chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Bell's palsy, Facial paralysis, Fear
Clinical narrative: Facial droop; Left sided Bell's palsy; This serious case was reported by a consumer and described the occurrence of facial droop in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number Y433H) for prophylaxis.   Concomitant products included acetaminophen-codeine# 4, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (Adderall), fluoxetine, fluticasone propionate, ibuprofen, lamotrigine, ethinyloestradiol, ferrous fumarate, norethisterone acetate (Lo Loestrin Fe), metoprolol and metronidazole.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced facial droop (Verbatim: Facial droop) (serious criteria GSK medically significant and clinically significant/intervention required) and bell's palsy (Verbatim: Left sided Bell's palsy) (serious criteria GSK medically significant).  The patient was treated with prednisone (Deltasone) and valaciclovir hydrochloride (Valtrex). The outcome of the facial droop was resolved and the outcome of the bell's palsy was not reported.   It was unknown if the reporter considered the facial droop and bell's palsy to be related to Shingrix.     It was unknown if the company considered the facial droop and bell's palsy to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-SEP-2023 The reporter reported that the seriousness for facial droop was intervention required. The reporter stated that he or she was afraid to get new immunizations.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Kidney infection, Pain, Vaccination failure
Clinical narrative: fully vaccinated, had shingles/Suspected vaccination failure; Kidney infection; Shingles on back; Painful; 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: fully vaccinated, had shingles/Suspected vaccination failure) (serious criteria GSK medically significant), kidney infection (Verbatim: Kidney infection) (serious criteria GSK medically significant), shingles (Verbatim: Shingles on back) and pain (Verbatim: Painful).  The outcome of the vaccination failure was unknown and the outcome of the kidney infection, shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, kidney infection, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, kidney infection, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2023 This case was reported via interactive digital media. It was reported that patient had shingles, third time and was fully vaccinated.  They were painful and were present on patient's back this time. The patient had shingles right after kidney infection. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Meningitis
Clinical narrative: Meningitis; This serious case was reported by a consumer via interactive digital media and described the occurrence of meningitis 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 meningitis (Verbatim: Meningitis) (serious criteria GSK medically significant).The outcome of the meningitis was not reported.   The reporter considered the meningitis to be related to Shingles vaccine.     The company considered the meningitis to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2023 This case was reported by a patient via interactive digital media. The patient stated that he/she got meningitis from this Shingles vaccine. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; 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.   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) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 17-SEP-2023 This case was reported by a patient via interactive digital media. The patient stated that, he/she was stupid enough to take that vaccine (Shingles vaccine) and got shingles just like that. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles).The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 17-SEP-2023 This case was reported by a patient via interactive digital media. The patient got vaccinated with Shingles vaccine, then got the shingles a few years later.  The reporter further stated that the vaccine was not always the answer.  This case was considered as suspected vaccination failure since the detail regarding primary vaccination schedule and laboratory confirmation of shingles was unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: FLUX, TDAP
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine and Tdap Vaccine. On an unknown date, an unknown time after receiving Flu vaccine and Tdap Vaccine, the patient experienced allergic reaction (Verbatim: Allergic reaction).The outcome of the allergic reaction was not reported.   It was unknown if the reporter considered the allergic reaction to be related to Flu vaccine and Tdap Vaccine.   It was unknown if the company considered the allergic reaction to be related to Flu vaccine and Tdap Vaccine.   Additional Information: GSK Receipt Date: 12-SEP-2023 The reporter called in to medical information to ask if it was recommended that patients that had prior vaccine reactions to not have Arexvy administered in an outpatient pharmacy setting. The reporter had a patient that had prior allergic reaction to flu and tdap vaccines. The reporter did not know what component of the vaccine that patient reacted to or which brand the vaccines were. No information about the reactions were reported. The reporter did not consent to follow up.
Sex: U
Vaccine: RVX
Symptoms: Fatigue
Clinical narrative: little fatigue; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced fatigue (Verbatim: little fatigue).  The outcome of the fatigue was resolved.   It was unknown if the reporter considered the fatigue to be related to RSV vaccine.     It was unknown if the company considered the fatigue to be related to RSV vaccine.   Additional Information: GSK receipt date: 13-Sept-2023 The case was received from the patient via (social media) interactive digital media. The patient just got the shot and a little fatigue. The patient was now fine. The follow-up could not be possible as no contact detail was available.
Sex: U
Vaccine: RVX
Symptoms: Pain in extremity
Clinical narrative: A sore arm; 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 RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On 13-SEP-2023, the patient received RSV vaccine. In SEP-2023, less than a day after receiving RSV vaccine, the patient experienced pain in arm (Verbatim: A sore arm).  The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to RSV vaccine.     It was unknown if the company considered the pain in arm to be related to RSV vaccine.   Additional Information: GSK receipt date: 14-Sept-2023  The case was received from the patient via (social media) interactive digital media. The patient just got the RSV vaccine one day before the vaccination and had no side effects except a sore arm.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: husband is suffering terrible to this week from shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a male 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 shingles (Verbatim: husband is suffering terrible to this week from shingles).  The outcome of the shingles was not resolved.   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: 17-SEP-2023 This case was reported by a patient's wife via interactive digital media. The reporter stated that her husband suffering terrible to this from shingles. The reporter and the patient both received 1st shots two months ago. The vaccine did not keep the patient from getting shingles. The patient had a very bad case. Follow-up was not possible as no contact details were available.
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Mobility decreased, Muscular weakness, Pain
Clinical narrative: still have a lot of pain; muscle weakness; hardly lift my right hand above my shoulder/can barely lift anything; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and PNEUMONIA VACCINE. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: still have a lot of pain), muscle weakness (Verbatim: muscle weakness) and mobility decreased (Verbatim: hardly lift my right hand above my shoulder/can barely lift anything).The outcome of the pain and muscle weakness were not resolved and the outcome of the mobility decreased was not reported.   It was unknown if the reporter considered the pain, muscle weakness and mobility decreased to be related to Shingles vaccine.   It was unknown if the company considered the pain, muscle weakness and mobility decreased to be related to Shingles vaccine.   Additional Information: GSK receipt date: 17-SEP-2023 This case was reported by a patient via interactive digital media. The patient got his/her first Shingles vaccine over three months ago and he/she also still had a lot of pain and muscle weakness. The patient got the Pneumonia vaccine also and now he/she afraid to get second dose of Shingles vaccine. The patient could hardly lift his/her right hand above his/her shoulder and could barely lift anything, so there was no way she could take the 2nd dose of vaccine in his/her left arm and would not be able to function.  It was unknown if the reporter considered the pain, muscle weakness and mobility decreased to be related to Pneumonia vaccine. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: administration of expired Fluarix vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 953Y2, expiry date 30-JUN-2023) for prophylaxis.   On 12-SEP-2023, the patient received Fluarix Quadrivalent 2022-2023 season. On 12-SEP-2023, an unknown time after receiving Fluarix Quadrivalent 2022-2023 season, the patient experienced expired vaccine used (Verbatim: administration of expired Fluarix vaccine).  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: 12-SEP-2023    The pharmacist reported the administration of expired Fluarix vaccine to patient who was administered 2022-2023 Fluarix instead of Fluarix for 2023-2024 which led to expired vaccine used. The reporter consented to follow up. This case was one of 9 cases, reported by same reporter.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: expired Engerix-B was administered to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 21-year-old female patient who received HBV (Engerix B) (batch number 39TZ2, expiry date 07-SEP-2023) for prophylaxis.   On 12-SEP-2023, the patient received Engerix B. On 12-SEP-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: expired Engerix-B was administered to a patient).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 12-SEP-2023 The nurse reported an patient received a dose of  Engerix-B on 12th September 2023,which was expired on 7th September 2023, which led to expired vaccine used. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pityriasis rosea
Clinical narrative: she experienced Pityriasis rosea on her back; This non-serious case was reported by a other health professional via call center representative and described the occurrence of pityriasis rosea in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 06-AUG-2023, the patient received the 1st dose of Shingrix. In JUN-2023, several hours after receiving Shingrix, the patient experienced pityriasis rosea (Verbatim: she experienced Pityriasis rosea on her back).  The outcome of the pityriasis rosea was resolved.   It was unknown if the reporter considered the pityriasis rosea to be related to Shingrix.     It was unknown if the company considered the pityriasis rosea to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-SEP-2023 Internal contact was the reporter, stated that a nurse practioner reported to him an adverse event associated with Shingrix. The patient was a 66 year old female. The patient received first dose of Shingrix and few hours after administration she experienced Pityriasis rosea on her back. The adverse event was reported to the nurse practioner on 9th June 2023. In 2023, the Pityriasis rosea lasted approximately one month. The patient reported that she had never experienced Pityriasis rosea prior to vaccination with Shingrix. The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Dizziness
Clinical narrative: Dizziness; This non-serious case was reported by a other health professional via call center representative and described the occurrence of dizziness in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   In SEP-2023, the patient received Arexvy. In SEP-2023, 1 hr after receiving Arexvy, the patient experienced dizziness (Verbatim: Dizziness). The outcome of the dizziness was not resolved.   It was unknown if the reporter considered the dizziness to be related to Arexvy.     It was unknown if the company considered the dizziness to be related to Arexvy.  Additional Information: GSK Receipt Date: 12-SEP-2023 and 16-SEP-2023 A retired physician assistant called to report that his wife (patient) received the Arexvy vaccine a week ago (from the reporting date) and about 1 hour after she got the shot she got dizzy. The reporter mentioned that his wife had continued with dizziness since last week and asked if, during the clinical trials, patients reported dizziness after vaccination and, if so, how long did this reaction last or how it was treated. The dizziness condition that the patient presented had not diminished, and that dizziness was still present (at the time of reporting). The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: the patient did not receive a full dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a male 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 incomplete dose administered (Verbatim: the patient did not receive a full dose).The outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 13-SEP-2023 The reporter reported that while she was administering a dose of Shingrix, some of the vaccine squirted out of the junction between the needle and syringe and the patient did not receive a full dose, which led to incomplete dose administered. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Maladmisnitration Boostrix after expiration date; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 20-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number HF2YA, expiry date 15-JUL-2023) for prophylaxis.   On 12-SEP-2023, the patient received Boostrix. On 12-SEP-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Maladmisnitration Boostrix after expiration date).The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 13-SEP-2023 The expired Boostrix was administered to the patient , which led to expired vaccine used. The reporter consented to follow up via email.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Muscle spasms, Product administered to patient of inappropriate age, Tremor, Wrong product administered
Clinical narrative: feeling uneasy; Shakiness; Adolescent patient received shingrix; Cramping in forearm (injected arm) from the elbow down; This non-serious case was reported by a consumer via call center representative and described the occurrence of cramp of limb in a adolescent female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12-SEP-2023, the patient received Shingrix (unknown arm). On 12-SEP-2023, less than a day after receiving Shingrix, the patient experienced cramp of limb (Verbatim: Cramping in forearm (injected arm) from the elbow down) and inappropriate age at vaccine administration (Verbatim: Adolescent patient received shingrix). On 13-SEP-2023, the patient experienced feeling abnormal (Verbatim: feeling uneasy) and tremor (Verbatim: Shakiness).  The outcome of the cramp of limb was resolved and the outcome of the feeling abnormal, tremor and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the cramp of limb, feeling abnormal and tremor to be related to Shingrix.     It was unknown if the company considered the cramp of limb, feeling abnormal and tremor to be related to Shingrix.   Additional Information: GSK Receipt date: 13-SEP-2023 The patient self-reported this case. Later that evening of vaccination, the patient experienced cramping in the forearm (the injected arm), from the elbow down.  This cramping went away overnight.  This morning (on reporting day), the patient reported shakiness and feeling uneasy.   The reporter stated that according to the chart, she received Shingrix, however the patient though she was getting the Flu vaccine, and the patient was going to contact her doctor to clarify what she received.  The reporter did not provide further details as the patient wanted to check with doctors' office to confirm which vaccine the patient received. Adolescent patient received Shingrix which led to inappropriate age at vaccine administration. The reporter did not consent to follow up.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Circumstance or information capable of leading to medication error, Incorrect dose administered
Clinical narrative: child got his hands free and not all of the Havrix vaccine was injected; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a 26-month-old male patient who received HAV (Havrix 720 Junior) (batch number 3397t, expiry date 30-NOV-2023) for prophylaxis.   On 12-SEP-2023, the patient received Havrix 720 Junior. On 12-SEP-2023, an unknown time after receiving Havrix 720 Junior, the patient experienced incomplete dose administered (Verbatim: child got his hands free and not all of the Havrix vaccine was injected).  The outcome of the incomplete 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:13-SEP-2023 The registered nurse reported that a child got his hands free and not all of the Havrix vaccine was injected, which led to incomplete dose administered. The reporter consented to follow up.
Age: 48.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: expired Hiberix vaccine today; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 48-year-old female patient who received Hib (Hiberix) (batch number J7CS5, expiry date 01-APR-2023) for prophylaxis.   On 13-SEP-2023, the patient received Hiberix (intramuscular, right arm). On 13-SEP-2023, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: expired Hiberix vaccine today).The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 13-SEP-2023 The reporter called to report that she gave a patient an expired Hiberix vaccine , which led to expired vaccine used. The reporter consented to follow up.
Age: 0.42
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a 6 month old patient was inadvertently administered a Kinrix; administered a Kinrix dose on 8/31/23 in the Left Thigh, instead of the intended Pentacel; kinrix received as 2nd dose of Dtap; 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 6-month-old female patient who received DTPa-IPV (Kinrix) (batch number T343J, expiry date 25-JAN-2025) for prophylaxis.   Previously administered products included Pentacel vaccine (received first dose on an unknown date).   On 31-AUG-2023, the patient received Kinrix (left thigh). On 31-AUG-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a 6 month old patient was inadvertently administered a Kinrix), wrong vaccine administered (Verbatim: administered a Kinrix dose on 8/31/23 in the Left Thigh, instead of the intended Pentacel) and inappropriate schedule of vaccine administered (Verbatim: kinrix received as 2nd dose of Dtap).  The outcome of the inappropriate age at vaccine administration, wrong vaccine administered and inappropriate schedule of 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: 13-Sept-2023 Medical assistant called to inquired that how to proceed. Did not consent to follow-up. Kinrix was inadvertently administered as Dtap 2nd dose to a patient instead of Pentacel at an inappropriate age, which led to inappropriate age at vaccine administration, wrong vaccine administered and inappropriate schedule of vaccine administered.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Incorrect route of product administration, Pain
Clinical narrative: soreness; redness; Muscle was missed and went SQ; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of pain in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 7532P, expiry date 18-AUG-2024) for prophylaxis.   On 13-SEP-2023, the patient received Shingrix (subcutaneous). On 13-SEP-2023, less than a day after receiving Shingrix, the patient experienced pain (Verbatim: soreness), erythema (Verbatim: redness) and intramuscular formulation administered by other route (Verbatim: Muscle was missed and went SQ).The outcome of the pain and erythema were not resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the pain and erythema to be related to Shingrix.    It was unknown if the company considered the pain and erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-SEP-2023 The reporter wanted to know if Shingrix was not administered IM (intramuscular) and the muscle was missed and went SQ, which led to intramuscular formulation administered by other route. On 13th September 2023, the patient still had redness and soreness. The reporter consented to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash papular, Rash pruritic, Urticaria
Clinical narrative: she developed itching rash with bumps/itching rash with bumps on bilateral arms close to her elbows and bilateral inner thighs behind the knees; she developed itching rash with bumps/itching rash with bumps on bilateral arms close to her elbows and bilateral inner thighs behind the knees; Urticaria (itchy bumps / rash); skin rash on her two arms; This non-serious case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12-SEP-2023, the patient received the 1st dose of Shingrix (left deltoid). On 13-SEP-2023, 1 days after receiving Shingrix, the patient experienced itchy rash (Verbatim: she developed itching rash with bumps/itching rash with bumps on bilateral arms close to her elbows and bilateral inner thighs behind the knees), papular rash (Verbatim: she developed itching rash with bumps/itching rash with bumps on bilateral arms close to her elbows and bilateral inner thighs behind the knees), urticaria (Verbatim: Urticaria (itchy bumps / rash)) and rash (Verbatim: skin rash on her two arms). The outcome of the itchy rash, papular rash and urticaria were not resolved and the outcome of the rash was not reported.   It was unknown if the reporter considered the itchy rash, papular rash, urticaria and rash to be related to Shingrix.     It was unknown if the company considered the itchy rash, papular rash, urticaria and rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-SEP-2023 The reporter called on behalf of her family member stated that his cousin (patient) received the Shingrix and this morning (reporting day) she developed itching rash with bumps on bilateral arms close to her elbows, left hand, and bilateral inner thighs behind the knees.  The patient also developed skin rash on her two arms on reporting day morning. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: apperantly they received 3 shingrix so far; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: apperantly they received 3 shingrix so far).  The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 13-SEP-2023 The reporter was working and a pateint walked in and apperantly they received 3 shingrix so far. The reporter consented to follow up. The provider had no information on the patient. The patient received 3rd dose of Shingrix, which led to extra dose administered.
Sex: F
Vaccine: RSV
Symptoms: Injection site swelling
Clinical narrative: inspected the injected arm of the female patient and described it as "a gnarly golf ball size" bump/bump at injection site (arm); This non-serious case was reported by a other health professional via sales rep and described the occurrence of injection site swelling in a elderly female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy (unknown arm). On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site swelling (Verbatim: inspected the injected arm of the female patient and described it as "a gnarly golf ball size" bump/bump at injection site (arm)).  The outcome of the injection site swelling was unknown.   It was unknown if the reporter considered the injection site swelling to be related to Arexvy.     It was unknown if the company considered the injection site swelling to be related to Arexvy.   Additional Information: GSK Receipt Date: 13-SEP-2023 GSK field representative spoken to a physician's assistant regarding a female patient who received AREXVY.  The reporter did not have the patient's initials or date of birth. The patient was 65 years of age or older (elderly). The reporter did not have the lot number of the AREXVY that was administered. The vaccine was administered at a pharmacy and not at the provider's office. The physician's assistant inspected the injected arm of the patient and described it as "a gnarly golf ball size" bump.  The physician's assistant was not sure if the bump was due to the AREXVY medication itself or if it was "the pharmacist jabbing her arm"  that was possible improper injection technique. The reporter was not informed that GSK safety would contact and she was unaware. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: 58 year old patient received a 0.5 mL pediatric dose of Havrix instead of the full Adult dose; 58 year old patient received a 0.5 mL pediatric dose of Havrix instead of the full Adult dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 58-year-old female patient who received HAV (Havrix pediatric) (batch number 2Y534, expiry date 02-MAR-2025) for prophylaxis.   On 13-SEP-2023, the patient received Havrix pediatric (right deltoid) .5 ml. On 13-SEP-2023, an unknown time after receiving Havrix pediatric, the patient experienced underdose (Verbatim: 58 year old patient received a 0.5 mL pediatric dose of Havrix instead of the full Adult dose) and adult use of a child product (Verbatim: 58 year old patient received a 0.5 mL pediatric dose of Havrix instead of the full Adult dose).The outcome of the 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: 13-SEP-2023 The reporter was clinic coordinator called to inquire that how to proceed. The reporter reported that a patient received a 0.5 mL pediatric dose of Havrix instead of the full adult dose, which led to underdose and adult use of a child product. The reporter did not consent to follow-up.
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: where 2 doses were given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number M7S2F, expiry date 12-OCT-2024) for prophylaxis.   On 12-SEP-2023, the patient received Arexvy. On 12-SEP-2023, an unknown time after receiving Arexvy, the patient experienced overdose (Verbatim: where 2 doses were given). The outcome of the overdose was unknown.   Additional Information: GSK Receipt Date: 13-SEP-2023. An anonymous healthcare professional called in to request information about the protocol for the scenario where 2 doses were given.  They provided partial information about vaccine, event and patient. Follow-up accepted. The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. The patient received 2 doses of Arexvy at a time, which lead to overdose.
Age: 7.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administration of Kinrix to a patient after his 7th birthday; 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 7-year-old male patient who received DTPa-IPV (Kinrix) (batch number T343J, expiry date 25-JAN-2025) for prophylaxis.   On 11-SEP-2023, the patient received Kinrix. On 11-SEP-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: administration of Kinrix to a patient after his 7th birthday).  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: 13-SEP-2023 The Healthcare professional called and reported administration of Kinrix to a patient after his 7th birthday which led to inappropriate age at vaccine administration. The Healthcare professional asked if this dose was considered valid. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023126111:same reporter
Sex: U
Vaccine: RSV
Symptoms: Accidental exposure to product, Exposure via skin contact, Incorrect dose administered, Product leakage, Underdose
Clinical narrative: large portion leaked; large portion leaked out on to the arm; large portion leaked out on to the arm; 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 RSVPreF3 adjuvanted (Arexvy) (batch number h2522, expiry date 09-DEC-2024) for prophylaxis.   On 13-SEP-2023, the patient received Arexvy. On 13-SEP-2023, an unknown time after receiving Arexvy, the patient experienced incomplete dose administered (Verbatim: large portion leaked), inadvertent exposure to vaccine (Verbatim: large portion leaked out on to the arm) and exposure via skin contact (Verbatim: large portion leaked out on to the arm).  The outcome of the incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact were unknown.   Additional Information: GSK Receipt Date: 13-SEP-2023 The pharmacist reported that a patient received Arexvy on day of reporting and while receiving the vaccine a large portion leaked out on to the arm, seemed like a lot which led to inadvertent exposure to vaccine, exposure via skin contact and incomplete dose administered. The reporter consented to follow up.
Sex: U
Vaccine: FLU4, MENB, RV1
Symptoms: Product storage error
Clinical narrative: box has been ripped off, so the vials are exposed to the fridge light; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Rota (Rotarix liquid formulation) (batch number 732L4, expiry date 25-APR-2025) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis and Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient received Rotarix liquid formulation, Bexsero and FluLaval Quadrivalent. On an unknown date, an unknown time after receiving Rotarix liquid formulation, Bexsero and FluLaval Quadrivalent, the patient experienced incorrect storage of drug (Verbatim: box has been ripped off, so the vials are exposed to the fridge light).  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: 13-Sept-2023 The health care professional stated that their vaccine fridge had a light inside that stays on all the time.  The top of the Rotarix (liquid only formulation) box has been ripped off, so the vials were exposed to the fridge light and the product had been administered.  Upon further questioning, the facility purposefully ripped the tops off the boxes to make it easier for staff to retrieve the product.  In addition to the Rotarix vaccines, the facility also had FluLaval QIV and Bexsero vaccines that had been exposed to light despite product label instructions to protect from light.  The reporter knew that the vaccines had been administered, but she did not have any information on how many doses, dates of administration, or patient information at the time of call. The Vaccine Administration Facility was the same as Primary Reporter. The reporter gave permission for follow-up. The patient received Rotarix liquid formulation, Bexsero and Flulaval QIV after the temperature excursion, which led to incorrect storage of drug.
Sex: F
Vaccine: RSV
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered the adjuvant portion of Arexvy without reconstituting; administered the adjuvant portion of Arexvy without reconstituting; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a 78-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 08-SEP-2023, the patient received Arexvy. On 08-SEP-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: administered the adjuvant portion of Arexvy without reconstituting) and inappropriate dose of vaccine administered (Verbatim: administered the adjuvant portion of Arexvy without reconstituting).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 13-Sept-2023 and 14-Sept-2023 The case was received from nurse of the department of health. The Vaccine Administration Facility was the same as Primary Reporter. Any follow up should go to the health care professional in details above, or the field representative. The patient was administered the adjuvant portion of Arexvy without reconstituting it with the antigen portion of the vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administration of only diluent portion of Menveo; administration of only diluent portion 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 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA960A, expiry date 31-OCT-2023) for prophylaxis.   On 12-SEP-2023, the patient received Menveo. On 12-SEP-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: administration of only diluent portion of Menveo) and inappropriate dose of vaccine administered (Verbatim: administration of only diluent portion of Menveo).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 14-SEP-2023 The medical Assistant reported the administration of diluent portion of Menveo (2 vial presentation) only to a 12 year old patient which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow up.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: patient received the diluent portion of Menveo without reconstitution; patient received the diluent portion of Menveo without reconstitution; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA911A, expiry date 31-MAR-2024) for prophylaxis.   On 14-SEP-2023, the patient received Menveo. On 14-SEP-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: patient received the diluent portion of Menveo without reconstitution) and inappropriate dose of vaccine administered (Verbatim: patient received the diluent portion of Menveo without reconstitution). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 14-SEP-2023 The pharmacist called in to request information about how to proceed after a patient received the diluent portion of Menveo without reconstitution, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: M
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: not received 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 55-year-old male patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (1st dose received in April 2023).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: not received 2nd dose yet).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 14-SEP-2023 The pharmacist reported that a patient received a first dose of Engerix B back in April 2023 and never received a second dose. The reporter consented to follow up via mail. The reporter was not at their facility at the moment of call, age, gender and initials of the patient were given but not sure of veracity. No more information about exact date was available. Patient had not received a second dose at the moment of the call. Till the time of reporting, the patient did not receive 2nd dose of Engerix B, which led to incomplete course of vaccination.
Sex: U
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Infanrix was accidentally administered instead of a dose of Boostrix; 12 year old received Infanrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old patient who received DTPa (Infanrix) for prophylaxis.   On an unknown date, the patient received Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: Infanrix was accidentally administered instead of a dose of Boostrix) and inappropriate age at vaccine administration (Verbatim: 12 year old received 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: 14-SEP-2023 A pharmacist called in to request information about the recommendations available for instances where a dose of Infanrix was accidentally administered instead of a dose of Boostrix in a 12 year old patient which led to Inappropriate age at vaccine administration and Wrong vaccine administered They had very limited information about the event, vaccine and patient but consented to receive follow up via e mail. The vaccine administration facility is the same as primary reporter. The reporter consented to follow up.