chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Pallor, Syncope
Clinical narrative: patient came to the pharmacy to get the first dose of the pfizer covid-19 vaccine. after the shot was administered patient reported feeling dizzy, she sat down and fainted for about 15 seconds, her name was called out and she slowly responded. she looked pale, and was sweating. this happened on febuary 22, 2022 around 4:30pm. her blood pressure was checked and was within normal limits. she has no chronic conditions, no allergies, and no history of adverse events to vaccine
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Clostridium difficile infection
Clinical narrative: I developed C-dif during the time between my second and third shot, not sure if it was related to the vaccine.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Blood test normal, Lip swelling, Pruritus, Swelling
Clinical narrative: I had a reaction the second vaccine in my covid vaccine series. I got home from work the next day (4/19/2021) and had hives on my wrist that were swollen and itchy. I woke up in the middle of the night on the 19th with my lip swollen experiencing angioedema. i called the doctors office and they said to take benadryl and if it wasnt better in the morning to come in. i  went to the doctor the next day 4/20/2021 as it was getting better but not completely. after the swelling was gone i was fine for about a month until i started getting hives and devleoping the angioedema again. i then went to the doctors and they sent me to the ER because of having a swollen lip. i was put in steroids for the swelling and sent home. the hives subsided taking the steroids but then once the course of steoids was over they came back aggresively. this continued to be a routine for months. i went to an allergist who put me on zyrtec and pepcid to help and then we added in singular and doxepin and i still was not able to come off the steroids with out an aggresive flare up. we then began working on getting xolair approved for injections as nothing else was working and i cant take steroids forever at a varying dose. i started getting xolair injections in july of 2021 and they began to help and i was able to go off the steroids. i was experiencing hair loss after about three injections so we had to stop them. while getting the injections i was also able to stop the doxepin. now that we have stopped the injections we are being able to manage the hives with the zyrtec pepcid and singular and only having an occasional flare up that warrants more medication such as benadryl or steroids.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: I had a reaction the second vaccine in my covid vaccine series. I got home from work the next day (4/19/2021) and had hives on my wrist that were swollen and itchy. I woke up in the middle of the night on the 19th with my lip swollen experiencing angioedema. i called the doctors office and they said to take benadryl and if it wasnt better in the morning to come in. i  went to the doctor the next day 4/20/2021 as it was getting better but not completely. after the swelling was gone i was fine for about a month until i started getting hives and devleoping the angioedema again. i then went to the doctors and they sent me to the ER because of having a swollen lip. i was put in steroids for the swelling and sent home. the hives subsided taking the steroids but then once the course of steoids was over they came back aggresively. this continued to be a routine for months. i went to an allergist who put me on zyrtec and pepcid to help and then we added in singular and doxepin and i still was not able to come off the steroids with out an aggresive flare up. we then began working on getting xolair approved for injections as nothing else was working and i cant take steroids forever at a varying dose. i started getting xolair injections in july of 2021 and they began to help and i was able to go off the steroids. i was experiencing hair loss after about three injections so we had to stop them. while getting the injections i was also able to stop the doxepin. now that we have stopped the injections we are being able to manage the hives with the zyrtec pepcid and singular and only having an occasional flare up that warrants more medication such as benadryl or steroids.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Admitted for inpatient observation and tested positive for COVID.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient is 15 years old and got the pediatric Pfizer
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient was given the 12 and older vaccine 0.3 ML, no known symptoms or problems
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fluid retention, Headache, Injection site pain, Lymphadenopathy, Pain
Clinical narrative: In addition to generalized injection site pain, my left arm and armpit glands were swollen, retaining water and quite painful. I had similar reaction to 2nd shot. However, I had a pretty much debilitating headache that rendered me bed ridden for the day. On the second day after the booster shot I am still experiencing headaches when I move from sitting to standing. My blood pressure- taken today was 117/76 which is within normal range.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: In addition to generalized injection site pain, my left arm and armpit glands were swollen, retaining water and quite painful. I had similar reaction to 2nd shot. However, I had a pretty much debilitating headache that rendered me bed ridden for the day. On the second day after the booster shot I am still experiencing headaches when I move from sitting to standing. My blood pressure- taken today was 117/76 which is within normal range.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to and that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of Agency. The  website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Acute left ventricular failure, Cardiac failure congestive, Death, SARS-CoV-2 test
Clinical narrative: pt admitted to SNF with acute diastolic congestive heart failure and history of COVID pneumonia; (COVID test on 9/12/2021); was treated with antibiotics; in SNF for PT/OT, O2 supplementation; aggressive comfort measures; pt passed away in the SNF
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Chills, Decreased appetite, Dyspnoea
Clinical narrative: fever, chills, muscle pain, joint pain, malaise, sweat, loss of appetite, severe chest pain, shortness of breath, headache, drowsiness and slept all day. Severe symptoms and bedridden for 4 days.  Brain fog for a month. Took tylenol on day 3.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Hyperhidrosis, Malaise, Mobility decreased
Clinical narrative: fever, chills, muscle pain, joint pain, malaise, sweat, loss of appetite, severe chest pain, shortness of breath, headache, drowsiness and slept all day. Severe symptoms and bedridden for 4 days.  Brain fog for a month. Took tylenol on day 3.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Somnolence
Clinical narrative: fever, chills, muscle pain, joint pain, malaise, sweat, loss of appetite, severe chest pain, shortness of breath, headache, drowsiness and slept all day. Severe symptoms and bedridden for 4 days.  Brain fog for a month. Took tylenol on day 3.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid-19 illness
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the Health Clinic that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of (privacy). The CDC website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the Health Clinic that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of (privacy) The CDC website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the Clinic that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of clinic. The CDC website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to -15 degrees C) beyond 14 days. On 22JAN22 Pfizer responded to the Health Agency and Health Clinic that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of Health Agency and Health Clinic. The regulatory authority website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid-19 illness
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the Health Agency and Health Clinic that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of HA. The CDC website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the clinic that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of clinic. The CDC website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the Health Agency that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of local authority. The CDC website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the Health Agency that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of local authority. The CDC website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the Health Agency and Health Clinic that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of HA/HC. The regulatory authority website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dyspnoea
Clinical narrative: Patient  is having chest pain and breathing difficulty and chills
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the agency, that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of agency. The website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase, Blood thyroid stimulating hormone, Full blood count, Human chorionic gonadotropin, Limb discomfort
Clinical narrative: Day after Vaccine- Bilateral Calf Myalgia. Constant ache that increased to muscle spasms, and intermittent shooting pains over the next 2 days.  3rd day after vaccine- Bilateral bicep Myalgia with arm heaviness and tingling.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Muscle spasms, Myalgia, Pain, Paraesthesia
Clinical narrative: Day after Vaccine- Bilateral Calf Myalgia. Constant ache that increased to muscle spasms, and intermittent shooting pains over the next 2 days.  3rd day after vaccine- Bilateral bicep Myalgia with arm heaviness and tingling.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound Doppler, Urine analysis
Clinical narrative: Day after Vaccine- Bilateral Calf Myalgia. Constant ache that increased to muscle spasms, and intermittent shooting pains over the next 2 days.  3rd day after vaccine- Bilateral bicep Myalgia with arm heaviness and tingling.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid-19 illness
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the Health Clinic that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of clinic. The CDC website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cerebral mass effect, Computerised tomogram head abnormal, Death, Endotracheal intubation
Clinical narrative: Pt became unresponsive on 2/21 and was taken to the ED. COVID test was positive, CT showed large left-sided intracranial hemorrhage with midline shift, pt was intubated and transferred to critical care. Per pt and family wishes, patient was transferred for terminal wean and end of life care. Pt was extubated at 1:00 PM on 2/21 and passed away at 3:03 PM
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage intracranial, Intensive care, SARS-CoV-2 test positive, Unresponsive to stimuli
Clinical narrative: Pt became unresponsive on 2/21 and was taken to the ED. COVID test was positive, CT showed large left-sided intracranial hemorrhage with midline shift, pt was intubated and transferred to critical care. Per pt and family wishes, patient was transferred for terminal wean and end of life care. Pt was extubated at 1:00 PM on 2/21 and passed away at 3:03 PM
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the Agency that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of Agency. The website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the Health Clinic that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of agency. The CDC website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the Health Agency that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility local authority. The CDC website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the Health Clinic that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of clinic. The CDC website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the Health Clinic that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of clinic. The CDC website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the Health Agency that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of local authority. The CDC website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid-19 illness
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chiropractic
Clinical narrative: A couple of days after my first dose of the Moderna  Vaccine I started having sever joint pain. My hip joints are the worst. I asked my doctor about and he said that he was unsure of the cause so I went to a chiropractor to see if that would help. It did not help and I am still having sever hip joint pain
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid-19 illness
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Patient isolation, Pyrexia, Quarantine, SARS-CoV-2 test negative
Clinical narrative: Patient had a fever of 101.1 F. He was given 400mg of Ibuprofen at 7:30 am and 12.5ml of Dayquil at about 9:15 am (temp. 99.9F.) his fever went down at 10:17 am to 98. 2 F.  He had no more symptoms thereafter, quarantine/isolation and observation was initiated immediately after.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid-19 illness
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the Health Agency and Health Clinic (HC) that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of HA / HC. The regulatory authority website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the Health Agency that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of vaccine facility. The CDC website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Intensive care
Clinical narrative: Stroke, 3 days in Hospital
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the agency, that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of agency. The website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, COVID-19, Diarrhoea, Faeces discoloured, Haemoglobin
Clinical narrative: Patient was treated with doxycycline for bronchitis around 1 and half months ago.  Apparently patient started having diarrhea after that and which gradually worsened.  Her stool is darker than normal but nonbloody.  In the ED, patient was hypertensive with blood pressure 180/74, heart rate 96, temperature 97.8°.  She was saturating at 95 percent on room air.  She was also transfused with 2 units of PRBC.  COVID-19 came back positive.  Patient did not have any respiratory symptoms and was on room air.  Patient did not have any further diarrhea in the hospital.  Her hemoglobin thereafter remained stable.   Patient improved and was tolerating regular diet.  She was discharged in stable condition.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Packed red blood cell transfusion, SARS-CoV-2 test positive
Clinical narrative: Patient was treated with doxycycline for bronchitis around 1 and half months ago.  Apparently patient started having diarrhea after that and which gradually worsened.  Her stool is darker than normal but nonbloody.  In the ED, patient was hypertensive with blood pressure 180/74, heart rate 96, temperature 97.8°.  She was saturating at 95 percent on room air.  She was also transfused with 2 units of PRBC.  COVID-19 came back positive.  Patient did not have any respiratory symptoms and was on room air.  Patient did not have any further diarrhea in the hospital.  Her hemoglobin thereafter remained stable.   Patient improved and was tolerating regular diet.  She was discharged in stable condition.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid-19 illness
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the Health Agency and Health Clinic (HC) that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of HA / HC. The CDC website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the Health Agency and Health Clinic (HC) that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of HA / HC. The CDC website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the Health Agency and Health Clinic that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of Health Agency/ Health Clinic. The CDC website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the Health Agency and Health Clinic (HC) that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of HA / HC. The CDC website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Muscle spasms, Pain, Pain in extremity
Clinical narrative: spasm in thigh and burning acute pain that last for two weeks in lower back and upper leg.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the agency, that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of agency. The website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the Health Agency that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of local authority. The CDC website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test normal, Mechanical urticaria, Pruritus, Swelling
Clinical narrative: Patient developed subcutaneous swelling, itching of the neck, dermographia
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory failure, COVID-19, COVID-19 pneumonia, Death, Inappropriate schedule of product administration
Clinical narrative: Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccine on 3/11/21 and 4/10/21. Presented to ED from clinic c/o Covid sxs and COVID+ on 1/27/22.  Admitted for acute respiratory failure 2/2 Covid PNA. Tx'd w/steroids and O2. O2 requirements increased, requested DNAR/COT status on 1/30/22. O2 requirements continued to increase. Transitioned to comfort care, expired 2/10/22. Pt was transitioned to comfort care. Treated with decadron,ceftriaxone, piperacilin/tazobactam. Pt expired on 2/09/22.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, SARS-CoV-2 test positive
Clinical narrative: Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccine on 3/11/21 and 4/10/21. Presented to ED from clinic c/o Covid sxs and COVID+ on 1/27/22.  Admitted for acute respiratory failure 2/2 Covid PNA. Tx'd w/steroids and O2. O2 requirements increased, requested DNAR/COT status on 1/30/22. O2 requirements continued to increase. Transitioned to comfort care, expired 2/10/22. Pt was transitioned to comfort care. Treated with decadron,ceftriaxone, piperacilin/tazobactam. Pt expired on 2/09/22.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the (Privacy) Health Clinic that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of (Privacy). The CDC website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Product dose omission issue
Clinical narrative: It was noted on 2/23/22 that there was only a single dose of Hib left in the Pentacel box. We reviewed all patients that received this lot # and were able to narrow it down to this patient being the one that did not receive Hib. A safety report has been filed with the manufacturer. The Owner/Physician of our practice has been notified and will be reaching out to the family to schedule the dose of hib. Sanofi is shipping a pack of hib diluent so we can administer the remaining vaccine.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the Health Clinic that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of (privacy). The CDC website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the Health Agency and Health Clinic that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of Health Agency / Health Clinic. The CDC website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the agency that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of agency. The website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory failure, COVID-19, COVID-19 pneumonia, Chest X-ray abnormal, Chronic obstructive pulmonary disease
Clinical narrative: Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccine on 3/12/21 and 4/13/21. Presented to the ER on 1/26/22 with c/o SOB and cough, Covid+. At home her oxygen saturation was 82%. Admitted for acute hypoxemic resp failure 2/2 Covid PNA c/b COPD exacerbation.  Placed on non-rebreather mask. On 02/02/2022-respiratory status worsened left side, placed on BiPAP.  CXR showed worsening bilateral infiltrates. Throughout admission continued to decompensate, placed on comfort care/DNAR. Tx'd with rocephin, azithromycin,steroids, vitamin c, zinc and remdesivir. Expired on 2/09/22.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Cough, Death, Dyspnoea, Inappropriate schedule of product administration
Clinical narrative: Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccine on 3/12/21 and 4/13/21. Presented to the ER on 1/26/22 with c/o SOB and cough, Covid+. At home her oxygen saturation was 82%. Admitted for acute hypoxemic resp failure 2/2 Covid PNA c/b COPD exacerbation.  Placed on non-rebreather mask. On 02/02/2022-respiratory status worsened left side, placed on BiPAP.  CXR showed worsening bilateral infiltrates. Throughout admission continued to decompensate, placed on comfort care/DNAR. Tx'd with rocephin, azithromycin,steroids, vitamin c, zinc and remdesivir. Expired on 2/09/22.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lung infiltration, Positive airway pressure therapy, Respiratory disorder, SARS-CoV-2 test positive
Clinical narrative: Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccine on 3/12/21 and 4/13/21. Presented to the ER on 1/26/22 with c/o SOB and cough, Covid+. At home her oxygen saturation was 82%. Admitted for acute hypoxemic resp failure 2/2 Covid PNA c/b COPD exacerbation.  Placed on non-rebreather mask. On 02/02/2022-respiratory status worsened left side, placed on BiPAP.  CXR showed worsening bilateral infiltrates. Throughout admission continued to decompensate, placed on comfort care/DNAR. Tx'd with rocephin, azithromycin,steroids, vitamin c, zinc and remdesivir. Expired on 2/09/22.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: DILUTED Pfizer BIONTECH COVID 19 WHICH SHOULDN'T BE DILUTED. ADMINISTERED 0.3 ML. CALLED PATIENT AND ASKED TO COME GAIN FOR THE CORRECT DOSE
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the Health Agency that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of local authority. The CDC website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Age: 32.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Anger, Irritability, Mood altered, Self-injurious ideation, Suicidal ideation
Clinical narrative: Irritability, mood changes, angry outbursts, self injury ideation and urges, suicidal ideation and urges. None of the symptoms were felt before vaccine
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the Health Clinic that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of clinic. The CDC website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the agency, that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of agency. The CDC website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Acute respiratory failure, Anaemia, Blood culture positive, COVID-19
Clinical narrative: Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccine on 1/08/21 and 1/29/21. Covid + 1/27/22. Presented to ED with acute anemia Hg 5.9, right hip hematoma measuring 9.2 x 5.8 cm along with acute respiratory failure, acute renal insufficiency, acute transaminitis and clinical evidence of volume overload. Recently hospitalized with Staph epi bacteremia and treated for infective endocarditis despite negative TEE dt recurrent + bld cxs with 6 weeks of IV vancomycin and rifampin SOT 12/29/2021 and 1/4/2022 respectively. Resp status continued to decline, transitioned to comfort care. Tx'd with meropenem and daptomycin. Expired on 2/09/22.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Echocardiogram, Haematoma, Haemoglobin decreased, Hypervolaemia
Clinical narrative: Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccine on 1/08/21 and 1/29/21. Covid + 1/27/22. Presented to ED with acute anemia Hg 5.9, right hip hematoma measuring 9.2 x 5.8 cm along with acute respiratory failure, acute renal insufficiency, acute transaminitis and clinical evidence of volume overload. Recently hospitalized with Staph epi bacteremia and treated for infective endocarditis despite negative TEE dt recurrent + bld cxs with 6 weeks of IV vancomycin and rifampin SOT 12/29/2021 and 1/4/2022 respectively. Resp status continued to decline, transitioned to comfort care. Tx'd with meropenem and daptomycin. Expired on 2/09/22.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Respiratory disorder, SARS-CoV-2 test positive, Transaminases increased
Clinical narrative: Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccine on 1/08/21 and 1/29/21. Covid + 1/27/22. Presented to ED with acute anemia Hg 5.9, right hip hematoma measuring 9.2 x 5.8 cm along with acute respiratory failure, acute renal insufficiency, acute transaminitis and clinical evidence of volume overload. Recently hospitalized with Staph epi bacteremia and treated for infective endocarditis despite negative TEE dt recurrent + bld cxs with 6 weeks of IV vancomycin and rifampin SOT 12/29/2021 and 1/4/2022 respectively. Resp status continued to decline, transitioned to comfort care. Tx'd with meropenem and daptomycin. Expired on 2/09/22.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Injury, Mobility decreased, Muscle spasms, Posture abnormal
Clinical narrative: I was vaccinated on Wednesday afternoon. Friday morning I woke up with a sore spine. As the day continued my ability to move, level of pain, and level of functioning significantly decreased. By 4 pm that afternoon I was having severe back spasms which prevented me from walking. The pain was intolerable. I was taken to the ER where I had 2 more full back spasms while entering the ER. I was unable to straighten my spine. I was treated at the ER but was unable to have full mobility of my body until 2/21. My back still does not feel ok.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Spinal pain
Clinical narrative: I was vaccinated on Wednesday afternoon. Friday morning I woke up with a sore spine. As the day continued my ability to move, level of pain, and level of functioning significantly decreased. By 4 pm that afternoon I was having severe back spasms which prevented me from walking. The pain was intolerable. I was taken to the ER where I had 2 more full back spasms while entering the ER. I was unable to straighten my spine. I was treated at the ER but was unable to have full mobility of my body until 2/21. My back still does not feel ok.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the Health Agency that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of local authority. The CDC website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, COVID-19 pneumonia, Chest X-ray, Death
Clinical narrative: Pt tested + for COVID as out-patient 12/09/2021. Referred to ED due to ongoing dyspnea and hypoxia. Fully vaccinated, has not received booster.  Presented at ED 12/09/2022 and admitted. Date of death: 12/21/2021;  Acute hypoxic respiratory failure , COVID 19 pneumonia
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Hypoxia, Laboratory test, SARS-CoV-2 test positive
Clinical narrative: Pt tested + for COVID as out-patient 12/09/2021. Referred to ED due to ongoing dyspnea and hypoxia. Fully vaccinated, has not received booster.  Presented at ED 12/09/2022 and admitted. Date of death: 12/21/2021;  Acute hypoxic respiratory failure , COVID 19 pneumonia
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the Health Agency that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of local authority. The CDC website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered vaccine 1 day past expiration date
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Blood culture positive, COVID-19, COVID-19 pneumonia, Catheter removal, Death
Clinical narrative: Janssen COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Janssen Vaccine on 3/12/21. Presented to ED from HD clinic 2/2 +blood cxs. Admitted for septic shock and coagulase-negative Staph bacteremia, also positive for COVID-19 PNA. Developed fungemia and tunneled dialysis catheter was removed. Course c/b hypoxic respiratory failure, transferred to ICU. After long and complicated ICU course, continued to deteriorate. Transitioned to comfort care/DNAR. Treated with levaquin,remdesivir, hydrocortisone, ancef, zosyn, and micafungin. Expired on 2/12/22.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Fungaemia, General physical health deterioration, Intensive care, Respiratory failure, SARS-CoV-2 test positive
Clinical narrative: Janssen COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Janssen Vaccine on 3/12/21. Presented to ED from HD clinic 2/2 +blood cxs. Admitted for septic shock and coagulase-negative Staph bacteremia, also positive for COVID-19 PNA. Developed fungemia and tunneled dialysis catheter was removed. Course c/b hypoxic respiratory failure, transferred to ICU. After long and complicated ICU course, continued to deteriorate. Transitioned to comfort care/DNAR. Treated with levaquin,remdesivir, hydrocortisone, ancef, zosyn, and micafungin. Expired on 2/12/22.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Septic shock, Staphylococcal bacteraemia, Staphylococcal infection
Clinical narrative: Janssen COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Janssen Vaccine on 3/12/21. Presented to ED from HD clinic 2/2 +blood cxs. Admitted for septic shock and coagulase-negative Staph bacteremia, also positive for COVID-19 PNA. Developed fungemia and tunneled dialysis catheter was removed. Course c/b hypoxic respiratory failure, transferred to ICU. After long and complicated ICU course, continued to deteriorate. Transitioned to comfort care/DNAR. Treated with levaquin,remdesivir, hydrocortisone, ancef, zosyn, and micafungin. Expired on 2/12/22.