chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia, Respiratory failure, Vitamin D
Clinical narrative: Discharge Summary MD (Physician) ? General Medicine BRIEF OVERVIEW: Admission Date: 2/21/2025 Discharge Date: 2/27/2025 Discharge Disposition:  Home without services  Active Issues Requiring Follow-up: COPD DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Mixed metabolic and respiratory acidosis of newborn [P84] Pneumonia due to infectious organism, unspecified laterality, unspecified part of lung [J18.9] Acute on chronic hypoxic respiratory failure [J96.21] Acute on chronic respiratory failure [J96.20]  HOSPITAL COURSE: 64 y.o. female with a history of  COPD on 1.5-2 L nasal cannula at baseline, OSA, morbid obesity, and Crohn's disease who presented for increased shortness of breath and dyspnea.    Acute on chronic hypoxic respiratory failure - resolved COPD Exacerbation  - improving Leukocytosis  Recent COVID-19 infection - On Chronic 1.5-2L of O2 at home but now requiring HFNC.  O2 supplementation PRN w/ goal O2 saturation 88-92% - CT chest notable for extensive multifocal airspace disease - Remdesivir  - Levaquin, metronidazole, vancomycin - Oral dexamethasone - Symbicort - Continued home montelukast  - Albuterol PRN  - Supportive care  Hypertension  - Continue home amlodipine - Home losartan increased from 25 to 50 mg; continue  Hyperglycemia in the setting of steroid use Type II Diabetes, not on long term insulin  - HbA1c 7.2 - Held home oral diabetic medications - Lantus 34U - Basal bolus insulin - Carb Control Diet  History of CVA - Continued ASA, statin   GAD - Continued BuSpar  - Held trazodone - PRN Atarax  Chronic low back pain  Glaucoma - Continued eye drops  Hyponatremia, mild - stable   Hypocalcemia - resolved - Checked ionized calcium  - Checked vitamin D  History of Crohns  Does not appear to be on immunomodulating therapy - Continued Bentyl   Vertigo - PRN meclizine   Microcytic anemia   Morbid obesity   CONSULTS / RECOMMENDATION:  IP CONSULT TO NUTRITION Discharged to Home.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal X-ray, Abdominal pain, Blood lactic acid increased, COVID-19, Computerised tomogram abdomen abnormal
Clinical narrative: Name:  Medical Record #: Age: 71 y.o. DOB: 4/X/19XX  Admit date: 3/2/2025  Discharge date: 3-5-25  Admitting Physician: MD   Attending Physician at the Time of Discharge: MD   Primary Care Physician: MD  Reason for Admission: Small bowel obstruction  Brief Summary of Hospital Stay: 71 year old female admitted with abdominal pain, nausea, and vomiting.  Abdominal surgical history includes cholecystectomy, sleeve gastrectomy (2014) with a recent medical history of positive Covid (2-27-25).  CT abd/pel were concerning for possible small bowel obstruction and possible pneumatosis intestinalis of jejunal loops.  Laboratory studies were significant for lactic acid of 2.7.  Patient was admitted and a gastrografin challenge was completed - no evidence of fecal impaction with oral contrast within the colon and distal ileum.    A clear liquid diet was started and tolerated.  Zosyn 4.5 g IV was ordered due to the concern of pneumatosis intestinalis.  That was discontinued on hospital day #2.  Patient was in isolation due to her recent Covid status but ambulated in room, completed her own self care without difficulty.  Abdominal pain, nausea, and vomiting subsided.   As patient is a bariatric patient, diet and behaviors were discussed.  Patient has not been to the bariatric clinic for several years.  Patient agreed to return to get her dietary choices back on track.  By hospital day #2, patient tolerated full liquids with diet advancement.  There was no return of abdominal pain, nausea, or vomiting.  It was determined that patient was stable for discharge home.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Patient isolation, SARS-CoV-2 test positive, Scan with contrast normal, Vomiting
Clinical narrative: Name:  Medical Record #: Age: 71 y.o. DOB: 4/X/19XX  Admit date: 3/2/2025  Discharge date: 3-5-25  Admitting Physician: MD   Attending Physician at the Time of Discharge: MD   Primary Care Physician: MD  Reason for Admission: Small bowel obstruction  Brief Summary of Hospital Stay: 71 year old female admitted with abdominal pain, nausea, and vomiting.  Abdominal surgical history includes cholecystectomy, sleeve gastrectomy (2014) with a recent medical history of positive Covid (2-27-25).  CT abd/pel were concerning for possible small bowel obstruction and possible pneumatosis intestinalis of jejunal loops.  Laboratory studies were significant for lactic acid of 2.7.  Patient was admitted and a gastrografin challenge was completed - no evidence of fecal impaction with oral contrast within the colon and distal ileum.    A clear liquid diet was started and tolerated.  Zosyn 4.5 g IV was ordered due to the concern of pneumatosis intestinalis.  That was discontinued on hospital day #2.  Patient was in isolation due to her recent Covid status but ambulated in room, completed her own self care without difficulty.  Abdominal pain, nausea, and vomiting subsided.   As patient is a bariatric patient, diet and behaviors were discussed.  Patient has not been to the bariatric clinic for several years.  Patient agreed to return to get her dietary choices back on track.  By hospital day #2, patient tolerated full liquids with diet advancement.  There was no return of abdominal pain, nausea, or vomiting.  It was determined that patient was stable for discharge home.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray normal
Clinical narrative: Name:  Medical Record #: Age: 71 y.o. DOB: 4/X/19XX  Admit date: 3/2/2025  Discharge date: 3-5-25  Admitting Physician: MD   Attending Physician at the Time of Discharge: MD   Primary Care Physician: MD  Reason for Admission: Small bowel obstruction  Brief Summary of Hospital Stay: 71 year old female admitted with abdominal pain, nausea, and vomiting.  Abdominal surgical history includes cholecystectomy, sleeve gastrectomy (2014) with a recent medical history of positive Covid (2-27-25).  CT abd/pel were concerning for possible small bowel obstruction and possible pneumatosis intestinalis of jejunal loops.  Laboratory studies were significant for lactic acid of 2.7.  Patient was admitted and a gastrografin challenge was completed - no evidence of fecal impaction with oral contrast within the colon and distal ileum.    A clear liquid diet was started and tolerated.  Zosyn 4.5 g IV was ordered due to the concern of pneumatosis intestinalis.  That was discontinued on hospital day #2.  Patient was in isolation due to her recent Covid status but ambulated in room, completed her own self care without difficulty.  Abdominal pain, nausea, and vomiting subsided.   As patient is a bariatric patient, diet and behaviors were discussed.  Patient has not been to the bariatric clinic for several years.  Patient agreed to return to get her dietary choices back on track.  By hospital day #2, patient tolerated full liquids with diet advancement.  There was no return of abdominal pain, nausea, or vomiting.  It was determined that patient was stable for discharge home.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Ankle fracture, Open reduction of fracture, Pain in extremity, Procedural pain, Radiotherapy
Clinical narrative: Name:   Medical Record #:  Age:  67 y.o. DOB:  11/X/19XX  Admit date: 3/3/2025  Discharge date: 3/5/2025   Admitting Physician:  MD  Attending Physician at the Time of Discharge: DO  Primary Care Physician: PAC  Reason for Admission: Right trimalleolar fracture  Hospital Course: Patient is a 67 YO F with PMHx of stage I vulvar cancer, type 2 diabetes mellitus, hypertension, chronic obstructive pulmonary disease, CKD 3, chronic pain/fibromyalgia who presents after syncopal event with right leg pain and found to have unstable right trimalleolar fracture, status post ORIF on 3/4 by Dr.  Post operative pain was difficult to control, but on the day of discharge she was well controlled with oxycodone 10 mg every 3 hours.  She received radiation therapy in the hospital. She and her husband refused placement as she is essentially wheelchair-bound at baseline, following surgery was nonweightbearing right lower extremity on day of discharge. She was discharged home with home healthcare services on 3/5/2025
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Wheelchair user
Clinical narrative: Name:   Medical Record #:  Age:  67 y.o. DOB:  11/X/19XX  Admit date: 3/3/2025  Discharge date: 3/5/2025   Admitting Physician:  MD  Attending Physician at the Time of Discharge: DO  Primary Care Physician: PAC  Reason for Admission: Right trimalleolar fracture  Hospital Course: Patient is a 67 YO F with PMHx of stage I vulvar cancer, type 2 diabetes mellitus, hypertension, chronic obstructive pulmonary disease, CKD 3, chronic pain/fibromyalgia who presents after syncopal event with right leg pain and found to have unstable right trimalleolar fracture, status post ORIF on 3/4 by Dr.  Post operative pain was difficult to control, but on the day of discharge she was well controlled with oxycodone 10 mg every 3 hours.  She received radiation therapy in the hospital. She and her husband refused placement as she is essentially wheelchair-bound at baseline, following surgery was nonweightbearing right lower extremity on day of discharge. She was discharged home with home healthcare services on 3/5/2025
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Joint swelling, Muscle atrophy, Pain
Clinical narrative: Joint swelling, pain, inflammation. Right arm and right shoulder muscle breakdown, muscle loss. Pt was prescribed Methotrexate, Humira, prednisone, then Rinvoq.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Blood glucose normal, Cerebral haemorrhage, Disorientation, Fall
Clinical narrative: Name:  Date of Birth: 6/XX/19XX (Age: 70 y.o.)    Date of Admission: 3/5/2025 Date of Discharge: 3/9/2025 Consultants:  neurology, neurosurgery Intern/Resident: n/a  Hospital Course by Discharge Diagnoses: Intraparenchymal Hemorrhage and Subdural Hematoma -involving left frontal lobe, left tentorium and right lateral ventricle -appreciate neurosurgery input, no surgical intervention planned, keep systolic bp<150 -cont to hold any asa or ac at this time until resolved on serial imaging -stable for dc home per PT/OT recs, home therapy -f/u ct head ordered by neurosurgery   Diabetes Mellitus -carb restrict, on ssi, glucose relatively controlled -cont home meds which includes jardiance, A1c 6.6  History of Substance Abuse -h/o endocarditis -mod-severe tricuspid regurg -cont home methadone  Hypertension -increase valsartan, cont home spironolactone, resume home amlodipine  Hyperlipidemia -cont statin  Anxiety/Depression -cont citalopram, buspirone  BPH-cont tamsulosin  Tobacco Use -counsel cessation, nicotine patch  Microcytosis without Anemia -fe studies normal, likely beta thalassemia  Brief Admission History/Reason for Admission: Per H&P: 70 y.o.male with PMHx of alcohol abuse, opiate abuse, MDD, diabetes type 2, BPH, hypertension, osteoporosis who presented to the hospital overnight after an unwitnessed fall at home. His daughter, who is present for exam, states that she and her sister were with him and heard a loud thud around 2:00am. They went to check on their dad and he was on the ground in the bathroom. He does not recall the events of the fall or if he experienced any presyncopal symptoms. He is still unsure what occurred. He complains of a headache and is tired and slightly altered to orientation at this time, but denise any troubles with speech, hearing, numbness or weakness in his extremities or other focal neurologic deficits. He does not take ASA or other anticoagulation. Discharged to Home.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Glycosylated haemoglobin normal, Headache, Subdural haematoma
Clinical narrative: Name:  Date of Birth: 6/XX/19XX (Age: 70 y.o.)    Date of Admission: 3/5/2025 Date of Discharge: 3/9/2025 Consultants:  neurology, neurosurgery Intern/Resident: n/a  Hospital Course by Discharge Diagnoses: Intraparenchymal Hemorrhage and Subdural Hematoma -involving left frontal lobe, left tentorium and right lateral ventricle -appreciate neurosurgery input, no surgical intervention planned, keep systolic bp<150 -cont to hold any asa or ac at this time until resolved on serial imaging -stable for dc home per PT/OT recs, home therapy -f/u ct head ordered by neurosurgery   Diabetes Mellitus -carb restrict, on ssi, glucose relatively controlled -cont home meds which includes jardiance, A1c 6.6  History of Substance Abuse -h/o endocarditis -mod-severe tricuspid regurg -cont home methadone  Hypertension -increase valsartan, cont home spironolactone, resume home amlodipine  Hyperlipidemia -cont statin  Anxiety/Depression -cont citalopram, buspirone  BPH-cont tamsulosin  Tobacco Use -counsel cessation, nicotine patch  Microcytosis without Anemia -fe studies normal, likely beta thalassemia  Brief Admission History/Reason for Admission: Per H&P: 70 y.o.male with PMHx of alcohol abuse, opiate abuse, MDD, diabetes type 2, BPH, hypertension, osteoporosis who presented to the hospital overnight after an unwitnessed fall at home. His daughter, who is present for exam, states that she and her sister were with him and heard a loud thud around 2:00am. They went to check on their dad and he was on the ground in the bathroom. He does not recall the events of the fall or if he experienced any presyncopal symptoms. He is still unsure what occurred. He complains of a headache and is tired and slightly altered to orientation at this time, but denise any troubles with speech, hearing, numbness or weakness in his extremities or other focal neurologic deficits. He does not take ASA or other anticoagulation. Discharged to Home.
Age: 16.0
Sex: M
Vaccine: FLU3, MENB, MNQ
Symptoms: Arthralgia, Shoulder injury related to vaccine administration
Clinical narrative: Pain in both shoulders after vaccines, right worse than left.  SIRVA
Age: 66.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Asthenia, Dizziness, Heart rate irregular
Clinical narrative: 66 with notable PMH of HIV and HSV received flu vax (>65) in right delt and RSV vax in left delt at internal medicine clinic. pt had received flu vaccine prior (last admin documented in 2020), however this was pt's first time receiving 65+ vax. this was also first time receiving RSV vax. after vaccine administration, pt reported feeling dizzy and weak, and RRT was called and pt was transported to ED. Pt reported that her partner had some sort of viral illness prior to visit, but reported feeling well in ED other than body aches. Pt was admitted for observation and ultimately diagnosed with HRV. No notable events occurred during admission and pt was discharged the next day
Age: 0.33
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: REPORT BEING SUBMITTED ON THE DAY THE VACCINE WAS GIVEN, NO IMMEDIATE SYMPTOMS. PARENT OF PATIENT WAS GIVEN A INFORMATIONAL SHEET AND ASKED TO CONTACT OUR OFFICE OR TAKE PATIENT TO ER IF SYMPTOMS WERE SEVERE.  NO TREATMENT NECESSARY AT THIS TIME.
Age: 53.0
Sex: F
Vaccine: PNC20
Symptoms: Diarrhoea, Nausea, Palpitations, Vomiting
Clinical narrative: Diarrhea, nausea, vomiting, palpitations
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Anisomastia, Micromastia
Clinical narrative: The covid vaccination was given in the left arm and the left breast is significantly smaller than the right breast. will need surgery to increase the size. has been seen by OBGYN. micromastia to the left breast.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Seborrhoeic dermatitis
Clinical narrative: Two different skin rashes appeared on legs, torso and face.  One was Seborrheic Dermatitis and the other was not explained.  Rashes began on 12/13/2024 and has not gone away as of 3/10/2025.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given an adult dose of the Hepatitis B vaccine.  No adverse events reported.
Age: 0.67
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient was brought into clinic on 12/23/2024 to receive booster flu vaccination and flu vaccination was administered that day. The flu vaccination was not documented into clinic system as being administered. Patient was brought in for an appointment on 02/18/2025 and was administered another flu vaccination dose because the dose on 12/23/2024 was not documented and it looked like patient still needed flu booster vaccination. Patient received a total of 3 flu vaccinations. Patient has been reported to be doing fine and displayed no side effects on 03/05/2025.
Age: 61.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site warmth, Lethargy, Pain, Pyrexia
Clinical narrative: Patient developed red warm circular area around the injection site approximately 1 day after receiving the vaccine.  He also became lethargic and mild fever/body aches temporarily the day following.  He is continuing to have redness around injection site 2 days post vaccination.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: 10 years prior he good stomach pains from a flu vaccine.
Age: 61.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: 5 days post vaccine.  Itchy, raised & red area at inj site with soreness.
Age: 46.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: given out of age range
Age: 26.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site pain
Clinical narrative: Severe pain in shoulder where vaccination was given
Age: 59.0
Sex: M
Vaccine: PNC21
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: cellulitis (severe redness and swelling) around inject site. prescriber put the patient on doxycycline on 3/10/2025
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Gaze palsy, Hyperhidrosis, Loss of consciousness, Malaise, Seizure like phenomena
Clinical narrative: Pt presented to the office for TDAP vaccine and HPV vaccine.  Prior to administration, pt stated that she has not ever passed out after a vaccine or had any adverse reactions.  Vaccine were given by someone under my supervision. With in 30 seconds of receiving the HPV vaccine patient let us know she was not feeling well. The patient then passed out, eyes rolled back in her head, started having seizure like activity, loss of bladder control, sweating, shaking. This lasted about 60 seconds. The call bell was pulled, Person went to get the BP cart and doctor. We moved the patient to the table and her BP was taken. Doctor did an exam. Pt was given water and graham cracker. Vital signs were stable. Doctor discussed symptoms with another provider, and was decided that she should be sent to the ED for evaluation, due to seizure like activity. Pt was agreeable, and her mother in law came to get her. Pt was wheeled out to mother in laws vehicle. Pt was transferred to vehicle and they are going to hospital.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Tremor, Urinary incontinence
Clinical narrative: Pt presented to the office for TDAP vaccine and HPV vaccine.  Prior to administration, pt stated that she has not ever passed out after a vaccine or had any adverse reactions.  Vaccine were given by someone under my supervision. With in 30 seconds of receiving the HPV vaccine patient let us know she was not feeling well. The patient then passed out, eyes rolled back in her head, started having seizure like activity, loss of bladder control, sweating, shaking. This lasted about 60 seconds. The call bell was pulled, Person went to get the BP cart and doctor. We moved the patient to the table and her BP was taken. Doctor did an exam. Pt was given water and graham cracker. Vital signs were stable. Doctor discussed symptoms with another provider, and was decided that she should be sent to the ED for evaluation, due to seizure like activity. Pt was agreeable, and her mother in law came to get her. Pt was wheeled out to mother in laws vehicle. Pt was transferred to vehicle and they are going to hospital.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral, Herpes zoster, Hordeolum, Magnetic resonance imaging head normal
Clinical narrative: Loss of hearing in my left ear, had MRI, normal, took steriod, had steriod injection in my left ear.  Follow up visit scheduled for 3/26.  I am not noticing any difference, still cannot hear in my left ear.     On February 20, I got shingles.  On February 24, I started with a viral infection.  On March 7, 2025, I started with a stye in my right eye
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Viral infection
Clinical narrative: Loss of hearing in my left ear, had MRI, normal, took steriod, had steriod injection in my left ear.  Follow up visit scheduled for 3/26.  I am not noticing any difference, still cannot hear in my left ear.     On February 20, I got shingles.  On February 24, I started with a viral infection.  On March 7, 2025, I started with a stye in my right eye
Age: 32.0
Sex: F
Vaccine: HEPA, MMR
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Patient presented in our office requesting vaccinations for her nursing school.  Patient was 18 weeks pregnant.  Nurse Practitioner ordered the vaccines.  Patient was given consent forms and signed for both vaccines.   Patient received vaccines.  Patient was instructed to return in 1 month for the second MMR.  Patient returned on 2/24/25.  Patient again was given consent and signed for vaccine.  Received second MMR.  Patients OB/GYN notified us of error.  Advised that fetus appears to be fine.  Patient advised of symptoms to be aware of.  Patient states she is fine also.  Followed up with patient to assure no adverse reactions.   Primary Care advised of error.  Staff educated on policy and protocol regarding live vaccines and women of childbearing age.
Age: 40.0
Sex: M
Vaccine: HEPAB, MMR, TDAP
Symptoms: Loss of consciousness
Clinical narrative: patient experience possible panic or seizure attack during vaccination. loss conscious for few second and recover afterward. no medication was used.
Age: 67.0
Sex: M
Vaccine: FLU3, PNC21
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: REDNESS, SORENESS AND PAINFULL AT THE INJECTION SITE
Age: 28.0
Sex: M
Vaccine: RAB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: SYMPTOM REPORTED INCLUDE MILD SKIN REDNESS AND MILD SWELLING TO LEFT DELTOID AT INJECTION SITE. NO FURTHER SYMPTOMS.   TREATMENT PROVIDED ICE PACK WAS APPLIED TO LEFT DELTOID BY INJECTION SITE.
Age: 18.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Rash, Rash pruritic
Clinical narrative: PT received vaccines on 02/25/25 and reported to clinic today (3/10/25) with a rash noted all over face and scattered on her back. Pt states the rash is itchy and painful at times. Pt was at school and seen school nurse whom she told that she had recently received vaccines and the nurse sent her to this clinic where she received them. This nurse consulted with regional medical director, who stated patient needs to be seen by her PCP or pediatrician. Referred family to pediatrician.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient developed red swollen left arm, warm to touch, the next day following vaccines.  Instructed parent to apply a cool compress to child's arm and if it does not subside within a few days, take child in to get checked by a medical provider.
Age: 19.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Head injury, Loss of consciousness
Clinical narrative: Patient administered two vaccines.  2nd hepB vax and boostrix.  Approximately 2mins after administration pt was standing and conversing with pharmacist and technician then suddenly lost consciousness.  Patient mildly/moderately struck head on wall while being caught by technician and another patient standing by.  Patient was caught before falling to ground with no skin broken and no bleeding observed or reported by patient.  911 was called and ambulance team arrived.  Patient refused further medical attention and exited on his own volition.
Age: 53.0
Sex: F
Vaccine: PNC20
Symptoms: Circumstance or information capable of leading to medication error, Underdose
Clinical narrative: pt only got a partial does of the pneumococcal PVC 20 vaccine. the pt flinched while getting the vaccine and only have of a dose went it.  pt will have to return to get another dose since this one is considered not a real dose according to the manufacturer.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Dyspnoea, Feeling abnormal, Injection site erythema, Injection site pruritus
Clinical narrative: On 3/6/25 patient developed a 2 inch diameter itchy, raised reddened bump.  Mother gave patient benadryl.  Patient had no systemic signs.  On 3/7/25 mother reported breathing difficulties and patient felt warm to the touch as well as reddened and itchy area going around patient's thigh.  Mother gave patient tylenol and took patient to the ER.  ER found circumferential area of erythema, nontender and some surrounding  scattered area of urticaria.  ER found no respiratory abnormality.  ER gave prednisolone and benadryl and observed patient for improvement and discharged patient home.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Hypertonia, Syncope
Clinical narrative: The patient's face became void of expression and she started tipping over. Her mother was with her and she came to pretty soon after fainting. The patient remembered the pharmacist leaving the room and she remembered sitting back up after fainting, but she does not remember the time (less than 5-10 seconds) during which the fainting spell occurred. She was shaken up afterward, but no more episodes occurred. Water was offered but not accepted. The patient stayed in the vaccine room for 20 more minutes and felt back normal during that time.
Age: 20.0
Sex: M
Vaccine: HEPA, HPV9, MENB
Symptoms: Hyperhidrosis, Loss of consciousness, Nausea, Pallor, Vomiting
Clinical narrative: Approximately 11:15 am-Patient became pale, diaphoretic and passed out. Patient aroused quickly after smelling alcohol pad.  Patient reclined back with feet elevated. Cool cloth to forehead and back of neck.  Complained of nausea with small clear, watery emesis. Water given and refused food.  States he did not eat before appointment. Alert and oriented x 3. Refused to go to the ER. Instructed to seek medical attention if need and patient verbalized understanding.  Stayed in facility x 25 minutes after adverse event.  Patient left facility ambulating with steady gait. Skin W/D/Pale Pink. Denies issues/concerns upon exiting the building.
Age: 57.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient has received prevnar 20 on 11/22/2023 and 03/08/2025
Age: 42.0
Sex: F
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: None- reporting as patient was only  administered the prefilled sterile saline diluent without first mixing it with the lyophilized antigen component. Patient left clinic. Mistake was noticed within the hour by another Medical Assistant.  Patient and Quality Nurse were notified.  Medical Assistant called vaccine manufacturer and was told there was nothing to worry about since it was the sterile diluent and the vaccine could be immediately correctly administered.  Medical Assistant shared info with patient and patient is to call back to come in for vaccine.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chest pain
Clinical narrative: After the vaccine admin and in less than 5 minutes I began to feel a substernal pain and it worsened as I drove the 5-10 home. My husband whose injection followed mine was experiencing the same but less severe. We both took.a Benadryl. I got the EpiPens out, having has anaphylaxis before. I used my albuterol inhaler. The pain persisted. Finally used the pulse ox and it was 98% so not respiratory. Took my BP and it was 203/176. Never had BP elevated to that level before. It is controlled at 125-130/70.  The feelings continued for 2 hrs. I have had multiple Pfizer covid vaccine injections with no side effects. This is the first time for any post vaccine effects. Concerning for me as an RN with multi drug allergies.
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC reported.; Nurse calling to report an expired dose of VARIVAX was inadvertently administered to a patient. Caller confirmed product did not undergo any temperature excursions and was not supported per Post-Expiry Memo. Permission to contact HCP was granted. No; This spontaneous report was received from an other health professional 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 14-FEB-2025, the patient was vaccinated with expired dose of varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE) (administered with sterile diluent (MERCK STERILE DILUENT)),  lot #W003820, expiration date: 02-FEB-2024 for prophylaxis (exact dose, dose number, route and site of administration were not provided) (expired vaccine administered). Caller confirmed product did not undergo any temperature excursions and was not supported per Post-Expiry Memo. No additional information provided. No additional adverse event/product quality complaint reported (no adverse event)
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms reported; administered improperly stored GARDASIL 9; This spontaneous report was received from nurse 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. Previous temperature excursion: None.  On 13-Feb-2025, the patient was vaccinated with improperly stored (temperature drift, occurred on 12-FEB-2025, Temperature: 46.9F; Time frame: 1 Hour 45 Minutes 0 Seconds) Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) 0.5 mL/dose for prophylaxis by Health Professional (lot #Y010466, expiration date: 29-Oct-2026) (product storage error). No symptoms reported (no adverse event).
Age: 1.25
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; while the dose was being administered to the patient the vaccine began leaking out of the DILUENT syringe and splattered everywhere; while the dose was being administered to the patient the vaccine began leaking out of the DILUENT syringe "and splattered everywhere".; patient received no more than 25% of the recommended dose; This spontaneous report was received from a Physician Assistant and refers to a 15-month-old patient of unknown gender.   The patient's medical history, concurrent conditions, previous drugs reactions or allergies and concomitant therapies were not reported.    On 25-FEB-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) into the patient's thigh intramuscularly, (vaccination scheme, dose description not provided, lot #Y010374, expiration date: 05-JUN-2026) with sterile diluent syringe (dose description not provided, lot # 2050911, expiration date: 11-FEB-2027) for the treatment of prophylaxis, it was states that the medical assistant reconstituted the vaccine  with no issues or concerns and while the dose was being administered to the patient the vaccine began leaking out of the diluent syringe and splattered everywhere (Poor quality device used, Syringe leak); they estimate that the patient received no more than 25% of the recommended dose (Accidental underdose). No additional adverse events were reported.  Follow up was received from the Physician Assistant on 05-MAR-2025. The vaccine was administered by health professional. The operator was trained.
Age: 6.0
Sex: M
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; patient received improperly stored Proquad; This spontaneous report was received from a Nurse and refers to a 5-year-old male patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 13-Jan-2025, the vaccine arrived at the facility. It was assumed that the vaccine could be refrigerated at 36 to 46 degrees Fahrenheit. On 07-Feb-2025, the patient was vaccinated with the second dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) administered by Subcutaneous route in Left Thigh (formulation, strength, frequency, and vaccination scheme were not provided; lot # Y017208 which has been verified as a valid number, and expiration date was not reported); this vaccine was dissolved in a sterile diluent as a prophylaxis (improper storage of product in use). On an unknown date, the patient started therapy with HEO A (HAVRIX)) (Left thigh, dose 1), administered by Intramuscular route (Lot# T5727; indication, expiration date and lot # were not reported). It was unknown if a data logger was used. The patient had No adverse effects reported.
Age: 5.0
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; ProQuad were moved to the refrigerators where they remained withing normal refrigerated temperature range until administration. The dose administered to this client was one that was removed from the freezer to the refrigerator on October 1, 2024.; This spontaneous report was received from a Nurse regarding a 5-year-old male patient.   The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported.   On 01-OCT-2024, a temperature excursion (TE) occurred for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) after the doses were moved to the refrigerators where they remained within normal refrigerated temperature range until administration. On 24-OCT-2024, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (RHA)(PROQUAD), dose 2, administered by Subcutaneous route in Left Thigh for prophylaxis (formulation and dose were not reported; lot number X012418 has been verified to be a valid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live [PROQUAD], expiration date was not reported but upon internal validation it was established as 28-OCT-2024), which was reconstituted with sterile diluent (BAXTER STERILE DILUENT). It was reported that the TE for this dose was in the range of 15 to 46 degree Fahrenheit (-9 to 8 degree Celsius) during 552 (units not provided). No additional adverse event was reported for the patient.
Age: 2.0
Sex: M
Vaccine: UNK
Symptoms: No adverse event
Clinical narrative: No additional adverse event; Proquad were moved to the refrigerators where they remained whthin normal refrigerated temperature range (36 to 46 degrees fahrenheit) from 01-OCT-2024 until administration on 20-NOV-2024; This spontaneous report was received from a Nurse regarding a 2-year-old male patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included  Influenza vaccine live reassort 4v (FLUMIST QUADRIVALENT), Pneumococcal vaccine conj 20v (CRM197) (PREVNAR 20), Hepatitis a vaccine inact (HAVRIX) and DTAP IPV HEP B HIB VACCINE Injection (VAXELIS).   On 01-OCT-2024, a temperature excursion (TE) occurred for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) after the doses were moved to the refrigerator where they remained within normal refrigerated temperature range (36 to 46 degree Fahrenheit) until administration. On 20-NOV-2024, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), dose 1, administered by Subcutaneous route in Left Thigh as prophylaxis (lot number Y013583 has been verified to be a valid number for Measles, Mumps, Rubella and Varicella [Oka-Merck] Virus Vaccine Live [PROQUAD], expiration date 03-FEB-2026; dose and formulation were not reported). No adverse event was reported for the patient.    This is one of several reports from the same reporter.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-02-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 11/15/2022 , Central date : 2025-02-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE cases; T/E for VAQTA that was administered; This spontaneous report was received from a Nurse 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 18-FEB-2025, there was a temperature excursion of Hepatitis A Vaccine, Inactivated (VAQTA) with 32.0°F during 2 hours 12 minutes 0 seconds. Then on 03-Mar-2025, the patient was vaccinated with that dose (second dose) of Hepatitis A Vaccine, Inactivated (VAQTA) lot #Y008483, expiration date: 26-Nov-2025 (strength, dose, route and anatomical location were not provided) for prophylaxis. There was no previous temperature excursion.  No adverse events reported.
Vaccine: HIBV, PNC15, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; improperly stored temperature excursion; This spontaneous report was received from a nurse and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On 18-FEB-2025, the vaccines of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), and Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) experienced improperly stored temperature excursion, with temperature of 32.0 Fahrenheit (F) and time frame of 2 hours 12 minutes. There was no previous temperature excursion.  On 03-MAR-2025, the patient was vaccinated with these vaccines of Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) injection strength 0.5ml (2nd dose, lot #Y005465, expiration date: 08-JAN-2027; dose and route were not reported); Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) (2nd dose, lot #Y006393, expiration date: 07-NOV-2026; strength, dose, and route were not reported); Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (2nd dose, lot #Y009341, expiration date: 24-NOV-2025, via orally; strength and dose were not reported), all for prophylaxis (Product storage error). No additional AE was reported.
Sex: F
Vaccine: UNK, UNK, UNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 3rd dose 9 months old; This spontaneous report was received from a physician and refers to a 9-month-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 30-MAY-2003, the patient was vaccinated with the first dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) injection (reported as Hep B, adolescent or pediatric) (dose, route of administration, anatomical location, lot number and expiration date were not reported), on 30-JUN-2003, the patient the second dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) and on 05-MAR-2004, she received the third dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) for prophylaxis (inappropriate schedule of product administration). The pt additionally received unspecified diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTP VACCINE) (reported as Tdap and DTaP) (on 26-MAR-2021, 02-MAR-2020, 07-JUL-2014, 26-JUL-2007, 23-NOV-2004, 12-DEC-2003, 02-OCT-2003 and 01-AUG-2003); unspecified immunoglobulin antihepatitis a (HEPATITIS A VACCINE) (reported as Hep A, ped/adol, 2 dose) (on 02-MAY-2006 and 29-JUN-2005), unspecified hib vaccine (reported as HIB) (on 30-AUG-2004, 12-DEC-2003, 02-OCT-2003 and 01-AUG-2003); unspecified meningococcal vaccine (reported as meningococcal MCV4P) (on 02-MAR-2020 and 07-JUL-2014); unspecified polio vaccine (reported as IPV) (on 26-JUL-2007, 23-NOV-2004, 02-OCT-2003 and 01-AUG-2003); unspecified varicella zoster vaccine (reported as varicella) (on 26-JUL-2007 and 11-JUN-2004); unspecified measles vaccine, mumps vaccine, rubella vaccine (MMR) (on 26-JUL-2007 and 11-JUN-2004): unspecified pneumococcal vaccine (reported as pneumococcal conjugate PCV 7) (on 29-JUN-2005, 23-NOV-2004, 02-OCT-2003 and 01-AUG-2003), unspecified influenza vaccine (reported as Influenza, seasonal, injectable, presentative free) (on 22-OCT-2013), unspecified tuberculin PPD (reported as TST-PPD intradermal) (on 11-JUN-2013); quadrivalent human papillomavirus (GARDASIL) (on 18-AUG-2015) (captured in case 2262110) and human papillomavirus, recombinant (GARDASIL 9) (captured in case 2221838) (on 26-MAR-2021).
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms reported. No additional AE details reported.; a patient who was administered improperly stored VARIVAX on 2/17/2025; This spontaneous report was received from an Other health professional and referred 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.   On 18-Feb-2025, the patient was vaccinated with the improperly stored Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Y015559, expiration date: 16-Sep-2026) (0.5ml/dose) for prophylaxis; The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT). It was reported that the suspect vaccine was underwent temperature excursions (minus 13.9C or minus 14C up to minus 10C) for 10 Minutes on 14-Feb-2025 (product storage error). There were no previous temperature excursions. No additional adverse event (AE) was reported (no adverse event).
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: pain and redness at the injection site; pain and redness at the injection site; This non-serious case was reported by a consumer via patient support programs and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In SEP-2024, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain and redness at the injection site) and injection site erythema (Verbatim: pain and redness at the injection site). The outcome of the injection site pain and injection site erythema were not reported.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.     It was unknown if the company considered the injection site pain and injection site erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-FEB-2025 The patient was the reporter. The patient was a 55-year-old female that received her first Shingrix vaccine in September 2024 (unsure of exact date). The reporter stated that after the first vaccination she had mild common symptoms as far as pain and redness at the injection site.
Age: 89.0
Sex: F
Vaccine: RVX
Symptoms: Injection site discolouration, Injection site erythema, Injection site irritation
Clinical narrative: that the vaccine ate her flesh and that her flesh turned black; She said that initially it was a large red ring, about 5 inches wide, and turned into an inch-wide spot; But then the patient put an unspecified salve on it and it is now irritated again; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site discoloration in a 90-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On 29-JAN-2025, the patient received RSV vaccine (left arm). On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced injection site discoloration (Verbatim: that the vaccine ate her flesh and that her flesh turned black), injection site erythema (Verbatim: She said that initially it was a large red ring, about 5 inches wide, and turned into an inch-wide spot) and injection site irritation (Verbatim: But then the patient put an unspecified salve on it and it is now irritated again). The outcome of the injection site discoloration, injection site erythema and injection site irritation were not resolved.   It was unknown if the reporter considered the injection site discoloration, injection site erythema and injection site irritation to be related to RSV vaccine.     It was unknown if the company considered the injection site discoloration, injection site erythema and injection site irritation to be related to RSV vaccine.   Additional Information: GSK receipt date: 28-FEB-2025 The reporter was the granddaughter of the patient. The reporter reported that her grandmother was 90 years old and received the RSV vaccine made by Glasosmithkline on 29th January 2025. The brand name of the vaccine could not be confirmed and the lot number was not available. The reporter provided the name of the pharmacy (and location) of where the pharmacy where the shot was administered. The reporter could not find the pharmacy receipt to confirm the name of the product or the lot number though the pharmacy told her that it was the RSV vaccine that Glasosmithkline makes. The expiry date was not provided. The reporter stated that she had already reported the "site reaction" adverse event to the pharmacy. It was unknown if the pharmacy reported this event or not. The reporter states, that her grandmother's arm which received the injection was "rotting" and that the vaccine "ate her flesh" and that her flesh "turned black." She said that initially it was a large red ring, about 5 inches wide, and turned into an inch-wide spot. It was treated with A&D ointment and covered. When the bandage was taken off it was healing and had a scab. But then the patient put an unspecified salve on it and it was now irritated again and had left a "valley/indent" on the injected arm.