chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Gait inability
Clinical narrative: I currently cant even walk; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of unable to walk in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced unable to walk (Verbatim: I currently cant even walk). The outcome of the unable to walk was not resolved.   It was unknown if the reporter considered the unable to walk to be related to Shingles vaccine.     It was unknown if the company considered the unable to walk to be related to Shingles vaccine.   Additional Information: GSK receipt date: 20-JUN-2023 This case was reported the patient via interactive digital media. Patient asked not to do that. Vaccine screwed up the patient and currently the patient cannot even walk. Follow-up not possible as no contact details provided.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Skin burning sensation
Clinical narrative: i have a burning when my cloths touch my skin; some pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of burning sensation skin in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. In JUN-2023, an unknown time after receiving Shingles vaccine, the patient experienced burning sensation skin (Verbatim: i have a burning when my cloths touch my skin) and pain (Verbatim: some pain). The outcome of the burning sensation skin and pain were not resolved.   It was unknown if the reporter considered the burning sensation skin and pain to be related to Shingles vaccine.     It was unknown if the company considered the burning sensation skin and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 20-JUN-2023 The patient self-reported this case. This case was reported by a patient via interactive digital media. The patient got the two shots this might the last one but for the last 4 days on back around bra and had a burning when cloths touched the skin and some pain when moved a certain way. The reporter asked if anyone could still get shingles after the shots or was this something else.
Sex: U
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: Nerve pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of nerve pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced nerve pain (Verbatim: Nerve pain). The outcome of the nerve pain was not reported.   It was unknown if the reporter considered the nerve pain to be related to Shingles vaccine.     It was unknown if the company considered the nerve pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 21-JUN-2023 This case was reported by patient via interactive digital media. The reporter reported that the patient received 1st dose of Shingles vaccine it took him out for 2 days and experienced nerve pain.  The reporter stated that the 2nd shot was on 2 months and the nerve pain was worse and also states these vaccines are brutal too. Follow up was not possible, as no contact details were available.
Age: 71.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: drug dosage duration too long; This non-serious case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too long in a 71-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix  (received 1st dose on 11th January 2023).   On 21-JUN-2023, the patient received the 2nd dose of Twinrix. On 21-JUN-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: drug dosage duration too long). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 21-Jun-2023 No reaction was reported. The reporter consented to follow-up via postal. The patient received 2nd dose of Twinrix later than the recommended interval, which led to lengthening of vaccine schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a 68-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles when he/she was 10 years old).   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.   It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 22-JUN-2023 This case was reported by a patient via interactive digital media. The patient had his/her shingles booster shot and developed shingles the next day. The doctor confirmed it.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the liquidcomponent of Menveo; received only the liquid component of Menveo; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a adolescent male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: received only the liquidcomponent of Menveo) and inappropriate dose of vaccine administered (Verbatim: received only the liquid component of Menveo). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 22-JUN-2023 The reporter was a medical assistant. The reporter consented to follow up. The reporter reported that a patient received only the liquid component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 1.0
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: administered Infanrix today 20Jun2023 from lot number 7KM93, which had an expiration date of 10Jun2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 15-month-old patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10-JUN-2023) for prophylaxis.   On 20-JUN-2023, the patient received Infanrix. On 20-JUN-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: administered Infanrix today 20Jun2023 from lot number 7KM93, which had an expiration date of 10Jun2023). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-JUN-2023 At the time of reporting, the dose had not been repeated. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  The reporter reported that a patient was administered expired Infanrix, which led to expired vaccine used.
Age: 61.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: inadvertently administered an expired Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 61-year-old female patient who received HAV (Havrix adult) (batch number NZ7GR, expiry date 17-JUN-2023) for prophylaxis.   On 20-JUN-2023, the patient received Havrix adult. On 20-JUN-2023, an unknown time after receiving Havrix adult, the patient experienced expired vaccine used (Verbatim: inadvertently administered an expired Havrix). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 20-JUN-2023 It was reported that a patient was inadvertently administered an expired Havrix which led to expired vaccine used. The reporter enquired that should the patient be revaccinated. The reporter did not consent to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear discomfort, Ear pain, Oropharyngeal discomfort, Oropharyngeal pain, Paranasal sinus discomfort
Clinical narrative: pain in sinuses; pain in  throat; pain in ears; pressure in sinuses; pressure in throat; pressure in ears; This non-serious case was reported by a consumer via call center representative and described the occurrence of sinus pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In APR-2023, the patient received the 1st dose of Shingrix. In APR-2023, 5 days after receiving Shingrix, the patient experienced sinus pain (Verbatim: pain in sinuses), throat pain (Verbatim: pain in  throat), ear pain (Verbatim: pain in ears), sinus pressure (Verbatim: pressure in sinuses), throat discomfort (Verbatim: pressure in throat) and sensation of pressure in ear (Verbatim: pressure in ears). The outcome of the sinus pain, throat pain, ear pain, sinus pressure, throat discomfort and sensation of pressure in ear were resolved.   It was unknown if the reporter considered the sinus pain, throat pain, ear pain, sinus pressure, throat discomfort and sensation of pressure in ear to be related to Shingrix.     It was unknown if the company considered the sinus pain, throat pain, ear pain, sinus pressure, throat discomfort and sensation of pressure in ear to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-JUN-2023 The reporter was the patient who stated that she received Shingrix first dose at the beginning of April 2023 and 5 days later she developed pressure and pain in her sinuses, ears and throat that she believed was an outbreak of Shingles. No rash or other symptom reported. Patient did not notify her doctor and she was not diagnosed with Shingles. The reporter did not consent to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Sinus pain
Clinical narrative: pain in sinuses; pain in  throat; pain in ears; pressure in sinuses; pressure in throat; pressure in ears; This non-serious case was reported by a consumer via call center representative and described the occurrence of sinus pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In APR-2023, the patient received the 1st dose of Shingrix. In APR-2023, 5 days after receiving Shingrix, the patient experienced sinus pain (Verbatim: pain in sinuses), throat pain (Verbatim: pain in  throat), ear pain (Verbatim: pain in ears), sinus pressure (Verbatim: pressure in sinuses), throat discomfort (Verbatim: pressure in throat) and sensation of pressure in ear (Verbatim: pressure in ears). The outcome of the sinus pain, throat pain, ear pain, sinus pressure, throat discomfort and sensation of pressure in ear were resolved.   It was unknown if the reporter considered the sinus pain, throat pain, ear pain, sinus pressure, throat discomfort and sensation of pressure in ear to be related to Shingrix.     It was unknown if the company considered the sinus pain, throat pain, ear pain, sinus pressure, throat discomfort and sensation of pressure in ear to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-JUN-2023 The reporter was the patient who stated that she received Shingrix first dose at the beginning of April 2023 and 5 days later she developed pressure and pain in her sinuses, ears and throat that she believed was an outbreak of Shingles. No rash or other symptom reported. Patient did not notify her doctor and she was not diagnosed with Shingles. The reporter did not consent to follow up.
Age: 0.5
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix was given instead of Pediarix; Kinrix was given at the 6 month; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 6-month-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: Kinrix was given instead of Pediarix) and inappropriate age at vaccine administration (Verbatim: Kinrix was given at the 6 month). 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 Information: GSK receipt date: 20-JUN-2023 The Kinrix was given instead of Pediarix at the 6 month of age, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter asked was there any harm from this? Did any vaccines need to be made up? The reporter did not consent to follow-up.
Age: 4.0
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered
Clinical narrative: 4 year old patient received an extra dose of Pediarix in the same visit; This non-serious case was reported by a consumer via sales rep and described the occurrence of extra dose administered in a 4-year-old patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   On an unknown date, the patient received Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced extra dose administered (Verbatim: 4 year old patient received an extra dose of Pediarix in the same visit). 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 Information: GSK Receipt Date: 20-JUN-2023 The healthcare professional reported that the patient received an extra dose of Pediarix in the same visit, which led to extra dose administered.  No other information known or provided. The reporter did not consent to follow-up.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix administrared to 4 month old baby; Kinrix was administrated when Pentacel was intended to be given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 09-NOV-2023) for prophylaxis.   On 20-JUN-2023, the patient received Kinrix. On 20-JUN-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix administrared to 4 month old baby) and wrong vaccine administered (Verbatim: Kinrix was administrated when Pentacel was intended to be given). 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 Information: GSK receipt date: 21-Jun-2023 The Kinrix was administrated to patient 4 month age when Pentacel was intended to be given, which led to wrong vaccine administered and inappropriate age at vaccine administration. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Age: 27.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 10 Mar 2023, 2nd dose on 20 Jun 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 27-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received on 10-MAR-2023).   On 20-JUN-2023, the patient received the 2nd dose of Twinrix. On 20-JUN-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose on 10 Mar 2023, 2nd dose on 20 Jun 2023). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-JUN-2023 The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccinations schedule. The pharmacist asked how to proceed with the 3rd dose of Twinrix. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via postal.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Injection site haemorrhage, Pain
Clinical narrative: Bleeding at injection site; lightheaded; chills and shivering; tired and sleepy; achy all over; Sleepy; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site hemorrhage in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on an unknown date and had no problems).   On 20-JUN-2023, the patient received the 2nd dose of Shingrix (intramuscular, left arm). In JUN-2023, an unknown time after receiving Shingrix, the patient experienced light headedness (Verbatim: lightheaded), chills (Verbatim: chills and shivering), tiredness (Verbatim: tired and sleepy), general body pain (Verbatim: achy all over) and sleepiness (Verbatim: Sleepy). On 20-JUN-2023, the patient experienced injection site hemorrhage (Verbatim: Bleeding at injection site). The outcome of the injection site hemorrhage was resolved and the outcome of the light headedness, chills, tiredness, general body pain and sleepiness were not resolved.   It was unknown if the reporter considered the injection site hemorrhage, light headedness, chills, tiredness, general body pain and sleepiness to be related to Shingrix.     It was unknown if the company considered the injection site hemorrhage, light headedness, chills, tiredness, general body pain and sleepiness to be related to Shingrix.   Additional Information: GSK receipt date: 21-Jun-2023 The patient received a dose of Shingrix and this time had the injection site bled (down her arm) after shot given. In June 2023, hours later the patient experienced lightheadedness, chills and shivering and had been achy all over. The patient also been sleepy and tired. Referred to health care professional. The reporter did not consent to follow-up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: Bleeding at injection site; lightheaded; chills and shivering; tired and sleepy; achy all over; Sleepy; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site hemorrhage in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on an unknown date and had no problems).   On 20-JUN-2023, the patient received the 2nd dose of Shingrix (intramuscular, left arm). In JUN-2023, an unknown time after receiving Shingrix, the patient experienced light headedness (Verbatim: lightheaded), chills (Verbatim: chills and shivering), tiredness (Verbatim: tired and sleepy), general body pain (Verbatim: achy all over) and sleepiness (Verbatim: Sleepy). On 20-JUN-2023, the patient experienced injection site hemorrhage (Verbatim: Bleeding at injection site). The outcome of the injection site hemorrhage was resolved and the outcome of the light headedness, chills, tiredness, general body pain and sleepiness were not resolved.   It was unknown if the reporter considered the injection site hemorrhage, light headedness, chills, tiredness, general body pain and sleepiness to be related to Shingrix.     It was unknown if the company considered the injection site hemorrhage, light headedness, chills, tiredness, general body pain and sleepiness to be related to Shingrix.   Additional Information: GSK receipt date: 21-Jun-2023 The patient received a dose of Shingrix and this time had the injection site bled (down her arm) after shot given. In June 2023, hours later the patient experienced lightheadedness, chills and shivering and had been achy all over. The patient also been sleepy and tired. Referred to health care professional. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Only received first dose of shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in November 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Only received first dose of shingrix). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 21-JUN-2023 The reporter asked for information regarding a patient who had not received the second dose of Shingrix yet. The reporter asked if they could administer the second dose or if the patient had to restart the vaccination. The reporter did not provide information about first Shingrix dose (lot number, expiry date). The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Shingrix: 2nd dose longer than recommended intervals; This non-serious case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too long in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 1 year ago).   On an unknown date, the patients received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patients experienced drug dose administration interval too long (Verbatim: Shingrix: 2nd dose longer than recommended intervals). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 21-Jun-2023 The physician reported that several patients, she did not had the count or details probably around 5 to 8 patients they come in for the 2nd dose of Shingrix after 1 year and she gave the 2nd dose. No other information was available. The reporter consented to follow-up. The patients received the 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pain in extremity, Presyncope
Clinical narrative: severe fatigue (so tired that he felt like he was going to pass out); myalgia that resulted in him feeling muscle pain from his feet up to his neck; his arm was sore; he felt like he was going to pass out; This non-serious case was reported by a consumer via call center representative and described the occurrence of fatigue in a 79-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, an unknown time after receiving Shingrix, the patient experienced fatigue (Verbatim: severe fatigue (so tired that he felt like he was going to pass out)), myalgia (Verbatim: myalgia that resulted in him feeling muscle pain from his feet up to his neck), pain in arm (Verbatim: his arm was sore) and presyncope (Verbatim: he felt like he was going to pass out). The outcome of the fatigue, myalgia, pain in arm and presyncope were resolved (duration 4 days).   It was unknown if the reporter considered the fatigue, myalgia, pain in arm and presyncope to be related to Shingrix.     It was unknown if the company considered the fatigue, myalgia, pain in arm and presyncope to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-JUN-2023 Consumer was the reporter.  The reporter stated that after receiving first dose of Shingrix he experienced severe fatigue so tired that he felt like he was going to pass out and myalgia that resulted in him feeling muscle pain from his feet up to his neck.  The reporter also reported that his arm was sore.  Took him about 4 days to get over the adverse reaction. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Needle issue
Clinical narrative: received only a partial (unknown volume) of Shingrix today when the needle leaked; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22-JUN-2023, the patient received Shingrix. On 22-JUN-2023, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: received only a partial (unknown volume) of Shingrix today when the needle leaked). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK receipt date: 22-JUN-2023 The reporter was the health care professional (pharmacist).  No Product quality complaint (PQC), it was ruled out. Nothing else was reported. A patient received only a partial (unknown volume) of Shingrix when the needle leaked, which led to incomplete dose administered.
Age: 38.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Havrix was administered today on June 22 2023. Havrix expired on June 17th 2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 38-year-old male patient who received HAV (Havrix) (batch number NZ7GR, expiry date 17-JUN-2023) for prophylaxis.   On 22-JUN-2023, the patient received Havrix. On 22-JUN-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Havrix was administered today on June 22 2023. Havrix expired on June 17th 2023). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 22-JUN-2023 The reporter consented to follow up. Preferred follow up via email.      On the day of reporting, the patient received an expired dose of Havrix, which led to expired vaccine used.
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Incorrect route of product administration
Clinical narrative: Wrong Route of Administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 52-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 22-JUN-2023, the patient received Boostrix (intravenous). On 22-JUN-2023, an unknown time after receiving Boostrix, the patient experienced intramuscular formulation administered by other route (Verbatim: Wrong Route of Administration). The outcome of the intramuscular formulation administered by other route was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-JUN-2023 The vaccine administration facility is the same as primary reporter. HCP did not had the lot number of expiration date of the vaccine.  The reporter stated that he/she selected PFS as failed to ask the formulation.  The reporter consented to follow up via postal. On the day of reporting, the patient was administered Boostrix intravenously (IV), which led to intramuscular formulation administered by other route.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Menveo: only diluent administered; Menveo: only diluent administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA9345) for prophylaxis.   On 22-JUN-2023, the patient received Menveo. On 22-JUN-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Menveo: only diluent administered) and inappropriate dose of vaccine administered (Verbatim: Menveo: only diluent administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 22-JUN-2023 The nurse reported that a college student was administered only the liquid component of Menveo (booster dose) and the powder was not administered. The reporter did not consent to follow-up. On the day of reporting, the patient received only the liquid component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose has not been administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received a year ago in 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 2nd dose has not been administered). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 22-JUN-2023 Sales representative called informing that was not able to race information. The nurse who was also a patient had not been administered yet with second dose. The reporter consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 0.17
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient accidentally received a dose of Kinrix instead of Infanrix; patient accidentally received a dose of Kinrix instead of Infanrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 2-month-old female patient who received DTPa-IPV (Kinrix) (batch number F5492, expiry date 27-OCT-2024) for prophylaxis.   On 21-JUN-2023, the patient received Kinrix. On 21-JUN-2023, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: patient accidentally received a dose of Kinrix instead of Infanrix) and inappropriate age at vaccine administration (Verbatim: patient accidentally received a dose of Kinrix instead of Infanrix). 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 Information: GSK Receipt Date: 22-JUN-2023 A medical assistant called in to report that a patient accidentally received a dose of Kinrix instead of Infanrix and wished to know how to proceed.  They provided information about the vaccine, patient and event.  Medical information was solicited be sent via fax. The reporter consented to follow up.  The patient received Kinrix instead of Infanrix, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix - Inappropriate age; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-month-old female patient who received DTPa-IPV (Kinrix) (batch number G9N2M, expiry date 14-APR-2024) for prophylaxis.   On 05-JUN-2023, the patient received Kinrix. On 05-JUN-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix - Inappropriate age). 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 Information: GSK Receipt Date: 22-JUN-2023 The reporter asked for recommendations on this situation. The reporter consented to follow up via email. The reporter reported that the administration of Kinrix to a 12 month-old patient, which led to inappropriate age at vaccine administration.
Age: 45.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: expired dose administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 45-year-old male patient who received HAV (Havrix) (batch number NZ7GR, expiry date 17-JUN-2023) for prophylaxis.   On 22-JUN-2023, the patient received Havrix. On 22-JUN-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: expired dose administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 22-JUN-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via email. The patient received an expired dose of Havrix, which led to expired vaccine used.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Engerix-B pediatric dose administered to an adult; Engerix-B pediatric dose administered to an adult; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 51-year-old female patient who received HBV (Engerix B pediatric) (batch number P49X7, expiry date 07-DEC-2023) for prophylaxis.   On 17-JUN-2023, the patient received the 3rd dose of Engerix B pediatric. On 17-JUN-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Engerix-B pediatric dose administered to an adult) and adult use of a child product (Verbatim: Engerix-B pediatric dose administered to an adult). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK receipt date: 22-Jun-2023 The reporter consented to follow-up via email. An adult patient received third dose of Engerix-B by error, which led to underdose and adult use of a child product.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: patient already received a dose of Boostrix on 24-MAY-2023, and was not supposed to receive that vaccine today; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 26-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number LP2G2, expiry date 19-SEP-2025) for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS VACCINE ACELLULAR + TETANUS VACCINE TOXOID (BOOSTRIX).   On 22-JUN-2023, the patient received the 2nd dose of Boostrix (left arm). On 22-JUN-2023, an unknown time after receiving Boostrix, the patient experienced extra dose administered (Verbatim: patient already received a dose of Boostrix on 24-MAY-2023, and was not supposed to receive that vaccine today). 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 Information: GSK receipt date: 22-Jun-2023 The reporter was patient's wife. The patient was not supposed to receive that vaccine on the day of reporting. The reporter did not ask for consent as the patient was not on the phone. The patient received the 2nd dose of Boostrix, which led to extra dose administered.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Inappropriate schedule of vaccine/ not received her second dose yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose 2 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Inappropriate schedule of vaccine/ not received her second dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 22-Jun-2023 The reporter was the patient. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Patient came down with shingles after receiving SHINGRIX Vaccine/Suspected vaccination failure; Shingles; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Patient came down with shingles after receiving SHINGRIX Vaccine/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). 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.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-JUN-2023 The physician reported that the patient came down with shingles after receiving Shingrix vaccine. Limited information was provided. It was unknown of the gender, age, name of patient. It was unknown after which dose (first or second) the patient came down with shingles. According to the GlaxoSmithKline agent, the reporter had a lengthy conversation about the events. The reporter did not consent to follow-up. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This is 1 of 2 patients case reported by the same reporter for different patient.; Sender's Comments:  US-GSK-US2023AMR088322:Same reporter, Report for 2 patient
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: patient accidentally received 2 doses of Boostrix 1 month; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 26-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS VACCINE ACELLULAR + TETANUS VACCINE TOXOID (BOOSTRIX).   On an unknown date, the patient received the 2nd dose of Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced extra dose administered (Verbatim: patient accidentally received 2 doses of Boostrix 1 month). 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 Information: GSK Receipt Date: 22-JUN-2023 The reporter reported that a patient accidentally received 2 doses of Boostrix 1 month apart and wished to know if there was any information available.  They asked to not have their information registered, did not provide specific information about the vaccines or event, only about the patient. The Vaccine Administration Facility was the same as Primary Reporter. The reporter reported that a patient accidentally received 2 doses of Boostrix 1 month apart, which led to extra dose administered.
Age: 30.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 30 year old patient was administered Infanrix instead of Boostrix; Inappropriate age at vaccine Administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 30-year-old female patient who received DTPa (Infanrix) (batch number 7HM5J, expiry date 13-SEP-2024) for prophylaxis.   On 23-JUN-2023, the patient received Infanrix. On 23-JUN-2023, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: 30 year old patient was administered Infanrix instead of Boostrix) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine Administration). 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 Information: GSK Receipt Date: 23-JUN-2023 The reporter declined to provide initials of patient.  The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up via postal. The reporter stated that a 30-year old patient was administered Infanrix instead of Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Age: 1.83
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Underage administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 22-month-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   In JUN-2023, the patient received Kinrix. In JUN-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Underage administration). 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 Information: GSK Receipt Date: 23-JUN-2023 The reporter could not provide the patient's date of birth or gender.  The reporter noted that the dose of Kinrix was administered 5-6 days ago from the day of reporting.  The reporter did not have lot number or expiration date for product.  No additional information was available. The reporter consented to follow up. The reporter reported that a 22 month old patient was given a dose of Kinrix, which led to inappropriate age at vaccine administration.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose of SHINGRIX on June 8, 2023 and second dose on June 21, 2023; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (3 bouts in the past). Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 21-JUN-2023, the patient received the 2nd dose of Shingrix. On 21-JUN-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: 1st dose of SHINGRIX on June 8, 2023 and second dose on June 21, 2023). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 23-JUN-2023 The reporter is the wife of the patient. The patient received both doses of Shingrix vaccine at the nursing home. The reporter did consent to follow up. The patient received 2nd dose of Shingrix early than recommended time frame, which led to shortening of vaccination schedule.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number DH3SB, expiry date 20-MAY-2024) for prophylaxis.   On 13-APR-2023, the patient received the 1st dose of Shingrix. In MAY-2023, 1 month after receiving Shingrix, the patient experienced shingles (Verbatim: shingles). The outcome of the shingles was resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.   It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-JUN-2023 The reporter stated that a patient received Shingrix and developed shingles a month later.  It was now resolved. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up via postal.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain
Clinical narrative: had a headache; pain all over her body/pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22-JUN-2023, the patient received Shingrix. In JUN-2023, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: had a headache) and general body pain (Verbatim: pain all over her body/pain). The outcome of the headache and general body pain were unknown.   It was unknown if the reporter considered the headache and general body pain to be related to Shingrix.   It was unknown if the company considered the headache and general body pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-JUN-2023 The reporter was a patient's friend. The reporter wished to remain anonymous and provided limited details.  The reporter stated that the patient received Shingrix.  The reporter stated that the patient reported to her that she was in pain all over her body and had a headache.  The reporter did not consent to follow-up.