chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site infection, Injection site swelling
Clinical narrative: had a swollen left arm at the injection site up to her shoulder; infected left arm/patient can not left or move arm; injection site infection; This non-serious case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb (Verbatim: had a swollen left arm at the injection site up to her shoulder), injected limb mobility decreased (Verbatim: infected left arm/patient can not left or move arm) and injection site infection (Verbatim: injection site infection). The outcome of the extensive swelling of vaccinated limb and injection site infection were not resolved and the outcome of the injected limb mobility decreased was not reported.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injected limb mobility decreased and injection site infection to be related to Shingrix.     It was unknown if the company considered the extensive swelling of vaccinated limb, injected limb mobility decreased and injection site infection to be related to Shingrix.   Additional Information: GSK receipt date: 14-OCT-2024 The reporter was the spouse of the patient that lived in assisted living. The patient received her Shingrix vaccination approximately one year ago and ever since patient had a swollen left arm at the injection site up to her shoulder. The reporter stated that the patient could not left or move arm. When the reporter went on the day of reporting to see the patient he noticed a bandage on the left arm and it was infected at the site of the injection.
Age: 10.0
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, Extra dose administered
Clinical narrative: Flulaval - Second dose same season; was given on Oct 11th 2024 and expired 5/13/2024; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 10-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2024-2025 season) (batch number 2XK44, expiry date 13-MAY-2024) for prophylaxis.   Concomitant products included Influenza vaccine inact split 4v (Flulaval quadrivalent).   On 11-OCT-2024, the patient received the 2nd dose of FluLaval Quadrivalent 2024-2025 season. On 11-OCT-2024, an unknown time after receiving FluLaval Quadrivalent 2024-2025 season, the patient experienced extra dose administered (Verbatim: Flulaval - Second dose same season) and expired vaccine used (Verbatim: was given on Oct 11th 2024 and expired 5/13/2024). The outcome of the extra dose administered and expired vaccine used 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-OCT-2024 The medical assistant called to report the administration of a second dose of Flulaval to a patient, which led extra dose administered. The 2nd dose was expired on 13-May-2024, which led expired vaccine used. The medical assistant mentioned they monitored the patient according to their protocols and patient did not report an adverse reaction. The reporter consented to follow up.
Age: 15.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Engerix-B - Splitting adult dose to give a 10mcg dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult product administered to child in a 15-year-old male patient who received HBV (Engerix B adult) (batch number TP2F9, expiry date 02-AUG-2024) for prophylaxis.   On 12-OCT-2024, the patient received Engerix B adult. On 12-OCT-2024, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: Engerix-B - Splitting adult dose to give a 10mcg dose). The outcome of the adult product administered to child 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: 14-OCT-2024 A pharmacist mentioned they administered half of the adult Engerix-B dose (0.5 ml) to an adolescent patient, which led adult product administered to child. The reporter did not consent to follow up.
Sex: U
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: nurse given the vaccination had pool the old box, that was expired,; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in an unspecified number of patients who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2024-2025 season) (batch number JT7S3, expiry date 30-JUN-2024) for prophylaxis.   On 11-OCT-2024, the patients received FluLaval Quadrivalent 2024-2025 season. On 11-OCT-2024, an unknown time after receiving FluLaval Quadrivalent 2024-2025 season, the patient experienced expired vaccine used (Verbatim: nurse given the vaccination had pool the old box, that was expired,). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-OCT-2024 The reporter reported 9 doses of influenza last season vaccination (Flulaval), and refrigerated at one of our clinics and vaccinating, for this season vaccination, and the nurse given the vaccination had pool the old box, that was expired, and given these 9 doses and then realize, when she opens the next box, which led expired vaccine used. Health care professional mentioned that this 9 expire doses were administrate to her coworkers.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash on the chest; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of rash in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced rash (Verbatim: rash on the chest). The outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.     It was unknown if the company considered the rash to be related to Shingrix.   Additional Information: GSK receipt date: 14-OCT-2024 The reporter reported that a patient, he was thinking on getting the Arexvy vaccine, he had a reaction when he got the Shingrix vaccine so, he was worried that he might had a crossed reactivity. The patient was older than 50 years old, but Pharmacist declined to provide initials, DOB (Date of birth) and gender since he said he was not authorized. Patient did not complete the Shingrix schedule due to the reaction and only received one dose of Shingrix. The reporter stated that the patient had not received the Arexvy vaccine, only received Shingrix vaccine.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: received two doses of Flulaval TIV on the same day on October 14, 2024.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 11-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) (batch number 9NR5N, expiry date 30-JUN-2025) for prophylaxis.   On 14-OCT-2024, the patient received FluLaval Quadrivalent 2023-2024 season. On 14-OCT-2024, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced overdose (Verbatim: received two doses of Flulaval TIV on the same day on October 14, 2024.). The outcome of the overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-OCT-2024 The office manager called and reported that they administered two doses of Flulaval TIV (Flu Laval quadrivalent 2023-2024) on the same day to a patient, which led to overdose. The reporter asked do they had any safety information about this.
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: 20 year old patient received a pediatric dose of Havrix; 20 year old patient received a pediatric dose of Havrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 20-year-old male patient who received HAV (Havrix pediatric) (batch number 423NL) for prophylaxis.   On 20-AUG-2024, the patient received Havrix pediatric. On 20-AUG-2024, an unknown time after receiving Havrix pediatric, the patient experienced underdose (Verbatim: 20 year old patient received a pediatric dose of Havrix) and adult use of a child product (Verbatim: 20 year old patient received a pediatric dose of Havrix). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 15-OCT-2024 The reporter explained that a 20-year-old patient received a pediatric dose of Havrix, which led to underdose and adult use of a child product. Expiration date of the vaccine was unknown by caller.  Medical Information Specialist did not ask if that was the only dose of Havrix for the patient. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Exposure via skin contact, Syringe issue, Underdose
Clinical narrative: skin exposure/half of the immunization leaked out and ran down her arm; skin exposure/half of the immunization leaked out and ran down her arm; underdose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of exposure via skin contact in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 14-SEP-2018).   On 24-JAN-2019, the patient received the 2nd dose of Shingrix. On 24-JAN-2019, an unknown time after receiving Shingrix, the patient experienced exposure via skin contact (Verbatim: skin exposure/half of the immunization leaked out and ran down her arm), inadvertent exposure to vaccine (Verbatim: skin exposure/half of the immunization leaked out and ran down her arm) and accidental underdose (Verbatim: underdose). The outcome of the exposure via skin contact, inadvertent exposure to vaccine and accidental underdose were unknown.   Additional Information: GSK receipt date: 16-OCT-2024 The reporter reported he had a patient come into the pharmacy last week requesting a Shingrix vaccine. He saw in her chart she had received two doses of Shingrix vaccine. The reporter asked the patient why she was requesting a third dose and she told him when she received the second dose, about half of the immunization leaked out and ran down her arm which led to, exposure via skin contact, inadvertent exposure to vaccine and accidental underdose. The pharmacist did not had the product lot number and expiration date information.  At the time of call, a third dose had not been administered. The vaccine administration facility was the same as primary reporter.
Age: 6.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: we gave TDap instead of DTap to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 6-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 333BM, expiry date 17-AUG-2026) for prophylaxis.   Co-suspect products included DTPa (DTPa vaccine) for prophylaxis.   On 09-OCT-2024, the patient received Boostrix. On an unknown date, the patient did not receive DTPa vaccine. On 09-OCT-2024, an unknown time after receiving Boostrix and not applicable after receiving DTPa vaccine, the patient experienced wrong vaccine administered (Verbatim: we gave TDap instead of DTap to a patient). The outcome of the wrong vaccine 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: 16-OCT-2024 The reporter reported that a nurse called to inform they that they had a vaccine discrepancy they gave TDap instead of DTap vaccine to a patient which led to, wrong vaccine administered.
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: administered only the sterile diluent of the Hiberix to a patient; administered only the sterile diluent of the Hiberix to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 6-month-old female patient who received Hib (Hiberix) (batch number TC3N5, expiry date 17-MAR-2026) for prophylaxis.   On 10-OCT-2024, the patient received Hiberix. On 10-OCT-2024, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: administered only the sterile diluent of the Hiberix to a patient) and inappropriate dose of vaccine administered (Verbatim: administered only the sterile diluent of the Hiberix to a patient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 16-OCT-2024 The LVN (Licensed vocational nurses) stated an employee administered only the sterile diluent of the Hiberix to a patient which led to, inappropriate preparation of medication and inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter.
Sex: U
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: Vaccine stored outside recommended conditions and administered to patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number 7554T, expiry date 30-JUN-2025) for prophylaxis.   On an unknown date, the patient received Fluarix 2024-2025 season. On an unknown date, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-OCT-2024 The pharmacist reported that they had a refrigerator that went out of temperature range and, it did not get super hot before they set it, but a number of these Fluarix were given after the temperature excursion which led to incorrect product storage error. The vaccine was stored at 56 degree Fahrenheit for 135 hours. The pharmacist reported that the vaccine was given to patient.  The pharmacist reported that the vaccines were given to 17 patients but he gave the initials of 20 patients. The pharmacist was not sure which patients got the doses before the maximum cumulative time of the extended stability data was reached. This was 20 of 20 linked cases, reported by same reporter.; Sender's Comments:  US-GSK-US2024128758:same reporter/different patient US-GSK-US2024128727:same reporter/different patient US-GSK-US2024128760:same reporter/different patient US-GSK-US2024128754:same reporter/different patient US-GSK-US2024128724:same reporter/different patient US-GSK-US2024128730:same reporter/different patient US-GSK-US2024128736:same reporter/different patient US-GSK-US2024128739:same reporter/different patient US-GSK-US2024128763:same reporter/different patient US-GSK-US2024128771:same reporter/different patient US-GSK-US2024128716:same reporter/different patient US-GSK-US2024128719:same reporter/different patient US-GSK-US2024128734:same reporter/different patient US-GSK-US2024128740:same reporter/different patient US-GSK-US2024128747:same reporter/different patient US-GSK-US2024128750:same reporter/different patient US-GSK-US2024128756:same reporter/different patient US-GSK-US2024128767:same reporter/different patient US-GSK-US2024128774:same reporter/different patient
Sex: U
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Maladministration of Pediatric Dose on an Adult Patient; Maladministration of Pediatric Dose on an Adult Patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a adult patient who received HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced accidental underdose (Verbatim: Maladministration of Pediatric Dose on an Adult Patient) and adult use of a child product (Verbatim: Maladministration of Pediatric Dose on an Adult Patient). The outcome of the accidental underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-OCT-2024 The reporter asked about the administration of a Pediatric dose on an adult patient, which led to accidental underdose and adult use of a child product. The reporter did not consent follow-up from Safety Department and also did not provide any vaccination date, vaccine detail or patient demographics in this call. The reporter did not consent to follow-up.
Age: 11.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: a 12 year-old male patient received Havrix second dose adult; a 12 year-old male patient received Havrix second dose adult; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 12-year-old male patient who received HAV (Havrix adult) (batch number 3S54K, expiry date 18-DEC-2025) for prophylaxis.   On 17-OCT-2024, the patient received the 2nd dose of Havrix adult. On 17-OCT-2024, an unknown time after receiving Havrix adult, the patient experienced overdose (Verbatim: a 12 year-old male patient received Havrix second dose adult) and adult product administered to child (Verbatim: a 12 year-old male patient received Havrix second dose adult). The outcome of the overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt Date: 25-OCT-2024 Medical Assistant reported that a patient received Havrix dose adult, which led to overdose and adult product administered to child. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter.
Age: 1.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Adult dose to a 1 YO patient; Adult dose to a 1 YO patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 1-year-old male patient who received HBV (Engerix B adult) (batch number MD9SL, expiry date 08-DEC-2026) for prophylaxis.   On 25-OCT-2024, the patient received the 1st dose of Engerix B adult. On 25-OCT-2024, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: Adult dose to a 1 YO patient) and adult product administered to child (Verbatim: Adult dose to a 1 YO patient). The outcome of the overdose and adult product administered to child 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: 25-OCT-2024 There was an incident in our office at the time of reporting, where a 1 year old was given an adult Hep B vaccination, they were wondering what effects do we need to look for, which led to overdose and adult product administered to child. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: Arexvy was administered during pregnancy; Arexvy was administered 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 31-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number BL473, expiry date 13-OCT-2026) for prophylaxis.   On 25-OCT-2024, the patient received Arexvy. On 25-OCT-2024, an unknown time after receiving Arexvy, the patient experienced product use in unapproved population (Verbatim: Arexvy was administered during pregnancy). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Arexvy was administered during pregnancy). The outcome of the vaccine exposure during pregnancy and product use in unapproved population were unknown.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 35 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date: 28-OCT-2024 The reporter reported that a dose of Arexvy was administered to a pregnant women which led to, vaccine exposure during pregnancy and product use in unapproved population. The vaccine administration facility was the same as primary reporter.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: 3 years and 11 months old pateint, was administered an adult dose; Inappropriate dose/administered an adult dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 3-year-old male patient who received HAV (Havrix adult) (batch number 4T93R, expiry date 11-JUL-2026) for prophylaxis.   On 28-OCT-2024, the patient received Havrix adult. On 28-OCT-2024, an unknown time after receiving Havrix adult, the patient experienced overdose (Verbatim: 3 years and 11 months old pateint, was administered an adult dose) and adult product administered to child (Verbatim: Inappropriate dose/administered an adult dose). The outcome of the overdose and adult product administered to child were unknown.   Additional Information: GSK receipt date: 28-OCT-2024 The reporter asking for recommendations for a patient due to him getting the wrong dose of HepA (Havrix vaccine). According to reporter, patient was 3 years and 11 months old, and was administered an adult dose earlier that day which led to overdose and adult product administered to child. The vaccine administration facility was the same as primary reporter.
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-month-old male patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 332H7, expiry date 30-MAR-2025) for prophylaxis.   On 28-OCT-2024, the patient received FluLaval 2024-2025 season. On 28-OCT-2024, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-OCT-2024 The nurse reported that a dose of FluLaval vaccine was administered for a patient 1 month old which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 87.0
Sex: M
Vaccine: RSV
Symptoms: Blood pressure decreased, Mobility decreased
Clinical narrative: drop in blood pressure; patient frozen  (unmoving) while attempting to brush his teeth; This serious case was reported by a other health professional via call center representative and described the occurrence of blood pressure decreased in a 87-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 29Z7E, expiry date 01-JUL-2025) for prophylaxis.   On 31-OCT-2024, the patient received Arexvy. On 01-NOV-2024, 1 days after receiving Arexvy, the patient experienced blood pressure decreased (Verbatim: drop in blood pressure) (serious criteria other: serious as per reporter) and movements reduced (Verbatim: patient frozen  (unmoving) while attempting to brush his teeth) (serious criteria other: serious as per reporter). The outcome of the blood pressure decreased and movements reduced were unknown.   It was unknown if the reporter considered the blood pressure decreased and movements reduced to be related to Arexvy.     The company considered the blood pressure decreased and movements reduced to be unrelated to Arexvy.   Additional Information: GSK receipt date: 04-NOV-2024. The HCP reported that the patient received his AREXVY vaccine on 31st October at approximately 4:00 pm. At some time after midnight, a family member discovered the patient "frozen" (unmoving) while attempting to brush his teeth.  EMTs were called and he was transported to the ER, where they noted that his blood pressure had dropped sharply.; Sender's Comments: Blood pressure decreased and Hypokinesia are unlisted events which are considered unrelated to GSK vaccine Arexvy.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Skin lesion, Vaccination failure
Clinical narrative: lesions are at mid-waist level,sternum,around spine of left side; Suspected vaccination failure; shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In AUG-2022, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On 14-OCT-2024, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). On an unknown date, the patient experienced skin lesion (Verbatim: lesions are at mid-waist level,sternum,around spine of left side). The outcome of the vaccination failure and skin lesion were not reported and the outcome of the shingles was unknown.   It was unknown if the reporter considered the vaccination failure, shingles and skin lesion to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles and skin lesion to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 04-NOV -2024 The patient reported that he received both Shingrix doses in 2022, with the 2nd dose being in August 2022. Three weeks ago, he contracted shingles, which he stated was a pretty severe case.  The lesions were at mid-waist level and start at the sternum, wrapping around to the spine of his left side. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).
Sex: M
Vaccine: UNK
Symptoms: Angioedema, Skin reaction, Stevens-Johnson syndrome
Clinical narrative: angioedema; stevens johnson syndrome; skin reaction similar to (Angioedema and Stevens-Johnson syndrome like) after administration; This serious case was reported by a physician via call center representative and described the occurrence of angioedema in a 70-year-old male patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number PG52S, expiry date 30-JUN-2025) for prophylaxis.   On 29-OCT-2024, the patient received Fluarix 2024-2025 season. On an unknown date, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced angioedema (Verbatim: angioedema) (serious criteria GSK medically significant), stevens johnson syndrome (Verbatim: stevens johnson syndrome) (serious criteria GSK medically significant) and skin reaction (Verbatim: skin reaction similar to (Angioedema and Stevens-Johnson syndrome like) after administration). The patient was treated with epinephrine. The outcome of the angioedema, stevens johnson syndrome and skin reaction were unknown.   It was unknown if the reporter considered the angioedema, stevens johnson syndrome and skin reaction to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.     The company considered the angioedema to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device. The company considered the stevens johnson syndrome to be unrelated to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device. It was unknown if the company considered the skin reaction to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.   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: 05-NOV-2024 The patient experienced a severe skin reaction similar to Angioedema and Stevens-Johnson syndrome, that required Epinephrin treatment at an emergency room, physician wanted further guidance/assistance to this topic. The reporter stated that in ten year using flu vaccine and this had not yet happened. The vaccination date, vaccine detail and patient demographics were obtained from the Physician´s end during this call. The vaccine administration facility was the same as primary reporter.; Sender's Comments: Angioedema is a listed event which is considered related to GSK vaccine Fluarix 2024-2025 season and Fluarix PRE-FILLED SYRINGE DEVICE.  Stevens-Johnson syndrome is an unlisted event which is considered unrelated to GSK vaccine Fluarix 2024-2025 season and Fluarix PRE-FILLED SYRINGE DEVICE.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles after vaccination; This serious case was reported by a physician via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included bell's palsy (had Bell's palsy and recovered about 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles after vaccination). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 05-NOV-2024 The last year, the patient got 2 Shingrix shots and less than a year later the patient had an outbreak of shingles (this year). The reporter wanted to know why that would happen and how frequently a patient could get shingles after getting both shots. This case was considered as suspected vaccination failure as details regarding laboratory confirmation for shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (dose 1) and Shingrix (dose 2).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Hypoaesthesia
Clinical narrative: Slept 30 of 36 hours starting about 7-8 hours after administration of vaccine; Numbness in face, hands and feet; This spontaneous case was reported by a patient and describes the occurrence of HYPERSOMNIA (Slept 30 of 36 hours starting about 7-8 hours after administration of vaccine) and HYPOAESTHESIA (Numbness in face, hands and feet) in a 42-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Nov-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 03-Nov-2024, the patient experienced HYPERSOMNIA (Slept 30 of 36 hours starting about 7-8 hours after administration of vaccine) and HYPOAESTHESIA (Numbness in face, hands and feet). On 04-Nov-2024, HYPERSOMNIA (Slept 30 of 36 hours starting about 7-8 hours after administration of vaccine) and HYPOAESTHESIA (Numbness in face, hands and feet) had resolved.            No concomitant medication was reported.  It was reported that, patient had numbness in face, hands and feet and took about 10 hours to wear off after onset. Slept 30 of 36 hours starting about 7 to 8 hours after administration of vaccine.  It was unknown if the patient experienced any additional symptoms or events. Reporter causality was not reported.  No treatment information was provided.; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: pain in the muscle; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MYALGIA (pain in the muscle) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Oct-2024, the patient received first dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (pain in the muscle). At the time of the report, MYALGIA (pain in the muscle) outcome was unknown.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Patient complained about pain in the muscle because it seemed like that druggist put the injection in much higher than prior injections. Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-776610 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-776610:Same Reporter different patient
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: feeling tired for a little bit; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (feeling tired for a little bit) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (feeling tired for a little bit). At the time of the report, FATIGUE (feeling tired for a little bit) had resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medication was reported.  No treatment information was reported.   Reporter did not allow further contact
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Hypersensitivity, Pain, Pyrexia
Clinical narrative: small bumps on the left wrist which subsequently developed into blisters/similar bumps on multiple areas of her body; general aches and pains; hypersensitivity; fever; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (small bumps on the left wrist which subsequently developed into blisters/similar bumps on multiple areas of her body), PAIN (general aches and pains), HYPERSENSITIVITY (hypersensitivity) and PYREXIA (fever) in an 81-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    In September 2024, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. In 2024, the patient experienced BLISTER (small bumps on the left wrist which subsequently developed into blisters/similar bumps on multiple areas of her body), PAIN (general aches and pains), HYPERSENSITIVITY (hypersensitivity) and PYREXIA (fever). At the time of the report, BLISTER (small bumps on the left wrist which subsequently developed into blisters/similar bumps on multiple areas of her body), PAIN (general aches and pains), HYPERSENSITIVITY (hypersensitivity) and PYREXIA (fever) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Dosage text for suspect product was reported as unknown. Patient had received 5 prior doses. Usual side effects are fever and general aches and pains.  Patient got vaccinated in September 2024 usual side effects however 2 days after receiving the vaccine, developed a couple of small bumps on the left wrist which subsequently developed into blisters. Every couple of days she developed similar bumps on multiple areas of her body. Condition persisted for a month. Patient's HCP prescribed steroid cream and antihistamine to treat the hypersensitivity reaction.   This case was linked to MOD-2024-776940 (Patient Link).
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Blood test normal, Diarrhoea
Clinical narrative: Explosive diarrhea; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 63-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 12Sep2024 at 11:30 as dose number unknown, single (Batch/Lot number: unknown) at the age of 63 years, in left arm for immunisation. The patient's relevant medical history included: "breast cancer", start date: 2019 (unspecified if ongoing), notes: 2 breast cancers in 2019. Concomitant medication(s) included: LETROZOLE taken for breast cancer female. The following information was reported: DIARRHOEA (non-serious) with onset 13Sep2024 at 06:00, outcome "recovered" (Oct2024), described as "Explosive diarrhea". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of diarrhoea.  Additional information: the patient got the vaccine around 11:30 in the afternoon on a Thursday, woke up 6 to 6:30 in the morning, on Friday with explosive diarrhea that continues quite 10 hours and there is nothing else that was related to that. She has no other vaccines, nothing else, different. The patient is a licensed psychologist. Patient has post cancer. For lab work, patient stated everything was fine. Her doctor was not concerned with anything. For treatment, patient stated she took the IMODIUM (LOT: P132666, Expiration date: Nov2025) and then she could not go and then she took 'IBSOL' and it took 3 weeks for her system to finally get regulated again. (Further treatment details were not clarified). For ABRYSVO route, patient stated it was an injection. For prior vaccination patient stated, No, she spaced out her vaccines because her immune system cannot handle. Causality was reported as Yes.   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Brain fog, Neurological symptom, Pain
Clinical narrative: neurological symptoms; she cannot think. She is having brain fog; She was having pain all the time; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 01Nov2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEUROLOGICAL SYMPTOM (hospitalization), outcome "unknown", described as "neurological symptoms"; BRAIN FOG (hospitalization), outcome "unknown", described as "she cannot think. She is having brain fog"; PAIN (non-serious), outcome "unknown", described as "She was having pain all the time". The patient was hospitalized for neurological symptom, brain fog (start date: 06Nov2024). The events "neurological symptoms", "she cannot think. she is having brain fog" and "she was having pain all the time" required emergency room visit. Therapeutic measures were taken as a result of pain. On 07Nov2024 night she went to the Emergency Room and was admitted to the hospital last night last minute. However, she signed out against medical advice (AMA) because they were withholding pain medicine. She was having pain all the time and it was starting to act up.   Batch/lot number is not provided, and it cannot be obtained.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: severe COVID-19; severe COVID-19; This is a spontaneous report received from a Physician and a Consumer or other non HCP.  A 64-year-old male patient received BNT162b2 omicron (KP.2) (COMIRNATY (2024-2025 FORMULA)), on 24Oct2024 as dose 1, single (Lot number: LM2222) at the age of 64 years, in the shoulder (as reported) for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLULAVAL taken for immunisation, on 24Oct2024 as dose 1, single.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Nov2024, outcome "not recovered" and all described as "severe COVID-19". The event "severe COVID-19" required physician office visit. The clinical course was reported as follows: The patient developed severe COVID-19 with a combination of respiratory, ear-nose-and-throat (ENT), gastrointestinal (GI) symptoms, high fever, and dehydration. The patient was prescribed nirmatrelvir, ritonavir (PAXLOVID) by treating physician and started treatment on 04Nov2024. The symptoms improved after 48 hours (as reported). As of 08Nov2024, the patient had not recovered (as reported).; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported event vaccination failure and covid-19 based on the known safety profile and temporal association.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash macular, Rash vesicular
Clinical narrative: itching and red spots on his chest, back and neck and behind his ear; itching and red spots on his chest, back and neck and behind his ear; These spots are all red on his body and starting to bubble; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 64-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH VESICULAR (non-serious) with onset 2024, outcome "not recovered", described as "These spots are all red on his body and starting to bubble"; PRURITUS (non-serious), RASH MACULAR (non-serious) all with onset 2024, outcome "not recovered" and all described as "itching and red spots on his chest, back and neck and behind his ear".  Additional information: The patient got the covid vaccine 3 years ago. He stated that last week he started noticing itching and red spots on his chest, back and neck and behind his ear.  These spots are all red on his body and starting to bubble.  He's not eaten anything unusual and is not allergic to food or anything.  He looked on the internet for side effects of the vaccine and saw that it could cause itching and was wondering if this could be what was causing this. He didn't notice it until all of a sudden, the shirt he was wearing started to itch, was red all over. He started to itch, and half the chest was red.  Now, his hands and arms were red. He went online and it showed it was one of the side effects of the vaccine. It was getting worse and started to spread on his neck, by hair, behind the ear and shoulders. He called the doctor to make an appointment and will be seen 20Nov2024. He stated that he never had this before. The patient was driving and did not have the product to provide details such as NDC, lot, expiry date. Attempted to confirm product name and patient stated that he just knows it was a Pfizer Covid vaccine.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Feeling hot, Movement disorder, Pain in extremity
Clinical narrative: Severe shoulder pain; Arm pain; Weakness; No movement of my hand, it was hot, very low control of her hands; No movement of my hand, it was hot, very low control of her hands; This is a spontaneous report received from a Consumer or other non HCP.  A 33-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 25Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 33 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "Severe shoulder pain"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm pain"; ASTHENIA (non-serious), outcome "unknown", described as "Weakness"; MOVEMENT DISORDER (non-serious), FEELING HOT (non-serious), outcome "unknown" and all described as "No movement of my hand, it was hot, very low control of her hands". Therapeutic measures were taken as a result of arthralgia, pain in extremity, asthenia, movement disorder, feeling hot.  Additional information: Patient reported that she was having severe shoulder pain, arm pain, weakness, no movement of my hand, it was hot, very low control of her hands. Vaccine was administered around 7 pm. Patient was just taking Ibuprofen.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.