
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Cognitive disorder, Fear, Feeling abnormal, Nausea
Clinical narrative: SHORT-TERM MEMORY LOSS; FEELS LIKE GOING SENILE; CAN'T STAY AWAKE; FELT IN A FOG/FELT LIKE SYMPTOMS HIT LIKE A BRICK WALL; FEAR OF DRIVING; NAUSEATED; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes, and other pre-existing medical conditions included patient described himself as healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 26-APR-2021 for prophylactic vaccination. Concomitant medications included metformin for type 2 diabetes.  On MAY-2021, the subject experienced feels like going senile. On MAY-2021, the subject experienced short-term memory loss. On MAY-2021, the subject experienced can't stay awake. On MAY-2021, the subject experienced felt in a fog/felt like symptoms hit like a brick wall. On MAY-2021, the subject experienced fear of driving. On MAY-2021, the subject experienced nauseated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from short-term memory loss, nauseated, can't stay awake, feels like going senile, felt in a fog/felt like symptoms hit like a brick wall, and fear of driving. This report was non-serious. This case, from the same reporter is linked to 20210754945.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: SHORT-TERM MEMORY LOSS; FEELS LIKE GOING SENILE; CAN'T STAY AWAKE; FELT IN A FOG/FELT LIKE SYMPTOMS HIT LIKE A BRICK WALL; FEAR OF DRIVING; NAUSEATED; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes, and other pre-existing medical conditions included patient described himself as healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 26-APR-2021 for prophylactic vaccination. Concomitant medications included metformin for type 2 diabetes.  On MAY-2021, the subject experienced feels like going senile. On MAY-2021, the subject experienced short-term memory loss. On MAY-2021, the subject experienced can't stay awake. On MAY-2021, the subject experienced felt in a fog/felt like symptoms hit like a brick wall. On MAY-2021, the subject experienced fear of driving. On MAY-2021, the subject experienced nauseated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from short-term memory loss, nauseated, can't stay awake, feels like going senile, felt in a fog/felt like symptoms hit like a brick wall, and fear of driving. This report was non-serious. This case, from the same reporter is linked to 20210754945.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.