chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: No AE; PROQUAD was potentially confused with MMR II; PROQUAD was potentially confused with MMR II; a dose of PROQUAD was accidentally co-administered with VARIVAX, 10/3/2024; This spontaneous report was received from a pharmacist and refers to a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 03-OCT-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (anatomical location, strength, lot #, expiry date, and route of administration were not provided); accidentally co-administered with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 ml, administered for prophylaxis (anatomical location, strength, lot #, expiry date, and route of administration were not provided). Measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was potentially confused with rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (Wrong product administered, Product confusion, Accidental overdose). No adverse events.  Lot # is being requested and will be submitted if received.
Age: 47.0
Sex: F
Vaccine: FLU3, MMR
Symptoms: No adverse event, Product preparation error
Clinical narrative: No other adverse effects were reported.; HCP called to report that MMR II was inadvertently reconstituted with FLUARIX ( lot k9xl5 exp 6/30/2025) vaccine instead of the STERILE DILUENT for a 47 yr old female patient today 10/4/2024.  No other adverse effects were reported. See request cases; This spontaneous report was received from a nurse and refers to a 47-year-old female patient. No information on patient's medical history, current conditions and concomitant medications was provided.  On 04-OCT-2024 the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (albumin status: rHA) lot # X019101 and expiration date 16-JUL-2025, 0.5 milliliter for prophylaxis (dose number, route and site of administration were not provided) and was inadvertently reconstituted with influenza vaccine inact split 3v (FLUARIX) lot # k9xl5 and expiration date 30-JUN-2025 (exact dose, dose number, route and site of administration were not provided) instead of  reconstitution with sterile diluent (STERILE DILUENT) (product preparation error). No additional adverse events were reported (no adverse event).
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Gout
Clinical narrative: Gout flare; This non-serious case was reported by a consumer and described the occurrence of gout flare in a 51-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included gout flare. Concomitant products included emtricitabine;tenofovir disoproxil fumarate (Truvada).   On 29-AUG-2024, the patient received Shingles vaccine (right arm). On 30-AUG-2024, 1 days after receiving Shingles vaccine, the patient experienced gout flare (Verbatim: Gout flare). The outcome of the gout flare was not resolved.   It was unknown if the reporter considered the gout flare to be related to Shingles vaccine.     It was unknown if the company considered the gout flare to be related to Shingles vaccine.   Additional Information: GSK Receipt Date-: 15April 2024 Reporter reported that he had Gout flare from 30 Aug 2024 which was still Ongoing. Reporter mentioned that seriousness for Gout flare was not Serious. Reported mentioned that he took other product was Truvada.
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Pruritus
Clinical narrative: Numbness arm; itching; This non-serious case was reported by a consumer and described the occurrence of numbness of upper extremities in a 69-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 16-AUG-2024, the patient received Shingles vaccine. On 20-AUG-2024, 4 days after receiving Shingles vaccine, the patient experienced numbness of upper extremities (Verbatim: Numbness arm) and pruritus (Verbatim: itching). The outcome of the numbness of upper extremities and pruritus were not resolved.   It was unknown if the reporter considered the numbness of upper extremities and pruritus to be related to Shingles vaccine.     It was unknown if the company considered the numbness of upper extremities and pruritus to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-SEP-2024 The patient self-reported this case for herself. The patient had Shingles vaccine and had numbness arm and itching which was ongoing till the time of reporting. The symptoms were not treated.
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations
Clinical narrative: heart was racing for about a day after; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of heart racing in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced heart racing (Verbatim: heart was racing for about a day after). The outcome of the heart racing was resolved (duration 1 day).   It was unknown if the reporter considered the heart racing to be related to Shingrix.     It was unknown if the company considered the heart racing to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-SEP-2024 This case was reported by a patient via interactive digital media. The patient reported that she got Shingrix vaccine and had a reaction that was the heart was racing for about a day after, so opted to not get it again. This case is linked with US2024AMR118375, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Palpitations, Product administered to patient of inappropriate age
Clinical narrative: numerous friends who had shigles before 50; numerous friends who had shigles before 50; had a reaction of heart racing; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in an unspecified number of patients 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 shingles (Verbatim: numerous friends who had shigles before 50), heart racing (Verbatim: had a reaction of heart racing) and inappropriate age at vaccine administration (Verbatim: numerous friends who had shigles before 50). The outcome of the shingles was not resolved and the outcome of the heart racing was resolved (duration 1 day) and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the shingles and heart racing to be related to Shingrix.     It was unknown if the company considered the shingles and heart racing to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-SEP-2024 This case was reported by a patient via interactive digital media. The reporter reported the numerous friends who had shingles before 50, even after getting the vaccine which led to, inappropriate age at vaccine administered. They thought that the vaccine helped make the reaction not as severe. Their doctor did not think they needed the shot but they got it anyway and had a reaction of heart racing for a day following.  Due to this, they did not receive second dose. This was 1 of 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR116846:same reporter, different patient
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; years later still break out; 2 weeks after getting 2nd shot broke out with shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, more than a year after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: years later still break out) and shingles (Verbatim: 2 weeks after getting 2nd shot broke out with shingles). The outcome of the vaccination failure and shingles were not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and shingles to be related to Shingles vaccine. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be related to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles and 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: 27-SEP-2024 This case was reported by a patient via interactive digital media. The patient received 2nd dose of shingles vaccine and 2 weeks after vaccination experienced broke out with shingles again, and still years later still had break out. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK Shingles vaccine (Dose 1 and Dose 2).
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles is around her eyes; still get light shingles outbreaks; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles prior to ever receiving Shingrix). Previously administered products included Zostavax (received Zostavax in the past on an unknown date). Concurrent medical conditions included diabetes and immunocompromised.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Shingles is around her eyes) (serious criteria GSK medically significant) and shingles (Verbatim: still get light shingles outbreaks). The patient was treated with valaciclovir (Valacyclovir). The outcome of the vaccination failure was not reported and the outcome of the ophthalmic herpes zoster and shingles were resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be related to Shingrix and Shingrix. The company considered the ophthalmic herpes zoster to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 28-SEP-2024 and 30-SEP-2024 The patient self-reported this case for herself. The patient received Shingrix 2 series vaccine in 2017, she had still got light shingles outbreaks. The patient was diabetic, due to being immunocompromised, she wanted to know would be she able to get a 2nd round of the 2 series shot, she had shingles twice this year in 2024. The patient began developing shingles when she was 13 or 14 years old. The patient was eventually diagnosed with shingles when she was in her 20's. The patient had developed shingles around her eyes. The patient's shingles was less severe than they used to be, and they would last for weeks.  The patient was treated with Valacyclovir (manufacturer not specified) and an eyedrop and the shingles goes away after 1 week. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingrix.  Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got shingles 2 times; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 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. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got shingles 2 times). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be related to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 29-SEP-2024 The case was received from the patient via interactive digital media. The patient had the vaccine and still got shingles 2 times after both shots. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingrix
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; itchy; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and pruritus (Verbatim: itchy). The outcome of the vaccination failure was not reported and the outcome of the shingles and pruritus were resolved (duration 2 weeks).   It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles and pruritus to be related to Shingles vaccine.   Additional Information: GSK receipt date: 30-SEP-2024 This case was reported by a patient via interactive digital media. The patient had the shingles shots and recently got shingles. It was annoyingly itchy but never any pain. The patient mentioned that it was cleared up in a little over 2 weeks. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm still hurts today after receiving the vaccine two years ago.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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 pain in arm (Verbatim: arm still hurts today after receiving the vaccine two years ago.). The outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK receipt date: 16-SEP-2024 This case was reported the patient via interactive digital media. The patient had a horrible reaction to the shingles shot so asked to was the doctor before get one. The patient arm still hurt today (at the time of reporting) and it was been almost over two years.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: know people who did get it after shot; know people who did get it after shot; This serious case was reported by a consumer via interactive digital media 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: know people who did get it after shot) (serious criteria GSK medically significant) and shingles (Verbatim: know people who did get it after shot). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-SEP-2024 This case was reported by a patient via interactive digital media. The reporter also know people who did get it after shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This was 1 of 3 linked cases, reported by the same reporter.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about details regarding time to onset for shingles , completion of primary vaccination schedule and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingrix. US-GSK-US2024AMR116846:same reporter, different patient
Sex: U
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Improper Storage Error; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) for prophylaxis.   On an unknown date, the patient received FluLaval 2024-2025 season. On an unknown date, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced incorrect storage of drug (Verbatim: Improper Storage Error). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-SEP-2024 The reporter reported that the transport of Flulaval vaccines outside of refrigeration to nursing units in a clear plastic bag not protected from light for administration to patients or staff, which led to incorrect storage of vaccine.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Single component of a two-component product administered
Clinical narrative: administered just the adjuvant component of non-reconstituted Shingrix; administered just the adjuvant component of non-reconstituted Shingrix; Drug dose administration interval too long; 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 51-year-old female patient who received Herpes zoster (Shingrix) (batch number KJ3N3, expiry date 17-APR-2026) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 03rd August 2023, with batch 2YS59, expiry 2nd August 2024).   On 23-SEP-2024, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid). On 23-SEP-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: administered just the adjuvant component of non-reconstituted Shingrix), inappropriate dose of vaccine administered (Verbatim: administered just the adjuvant component of non-reconstituted Shingrix) and drug dose administration interval too long (Verbatim: Drug dose administration interval too long). The outcome of the inappropriate preparation of medication and drug dose administration interval too long were unknown and the outcome of the inappropriate dose of vaccine administered was unchanged.   Additional Information: GSK receipt date: 24-SEP-2024 The reporter was a Medical Assistant calling to report that a different Medical Assistant in the physician's office administered just the adjuvant component of non-reconstituted Shingrix to a patient yesterday, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient received 2nd dose after the scheduled period, which led to lengthening of vaccination schedule. Consented to follow up.
Age: 31.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Administration of an expired dose of Engerix-B; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 31-year-old male patient who received HBV (Engerix B) (expiry date 12-AUG-2024) for prophylaxis.   On 23-SEP-2024, the patient received Engerix B. On 23-SEP-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Administration of an expired dose of Engerix-B). 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: 24-SEP-2024 The pharmacist called and reported that there was an administration of an expired dose of Engerix-B vaccine to a patient, which led to expired vaccine used. The reporter did not provided the lot number of the vaccine
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose 2 was given 5 years later in October 2020.; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in August 2015).   In OCT-2020, the patient received the 2nd dose of Shingrix. In OCT-2020, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Dose 2 was given 5 years later in October 2020.). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 24-SEP-2024 The patient self-reported this case. She received 2nd dose of Shingrix vaccine 5 years later after 1st dose. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: already received a prior Arexvy dose/Extra dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 79-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 3G55B, expiry date 30-JUN-2025) for prophylaxis.   Previously administered products included Arexvy (received first dose of Arexvy vaccine 19th October 2023).   On 24-SEP-2024, the patient received the 2nd dose of Arexvy. On 24-SEP-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: already received a prior Arexvy dose/Extra dose). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 24-SEP-2024 The pharmacist reported that the patient received the Arexvy vaccine and then remembered that she already received a prior Arexvy dose in another facility. The reporter did not have lot number or expiration date for the first dose.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: received Shingrix vaccine reconstituted with another diluent different than AS01B adjuvant solution; received Shingrix vaccine reconstituted with another diluent different than AS01B adjuvant solution; This non-serious 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 50-year-old female patient who received Herpes zoster (Shingrix) (batch number E3XT9, expiry date 19-JUN-2026) for prophylaxis.   On 24-SEP-2024, the patient received Shingrix. On 24-SEP-2024, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: received Shingrix vaccine reconstituted with another diluent different than AS01B adjuvant solution) and inappropriate dose of vaccine administered (Verbatim: received Shingrix vaccine reconstituted with another diluent different than AS01B adjuvant solution). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 25-SEP-2024 The other health professional reported they have a medical assistant who administered only one of the 2 vials of Shingrix, she administered the powder portion of the Shingrix vaccine and mixed with a regular diluent and not with the diluent provided in the box with the vaccine. The patient received Shingrix vaccine reconstituted with another diluent different than AS01B adjuvant solution which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation issue, Underdose
Clinical narrative: We had a patient that only got the diluent part of the vaccine; Only diluent administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA982A, expiry date 31-OCT-2024) for prophylaxis.   On 21-SEP-2024, the patient received Menveo. On 21-SEP-2024, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: We had a patient that only got the diluent part of the vaccine) and inappropriate dose of vaccine administered (Verbatim: Only diluent administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 25-SEP-2024 The patient had that only got the diluent part of the vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose of Shingrix on August 9th 2024 but then an early second dose was given on August 21st 2024.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number J327J, expiry date 19-JUN-2026) and (batch number T4HR9, expiry date 16-JUL-2026) for prophylaxis.   Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix).   On 21-AUG-2024, the patient received the 2nd dose of Shingrix. On 21-AUG-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: first dose of Shingrix on August 9th 2024 but then an early second dose was given on August 21st 2024.). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 25-SEP-2024 and 26-SEP-2024 The pharmacist explained that a patient received the first dose of Shingrix but then an early second dose was given. the patient received the 2nd dose of Shingrix earlier than the recommended interval, which led to shortening of vaccine schedule. The reporter mentioned they did not know if patient was immunocompromised.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: they gave her second dose, they gave it too early; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix).   On 22-NOV-2021, the patient received the 2nd dose of Shingrix. On 22-NOV-2021, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: they gave her second dose, they gave it too early). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 25-SEP-2024 The pharmacist reported that the patient received the first dose and second dose of Shingrix vaccine too early which led to shortening of vaccinations schedule. Due to the above schedule another adverse event was included since it had elapsed more than 6 months (3 years since last dose).
Age: 85.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: he had an Arexvy shot in March 2024, and had another one yesterday; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 85-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included Arexvy (received 1st dose of Arexvy vaccine in March 2024).   On 24-SEP-2024, the patient received the 2nd dose of Arexvy. On 24-SEP-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: he had an Arexvy shot in March 2024, and had another one yesterday). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 25-SEP-2024 The patient was the reporter. The reporter reported that he forgot he had an Arexvy shot in March 2024, and had another one day before reporting which led to extra dose administered. The reporter consented to follow up.
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: adult dose of Havrix was given to a 15-year-old patient by mistake; adult dose of Havrix was given to a 15-year-old patient by mistake; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 15-year-old female patient who received HAV (Havrix adult) (batch number 3J9G4, expiry date 30-AUG-2025) for prophylaxis.   On 23-JUL-2024, the patient received the 1st dose of Havrix adult. On 23-JUL-2024, an unknown time after receiving Havrix adult, the patient experienced overdose (Verbatim: adult dose of Havrix was given to a 15-year-old patient by mistake) and adult product administered to child (Verbatim: adult dose of Havrix was given to a 15-year-old patient by mistake). The outcome of the overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt Date: 25-SEP-2024 The pharmacist reported that the adult dose of Havrix was given to the child patient by mistake which led to Overdose and Adult product administered to child. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only adjuvant administered/administered without being reconstituted; only adjuvant administered/administered without being reconstituted; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number BT59B, expiry date 10-AUG-2026) for prophylaxis.   On 25-SEP-2024, the patient received the 1st dose of Shingrix. On 25-SEP-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: only adjuvant administered/administered without being reconstituted) and inappropriate dose of vaccine administered (Verbatim: only adjuvant administered/administered without being reconstituted). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 25-SEP-2024 The reporter explained that a patient received a first dose of Shingrix today (On the day of reporting) but only the adjuvant component was administered without being reconstituted. which led to, inappropriate preparation of medication and inappropriate dose of vaccine administered.  The reporter reported that the caller explained she cannot provide any patient demographics. The vaccine administration facility was the same as primary reporter. The reporter consented to the follow up.
Age: 5.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: overdose; an adult dose of Engerix-B was administered to a 5-year-old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 5-year-old female patient who received HBV (Engerix B adult) (batch number 4H297, expiry date 06-APR-2025) for prophylaxis.   On 10-SEP-2024, the patient received Engerix B adult. On 10-SEP-2024, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: overdose) and adult product administered to child (Verbatim: an adult dose of Engerix-B was administered to a 5-year-old patient). The outcome of the overdose and adult product administered to child were unknown.   Additional Information: GSK receipt date: 25-SEP-2024 The reporter reported that the adult dose of Engerix B was administered to a child which led to, overdose and adult product administered to child. The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never received second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   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: never received second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 25-SEP-2024 The reporter reported that the patient got one dose in 2019, then she never had received the second dose yet, and they want to know if it was okay to gave the second dose or did she need to start over. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to the follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pruritus, Urticaria
Clinical narrative: feeling nauseated; her scalp was itching; she woke up with hives on her neck; her arm was sore that evening; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included multiple allergies.   On 23-SEP-2024, the patient received the 1st dose of Shingrix (left arm). On 23-SEP-2024, less than a day after receiving Shingrix, the patient experienced pain in arm (Verbatim: her arm was sore that evening). On 26-SEP-2024, the patient experienced nausea (Verbatim: feeling nauseated), itchy scalp (Verbatim: her scalp was itching) and hives (Verbatim: she woke up with hives on her neck). The outcome of the pain in arm was unknown and the outcome of the nausea, itchy scalp and hives were not resolved.   It was unknown if the reporter considered the pain in arm, nausea, itchy scalp and hives to be related to Shingrix.     It was unknown if the company considered the pain in arm, nausea, itchy scalp and hives to be related to Shingrix.   Additional Information: GSK receipt date: 26-SEP-2024 The reporter was the patient.  The patient had received the 1st dose of Shingrix vaccine on Monday at a local pharmacy.  The patient reported that her arm was sore that evening, and this (on the day of reporting) morning she woke up with hives on her neck, and stated her scalp was itching.  The patient was sensitivity to a lot a things.  The patient reported that for the past 4 years she has been getting allergy shots, she took 2 shots per week for 1 year, and now got one shot per week.  Patient also reported she took and oral medication for allergies.  Patient reported that she was considering going to an urgent care because she was feeling nauseated. Customer had to disconnect.  No additional information was reported. Did not consent to follow-up.
Age: 11.0
Sex: M
Vaccine: DTPPVHBHPB, TDAP
Symptoms: Extra dose administered
Clinical narrative: inadvertently also administered the patient a dose of Vaxelis on the same day; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 11-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number X4494, expiry date 20-OCT-2026) for prophylaxis.   Co-suspect products included Vaxelis for prophylaxis.   On 23-SEP-2024, the patient received Boostrix and Vaxelis. On 23-SEP-2024, an unknown time after receiving Boostrix and an unknown time after receiving Vaxelis, the patient experienced accidental overdose (Verbatim: inadvertently also administered the patient a dose of Vaxelis on the same day). The outcome of the accidental overdose 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: 26-SEP-2024 Medical Assistant reported she administered a dose of Boostrix to a patient on 23Sep2024, and inadvertently also administered the patient a dose of Vaxelis on the same day, which contains DTaP, which led to accidental overdose. The Vaccine Administration Facility was the same as Primary Reporter
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Arexvy second dose on 9/19/2024; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 65-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 2FP37, expiry date 01-JUL-2025) for prophylaxis.   Previously administered products included Arexvy (received first dose on 24-SEP-2023, lot number 7L273).   On 19-SEP-2024, the patient received the 2nd dose of Arexvy. On 19-SEP-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: Arexvy second dose on 9/19/2024). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 26-SEP-2024 The pharmacist reported that a patient received Arexvy first dose and Arexvy second dose, which led to extra dose administered. The Vaccine Administration Facility was the same as Primary Reporter.
Age: 82.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Second dose of Arexvy vaccine given to the patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 82-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 7427S, expiry date 12-OCT-2025) for prophylaxis.   Previously administered products included Arexvy (received 1st dose on an unknown date).   On 26-SEP-2024, the patient received the 2nd dose of Arexvy. On 26-SEP-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: Second dose of Arexvy vaccine given to the patient). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 26-SEP-2024 The healthcare professional reported that the 2nd dose of Arexvy vaccine was given to the patient, which led to extra dose administered. The reporter asked do GSK had any studies on a second dose of Arexvy vaccine given to the patient.
Sex: U
Vaccine: DTAPHEPBIP, DTAPIPV, TDAP
Symptoms: Product storage error
Clinical narrative: product Storage Error/Kinrix, Pediarix, Boostrix were exposed to 57 F for an unknown amount of time; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa-IPV (Kinrix) (batch number 3RT93, expiry date 03-APR-2026) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) (batch number 9P329, expiry date 06-MAR-2026) for prophylaxis and DTPa (Reduced antigen) (Boostrix) (batch number NR5DX, expiry date 02-FEB-2026) for prophylaxis.   On an unknown date, the patient received Kinrix, Pediarix and Boostrix. On an unknown date, an unknown time after receiving Kinrix, Pediarix and Boostrix, the patient experienced incorrect storage of drug (Verbatim: product Storage Error/Kinrix, Pediarix, Boostrix were exposed to 57 F for an unknown amount of time). The action taken with Pediarix was unknown. The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-SEP-2024 The reporter reported that Kinrix, Pediarix, Boostrix vaccine were exposed to 57 Fahrenheit for an unknown amount of time and the reporter mentioned that they lost their documentation from the beginning of May to the beginning of June. She stated that some of the vaccines had been administered which led to incorrect storage of drug but she did not had a number of patients at the time of reporting. The vaccine administration facility was the same as primary reporter.
Age: 46.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Accidental underdose; We had a patient come in 46 years old, he was coming in for his 3rd Hep B vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 46-year-old male patient who received HBV (Engerix B pediatric) (batch number ZP72S, expiry date 15-DEC-2024) for prophylaxis.   On 27-SEP-2024, the patient received the 3rd dose of Engerix B pediatric. On 27-SEP-2024, an unknown time after receiving Engerix B pediatric, the patient experienced accidental underdose (Verbatim: Accidental underdose) and adult use of a child product (Verbatim: We had a patient come in 46 years old, he was coming in for his 3rd Hep B vaccine). The outcome of the accidental underdose and adult use of a child product 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: 27-SEP-2024 The reporter had a patient come in 46 years old, he was coming in for his 3rd Hepatitis B vaccine (Engerix-B), he was given the 10 mcg dose, instead of the 20 mcg, the providers just want to know, could they gave a 2nd 10 mcg dose to equal to 20 or was he fine which led to accidental underdose and adult use of a child product. The vaccine administration facility was the same as primary reporter.
Age: 60.0
Sex: F
Vaccine: RSV
Symptoms: Product preparation error
Clinical narrative: patient was administered an Arexvy vaccine that was reconstituted with an incorrect diluent, not the supplied adjuvant.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 60-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced wrong solution used in drug reconstitution (Verbatim: patient was administered an Arexvy vaccine that was reconstituted with an incorrect diluent, not the supplied adjuvant.). The outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 27-SEP-2024 The pharmacist reports a patient was administered an Arexvy vaccine that was reconstituted with an incorrect diluent not the supplied adjuvant, which led wrong solution used in drug reconstitution. The reporter did not consent to follow-up.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: administered a dose of Kinrix that had expired; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 7-year-old female patient who received DTPa-IPV (Kinrix) (batch number PP9L5, expiry date 16-OCT-2021) for prophylaxis.   On 25-OCT-2021, the patient received Kinrix. On 25-OCT-2021, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: administered a dose of Kinrix that had expired). 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: 27-SEP-2024 The nurse reported, she had just noticed that a patient was administered a dose of Kinrix that had expired which led to expired vaccine used. The vaccine was administered 9 days after the expiration date.  The Vaccine Administration Facility was the same as Primary Reporter