chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HEP
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Our Patient Received Twinrix As A Second Dose After Receiving A First Dose of Heplisav-B; Initial report received on 15-Jul-2025.    A pharmacist reported that a 31-year-old male patient (race and ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and then received TWINRIX as a second dose.   No medical history or concomitant medications were reported.    In Jun-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot # 946065, expiration date 02-Nov-2027, NDC # 43528-0003-05, route and site not available).   On an unknown date, after having been vaccinated with HEPLISAV-B, the patient received a dose of TWINRIX (no details provided) as a second dose of hepatitis B vaccination. The reporter stated that the patient had no other side effects reported.   No other information was available.      Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Vaccine: HEP
Symptoms: Interchange of vaccine products
Clinical narrative: Patient Received 1 Dose of HEPLISAV-B, and Then 1 Dose of Engerix; Initial report received on 16-Jul-2025.  A medical assistant reported that a patient (age, gender, race, ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and received ENGERIX-B as the second dose.  No medical history or concomitant medications were reported.    On Jan-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC #, route, and site not provided).    On an unknown date, after having been vaccinated with HEPLISAV-B, the patient received ENGERIX-B (lot #, expiration date, and NDC # rote, and site not provided).   No other information was available.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 60.0
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: Got Their 1st Dose, Trying to Get Their 2nd Dose Over the One Month Mark; Initial report received on 21-Jul-2025.  A pharmacist reported that a 60-year-old female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and was trying to get the second dose over one month after the first.  No medical history or concomitant medications were reported.  On 22-May-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number 945664, expiration date 31-Jan-2027 and NDC number 43528-003-05)] intramuscularly in the left deltoid.   On 21-Jul-2025, 61 days after receiving the first dose of HEPLISAV-B, the patient presented to the same pharmacy location as the first dose and attempted to get the second dose. The reporter contacted medical information to ask if the patient needed to restart the series. The second dose was not administered. No adverse reactions were reported.     No additional information was reported.    Company Comment The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16-Year-Old Patient Received HEPLISAV-B; Initial report received on 21-Jul-2025.  A pharmacist reported that a 16-year-old patient received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history or concomitant medications were reported.  On 21-Jul-2025, the patient received a dose of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available). The patient was 16 years old at the time of administration.  No other information was available.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 64.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Given HEPLISAV-B that Went Out of Temperature Range for 3 1/2 Hours; Initial report received on 22-Jul-2025.  A healthcare coordinator reported that a 64-year-old female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had been out of temperature range for 3.5 hours.  No medical history or concomitant medications were reported.  On 17-Jul-2025, the patient received a dose of a hepatitis B vaccine HEPLISAV-B (lot number 946065, expiration date 02-Nov-2027, and NDC number 43528-000 3-01) intramuscularly in the right deltoid. The HEPLISAV-B dose given was out of temperature range for 3.5 hours with a temperature low of -0.2 degrees Celsius. No other side effects reported.  No other information was available.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the previous dosing schedule of 0 and more than 1 month instead of the current dosing schedule; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in an unspecified number of patients who received Men B NVS (Bexsero) (batch number 5XA2J) for prophylaxis.   On an unknown date, the patients received Bexsero .5 ml. On an unknown date, an unknown time after receiving Bexsero, the patients experienced inappropriate schedule of vaccine administered (Verbatim: received the previous dosing schedule of 0 and more than 1 month instead of the current dosing schedule). The outcome of the inappropriate schedule of vaccine administered 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: 09-JUL-2025 The reporter was a Health Care Professional.   The reporter stated that patients (unspecified amount) received Bexsero outside of the current dosing recommendations The patients received the previous dosing schedule of 0 and more than or equal to 1 month instead of the current dosing schedule which led to inappropriate schedule of vaccine administered. The HCP did not have specific patient identifiers
Vaccine: MENB
Symptoms: Wrong technique in product usage process
Clinical narrative: introduced a syringe inside the prefilled syringe of Bexsero instead of following the instructions as per the PI; This non-serious case was reported by the other health professional via call center representative and described the occurrence of wrong technique in product usage process in a patient who received Men B NVS (Bexsero) (batch number 52n4S) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced wrong technique in product usage process (Verbatim: introduced a syringe inside the prefilled syringe of Bexsero instead of following the instructions as per the PI). The outcome of the wrong technique in product usage process was not applicable.   It was unknown if the reporter considered the wrong technique in product usage process to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the wrong technique in product usage process to be related to Bexsero and Bexsero 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: 18-JUL-2025 Healthcare professional reported that they introduced a syringe inside the prefilled syringe of Bexsero instead of following the instructions as per the prescribing information (PI) which led to wrong technique in product usage process.
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: that expired on 7/13/25; This non-serious case was reported by a physician via sales rep and described the occurrence of expired vaccine used in a patient who received DTPa (Infanrix) (expiry date 13-JUL-2025) for prophylaxis.   On 24-JUL-2025, the patient received Infanrix. On 24-JUL-2025, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: that expired on 7/13/25). The outcome of the expired vaccine used 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: 24-JUL-2025 The physician reported that the patient received an expired dose of Infanrix vaccine, which led to expired vaccine used.
Age: 45.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: couldn't get the third dose; Interval is more than recommended between dose 1 and 2; 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 an adult male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (Received 1st dose of Engerix B vaccine on 01-SEP-2024).   On 12-OCT-2024, the patient received the 2nd dose of Engerix B. The patient did not receive the 3rd dose of Engerix B. On 12-OCT-2024, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: Interval is more than recommended between dose 1 and 2). The patient had incomplete course of vaccination (Verbatim: couldn't get the third dose). The outcome of the drug dose administration interval too long and incomplete course of vaccination 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: 18-JUL-2025 Pharmacist wanted to know how to proceed with a patient that received the first two doses of Engerix-B back on 01-Sept-2024 and 12-Oct-2024, respectively, which led to drug dose administration interval too long. The patient couldn't get the third dose which led to incomplete course of vaccination and now wanted to receive it. These two doses were given in another facility.
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: 10 different patients received a dose of Boostrix after a temperature excursion; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a specified number of patients who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: 10 different patients received a dose of Boostrix after a temperature excursion). The outcome of the incorrect storage of drug 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: 18-JUL-2025 Registered nurse called to ask about the stability of Boostrix, after a temperature excursion of 12-degree Fahrenheit for 5 minutes.  After agent confirmed the vaccines were not stable anymore the Nurse mentioned that they administered 10 doses of Boostrix after this temperature excursion to 10 different patients, which led to incorrect storage of drug. The reporter wants to ask that they need to revaccinate them or not. Nurse did not provide more details about initials, age or gender for the patients and did not have the lot number and expiration dates of the doses of Boostrix that were administered.
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Maladministration of a KINRIX vaccine to a twenty five month old patient (wrong vaccine administered on a wrong age); This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 25-month-old male patient who received DTPa-IPV (Kinrix) (batch number Y49BZ, expiry date 17-MAY-2026) for prophylaxis.   Previously administered products included Vaxelis (received on 19-AUG-2023) and Engerix B (received 2 doses on an unknown date). Concomitant products included Pediarix.   On 10-JUL-2025, the patient received Kinrix. On 10-JUL-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Maladministration of a KINRIX vaccine to a twenty five month old patient (wrong vaccine administered on a wrong age)). 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: 21-JUL-2025 The nurse reported that the twenty five month old patient received Kinrix vaccine, and at the same time we administered the Pediarix vaccine. The reporter was ask was there any safety concern. The patient was administered with a previous Vaxelis vaccine (no vaccine schedule/doses confirmed from the licensed practical nurse´s end). The vaccine administration facility was the same as primary reporter. The patient received dose of Kinrix vaccine at an inappropriate age, which led to inappropriate age at vaccine administration.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: administration of a second dose of Boostrix, 1 week apart from 1st dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 12-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number X449Y, expiry date 20-OCT-2026) for prophylaxis.   Concomitant products included Diphtheria vaccine toxoid, Pertussis vaccine acellular 3-component, Tetanus vaccine toxoid (Boostrix).   On 21-JUL-2025, the patient received the 2nd dose of Boostrix. On 21-JUL-2025, an unknown time after receiving Boostrix, the patient experienced extra dose administered (Verbatim: administration of a second dose of Boostrix, 1 week apart from 1st dose). The outcome of the extra dose administered 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: 22-JUL-2025 The reporter reported that there was administration of a second dose of Boostrix, 1 week apart to a patient, which led to extra dose administered. She called to know how proceed and if there were some safety comments to be shared with the parents of patient. The Vaccine Administration Facility was the same as Primary Reporter.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Resident expired on 7/26/2025
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Resident expired
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Resident expired
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain
Clinical narrative: redness and soreness
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: 2 days post vaccine patient suddenly began to experience severe vertigo. It has lasted so far until today's date. She sought medical treatment and was put on meclizine with no relief and then prescriber added diazepam
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: Left arm pain that developed a few hours after vaccine. Severe pain limiting ROM. Pain has lasted more than a week. Has pain with active and passive ROM. Concern for rotator cuff injury.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Carpal tunnel decompression, Pain in extremity, Rheumatoid factor positive
Clinical narrative: I started to have intense pain in my hands.  Had carpal tunnel surgery on each hand and the pain did not subside.  I was then tested for rheumatoid arthritis and I tested positive.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Carcinoid tumour of the small bowel, Death
Clinical narrative: He died of carsonoid tumor in his small intestines
Sex: F
Vaccine: COVID19
Symptoms: Mast cell activation syndrome, Weight
Clinical narrative: Diagnosed to have Mast Cell Syndrome, and added that she has mast cells in her stomach/sick all the time/gets flare ups in the forms of hives and rashes/pain in her body and limbs/always feel weak/her joints hurt/had ongoing vomiting and diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of MAST CELL ACTIVATION SYNDROME (Diagnosed to have Mast Cell Syndrome, and added that she has mast cells in her stomach/sick all the time/gets flare ups in the forms of hives and rashes/pain in her body and limbs/always feel weak/her joints hurt/had ongoing vomiting and diarrhea) in an adult female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced MAST CELL ACTIVATION SYNDROME (Diagnosed to have Mast Cell Syndrome, and added that she has mast cells in her stomach/sick all the time/gets flare ups in the forms of hives and rashes/pain in her body and limbs/always feel weak/her joints hurt/had ongoing vomiting and diarrhea) (seriousness criterion medically significant). At the time of the report, MAST CELL ACTIVATION SYNDROME (Diagnosed to have Mast Cell Syndrome, and added that she has mast cells in her stomach/sick all the time/gets flare ups in the forms of hives and rashes/pain in her body and limbs/always feel weak/her joints hurt/had ongoing vomiting and diarrhea) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: she used to be 196 lbs and is currently down to 140 lbs..     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.   In 2020 or 2021, when the first vaccine came out, patient took it. Patient took another one a year later. She had since been sick all the time. She got flare-ups in the forms of hives and rashes. She felt pain in her body and limbs, and they always felt weak. Her joints hurt. She went to a dermatologist, but he was not able to diagnose her. She also had ongoing vomiting and diarrhea accompanied by abdominal pain. When she went to the ER, they were not able to tell her what the problem was. She used to be 196 lbs and was currently down to 140 lbs. She was finally diagnosed to have Mast Cell Syndrome. It was also reported that she had mast cells in her stomach.   It was unknown if the patient experienced any additional symptoms or events.   Treatment medication was not reported.   This case was linked to MOD-2025-788256 (Patient Link).; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: I have not been able to taste anything that I eat. Most thing taste like a sandy taste.
Age: 15.0
Sex: M
Vaccine: COVID19, MENB, MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse events.  but the teen received the MCV4 and Men B in error..  these vaccines were not due until age 16yrs- which is 6 months and 1 week in the future
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Other Vaccines:  VaccineTypeBrand: Boosttix; Manufacturer: GSK; LotNumber: 37R35; Route: IM; BodySite: Left arm; Dose: ; VaxDate: UNKNOWN
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood culture, Computerised tomogram, Laboratory test, Malaise, Positron emission tomogram
Clinical narrative: Shortly after receiving the vaccine, I started feeling sick and running low grade fevers every day.  Four years later, I am still having fevers every day.  Diagnosed as Fevers of Unknown Origin.  Fevers are usually 99.3 to 101 almost every day.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Shortly after receiving the vaccine, I started feeling sick and running low grade fevers every day.  Four years later, I am still having fevers every day.  Diagnosed as Fevers of Unknown Origin.  Fevers are usually 99.3 to 101 almost every day.
Sex: M
Vaccine: COVID19
Symptoms: Allergic reaction to excipient, Vaccination site macule
Clinical narrative: A few years later found out that he had an allergy to polyethylene glycol.; Local reaction with large spot on leg that lasted 3-4 days; This is a spontaneous report received from a Consumer or other non HCP from a sales representative.  A male patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), in 2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; polyethylene glycol [macrogol] (POLYETHYLENE GLYCOL [MACROGOL]), in 2022 as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALLERGIC REACTION TO EXCIPIENT (non-serious) with onset 2022, outcome "recovered" (2022), described as "A few years later found out that he had an allergy to polyethylene glycol."; VACCINATION SITE MACULE (non-serious) with onset 2022, outcome "recovered" (2022), described as "Local reaction with large spot on leg that lasted 3-4 days". Therapeutic measures were taken as a result of allergic reaction to excipient, vaccination site macule.  Additional information: Person reported their son had a local reaction to the COVID vaccine when patient was a baby.  Reporter thought date of vaccination was 2022. Local reaction with large spot on leg that lasted 3-4 days. Reporter was unsure which Covid vaccine patient was received. A few years later found out that patient had an allergy to polyethylene glycol. Patient received "Hydrocortisone cream" as a treatment for the adverse event. Patient received any other vaccines on the same date as the vaccine was mentioned as "Unknown". Patient received any other vaccines within 4 weeks prior to the vaccine was mentioned as "Unknown". Patient took any other medications within 2 weeks of the event started was mentioned as "Unknown".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient reported that when administered it felt like a bee sting that persisted for 2/3 days.; Area where it was administered was red and had some swelling; Area where it was administered was red and had some swelling; This is a spontaneous report received from a Consumer or other non HCP from a sales representative.  A female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 21Jul2025 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 21Jul2025, outcome "recovering" and all described as "Area where it was administered was red and had some swelling"; VACCINATION SITE PAIN (non-serious) with onset 21Jul2025, outcome "recovering", described as "Patient reported that when administered it felt like a bee sting that persisted for 2/3 days.". It was unknown if therapeutic measures were taken as a result of vaccination site pain, vaccination site swelling, vaccination site erythema. Additional information: The patient didn't receive any other vaccines on the same date as the vaccine(s) for which you are reporting. It was unknown if the patient received any other vaccines within 4 weeks PRIOR to the vaccine(s) for which you are reporting. It was unknown if the patient was taking any other medications within 2 weeks of the event starting.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 28.0
Sex: M
Vaccine: TD
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: administered the TENIVAC vaccine via IV to a patient with no reported adverse event; Initial information received on 23-Jul-2025 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 28 years old male patient who received the diphtheria-2/tetanus-5 adsorbed toxoids NO preservative adult [tenivac] via IV (Intravenous) to a patient with no reported adverse event  The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On 23-Jul-2025, the patient received unknown dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids NO preservative adult Suspension for injection (Unknown strength, lot and expiry date) via IV NOS (Intravenous Not otherwise specified) route in unknown administration site for Immunization with no reported adverse event (incorrect route of product administration) (Latency same day).  Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly, Nurse administered the vaccine.   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: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Bronchoscopy abnormal, Dyspnoea, Lung disorder
Clinical narrative: I cannot breathe!
Age: 68.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Confusional state, Dyspnoea, Hyperhidrosis
Clinical narrative: Hard to breathe, confusion, sweating
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Computerised tomogram abnormal, Frontotemporal dementia, Muscle atrophy, Renal cancer
Clinical narrative: Renal Cancer 2022, COPD 2021, FTD2021, MUSCLE WASTING 2022
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Back pain, Electroencephalogram abnormal, Joint noise, Muscle spasms, Myoclonic epilepsy
Clinical narrative: Patient reports she received a meningitis vaccine in January 2023. Since then she has noticed the jerking but fairly intermittently. Then in January 2025 she has more prolonged episodes of jerking and more frequent. She estimates 15-30 minutes episodes about 3 times per week.    Then on 7/3/25 she was with her family and she was sleeping next to her mother. They were trying to sleep and she had extremity jerking for about 30 minutes. She was able to communicate this to her mother and remembers this entirely. Then her mother heard her make like a nervous laughter noise. Her mom said "it's not funny", and then patient said "I know." Then she remembers her left arm clenching up and lost consciousness. Mother could tell something happened, suddenly turned on the lights and then saw her having whole body shaking with eyes rolled back and muscles tense and rigid. Estimated lasted 1-2 minutes. Then after she stopped seizing she was staring with eyes wide and seemed confused after. The next things she remembers is waking up confused as to why paramedics were around. Originally seen in the ED and CT negative. They recommended stopping accutane and close outpatient follow up for MRI and EEG. After returning home, she felt like she might have another seizure so then was brought into ED and admitted for further workup. MRI brain negative. EEG showed generalized epileptiform discharges. She was loaded with Keppra and then started on 500 mg BID maintenance with outpatient follow up. Patient has remained seizure free since discharge. She has been on Keppra for just over 1 week. She is overall tolerating it okay. She has been feeling pretty anxious and nervious since the seizure. She is not irritable or agitated, just anxious. No noticeable depression symptoms. She is not sleeping well as she is anxious/scared to go to sleep and worried about it happening again. She is also feeling tired. Reports excellent compliance with Keppra. She has still had some intermittent jerking, primarily of the upper extremities, occasionally in the legs. She had a few small jerks since the hospital and then 7/10 has noticed a few more jerks. They have not progressed further and she remains conscious. Can be during the day, more often at night.    She reports her muscles still feel super tense and some generalized soreness.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Neck pain, Seizure, Unresponsive to stimuli
Clinical narrative: Patient reports she received a meningitis vaccine in January 2023. Since then she has noticed the jerking but fairly intermittently. Then in January 2025 she has more prolonged episodes of jerking and more frequent. She estimates 15-30 minutes episodes about 3 times per week.    Then on 7/3/25 she was with her family and she was sleeping next to her mother. They were trying to sleep and she had extremity jerking for about 30 minutes. She was able to communicate this to her mother and remembers this entirely. Then her mother heard her make like a nervous laughter noise. Her mom said "it's not funny", and then patient said "I know." Then she remembers her left arm clenching up and lost consciousness. Mother could tell something happened, suddenly turned on the lights and then saw her having whole body shaking with eyes rolled back and muscles tense and rigid. Estimated lasted 1-2 minutes. Then after she stopped seizing she was staring with eyes wide and seemed confused after. The next things she remembers is waking up confused as to why paramedics were around. Originally seen in the ED and CT negative. They recommended stopping accutane and close outpatient follow up for MRI and EEG. After returning home, she felt like she might have another seizure so then was brought into ED and admitted for further workup. MRI brain negative. EEG showed generalized epileptiform discharges. She was loaded with Keppra and then started on 500 mg BID maintenance with outpatient follow up. Patient has remained seizure free since discharge. She has been on Keppra for just over 1 week. She is overall tolerating it okay. She has been feeling pretty anxious and nervious since the seizure. She is not irritable or agitated, just anxious. No noticeable depression symptoms. She is not sleeping well as she is anxious/scared to go to sleep and worried about it happening again. She is also feeling tired. Reports excellent compliance with Keppra. She has still had some intermittent jerking, primarily of the upper extremities, occasionally in the legs. She had a few small jerks since the hospital and then 7/10 has noticed a few more jerks. They have not progressed further and she remains conscious. Can be during the day, more often at night.    She reports her muscles still feel super tense and some generalized soreness.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Anxiety, Computerised tomogram normal, Confusional state, Dyskinesia, Electroencephalogram abnormal
Clinical narrative: Patient reports she received a meningitis vaccine in January 2023. Since then she has noticed the jerking but fairly intermittently. Then in January 2025 she has more prolonged episodes of jerking and more frequent. She estimates 15-30 minutes episodes about 3 times per week.    Then on 7/3/25 she was with her family and she was sleeping next to her mother. They were trying to sleep and she had extremity jerking for about 30 minutes. She was able to communicate this to her mother and remembers this entirely. Then her mother heard her make like a nervous laughter noise. Her mom said "it's not funny", and then patient said "I know." Then she remembers her left arm clenching up and lost consciousness. Mother could tell something happened, suddenly turned on the lights and then saw her having whole body shaking with eyes rolled back and muscles tense and rigid. Estimated lasted 1-2 minutes. Then after she stopped seizing she was staring with eyes wide and seemed confused after. The next things she remembers is waking up confused as to why paramedics were around. Originally seen in the ED and CT negative. They recommended stopping accutane and close outpatient follow up for MRI and EEG. After returning home, she felt like she might have another seizure so then was brought into ED and admitted for further workup. MRI brain negative. EEG showed generalized epileptiform discharges. She was loaded with Keppra and then started on 500 mg BID maintenance with outpatient follow up. Patient has remained seizure free since discharge. She has been on Keppra for just over 1 week. She is overall tolerating it okay. She has been feeling pretty anxious and nervious since the seizure. She is not irritable or agitated, just anxious. No noticeable depression symptoms. She is not sleeping well as she is anxious/scared to go to sleep and worried about it happening again. She is also feeling tired. Reports excellent compliance with Keppra. She has still had some intermittent jerking, primarily of the upper extremities, occasionally in the legs. She had a few small jerks since the hospital and then 7/10 has noticed a few more jerks. They have not progressed further and she remains conscious. Can be during the day, more often at night.    She reports her muscles still feel super tense and some generalized soreness.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Fatigue, Gaze palsy, Loss of consciousness, Magnetic resonance imaging head normal, Muscle contractions involuntary
Clinical narrative: Patient reports she received a meningitis vaccine in January 2023. Since then she has noticed the jerking but fairly intermittently. Then in January 2025 she has more prolonged episodes of jerking and more frequent. She estimates 15-30 minutes episodes about 3 times per week.    Then on 7/3/25 she was with her family and she was sleeping next to her mother. They were trying to sleep and she had extremity jerking for about 30 minutes. She was able to communicate this to her mother and remembers this entirely. Then her mother heard her make like a nervous laughter noise. Her mom said "it's not funny", and then patient said "I know." Then she remembers her left arm clenching up and lost consciousness. Mother could tell something happened, suddenly turned on the lights and then saw her having whole body shaking with eyes rolled back and muscles tense and rigid. Estimated lasted 1-2 minutes. Then after she stopped seizing she was staring with eyes wide and seemed confused after. The next things she remembers is waking up confused as to why paramedics were around. Originally seen in the ED and CT negative. They recommended stopping accutane and close outpatient follow up for MRI and EEG. After returning home, she felt like she might have another seizure so then was brought into ED and admitted for further workup. MRI brain negative. EEG showed generalized epileptiform discharges. She was loaded with Keppra and then started on 500 mg BID maintenance with outpatient follow up. Patient has remained seizure free since discharge. She has been on Keppra for just over 1 week. She is overall tolerating it okay. She has been feeling pretty anxious and nervious since the seizure. She is not irritable or agitated, just anxious. No noticeable depression symptoms. She is not sleeping well as she is anxious/scared to go to sleep and worried about it happening again. She is also feeling tired. Reports excellent compliance with Keppra. She has still had some intermittent jerking, primarily of the upper extremities, occasionally in the legs. She had a few small jerks since the hospital and then 7/10 has noticed a few more jerks. They have not progressed further and she remains conscious. Can be during the day, more often at night.    She reports her muscles still feel super tense and some generalized soreness.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Muscle rigidity, Muscle tightness, Myalgia, Nervousness, Poor quality sleep
Clinical narrative: Patient reports she received a meningitis vaccine in January 2023. Since then she has noticed the jerking but fairly intermittently. Then in January 2025 she has more prolonged episodes of jerking and more frequent. She estimates 15-30 minutes episodes about 3 times per week.    Then on 7/3/25 she was with her family and she was sleeping next to her mother. They were trying to sleep and she had extremity jerking for about 30 minutes. She was able to communicate this to her mother and remembers this entirely. Then her mother heard her make like a nervous laughter noise. Her mom said "it's not funny", and then patient said "I know." Then she remembers her left arm clenching up and lost consciousness. Mother could tell something happened, suddenly turned on the lights and then saw her having whole body shaking with eyes rolled back and muscles tense and rigid. Estimated lasted 1-2 minutes. Then after she stopped seizing she was staring with eyes wide and seemed confused after. The next things she remembers is waking up confused as to why paramedics were around. Originally seen in the ED and CT negative. They recommended stopping accutane and close outpatient follow up for MRI and EEG. After returning home, she felt like she might have another seizure so then was brought into ED and admitted for further workup. MRI brain negative. EEG showed generalized epileptiform discharges. She was loaded with Keppra and then started on 500 mg BID maintenance with outpatient follow up. Patient has remained seizure free since discharge. She has been on Keppra for just over 1 week. She is overall tolerating it okay. She has been feeling pretty anxious and nervious since the seizure. She is not irritable or agitated, just anxious. No noticeable depression symptoms. She is not sleeping well as she is anxious/scared to go to sleep and worried about it happening again. She is also feeling tired. Reports excellent compliance with Keppra. She has still had some intermittent jerking, primarily of the upper extremities, occasionally in the legs. She had a few small jerks since the hospital and then 7/10 has noticed a few more jerks. They have not progressed further and she remains conscious. Can be during the day, more often at night.    She reports her muscles still feel super tense and some generalized soreness.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Seizure, Tremor
Clinical narrative: Patient reports she received a meningitis vaccine in January 2023. Since then she has noticed the jerking but fairly intermittently. Then in January 2025 she has more prolonged episodes of jerking and more frequent. She estimates 15-30 minutes episodes about 3 times per week.    Then on 7/3/25 she was with her family and she was sleeping next to her mother. They were trying to sleep and she had extremity jerking for about 30 minutes. She was able to communicate this to her mother and remembers this entirely. Then her mother heard her make like a nervous laughter noise. Her mom said "it's not funny", and then patient said "I know." Then she remembers her left arm clenching up and lost consciousness. Mother could tell something happened, suddenly turned on the lights and then saw her having whole body shaking with eyes rolled back and muscles tense and rigid. Estimated lasted 1-2 minutes. Then after she stopped seizing she was staring with eyes wide and seemed confused after. The next things she remembers is waking up confused as to why paramedics were around. Originally seen in the ED and CT negative. They recommended stopping accutane and close outpatient follow up for MRI and EEG. After returning home, she felt like she might have another seizure so then was brought into ED and admitted for further workup. MRI brain negative. EEG showed generalized epileptiform discharges. She was loaded with Keppra and then started on 500 mg BID maintenance with outpatient follow up. Patient has remained seizure free since discharge. She has been on Keppra for just over 1 week. She is overall tolerating it okay. She has been feeling pretty anxious and nervious since the seizure. She is not irritable or agitated, just anxious. No noticeable depression symptoms. She is not sleeping well as she is anxious/scared to go to sleep and worried about it happening again. She is also feeling tired. Reports excellent compliance with Keppra. She has still had some intermittent jerking, primarily of the upper extremities, occasionally in the legs. She had a few small jerks since the hospital and then 7/10 has noticed a few more jerks. They have not progressed further and she remains conscious. Can be during the day, more often at night.    She reports her muscles still feel super tense and some generalized soreness.
Vaccine: PNC21
Symptoms: Injection site rash, Lymphadenopathy, Rash erythematous
Clinical narrative: Reports swollen lymph node and raised irregular red rash i; raised irregular red rash in front of armpit on left side approx 3 x 3 inches appeared the day after.; This spontaneous report was received from a consumer via company representative and refers to a patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 07-Jul-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot #Y019158 which has been verified to be a valid number, expiration date reported an validated as 20-May-2026), administered by Intramuscular route in left arm (deltoid), as a prophylaxis.  On 08-Jul-2025 (the day after), the patient experienced swollen lymph node and raised irregular red rash in front of armpit on left side approx. 3 x 3 inches appeared. At the reporting time, the outcome of swollen lymph nodes and red rash was unknown.   The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not provided.
Age: 6.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: inadvertently administered ADACEL to a pediatric patient instead of the scheduled DAPTACEL with no reported adverse event; administering adacel to a 6-year-old patient with no reported adverse event; Initial information received on 23-Jul-2025 (live follow up processed together) regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 years old pediatric female patient who was inadvertently administered diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] instead of the scheduled diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] with no reported adverse event and administering adacel to a 6-year-old 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 Polio vaccine (Polio vaccine) and Hepatitis a vaccine (Hepatitis a vaccine) for prophylactic vaccination (Immunisation).  On 23-Jul-2025, the 6-year-old pediatric patient received a dose of 0.5 ml of suspect diphtheria-2/tetanus/5 ac pertussis vaccine, suspension for injection (lot UA8274AA and expiry date: 30-Aug-2026) (strength not reported) via intramuscular route in the left deltoid for prophylactic vaccination (Immunisation) instead of the scheduled diphtheria-15/tetanus/5 ac pertussis vaccine with no reported adverse event (wrong product administered) (product administered to patient of inappropriate age) (Latency: same day).  Reportedly, The patient's supposed to receive her 5th dose of DTaP, but was given with ADACEL instead.  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.
Sex: F
Vaccine: RVX
Symptoms: Angioedema, Mastocytosis
Clinical narrative: Giant hives; Mastosyposis; This serious case was reported by a consumer and described the occurrence of giant hives in a 78-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On 14-JUL-2025, the patient received RSV vaccine. On 14-JUL-2025, less than a day after receiving RSV vaccine, the patient experienced giant hives (Verbatim: Giant hives) (serious criteria GSK medically significant). In JUL-2025, the patient experienced mastocytosis (Verbatim: Mastosyposis). The outcome of the giant hives was not resolved and the outcome of the mastocytosis was not reported.   It was unknown if the reporter considered the giant hives and mastocytosis to be related to RSV vaccine.     The company considered the giant hives to be unrelated to RSV vaccine. It was unknown if the company considered the mastocytosis to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 16-JUL-2025 The reporter reported that the patient had mastosyposis and giant hives.; Sender's Comments: A case of Angioedema, less than a day after receiving RSV vaccine, in a 78-year-old female patient.  Based on the available information, a possible causality that the event(s) was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.