chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Chills, Fatigue, Injection site pain, Injection site swelling, Loss of personal independence in daily activities
Clinical narrative: For two days patient experienced symptoms that interfered with ability to perform activities of daily living. Patient experienced severe exhaustion, moderate body aches, chills, fever, frequent urination, and a very swollen and painful arm of the injection site.
Age: 38.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Pain, Pollakiuria, Pyrexia
Clinical narrative: For two days patient experienced symptoms that interfered with ability to perform activities of daily living. Patient experienced severe exhaustion, moderate body aches, chills, fever, frequent urination, and a very swollen and painful arm of the injection site.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Hepatic failure, Intermenstrual bleeding, Malaise
Clinical narrative: 3 days following vaccination for 1 one I spotted I was due for my regular menstruation . I only spotted twice in one day and it went away . I ignored it thinking it was stress because I just took my dad off life support with Covid.  I received second shot 4/22/24  also Pfizer  EW0158 . I never got my menstruation again . I get ill very easily and now in November of 24 My liver is failing .
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Chest X-ray, Influenza virus test, SARS-CoV-2 test positive
Clinical narrative: 1-1-2025. Tested for flu and covid.  Covid was positive in the emergency room.
Age: 18.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Dizziness, Syncope
Clinical narrative: PATIENT WAS SEATED AND REPORTED FEELING FAINT ABOUT 1 MINUTE AFTER BOTH VACCINES THEN FAINTED.  i APPLIED A COOL PACK SHE CAME TO ABOUT A MINUTE LATER, DRANK SOME WATER THEN FELT A LITTLE NAUSEOUSE BUT DID NOT THROW UP.  SHE THEN ASKED TO LIE DOWN AND WE HAD HER LIE DOWN FOR A FEW MINUTES AFTER WHICH SHE SAID SHE FELT MUCH BETTER.  SHE THEN REMAINED FOR A FEW MORE MINUTES THEN LEFT WITH A FAMILY MEMBER
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy skin abnormal, Folliculitis
Clinical narrative: I had all the vaccines and had no problem or reaction after them. However, around December of the same year, I started having problems with my scalp and visited many doctors and had 3 biopsies and they all confirmed that I had FOLLICULITIS. Had many medications which included antibiotics, shampoos, creams, injections in my head, visited all together 33 dermatologists including one at a Clinic, and unable to help me. Some of the medications gave me serious side effects and had to be changed. Right now I have an appointment with another dermatologist and I would like to know if I can be a candidate to use the  Photodymamic Treatment or (Blue Light) as my last resort. Since 2022 until today 2025 I have this problem, and unable to find a cure.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Folliculitis
Clinical narrative: I had all the vaccines and had no problem or reaction after them. However, around December of the same year, I started having problems with my scalp and visited many doctors and had 3 biopsies and they all confirmed that I had FOLLICULITIS. Had many medications which included antibiotics, shampoos, creams, injections in my head, visited all together 33 dermatologists including one at a Clinic, and unable to help me. Some of the medications gave me serious side effects and had to be changed. Right now I have an appointment with another dermatologist and I would like to know if I can be a candidate to use the  Photodymamic Treatment or (Blue Light) as my last resort. Since 2022 until today 2025 I have this problem, and unable to find a cure.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy, Folliculitis
Clinical narrative: I had all the vaccines and had no problem or reaction after them. However, around December of the same year, I started having problems with my scalp and visited many doctors and had 3 biopsies and they all confirmed that I had FOLLICULITIS. Had many medications which included antibiotics, shampoos, creams, injections in my head, visited all together 33 dermatologists including one at a Clinic, and unable to help me. Some of the medications gave me serious side effects and had to be changed. Right now I have an appointment with another dermatologist and I would like to know if I can be a candidate to use the  Photodymamic Treatment or (Blue Light) as my last resort. Since 2022 until today 2025 I have this problem, and unable to find a cure.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Duplicate vaccination 12/21/23 and 12/31/24
Age: 77.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Duplicate RSV vaccination on 12/21/23 and 12/31/24
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspepsia, Pain
Clinical narrative: Severe pain from heartburn. Although I suffer from GERD, I RARELY have heartburn and when I have in the past, it has NEVER been this severe. This continued for 3-4 hours at a high level and continued at a minor level for another two days.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Oxygen saturation decreased, Rash macular, Stridor
Clinical narrative: WITH IN 2 MINUTES AFTER VACCINE PATIENT BEGAN TO HAVE RED SPLOTCHY SKIN, THEN STRIDER IN BREATHING COULD BE HEARD AND HER O2 SATURATION WENT DOWN.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Received a second RSV vaccine (Abrysvo) on 01/04/2025 after receiving Arexvy on 03/02/2024. No adverse effects.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Asthenia, Developmental regression, Hypotonia
Clinical narrative: Hypotonia.Reported to pediatrician regression of my sons muscle usage around Nov 2023, (was sitting up  almost unassisted holding head and  babbling/cooing) then no longer did these things until over  9months. Unable to sit up till 10months unassisted. His babbling had disappeared and did not resurface till 11months.  He was delayed, but not as severe and started to catch up. He was starting to get functions back by his one year checkup. I still voiced many concerns, again. He received the same vaccination PENTACEL on 04/22/2024 at his  ONE year check along with HepB. I self referred to State Program early May 2024, although they noted  delays,  he did not qualify for services. He became hypotonic again and lost the ability to crawl early June 2024  and after first steps had already seen him.. Come August,  I had State Program come in again and re-evaluate him again, in which he qualified due to  speech regression (loss of words) and poor mobility. I also had his 16m checkup in AUGUST 2024 which is when NP and I talked more aggressively about my concerns and the state he falls into after vaccination appearing to be hypotonic state, and we ordered outpatient aggressive  therapy. State Program CAUGHT THE CHANGE from 12-16months. Outpatient therapy report shows the staged age he was at during initial evaluation to his and low muscle tone/strength. We finally seen neurology 9months after the last hypotonic episode, and he found no birth defects, muscle concerns and had no answer for why my son falls into the hypotonic/low muscle tone state after the vaccination.
Age: 53.0
Sex: M
Vaccine: PNC20
Symptoms: Eye irritation, Feeling cold, Headache, Injection site pain, Malaise
Clinical narrative: Feeling ill, sore throat, eye burning, headache, sore arm at site of injection, cold, feeling cold, fever
Age: 53.0
Sex: M
Vaccine: PNC20
Symptoms: Nasopharyngitis, Oropharyngeal pain, Pyrexia
Clinical narrative: Feeling ill, sore throat, eye burning, headache, sore arm at site of injection, cold, feeling cold, fever
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: After receiving vaccine, patient stated that they waited in their car and began experiencing pain, tingling, numbness, and weakness in right arm after 10 minutes.
Age: 28.0
Sex: M
Vaccine: PNC20
Symptoms: Blister, Injection site erythema, Injection site pain, Nausea, Pyrexia
Clinical narrative: Bulla yellow in color close to the vaccination site, significant erythema (still extending) and pain, nausea, fever
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Persistent migraine 21 days level 8 on 1-10 scsle
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5
Symptoms: Crying, Injection site induration, Injection site swelling, Irritability, Pyrexia
Clinical narrative: RIGHT LEG AT INJECTION SITE SWOLLEN AND HARD, HIGH FEVER GREATER THAN 3 DAYS, IRRITABILITY AND CONSTANT CRYING.; RIGHT LEG AT INJECTION SITE SWOLLEN AND HARD, HIGH FEVER GREATER THAN 3 DAYS, IRRITABILITY AND CONSTANT CRYING.; RIGHT LEG AT INJECTION SITE SWOLLEN AND HARD, HIGH FEVER GREATER THAN 3 DAYS, IRRITABILITY AND CONSTANT CRYING.; RIGHT LEG AT INJECTION SITE SWOLLEN AND HARD, HIGH FEVER GREATER THAN 3 DAYS, IRRITABILITY AND CONSTANT CRYING.; RIGHT LEG AT INJECTION SITE SWOLLEN AND HARD, HIGH FEVER GREATER THAN 3 DAYS, IRRITABILITY AND CONSTANT CRYING.; This non-serious spontaneous safety report, with reference number 2777135-1, was received by a partner on 23-SEP-2024 and forwarded to agency on 25-SEP-2024 from a regulatory authority.   The reporter did not assess the causal relationship between Vaxelis and the reported events of "right leg at injection site swollen and hard, high fever greater than 3 days, irritability and constant crying."   Due to the nature of the event, the causality between the event "right leg at injection site swollen and hard, high fever greater than 3 days, irritability and constant crying." and Vaxelis was not applicable.   Further information is not expected.  This duplicate case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 16-OCT-2024 with the following VAERS Primary ID 2777135-1. The original narrative from the sender is the following:  Right leg at injection site swollen and hard, high fever greater than 3 days, irritability and constant crying.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC15
Symptoms: Swelling, Wheezing
Clinical narrative: Patient came in 07-16-2024. For swelling and wheezing.; Patient came in 07-16-2024. For swelling and wheezing.; This non-serious spontaneous safety report, with reference number: 2779988-1 was received by a partner on 23-SEP-2024 and forwarded to agency on 27-SEP-2024 from a healthcare professional.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events; "Patient came in 07-16-2024. For swelling and wheezing."  Further information is not expected.  This duplicate case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 16-OCT-2024 with the following VAERS Primary ID 2779988-1. The original narrative from the sender is the following:  Patient came in 07-16-2024. For swelling and wheezing.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC15
Symptoms: Crying, Injection site erythema, Injection site mass, Pyrexia, Sleep disorder
Clinical narrative: Has a non-red knot on the RAT; never slept; mom called on 07/22/2024 1318 to report her son cried for 3 days straight and never slept; ran a fever off/on; This non-serious spontaneous safety report, with reference number: 2780719-1 was received by a partner on 23-SEP-2024 and forwarded to agency on 27-SEP-2024 from a healthcare professional.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events.   Further information is not expected.  This duplicate case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 16-OCT-2024 with the following VAERS Primary ID 2780719-1. The original narrative from the sender is the following:  Mom called on 07/22/2024 1318 to report her son cried for 3 days straight and never slept. Has a non-red knot on the RAT and ran a fever off/on and  she alternated tyl/Ibuprofen and used cool compresses on the leg but is still concerned because the knot is still there.  Mom reports not taking the child to the ER nor the pediatrician.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No reaction; Vaccination given in error; Nurse practitioner reported to him today that VAXELIS was given to a 20-year-old patient; This non-serious spontaneous safety report with reference number # 02238408, was received by partner on 25-SEP-2024 and forwarded to agency on 26-SEP-2024 from a health care professional.  Due to the nature of the event "Nurse practitioner reported to him today that VAXELIS was given to a 20-year-old patient", the causality assessment between Vaxelis and the Product administered to patient of inappropriate age is not applicable.  Further information is expected.  Significant Follow-up information was received by the partner on 14-OCT-2024 and forwarded to agency on 14-OCT-2024, from other health professional. The case is maintained as non-serious.  Due to the nature of the event, the causality between the event 'Vaccination given in error', 'Nurse practitioner reported to him today that VAXELIS was given to a 20-year-old patient' and Vaxelis was not applicable.  Further information is not expected.  Significant Follow-up information was during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 16-OCT-2024 with the following VAERS Primary ID 2792808.   Due to the nature of the event, the causality between the event patient of inappropriate age/No adverse reaction was not applicable.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5
Symptoms: Livedo reticularis
Clinical narrative: PATIENT BOTH LEG GOT MOTTLED AFTER RECEIVING THE VACCINES FOR ABOUT 20 MINUTES. *ARE WE ABLE TO GIVE HIS 4 MONTHS VACCINE; This non-serious spontaneous safety report, with reference number 2794415-1, was received by partner on 12-NOV-2024 and forwarded to agency on 15-NOV-2024 from other health professional.   The reporter did not provide an assessment of causal relationship between Vaxelis and the reported event.  Further information is not expected.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Brain fog, Dizziness, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory
Clinical narrative: brain fog; felt dizzy; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 72-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 05Sep2024 as dose 1, single (Batch/Lot number: unknown) intramuscular, in right arm for covid-19 immunization; influenza vaccine (INFLUENZA VACCINE), on 05Sep2024 as dose number unknown, single) for immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1, SINGLE), for COVID-19 immunization; Comirnaty (DOSE 2, SINGLE), for COVID-19 immunization; Comirnaty (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: DIZZINESS (medically significant) with onset Sep2024, outcome "not recovered", described as "felt dizzy"; BRAIN FOG (non-serious), outcome "unknown". The event "felt dizzy" required physician office visit. The patient underwent the following laboratory tests and procedures: Echocardiogram: Unknown results; Electrocardiogram: Unknown results; Electrocardiogram ambulatory: Unknown results; Magnetic resonance imaging: Unknown results; Ultrasound scan: Unknown results. Therapeutic measures were taken as a result of dizziness.  Clinical course: This was regarding the Comirnaty vaccine. Patient had her last dose on 05Sep2024, her 4th dose of Comirnaty vaccine (in 4 years) and then a week later (on 12Sep2024) she felt dizzy, and then also she had been feeling dizzy up until today (date of reporting). So, she had been checked by her doctor, she went to PT, neurologist, cardiologist, nobody knew how long this was going to last, she tried different remedies (Further not clarified hence captured as Unspecified medication) but it was not working she was still getting dizzy. She would like to know if this was normal, and she added brain fog as one of her symptoms. It had been 106 days of dizziness, not good. Patient took Dramamine one pill twice a day, for dizziness as treatment. Patient administered Flu vaccine (Unspecified Flu Vaccine) on same date with the Pfizer vaccine. Patient had a EKG, MRI, Echocardiogram, Ultrasound, Holter monitor and on 01Jan2025 (tomorrow), patient giving a stress test.  Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Magnetic resonance imaging, Ultrasound scan
Clinical narrative: brain fog; felt dizzy; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 72-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 05Sep2024 as dose 1, single (Batch/Lot number: unknown) intramuscular, in right arm for covid-19 immunization; influenza vaccine (INFLUENZA VACCINE), on 05Sep2024 as dose number unknown, single) for immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1, SINGLE), for COVID-19 immunization; Comirnaty (DOSE 2, SINGLE), for COVID-19 immunization; Comirnaty (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: DIZZINESS (medically significant) with onset Sep2024, outcome "not recovered", described as "felt dizzy"; BRAIN FOG (non-serious), outcome "unknown". The event "felt dizzy" required physician office visit. The patient underwent the following laboratory tests and procedures: Echocardiogram: Unknown results; Electrocardiogram: Unknown results; Electrocardiogram ambulatory: Unknown results; Magnetic resonance imaging: Unknown results; Ultrasound scan: Unknown results. Therapeutic measures were taken as a result of dizziness.  Clinical course: This was regarding the Comirnaty vaccine. Patient had her last dose on 05Sep2024, her 4th dose of Comirnaty vaccine (in 4 years) and then a week later (on 12Sep2024) she felt dizzy, and then also she had been feeling dizzy up until today (date of reporting). So, she had been checked by her doctor, she went to PT, neurologist, cardiologist, nobody knew how long this was going to last, she tried different remedies (Further not clarified hence captured as Unspecified medication) but it was not working she was still getting dizzy. She would like to know if this was normal, and she added brain fog as one of her symptoms. It had been 106 days of dizziness, not good. Patient took Dramamine one pill twice a day, for dizziness as treatment. Patient administered Flu vaccine (Unspecified Flu Vaccine) on same date with the Pfizer vaccine. Patient had a EKG, MRI, Echocardiogram, Ultrasound, Holter monitor and on 01Jan2025 (tomorrow), patient giving a stress test.  Batch/lot number is not provided, and it cannot be obtained.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Breast cancer female, Breast mass, Diarrhoea, Dizziness, Vomiting
Clinical narrative: Patient reported dizziness, vomiting and diarrhea the day she got her vaccine.  Recently, the patient had a lump in her breast and was diagnosed with cancer.  The patient reported this happened 3 months after receiving her flu vaccine and asked that this be reported.
Age: 29.0
Sex: F
Vaccine: UNK, UNK, FLU3, TDAP
Symptoms: Chills, Exposure during pregnancy, Headache, Pain, Pyrexia
Clinical narrative: Patient stated she had fever, headache, blurry vision, diarrhea and vomiting in the two days after the vaccine
Age: 29.0
Sex: F
Vaccine: UNK, UNK, FLU3, TDAP
Symptoms: Diarrhoea, Headache, Pyrexia, Vision blurred, Vomiting
Clinical narrative: Patient stated she had fever, headache, blurry vision, diarrhea and vomiting in the two days after the vaccine
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: gave an expired vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number X9HS4, expiry date 25-MAR-2024) for prophylaxis.   On an unknown date, the patient received Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: gave an expired vaccine). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-DEC-2024 The licensed practical nurse reported that one of their nurses in their office gave an expired dose of Pediarix vaccine , which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: developed chicken pox on her feet; This non-serious case was reported by a consumer via call center representative and described the occurrence of chickenpox in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced chickenpox (Verbatim: developed chicken pox on her feet). The outcome of the chickenpox was unknown.   It was unknown if the reporter considered the chickenpox to be related to Shingrix.     It was unknown if the company considered the chickenpox to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-DEC-2024 The patient self-reported this case. The patient received the first dose of Shingrix she developed chicken pox on her feet.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose was in "January 2022, 2nd dose was October 2024 of this year; 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 adult female patient who received Herpes zoster (Shingrix) (batch number E7335, expiry date 15-JUN-2026) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in January 2022).   In OCT-2024, the patient received the 2nd dose of Shingrix. In OCT-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose was in "January 2022, 2nd dose was October 2024 of this year). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 16-DEC-2024 The pharmacist reported that the patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-month-old female patient who received Hib (Hiberix) (batch number YJ4KC, expiry date 14-DEC-2024) for prophylaxis.   On 16-DEC-2024, the patient received the 4th dose of Hiberix. On 16-DEC-2024, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: Expired dose administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt date: 16-DEC-2024 Nurse stated they administered an expired dose of Hiberix, which led to expired vaccine used. The reporter explained that the patient already received 3 prior doses of Haemophilus influenzae type b vaccine, but they did not have dates of administration of those 3 doses. The reporter consented to follow up.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: received an expired Engerix-B Vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received HBV (Engerix B) (batch number ZP72S, expiry date 15-DEC-2024) for prophylaxis.   On 16-DEC-2024, the patient received Engerix B (intramuscular). On 16-DEC-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: received an expired Engerix-B Vaccine). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-DEC-2024 The reporter calling to report one of their patients received an expired Engerix-B Vaccine at the time of reporting, which led to expired vaccine used. The reporter consented to follow up.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: expired dose of Priorix was accidentally given to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 3-year-old female patient who received MMR (Priorix) (batch number LG722, expiry date 01-DEC-2024) for prophylaxis.   On 16-DEC-2024, the patient received the 1st dose of Priorix. On 16-DEC-2024, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: expired dose of Priorix was accidentally given to a patient). 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:16-DEC-2024 A nurse practitioner contacted GSK to report that an expired dose of Priorix was accidentally given to a patient , which led to expired vaccine used. The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administer to a patient less than 50 years of age; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate age at vaccine administration in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: administer to a patient less than 50 years of age). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 18-DEC-2024 The medical office manager reported that Shingrix was administered to a patient less than 50 years of age. The patient received a dose of Shingrix at an inappropriate age, which led to inappropriate age at vaccine administration.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: administration of a second dose of Shingrix 2 years after the initial dose.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 82-year-old female patient who received Herpes zoster (Shingrix) (batch number HN24H) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: administration of a second dose of Shingrix 2 years after the initial dose.). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 18-DEC-2024 The healthcare professional reported about the administration of a second dose of Shingrix 2 years after the initial dose. 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.
Age: 40.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: a patient accidentally received their first Havrix dose, but it was expired; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 40-year-old male patient who received HAV (Havrix) (batch number 95DB2, expiry date 13-DEC-2024) for prophylaxis.   On 23-DEC-2024, the patient received the 1st dose of Havrix. On 23-DEC-2024, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: a patient accidentally received their first Havrix dose, but it 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: 23-DEC-2024 The reporter called to report that a patient accidentally received their first Havrix dose, but it was expired, which led to expired vaccine used. The data about the vaccine, patient and event given. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Influenza
Clinical narrative: Diarrhea; Initial information received on 01-Jan-2025 regarding an unsolicited valid social media non-serious case received from a Patient.  This case involves Adult female patient who experienced diarrhea after receiving Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in Aug-2024, the patient received an unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (strength, expiry date, lot number not reported) via unknown route in unknown administration site for immunization.Information regarding batch number corresponding to the one at time of event occurrence is requested.  On an unknown date the patient developed diarrhea (diarrhoea) (unknown latency) following the administration of Influenza Vaccine.  Reportedly,Had it in August, the big one "flu/covid"..diarrhea for 10 days. Today was diagnosed with the "flu".  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (Diarrhea).  At time of reporting, the outcome was Unknown for the event diarrhea.
Sex: M
Vaccine: FLU3
Symptoms: Nasopharyngitis, Underdose
Clinical narrative: development of cold like symptom; they are not sure the patient received a full dose/underdose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of cold symptoms in a 3-year-old male patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number 745P4, expiry date 30-JUN-2025) for prophylaxis.   On 07-DEC-2024, the patient received Fluarix 2024-2025 season. On 07-DEC-2024, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced underdose (Verbatim: they are not sure the patient received a full dose/underdose). On an unknown date, the patient experienced cold symptoms (Verbatim: development of cold like symptom). The outcome of the cold symptoms and underdose were unknown.   It was unknown if the reporter considered the cold symptoms to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.     It was unknown if the company considered the cold symptoms 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: 09-DEC-2024 Pharmacist reported that in the weekend his colleague administered a Fluarix vaccine to a three-year-old male patient. They were not sure the patient received a full dose, they wanted advise for this situation. Pharmacist also reported development of cold like symptom (not specified in the call) by this patient as well.  Vaccine detail, vaccination date and patient demographics were retrieved during this call. No further information was obtained during this call. The patient did not receive the full dose which led to underdose.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Hyperhidrosis
Clinical narrative: Patient woke up at 2:00 am on 1/3/25 with low grade fever, chills, sweats, major muscle and joint pain, fatigue, racing heart, nausea and weakness. Lasted 24 hours and had injection site redness, swelling. Broke out with red bumps on left flank and abdomen.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Myalgia, Nausea, Palpitations
Clinical narrative: Patient woke up at 2:00 am on 1/3/25 with low grade fever, chills, sweats, major muscle and joint pain, fatigue, racing heart, nausea and weakness. Lasted 24 hours and had injection site redness, swelling. Broke out with red bumps on left flank and abdomen.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Rash, Rash erythematous
Clinical narrative: Patient woke up at 2:00 am on 1/3/25 with low grade fever, chills, sweats, major muscle and joint pain, fatigue, racing heart, nausea and weakness. Lasted 24 hours and had injection site redness, swelling. Broke out with red bumps on left flank and abdomen.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Expired MMR II was administered on 18-DEC-2024 with an expiration date of 06-NOV-2024 (Lot # X022410); This spontaneous report was received from the nurse and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 18-DEC-2024, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, recombinant human albumin (rHa), valid lot # X022410, expiration date: 06-NOV-2024, administered for prophylaxis (dose, strength and route of administration were not provided) (expired product administered). There were no reported signs/symptoms of adverse effects from administered dose. No additional adverse event (AE) was reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash papular
Clinical narrative: Starting at 6:00 am 10/17/2024 red, burning, raised rash on face (like having a very bad sunburn but in this instance I was not in the sun that day for previous days).
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Blistery rash
Age: 24.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient had already received an annual influenza vaccine prior to 12/5/24. This nurse did not realize that. This nurse gave a second dose on 12/5/24.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bone pain, Breast pain, Chest X-ray normal, Injection site pain, Laboratory test
Clinical narrative: after the vaccine the pain came into the arm around the injection site into the bone and it went around the breast. Used heating pads to try to help with the pain. On 12/19/24 went to hospital, Was given chest xray which was negative. Her O2 level was low so was kept until 12/21/24. She was given IV with antibiotics. They told her they could not find anything wrong with her arm and told her they felt like she must have slept wrong but she feels like it was from the injection since it started at the injection site and the pain moved into the bone in the arm and then down around the breast. Now when lifting the arm there is a feeling of pressure and if there is anymore extension then that is when she starts having the pain in the arm and breast.  She was discharged with a precription of zithromax. She is going to follow with PCP on 1/22/25 and her pulmonologist Dr., MD. on 1/16/25.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort, Oxygen saturation decreased, Pain
Clinical narrative: after the vaccine the pain came into the arm around the injection site into the bone and it went around the breast. Used heating pads to try to help with the pain. On 12/19/24 went to hospital, Was given chest xray which was negative. Her O2 level was low so was kept until 12/21/24. She was given IV with antibiotics. They told her they could not find anything wrong with her arm and told her they felt like she must have slept wrong but she feels like it was from the injection since it started at the injection site and the pain moved into the bone in the arm and then down around the breast. Now when lifting the arm there is a feeling of pressure and if there is anymore extension then that is when she starts having the pain in the arm and breast.  She was discharged with a precription of zithromax. She is going to follow with PCP on 1/22/25 and her pulmonologist Dr., MD. on 1/16/25.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Bone pain, Breast pain, Bronchitis, Chest pain
Clinical narrative: after the vaccine the pain came into the arm around the injection site into the bone and it went around the breast. Used heating pads to try to help with the pain. On 12/19/24 went to hospital, Was given chest xray which was negative. Her O2 level was low so was kept until 12/21/24. She was given IV with antibiotics. They told her they could not find anything wrong with her arm and told her they felt like she must have slept wrong but she feels like it was from the injection since it started at the injection site and the pain moved into the bone in the arm and then down around the breast. Now when lifting the arm there is a feeling of pressure and if there is anymore extension then that is when she starts having the pain in the arm and breast.  She was discharged with a precription of zithromax. She is going to follow with PCP on 1/22/25 and her pulmonologist Dr., MD. on 1/16/25.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Joint range of motion decreased, Muscle strain, Oxygen saturation, Pain in extremity
Clinical narrative: after the vaccine the pain came into the arm around the injection site into the bone and it went around the breast. Used heating pads to try to help with the pain. On 12/19/24 went to hospital, Was given chest xray which was negative. Her O2 level was low so was kept until 12/21/24. She was given IV with antibiotics. They told her they could not find anything wrong with her arm and told her they felt like she must have slept wrong but she feels like it was from the injection since it started at the injection site and the pain moved into the bone in the arm and then down around the breast. Now when lifting the arm there is a feeling of pressure and if there is anymore extension then that is when she starts having the pain in the arm and breast.  She was discharged with a precription of zithromax. She is going to follow with PCP on 1/22/25 and her pulmonologist Dr., MD. on 1/16/25.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Panic disorder, Sleep disorder due to general medical condition, insomnia type, Vaccination site pain, X-ray
Clinical narrative: after the vaccine the pain came into the arm around the injection site into the bone and it went around the breast. Used heating pads to try to help with the pain. On 12/19/24 went to hospital, Was given chest xray which was negative. Her O2 level was low so was kept until 12/21/24. She was given IV with antibiotics. They told her they could not find anything wrong with her arm and told her they felt like she must have slept wrong but she feels like it was from the injection since it started at the injection site and the pain moved into the bone in the arm and then down around the breast. Now when lifting the arm there is a feeling of pressure and if there is anymore extension then that is when she starts having the pain in the arm and breast.  She was discharged with a precription of zithromax. She is going to follow with PCP on 1/22/25 and her pulmonologist Dr., MD. on 1/16/25.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Unevaluable event
Clinical narrative: Unknown
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Autoimmune disorder, Dermatitis allergic, Herpes zoster, Injection site erythema, Injection site pain
Clinical narrative: Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Autoimmune Disease (diagnosed by MD)-Medium, Systemic: 2 Oblong blisters at injection site-Severe, Additional Details: Recent (>30 days) Shingles infection
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site swelling, Injection site vesicles
Clinical narrative: Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Autoimmune Disease (diagnosed by MD)-Medium, Systemic: 2 Oblong blisters at injection site-Severe, Additional Details: Recent (>30 days) Shingles infection
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Mobility decreased
Clinical narrative: Systemic: "Weak in bed"-Medium, Systemic: Weakness-Medium
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypotension, Vomiting
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Medium, Systemic: Vomiting-Medium
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Insomnia
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Headache-Mild, Systemic: Unable to Sleep-Severe
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Pain
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Headache-Mild, Systemic: Unable to Sleep-Severe
Age: 16.0
Sex: F
Vaccine: FLUC4
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Additional Details: PATIENT FAINTED FOR 2 MINUTES AFTER VACCINATION, BUT WOKE UP AFTERWARDS, Other Vaccines:  VaccineTypeBrand: BOOSTRIX TDAP; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: UNKNOWN
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Pruritus
Clinical narrative: Site: Itching at Injection Site-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: no exeternal rash seen but pt has extreme itching-Severe
Age: 17.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood glucose normal, Dizziness, Dysarthria, Fatigue, Flushing
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Lymph Node Swelling-Severe, Additional Details: After getting vaccinated with the Meningitis and Flu vaccines, patient had her 1st vagal episode at approximately 1:09pm on 12/28/24. She was revived within minutes by her putting her legs up and alcohol swabs. 2nd vagal episode was at approximately 1:25pm in the waiting room. Patient was drenched with sweat, having slurred speech. 911 called, arrived at 1:40pm. Paramedics put her on a stretcher to her Mom's car, after confirming: vitals, blood sugar all normal. , Other Vaccines:  VaccineTypeBrand: Sanofi MenQuadfi; Manufacturer: Sanofi; LotNumber: 391416 ; Route: ; BodySite: left deltoid; Dose: 1; VaxDate: 12/28/2024
Age: 17.0
Sex: F
Vaccine: FLUC4
Symptoms: Hyperhidrosis, Lethargy, Lymphadenopathy, Presyncope, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Lymph Node Swelling-Severe, Additional Details: After getting vaccinated with the Meningitis and Flu vaccines, patient had her 1st vagal episode at approximately 1:09pm on 12/28/24. She was revived within minutes by her putting her legs up and alcohol swabs. 2nd vagal episode was at approximately 1:25pm in the waiting room. Patient was drenched with sweat, having slurred speech. 911 called, arrived at 1:40pm. Paramedics put her on a stretcher to her Mom's car, after confirming: vitals, blood sugar all normal. , Other Vaccines:  VaccineTypeBrand: Sanofi MenQuadfi; Manufacturer: Sanofi; LotNumber: 391416 ; Route: ; BodySite: left deltoid; Dose: 1; VaxDate: 12/28/2024
Age: 17.0
Sex: F
Vaccine: FLUC4
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Lymph Node Swelling-Severe, Additional Details: After getting vaccinated with the Meningitis and Flu vaccines, patient had her 1st vagal episode at approximately 1:09pm on 12/28/24. She was revived within minutes by her putting her legs up and alcohol swabs. 2nd vagal episode was at approximately 1:25pm in the waiting room. Patient was drenched with sweat, having slurred speech. 911 called, arrived at 1:40pm. Paramedics put her on a stretcher to her Mom's car, after confirming: vitals, blood sugar all normal. , Other Vaccines:  VaccineTypeBrand: Sanofi MenQuadfi; Manufacturer: Sanofi; LotNumber: 391416 ; Route: ; BodySite: left deltoid; Dose: 1; VaxDate: 12/28/2024
Age: 61.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site bruising, Injection site pain, Injection site reaction, Joint swelling, Rash
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: Told to take claritin and to keep watch on her left arm and if it gets bigger or starts to feel hot to go to the dr's office., Other Vaccines:  VaccineTypeBrand: Flucelvax Trival 2024-20245 Syr; Manufacturer: Seqirus; LotNumber: 391416; Route: IM; BodySite: Left Arm; Dose: 1; VaxDate: 12/23/2024
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Gait inability, Injection site erythema, Pyrexia
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Fever-Medium, Systemic: Joint Pain-Medium, Systemic: Weakness-Medium, Additional Details: Right hip pain with inability to walk for 2 days post injection,
Age: 68.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No additional AE; an adult patient was given a pediatric dose of VAQTA; This spontaneous report was received from a medical assistant and refers to a 68-year-old patient of unknown gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 20-DEC-2024, the patient was vaccinated with a pediatric dose of hepatitis A vaccine, inactivated (VAQTA) intramuscular injection (Incorrect dose administered), administered for prophylaxis (lot #X025485, has been verified to be a valid lot number, expiration date reported and upon internal validation both confirmed as 13-MAY-2025; strength, dose and route of administration were not provided). No adverse side effects were reported. There was no additional adverse event (AE) or product quality complaint (PQC) provided.