chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cough, Headache, Influenza A virus test negative, Influenza B virus test, Pruritus
Clinical narrative: Pruritus onset 2/20/23 in evening, then red itchy rash by 8AM 2/21/23 that spread over next 24 hours and was associated with mild cough. Onset of low-grade fever 99-100 on AM 2/22/23, followed by headache midday 2/22/23. Cough and low-grade resolved by end of 2/22/23. Stable pruritus and rash 2/23/23.
Age: 6.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, Rash erythematous, Rash pruritic, SARS-CoV-2 test negative, Streptococcus test negative
Clinical narrative: Pruritus onset 2/20/23 in evening, then red itchy rash by 8AM 2/21/23 that spread over next 24 hours and was associated with mild cough. Onset of low-grade fever 99-100 on AM 2/22/23, followed by headache midday 2/22/23. Cough and low-grade resolved by end of 2/22/23. Stable pruritus and rash 2/23/23.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient wanted to get Bivalent booster and received monovalent instead. No symptoms reported at this time.
Age: 1.5
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Vaccine was administered undiluted.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, Cancer pain, Chronic obstructive pulmonary disease, Condition aggravated
Clinical narrative: Discharge Provider: MD Primary Care Provider: MD Admission Date: 2/19/2023 Discharge Date: 2/22/2023  PRESENTING PROBLEM: Severe COVID-19 infection Acute on chronic respiratory failure with hypoxia, improving Severe COPD with exacerbation 2/2 above Primary adenocarcinoma bilateral lungs Cancer related pain Parkinson's disease   HOSPITAL COURSE: This patient is a 73-year-old woman with PMH of chronic respiratory failure with hypoxemia (on 2 L of oxygen) secondary to COPD, primary adenocarcinoma bilateral lungs status post chemoradiation, PE/DVT on Eliquis, central sleep apnea on CPAP and Parkinson's disease who presented on 02/19 with acute shortness of breath.  Patient was found to have acute on chronic respiratory failure with hypoxemia secondary to COVID-19 infection leading to severe exacerbation of her underlying COPD. She was placed on 6 L of oxygen and started on remdesivir and Decadron and inhalers.  Patient improved with above measure.  She was evaluated by pulmonary rehab recommended 2L of oxygen at rest and 3L with activity.   Patient was evaluated by PT/OT who recommended home with assistance.  Patient was discharged in stable condition with plan to follow up with PCP and her pulmonologist.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypoxia, Parkinson's disease, Respiratory failure
Clinical narrative: Discharge Provider: MD Primary Care Provider: MD Admission Date: 2/19/2023 Discharge Date: 2/22/2023  PRESENTING PROBLEM: Severe COVID-19 infection Acute on chronic respiratory failure with hypoxia, improving Severe COPD with exacerbation 2/2 above Primary adenocarcinoma bilateral lungs Cancer related pain Parkinson's disease   HOSPITAL COURSE: This patient is a 73-year-old woman with PMH of chronic respiratory failure with hypoxemia (on 2 L of oxygen) secondary to COPD, primary adenocarcinoma bilateral lungs status post chemoradiation, PE/DVT on Eliquis, central sleep apnea on CPAP and Parkinson's disease who presented on 02/19 with acute shortness of breath.  Patient was found to have acute on chronic respiratory failure with hypoxemia secondary to COVID-19 infection leading to severe exacerbation of her underlying COPD. She was placed on 6 L of oxygen and started on remdesivir and Decadron and inhalers.  Patient improved with above measure.  She was evaluated by pulmonary rehab recommended 2L of oxygen at rest and 3L with activity.   Patient was evaluated by PT/OT who recommended home with assistance.  Patient was discharged in stable condition with plan to follow up with PCP and her pulmonologist.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Pain and swelling at amd around injection site Joint pain all over, especial hips, knees, upper back general malaise
Age: 62.0
Sex: M
Vaccine: COVID19-2, FLUC4
Symptoms: Anaemia, COVID-19, Haemoglobin decreased, Malaise, Red blood cell transfusion
Clinical narrative: Primary Care Physician at Discharge: MD Hematologist/Oncologist: Dr. Admission Date: 2/17/2023 Discharge Date: 02/20/2023 Patient's Discharge Disposition:  Home in stable condition.  This is a 63 yo with a history of metastatic myxoid liposarcoma who presents to hospital on 2/17/23 for planned cycle 5 of Doxorubicin/Ifosfamide. He reports after the last chemo cycle he did get more fatigued than with previous cycles but that has since resolved. For his cycles he has been discharging prior to last inpatient doses of mesna and has a PO mesna script to take after discharge. He also self-injects Nyvepria. He has both mesna and nyvepria scripts already filled. He gets labs weekly and has standing orders there that are current. He usually follows up with staff or Dr. prior to his next cycle. Patient did tolerate chemotherapy but on 2/19 he woke up feeling very congested and reported other family members were sick at home. Film array was positive for covid-19. Given this finding and patient not feeling well discharge was delayed. He did receive IV mesna after his last ifosfamide instead of taking the PO at dc. He got 2 doses of IV remdesivir. He is afebrile and was feeling better on 2/20. He was given 1 unit of PRBC given mild anemia of 8.4. Discussed with Dr. and given he is feeling okay despite covid-19 infection will discharge home today. He can still do the self-inject Nyvepria later Monday evening or Tuesday evening. He will complete PO dex Days 4-6 of this cycle (has script at home). Given he will be in covid iso through 2/23 he will get labs drawn on Friday instead of Wednesday. We reviewed that if he has any worsening symptoms related to covid-19 infection he is to call our office. The patient is discharging home tonight in stable condition.
Age: 62.0
Sex: M
Vaccine: COVID19-2, FLUC4
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Primary Care Physician at Discharge: MD Hematologist/Oncologist: Dr. Admission Date: 2/17/2023 Discharge Date: 02/20/2023 Patient's Discharge Disposition:  Home in stable condition.  This is a 63 yo with a history of metastatic myxoid liposarcoma who presents to hospital on 2/17/23 for planned cycle 5 of Doxorubicin/Ifosfamide. He reports after the last chemo cycle he did get more fatigued than with previous cycles but that has since resolved. For his cycles he has been discharging prior to last inpatient doses of mesna and has a PO mesna script to take after discharge. He also self-injects Nyvepria. He has both mesna and nyvepria scripts already filled. He gets labs weekly and has standing orders there that are current. He usually follows up with staff or Dr. prior to his next cycle. Patient did tolerate chemotherapy but on 2/19 he woke up feeling very congested and reported other family members were sick at home. Film array was positive for covid-19. Given this finding and patient not feeling well discharge was delayed. He did receive IV mesna after his last ifosfamide instead of taking the PO at dc. He got 2 doses of IV remdesivir. He is afebrile and was feeling better on 2/20. He was given 1 unit of PRBC given mild anemia of 8.4. Discussed with Dr. and given he is feeling okay despite covid-19 infection will discharge home today. He can still do the self-inject Nyvepria later Monday evening or Tuesday evening. He will complete PO dex Days 4-6 of this cycle (has script at home). Given he will be in covid iso through 2/23 he will get labs drawn on Friday instead of Wednesday. We reviewed that if he has any worsening symptoms related to covid-19 infection he is to call our office. The patient is discharging home tonight in stable condition.
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Death
Clinical narrative: Resident expired within 14days of receiving Bivalent dose.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Accidental improper storage of vaccine leading to temperature excursion prior to vaccine administration
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Accidental improper storage of vaccine leading to temperature excursion prior to vaccine administration
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Accidental improper storage of vaccine leading to temperature excursion prior to vaccine administration
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: Death
Clinical narrative: Unexplained Death
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Accidental improper storage of vaccine leading to temperature excursion prior to vaccine administration
Age: 70.0
Sex: F
Vaccine: COVID19-2, VARZOS
Symptoms: Headache, Nausea, Product use issue
Clinical narrative: Dose of the Covid Bivalent Booster was given 4 days after the BUD.  The vial had been in the refrigerator since 1/11/23 and should have been salvaged on 2/10/23.  Vaccine was given 2/14/23.  Patient states that she had a headache and some nausea and was in bed for 1 day, but states that she feels fine now.  Reported no swelling or redness.
Age: 10.0
Sex: M
Vaccine: DTAP, FLU4, HEP, HEPA, MMR, MNQ, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: dtap vaccine was inadvertently given to a 10 year old
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Accidental improper storage of vaccine leading to temperature excursion prior to vaccine administration
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Developed hives all over body on 10th day
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Accidental improper storage of vaccine leading to temperature excursion prior to vaccine administration
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Accidental improper storage of vaccine leading to temperature excursion prior to vaccine administration
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient received a third primary dose instead of bivalent booster.  Patient did not have any reported adverse events due to the third monovalent.  Was told to report to VAERS from the immunization program.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received 3rd dose of Shingrix
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Joint swelling
Clinical narrative: Patient came to the pharmacy on 02/23/2023 saying he had swelling and redness in his right elbow 3-4 days after Shingrix administration. He referred to his doctor and his doctor advised him to take Ibuprofen. The swelling became less and redness disappeared. There is still swelling in his right elbow.
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient had never received covid-19 vaccines before, and received Pfizer bivalent booster  vaccine.
Age: 52.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood test, Muscular weakness, Myalgia, Pain, Urine analysis
Clinical narrative: Muscular weakness or myalgia; extended soreness after routine activity; delayed recovery after physical therapy. Got worse after November 26th 2022. Referred to Neurologist.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pelvic floor dysfunction
Clinical narrative: Pelvic floor muscles contracting with force causing pain to patient, started about 3 to 5 minutes after injection, gave patient 25mg benadryl and effects subsided after around 10 minutes
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS POSSIBLY PAST THE BUD AT VACCINATION ACCORDING TO THE VACCINE RECORD.  NURSE REPORTED ON VACCINE RECORD THAT VACCINE WAS GIVEN ON 10/31/22 BUT VIAL WAS OPENED ON 10/27/22.  UNABLE TO CONFIRM IF INDIVIDUAL WAS VACCINATED ON 10/27 OR 10/31.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: VACCINE WAS POSSIBLY PAST THE BUD AT VACCINATION ACCORDING TO THE VACCINE RECORD.  NURSE REPORTED ON VACCINE RECORD THAT VACCINE WAS GIVEN ON 11/1/22 BUT VIAL WAS OPENED ON 10/27/22.  UNABLE TO CONFIRM IF INDIVIDUAL WAS VACCINATED ON 10/27 OR 11/1.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: VACCINE WAS POSSIBLY PAST THE BUD AT VACCINATION ACCORDING TO THE VACCINE RECORD.  NURSE REPORTED ON VACCINE RECORD THAT VACCINE WAS GIVEN ON 11/1/22 BUT VIAL WAS OPENED ON 10/27/22.  UNABLE TO CONFIRM IF INDIVIDUAL WAS VACCINATED ON 10/27 OR 11/1.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: FACILITY BELIEVES THEY GAVE PRIMARY MONOVALENT VACCINE IN ERROR FOR BIVALENT VACCINE.  NURSING COULD NOT TELL THE DIFFERENCE BETWEEN THE BOTTLES AND REPORTED THE LOT # FP7137 WAS USED FOR VACCINATION WHICH IS PRIMARY MONOVALENT VACCINE.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: FACILITY BELIEVES THEY GAVE PRIMARY MONOVALENT VACCINE IN ERROR FOR BIVALENT VACCINE.  NURSING COULD NOT TELL THE DIFFERENCE BETWEEN THE BOTTLES AND REPORTED THE LOT # FP7137 WAS USED FOR VACCINATION WHICH IS PRIMARY MONOVALENT VACCINE.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: FACILITY BELIEVES THEY GAVE PRIMARY MONOVALENT VACCINE IN ERROR FOR BIVALENT VACCINE.  NURSING COULD NOT TELL THE DIFFERENCE BETWEEN THE BOTTLES AND REPORTED THE LOT # FP7137 WAS USED FOR VACCINATION WHICH IS PRIMARY MONOVALENT VACCINE.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: FACILITY BELIEVES THEY GAVE PRIMARY MONOVALENT VACCINE IN ERROR FOR BIVALENT VACCINE.  NURSING COULD NOT TELL THE DIFFERENCE BETWEEN THE BOTTLES AND REPORTED THE LOT # FP7137 WAS USED FOR VACCINATION WHICH IS PRIMARY MONOVALENT VACCINE.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: FACILITY BELIEVES THEY GAVE PRIMARY MONOVALENT VACCINE IN ERROR FOR BIVALENT VACCINE.  NURSING COULD NOT TELL THE DIFFERENCE BETWEEN THE BOTTLES AND REPORTED THE LOT # FP7137 WAS USED FOR VACCINATION WHICH IS PRIMARY MONOVALENT VACCINE.
Age: 98.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: FACILITY BELIEVES THEY GAVE PRIMARY MONOVALENT VACCINE IN ERROR FOR BIVALENT VACCINE.  NURSING COULD NOT TELL THE DIFFERENCE BETWEEN THE BOTTLES AND REPORTED THE LOT # FP7137 WAS USED FOR VACCINATION WHICH IS PRIMARY MONOVALENT VACCINE.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: FACILITY BELIEVES THEY GAVE PRIMARY MONOVALENT VACCINE IN ERROR FOR BIVALENT VACCINE.  NURSING COULD NOT TELL THE DIFFERENCE BETWEEN THE BOTTLES AND REPORTED THE LOT # FP7137 WAS USED FOR VACCINATION WHICH IS PRIMARY MONOVALENT VACCINE.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Product packaging confusion
Clinical narrative: FACILITY BELIEVES THEY GAVE PRIMARY MONOVALENT VACCINE IN ERROR FOR BIVALENT VACCINE.  NURSING COULD NOT TELL THE DIFFERENCE BETWEEN THE BOTTLES AND REPORTED THE LOT # FP7137 WAS USED FOR VACCINATION WHICH IS PRIMARY MONOVALENT VACCINE.
Age: 71.0
Sex: M
Vaccine: COVID19-2, VARZOS
Symptoms: Expired product administered, Pain in extremity, Peripheral swelling, Product storage error
Clinical narrative: Dose of the Moderna Covid Bivalent booster was given 4 days after the vial's BUD.  The vial had been in the refrigerator since 1/11/23 (unpunctured) and should have been salvaged on 2/10/23 (30 days after being removed from freezer).  Vaccine vial was first punctured 2/14/23 and dose was given that same day. Patient states that he had some arm soreness and some swelling for 1 day, but denied any lasting effects.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Product administration error
Clinical narrative: FACILITY BELIEVES THEY GAVE PRIMARY MONOVALENT VACCINE IN ERROR FOR BIVALENT VACCINE.  NURSING COULD NOT TELL THE DIFFERENCE BETWEEN THE BOTTLES AND REPORTED THE LOT # FP7137 WAS USED FOR VACCINATION WHICH IS PRIMARY MONOVALENT VACCINE.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: FACILITY BELIEVES THEY GAVE PRIMARY MONOVALENT VACCINE IN ERROR FOR BIVALENT VACCINE.  NURSING COULD NOT TELL THE DIFFERENCE BETWEEN THE BOTTLES AND REPORTED THE LOT # FP7137 WAS USED FOR VACCINATION WHICH IS PRIMARY MONOVALENT VACCINE.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: FACILITY BELIEVES THEY GAVE PRIMARY MONOVALENT VACCINE IN ERROR FOR BIVALENT VACCINE.  NURSING COULD NOT TELL THE DIFFERENCE BETWEEN THE BOTTLES AND REPORTED THE LOT # FP7137 WAS USED FOR VACCINATION WHICH IS PRIMARY MONOVALENT VACCINE.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Product packaging confusion
Clinical narrative: FACILITY BELIEVES THEY GAVE PRIMARY MONOVALENT VACCINE IN ERROR FOR BIVALENT VACCINE.  NURSING COULD NOT TELL THE DIFFERENCE BETWEEN THE BOTTLES AND REPORTED THE LOT # FP7137 WAS USED FOR VACCINATION WHICH IS PRIMARY MONOVALENT VACCINE.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Anaemia, Colectomy, Computerised tomogram, Diverticulitis
Clinical narrative: Patient reported abdominal discomfort beginning in the summer of 2021.  He underwent a partial colectomy due to  diverticulitis. Labs in November 2021 revelaed significant anemia.  Patient saw a hematologist/oncologist in December 2021 and was diagnosed with a malignant gastric mass with multiple metastases.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test abnormal, Metastatic gastric cancer, Positron emission tomogram
Clinical narrative: Patient reported abdominal discomfort beginning in the summer of 2021.  He underwent a partial colectomy due to  diverticulitis. Labs in November 2021 revelaed significant anemia.  Patient saw a hematologist/oncologist in December 2021 and was diagnosed with a malignant gastric mass with multiple metastases.
Age: 49.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, Swelling
Clinical narrative: The patient was scheduled for a 2nd Moderna primary vaccine at our clinic to complete his primary series; however, the nurse, gave the patient a Pfizer bivalent vaccine instead. The patient was called and informed of the error; he stated he had no side effects that day. The patient was called 2 days later for a follow-up and he stated he only had some swelling in the area but it went away. He stated he had no other side effects. The patient was not upset and understood the error.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received expired COVID vaccine that expired on 2/12/2022. The patient had no adverse symptoms reported at time of injection.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Wheelchair user
Clinical narrative: patient had a severe allergic reactions and now she is in wheelchair
Age: 48.0
Sex: M
Vaccine: FLUC4, PNC20
Symptoms: Swelling, Tachycardia
Clinical narrative: 5.5 hours post injection patient experienced significant labial swelling and tachycardia (100 BPM) that subsided after 5 hours and self-administration of 50 mg. Benadryl.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: The wrong vaccine was administered by mistake.
Age: 0.5
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: At 1108 on 02/23/2023 patient was administered 0.25 mL of Moderna 6m - 5yr Bivalent booster. Patient tolerated injection well during the 15 minute observation period. Parents notified. Confirmed with Pediatrician that no harm will come to the patient.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Patient was given a Moderna shot that had been in the fridge in for 33 days instead of 30, so it was 3 days past its BUD. The patient experienced no adverse effects. And Moderna stated the patient did not need to re-vaccinate.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: BIVALENT VACCINE WAS GIVEN TWICE. RESIDENT RECEIVED BIVALENT DOSE ON 11/3/2022, THEN AGAIN ON 2/2/2023.
Age: 1.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: At 1206 on 02/23/2023 patient was administered 0.25 mL of Moderna 6m - 5yr Bivalent booster. Patient tolerated injection well during the 15 minute observation period. Parents notified. Confirmed with Pediatrician that no harm will come to the patient.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient was given a Moderna shot that had been in the fridge in for 33 days instead of 30, so it was 3 days past its BUD. The patient experienced no adverse effects. And Moderna stated the patient did not need to re-vaccinate.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Urticaria
Clinical narrative: Began having welps approximately 18 hours after the vaccine, which continued to appear for the next several days.  They ultimately blistered and were diagnosed as shingles by a physician on day 5.
Age: 1.5
Sex: F
Vaccine: HIBV
Symptoms: Extra dose administered
Clinical narrative: The patient was seen in the office on 02/08/2023 and received her 4th Hib vaccine, however it was not required since the patient had already received her third dose after the age of 12 months (on 7/28/2022). Therefore, the patient received an extra dose of Hib.
Age: 0.67
Sex: F
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: At 1108 on 02/23/2023 patient was administered 0.25 mL of Moderna 6m - 5yr Bivalent booster. Patient tolerated injection well during the 15 minute observation period. Parents notified. Confirmed with Pediatrician that no harm will come to the patient.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product use issue
Clinical narrative: Patient was given a Moderna shot that had been in the fridge in for 35 days instead of 30, so it was 5 days past its BUD. The patient experienced no adverse effects. And Moderna stated the patient did not need to re-vaccinate.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Dyspnoea exertional, Exercise tolerance decreased, Hypoaesthesia, Loss of personal independence in daily activities
Clinical narrative: Starting soon after my COVID vaccine i began experiencing trouble breathing during normal activity. I'm an avid runner and swimmer and had been doing this throughout COVID with no issue. I've always been an asthmatic (not exercise induced), but have always been fine just taking albuterol 15 minutes before activity. and never had any issues. After the vaccine I began finding myself short of breath after relatively easy activity. For example, I typically swam 100 yards at a relaxed rate with no heavy breathing on 1 minute 30 seconds. this would have been a warm-up pace for me. Suddenly I was struggling to even complete 100 yards in that time and when i got to the wall I would be gasping for air. While swimming my arms and legs would feel sort of numb like they werent getting oxygen. This is not how I feel when I have an asthma attack. For an asthma attack it's always the same, I am wheezing, then my lips start to tingle and go numb, followed by my nose and then my hands start to cramp. What I was experiencing was not an asthma attack, there was no tingling/numbness in my face and I was never wheezing. Plus, my inhaler did nothing to help. I was just easily out of breath which is very odd for me, a lifetime athlete and former swimmer. Looking back I finally pinpointed when the issues began and it was right after the vaccine. I literally went from swimming fast with almost no effort to barely being able to swim  without feeling the need to stop at a wall. The issues seemed to subside over time, and then I got a booster shot and they started up again. I have not gotten another booster since and I believe the symptoms are slowly getting better, but I am nowhere near being able to do what I did prior to the vaccine.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary function test normal
Clinical narrative: Starting soon after my COVID vaccine i began experiencing trouble breathing during normal activity. I'm an avid runner and swimmer and had been doing this throughout COVID with no issue. I've always been an asthmatic (not exercise induced), but have always been fine just taking albuterol 15 minutes before activity. and never had any issues. After the vaccine I began finding myself short of breath after relatively easy activity. For example, I typically swam 100 yards at a relaxed rate with no heavy breathing on 1 minute 30 seconds. this would have been a warm-up pace for me. Suddenly I was struggling to even complete 100 yards in that time and when i got to the wall I would be gasping for air. While swimming my arms and legs would feel sort of numb like they werent getting oxygen. This is not how I feel when I have an asthma attack. For an asthma attack it's always the same, I am wheezing, then my lips start to tingle and go numb, followed by my nose and then my hands start to cramp. What I was experiencing was not an asthma attack, there was no tingling/numbness in my face and I was never wheezing. Plus, my inhaler did nothing to help. I was just easily out of breath which is very odd for me, a lifetime athlete and former swimmer. Looking back I finally pinpointed when the issues began and it was right after the vaccine. I literally went from swimming fast with almost no effort to barely being able to swim  without feeling the need to stop at a wall. The issues seemed to subside over time, and then I got a booster shot and they started up again. I have not gotten another booster since and I believe the symptoms are slowly getting better, but I am nowhere near being able to do what I did prior to the vaccine.
Age: 2.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: At 1108 on 02/23/2023 patient was administered 0.25 mL of Moderna 6m - 5yr Bivalent booster. Patient tolerated injection well during the 15 minute observation period. Parents notified. Confirmed with Pediatrician that no harm will come to the patient.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Nasal mucosal blistering, Oral mucosal blistering
Clinical narrative: Developed a blister on left side of  mouth and inside left nostril, fatigue.  These would not have alarmed me except that my friend had the same shot at the same pharmacy two days earlier than I did and was just diagnosed by his physician today wth Shingles, likely reactivated after vaccine, which I know is rare.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Hypersensitivity, Rash
Clinical narrative: After 10 minutes of my 3rd dose I started having allergic reaction. I experienced lightheaded, pressure in my chest, and difficulty breathing. I even broke out with rash on my right arm. Since I was at the clinic when it all started the people there called ER. When I was at the ER the doctor's prescribed me with a medication more stronger than BENADRYL. I don't know the exact name of it. They also gave me IV with saline fluids to clear my body. They advised me to drink plenty of fluids. It took me 3-4 days to fully recover.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test negative
Clinical narrative: After 10 minutes of my 3rd dose I started having allergic reaction. I experienced lightheaded, pressure in my chest, and difficulty breathing. I even broke out with rash on my right arm. Since I was at the clinic when it all started the people there called ER. When I was at the ER the doctor's prescribed me with a medication more stronger than BENADRYL. I don't know the exact name of it. They also gave me IV with saline fluids to clear my body. They advised me to drink plenty of fluids. It took me 3-4 days to fully recover.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Dizziness, Dyspepsia, Fatigue
Clinical narrative: 1st Shingrix shot in November 2022. 2nd Shingrix shot 2/18/23 at 3:30pm. Starting at 6:30am on 2/19/23 the following symptoms began: nausea, diarrhea, heartburn, dizziness/vertigo, headache, congestion, sneezing, severe exhaustion, malaise, muscle aches, severe/unrelenting chills, rash at the injection site, plus severe pain, redness, and swelling at the injection site. After 48 hours most of the above listed symptoms improved except for pain at the injection site. Then, on 2/22/23, the following symptoms started: severe chills returned, plus congestion, sore throat, sneezing,  several cold sores, and also the exhaustion returned. As of 02/23/23, 5 days after the 2nd dose, these symptoms are ongoing  plus continuing injection site pain. The pharmacy text told me NOTHING about these potential side effects.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: 1st Shingrix shot in November 2022. 2nd Shingrix shot 2/18/23 at 3:30pm. Starting at 6:30am on 2/19/23 the following symptoms began: nausea, diarrhea, heartburn, dizziness/vertigo, headache, congestion, sneezing, severe exhaustion, malaise, muscle aches, severe/unrelenting chills, rash at the injection site, plus severe pain, redness, and swelling at the injection site. After 48 hours most of the above listed symptoms improved except for pain at the injection site. Then, on 2/22/23, the following symptoms started: severe chills returned, plus congestion, sore throat, sneezing,  several cold sores, and also the exhaustion returned. As of 02/23/23, 5 days after the 2nd dose, these symptoms are ongoing  plus continuing injection site pain. The pharmacy text told me NOTHING about these potential side effects.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Myalgia, Nausea, Oral herpes, Oropharyngeal pain
Clinical narrative: 1st Shingrix shot in November 2022. 2nd Shingrix shot 2/18/23 at 3:30pm. Starting at 6:30am on 2/19/23 the following symptoms began: nausea, diarrhea, heartburn, dizziness/vertigo, headache, congestion, sneezing, severe exhaustion, malaise, muscle aches, severe/unrelenting chills, rash at the injection site, plus severe pain, redness, and swelling at the injection site. After 48 hours most of the above listed symptoms improved except for pain at the injection site. Then, on 2/22/23, the following symptoms started: severe chills returned, plus congestion, sore throat, sneezing,  several cold sores, and also the exhaustion returned. As of 02/23/23, 5 days after the 2nd dose, these symptoms are ongoing  plus continuing injection site pain. The pharmacy text told me NOTHING about these potential side effects.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Respiratory tract congestion, Sneezing, Vertigo
Clinical narrative: 1st Shingrix shot in November 2022. 2nd Shingrix shot 2/18/23 at 3:30pm. Starting at 6:30am on 2/19/23 the following symptoms began: nausea, diarrhea, heartburn, dizziness/vertigo, headache, congestion, sneezing, severe exhaustion, malaise, muscle aches, severe/unrelenting chills, rash at the injection site, plus severe pain, redness, and swelling at the injection site. After 48 hours most of the above listed symptoms improved except for pain at the injection site. Then, on 2/22/23, the following symptoms started: severe chills returned, plus congestion, sore throat, sneezing,  several cold sores, and also the exhaustion returned. As of 02/23/23, 5 days after the 2nd dose, these symptoms are ongoing  plus continuing injection site pain. The pharmacy text told me NOTHING about these potential side effects.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Accidental improper storage of vaccine leading to temperature excursion prior to vaccine administration
Age: 17.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Bivalent (12 and older) administered as primary dose. No adverse signs or symptoms.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Accidental improper storage of vaccine leading to temperature excursion prior to vaccine administration
Age: 16.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Bivalent (12 and older) administered as primary dose. No adverse signs or symptoms.
Age: 17.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Bivalent (12 and older) administered as primary dose. No adverse signs or symptoms.
Age: 15.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Bivalent (12 and older) administered as primary dose. No adverse signs or symptoms.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Biopsy, Culture wound, Limb injury, Wound
Clinical narrative: OPEN WOUNDS ON BOTH LOWER EXTREMITIES AND LEFT UPPER EXTREMITY BELOW ELBOW.
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Bell's palsy, Computerised tomogram
Clinical narrative: Bell?s Palsy
Age: 16.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Bivalent (12 and older) administered as primary dose. No adverse signs or symptoms.
Age: 0.58
Sex: F
Vaccine: COVID19, FLU4
Symptoms: No adverse event
Clinical narrative: No adverse effects.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was beyond use date. Awaiting information from Moderna regarding stability beyond use date.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis allergic, Injection site bruising, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: After vaccination, the patient developed a small bruise at injection site and a red, raised, warm, rash below the injection site. Patient returned to the pharmacy a few days later and showed RPh on duty. We advised her to be seen by primary care doctor. She was seen and PCP said it looked like allergic type skin reaction and recommended Tylenol and Anti-histamine.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: After vaccination, the patient developed a small bruise at injection site and a red, raised, warm, rash below the injection site. Patient returned to the pharmacy a few days later and showed RPh on duty. We advised her to be seen by primary care doctor. She was seen and PCP said it looked like allergic type skin reaction and recommended Tylenol and Anti-histamine.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Pt received vaccine beyond use date. waiting on information from moderna on stability
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Pt received vaccine beyond use date - waiting on information from moderna for stability
Age: 0.83
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt was in office for 2nd dose of COVID vaccine but the first one was never documented that is was received. Pt was too early for Bivalent dose per CDC guidelines. Covid dose two was admin on 2/2/23.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Sudden death
Clinical narrative: Patients wife states he had covid vaccine end of July 2022 and was dead 8/3/2022. Patient's wife wanted us to file vaccine adverse event on her husbands behalf. She states he received covid booster in July 2022 and died sudden death August 3, 2022
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Abnormal loss of weight, Bladder diverticulum, COVID-19
Clinical narrative: Tested covid 19 positive for the second time Jan2022; Tested covid 19 positive for the second time Jan2022; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), in Sep2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid 19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "Tested covid 19 positive for the second time Jan2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Jan2022) Positive, notes: Tested covid 19 positive for the second time; Weight: (unspecified date) losing 30, notes: losing 30 lbs.  Clinical course: Reporter stated He received 2nd Pfizer covid vaccine Sep2021. Episode of acute pancreatitis Dec2021. Tested covid 19 positive for the second time Jan2022. Diagnosed with exocrine pancreatic insufficiency after several months of diarrhea, losing 30 lbs, and other classical signs of EPI. Health 32 year old male with no preexisting hx documented by regular pcp visits. Pfizer was given less than 1 year to produce vaccine and now more info comes out. Who would be accountable further asked.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) and  Covid 19 cannot be ruled out.
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chills, Computerised tomogram abdomen abnormal, Diarrhoea, Faecal elastase test, Hepatobiliary scan
Clinical narrative: Tested covid 19 positive for the second time Jan2022; Tested covid 19 positive for the second time Jan2022; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), in Sep2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid 19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "Tested covid 19 positive for the second time Jan2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Jan2022) Positive, notes: Tested covid 19 positive for the second time; Weight: (unspecified date) losing 30, notes: losing 30 lbs.  Clinical course: Reporter stated He received 2nd Pfizer covid vaccine Sep2021. Episode of acute pancreatitis Dec2021. Tested covid 19 positive for the second time Jan2022. Diagnosed with exocrine pancreatic insufficiency after several months of diarrhea, losing 30 lbs, and other classical signs of EPI. Health 32 year old male with no preexisting hx documented by regular pcp visits. Pfizer was given less than 1 year to produce vaccine and now more info comes out. Who would be accountable further asked.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) and  Covid 19 cannot be ruled out.
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Lipase increased, Nausea, Pancreatic failure, Pancreatitis acute, SARS-CoV-2 test positive
Clinical narrative: Tested covid 19 positive for the second time Jan2022; Tested covid 19 positive for the second time Jan2022; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), in Sep2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid 19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "Tested covid 19 positive for the second time Jan2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Jan2022) Positive, notes: Tested covid 19 positive for the second time; Weight: (unspecified date) losing 30, notes: losing 30 lbs.  Clinical course: Reporter stated He received 2nd Pfizer covid vaccine Sep2021. Episode of acute pancreatitis Dec2021. Tested covid 19 positive for the second time Jan2022. Diagnosed with exocrine pancreatic insufficiency after several months of diarrhea, losing 30 lbs, and other classical signs of EPI. Health 32 year old male with no preexisting hx documented by regular pcp visits. Pfizer was given less than 1 year to produce vaccine and now more info comes out. Who would be accountable further asked.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) and  Covid 19 cannot be ruled out.
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Ultrasound abdomen normal, Weight decreased
Clinical narrative: Tested covid 19 positive for the second time Jan2022; Tested covid 19 positive for the second time Jan2022; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), in Sep2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid 19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "Tested covid 19 positive for the second time Jan2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Jan2022) Positive, notes: Tested covid 19 positive for the second time; Weight: (unspecified date) losing 30, notes: losing 30 lbs.  Clinical course: Reporter stated He received 2nd Pfizer covid vaccine Sep2021. Episode of acute pancreatitis Dec2021. Tested covid 19 positive for the second time Jan2022. Diagnosed with exocrine pancreatic insufficiency after several months of diarrhea, losing 30 lbs, and other classical signs of EPI. Health 32 year old male with no preexisting hx documented by regular pcp visits. Pfizer was given less than 1 year to produce vaccine and now more info comes out. Who would be accountable further asked.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) and  Covid 19 cannot be ruled out.
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pancreatic failure, Pancreatitis acute, SARS-CoV-2 test, Weight decreased
Clinical narrative: Tested covid 19 positive for the second time Jan2022; Tested covid 19 positive for the second time Jan2022; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), in Sep2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid 19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "Tested covid 19 positive for the second time Jan2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Jan2022) Positive, notes: Tested covid 19 positive for the second time; Weight: (unspecified date) losing 30, notes: losing 30 lbs.  Clinical course: Reporter stated He received 2nd Pfizer covid vaccine Sep2021. Episode of acute pancreatitis Dec2021. Tested covid 19 positive for the second time Jan2022. Diagnosed with exocrine pancreatic insufficiency after several months of diarrhea, losing 30 lbs, and other classical signs of EPI. Health 32 year old male with no preexisting hx documented by regular pcp visits. Pfizer was given less than 1 year to produce vaccine and now more info comes out. Who would be accountable further asked.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) and  Covid 19 cannot be ruled out.