chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: F
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: inadvertently administered two patients under the age of 10 the Menveo 1 vial presentation on 11/10/23.; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number 9C2KP, expiry date 31-DEC-2024) for prophylaxis.   On 10-NOV-2023, the patient received Menveo. On 10-NOV-2023, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: inadvertently administered two patients under the age of 10 the Menveo 1 vial presentation on 11/10/23.). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt date: 16-NOV-2023 The medical doctor reported the inadvertently administered two patients under the age of 10 the Menveo 1 vial presentation which led to inappropriate age at vaccine administration. The medical doctor mentioned they carried the Menveo 2 vial presentation before and now had the 1 vial, which they inadvertently administered to the reported patients under recommended age.; Sender's Comments:  US-GSK-US2023159124:Same Reporter , same Product .
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Syringe issue, Underdose
Clinical narrative: syringe leaked between the needle; States she was in the process of administering a FLUARIX vaccine and the pre-filled syringe leaked between the needle and the luer lock device; syringe leaked between the needle; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 51-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2023-2024 season) (batch number 7z423, expiry date 30-JUN-2024) for prophylaxis. This case was associated with a product complaint.   On 16-NOV-2023, the patient received Fluarix Quadrivalent 2023-2024 season. On 16-NOV-2023, an unknown time after receiving Fluarix Quadrivalent 2023-2024 season, the patient experienced accidental underdose (Verbatim: syringe leaked between the needle). On an unknown date, the patient experienced syringe leak (Verbatim: syringe leaked between the needle) and pharmaceutical product complaint (Verbatim: States she was in the process of administering a FLUARIX vaccine and the pre-filled syringe leaked between the needle and the luer lock device). The outcome of the accidental underdose, syringe leak and pharmaceutical product complaint 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: 16-NOV-2023 The reporter stated that she was in the process of administering a Fluarix vaccine and the pre-filled syringe leaked between the needle and the luer lock device and she removed the needle from the patient's arm and administered a different pre-filled Fluarix vaccine in the other arm which led to accidental underdose, syringe leak and pharmaceutical product complaint. The consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Erythema, Pruritus
Clinical narrative: Pimple on arm/Pimples on back; that were smaller and itchy; reports redness around the same; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of pimples in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 3B2YJ, expiry date 16-AUG-2025) for prophylaxis.   On 11-OCT-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced pimples (Verbatim: Pimple on arm/Pimples on back), pruritus (Verbatim: that were smaller and itchy) and erythema (Verbatim: reports redness around the same). The outcome of the pimples was not resolved and the outcome of the pruritus was unknown and the outcome of the erythema was resolved.   It was unknown if the reporter considered the pimples, pruritus and erythema to be related to Shingrix.     It was unknown if the company considered the pimples, pruritus and erythema to be related to Shingrix.   Additional Information: GSK receipt date: 16-NOV-2023 The reporter was a pharmacist calling on behalf of a female patient that received her 1st dose of Shingrix in her left arm and reported that right after receiving the 1st dose of Shingrix (no specific time frame or date provided) a pimple showed up on her arm (not sure which arm), which she popped. After a few days, the patient reported the pimple came back on her arm and she popped it again.  As of today (on the day of reporting), this pimple was miniscule per the pharmacist, about the size of the point of a pin.  The patient also reported around the same time frame as this pimple on her arm, she also had some pimples that were smaller and itchy on her lower back. The patient also reported redness around the same time frame as the pimples, and that there was no more redness (no further information or location was provided about this event). The reporter had reported all was provided about these adverse events. The reporter consented to follow up.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 5 year old child received 2 doses of Fluarix QIV, one on 8-Nov-2023 and one today; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 5-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2023-2024 season) (batch number 99r27, expiry date 30-JUN-2024) for prophylaxis.   Concomitant products included Influenza vaccine inact split 4v (Fluarix quadrivalent).   On 17-NOV-2023, the patient received the 2nd dose of Fluarix Quadrivalent 2023-2024 season. On 17-NOV-2023, an unknown time after receiving Fluarix Quadrivalent 2023-2024 season, the patient experienced drug dose administration interval too short (Verbatim: 5 year old child received 2 doses of Fluarix QIV, one on 8-Nov-2023 and one today). The outcome of the drug dose administration interval too short 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: 17-NOV-2023 A nurse reported that the patient received 2nd  dose of fluarix quadrivalent earlier than the recommended interval, which led to shortening of vaccine schedule. The reporter consented to follow up.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: hasn't received a second 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 27-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (In May 2023, received first dose).   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: hasn't received a second dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 17-NOV-2023 The reporter called to report that about six month ago from reporting day a patient received the first dose of Engerix B and had not received the second dose yet. Reporter stated that it happened at a different pharmacy, so he did not have the exact information related to batch number and vaccination date. Reporter did not consent to follow up. Till the time of reporting the patient did not receive the 2nd dose of Engerix B vaccine, which led to incomplete course of vaccination.
Age: 31.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: pregnant female was given Arexvy; 31 year old received Arexvy; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 31-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 37D4F, expiry date 20-MAR-2025) for prophylaxis.   On 14-NOV-2023, the patient received Arexvy. On 14-NOV-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: 31 year old received Arexvy). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant female was given Arexvy). The outcome of the inappropriate age at vaccine administration and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 37 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt date: 17-NOV-2023 The reporter was a pharmacist who stated that a pregnant female (37 weeks gestation) was given Arexvy which led to inappropriate age at vaccine administration and vaccine exposure during pregnancy.  The reporter consented to follow up.
Age: 71.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Administration of second dose of Arexvy; This non-serious case was reported by a nurse via sales rep and described the occurrence of extra dose administered in a 71-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number KY322, expiry date 02-FEB-2025) for prophylaxis.   Concomitant products included RSV VACCINE PROT. SUBUNIT PREF3 (AREXVY).   On 17-NOV-2023, the patient received the 2nd dose of Arexvy. On 17-NOV-2023, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: Administration of second dose of Arexvy). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt date: 17-NOV-2023 A nurse called to report the administration of a second dose of Arexvy to 2 patients(both husband and wife) The patients received the first dose on Oct 26th 2023 and day of reporting received the second dose which led to extra dose administered. The nurse asked for information regarding expected adverse reactions. The lot number KY322 corresponded to the second dose. Both patients received the same lot number. Patient initials for both patients were reported. The reporter consented to follow up. This case is linked with US2023159990, same reporter.; Sender's Comments:  US-GSK-US2023159990:for 1st patient
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: administration of a second dose of Arexvy; This non-serious case was reported by a nurse via sales rep and described the occurrence of extra dose administered in a 70-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number KY322, expiry date 02-FEB-2025) for prophylaxis.   Concomitant products included RSV VACCINE PROT. SUBUNIT PREF3 (AREXVY).   On 17-NOV-2023, the patient received the 2nd dose of Arexvy. On 17-NOV-2023, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: administration of a second dose of Arexvy). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt date: 17-NOV-2023 A nurse called to report the administration of a second dose of Arexvy to 2 patients(both husband and wife) The patients received the first dose on Oct 26th 2023 and day of reporting received the second dose which led to extra dose administered. The nurse asked for information regarding expected adverse reactions. The lot number KY322 corresponded to the second dose. Both patients received the same lot number. Patient initials for both patients were reported. The reporter consented to follow up. This case is linked with US2023159988, same reporter.; Sender's Comments:  US-GSK-US2023159988:for 2nd patient
Sex: M
Vaccine: VARZOS
Symptoms: Joint swelling, Polyarthritis
Clinical narrative: severe arthritis in multipole joints; severe swelling in mutipole joints; This serious case was reported by a physician via call center representative and described the occurrence of arthritis multiple joint in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   In OCT-2023, the patient received the 1st dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced arthritis multiple joint (Verbatim: severe arthritis in multipole joints) (serious criteria GSK medically significant) and swollen joints (Verbatim: severe swelling in mutipole joints). The outcome of the arthritis multiple joint and swollen joints were unknown.   It was unknown if the reporter considered the arthritis multiple joint and swollen joints to be related to Shingrix.     It was unknown if the company considered the arthritis multiple joint and swollen joints to be related to Shingrix.   Additional Information: GSK receipt date: 17-NOV-2023 The reporter stated that a patient received first dose of Shingrix a month ago from reporting date and two weeks later the patient developed severe swelling and arthritis in multiple joints. No other information was provided during the call. The healthcare professional (HCP) stated that he had an emergency work and ended the call. The reporter consented to follow up.
Age: 1.0
Sex: M
Vaccine: RV1
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Product preparation issue
Clinical narrative: patient receive Rotarix received the diluent alone (without the lyophilized powder component); patient receive Rotarix received the diluent alone (without the lyophilized powder component); 1 years old patient received rotarix; 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 1-year-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 422GF, expiry date 24-FEB-2025) for prophylaxis.   On 17-NOV-2023, the patient received Rotarix lyophilized formulation. On 17-NOV-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate preparation of medication (Verbatim: patient receive Rotarix received the diluent alone (without the lyophilized powder component)), inappropriate dose of vaccine administered (Verbatim: patient receive Rotarix received the diluent alone (without the lyophilized powder component)) and inappropriate age at vaccine administration (Verbatim: 1 years old patient received rotarix). The outcome of the inappropriate preparation of medication, inappropriate dose of 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: 17-NOV-2023 A office manager reported that a patient that was supposed to receive Rotarix received the diluent alone (without the lyophilized powder component) which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Healthcare professional mentioned that they would wait a month to administer the replacement dose. The vaccine administration facility was the same as primary reporter. 1 year old patient received Rotarix which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Alopecia
Clinical narrative: Hair loss after vaccination; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of hair loss in a 78-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 05-OCT-2023, the patient received the 1st dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced hair loss (Verbatim: Hair loss after vaccination). The outcome of the hair loss was unknown.   It was unknown if the reporter considered the hair loss to be related to Arexvy.     It was unknown if the company considered the hair loss to be related to Arexvy.   Additional Information: GSK receipt date: 17-NOV-2023 Pharmacist reported that the patient who had gotten the Arexvy vaccine. The reporter stated that after getting vaccinated her hair had began to fall out. The reporter had asked if there had been reports of hair loss after getting Arexvy.  The reporter had not been provided with the lot number and expiration date of the dose given. The reporter consented to follow up.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: patient received the Shingrix adjuvant portion only; patient received the Shingrix adjuvant portion only; 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 59-year-old male patient who received Herpes zoster (Shingrix) (batch number ZP22N, expiry date 27-SEP-2025) for prophylaxis.   On 08-NOV-2023, the patient received the 1st dose of Shingrix. On 08-NOV-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: patient received the Shingrix adjuvant portion only) and inappropriate dose of vaccine administered (Verbatim: patient received the Shingrix adjuvant portion only). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 17-NOV-2023 The reporter reported that the patient received the Shingrix adjuvant portion only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Exposure during pregnancy, Extra dose administered
Clinical narrative: Drug Exposure During Pregnancy; Two boostrix doses during pregnancy; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a 37-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number M4E4A, expiry date 05-OCT-2025) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 16-NOV-2023, the patient received the 2nd dose of Boostrix. On 08-APR-2023, the patient received the 1st dose of Boostrix. On 16-NOV-2023, an unknown time after receiving Boostrix, the patient experienced extra dose administered (Verbatim: Two boostrix doses during pregnancy). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Drug Exposure During Pregnancy). The outcome of the vaccine exposure during pregnancy and extra dose administered were unknown.   Pregnancy exposure: Pregnancy Exposure (Boostrix): To mother in third trimester Pregnancy Exposure (Boostrix): To mother in second trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: Update and rerun the narrative, GSK receipt date: 17-NOV-2023  The pharmacist reported that the patient had received a dose of Boostrix at 15-weeks pregnant and then another dose of Boostrix at 30-weeks pregnant, which led to vaccine exposure during pregnancy and extra dose administered. Reporter stated that the 1st dose was administered because of the patients daughter was in her 3rd trimester of pregnancy. Reporter stated that the patient was the primary caregiver. Reporter stated that the 2nd dose was given at the patients 3rd trimester as per the approved indication. The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Product preparation error
Clinical narrative: administer Arexvy adjuvant without active component; administer Arexvy adjuvant without active component; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a elderly 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 inappropriate preparation of medication (Verbatim: administer Arexvy adjuvant without active component) and inappropriate dose of vaccine administered (Verbatim: administer Arexvy adjuvant without active component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 17-NOV-2023 Field representative was the reporter. The reported stated during the office visit the patient twice administered Arexvy adjuvant without active component which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: RSV
Symptoms: Product preparation error
Clinical narrative: female patient received the liquid portion only of Arexvy; female patient received the liquid portion only of Arexvy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 60-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 5P4A5, expiry date 27-MAR-2025) for prophylaxis.   On 17-NOV-2023, the patient received Arexvy. On 17-NOV-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: female patient received the liquid portion only of Arexvy) and inappropriate dose of vaccine administered (Verbatim: female patient received the liquid portion only of Arexvy). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional Information: GSK Receipt date: 17-NOV-2023 The pharmacist reported that on November 17th 2023 a female patient received the liquid portion only of Arexvy which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 19 year old patient received Engericx; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 19-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   On an unknown date, the patient received the 1st dose of Engerix B adult 1 ml. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced inappropriate age at vaccine administration (Verbatim: 19 year old patient received Engericx). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt date: 17-NOV-2023 The physician had a 19 year old patient who had a prescription for Engerix B first dose, 1 ml dose and Doctor confirmed patient had received the vaccine which led to inappropriate age at vaccine administration. Physician was not sure if this was an adverse event and if she needs to report it. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not able to get 2nd dose; This non-serious case was reported by a other health professional via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2020).   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: not able to get 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 17-NOV-2023 The reporter stated if a patient only received one dose Shingrix  in 2020 and was not able to get the second dose, should the patient start over with getting two or would the second dose so far away from the first be sufficient Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: RSV
Symptoms: Intercepted product prescribing error
Clinical narrative: 46 year old female with immune problems given prescription for Aerxvy; This non-serious case was reported by a consumer via call center representative and described the occurrence of intercepted product prescribing error in a 46-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included immunocompromised (have had immune problems which were not specified).   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced intercepted product prescribing error (Verbatim: 46 year old female with immune problems given prescription for Aerxvy). The outcome of the intercepted product prescribing error was unknown.   Additional Information: GSK receipt date: 17-NOV-2023 The reporter was the patient's mother. The patient was given a prescription for Arexvy by her physician, but the vaccine had not been administered, which led to intercepted product prescribing error. Adverse event were recognized after call ended.  Report filed with limited information. The reporter did not consent to follow up. This is 2 of 2 linked reports reported by the same reporter, for different patient.; Sender's Comments:  US-GSK-US2023160020:2 of 2 report
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Menveo (2-vial) administered to a patient on 17OCT2023. Per expiration date is 30SEP2023.; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA728A, expiry date 30-SEP-2023) for prophylaxis.   On 17-OCT-2023, the patient received Menveo. On 17-OCT-2023, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Menveo (2-vial) administered to a patient on 17OCT2023. Per SF expiration date is 30SEP2023.). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 17-NOV-2023 The reported that the patient was administered the expired dose of Menveo vaccine (2-vial), Which led to expired vaccine administered. The reporter consent to follow up.
Sex: U
Vaccine: RSV
Symptoms: Product preparation error
Clinical narrative: received a dose of Arexvy after it was reconstituted  with Merck sterile diluent, which she said is most likely sterile water; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 37D4F, expiry date 20-MAR-2025) for prophylaxis.   On 03-NOV-2023, the patient received Arexvy (intramuscular). On 03-NOV-2023, an unknown time after receiving Arexvy, the patient experienced wrong solution used in drug reconstitution (Verbatim: received a dose of Arexvy after it was reconstituted  with Merck sterile diluent, which she said is most likely sterile water). The outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt date: 17-NOV-2023 A nurse reported that a patient on 03 November received a dose of Arexvy after it was reconstituted with Merck sterile diluent, which she said was most likely sterile water which led to Wrong solution used in drug reconstitution.  The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Pain, Sensory disturbance
Clinical narrative: sensory pain and; burning sensation on his scapula; This non-serious case was reported by a physician via sales rep and described the occurrence of sensory disturbance in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced sensory disturbance (Verbatim: sensory pain and) and burning sensation (Verbatim: burning sensation on his scapula). The outcome of the sensory disturbance and burning sensation were unknown.   It was unknown if the reporter considered the sensory disturbance and burning sensation to be related to Shingrix.     It was unknown if the company considered the sensory disturbance and burning sensation to be related to Shingrix.   Additional Information: GSK receipt date: 17-NOV-2023 The GlaxoSmithKline (GSK) field personnel was reported an adverse event that she learned on reported day. The day after the patient received Shingrix vaccination, he experienced sensory pain and burning sensation on his scapula on the same side that he received the shot. This was occurred sometime the last 30 days. The field personnel had no further information. The reporter consented to follow up.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Circumstance or information capable of leading to medication error, Exposure via skin contact, Underdose
Clinical narrative: Patient received a partial dose of Flulaval; child moved and liquid was on the patient's leg; child moved and liquid was on the patient's leg; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 4-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) for prophylaxis.   On 17-NOV-2023, the patient received FluLaval Quadrivalent 2023-2024 season. On 17-NOV-2023, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced accidental underdose (Verbatim: Patient received a partial dose of Flulaval), inadvertent exposure to vaccine (Verbatim: child moved and liquid was on the patient's leg) and exposure via skin contact (Verbatim: child moved and liquid was on the patient's leg). The outcome of the accidental underdose, inadvertent exposure to vaccine and exposure via skin contact 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: 17-Nov-2023 The reporter was a registered nurse. The reporter reported that the patient received partial dose of Flulaval vaccine due to the during the administration of the Flulaval vaccine the patient moved and liquid was on the patient's leg and on the healthcare professional glove, which led to accidental underdose, inadvertent exposure to the vaccine and exposure via skin contact. The reporter confirmed that the incident was due to the human error and not the device. The reporter asked how to proceed. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Pain, Peripheral swelling
Clinical narrative: Diarrhea; Headache; Body Aches; Arm Swelling; This non-serious case was reported by a physician via call center representative and described the occurrence of diarrhea in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 06-NOV-2023, the patient received Shingrix. On 06-NOV-2023, less than a day after receiving Shingrix, the patient experienced diarrhea (Verbatim: Diarrhea), headache (Verbatim: Headache), general body pain (Verbatim: Body Aches) and swelling arm (Verbatim: Arm Swelling). On 13-NOV-2023, the outcome of the diarrhea, headache, general body pain and swelling arm were resolved (duration 7 days).   It was unknown if the reporter considered the diarrhea, headache, general body pain and swelling arm to be related to Shingrix.     It was unknown if the company considered the diarrhea, headache, general body pain and swelling arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-NOV-2023 The patient (physician) self-reported this case. The reporter stated patient administered the Shingrix vaccine and experienced diarrhea, headache, body aches and arm swelling for 7 days. No additional details left on voice mail box. The safety team follow-up permission was unknown as this message was left on the afterhours voice mail box for medical information. The reporter consented to contact.
Sex: U
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administration to an immunocompetent patient younger than 50 years; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 50-year-old 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 inappropriate age at vaccine administration (Verbatim: Administration to an immunocompetent patient younger than 50 years). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 20-NOV-2023 The reporter mentioned that an immunocompetent 50 year-old patient was requesting the Shingrix vaccine but in the records it seems the patient received the vaccine 4 years ago. The MD asked if there was a blood test that could be done to find out whether or not the patient received the vaccine in the past. The patient received the Shingrix vaccine earlier the recommended age schedule, which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: instead of getting the 2nd Shingrix shot within the two-six month timeframe, she got it a year later; 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 female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of shingrix on unknown date).   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 drug dose administration interval too long (Verbatim: instead of getting the 2nd Shingrix shot within the two-six month timeframe, she got it a year later). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date - 20-NOV-2023 The patient stated that instead of getting 2nd dose of shingrix shot within two-six month timeframe, patient got after year, which led to lengthening of vaccine schedule. The patient would not provide any details but first name. The patient would not provide information.  The patient disconnected waiting for health care professional. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: and developed an outbreak of Shingles last week/suspected vaccination failure; Shingles Outbreak; This serious case was reported by a physician via call center representative and described the occurrence of vaccination failure in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. In NOV-2023, more than 2 years after receiving Shingrix, the patient experienced vaccination failure (Verbatim: and developed an outbreak of Shingles last week/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles Outbreak). The outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt date: 20-NOV-2023 The reporter was a retired physician who stated he received Shingrix vaccines in 2018 and developed an outbreak of Shingles last week. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting.  The reporter consented to follow up.
Age: 53.0
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administration of Arexvy to a 53 year-old patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 53-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 5275G), (batch number 5P4AF) and (batch number 3B252) for prophylaxis.   On 17-NOV-2023, the patient received Arexvy (intramuscular). On 17-NOV-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: administration of Arexvy to a 53 year-old patient). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date -20-Nov-2023 The pharmacist asked for information regarding the safety of Arexvy in patients younger than 60 year.  The pharmacist provided the lot numbers as, of the box: 5P4AF, of lyophilized vial: 5275G and of diluent vial: 3B252. The reporter consent to follow up. The patient received a dose of Arexvy at an inappropriate age, which led to inappropriate age at vaccine administration.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypertension, Tachycardia
Clinical narrative: High blood pressure; Tachycardia; This serious case was reported by a consumer via call center representative and described the occurrence of blood pressure high in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included prednisone.   On 16-NOV-2023, the patient received the 1st dose of Shingrix (right arm). On 17-NOV-2023, 1 days after receiving Shingrix, the patient experienced blood pressure high (Verbatim: High blood pressure) (serious criteria hospitalization) and tachycardia (Verbatim: Tachycardia) (serious criteria hospitalization). The patient was treated with nitroglycerin. The outcome of the blood pressure high and tachycardia were unknown.   It was unknown if the reporter considered the blood pressure high and tachycardia to be related to Shingrix.     It was unknown if the company considered the blood pressure high and tachycardia to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-Nov-2023 The patient was self-reported this case. The patient received Shingrix vaccine and on following day experienced high blood pressure and tachycardia.  The reporter reported that he received Nitroglycerin that night and on next morning on Saturday he had to call 911 because high blood pressure and the tachycardia was continued.  The patient was admitted in emergency room and stayed under observation for more than 24 hours and discharged yesterday afternoon.  The patient measured blood pressure yesterday around 6 pm and it was 170/120 and decided to call 911 and was admitted in the emergency room for 2 hours and then discharged.  The treating physician was not aware of the events. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not yet received his second dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2021).   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: not yet received his second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 20-NOV-2023 Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No permissions for follow-up given. The reporter did not consent to follow-up.
Age: 67.0
Sex: F
Vaccine: RSV, UNK
Symptoms: Abdominal pain lower, Asthenia, Diarrhoea, Dyspnoea, Headache
Clinical narrative: Rectal bleeding with clots; Both arms felt heavy; Both arm felt weak; Headache; Low abdominal cramps; Diarrhea; Shortness of breath; feels weak all over; This serious case was reported by a consumer via call center representative and described the occurrence of rectal bleeding in a female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 79T9F, expiry date 04-MAR-2025) for prophylaxis.   Co-suspect products included Fluticasone propionate (Flublock) for prophylaxis.   On 16-NOV-2023, the patient received Arexvy (left arm) and Flublock (right arm). In NOV-2023, an unknown time after receiving Arexvy, the patient experienced rectal bleeding (Verbatim: Rectal bleeding with clots) (serious criteria GSK medically significant), heaviness in arm (Verbatim: Both arms felt heavy), weakness of arms (Verbatim: Both arm felt weak), headache (Verbatim: Headache), cramp in lower abdomen (Verbatim: Low abdominal cramps), diarrhea (Verbatim: Diarrhea), shortness of breath (Verbatim: Shortness of breath) and feelings of weakness (Verbatim: feels weak all over). The outcome of the rectal bleeding, headache, cramp in lower abdomen, diarrhea and shortness of breath were resolved and the outcome of the heaviness in arm and weakness of arms were resolving and the outcome of the feelings of weakness was not resolved.   It was unknown if the reporter considered the rectal bleeding, heaviness in arm, weakness of arms, headache, cramp in lower abdomen, diarrhea, shortness of breath and feelings of weakness to be related to Arexvy.     It was unknown if the company considered the rectal bleeding, heaviness in arm, weakness of arms, headache, cramp in lower abdomen, diarrhea, shortness of breath and feelings of weakness to be related to Arexvy.   Additional Information: GSK Receipt Date: 20-Nov-2023 The patient was self-reported this case. The patient reported that on 16th November 2023 she received Arexvy vaccine and Flublock vaccines and hours later her both arms felt heavy and weak, headache, low abdominal cramps with diarrhea, and shortness of breath.  The patient reported that after the diarrhea stopped she started having rectal bleeding with clots.  The patient reported that all symptoms subsided except she still felt weak. It was unknown if the reporter considered the rectal bleeding, heaviness in arm, weakness of arms, headache, cramp in lower abdomen, diarrhea, shortness of breath and feelings of weakness to be related to Flublock. The reporter did consent to follow up.
Age: 67.0
Sex: F
Vaccine: RSV, UNK
Symptoms: Limb discomfort, Muscular weakness, Rectal haemorrhage, Thrombosis
Clinical narrative: Rectal bleeding with clots; Both arms felt heavy; Both arm felt weak; Headache; Low abdominal cramps; Diarrhea; Shortness of breath; feels weak all over; This serious case was reported by a consumer via call center representative and described the occurrence of rectal bleeding in a female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 79T9F, expiry date 04-MAR-2025) for prophylaxis.   Co-suspect products included Fluticasone propionate (Flublock) for prophylaxis.   On 16-NOV-2023, the patient received Arexvy (left arm) and Flublock (right arm). In NOV-2023, an unknown time after receiving Arexvy, the patient experienced rectal bleeding (Verbatim: Rectal bleeding with clots) (serious criteria GSK medically significant), heaviness in arm (Verbatim: Both arms felt heavy), weakness of arms (Verbatim: Both arm felt weak), headache (Verbatim: Headache), cramp in lower abdomen (Verbatim: Low abdominal cramps), diarrhea (Verbatim: Diarrhea), shortness of breath (Verbatim: Shortness of breath) and feelings of weakness (Verbatim: feels weak all over). The outcome of the rectal bleeding, headache, cramp in lower abdomen, diarrhea and shortness of breath were resolved and the outcome of the heaviness in arm and weakness of arms were resolving and the outcome of the feelings of weakness was not resolved.   It was unknown if the reporter considered the rectal bleeding, heaviness in arm, weakness of arms, headache, cramp in lower abdomen, diarrhea, shortness of breath and feelings of weakness to be related to Arexvy.     It was unknown if the company considered the rectal bleeding, heaviness in arm, weakness of arms, headache, cramp in lower abdomen, diarrhea, shortness of breath and feelings of weakness to be related to Arexvy.   Additional Information: GSK Receipt Date: 20-Nov-2023 The patient was self-reported this case. The patient reported that on 16th November 2023 she received Arexvy vaccine and Flublock vaccines and hours later her both arms felt heavy and weak, headache, low abdominal cramps with diarrhea, and shortness of breath.  The patient reported that after the diarrhea stopped she started having rectal bleeding with clots.  The patient reported that all symptoms subsided except she still felt weak. It was unknown if the reporter considered the rectal bleeding, heaviness in arm, weakness of arms, headache, cramp in lower abdomen, diarrhea, shortness of breath and feelings of weakness to be related to Flublock. The reporter did consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: mmunocompromised patient receved injection of shingrix 5 years ago but never followed up for 2; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix  5 year ago). Concurrent medical conditions included immunocompromised.   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: mmunocompromised patient receved injection of shingrix 5 years ago but never followed up for 2). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 20-NOV-2023 The physician stated that an immunocompromised patient was received Shingrix vaccine 5 year ago. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.