chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: 2 doses 3 yrs ago. Was diagnosed with shingles last week/ suspected vaccination failure; shingles; Rash started in hairline crusted over; Lymph nodes were very swollen; ear pain; hairline crusted over; This case was reported by a nurse via sales rep and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In March 2022, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash, enlargement of lymph nodes, ear pain and crust. The patient was treated with amoxicillin + clavulanic acid (Augmentin). On an unknown date, the outcome of the vaccination failure, shingles, enlargement of lymph nodes, ear pain and crust were unknown and the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash, enlargement of lymph nodes, ear pain and crust to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had 2 doses of Shingrix 3 years ago. The patient was diagnosed with shingles last week. Rash started in hairline, crusted over. Lymph nodes were very swollen, ear pain and had to start on augmentin. The rash was resolved. The reporter did not agree for follow up. This case was considered as suspected vaccination failure since details regarding laboratory confirmation was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Product administration error, Vaccination failure
Clinical narrative: it will cause recurring shingles/suspected vaccination failure; shingles; Dont get the shingles shot while you have the 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.   Concurrent medical conditions 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), shingles and drug administration error. On an unknown date, the outcome of the vaccination failure, shingles and drug administration error 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 case was reported by patient. The age at vaccination was not reported. The patient had shingles and received shingles shot. The patient was experienced recurring shingles. The patient's physician did not have clue about shingles. The patient advised that don't get the shingles shot while you have the shingles it would cause recurring shingles. This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Product administered to patient of inappropriate age, Vaccination failure
Clinical narrative: The one that got shingles, got shingles vaccine/suspected vaccination failure; shingles; Inappropriate age at vaccine administration; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a child patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (Family History) (6 of children including patient in the family had the chicken pox).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and inappropriate age at vaccine administration. On an unknown date, the outcome of the vaccination failure, shingles and inappropriate age at vaccine administration 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 case was reported by patient's parent. The age at vaccination was not reported. The reporter stated that all 6 of children in family had the chicken pox and the only one that got shingles was the one that got the shingles vaccine. The reporter would pass on it. This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation was not provided. Note: As per narrative the age group was captured as child and event inappropriate age at vaccine administration was captured as event conservatively.
Age: 3.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Accidental underdose, Product administered to patient of inappropriate age, Product administration error, Wrong product administered
Clinical narrative: WRONG VACCINE ADMINISTRED; vaccine was supposed to be given to another patient; Patient (DOB: 26-JUN-2018) was given boostrix; Accidental underdose; This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 3-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2g3ph, expiry date 27th October 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis and Men ACWY-CRM NVS (Menveo) (batch number amva640z, expiry date 20th November 2022) for prophylaxis.   On 15th March 2022, the patient received Boostrix, Boostrix Pre-Filled Syringe Device and Menveo. On 15th March 2022, unknown after receiving Boostrix, Boostrix Pre-Filled Syringe Device and Menveo, the patient experienced wrong vaccine administered, drug administration error, inappropriate age at vaccine administration and accidental underdose. On an unknown date, the outcome of the wrong vaccine administered, drug administration error, inappropriate age at vaccine administration and accidental underdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional details were provided as follows: The health care professional reported the vaccine boostrix and menveo was supposed to be given to another patient, which led to wrong vaccine administered, drug administration error, inappropriate age at vaccine administration and accidental underdose. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022047763:Same reporter - FU1 deleted US-GLAXOSMITHKLINE-US2022047764:Same reporter US-GLAXOSMITHKLINE-US2022047759:Same reporter US-GLAXOSMITHKLINE-US2022047756:Same reporter
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Balance disorder, Condition aggravated, Gait disturbance, Migraine
Clinical narrative: returned of her TMJ; headaches described as a migraine; difficulty walking; could not move her legs; lose her balance; upset stomach; This case was reported by a consumer via call center representative and described the occurrence of walking difficulty in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included temporomandibular joint disorder. Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on an unknown date and had no issues). Concurrent medical conditions included multiple sclerosis, rheumatoid arthritis and overactive bladder. Concomitant products included flavoxate.   On 21st February 2022, the patient received the 2nd dose of Shingrix (intramuscular) 50 µg. In February 2022, 24 hrs after receiving Shingrix, the patient experienced walking difficulty, movement disorder, loss of balance and upset stomach. On 13th March 2022, the patient experienced migraine. On an unknown date, the patient experienced temporomandibular joint disorder. On an unknown date, the outcome of the walking difficulty, movement disorder, loss of balance and upset stomach were recovered/resolved and the outcome of the migraine was not recovered/not resolved and the outcome of the temporomandibular joint disorder was unknown.   It was unknown if the reporter considered the walking difficulty, movement disorder, loss of balance, upset stomach, migraine and temporomandibular joint disorder to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR050421  Additional details were provided as follows:  The patient self-reported this case.   The patient had current medication history of multiple sclerosis, rheumatoid arthritis, and overactive bladder prior to her Shingrix vaccination.                                   The patient received her 2nd dose of Shingrix into the muscle of her left arm and 24 hours after, she had difficulty walking, could not move her legs, and would lose her balance.  The patient also experienced upset stomach.  These symptoms all resolved after 24 hours.  However, over that past few weeks, the patient reported having headaches and the return of her TMJ. She described her headache as a migraine which started last Sunday. The patient discontinued her Flavoxate prescription which she had been taking since 2016 for her overactive bladder, in case that was contributing to her headache.  Her headache had still not resolved but the patient stated she no longer had any overactive bladder symptoms. Patient had no issues with the 1st dose of Shingrix. The reporter could not provide the lot number or expiration of the vaccine given.  The reporter gave consent to contact health care professional (HCP).   The reporter consented to follow up. This case was linked with case US2022AMR050421, reported same reporter for same patient.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Movement disorder, Temporomandibular joint syndrome
Clinical narrative: returned of her TMJ; headaches described as a migraine; difficulty walking; could not move her legs; lose her balance; upset stomach; This case was reported by a consumer via call center representative and described the occurrence of walking difficulty in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included temporomandibular joint disorder. Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on an unknown date and had no issues). Concurrent medical conditions included multiple sclerosis, rheumatoid arthritis and overactive bladder. Concomitant products included flavoxate.   On 21st February 2022, the patient received the 2nd dose of Shingrix (intramuscular) 50 µg. In February 2022, 24 hrs after receiving Shingrix, the patient experienced walking difficulty, movement disorder, loss of balance and upset stomach. On 13th March 2022, the patient experienced migraine. On an unknown date, the patient experienced temporomandibular joint disorder. On an unknown date, the outcome of the walking difficulty, movement disorder, loss of balance and upset stomach were recovered/resolved and the outcome of the migraine was not recovered/not resolved and the outcome of the temporomandibular joint disorder was unknown.   It was unknown if the reporter considered the walking difficulty, movement disorder, loss of balance, upset stomach, migraine and temporomandibular joint disorder to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR050421  Additional details were provided as follows:  The patient self-reported this case.   The patient had current medication history of multiple sclerosis, rheumatoid arthritis, and overactive bladder prior to her Shingrix vaccination.                                   The patient received her 2nd dose of Shingrix into the muscle of her left arm and 24 hours after, she had difficulty walking, could not move her legs, and would lose her balance.  The patient also experienced upset stomach.  These symptoms all resolved after 24 hours.  However, over that past few weeks, the patient reported having headaches and the return of her TMJ. She described her headache as a migraine which started last Sunday. The patient discontinued her Flavoxate prescription which she had been taking since 2016 for her overactive bladder, in case that was contributing to her headache.  Her headache had still not resolved but the patient stated she no longer had any overactive bladder symptoms. Patient had no issues with the 1st dose of Shingrix. The reporter could not provide the lot number or expiration of the vaccine given.  The reporter gave consent to contact health care professional (HCP).   The reporter consented to follow up. This case was linked with case US2022AMR050421, reported same reporter for same patient.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Constipation, Dyspnoea, Fatigue, Flatulence
Clinical narrative: Fatigue; Myalgia; Headaches; Shivering; Fever; Insomnia; constipation; gas; Severe shortness of breath; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (Trelegy Ellipta) inhalation powder for drug use for unknown indication and fluticasone fur+umeclidinium+vilanterol ellipta dry powder inhaler device (Trelegy Ellipta Dry Powder Inhaler Device) inhaler (batch number unk, expiry date unknown) for drug use for unknown indication.   On 8th March 2022, the patient received the 1st dose of Shingrix. On 7th March 2022, the patient started Trelegy Ellipta 200 mcg/mg at an unknown frequency and Trelegy Ellipta Dry Powder Inhaler Device. On 7th March 2022, not applicable after receiving Shingrix, immediately after starting Trelegy Ellipta and Trelegy Ellipta Dry Powder Inhaler Device and immediately after starting Trelegy Ellipta and Trelegy Ellipta Dry Powder Inhaler Device, the patient experienced shortness of breath. On 15th March 2022, the patient experienced fatigue, myalgia, headache, shivering, fever, insomnia, constipation and gas. The action taken with Trelegy Ellipta was unknown. On 7th March 2022, the outcome of the shortness of breath was recovered/resolved. On an unknown date, the outcome of the fatigue, myalgia, headache, shivering, fever, insomnia, constipation and gas were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, myalgia, headache, shivering, fever, insomnia, constipation and gas to be related to Shingrix, Trelegy Ellipta and Trelegy Ellipta Dry Powder Inhaler Device. It was unknown if the reporter considered the shortness of breath to be related to Trelegy Ellipta and Trelegy Ellipta Dry Powder Inhaler Device.This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details reported were as follows: This case was reported by the patient. A week after receiving Shingrix, the patient developed fatigue, myalgia, headaches, shivering, fevers, insomnia and GI symptoms like constipation and gas.  The patient reported that none of the symptoms had resolved. He provided medical advice disclaimer and referred to healthcare professional.  On the before receiving Shingrix, the patient took a sample of TRELEGY from his healthcare professional and he developed severe shortness of breath right after taking it.  The patient used his rescue inhaler and the symptom resolved.  Permission to contact healthcare professional was given. The consent to follow up was given.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Insomnia, Myalgia, Pyrexia
Clinical narrative: Fatigue; Myalgia; Headaches; Shivering; Fever; Insomnia; constipation; gas; Severe shortness of breath; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (Trelegy Ellipta) inhalation powder for drug use for unknown indication and fluticasone fur+umeclidinium+vilanterol ellipta dry powder inhaler device (Trelegy Ellipta Dry Powder Inhaler Device) inhaler (batch number unk, expiry date unknown) for drug use for unknown indication.   On 8th March 2022, the patient received the 1st dose of Shingrix. On 7th March 2022, the patient started Trelegy Ellipta 200 mcg/mg at an unknown frequency and Trelegy Ellipta Dry Powder Inhaler Device. On 7th March 2022, not applicable after receiving Shingrix, immediately after starting Trelegy Ellipta and Trelegy Ellipta Dry Powder Inhaler Device and immediately after starting Trelegy Ellipta and Trelegy Ellipta Dry Powder Inhaler Device, the patient experienced shortness of breath. On 15th March 2022, the patient experienced fatigue, myalgia, headache, shivering, fever, insomnia, constipation and gas. The action taken with Trelegy Ellipta was unknown. On 7th March 2022, the outcome of the shortness of breath was recovered/resolved. On an unknown date, the outcome of the fatigue, myalgia, headache, shivering, fever, insomnia, constipation and gas were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, myalgia, headache, shivering, fever, insomnia, constipation and gas to be related to Shingrix, Trelegy Ellipta and Trelegy Ellipta Dry Powder Inhaler Device. It was unknown if the reporter considered the shortness of breath to be related to Trelegy Ellipta and Trelegy Ellipta Dry Powder Inhaler Device.This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details reported were as follows: This case was reported by the patient. A week after receiving Shingrix, the patient developed fatigue, myalgia, headaches, shivering, fevers, insomnia and GI symptoms like constipation and gas.  The patient reported that none of the symptoms had resolved. He provided medical advice disclaimer and referred to healthcare professional.  On the before receiving Shingrix, the patient took a sample of TRELEGY from his healthcare professional and he developed severe shortness of breath right after taking it.  The patient used his rescue inhaler and the symptom resolved.  Permission to contact healthcare professional was given. The consent to follow up was given.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Feeling abnormal, Herpes zoster, Paraesthesia, Pruritus
Clinical narrative: Being miserable; Experiencing eye pain/eye pain as feeling like someone had hit her in the eye; The itchiness was like a poison ivy reaction/tickling it with a feather; itchiness was like a poison ivy reaction and tickling it with a feather; Shingles all over the left side of her face and scalp; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included feeling unwell (patient felt unwell on a Thursday in September 2021, before received vaccine).   In September 2021, the patient received the 1st dose of Shingrix. In September 2021, 1 day after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced feeling miserable, eye pain, pruritus and tingling. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the shingles, feeling miserable, eye pain, pruritus and tingling were unknown.   It was unknown if the reporter considered the shingles, feeling miserable, eye pain, pruritus and tingling to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient reported feeling unwell on a Thursday in September 2021. The Saturday after that, the patient received the first dose of Shingrix.  The next day, the patient broke out with shingles all over the left side of her face and scalp. The patient also felt being miserable and was experiencing eye pain described as feeling like someone had hit her in the eye with a baseball bat and the itchiness was like a poison ivy reaction and tickling it with a feather. As a measure the patient received three rounds of antivirals. The reporter also mentioned that her physician thought that the symptoms experienced that Thursday before the first dose of Shingrix were prodromal symptoms of zoster. The reporter consented to follow-up. GSK note- Time to onset for eye pain and itchiness was captured as less than 9 months because it was not clear, exactly when these events started.
Sex: U
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose in October 2021; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose of Twinrix vaccine received in October 2021).   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 details were provided as follows: The age at vaccination was not applicable for this report. The patient did not receive the 2nd dose of Twinrix adult till the time of reporting, which led to incomplete course of vaccination. The reporter consented to follow up by phone.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received dose 1 18-22 months ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received between 18 to 20 months ago of 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. The HCP (health care professional) reported that patient received first dose of Shingrix between 18-22 months ago.  No reactions reported. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up by email. GSK note- considering worst case approach, this case kept valid even though reporter did not commented for 2nd dose.
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 13 year old patient received Infanrix instead of Boostrix; 12 year old patient received Infanrix instead of Boostrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old female patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th March 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 18th March 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration 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 reporter only provided patient's demographics. The reporter reported that the 12 years old patient received Infanrix instead of Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter did not have lot number neither expiration date of Infanrix.  The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Has not received his second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 9th July 2021, intramuscularly in unknown arm ).   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 case was reported by patient's wife. The age at vaccination was not applicable for this report. The patient received his first dose and had not yet received his second dose, which led to incomplete course of vaccination. The reason for delay was unknown.  The reporter did not consent to follow-up.
Age: 66.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 12-jan-2020, the 2nd dose on 26-jul-2021 and 3rd dose on 17-sep-2021; 1st dose 12-jan-2020, the 2nd dose on 26-jul-2021 and 3rd dose on 17-sep-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 66-year-old male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix b (received 1st dose on 12th January 2020).   On 17th September 2021, the patient received the 3rd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 26th July 2021, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 26th July 2021, not applicable after receiving Engerix B and Engerix B Pre-Filled Syringe Device and unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On 17th September 2021, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long and drug dose administration interval too long 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 patient received Engerix-b  outside recommended schedule. The patient received the second and third dose late which led to lengthening of vaccination schedule. No knowside effect reported. No LOT number and expiration date provided. The reporter consented to follow up.
Sex: M
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient didn´t received 2nd dose-1st dose was given on october 2021; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 50-year-old male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix b (received 1st dose on October 2021).   On an unknown date, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B 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 details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that a patient didn´t received 2nd dose of engerix-b which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Beta haemolytic streptococcal infection, Ear pain, Oropharyngeal pain, Streptococcus test positive
Clinical narrative: Streptococcus Group A rapid antigen test results were positive; sore throat; left ear otalgia; This case was reported by a pharmacist via call center representative and described the occurrence of bacterial infection due to streptococcus, group a in a 44-year-old female patient who received HBV (Engerix B) (batch number 39TZ2, expiry date unknown) for prophylaxis.   On 24th February 2022, the patient received the 1st dose of Engerix B. On 28th February 2022, 4 days after receiving Engerix B, the patient experienced bacterial infection due to streptococcus, group a (serious criteria GSK medically significant), sore throat and otalgia. On an unknown date, the outcome of the bacterial infection due to streptococcus, group a, sore throat and otalgia were not recovered/not resolved.   It was unknown if the reporter considered the bacterial infection due to streptococcus, group a, sore throat and otalgia to be related to Engerix B.  Additional details were provided as follows: The case was reported by pharmacist for herself. The patient received a dose of Engerix B in left deltoid and started experiencing sore throat and left ear otalgia. On 3rd March 2022, the patient consulted with a health care provider and Streptococcus Group A rapid antigen test results were positive and was prescribed a 10 day course of antibiotics. The symptoms were reported as ongoing at the moment of the report.  The reporter consented to follow-up.
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: pediatric dose was administered to an adult; pediatric dose was administered to an adult; This case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 34-year-old male patient who received HBV (Engerix B pediatric) (batch number 77X47, expiry date 22nd December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th February 2022, the patient received the 1st dose of Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 25th February 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced adult use of a child product and underdose. On an unknown date, the outcome of the adult use of a child product and underdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was medical assistant. The reporter reported that a pediatric dose of Engerix-B was administered to an adult , which led to adult use of a child product and underdose. The reporter given permission to follow up via e-mail. Note: The consent to follow up granted was captured in general tab conservatively due to discrepant information in narrative about follow up granted or not.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: late for the 2nd dose.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 83-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 3rd May 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter reported that, the patient did not receive the second dose of Shingrix till the time of reporting, which led to incomplete course of vaccination. The reporter did not have the lot and expiry date.  The reporter consented to follow-up via mail.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Feeling cold, Headache, Immediate post-injection reaction, Nausea
Clinical narrative: Fever of 101.3; headache; nausea; dizziness; chills; This case was reported by a consumer via call center representative and described the occurrence of fever in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st March 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 21st March 2022, immediately after receiving Shingrix, the patient experienced headache, nausea, dizziness and chills. On 22nd March 2022, the patient experienced fever. On 22nd March 2022, the outcome of the headache, nausea, dizziness and chills were recovered/resolved. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever, headache, nausea, dizziness and chills to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient's wife. The patient received his first Shingrix vaccination in an unknown deltoid. Soon after, he began to experience headache, nausea, chills and dizziness. These symptoms had all resolved. At the time of reporting, he was experiencing a fever of 101.3 degree F.  Fever had not resolved. The reporter was asking how long the fever might last.  No lot or expiration date for the vaccine was known. The reporter consented to follow up.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever of 101.3; headache; nausea; dizziness; chills; This case was reported by a consumer via call center representative and described the occurrence of fever in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st March 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 21st March 2022, immediately after receiving Shingrix, the patient experienced headache, nausea, dizziness and chills. On 22nd March 2022, the patient experienced fever. On 22nd March 2022, the outcome of the headache, nausea, dizziness and chills were recovered/resolved. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever, headache, nausea, dizziness and chills to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient's wife. The patient received his first Shingrix vaccination in an unknown deltoid. Soon after, he began to experience headache, nausea, chills and dizziness. These symptoms had all resolved. At the time of reporting, he was experiencing a fever of 101.3 degree F.  Fever had not resolved. The reporter was asking how long the fever might last.  No lot or expiration date for the vaccine was known. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: receiving a third dose by accident; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 3rd dose of Shingrix by accident from another HCP (health care professional), which led to extra dose administered.  The reporter unable to provided any patient and vaccine details. The reporter inquired about any information on a third dose of Shingrix administered. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered adjuvant without active component; administered adjuvant without active component; This case was reported by a physician via sales rep and described the occurrence of inappropriate preparation of medication in a 61-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, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient was administered the Shingrix adjuvant without the active component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The Shingrix vaccine batch number, expiration date were unknown The reporter consented to follow up. This case is linked with case US2022051810, US2022051804 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022051804:Same reporter. US-GLAXOSMITHKLINE-US2022051810:Same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administered adjuvant without the active component; Administered adjuvant without the active component; This case was reported by a physician via sales rep and described the occurrence of inappropriate preparation of medication in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that the patient was administered the Shingrix adjuvant without the active component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Shingrix vaccine batch number, expiration date were unknown. The reporter consented to follow up. This case has been linked with US2022051806 and US2022051804, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022051806:Same reporter. US-GLAXOSMITHKLINE-US2022051804:Same reporter.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose a few years ago, 2nd dose about 3 months ago; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the 1st dose of Shingrix a few 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 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 reported as follows: The pharmacist stated that the patient did not come back for the second dose until about 3 months ago from reporting date. The patient received the second dose later than the recommended interval, which led to lengthening of vaccination schedule. The patient came back on the day of reporting expecting a third dose, but a third dose was not administered. The reporter was trying to determine if a 3rd dose needed to be administered so she called for recommendations. After the information was provided to the healthcare professional, she stated that she would not be administering a 3rd dose. The registered pharmacist (RPh) was in a rush to receive information stating that she had a long line, thus did not probe any further for additional information. She also declined to have contact information stored and follow up. The reporter did not consent to follow up.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: reconstituted Menveo with Sterile water; reconstituted Menveo with Sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA689A, expiry date 31st October 2022) for prophylaxis.   On 9th March 2022, the patient received Menveo. On 9th March 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The medical assistant reconstituted Menveo with sterile water and administered to a patient on 9th March 2022, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This was all the information that was provided by healthcare professional. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Autoscopy, Body temperature, Chills, Feeling hot, Hallucination
Clinical narrative: HALLUCINATIONS WHILE ASLEEP; OUT OF BODY EXPERIENCE; COULDN'T SLEEP; SO WARM; FEVER; CHILLS; This solicited report received from a patient via media concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-MAR-2021 12:30 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 10-MAR-2021 22:00, the patient experienced chills. On 11-MAR-2021, the patient experienced hallucinations while asleep. On 11-MAR-2021, the patient experienced out of body experience. On 11-MAR-2021, the patient experienced couldn't sleep. On 11-MAR-2021, the patient experienced so warm. On 11-MAR-2021 00:45, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 (unit not provided). On 11-MAR-2021 01:30, Laboratory data included: Body temperature (NR: not provided) 103.1 (unit not provided). Treatment medications included: paracetamol. On 11-MAR-2021 02:30, treatment medications included: alprazolam. On 11-MAR-2021 00:45, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from so warm, and fever on 11-MAR-2021, and the outcome of chills, hallucinations while asleep, out of body experience and couldn't sleep was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and hallucinations while asleep, out of body experience, couldn't sleep, chills, so warm, and fever was related.  This report was serious (Other Medically Important Condition).  Version created to amend previously reported information on 11-MAR-2021. Upon review the following information was amended: case level seriousness and previously reported non-serious event of hallucinations was updated to serious. The company causality for all events was updated to related (previously captured as possible); Sender's Comments: Hallucinations while asleep. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are no other factors more likely to be associated with the event(s) than the drug. Therefore, this event(s) is considered related to COVID-19 vaccine ad26.cov2.s.