chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: C/O generalize weakness/fatigue, loss of appetite. Hospitalized due to CKD stage 4, acute UTI, hypomagnesemia, hypercalcemia, hyperthyroidism
Age: 42.0
Sex: M
Vaccine: COVID19-2
Symptoms: Axillary mass, Burning sensation, Pain
Clinical narrative: pt received vaccine on 1/26/23. Called hospital advice line reporting palpable half fist size of soft lump on left arm pit in this morning 1/26/23 and he feels burning sensation 7/10, pain 2/10 at this time.  Proceed the assessment with covid 19 vaccine side effect screening questions. Noted pt has no emergency s/sx at this time. Pt was advised to follow-up with ED for further evaluaiton.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Incorrect product formulation administered
Clinical narrative: I mistakenly used the Pfizer age 12 plus monovalent vial  instead of using the Pfizer age 12 plus bivalent as the booster. I contacted the mom about 20 to 30 minutes later after realizing it was the wrong vial, explained the patient had already received a monovalent dose last year as a booster. I had also told mom I talked with provider in the building and felt patient will most likely be fine as reassurance.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Incorrect product formulation administered
Clinical narrative: I mistakenly used the Pfizer age 12 plus monovalent vial instead of the Pfizer 12 plus bivalent vial to use for the booster dose. I called mom within 20 to 30 minutes after realizing it was the wrong vial used as the booster. Informed mom that I discussed with the provider and since he has already had this same vaccine last year he will most likely be fine. I had also reported the incident to the Nurse manager and reported through the company website as well.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Nausea, weakness, dizzy, tired.  It progressed to throwing up and diarrhea.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, SARS-CoV-2 test positive, Vomiting
Clinical narrative: Nausea, weakness, dizzy, tired.  It progressed to throwing up and diarrhea.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient presented to clinic for COVID-19 immunization. Patient previously received 3 doses of Pfizer COVID-19 vaccine. Patient presented for Bivalent booster. RN administered Pfizer 12+ primary series, not Bivalent formulation. Vaccine administered at 0915 today, contacted patient at 1004. Informed patient of situation. Patient denies currently experiencing any symptoms. Informed patient of possibility to receive Bivalent booster in 2 months per CDC guidelines. Patient verbalized understanding and willingness to receive Bivalent dose. Patient stated no further questions.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Decreased appetite, Dizziness, Fatigue, Headache
Clinical narrative: fever (topped out at 102.2), headache, nausea, dizziness, joint/muscle aches/pain, fatigue, loss of appetite, arm pain and inflammation at injection site accompanied by palm-sized area of redness and heat  Nothing taken for fever. Decided to ride it all out. Fever took 2.5 days to normalize.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site inflammation, Myalgia, Nausea, Pain in extremity
Clinical narrative: fever (topped out at 102.2), headache, nausea, dizziness, joint/muscle aches/pain, fatigue, loss of appetite, arm pain and inflammation at injection site accompanied by palm-sized area of redness and heat  Nothing taken for fever. Decided to ride it all out. Fever took 2.5 days to normalize.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia
Clinical narrative: fever (topped out at 102.2), headache, nausea, dizziness, joint/muscle aches/pain, fatigue, loss of appetite, arm pain and inflammation at injection site accompanied by palm-sized area of redness and heat  Nothing taken for fever. Decided to ride it all out. Fever took 2.5 days to normalize.
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Given Pfizer Bivalent vaccine instead of primary series first dose Monovalent Pfizer Vaccine. She had not received her primary series and told the pharmacy this and they gave the Bivalent stating it covers the monovalent and no primary series needed.
Age: 4.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Fourth covid vaccine, Bivalent dose given in error. No adverse symptoms or outcome.
Age: 2.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Fourth covid vaccine, Bivalent dose given in error. No adverse symptoms or outcome.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Pt came in 2/1/23 to the pharmacy and reported having pain in her arm at the injection site ever since injection on 12/27/22.  I advised her this did not sound like a normal reaction and she should follow up with her doctor.
Age: 5.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: patient was given a booster dose instead of a primary series does as their second dose.
Age: 61.0
Sex: F
Vaccine: HEPA
Symptoms: Arthralgia, Bursitis, Injection site pain, Periarthritis, Wrong technique in product usage process
Clinical narrative: Patient states that she started to experience pain after the injection at the site for a few days as expected.  She states that she developed sub acromial bursitis and frozen shoulder of her left shoulder.  Patient is a pediatrician and she immediately felt that it was administered incorrectly.  She began to have joint pain a week later.   The shoulder pain got worse over time and she went in to see a specialist and was dx with the above. She is being seen by Dr. at Facility.  She was seen today for the initial visit.  Received a steroid injection today and will start PT at some point.
Age: 61.0
Sex: F
Vaccine: HEPA
Symptoms: X-ray
Clinical narrative: Patient states that she started to experience pain after the injection at the site for a few days as expected.  She states that she developed sub acromial bursitis and frozen shoulder of her left shoulder.  Patient is a pediatrician and she immediately felt that it was administered incorrectly.  She began to have joint pain a week later.   The shoulder pain got worse over time and she went in to see a specialist and was dx with the above. She is being seen by Dr. at Facility.  She was seen today for the initial visit.  Received a steroid injection today and will start PT at some point.
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Dizziness, Dysstasia, Echocardiogram
Clinical narrative: I woke up early Monday 11/14/22 with severe dizziness, room was spinning. I had to call for my husband to assist me to get out of bed. When I got to the bathroom I was violently vomiting and could not stand or walk on my own. Since I was 34 weeks pregnant, we decided to call 911. I was taken to the hospital where I stayed for 2 days inpatient and required multiple physicians, physical therapy and a myriad of medical tests. It wasn't until the third day that I could stand up with the assistance of a walker. I was diagnosed with severe vertigo. My symptoms persisted for about 5-6 weeks. I was due to deliver my baby 12/25/22 but my follow up lab results with my PCP on 11/21/22 showed abnormally high liver enzymes. They increased for the next 2 weeks and on 12/1/22 I was admitted to the hospital where I delivered about 3 weeks early. I had a painfully long induction. My baby was 7lbs at birth.
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Electrocardiogram, Exposure during pregnancy, Gait disturbance, Hepatic enzyme increased, Laboratory test
Clinical narrative: I woke up early Monday 11/14/22 with severe dizziness, room was spinning. I had to call for my husband to assist me to get out of bed. When I got to the bathroom I was violently vomiting and could not stand or walk on my own. Since I was 34 weeks pregnant, we decided to call 911. I was taken to the hospital where I stayed for 2 days inpatient and required multiple physicians, physical therapy and a myriad of medical tests. It wasn't until the third day that I could stand up with the assistance of a walker. I was diagnosed with severe vertigo. My symptoms persisted for about 5-6 weeks. I was due to deliver my baby 12/25/22 but my follow up lab results with my PCP on 11/21/22 showed abnormally high liver enzymes. They increased for the next 2 weeks and on 12/1/22 I was admitted to the hospital where I delivered about 3 weeks early. I had a painfully long induction. My baby was 7lbs at birth.
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Labour induction, Labour pain, Magnetic resonance imaging head, Premature delivery, Urine analysis
Clinical narrative: I woke up early Monday 11/14/22 with severe dizziness, room was spinning. I had to call for my husband to assist me to get out of bed. When I got to the bathroom I was violently vomiting and could not stand or walk on my own. Since I was 34 weeks pregnant, we decided to call 911. I was taken to the hospital where I stayed for 2 days inpatient and required multiple physicians, physical therapy and a myriad of medical tests. It wasn't until the third day that I could stand up with the assistance of a walker. I was diagnosed with severe vertigo. My symptoms persisted for about 5-6 weeks. I was due to deliver my baby 12/25/22 but my follow up lab results with my PCP on 11/21/22 showed abnormally high liver enzymes. They increased for the next 2 weeks and on 12/1/22 I was admitted to the hospital where I delivered about 3 weeks early. I had a painfully long induction. My baby was 7lbs at birth.
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vertigo, Vomiting, Walking aid user
Clinical narrative: I woke up early Monday 11/14/22 with severe dizziness, room was spinning. I had to call for my husband to assist me to get out of bed. When I got to the bathroom I was violently vomiting and could not stand or walk on my own. Since I was 34 weeks pregnant, we decided to call 911. I was taken to the hospital where I stayed for 2 days inpatient and required multiple physicians, physical therapy and a myriad of medical tests. It wasn't until the third day that I could stand up with the assistance of a walker. I was diagnosed with severe vertigo. My symptoms persisted for about 5-6 weeks. I was due to deliver my baby 12/25/22 but my follow up lab results with my PCP on 11/21/22 showed abnormally high liver enzymes. They increased for the next 2 weeks and on 12/1/22 I was admitted to the hospital where I delivered about 3 weeks early. I had a painfully long induction. My baby was 7lbs at birth.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: A vial of 10 doses was not diluted and given all 10 doses in vial.  Pt was observed.  After 2 hours still no problems.  VS's stable.  Pt not complaining of arm pain.  Talking up a storm like usual.
Age: 26.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient came in for a scheduled appointment for their first dose of the primary series (monovalent) COVID vaccine. The technician who took in the patient failed to check what the appointment was for in the appointment scheduler and failed to verify which vaccine the patient was expecting to receive. She then entered the Bivalent booster instead of the monovalent and administered it. Patient came back 21 days later for their second dose and a different technician noticed and investigated the error. The CDC was contacted and upon their guidance the patient was given the monovalent as a completion to the initial series.
Age: 87.0
Sex: M
Vaccine: UNK
Symptoms: Blood gases, Catheterisation cardiac, Chest X-ray, Computerised tomogram thorax, Death
Clinical narrative: Pt developed acute onset of dyspnea 5 days following reception of the mRNA booster.  Symptoms progressed and he was admitted to the hospital 2 days later. He subsequently developed acute pulmonary fibrosis and succumbed to his illness on 2/26/22. Covid PCR testing was negative x 3 while in the hospital.
Age: 87.0
Sex: M
Vaccine: UNK
Symptoms: Dyspnoea, Illness, Pulmonary fibrosis, SARS-CoV-2 test negative
Clinical narrative: Pt developed acute onset of dyspnea 5 days following reception of the mRNA booster.  Symptoms progressed and he was admitted to the hospital 2 days later. He subsequently developed acute pulmonary fibrosis and succumbed to his illness on 2/26/22. Covid PCR testing was negative x 3 while in the hospital.
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Asthenia, Cold sweat, Fear of injection, Foaming at mouth, Hyperhidrosis
Clinical narrative: Vaccine administered. Patient .  Sheturned to bare left arm for 2 more immunizations and she leaned down.  She then leaned back in chair by  and starting seizing and  foaming at mouth. for about 30 seconds.  She came too and was white,clamy and sweating.  She also urinated on herself during that time.  Once she came too she was weak.  I asked her husband who was with her whole time did she have seizure disorder.  He said no but she was deathly afraid of needles.  She then said she has history of doing this since a little girl.  She said she has to take anxiety med before goes to Dr so she will not pass out from extreme anxiety. She said she only did this because of her anxiety to needles.  She has done this numerous times in past.  We called 911 but she refused and was feeling better in about 10 minutes and walked out on her on accord.  I called her Dr to report and his nurse informed me that she has done this in their office before due to anxiety.
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Pallor, Seizure, Urinary incontinence
Clinical narrative: Vaccine administered. Patient .  Sheturned to bare left arm for 2 more immunizations and she leaned down.  She then leaned back in chair by  and starting seizing and  foaming at mouth. for about 30 seconds.  She came too and was white,clamy and sweating.  She also urinated on herself during that time.  Once she came too she was weak.  I asked her husband who was with her whole time did she have seizure disorder.  He said no but she was deathly afraid of needles.  She then said she has history of doing this since a little girl.  She said she has to take anxiety med before goes to Dr so she will not pass out from extreme anxiety. She said she only did this because of her anxiety to needles.  She has done this numerous times in past.  We called 911 but she refused and was feeling better in about 10 minutes and walked out on her on accord.  I called her Dr to report and his nurse informed me that she has done this in their office before due to anxiety.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Ear discomfort, Lip blister, Oral disorder, Oral mucosal blistering
Clinical narrative: Today 2/1/23 the patient reported to us that: a day after getting shingrix she started to have blisters inside the mouth, and around her lips & chin, and a burning sensation in her left ear, these side effects were getting worse over time. At her first phone encounter with her family dr, she was given peridex for mouth lesions, but it has not worked. She just had the 2nd phone encounter with her dr today 2/1/23 & waiting for the provider to decide if anything else would be prescribed for her.
Age: 31.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient came in for a scheduled appointment for their first dose of the primary series (monovalent) COVID vaccine. The technician who took in the patient failed to check what the appointment was for in the appointment scheduler and failed to verify which vaccine the patient was expecting to receive. She then entered the Bivalent booster instead of the monovalent and administered it. Patient came back 21 days later for their second dose and a different technician noticed and investigated the error. The CDC was contacted and upon their guidance the patient was given the monovalent as a completion to the initial series.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Biliary colic, Blood bilirubin, Blood potassium
Clinical narrative: My son was born the due date was July 18th so he was late, and he was 10lbs 0oz. My son was born and it was a really long and complicated birth along with a complicated pregnancy. I developed gestational diabetes when I was pregnant as well. I had along labor over 33 hours- I also had a post-partum hemorrhage I lost 2.5 liters of blood and needed a blood transfusion; I also went septic. About six weeks later I had a gallbladder attack, but I thought I was a heart attack based on the pain. I went to the ER because of this, and I was sent home with meds but was back two days later, I was then admitted on September 12th and had my gallbladder taken out.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Cholecystectomy, Complication of pregnancy, Exposure during pregnancy, Gestational diabetes, Haematocrit
Clinical narrative: My son was born the due date was July 18th so he was late, and he was 10lbs 0oz. My son was born and it was a really long and complicated birth along with a complicated pregnancy. I developed gestational diabetes when I was pregnant as well. I had along labor over 33 hours- I also had a post-partum hemorrhage I lost 2.5 liters of blood and needed a blood transfusion; I also went septic. About six weeks later I had a gallbladder attack, but I thought I was a heart attack based on the pain. I went to the ER because of this, and I was sent home with meds but was back two days later, I was then admitted on September 12th and had my gallbladder taken out.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatic enzyme, Labour complication, Magnetic resonance imaging, Pain, Postmature baby
Clinical narrative: My son was born the due date was July 18th so he was late, and he was 10lbs 0oz. My son was born and it was a really long and complicated birth along with a complicated pregnancy. I developed gestational diabetes when I was pregnant as well. I had along labor over 33 hours- I also had a post-partum hemorrhage I lost 2.5 liters of blood and needed a blood transfusion; I also went septic. About six weeks later I had a gallbladder attack, but I thought I was a heart attack based on the pain. I went to the ER because of this, and I was sent home with meds but was back two days later, I was then admitted on September 12th and had my gallbladder taken out.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Postpartum haemorrhage, Prolonged labour, Sepsis, Transfusion, Ultrasound abdomen
Clinical narrative: My son was born the due date was July 18th so he was late, and he was 10lbs 0oz. My son was born and it was a really long and complicated birth along with a complicated pregnancy. I developed gestational diabetes when I was pregnant as well. I had along labor over 33 hours- I also had a post-partum hemorrhage I lost 2.5 liters of blood and needed a blood transfusion; I also went septic. About six weeks later I had a gallbladder attack, but I thought I was a heart attack based on the pain. I went to the ER because of this, and I was sent home with meds but was back two days later, I was then admitted on September 12th and had my gallbladder taken out.
Age: 31.0
Sex: F
Vaccine: COVID19, FLU4, HEP, TDAP
Symptoms: Blood glucose normal, Blood pressure decreased, Dizziness, Dysphagia, Gait disturbance
Clinical narrative: 15:45 PM: PATIENT RECEIVED VACCINATIONS AFTER COMPLETING HER HEALTH ASSESSMENTS: TDAP, HEP-B, COVID-19 & FLU 15:55 PM: PATIENT WAS D/C HOME AND DENIED FEELING ANY S/S OF NAUSEA, VOMITING LIGHTHEADNESS. 16:00 PM: PATIENT REPORTED FEELING LIGHTHEAD AND DIZZY AND NEEDED TO SIT DOWN. PATIENT WAS FOUND BY AN EMPLOYEE IN THE ELEVATOR SITTING ON THE FLOOR OF THE ELEVATOR. PATIENT WAS AWAKE AND ALERT. 16:02PM: PATIENT WAS ABLE TO WALK WITH ASSISTANCE TO A CHAIR NEAR THE ELEVATOR. 16:03 PM: STAT VITAL SIGNS TAKEN: B/P: 86/55, P: 62, SAT: 100% & T: 97.7F. LUNGS SOUNDS CLEAR AND NO ECTOPIC HEART TONES NOTED. 16:06 PM: PATIENT STARTED TO REPORT NUMBNESS TO HER THROAT AND SLIGHT DIFFICULTY SWALLOWING. PALLOR NOTED AND DIAPHORESIS NOTED. 16:09 PM: PATIENT GIVEN DIPHENHYDRAMINE 25MG IM X 1 TO L DELTOID. 16:15 PM: REPEAT SET OF VS: B/P: 109/80, P;82 & 100%, BLOOD SUGAR: 110. LUNGS CLEAR-BILATERAL. 16:20 PM PATIENT STATES SHE WAS FEELING BETTER AND NO LONGER FELT HER THROAT NUMBNESS OR DIFFICULTY SWALLOWING. 16:30PM: PATIENT WAS STABLE AND LEFT SITTING IN THE CHAIR WITH ROUTINE V/S TAKEN. 16:50 PM: ATTEMPTED TO HAVE PATIENT STAND UP WITH ASSISTANCE AND PATIENT EXPERIENCED ORTHOSTATIC HYPOTENSION. B/P DROPPED TO 75/55, P: 100. 16:51 PM: PATIENT WAS ASSISTED TO FLOOR AND PLACE IN TRENDELENBURG POSITION. B/P RECHECKED: 92/70, P: 84 O2 SAT: 100%. 16:52 PM: EMS ACTIVATED 16:53 PM: VS REASSESSED: 79/60, P: 72 & O2 SAT: 82% 16:54 PM: VS: REASSESSED: 90/62, P: 76 & O2 SAT: 100%. PATIENT WAS DENYING FEELING SICK OR SHORT OF BREATH. DENIED CHEST PAIN. 17:03 PM: EMS ARRIVED 17: 10PM: EMS COMPLETED ASSESSMENT AND OFFERED TO TRANSPORT TO MEDICAL FACILITY FOR FURTHER MEDICAL EVALUATION AND TREATMENT. PATIENT AND SPOUSE REFUSED. PATIENT STATED SHE FELT MUCH BETTER AND WANTED TO GO HOME. 17:1PM:  EMS ESCORTED PATIENT AND SPOUSE TO PERSONNEL VEHICLE. 17:20 PM: NO FURTHER INCIDENT NOTED.
Age: 31.0
Sex: F
Vaccine: COVID19, FLU4, HEP, TDAP
Symptoms: Hyperhidrosis, Orthostatic hypotension, Pallor, Pharyngeal hypoaesthesia, Trendelenburg position
Clinical narrative: 15:45 PM: PATIENT RECEIVED VACCINATIONS AFTER COMPLETING HER HEALTH ASSESSMENTS: TDAP, HEP-B, COVID-19 & FLU 15:55 PM: PATIENT WAS D/C HOME AND DENIED FEELING ANY S/S OF NAUSEA, VOMITING LIGHTHEADNESS. 16:00 PM: PATIENT REPORTED FEELING LIGHTHEAD AND DIZZY AND NEEDED TO SIT DOWN. PATIENT WAS FOUND BY AN EMPLOYEE IN THE ELEVATOR SITTING ON THE FLOOR OF THE ELEVATOR. PATIENT WAS AWAKE AND ALERT. 16:02PM: PATIENT WAS ABLE TO WALK WITH ASSISTANCE TO A CHAIR NEAR THE ELEVATOR. 16:03 PM: STAT VITAL SIGNS TAKEN: B/P: 86/55, P: 62, SAT: 100% & T: 97.7F. LUNGS SOUNDS CLEAR AND NO ECTOPIC HEART TONES NOTED. 16:06 PM: PATIENT STARTED TO REPORT NUMBNESS TO HER THROAT AND SLIGHT DIFFICULTY SWALLOWING. PALLOR NOTED AND DIAPHORESIS NOTED. 16:09 PM: PATIENT GIVEN DIPHENHYDRAMINE 25MG IM X 1 TO L DELTOID. 16:15 PM: REPEAT SET OF VS: B/P: 109/80, P;82 & 100%, BLOOD SUGAR: 110. LUNGS CLEAR-BILATERAL. 16:20 PM PATIENT STATES SHE WAS FEELING BETTER AND NO LONGER FELT HER THROAT NUMBNESS OR DIFFICULTY SWALLOWING. 16:30PM: PATIENT WAS STABLE AND LEFT SITTING IN THE CHAIR WITH ROUTINE V/S TAKEN. 16:50 PM: ATTEMPTED TO HAVE PATIENT STAND UP WITH ASSISTANCE AND PATIENT EXPERIENCED ORTHOSTATIC HYPOTENSION. B/P DROPPED TO 75/55, P: 100. 16:51 PM: PATIENT WAS ASSISTED TO FLOOR AND PLACE IN TRENDELENBURG POSITION. B/P RECHECKED: 92/70, P: 84 O2 SAT: 100%. 16:52 PM: EMS ACTIVATED 16:53 PM: VS REASSESSED: 79/60, P: 72 & O2 SAT: 82% 16:54 PM: VS: REASSESSED: 90/62, P: 76 & O2 SAT: 100%. PATIENT WAS DENYING FEELING SICK OR SHORT OF BREATH. DENIED CHEST PAIN. 17:03 PM: EMS ARRIVED 17: 10PM: EMS COMPLETED ASSESSMENT AND OFFERED TO TRANSPORT TO MEDICAL FACILITY FOR FURTHER MEDICAL EVALUATION AND TREATMENT. PATIENT AND SPOUSE REFUSED. PATIENT STATED SHE FELT MUCH BETTER AND WANTED TO GO HOME. 17:1PM:  EMS ESCORTED PATIENT AND SPOUSE TO PERSONNEL VEHICLE. 17:20 PM: NO FURTHER INCIDENT NOTED.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient came to the pharmacy for a scheduled Bivalent booster. Technician entering vaccine failed to verify stock on Bivalent - the pharmacy had been out since the 26th due to the hub store being out of stock. We had a patient earlier in the day that had gotten their second dose of the monovalent and had a vial in a tote in the cooler. The administering technician pulled the vial without verifying and the traveling pharmacist on duty did not verify or ask to verify the vaccine before the technician gave the shot. I returned to the pharmacy and the technician let me know they had pulled the last vial of bivalent. Knowing that we did not have any I informed the technician of the error. Patient had been given a third dose of monovalent instead of bivalent.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: Hives started on hands, feet, and abdomen on the evening of 9/14/2022.  Rash spread throughout body on 09/15/22
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient came to the pharmacy for a scheduled Bivalent booster. Entering technician did not verify stock. (We have been out of Bivalent sine 1/26) . We had administered a monovalent dose earlier in the day so there was a vail in the cooler. The administering technician did not reverify the vial before drawing and the pharmacist on duty did not review the vaccine before the tech left the pharmacy with it. When I returned to the pharmacy the technician let me know that they had pulled the last bivalent vial. Knowing that the vaccine was not in stock I then told the technician about their error.
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: Biopsy skin abnormal, COVID-19, Eczema, Rash, SARS-CoV-2 test positive
Clinical narrative: In early November I had a rash and went to my primary care doctor.  She thought it was a yeast infection and gave me an antifungal.  The prescription did not work.  Then I was prescribed prednisone pack and that did not work either.  I then went to see the dermatologist.  I was diagnosed with eczema.  I was prescribed a lotion but none of that really worked.  I went back to my primary care office, and I was given Quercetin, supplemental.  Also was told to discover antihistamine foods for allergy.  I went back to the dermatologist and was given a biopsy.  In January I was diagnosed with subcutaneous lupus.  I went back to primary care and both doctors told me it was caused by the HCTZ.  I was taken off this medicine and my blood pressure spiked for two weeks.  I went back on HCTZ (hydrochlorothiazide).  I have an appointment with heart doctor, January 31, 2023, I tested positive with COVID-19.
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: Subacute cutaneous lupus erythematosus
Clinical narrative: In early November I had a rash and went to my primary care doctor.  She thought it was a yeast infection and gave me an antifungal.  The prescription did not work.  Then I was prescribed prednisone pack and that did not work either.  I then went to see the dermatologist.  I was diagnosed with eczema.  I was prescribed a lotion but none of that really worked.  I went back to my primary care office, and I was given Quercetin, supplemental.  Also was told to discover antihistamine foods for allergy.  I went back to the dermatologist and was given a biopsy.  In January I was diagnosed with subcutaneous lupus.  I went back to primary care and both doctors told me it was caused by the HCTZ.  I was taken off this medicine and my blood pressure spiked for two weeks.  I went back on HCTZ (hydrochlorothiazide).  I have an appointment with heart doctor, January 31, 2023, I tested positive with COVID-19.
Age: 44.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient given Bivalent Booster (Pfizer) prior to primary series. No known adverse events thus far.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke
Age: 2.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Pt received a bivalent 6mo-4y dose instead of the recommended monovalent for dose number 2 in the series.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bell's palsy, Computerised tomogram, Electrocardiogram, Magnetic resonance imaging
Clinical narrative: Feb 01, 2022 developed Bell's Palsy in the left side of my face. Hospitalized to check for stroke until Feb 03, 2022. Bell's Palsy recovered over the next 2 months, face returned to the 95% normalcy.
Age: 30.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, Injection site pain
Clinical narrative: pt came in  on 01/05 received pfizer bivalent vaccine instead of 1st monovalent pfizer vaccine. pt doesnt have any adverse reaction to the vaccine except soreness at injection site
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Coordination abnormal, Gait disturbance, Loss of personal independence in daily activities, Walking aid user
Clinical narrative: Immediate wobbliness and loss of coordination, which stayed with me, getting some better over the next year, but still limits my daily life.  I took glutathione as recommended by my chiropracter, went to physical therapy, and am still doing PT.  Have an appointment with a neurologist the end of March.  Hopefully, will find out what was triggered by the booster, and what can be done, if anything.  I used a walker for the first three or four months, but barely left the house for fear of falling.  I did fall last August and broke a vertabrae in my back, then had a kyphoplasty to repair.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pt received Moderna Magenta Label 6mo-5y as dose number 1. He was given Pfizer Maroon 6m-4y as dose number 2.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Blood culture, C-reactive protein, Coagulation test, Full blood count, Kawasaki's disease
Clinical narrative: developed kawaski disease in the 2 weeks following, fevers started day of vaccination
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Metabolic function test, Pyrexia, Red blood cell sedimentation rate, Urine analysis
Clinical narrative: developed kawaski disease in the 2 weeks following, fevers started day of vaccination
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Mom states that teacher says the area is slightly raised, warm to touch, no fever, no pain.  Pt's mom reports that area is slightly red and pt is itching, but does not c/o other sx.
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Chills, Malaise, Myalgia, SARS-CoV-2 test positive
Clinical narrative: My COVID-19 infection symptoms started on 12/31/2022 in the afternoon. I felt chilled and I had muscle aches.  I wasn't  feeling well so I might have taken Tylenol and  I also  did a COVID-19 home test which was negative.  On 01/01/2023  I did a home COVID-19 test which was positive. I waited till Monday  to go to the Urgent care because I wasn't sure if the urgent care were open. I felt  a little under the weather that day. In the urgent care they  did COVID-19 test which was also positive on 01/02/2023. They  prescribe me with Paxlovid for 5 days which I started taking it the same day.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Aldolase increased, Anti-platelet antibody positive, Anti-thyroid antibody positive, Antibody test abnormal
Clinical narrative: Thrombocytopenia (10/13/2022). Positive anti-SS-A on 11/28/2022. Elevated enzymes (aldolase, AST, ALT), positive ANA (1:640), positive anti-TPO antibodies and positive anti-platelet antibodies (IIB/IIIA, IB/IX, IA/IIA) on 1/16/2023. Of note, the patient had COVID-19 (PCR confirmed) -19 on 1/19/2022. Primary COVID-19 vaccine series on 6/8/2021 and 7/28/2021. The patient was evaluated at the pediatric rheumatology clinic on 1/19/2023 and a treatment plan will be established after her evaluation is complete.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody positive, Aspartate aminotransferase increased, COVID-19, Hepatic enzyme increased, SARS-CoV-2 test positive
Clinical narrative: Thrombocytopenia (10/13/2022). Positive anti-SS-A on 11/28/2022. Elevated enzymes (aldolase, AST, ALT), positive ANA (1:640), positive anti-TPO antibodies and positive anti-platelet antibodies (IIB/IIIA, IB/IX, IA/IIA) on 1/16/2023. Of note, the patient had COVID-19 (PCR confirmed) -19 on 1/19/2022. Primary COVID-19 vaccine series on 6/8/2021 and 7/28/2021. The patient was evaluated at the pediatric rheumatology clinic on 1/19/2023 and a treatment plan will be established after her evaluation is complete.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombocytopenia
Clinical narrative: Thrombocytopenia (10/13/2022). Positive anti-SS-A on 11/28/2022. Elevated enzymes (aldolase, AST, ALT), positive ANA (1:640), positive anti-TPO antibodies and positive anti-platelet antibodies (IIB/IIIA, IB/IX, IA/IIA) on 1/16/2023. Of note, the patient had COVID-19 (PCR confirmed) -19 on 1/19/2022. Primary COVID-19 vaccine series on 6/8/2021 and 7/28/2021. The patient was evaluated at the pediatric rheumatology clinic on 1/19/2023 and a treatment plan will be established after her evaluation is complete.
Age: 1.33
Sex: F
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: 1/31/2023 - redness at vaccine site 2/1/2023 - red, swollen, hot to touch, bigger in size at vaccine site
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Dizziness, Fatigue, Feeling abnormal, Mobility decreased
Clinical narrative: The patient said she felt terrible after the second dose. Symptoms included fever, diarrhea, dizziness, tiredness, sore arm, fatigue, could not get out of the bed
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: The patient said she felt terrible after the second dose. Symptoms included fever, diarrhea, dizziness, tiredness, sore arm, fatigue, could not get out of the bed
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: PATIENT RECEIVED PFIZER MONOVALENT VACCINE INSTEAD OF PFIZER BIVALENT VACCINE BOOSTER
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Patient was administered with moderna covid-19 vaccine for 6-11 yrs of age instead of the updated moderna bivalent booster
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: Angiogram cerebral normal, Condition aggravated, Magnetic resonance imaging head normal, Tinnitus, Ultrasound Doppler normal
Clinical narrative: Tinnitus, including Pulsatile tinnitus.  I experienced "low level" bilateral tinnitus for approximately 4 years prior to receiving this vaccine (1-2 level on a scale of 1-10).  Following receipt of the Pfizer Bivalent booster in early October 2022, my tinnitus level increased substantially (now 7-8 on a scale of 1-10), including onset of intermittent Pulsatile tinnitus primarily in my left ear.
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: Venogram
Clinical narrative: Tinnitus, including Pulsatile tinnitus.  I experienced "low level" bilateral tinnitus for approximately 4 years prior to receiving this vaccine (1-2 level on a scale of 1-10).  Following receipt of the Pfizer Bivalent booster in early October 2022, my tinnitus level increased substantially (now 7-8 on a scale of 1-10), including onset of intermittent Pulsatile tinnitus primarily in my left ear.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was administered with moderna covid-19 vaccine for 6-11 yrs of age instead of the updated moderna bivalent booster
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: PATIENT RECEIVED PFIZER MONOVALENT VACCINE AS BOOSTER INSTEAD OF PFIZER BIVALENT VACCINE
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was administered with moderna covid-19 vaccine for 6-11yrs of age instead of updated moderna bivalent booster
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: PATIENT RECEIVED PFIZER MONOVALENT VACCINE INSTEAD OF PFIZER BIVALENT VACCINE AS BOOSTER
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received Pfizer Monovalent vaccine instead of Pfizer Bivalent vaccine booster
Age: 5.0
Sex: M
Vaccine: UNK, UNK, VARCEL
Symptoms: Induration
Clinical narrative: Induration beginning the day of vaccination, 1/30/23.  Indurated area has gotten larger by the day and is approximately  7" in diameter (2/1/23, 8 p.m.).   The area looks like cellulitis.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymph node palpable, Lymphadenopathy
Clinical narrative: palpable swollen lymph node tender to touch, painful since after vaccination
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cognitive disorder, Dopamine transporter scintigraphy, Electromyogram, Laboratory test, Magnetic resonance imaging
Clinical narrative: Information was faxed in previously. I called multiple times, but was put on hold for long periods of time. So submitting again on the website but this information has been faxed. The vaccine was given and in March 2021, he began to have speech issues. Issues have progress and at this point and he is hardly able to be understood. He has had personality changes, cognitive changes. He has seen multiple doctors.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Personality change, Speech disorder
Clinical narrative: Information was faxed in previously. I called multiple times, but was put on hold for long periods of time. So submitting again on the website but this information has been faxed. The vaccine was given and in March 2021, he began to have speech issues. Issues have progress and at this point and he is hardly able to be understood. He has had personality changes, cognitive changes. He has seen multiple doctors.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Gait disturbance, Malaise, Pericardial effusion, Pericardial excision
Clinical narrative: After receiving the booster shot I start to slow up short of breath and every week it was getting worse.  I could not walk at all and my heart dr. wanted to know what happened to me.  He immediately sent me for test. In May of 2022 they discovered Fluid around the heart. A surgeon spoke to us, he told us about the fluid around, that I needed immediate surgery.  My partner asked how come this didn?t show up prior he said we did test in Feb. 2022 and there was no fluid and no need at this point for Valve replacement maybe in a couple of years.  She asked directly was it the booster shot.  That within a couple of days or so after the booster I started feeling sick.  He said I believe it is, I have seen many cases like this recently.   May 2022, at Hospital, I had surgery a Pericardial Window they removed 1.5 liters of fluid mostly blood it was crushing my heart; 20 days later I needed a TAVR heart valve at the same hospital by Dr.   Since getting the booster, I was never the same as time progressed I was getting worse and worse.  I almost did not survive.  In September 2022 at Heart Center, Dr. did a Mitra Valve Clip. I am now wearing oxygen 24 hours a days and I am on an inhaler everyday using a walker.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Transcatheter aortic valve implantation, Walking aid user
Clinical narrative: After receiving the booster shot I start to slow up short of breath and every week it was getting worse.  I could not walk at all and my heart dr. wanted to know what happened to me.  He immediately sent me for test. In May of 2022 they discovered Fluid around the heart. A surgeon spoke to us, he told us about the fluid around, that I needed immediate surgery.  My partner asked how come this didn?t show up prior he said we did test in Feb. 2022 and there was no fluid and no need at this point for Valve replacement maybe in a couple of years.  She asked directly was it the booster shot.  That within a couple of days or so after the booster I started feeling sick.  He said I believe it is, I have seen many cases like this recently.   May 2022, at Hospital, I had surgery a Pericardial Window they removed 1.5 liters of fluid mostly blood it was crushing my heart; 20 days later I needed a TAVR heart valve at the same hospital by Dr.   Since getting the booster, I was never the same as time progressed I was getting worse and worse.  I almost did not survive.  In September 2022 at Heart Center, Dr. did a Mitra Valve Clip. I am now wearing oxygen 24 hours a days and I am on an inhaler everyday using a walker.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism
Clinical narrative: DVT, Pulmanory Embolism
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Necrosis, Osteoarthritis, X-ray of pelvis and hip
Clinical narrative: Pain in left hip that increased to the point of  need of a hip replacement!!
Age: 24.0
Sex: M
Vaccine: COVID19, FLU4, TDAP
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Pallor, Tinnitus
Clinical narrative: Patient received 3 vaccines. Immediately after, while still seated, he felt faint and passed out for less than 30 seconds. When he awoke on his own,  he had ringing in his ears, was sweaty and pale in color. Patient was provided a cold wet towel for his forehead and some water.  He sat for 20 minutes or so until he was ready to leave.
Age: 18.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Extra dose administered
Clinical narrative: Male patient 18 years of age, came into the clinic to receive vaccines. He was registered and verified. When patient arrived to the nurse to receive multiple vaccines; nurse asked patient if he had any shot record; patient stated no. Nurse asked patient had he ever received any vaccines before he stated yes but had no proof. Patient was vaccinated with MCV4 and HPV. After being vaccinated the school nurse produced shot records that were not provided prior. After reviewing records, patient was explained that he did not need to receive MCV4 because he had received a previous dose. Explain the side effects and allergic reactions. Advised patient if he has any problems please seek medical attention immediately.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Decreased appetite, Influenza virus test negative, Irritability, Mobility decreased, Muscle twitching
Clinical narrative: High fever, extreme fussiness, possible seizure (twitching of extremities and trunk). Decreased appetite and activity.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: High fever, extreme fussiness, possible seizure (twitching of extremities and trunk). Decreased appetite and activity.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray normal, Electrocardiogram ambulatory normal, Electrocardiogram normal, Laboratory test normal, Unevaluable event
Clinical narrative: None stated.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: severe headache, body (muscle) aches and fatigue
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness Narrative:
Age: 2.0
Sex: F
Vaccine: COVID19, FLU3, COVID19, UNK
Symptoms: Death
Clinical narrative: The little girl Died on december 16, 2022; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (The little girl Died on december 16, 2022) in a 2-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS1414B) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL) for an unknown indication.    No Medical History information was reported.   On 15-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL) (unknown route) 1 dosage form. Death occurred on 16-Dec-2022 The patient died on 16-Dec-2022. The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant product use was not provided by the reporter.  GSK Product Flulaval vaccine batch number 5ES77. The little girl was vaccinated on 15-Dec-2022 and died on 16-Dec-2022.  Flu vaccine was given with covid-19 vaccine (batch number: AS1414B).  Treatment information was not provided.  Company Comment: This is an Spontaneous case concerning a 2-year-old female patient with no medical history reported, who experienced the serious unexpected event of Death. It was reported that the patient died the day after being vaccinated with INFLUENZA VACCINE INACT SPLIT 3V and with an unknown dose number of mRNA-1273 BIVALENT vaccine. Very limited information regarding this event has been provided at this time, the cause of death was not reported and it is unknown if an autopsy was performed. Concomitant vaccination with Flulaval remains a confounder. The benefit-risk relationship of mRNA-1273 BIVALENT is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Age: 88.0
Sex: M
Vaccine: COVID19-2, FLU4, COVID19-2, FLU4, VARZOS
Symptoms: Asthenia, COVID-19, Confusional state, Disorientation, SARS-CoV-2 test positive
Clinical narrative: Discharge Provider: MD Primary Care Physician at Discharge: DO  Admission Date: 1/13/2023   PRESENTING PROBLEM: Compression fracture of L5 lumbar vertebra, closed, initial encounter [S32.050A] Compression fracture of L5 vertebra, initial encounter [S32.050A] Pneumonia due to COVID-19 virus [U07.1, J12.82] COVID-19 [U07.1]   HOSPITAL COURSE: Patient was a 88-year-old man who presents to the hospital with COVID-19 infection causing pneumonia.  He started having frequent falls.  He then developed severe back pain and presented to the emergency department on 01/13.  He was found to have L5 superior endplate compression fracture.  He was started on Lyrica, Flexeril and oxycodone.  He was awaiting rehab placement since he was in quarantine for COVID-19.  On the morning of 1/18 he was found on the floor.  CT head was negative.  X-ray of right shoulder done secondary to pain was negative.  On that day he seems slightly confused.  Oxycodone was discontinued and changed to Norco.  He started to require Zyprexa for confusion and agitation.  Norco and Lyrica were then discontinued.  The patient had another fall on 01/19.  CT head was repeated and negative.  CT lumbar spine repeated show worsening of the previous L5 compression fracture.  He started to develop delirium.  He then started to have decreased oral intake.  He started complaining of throat pain and was unable to swallow.  Strep swab was collected and negative.  Due to continued severe pain and inability to swallow, CT neck with contrast was performed which revealed epiglottitis.  I spoke with family about his poor oral intake, very low body mass index and concern for failure to thrive.  Patient decided to convert to comfort care measures only.  He was placed on sublingual morphine and passed away peacefully with his family at bedside.   Time of death 4:09 p.m. on 01/25/2023