chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: She states today he was given bexsero at the pharmacy; 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 16-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Bexsero (received 1st dose of vaccine at age of 11 of batch number MCB4P).   On 11-JUN-2025, the patient received the 2nd dose of Bexsero. On 11-JUN-2025, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too long (Verbatim: She states today he was given bexsero at the pharmacy). The outcome of the drug dose administration interval too long was not applicable.   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: 11-JUN-2025 The reporter was the mother of the patient.  She stated his healthcare professional ordered a meningitis vaccine to be given.  She stated that on the day of reporting he was given Bexsero at the pharmacy.  The registered pharmacist who gave it stated he would need to come back for a Bexsero booster in 3 years only if he was in college. The patient received 2nd dose of Bexsero, later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Antibody test positive, Herpes zoster, Vaccination failure
Clinical narrative: Shingles; Suspected vaccination failure; Shingles; This serious case was reported by a physician via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 14-JAN-2021, the patient received the 2nd dose of Shingrix (left deltoid). On 06-NOV-2020, the patient received the 1st dose of Shingrix (left deltoid). In NOV-2024, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). In MAY-2025, the patient experienced shingles (Verbatim: Shingles). The outcome of the vaccination failure, shingles and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, shingles 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 and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 12-JUN-2025 The reporter was the patient who was also a Dentist. The patient received the first dose of Shingrix on 6th November 2020, and the second dose on 14th January 2021. Both doses were received in the left deltoid. In November 2024 the patient developed Shingles and developed Shingles again in May 2025. The patient stated that the patient did not think that the Shingrix vaccine was effective. The patient had a Varicella Zoster IgG and IgM antibody tests obtained. The IgG was reactive, but a titer was not done. The IgM was negative. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles was 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, and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2).
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: he was vaccinated with his first dose of Shingrix in July 2024; This non-serious case was reported by a consumer 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 first dose in July 2024).   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: he was vaccinated with his first dose of Shingrix in July 2024). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 12-JUN-2025 The consumer (patient) was the reporter.  The consumer mentioned that he was vaccinated with his first dose of Shingrix in July 2024. The consumer does plan to have his second dose administered as soon as possible.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain lower, Back pain, Blister, Herpes zoster, Pain
Clinical narrative: suspected vaccination failure; shingles/pain/skin was sensitive to touch/shingles lesion/blisters or bumps; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included psoriatic arthritis, gastroesophageal reflux disease, depression and hyperlipidemia. Concomitant products included upadacitinib (Rinvoq), omeprazole, vortioxetine hydrobromide (Trintellix), evolocumab (Repatha) and tirzepatide (Mounjaro).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 30-MAY-2025, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles/pain/skin was sensitive to touch/shingles lesion/blisters or bumps). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   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: 12-JUN-2025 The patient received both doses of her Shingrix vaccine beginning in April 2023. Also stated that received both doses in appropriate time frame. She began experiencing pain in her back on 29-May 2025 and she described the pain as like being punched in the kidney her skin was sensitive to touch and the pain radiated from her low back spine around the right side of abdomen to her navel.  This is where the shingles lesions erupted as well.  Some of the lesions started to open and drain, but the majority of the lesion remain as intact blisters or bumps. 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 and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2).
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Secretion discharge, Sensitive skin, Skin lesion, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles/pain/skin was sensitive to touch/shingles lesion/blisters or bumps; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included psoriatic arthritis, gastroesophageal reflux disease, depression and hyperlipidemia. Concomitant products included upadacitinib (Rinvoq), omeprazole, vortioxetine hydrobromide (Trintellix), evolocumab (Repatha) and tirzepatide (Mounjaro).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 30-MAY-2025, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles/pain/skin was sensitive to touch/shingles lesion/blisters or bumps). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   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: 12-JUN-2025 The patient received both doses of her Shingrix vaccine beginning in April 2023. Also stated that received both doses in appropriate time frame. She began experiencing pain in her back on 29-May 2025 and she described the pain as like being punched in the kidney her skin was sensitive to touch and the pain radiated from her low back spine around the right side of abdomen to her navel.  This is where the shingles lesions erupted as well.  Some of the lesions started to open and drain, but the majority of the lesion remain as intact blisters or bumps. 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 and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2).
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: I had first dose if Shingrix 5 years ago but never had the second dose; This non-serious case was reported by a consumer via interactive digital media 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 5 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: I had first dose if Shingrix 5 years ago but never had the second dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 08-JUN-2025 This case was reported by a patient via interactive digital media. The reporter reported that he/she had first dose if Shingrix 5 years ago but never had the second dose. Did the patient had to get the first dose again. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Vaccine: VARZOS
Symptoms: Herpes zoster, Paraesthesia, Swelling, Swelling of eyelid, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-JUN-2025 This case was reported by a patient via interactive digital media. The patient had the vaccine last year in 2024 and a few months ago he/she had a tingly little bump on his/her belly.  A couple days later one popped up on his/her eyelid.  It was shingles so he/she started a course of Valtrex. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: the fourth dose in May 29, 2025.; second dose in January 29, 2025, the third dose in February 25, 2025; first dose in September 3, 2025, their second dose in January 29, 2025; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 34-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix b (received 1st dose on 03-SEP-2024).   On 29-MAY-2025, the patient received the 4th dose of Engerix B. On 25-FEB-2025, the patient received the 3rd dose of Engerix B. On 29-JAN-2025, the patient received the 2nd dose of Engerix B. On 29-JAN-2025, not applicable after receiving Engerix B and Engerix B and an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: first dose in September 3, 2025, their second dose in January 29, 2025). On 25-FEB-2025, the patient experienced drug dose administration interval too short (Verbatim: second dose in January 29, 2025, the third dose in February 25, 2025). On 29-MAY-2025, the patient experienced extra dose administered (Verbatim: the fourth dose in May 29, 2025.). The outcome of the drug dose administration interval too long, drug dose administration interval too short and extra dose administered were not applicable.   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: 09-JUN-2025 A registered nurse reported that the patient received their first dose of Engerix B on 3rd September 2024, their second dose on 29th January 2025, the third dose on 25th February 2025 and the fourth dose on 29th May 2025. The nurse initially stated they wanted data about the administration of a vaccine because the intervals were shorter than recommended. They also stated the need to test for titers. The Vaccine Administration Facility was the same as Primary Reporter The patient received 2nd dose of Engerix B, later than the recommended interval, which led to lengthening of vaccination schedule. The patient received 3rd dose of Engerix B earlier than recommended interval, which led to shortening of vaccination schedule.  The patient received 4th dose of Engerix B not as per local schedule, which led to extra dose administered.; Sender's Comments:  US-GSK-US2025071746:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose was given April 8, 2025; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number H97H2, expiry date 29-MAR-2027) for prophylaxis.   Previously administered products included Shingrix (a patient received a first dose of Shingrix back in September 21, 2018).   On 08-APR-2025, the patient received the 2nd dose of Shingrix. On 08-APR-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: second dose was given April 8, 2025). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK Receipt Date: 10-JUN-2025 Pharmacist called on June 10, 2025 to report a patient received a first dose of Shingrix back in September 21, 2018 and then a second dose was given April 8, 2025. The Vaccine Administration Facility was the same as Primary Reporter. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. This case was linked with US2025072148, reported by same reporter different patient.; Sender's Comments:  US-GSK-US2025072148:case created for husband and wife
Age: 42.0
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: the 1st dose in 08-Nov-2024, will get 2nd dose today; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 43-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose on 08-Nov-2024).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: the 1st dose in 08-Nov-2024, will get 2nd dose today). The outcome of the incomplete course of vaccination was not applicable.   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: 10-JUN-2025 Pharmacist reported that the following called regarding the Twinrix dosing, if the 1st dose was like 7 months ago on 8-Nov-2024 and they would get the 2nd dose now (on 10-Jun-2025). The reporter asked that when they should get the 3rd dose or not. During the call, the reporter confirmed that they will get the 2nd dose on the day of reporting. Pharmacist reported the 1st dose received it in a different location, they did not mention which one nor the address, they just said that it was different. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
Age: 1.0
Sex: M
Vaccine: DTAP, HEP
Symptoms: Product storage error
Clinical narrative: Infanrix and Engerix B have been used in patients; This non-serious case was reported by a nurse via call center representative and described the occurrence of product storage error in a male patient who received DTPa (Infanrix) (batch number 223Y9, expiry date 07-SEP-2026) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   On 27-MAY-2025, the patient received Infanrix. On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Infanrix and Engerix B, the patient experienced product storage error (Verbatim: Infanrix and Engerix B have been used in patients). The outcome of the product storage error was not applicable.   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:  Licensed Practical Nurse requested stability data for Havrix, Kinrix, Boostrix, Infanrix, Engerix B stored at 18.8 Celsius for 9 hours 20 minutes on 17 May 2025.  The excursion was caught when doing monthly quality check. There were no prior excursions. The Infanrix vaccine and Engerix B vaccine have been used in patients which led to product storage error.
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: Administration of Priorix to adult patients; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in an unspecified number of adult patients who received MMR (Priorix) for prophylaxis.   On an unknown date, the patients received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate age at vaccine administration (Verbatim: Administration of Priorix to adult patients). The outcome of the inappropriate age at vaccine administration was not applicable.   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: 11-JUN-2025 A sales representative called to transfer over a pharmacist, who informed that lately he had been getting a lot of adult patients that requested vaccination with Priorix in his facility which led to inappropriate age at vaccine administration  No more details were provided by reporter.
Vaccine: MENB
Symptoms: Incomplete course of vaccination
Clinical narrative: Late 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 adolescent patient who received Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Bexsero (1st dose received on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incomplete course of vaccination (Verbatim: Late 2nd dose). The outcome of the incomplete course of vaccination was not applicable.   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: 11-JUN-2025 Field Representative asked for information on what to tell an adolescent if it had been longer than 6 months since their first dose of Bexsero which led to incomplete course of vaccination  Do they go ahead and give the second dose, or do they re-start the series?
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Investigation
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a consumer, Program ID.  A 65-year-old male patient received BNT162b2 Omicron (KP.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Low immunity" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The event "covid-19" required physician office visit. The patient underwent the following laboratory tests and procedures: Test: Unknown results. During an inbound call for financial assistance, the patient's wife calling on behalf of his behalf. The patient's wife just took nirmatrelvir/ritonavir (PAXLOVID) and is in the middle of it, because she had COVID-19 since the other day. The patient has a prescription, and he went to a pharmacy. After he got, took the test, got the prescription from the doctor. The patient's wife just paid the other day. The patient has a low immunity so it's more important for him to have the PAXLOVID than it was his wife. The patient was still working but he's going to have to miss a whole week of work next week and his wife was not allowed to go in until Tuesday because of the 5-day period that will be up on Tuesday. The patient's wife did take PAXLOVID, had been taking it herself. So, it was easy for patient's wife but not so much for the patient. The patient and his wife did get Pfizer COVID-19 shots. They both have COVID-19 after receiving Pfizer COVID-19 shots. The patient also had a pharmacy wherein he gets his albuterol.   The information on the batch/lot number for BNT162b2 Omicron (KP.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500071903 Same reporter, product, and event; different patient;
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Pain, Pain in extremity, Sciatica
Clinical narrative: persistent body pain; blurry vision; I had an exacerbation of existing sciatica-related pain in my lower back that extended down to my right leg, accompanied by a pulsating sensation in my middle toes.; I had an exacerbation of existing sciatica-related pain in my lower back that extended down to my right leg, accompanied by a pulsating sensation in my middle toes.; I had an exacerbation of existing sciatica-related pain in my lower back that extended down to my right leg, accompanied by a pulsating sensation in my middle toes.; vomiting; nausea; dizziness; This is a spontaneous report received from a Consumer or other non HCP.  An elderly male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 01May2025 at 15:30 as dose number 1, single (Lot number: IMM309) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SCIATICA (non-serious), SENSORY DISTURBANCE (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 01May2025 at 18:00, outcome "not recovered" and all described as "I had an exacerbation of existing sciatica-related pain in my lower back that extended down to my right leg, accompanied by a pulsating sensation in my middle toes."; VISION BLURRED (non-serious) with onset 01May2025 at 18:00, outcome "not recovered", described as "blurry vision"; DIZZINESS (non-serious) with onset 01May2025 at 18:00, outcome "not recovered"; NAUSEA (non-serious) with onset 01May2025 at 18:00, outcome "not recovered"; PAIN (non-serious) with onset 01May2025 at 18:00, outcome "not recovered", described as "persistent body pain"; VOMITING (non-serious) with onset 01May2025 at 18:00, outcome "not recovered". Therapeutic measures were not taken as a result of pain, vision blurred, sciatica, sensory disturbance, pain in extremity, vomiting, nausea, dizziness.  Additional information: Vaccine was administered at Doctor's office/urgent care. The patient didn't receive any other vaccines on the same date or within 4 weeks prior to Comirnaty vaccine. Device Date: 16Jun2025.
Sex: M
Vaccine: COVID19
Symptoms: Sensory disturbance, Vision blurred, Vomiting
Clinical narrative: persistent body pain; blurry vision; I had an exacerbation of existing sciatica-related pain in my lower back that extended down to my right leg, accompanied by a pulsating sensation in my middle toes.; I had an exacerbation of existing sciatica-related pain in my lower back that extended down to my right leg, accompanied by a pulsating sensation in my middle toes.; I had an exacerbation of existing sciatica-related pain in my lower back that extended down to my right leg, accompanied by a pulsating sensation in my middle toes.; vomiting; nausea; dizziness; This is a spontaneous report received from a Consumer or other non HCP.  An elderly male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 01May2025 at 15:30 as dose number 1, single (Lot number: IMM309) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SCIATICA (non-serious), SENSORY DISTURBANCE (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 01May2025 at 18:00, outcome "not recovered" and all described as "I had an exacerbation of existing sciatica-related pain in my lower back that extended down to my right leg, accompanied by a pulsating sensation in my middle toes."; VISION BLURRED (non-serious) with onset 01May2025 at 18:00, outcome "not recovered", described as "blurry vision"; DIZZINESS (non-serious) with onset 01May2025 at 18:00, outcome "not recovered"; NAUSEA (non-serious) with onset 01May2025 at 18:00, outcome "not recovered"; PAIN (non-serious) with onset 01May2025 at 18:00, outcome "not recovered", described as "persistent body pain"; VOMITING (non-serious) with onset 01May2025 at 18:00, outcome "not recovered". Therapeutic measures were not taken as a result of pain, vision blurred, sciatica, sensory disturbance, pain in extremity, vomiting, nausea, dizziness.  Additional information: Vaccine was administered at Doctor's office/urgent care. The patient didn't receive any other vaccines on the same date or within 4 weeks prior to Comirnaty vaccine. Device Date: 16Jun2025.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: both had Covid after receiving Pfizer Covid Shots/had COVID-19; both had Covid after receiving Pfizer Covid Shots/had COVID-19; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "both had Covid after receiving Pfizer Covid Shots/had COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was calling on behalf of her husband, but she just took Paxlovid, she's in the middle of it because she had COVID-19. They both had Covid after receiving Pfizer Covid Shots.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500122715 Same reporter/drug/event; different patients;
Vaccine: COVID19
Symptoms: Autoimmune disorder
Clinical narrative: Pfizr Covid vaccines 2021 created in me autoimmune disorder; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) 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: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "Pfizr Covid vaccines 2021 created in me autoimmune disorder". Pfizr Covid vaccines 2021 created in patient autoimmune disorder so rhmaologist doctor won't let patient do more rna types.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Vaccine: MEN
Symptoms: No adverse event, Product preparation error
Clinical narrative: one of their providers mistakenly mixed sterile water diluent with MENQUADFI and a patient received it with no reported AE; Initial information received on 16-Jun-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who had received  Meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi] which was mistakenly mixed with sterile water diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 12-Jun-2025, the patient received an unknown  dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine, Solution for injection, lot U8494AA,expiry date: 30-Jun-2028, Frequency = once, Strength = standard via unknown route in unknown administration site for immunization which was mistakenly mixed with sterile water diluent with no reported adverse event (product preparation error) (latency: same day).  Reportedly, Vaccine program coordinator called saying that one of their providers mistakenly mixed sterile water diluent with MENQUADFI and a patient received it. They wanted to confirm if the patient should be revaccinated  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: inappropriate use due to a nurse accidentally administering ACT-HIB reconstituted with only sterile water as diluent to a patient with no reported adverse event; Initial information received on 17-Jun-2025 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 1 years old male patient who had inappropriate use due to a nurse accidentally administering HIB (PRP/T) vaccine [ACT-HIB] reconstituted with only sterile water as diluent to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel) for Immunisation.  On 11-Jun-2025, the patient accidentally administering an unknown dose (0.5ml) of suspect HIB (PRP/T) vaccine; Powder and solvent for solution for injection with strength: standard (lot UK201AC with expiry date 20-APR-2026) via intramuscular route in the right thigh for Immunization; act-hib reconstituted with only sterile water as diluent to a patient with no reported adverse event (product preparation error) (latency: same day)  Reportedly: patient was Not pregnant. Patient age was less then 1 year. their nurses accidentally administered ACT-HIB reconstituted using only sterile water as diluent to a patient. She called to check if this was considered as a valid dose.   Action taken was not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Expired vaccine only due to the fact that it was out of the freezer longer and in the refrigerator longer than manufacturer recommendation. No side effects or symptoms during occurrence
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pt reported no adverse reaction. Pt was just given expired vaccine .
Age: 56.0
Sex: F
Vaccine: HEP, HEPA, PNC20, TDAP, VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Patient called to report soreness and swelling in the arms following vaccines given the prior day with one arm (left) being more swollen
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse events, it was a wrong dose because two doses got administered instead of 1. first in february 2025 and second in june 2025
Age: 0.25
Sex: F
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Injection site discolouration
Clinical narrative: Parents report a small brown spot on child's right thigh which they first noticed about a day after vaccines were given. Parents deny any other symptoms at this time. When examining child's leg, small brown spot was noted on right thigh, similar to a mole. Spot is not raised to the touch and child does not seem to have any discomfort when pressing down on the spot. Advised parents to keep an eye on the right thigh and report any changes in size, any swelling or raising of small spot, or any other changes to the leg that they can observe as soon as possible. Advised parents that vaccines given today would both be given on left thigh to avoid aggravating skin, muscle, or any other tissue irritation the previous vaccine could have caused. Advised parents to report any changes to child's left thigh after today's vaccines although combination vaccine is different. Parent voiced understanding.
Age: 65.0
Sex: F
Vaccine: PNC21
Symptoms: Chills, Hypoaesthesia, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Pt received capvaxive on 6/11. Starting that night pt c/o chills and body aches. Then on 6/14, pt c/o L arm numbness so pt took gabapentin and it made her even more fatigued.  On 6/15, pt c/o L arm swelling and redness where pt received the vaccine. Pt states the area is very hard to the touch. Today, her symptoms improved, so she no longer has chills and body aches but still has some swelling and redness near injection site plus L arm numbness. Med taken: tylenol 500 mg 2po bid  Patient was seen at office on 06/16/25 for eval.  Exam: mild erythema and swelling 10 x 8 cm. no fluctuance Treatment: Rx cetirizine 10 mg prn, tylenol 500mg qid prn
Age: 65.0
Sex: F
Vaccine: PNC21
Symptoms: Muscle fatigue, Pain
Clinical narrative: Pt received capvaxive on 6/11. Starting that night pt c/o chills and body aches. Then on 6/14, pt c/o L arm numbness so pt took gabapentin and it made her even more fatigued.  On 6/15, pt c/o L arm swelling and redness where pt received the vaccine. Pt states the area is very hard to the touch. Today, her symptoms improved, so she no longer has chills and body aches but still has some swelling and redness near injection site plus L arm numbness. Med taken: tylenol 500 mg 2po bid  Patient was seen at office on 06/16/25 for eval.  Exam: mild erythema and swelling 10 x 8 cm. no fluctuance Treatment: Rx cetirizine 10 mg prn, tylenol 500mg qid prn
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Computerised tomogram head normal
Clinical narrative: 6/18/25 - Patient said after obtaining Spikevax (5/5/25), she developed Bells Palsys about a week after. She had nerve sensation on the left side of her face, so she went to the emergency room to rule out stroke. The CAT scan ruled out stroke. She is currently obtaining PT and it is getting better. Pt also noted that she have past medical history of Bells Palsy many decades ago, that have been resolved.
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Death
Clinical narrative: Patient Died 5 days after
Vaccine: DTPPVHBHPB, RVX
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called to report inadvertent administration of ROTATEQ and VAXELIS after a temperature excursion that occurred on 07MAY2025. ROTATEQ and VAXELIS were administered to a patient on 28MAY2025.; This spontaneous report was received from a Nurse and refers to a 2-month-old patient of unknown gender.   The patient's medical history, concurrent conditions, concomitant therapies, previous drugs reactions and allergies were not reported.   On 28-May-2025, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) administered as prophylaxis (strength, Lot No, expiration date, dose number, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided), also with an improperly stored dose of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus (VAXELIS) (indication, strength, Lot No, expiration date, dose number, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided); after a temperature excursion of 1.4 degree Celsius (C) during a time frame of 18 minutes that occurred (on 07-May-2025) (product storage error). No previous temperature excursions were reported. No additional adverse events or PQC were provided (no adverse event).
Sex: M
Vaccine: VARZOS
Symptoms: Colonoscopy, Fall, Glaucoma, Memory impairment, Mobility decreased
Clinical narrative: diagnosed with Parkinson's Disease; Glaucoma; Form of cancer; Fall; could not get up; This serious case was reported by a consumer via call center representative and described the occurrence of parkinson's disease in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included heart disorder (Heart trouble is unspecified).   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 parkinson's disease (Verbatim: diagnosed with Parkinson's Disease) (serious criteria GSK medically significant), glaucoma (Verbatim: Glaucoma) (serious criteria GSK medically significant), cancer (Verbatim: Form of cancer) (serious criteria GSK medically significant), fall (Verbatim: Fall) and mobility decreased (Verbatim: could not get up). The outcome of the parkinson's disease, glaucoma, cancer and fall were unknown and the outcome of the mobility decreased was not reported.   It was unknown if the reporter considered the parkinson's disease, glaucoma, cancer, fall and mobility decreased to be related to Shingrix.     The company considered the parkinson's disease, glaucoma and cancer to be unrelated to Shingrix. It was unknown if the company considered the fall and mobility decreased to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-JUN-2025 The reporter was the patient. The patient received both doses of Shingrix vaccine several years ago. In 2023 or 2024, the patient was diagnosed with Parkinson's opposes disease. The patient stated that he had trouble with his memory, it was unclear how long the patient was just diagnosed with glaucoma, and was currently using eye drops to treat this. The patient recently had a colonoscopy and was told that it was possible that he might have a form of cancer. The patient reported that he had fallen 6 times in which he could not get up. The patient had limited contact information for the healthcare professional.; Sender's Comments: Parkinson's disease, Glaucoma and Neoplasm malignant are unlisted events which are considered unrelated to GSK vaccine Shingrix.
Sex: M
Vaccine: VARZOS
Symptoms: Neoplasm malignant, Parkinson's disease
Clinical narrative: diagnosed with Parkinson's Disease; Glaucoma; Form of cancer; Fall; could not get up; This serious case was reported by a consumer via call center representative and described the occurrence of parkinson's disease in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included heart disorder (Heart trouble is unspecified).   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 parkinson's disease (Verbatim: diagnosed with Parkinson's Disease) (serious criteria GSK medically significant), glaucoma (Verbatim: Glaucoma) (serious criteria GSK medically significant), cancer (Verbatim: Form of cancer) (serious criteria GSK medically significant), fall (Verbatim: Fall) and mobility decreased (Verbatim: could not get up). The outcome of the parkinson's disease, glaucoma, cancer and fall were unknown and the outcome of the mobility decreased was not reported.   It was unknown if the reporter considered the parkinson's disease, glaucoma, cancer, fall and mobility decreased to be related to Shingrix.     The company considered the parkinson's disease, glaucoma and cancer to be unrelated to Shingrix. It was unknown if the company considered the fall and mobility decreased to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-JUN-2025 The reporter was the patient. The patient received both doses of Shingrix vaccine several years ago. In 2023 or 2024, the patient was diagnosed with Parkinson's opposes disease. The patient stated that he had trouble with his memory, it was unclear how long the patient was just diagnosed with glaucoma, and was currently using eye drops to treat this. The patient recently had a colonoscopy and was told that it was possible that he might have a form of cancer. The patient reported that he had fallen 6 times in which he could not get up. The patient had limited contact information for the healthcare professional.; Sender's Comments: Parkinson's disease, Glaucoma and Neoplasm malignant are unlisted events which are considered unrelated to GSK vaccine Shingrix.
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: intramuscular versus subcutaneous administration of PRIORIX.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a female patient who received MMR (Priorix) (batch number 7975C, expiry date 01-MAR-2027) for prophylaxis.   On an unknown date, the patient received Priorix (intramuscular use). On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: intramuscular versus subcutaneous administration of PRIORIX.). The outcome of the subcutaneous injection formulation administered by other route was not applicable.   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: 11-JUN-2025 Bachelor of Science in Nursing called to ask, are there any safety concerns regarding the intramuscular versus subcutaneous administration of Priorix which led to incorrect route of product administration. Vaccine details and patient demographics were obtained in this call. No vaccination was confirmed from the Bachelor of Science in Nursing's end. No further information was obtained in this call. The vaccine administration facility was the same as primary reporter.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Nausea, Pain, Pain in extremity
Clinical narrative: sweats; sore arm; Fever; chills; nausea/ vomiting; nausea/ vomiting; aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches), HYPERHIDROSIS (sweats), PAIN IN EXTREMITY (sore arm), PYREXIA (Fever) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jun-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 13-Jun-2025, the patient experienced PAIN (aches), PAIN IN EXTREMITY (sore arm), PYREXIA (Fever), CHILLS (chills), NAUSEA (nausea/ vomiting) and VOMITING (nausea/ vomiting). On an unknown date, the patient experienced HYPERHIDROSIS (sweats). At the time of the report, PAIN (aches), HYPERHIDROSIS (sweats), PAIN IN EXTREMITY (sore arm), PYREXIA (Fever), CHILLS (chills), NAUSEA (nausea/ vomiting) and VOMITING (nausea/ vomiting) was resolving.      The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown.   No concomitant medications were reported.  It was unknown if the patient experienced any additional symptoms or events.  No treatment medications were reported.