chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood sodium normal, Blood urea nitrogen/creatinine ratio, Blood urea normal, Blood urine absent, Brain natriuretic peptide normal
Clinical narrative: On July 30th, 2024, I had a heart attack due to a blood clot. I went to hospital for a successful thrombectomy and PCI of proximal to mid RCA.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Capillary nail refill test, Carbon dioxide decreased, Chest X-ray normal, Chest pain, Chromaturia
Clinical narrative: On July 30th, 2024, I had a heart attack due to a blood clot. I went to hospital for a successful thrombectomy and PCI of proximal to mid RCA.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Coagulation test normal, Condition aggravated, Differential white blood cell count, Dizziness, Dyspepsia
Clinical narrative: On July 30th, 2024, I had a heart attack due to a blood clot. I went to hospital for a successful thrombectomy and PCI of proximal to mid RCA.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Electrocardiogram ST segment depression, Electrocardiogram T wave inversion, Eosinophil count decreased, Eosinophil percentage decreased
Clinical narrative: On July 30th, 2024, I had a heart attack due to a blood clot. I went to hospital for a successful thrombectomy and PCI of proximal to mid RCA.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Full blood count, Glomerular filtration rate normal, Glucose urine absent, Haematocrit normal
Clinical narrative: On July 30th, 2024, I had a heart attack due to a blood clot. I went to hospital for a successful thrombectomy and PCI of proximal to mid RCA.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Haemoglobin normal, Hyperhidrosis, Hypothyroidism, Immature granulocyte count, International normalised ratio normal
Clinical narrative: On July 30th, 2024, I had a heart attack due to a blood clot. I went to hospital for a successful thrombectomy and PCI of proximal to mid RCA.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Iron deficiency anaemia, Leukocytosis, Lymphocyte count normal, Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal
Clinical narrative: On July 30th, 2024, I had a heart attack due to a blood clot. I went to hospital for a successful thrombectomy and PCI of proximal to mid RCA.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Mean cell haemoglobin decreased, Mean cell volume decreased, Mean platelet volume increased, Metabolic function test normal, Monocyte count normal
Clinical narrative: On July 30th, 2024, I had a heart attack due to a blood clot. I went to hospital for a successful thrombectomy and PCI of proximal to mid RCA.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Monocyte percentage, Myocardial infarction, Nausea, Neck surgery, Neutrophil count increased
Clinical narrative: On July 30th, 2024, I had a heart attack due to a blood clot. I went to hospital for a successful thrombectomy and PCI of proximal to mid RCA.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neutrophil percentage increased, Nitrite urine absent, Osteoarthritis, Pain, Palpitations
Clinical narrative: On July 30th, 2024, I had a heart attack due to a blood clot. I went to hospital for a successful thrombectomy and PCI of proximal to mid RCA.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Percutaneous coronary intervention, Platelet count normal, Protein urine absent, Prothrombin time normal, Red blood cell count normal
Clinical narrative: On July 30th, 2024, I had a heart attack due to a blood clot. I went to hospital for a successful thrombectomy and PCI of proximal to mid RCA.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Red blood cell nucleated morphology, Red cell distribution width normal, Specific gravity urine normal, Thrombectomy, Thrombosis
Clinical narrative: On July 30th, 2024, I had a heart attack due to a blood clot. I went to hospital for a successful thrombectomy and PCI of proximal to mid RCA.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Troponin I increased, Troponin increased, Urine ketone body absent, Urobilinogen urine decreased, White blood cell count increased
Clinical narrative: On July 30th, 2024, I had a heart attack due to a blood clot. I went to hospital for a successful thrombectomy and PCI of proximal to mid RCA.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: White blood cells urine negative, pH urine normal
Clinical narrative: On July 30th, 2024, I had a heart attack due to a blood clot. I went to hospital for a successful thrombectomy and PCI of proximal to mid RCA.
Age: 0.5
Sex: M
Vaccine: DTAPIPV, HEP, PNC20
Symptoms: Pyrexia
Clinical narrative: Patients mother called the office on 3/4/2025 stating the child had a very high fever of 107 on her at home thermometer and a possible seizure and took the child to the ER.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Mobility decreased, Pain
Clinical narrative: Day after vaccination, patient called stating that they were feeling numbness, pain, and inability to move the left arm.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Burning sensation, Hypoaesthesia, Injection site pain, Pain, Product administered at inappropriate site
Clinical narrative: Shot was given well above the muscle near shoulder.  Instant pain. Pharmacist said arm will probably be sore fo a couple of days.  Just take over the counter meds.  Shooting pain, fire like feeling from shoulder to tips of fingers and numbness. Took excedrin and used liacane patches still took well over an hour before it subsided.  This same thing has happened several times.  Mostly when I?m in bed.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Shot was given well above the muscle near shoulder.  Instant pain. Pharmacist said arm will probably be sore fo a couple of days.  Just take over the counter meds.  Shooting pain, fire like feeling from shoulder to tips of fingers and numbness. Took excedrin and used liacane patches still took well over an hour before it subsided.  This same thing has happened several times.  Mostly when I?m in bed.
Age: 80.0
Sex: F
Vaccine: HEP, RSV
Symptoms: Rash
Clinical narrative: Patient reports one week after injection that she had a rash over all of her body.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Injected limb mobility decreased, Pain, Peripheral swelling
Clinical narrative: LEft arm was puffy after 2 days post vaccination. There is severe pain extending all the way up to her collarbone and shoulder/scalp area, and down to her ifngers. it is a burning kind of pain to the point of throwin up. she cannot move her wrist and it is very tender. pt has been using ice and sports cream to help reduce heat. the dr has sent in prednisone to help with inflammation in the meantime. . patient will see dr tomorrow for examination.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: I noticed a rash underneath my breast about 9AM on the 28th, didnt go around to my back but it was up my neck and it was more on the left side of my body it did not itch it was not painful only had it 24-36 hours then it started itching and that lasted for about a day.
Age: 0.33
Sex: F
Vaccine: PNC15, RV5
Symptoms: Rash
Clinical narrative: Patient was given Rota Oral and Pneumo 15 second dose on 2/24. Mother states on 2/25 she noticed an all body rash but no fever or warmth at injection site. Rash lasted 3 days.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein increased, Chest discomfort, Dyspnoea, Echocardiogram abnormal, Electrocardiogram abnormal
Clinical narrative: Chest discomfort , shortness of breath. Ultimately diagnosed as Pericarditis. Three years of recurring pericarditis after vaccine.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: Chest discomfort , shortness of breath. Ultimately diagnosed as Pericarditis. Three years of recurring pericarditis after vaccine.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site hypoaesthesia
Clinical narrative: Numbness an inch or two below injection site about the size of a half dollar.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Aortic aneurysm, Aortic valve incompetence, Chills, Computerised tomogram thorax abnormal, Echocardiogram abnormal
Clinical narrative: Frequent PVCs, fatigue, exercise intolerance, all started on the morning of November 17th.  Vaccination was forgotten about and we didn't originally connect it to symptoms.   Seen by PCP on Dec 9. referred for routine tests and to see electrophysiologist.  Labs were unremarkable.  Had Holter monitor and Echocardiogram in mid January.  Holter showed 5% PVC load.  Holter showed new aortic regurgitation as compared to echo from march 2023. Saw electrophysiologist Jan 29th who offered no insight.  Was seen in ER in early February due to chills and echo changes causing concern for endocarditis. ER workup was negative.  Saw cardiothoracic surgeon in mid February who recommended cardiopulmonary exercise testing.  1 week later was reminded about vaccine and looked up the date of vaccination and made connection.  Symptoms slowly improving starting mid February but pvcs continue.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram ambulatory abnormal, Electrocardiogram normal, Exercise tolerance decreased, Fatigue, Full blood count normal
Clinical narrative: Frequent PVCs, fatigue, exercise intolerance, all started on the morning of November 17th.  Vaccination was forgotten about and we didn't originally connect it to symptoms.   Seen by PCP on Dec 9. referred for routine tests and to see electrophysiologist.  Labs were unremarkable.  Had Holter monitor and Echocardiogram in mid January.  Holter showed 5% PVC load.  Holter showed new aortic regurgitation as compared to echo from march 2023. Saw electrophysiologist Jan 29th who offered no insight.  Was seen in ER in early February due to chills and echo changes causing concern for endocarditis. ER workup was negative.  Saw cardiothoracic surgeon in mid February who recommended cardiopulmonary exercise testing.  1 week later was reminded about vaccine and looked up the date of vaccination and made connection.  Symptoms slowly improving starting mid February but pvcs continue.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test abnormal, Metabolic function test normal, Ventricular extrasystoles
Clinical narrative: Frequent PVCs, fatigue, exercise intolerance, all started on the morning of November 17th.  Vaccination was forgotten about and we didn't originally connect it to symptoms.   Seen by PCP on Dec 9. referred for routine tests and to see electrophysiologist.  Labs were unremarkable.  Had Holter monitor and Echocardiogram in mid January.  Holter showed 5% PVC load.  Holter showed new aortic regurgitation as compared to echo from march 2023. Saw electrophysiologist Jan 29th who offered no insight.  Was seen in ER in early February due to chills and echo changes causing concern for endocarditis. ER workup was negative.  Saw cardiothoracic surgeon in mid February who recommended cardiopulmonary exercise testing.  1 week later was reminded about vaccine and looked up the date of vaccination and made connection.  Symptoms slowly improving starting mid February but pvcs continue.
Age: 2.0
Sex: F
Vaccine: HIBV
Symptoms: Vaccination error
Clinical narrative: Unnecessary vaccine given
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Angioedema, Urticaria
Clinical narrative: pt developed hives and angioedema > 48 hours after his dose
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Amnesia, Feeling abnormal, Headache, Lethargy, Pyrexia
Clinical narrative: woke up the morning after the vaccination and as he described "did not feel right!".  wife stated  he was very lethargic, had a severe headache, had a fever.  Patient felt bad enough that wife called an ambulance and was taken to local emergency room.  Patient has no recollection of going to the hospital via ambulance and didn't realize he had been admitted until he woke up in the hospital.  Hospital treated symptoms and was released the following day.   Hospital physician told patient to reach out to pharmacy and have them file a report.
Age: 10.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Pyrexia, Rash
Clinical narrative: She had a 102 fever the night of the vaccine and a 7-8cm erythematous rash on her right deltoid 24 hours after the injection.  Then around 4/29/24 she developed a fixed painful annular rash on her hands which was determined by a pediatric dermatologist to be erythema multiforme minor. The lesions took approximately one week to resolve.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Pregnancy test positive
Clinical narrative: Patient took a pregnancy test on February 1st, and it came back positive. Since I received all my vaccines on January 3rd and January 17th
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Feeling jittery, Injection site erythema, Injection site nodule, Injection site swelling, Nausea
Clinical narrative: Donor states she had a reaction to the last immunization she received at the center on 02/21/25. Donor returned to the center on 03/05/25 to attempt donation where she stated to the medical staff about her reactions.  She stated her reactions included redness and swelling at the injection site, a knot where the needle was inserted about the size of a needle tip, jitteriness, nausea the next day. Donor stated she hydrated and took hot tub baths. She stated she did not seek outside medical care. It is also noted that she left the center before her 15-minute waiting period expired.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Amnesia, Arteriogram carotid, C-reactive protein, Computerised tomogram head, Electrocardiogram
Clinical narrative: 6 hours after injection, developed pain  at injection site, followed by myalgias that lasted 36 hours. 48 hours after injection developed acute memory loss.  Diagnosed with transient global amnesia.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza A virus test, Influenza B virus test, Injection site pain, Magnetic resonance imaging head, Metabolic function test
Clinical narrative: 6 hours after injection, developed pain  at injection site, followed by myalgias that lasted 36 hours. 48 hours after injection developed acute memory loss.  Diagnosed with transient global amnesia.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Red blood cell sedimentation rate, Respiratory syncytial virus test, SARS-CoV-2 test, Scan with contrast
Clinical narrative: 6 hours after injection, developed pain  at injection site, followed by myalgias that lasted 36 hours. 48 hours after injection developed acute memory loss.  Diagnosed with transient global amnesia.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Transient global amnesia, Troponin
Clinical narrative: 6 hours after injection, developed pain  at injection site, followed by myalgias that lasted 36 hours. 48 hours after injection developed acute memory loss.  Diagnosed with transient global amnesia.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness
Clinical narrative: Dizziness 24 hours post vaccine
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test normal, Computerised tomogram head normal, Electrocardiogram normal, Electromyogram normal, Gait disturbance
Clinical narrative: Woke up with paresthesia of right lower leg and foot. Waited over the weekend to see if it would go away, but it didn't. Went to the ER on 7/24/23 where they did blood work, CT scan, EKG and stroke screening. No findings and referred me to see a neurologist and get an MRI. MRI/brain done 8/21/23. Mixed opinion on results. Radiologist concluded chronic lacunar infarct left corona radiata pons. Since I couldn't get into a neurologist for months, I set up a second opinion with a neurologist at  He looked at the radiology and said he did NOT think I had evidence of lacunar infarct. Though he had no answer for my symptoms. I finally was able to get an appointment with a neurologist at  who conducted NCS/EMG testing on 2/28/24. Results were negative. Advised to start low dose aspirin, regular carotid checks and visits with pcp. Was told I would probably never get sensation back. As of now, nothing has improved. My foot becomes very difficult to walk on after being on it for over an hour. Especially in shoes. Chronic numbness.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Laboratory test normal, Magnetic resonance imaging head normal, Nerve conduction studies normal, Paraesthesia
Clinical narrative: Woke up with paresthesia of right lower leg and foot. Waited over the weekend to see if it would go away, but it didn't. Went to the ER on 7/24/23 where they did blood work, CT scan, EKG and stroke screening. No findings and referred me to see a neurologist and get an MRI. MRI/brain done 8/21/23. Mixed opinion on results. Radiologist concluded chronic lacunar infarct left corona radiata pons. Since I couldn't get into a neurologist for months, I set up a second opinion with a neurologist at  He looked at the radiology and said he did NOT think I had evidence of lacunar infarct. Though he had no answer for my symptoms. I finally was able to get an appointment with a neurologist at  who conducted NCS/EMG testing on 2/28/24. Results were negative. Advised to start low dose aspirin, regular carotid checks and visits with pcp. Was told I would probably never get sensation back. As of now, nothing has improved. My foot becomes very difficult to walk on after being on it for over an hour. Especially in shoes. Chronic numbness.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia
Clinical narrative: Shoulder pain since injection date
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient received flu vaccine early today on 03/05/2025 when actually needed on 8/1/25, no adverse events at this time.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Child had n adverse event following the vaccine being given, normal vaccine protocol was given with an outcome of being vaccine monitored for 2 week after error occurred and retrained on precautions that should be taken to assure vaccine errors do not occur
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic shock, Cough, Wheezing
Clinical narrative: PATIENT WENT INTO ANAPHYLACTIC SHOCK WITHIN 5 MINUTES AFTER SHINGLES VACCINATION. PATIENT BEGAN COUGHING AND WHEEZING, SHE SELF ADMINISTERED BENADRYL SHE BROUGHT HERSELF AS SHE HAS HAD MULTIPLE ALLERGIC REACTIONS TO VARIOUS DRUGS AND ALLERGENS AND "CAME PREPARED." PATIENT THEN BEGAN HAVING A DIFFICULT TIME BREATHING AND SELF-ADMINISTERED HER OWN EPI-PEN SHE BROUGHT WITH HER TO THE VACCINATION. ONE DOSE OF EPINEPHRINE WAS SELF-ADMINISTERED BY THE PATIENT IN THE THIGH AND SYMPTOMS RESOLVED QUICKLY. PATIENT WAITED ANOTHER 5 MINTUES RECOVERING AND PATIENT DECLINED EMS/FURTHER MEDICAL ATTENTION WHEN OFFERED TO THE PATIENT AS SHE HAS DEALT WITH ANAPHYLAXIS MULTIPLE TIMES.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: 11 CM TALL X 9 CM WIDE INDURATED, ERYTHEMATOUS, WARM AREA TO LEFT UPPER ARM CONSISTENT WITH INJECTION SITE REACTION - GIVEN DTAP/IPV TO THAT ARM. PAIN TO LEFT UPPER ARM. GOOD ROM.  MOM WAS NOTIFIED OF A HARD KNOT, REDNESS, SWELLING, AND WARMTH TO LEFT UPPER ARM FROM DAYCARE IN THE AFTERNOON OF 2/27/2025. RED, WARM AREA GREW OVERNIGHT TO CURRENT SIZE 2/28/2025. NO FEVER, SOB, SORE THROAT, DIFFICULTY SWALLOWING, RUNNY NOSE, N/V/D. SITE IS PAINFUL TO TOUCH. TREATED WITH CETERIZINE QAM AND BENDADRYL QPM UNTIL SYMPTOMS IMPROVE. ALSO ADVISED TO USE HYDROCORTISONE CREAM FOR ANY ITCHING AND MOTRIN OR TYLENOL FOR ANY DISCOMFORT. SIZE OF SITE WAS MARKED AND MONITORED BY MOM, NOW IMPROVED.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site warmth
Clinical narrative: 11 CM TALL X 9 CM WIDE INDURATED, ERYTHEMATOUS, WARM AREA TO LEFT UPPER ARM CONSISTENT WITH INJECTION SITE REACTION - GIVEN DTAP/IPV TO THAT ARM. PAIN TO LEFT UPPER ARM. GOOD ROM.  MOM WAS NOTIFIED OF A HARD KNOT, REDNESS, SWELLING, AND WARMTH TO LEFT UPPER ARM FROM DAYCARE IN THE AFTERNOON OF 2/27/2025. RED, WARM AREA GREW OVERNIGHT TO CURRENT SIZE 2/28/2025. NO FEVER, SOB, SORE THROAT, DIFFICULTY SWALLOWING, RUNNY NOSE, N/V/D. SITE IS PAINFUL TO TOUCH. TREATED WITH CETERIZINE QAM AND BENDADRYL QPM UNTIL SYMPTOMS IMPROVE. ALSO ADVISED TO USE HYDROCORTISONE CREAM FOR ANY ITCHING AND MOTRIN OR TYLENOL FOR ANY DISCOMFORT. SIZE OF SITE WAS MARKED AND MONITORED BY MOM, NOW IMPROVED.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt was given Comirnaty vaccine that is for 12 years and older on 02/25/25. We were notified in office by billing on 03/05/25. CMA called and spoke with parent and no adverse reaction.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Adenomyosis, Laboratory test, Menopause, Menstruation irregular, Ultrasound pelvis
Clinical narrative: After getting the mRNA Covid 19 Vaccine, I started to experience irregular periods. This has persisted to present day (03/05/2025). I since have also been diagnosed with Adenomyosis and have experience perimenopause symptoms for the last 2 years.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received Flu vaccine due to no records found that show Flu#2 was received. Flu vaccine was not listed on system and no outside media/records available. Electronic outside sources from "database" where delayed and updated post clinic visit. Patient did not have an adverse reaction and was discharged from the clinic asymptomatic. Parent of patient was contacted for follow up and ensure patient remained asymptomatic.
Age: 0.67
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Expired product administered
Clinical narrative: The vaccine was outdated.  The expiration date was 02/26/2025 and was administered on 03/04/2025
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye irritation, Eyelid margin crusting
Clinical narrative: patient experiencing eye burning, eye crustiness, started Saturday/Sunday after vaccine and continues today Wednesday after
Age: 66.0
Sex: F
Vaccine: PNC21, PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was inadvertenly given 2 pneumonia shots in one day. Patient has been informed and is not experiencing any complications.
Age: 66.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: An error occurred in mixing the vaccine with the incorrect diluent, which resulted in the patient not receiving the full vaccine. Although the patient experienced no adverse effects, they had to return to receive the vaccine with the correct diluent to be fully vaccinated.
Age: 70.0
Sex: F
Vaccine: COVID19, MMR, VARZOS
Symptoms: Oral pain, Stomatitis
Clinical narrative: Patient reports that the upper roof of her mouth became very painful ,sore and raw 2 days after she received the above 3 mentioned vaccinations.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: Lump swollen itching at site
Age: 67.0
Sex: F
Vaccine: MMR, PPV, UNK, UNK
Symptoms: Injection site swelling, Lymphadenopathy, Pain
Clinical narrative: reaction at injection site of swelling the size of the palm of her hand in her right arm; painful; swelling the size of the lymph nodes under right arm; This spontaneous report was received from a consumer referring to herself, a 67-year-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions included guaifenesin (DIMETAPP) reaction and latex allergy. Concomitant therapies were not reported.  On an unknown date in 2020 (reported as 5 years ago), the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) solution for injection, administered as vaccine in right arm (strength, dose, route, lot #, and expiration date were not reported). On the same date, the patient was also vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) lyophilisate and solvent for solution for injection and unspecified hepatitis vaccine (Hepatitis A Vaccine, Inactivated (manufacturer unknown) suspension for injection or Hepatitis B Vaccine (Recombinant) (manufacturer unknown) suspension for injection), administered for prophylaxis (formulation, strength, dose, route, lot#, and expiration date were not reported).  On an unknown date in 2020 (reported as about five years ago), the patient experienced reaction at injection site of swelling the size of the palm of her hand in her right arm (Vaccination site swelling) and the lymph nodes under right arm (injected on right side) (Lymphadenopathy). The events did not happen immediately, but they ended up swollen the whole upper portion of her arm. Painful was for 3-5 days then subsided. The patient had sought medical attention. No treatment was given. Outcome of the events was recovered 3-5 days later.  Causality between the events and all the suspect vaccines was not reported.  Lot# is being requested and will be submitted if received.
Age: 22.0
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: no symptomatic AE; an adult patient received a pediatric dose of VAQTA instead of an adult dose; This spontaneous report was received from a nurse and refers to a 22-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 25-JAN-2025, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA) suspension for injection, 0.5 ml, administered for prophylaxis by a health professional (lot #Y006122, expiration date: 17-MAY-2025; strength and route were not reported). The adult patient received a pediatric dose of Hepatitis A Vaccine, Inactivated (VAQTA) instead of an adult dose (Incorrect dose administered). No symptomatic adverse event (AE) was reported.
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Medical Assistant calling with a report of an adverse event regarding improperly stored and administered VARIVAX.; This spontaneous report was received from a physician 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 09-Jan-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX  REFRIGERATOR STABLE), 0.5 mL (lot #Y015108, has been verified to be a valid lot number, expiration date reported and upon internal validation both confirmed as 06-Sep-2026) dose description reported as 0.5 mL / Two dose series, administered for prophylaxis; with sterile diluent (BAXTER Sterile Diluent). It was reported that the vaccine was involved in multiple temperature excursions beginning on (05-DEC-2024), and the product was administered to the patient involved on 09-Jan-2025 (Product storage error). The reporter confirmed no reports of medical concerns or symptoms from the patient involved. No additional information provided. There was no additional adverse event (AE) or product quality complaint (PQC) provided.
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; the VARIVAX was involved in multiple temperature excursions beginning on 12/5/2024, and the product was administered to the patient involved on 1/9/2025; This spontaneous report was received from an Other health professional and refers to a(n) 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.   Beginning on 05-DEC-2024, Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX  REFRIGERATOR STABLE) was involved in multiple temperature excursions.  On 09-JAN-2025, the patient was vaccinated with the improperly stored Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX  REFRIGERATOR STABLE), (lot #Y015108, expiration date: 06-SEP-2026) 0.5 mL (0.5 mL / Two dose series) (route was not reported) with sterile diluent (MERCK STERILE DILUENT) for prophylaxis (product storage error). No additional adverse event (AE) was reported (no adverse event).
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no reports of medical concerns or symptoms; improperly stored and administered VARIVAX; This spontaneous report was received from a medical assistant referring 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 03-JAN-2025, the patient was administered a dose of improperly stored Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (0.5 mL, two dose series, lot # Y015108, expiration date: 06-SEP-2026; dose number, route and anatomical site were unknown) for prophylaxis (product storage error), which was reconstituted with sterile diluent (BAXTER Sterile Diluent) (dose, strength, batch/lot#, expiration date, routed and indication were unknown). The vaccine was involved in multiple temperature excursions beginning on 05-DEC-2024. No reports of medical concerns or symptoms from the patient involved (no adverse event). The outcome of the events was unknown.
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Medical Assistant calling with a report of an adverse event regarding improperly stored and administered VARIVAX.; This spontaneous report has been received from other health care professional (medical assistant) concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant medications were not provided by the reporter.  On 09-JAN-2025, the patient was vaccinated with an improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) solution for injection, 0.5 mL, lot# Y015108 that was verified to be a valid lot # (expiration date reported and validated as 06-SEP-2026) administered as prophylaxis (routed and anatomical location of administration were not provided). The dose was administered after underwent multiple temperature excursions (beginning on 05-DEC-2024) (product storage error). No medical concerns or symptoms from the patient involved were reported. No additional adverse event reported.
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; improper storage of product in use; This spontaneous report was received from a medical assistant referring to patient of unknown age and gender. Information regarding the patient's concurrent conditions, historical conditions and concomitant or historical medications was not provided. On 14-JAN-2025, the patient was vaccinated with an improperly stored dose of vaccine Varicella Virus Vaccine Live (Oka-Merck) injection, 0.5 milliliters, for prophylaxis, lot number Y015108 which has been verified to be valid, expiration date reported and validated as 06-SEP-2026 (strength, scheme, route of administration and expiration date not provided). The vaccine was  improperly stored since 05-DEC-2024. The previous temperature excursions of the vaccine were unknown (improper storage of product in use). There were no symptoms reported.
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; GARDASIL 9 were administered to two patients after experiencing a  temperature excursion; This spontaneous report has been received from a health care professional regarding a 12-year-old patient of unknown gender. Information regarding medical history, concurrent conditions and concomitant therapies was not reported. On January 2025 , the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, for prophylaxis, lot number 1957407 which has been verified to be valid, expiration date reported and validated as 23-JAN-2026(dose, strength, scheme, route of administration and anatomical site not provided). The administered dose of the vaccine was stored at 31.6 degrees Celsius (C), during 240 hours. There were not previous temperature excursions. There were no symptoms reported.
Vaccine: HIBV, PNC15, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; calling to report T/E for PEDVAX HIB , ROTATEQ, VAXNEUVANCE that was administered.; This spontaneous report was received from a health care professional referring to a patient, age and gender was not provided. Information regarding the patient's pertinent medical history, drug allergies or reactions, or concomitant medications was not provided. On 20-FEB-2025, the patient was vaccinated with an improperly stored dose of  Pneumococcal 15-valent Conjugate (VAXNEUVANCE) injection, for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location were not reported, lot number Y005465 with an expiration date on 08-JAN-2027) with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location were not reported, lot number Y005878 with an expiration date on 28-OCT-2025) and with a dose of haemophilus b conjugate vaccine (Meningococcal protein conjugate) (PEDVAXHIB-LIQUID) for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location were not reported, lot number X028614 with an expiration date on 07-NOV-2026). The administered dose of the vaccine experienced a temperature excursion 32.0 degrees Fahrenheit for 2 hours and 12minutes.It was not reported if the information was recorded by a data logger or not. There was no adverse effect reported.
Vaccine: HEPA, HIBV, PNC15
Symptoms: No adverse event
Clinical narrative: No additional AE reported; immunization coordinator calling to report T/E for VAQTA , PEDVAX HIB , VAXNEUVANCE that was administered.   T/E date was on 2/18/2025 and  VAQTA , PEDVAX HIB , VAXNEUVANCE were administered on 2/19/2025.; This spontaneous report was received from a Nurse regarding a patient of unknown age and gender.    The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported.   On 18-FEB-2025, a temperature excursion (TE) occurred for Hepatitis A Vaccine, Inactivated (VAQTA), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) and  Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) at 32 degree Fahrenheit (F) for 2 hours and 12 minutes, with not previous TE. After the TE, on 19-FEB-2025, the patient was vaccinated with an improperly stored dose of Hepatitis A Vaccine, Inactivated (VAQTA) 25U/0.5 ml Injection, prefilled syringe, first dose (lot number Y008483 has been verified to be valid for Hepatitis A Vaccine, Inactivated [VAQTA], expiration date 26-Nov-2025); with an improperly stored dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), second dose (lot number Y006393 has been verified to be valid for Haemophilus b Conjugate Vaccine [Meningococcal Protein Conjugate] [LIQUID PEDVAX HIB], expiration date 07-Nov-2026; formulation was not provided) and with an improperly stored dose of Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE), 0.5 ml Injection, prefilled syringe, third dose (lot number Y005465 has been verified to be a valid number for Pneumococcal 15-valent Conjugate Vaccine [VAXNEUVANCE], expiration date 08-Jan-2027); all vaccines were administered as prophylaxis (exact dose, route of administration and anatomical site of injection were not reported for any of the vaccines) (Product storage error). No additional adverse event was reported for the patient (No adverse event).   This is one of several reports from the same reporter.; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02763807-02763516 , CLIC number : , ESTAR number : , IRMS number : 500UW00000VCgbGYAT|04032025230033|5967 , Central date : 2025-03-05 , Classification : DMC, Attachment description : NSC Call , Safety case number : , MNSC case number : 02763807 , MNSC interaction number : 02763516 , Integration log UniqueID : 500UW00000VCgbGYAT|04032025230033|5967 , Service cloud CaseID : 500UW00000VCgbGYAT
Age: 33.0
Sex: F
Vaccine: HPV9
Symptoms: Accidental underdose, No adverse event, Poor quality device used
Clinical narrative: no adverse event; Accidental underdose; poor quality device used; This spontaneous report has been received from a health care professional regarding a 33-year-old female patient. Information regarding medical history, concurrent conditions and concomitant therapies was not reported. On 04-MAR-2025, the patient received HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (reported as GARDASIL 9 INJ 1DS X 10 SYRINGES), 0.5 mL for prophylaxis, lot number Y007322 which has been verified to be valid, expiration date reported and validated as 18-AUG-2026(strength, scheme, route of administration and anatomical site not provided). On the same date the health care professional reported that the vaccine leaked between the syringe hub luer lock and syringe needle while being administered.  No physical defects in the syringe were noted.  (accidental underdose) (poor quality device used) (no adverse event).
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Last week two individuals were vaccinated using Jynneos that should have been marked with a BUD but was not, the shipment was placed in refrigerator, BUD was on 20-Dec-2024; Case reference number US-BN-2025-000126 is a spontaneous case initially received from other health care professional via Med Communication (reference number: USBAV25-0116) on 15-Jan-2025 and concern a patients with unspecified age and gender (MULTI 2).  The patients medical history and concomitant medication details were not provided.  On 09-Jan-2025, two patients received Jynneos vaccine, (batch number: 96867; expiration date: Apr-2026 and beyond use date (BUD): 20-Dec-2024), at unknown dose, route or site of administration for unknown indication. The shipment was received on 25-Oct-2024 and placed in refrigerator, so the BUD was 20-Dec-2024 (explicitly coded as 'Expired product administered').  At the time of initial report, it was unknown if the patient experienced any adverse events due Jynneos.  No further information was provided.; Reporter's Comments: This case concerns two patients with unspecified age and gender who received Jynneos vaccine on 09-Jan-2025 (batch number: 96867; expiration date: Apr-2026 and beyond use date (BUD): 20-Dec-2024), at unknown dose, route or site of administration for unknown indication. The shipment was received on 25-Oct-2024 and placed in refrigerator, so the BUD was 20-Dec-2024 which is considered as expired product administered. Expired product administered is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events due Jynneos. The patients medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: This case concerns two patients with unspecified age and gender who received Jynneos vaccine on 09-Jan-2025 (batch number: 96867; expiration date: Apr-2026 and beyond use date (BUD): 20-Dec-2024), at unknown dose, route or site of administration for unknown indication. The shipment was received on 25-Oct-2024 and placed in refrigerator, so the BUD was 20-Dec-2024 which is considered as expired product administered. Expired product administered is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events due Jynneos. The patients medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Received First Dose June 2024, More than 1 Month and Hasn't Received Second; Initial report received on 12-Feb-2025.  A pharmacist reported that a male patient (race and ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization in Jun-2024 but had not received the second dose yet.   No medical history or concomitant medications were reported.  In Jun-2024, the patient received dose 1 of a hepatitis B vaccine [HEPLIAV-B (NDC # 43528-002-01, lot #, expiration date, route, and site not reported).    At the time of reporting, the patient had not received the second dose of HEPLISAV-B yet, more than a month after receiving the first dose. No adverse reactions were reported.  The reporter had no other information.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pediatric Patient (7 day old) Received Heplisav-B; Initial report received on 12-Feb-2025.  A medical assistant reported that a 7-day-old (gender, race, ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history or concomitant medications were reported.  On 12-Feb-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC #, route, and site not available)]. The patient was 7 days old when vaccinated with HEPLISAV-B.   No adverse reactions were reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Received First Dose , and Second Dose 9 Days Apart; Initial report received on 24-Feb-2025.    A nurse reported that a 21-year-old female (race, ethnicity not reported) received the second dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization 9 days after receiving the first dose.   No medical history or concomitant medications were reported.    On 13-Feb-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot # 945660, expiration date 31-Jan-2025, NDC # 43528-0003-01) intramuscularly in the left deltoid.    On 22-Feb-2025, 9 days after receiving after having been vaccinated with HEPLISAV-B, the patient received dose 2 of a hepatitis B vaccine [HEPLISAV-B (lot # 945660, expiration date 31-Jan-2027, NDC# 43528-003-01) intramuscularly in the left deltoid.   No adverse effects were reported.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Dizziness
Clinical narrative: Dizziness; Initial report received on 24-Feb-2025.    A nurse reported that a 26-year-old female (race, ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and experienced dizziness.   No medical history or concomitant medications were reported.       In Jan-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC #, route, and site not available)].   On an unknown date, a week after the first dose of HEPLISAV-B, the patient experienced dizziness.  The patient is due for her second dose but has been referred to her primary care provider for follow-up.   No additional information was provided.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: Received First Dose, Do I Need Second Dose; Initial report received on 24-Feb-2025.    A consumer reported that he, a 25-year-old male (race, ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization but has not received the second dose yet.    No medical history or concomitant vaccines were reported.    On 18-Dec-2024, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC #, route, and site not available).   At the time of this report, the patient has not received the second dose yet.   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: VARZOS
Symptoms: Epistaxis, Herpes zoster, Incomplete course of vaccination, Ophthalmic herpes zoster, Oral herpes zoster
Clinical narrative: Got the right eye; down his/her throat and roof of his/her mouth; Herpes zoster; inside of his/her nose had a spot where blood was coming out of; Herpes zoster; This serious case was reported by a consumer via interactive digital media and described the occurrence of ophthalmic herpes zoster in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. In NOV-2023, an unknown time after receiving Shingles vaccine, the patient experienced herpes zoster (Verbatim: Herpes zoster). In APR-2024, the patient experienced herpes zoster (Verbatim: Herpes zoster). On an unknown date, the patient experienced ophthalmic herpes zoster (Verbatim: Got the right eye) (serious criteria GSK medically significant), oral herpes zoster (Verbatim: down his/her throat and roof of his/her mouth) and epistaxis (Verbatim: inside of his/her nose had a spot where blood was coming out of). In NOV-2024, the outcome of the herpes zoster was resolved. The outcome of the ophthalmic herpes zoster, oral herpes zoster, herpes zoster and epistaxis were resolving.   It was unknown if the reporter considered the ophthalmic herpes zoster, oral herpes zoster, herpes zoster, herpes zoster and epistaxis to be related to Shingles vaccine.     The company considered the ophthalmic herpes zoster to be unrelated to Shingles vaccine. It was unknown if the company considered the oral herpes zoster, herpes zoster, herpes zoster and epistaxis to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-FEB-2025 This case was reported by a patient via interactive digital media. The patient had shingles in his/her head.  Patient had one shot before but never got the second, as he/she was afraid it would come back. However, it did return.  The first occurrence was in November, and the second time was in April the following year, lasting until November 2024.  It affected his/her right eye, the right side of his/her face, the top of his/her head, down his/her throat, the roof of his/her mouth, and even ate a hole in his/her nose.  Inside his/her nose, there was a spot where blood was coming out.  Eventually, it started to get better, but it took time.; Sender's Comments: Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine.