chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pain, Pain in extremity
Clinical narrative: I receive a Pfizer Covid booster shot at approximately 12:15 pm on 12/30/2021 in my left arm. On 12/31/2021, I began to have a severe burning pain in my left arm, left shoulder, neck and head. The pain intensified upon movement, even small movements made it worse. It was somewhat alleviated by a warm shower but would return within 15 minutes of leaving the shower. the pain lasted about 18 hours.
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Computerised tomogram, Diarrhoea, Feeding disorder, Fluid intake reduced
Clinical narrative: I am very concerned how it is being promoted that everyone should be just line up and get their Covid vaccines and booster. I went March of 2021 and got both my Pfizer vaccines. After the first one I developed a rash on my legs and my voice became very scratchy, my feet also felt a little numb. I went on and got the second shot on March 27th, 2021. No one asked me any health questions except did I have a cold or fever; I didn't. In the middle of the night after received my second vaccine I was violently ill. Vomiting, diarrhea, body aches, and even my skin hurt, I was unable to eat or drink for over two days. Then almost totally lost my voice, had numb feet and ankles, a rash on my legs and swollen lymph nodes. I went to my rheumatoid arthritis doctor who was concerned that I might have Gillame-Barre and recommended that I go to the emergency room. I spent April 2-6, 2021 in the hospital. No one seemed to know what was wrong with me. Doctors and nurses speculated that all my symptoms were caused by the vaccine. They all felt it was too much of a coincidence that everything developed immediately after I got the Pfized vaccine. I was subjected to almost every medical test available. Eventually my rash went away, my voice improved slightly and I was negative for Guillame-Barre. Unfortunately, I still have swollen lymph nodes and my feet are still numb. It is ridiculous that I worked a full time job, on my feet all day long and now I can barely walk around the block. I don't understand how these vaccines can be given with no questions asked. I have Rheumatoid Arthritis. I was on few drugs to treat the arthritis as well as prednisone. No one said there were any red flags. My life and health has been destroyed. I can no longer work. I can no longer walk and I can barely speak above a whisper. How can these vaccines be promoted for everyone? And now boosters are being promoted! How many other people have serious heatlh problems due to the vaccines. There are to be some responsibility from the drug companies. I deserve compensation for my medical bills and my inability to work. I would also, above all else, have my health issues resolved! I cannot begin to list all of the tests performed on from April 2-6 at the hospital. The tests were endless.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Gait inability, General physical health deterioration, Hypoaesthesia, Impaired work ability
Clinical narrative: I am very concerned how it is being promoted that everyone should be just line up and get their Covid vaccines and booster. I went March of 2021 and got both my Pfizer vaccines. After the first one I developed a rash on my legs and my voice became very scratchy, my feet also felt a little numb. I went on and got the second shot on March 27th, 2021. No one asked me any health questions except did I have a cold or fever; I didn't. In the middle of the night after received my second vaccine I was violently ill. Vomiting, diarrhea, body aches, and even my skin hurt, I was unable to eat or drink for over two days. Then almost totally lost my voice, had numb feet and ankles, a rash on my legs and swollen lymph nodes. I went to my rheumatoid arthritis doctor who was concerned that I might have Gillame-Barre and recommended that I go to the emergency room. I spent April 2-6, 2021 in the hospital. No one seemed to know what was wrong with me. Doctors and nurses speculated that all my symptoms were caused by the vaccine. They all felt it was too much of a coincidence that everything developed immediately after I got the Pfized vaccine. I was subjected to almost every medical test available. Eventually my rash went away, my voice improved slightly and I was negative for Guillame-Barre. Unfortunately, I still have swollen lymph nodes and my feet are still numb. It is ridiculous that I worked a full time job, on my feet all day long and now I can barely walk around the block. I don't understand how these vaccines can be given with no questions asked. I have Rheumatoid Arthritis. I was on few drugs to treat the arthritis as well as prednisone. No one said there were any red flags. My life and health has been destroyed. I can no longer work. I can no longer walk and I can barely speak above a whisper. How can these vaccines be promoted for everyone? And now boosters are being promoted! How many other people have serious heatlh problems due to the vaccines. There are to be some responsibility from the drug companies. I deserve compensation for my medical bills and my inability to work. I would also, above all else, have my health issues resolved! I cannot begin to list all of the tests performed on from April 2-6 at the hospital. The tests were endless.
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Lumbar puncture, Lymphadenopathy, Magnetic resonance imaging, Malaise
Clinical narrative: I am very concerned how it is being promoted that everyone should be just line up and get their Covid vaccines and booster. I went March of 2021 and got both my Pfizer vaccines. After the first one I developed a rash on my legs and my voice became very scratchy, my feet also felt a little numb. I went on and got the second shot on March 27th, 2021. No one asked me any health questions except did I have a cold or fever; I didn't. In the middle of the night after received my second vaccine I was violently ill. Vomiting, diarrhea, body aches, and even my skin hurt, I was unable to eat or drink for over two days. Then almost totally lost my voice, had numb feet and ankles, a rash on my legs and swollen lymph nodes. I went to my rheumatoid arthritis doctor who was concerned that I might have Gillame-Barre and recommended that I go to the emergency room. I spent April 2-6, 2021 in the hospital. No one seemed to know what was wrong with me. Doctors and nurses speculated that all my symptoms were caused by the vaccine. They all felt it was too much of a coincidence that everything developed immediately after I got the Pfized vaccine. I was subjected to almost every medical test available. Eventually my rash went away, my voice improved slightly and I was negative for Guillame-Barre. Unfortunately, I still have swollen lymph nodes and my feet are still numb. It is ridiculous that I worked a full time job, on my feet all day long and now I can barely walk around the block. I don't understand how these vaccines can be given with no questions asked. I have Rheumatoid Arthritis. I was on few drugs to treat the arthritis as well as prednisone. No one said there were any red flags. My life and health has been destroyed. I can no longer work. I can no longer walk and I can barely speak above a whisper. How can these vaccines be promoted for everyone? And now boosters are being promoted! How many other people have serious heatlh problems due to the vaccines. There are to be some responsibility from the drug companies. I deserve compensation for my medical bills and my inability to work. I would also, above all else, have my health issues resolved! I cannot begin to list all of the tests performed on from April 2-6 at the hospital. The tests were endless.
Sex: F
Vaccine: COVID19
Symptoms: Mycobacterium tuberculosis complex test, Pain, Pain of skin, Rash, Vomiting
Clinical narrative: I am very concerned how it is being promoted that everyone should be just line up and get their Covid vaccines and booster. I went March of 2021 and got both my Pfizer vaccines. After the first one I developed a rash on my legs and my voice became very scratchy, my feet also felt a little numb. I went on and got the second shot on March 27th, 2021. No one asked me any health questions except did I have a cold or fever; I didn't. In the middle of the night after received my second vaccine I was violently ill. Vomiting, diarrhea, body aches, and even my skin hurt, I was unable to eat or drink for over two days. Then almost totally lost my voice, had numb feet and ankles, a rash on my legs and swollen lymph nodes. I went to my rheumatoid arthritis doctor who was concerned that I might have Gillame-Barre and recommended that I go to the emergency room. I spent April 2-6, 2021 in the hospital. No one seemed to know what was wrong with me. Doctors and nurses speculated that all my symptoms were caused by the vaccine. They all felt it was too much of a coincidence that everything developed immediately after I got the Pfized vaccine. I was subjected to almost every medical test available. Eventually my rash went away, my voice improved slightly and I was negative for Guillame-Barre. Unfortunately, I still have swollen lymph nodes and my feet are still numb. It is ridiculous that I worked a full time job, on my feet all day long and now I can barely walk around the block. I don't understand how these vaccines can be given with no questions asked. I have Rheumatoid Arthritis. I was on few drugs to treat the arthritis as well as prednisone. No one said there were any red flags. My life and health has been destroyed. I can no longer work. I can no longer walk and I can barely speak above a whisper. How can these vaccines be promoted for everyone? And now boosters are being promoted! How many other people have serious heatlh problems due to the vaccines. There are to be some responsibility from the drug companies. I deserve compensation for my medical bills and my inability to work. I would also, above all else, have my health issues resolved! I cannot begin to list all of the tests performed on from April 2-6 at the hospital. The tests were endless.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Parosmia
Clinical narrative: Received second COVID shot on December 27th, on December 31st while eating dinner with family experienced a strong scent of a smell that caused a upset stomach. No one else could smell it, it was a very strong chemical smell. Have experienced the smell several times since then, usually around different food items. Was told by the pharmacist to report this.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: I started getting full body hives one week after receiving my Moderna booster shot. My first and second doses of the Covid vaccine shot were both Moderna and I have no serious side effects. It has now been 3 weeks since my hives first started to appear and I still get them daily and all over my body. The hives break out in patches all over and flare up my skin is rubbed, scratched, or exposed to heat (i.e. a hot shower).
Sex: F
Vaccine: COVID19
Symptoms: Bladder disorder, Bladder pain, Chills, Cough, Dysuria
Clinical narrative: Received J&J vaccine on Oct 29th 2021. Changes in menstruation November 7th(started early) continued bleeding until the month of November 2021.Symptoms of cough, headache, runny nose, sneezing and chills started on November 14th 2021(ended November 21st; bleeding ended Dec 20th 2021. Started having symptoms of Bladder urgency & pain(urinating frequency and pain). Went to clinic for testing of UtI. Received antibiotics. Went through antibiotics and still having issues. Went to Urgent care to receive more medical care. Another dose of antibiotics. Still having issues. I Will have to receive more medical care on bladder issue/urology
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heavy menstrual bleeding, Menstrual disorder, Micturition urgency, Pollakiuria
Clinical narrative: Received J&J vaccine on Oct 29th 2021. Changes in menstruation November 7th(started early) continued bleeding until the month of November 2021.Symptoms of cough, headache, runny nose, sneezing and chills started on November 14th 2021(ended November 21st; bleeding ended Dec 20th 2021. Started having symptoms of Bladder urgency & pain(urinating frequency and pain). Went to clinic for testing of UtI. Received antibiotics. Went through antibiotics and still having issues. Went to Urgent care to receive more medical care. Another dose of antibiotics. Still having issues. I Will have to receive more medical care on bladder issue/urology
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing, Urine analysis
Clinical narrative: Received J&J vaccine on Oct 29th 2021. Changes in menstruation November 7th(started early) continued bleeding until the month of November 2021.Symptoms of cough, headache, runny nose, sneezing and chills started on November 14th 2021(ended November 21st; bleeding ended Dec 20th 2021. Started having symptoms of Bladder urgency & pain(urinating frequency and pain). Went to clinic for testing of UtI. Received antibiotics. Went through antibiotics and still having issues. Went to Urgent care to receive more medical care. Another dose of antibiotics. Still having issues. I Will have to receive more medical care on bladder issue/urology
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury
Clinical narrative: acute renal failure within 60 days of third pfizer covid shot
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Ischaemic stroke
Clinical narrative: [Pfizer COVID-19 Vaccine] use for Emergency use Authorization (EUA): acute ischemic stroke 12/7/2021 after covid booster shot (pfizer) 10/6/2021
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain, Pyrexia, Tremor
Clinical narrative: Severe shaking and high fever with diffuse joint and muscle pain
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Mobility decreased, Muscle spasms, Rash, Rash erythematous
Clinical narrative: I got the 1st COVID vaccine 1/28, 9 days later I had a red rash come up on my arm in the same area with the injection, reported it. So now I tested positive for COVID on 12/7- received antibodies injection on 12/8 and 7 days later I start having cramping in the arm and area with injection site, no redness, reported it also, yesterday I had a red area come up hot to touch in the same spot as the cramping now I can hardly even use my arm without pain. I actually have a picture documentation from 2/6 and 12/13
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Skin warm
Clinical narrative: I got the 1st COVID vaccine 1/28, 9 days later I had a red rash come up on my arm in the same area with the injection, reported it. So now I tested positive for COVID on 12/7- received antibodies injection on 12/8 and 7 days later I start having cramping in the arm and area with injection site, no redness, reported it also, yesterday I had a red area come up hot to touch in the same spot as the cramping now I can hardly even use my arm without pain. I actually have a picture documentation from 2/6 and 12/13
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Adrenal insufficiency, Chronic disease, Cortisol decreased, General physical condition abnormal
Clinical narrative: Got Pfizer COVID-19 shot. It negatively affected my adrenal gland, causing adrenal insufficiency. I'm still required to take hydrocortisone to prevent adrenal crisis. It has caused several physical conditions that have impeded my boy to function normally. The cortisone medications have also resulted in many side effects. It appears this seems to be a chronic condition with no prognosis. One of the worst symptoms of adrenaline sufficiency is an impaired immune system.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, Blood iron decreased, Blood test, Burning sensation, Drug hypersensitivity
Clinical narrative: This is my 3rd time take Fluconazole 150 mg tablet and had a severe allergic reaction. Within 1 hour of ingestion my face began to burn. Then the edema lesions that were on my face and body began hugely enlarged with a red outer circle. My lip became chuffed and underneath the lips skin swelled then ripped. The lesions are very itchy and painful to touch. This is my 3rd time taking this tablet and I finally realized my body has rejected it. My first pill This year was February 2 weeks after my 2nd Moderna vaccination. Since being vaccinated I've become allergic to shell fish as well and randomly I break out and small hives coving my entire body. I've visited the Dermatologist around June 2021 who performed a punch biopsy and determined it was a Fixed Deug Eruption. I've visited the allergist who results were the same yet he found no additional allergies to be noted. And finally I visited a Hematologist who took over 15 blood samples and all he found was low Iron counts. Ultimately, I've been warned to consider not taking the booster shot fearing what reaction it may cause to my blood. I turned 40 March 2021 and I've never had a pimple or a blemish EVER. And I've taken Fluconazole 150 mg in the past years with no side effects. My fixed Drig Eruption markings have not left my body. It's been nearly 11 months I've suffered with these markings. Please advise.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Face oedema, Fixed eruption, Food allergy, Lip swelling
Clinical narrative: This is my 3rd time take Fluconazole 150 mg tablet and had a severe allergic reaction. Within 1 hour of ingestion my face began to burn. Then the edema lesions that were on my face and body began hugely enlarged with a red outer circle. My lip became chuffed and underneath the lips skin swelled then ripped. The lesions are very itchy and painful to touch. This is my 3rd time taking this tablet and I finally realized my body has rejected it. My first pill This year was February 2 weeks after my 2nd Moderna vaccination. Since being vaccinated I've become allergic to shell fish as well and randomly I break out and small hives coving my entire body. I've visited the Dermatologist around June 2021 who performed a punch biopsy and determined it was a Fixed Deug Eruption. I've visited the allergist who results were the same yet he found no additional allergies to be noted. And finally I visited a Hematologist who took over 15 blood samples and all he found was low Iron counts. Ultimately, I've been warned to consider not taking the booster shot fearing what reaction it may cause to my blood. I turned 40 March 2021 and I've never had a pimple or a blemish EVER. And I've taken Fluconazole 150 mg in the past years with no side effects. My fixed Drig Eruption markings have not left my body. It's been nearly 11 months I've suffered with these markings. Please advise.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema, Pruritus, Rash, Skin disorder, Skin laceration
Clinical narrative: This is my 3rd time take Fluconazole 150 mg tablet and had a severe allergic reaction. Within 1 hour of ingestion my face began to burn. Then the edema lesions that were on my face and body began hugely enlarged with a red outer circle. My lip became chuffed and underneath the lips skin swelled then ripped. The lesions are very itchy and painful to touch. This is my 3rd time taking this tablet and I finally realized my body has rejected it. My first pill This year was February 2 weeks after my 2nd Moderna vaccination. Since being vaccinated I've become allergic to shell fish as well and randomly I break out and small hives coving my entire body. I've visited the Dermatologist around June 2021 who performed a punch biopsy and determined it was a Fixed Deug Eruption. I've visited the allergist who results were the same yet he found no additional allergies to be noted. And finally I visited a Hematologist who took over 15 blood samples and all he found was low Iron counts. Ultimately, I've been warned to consider not taking the booster shot fearing what reaction it may cause to my blood. I turned 40 March 2021 and I've never had a pimple or a blemish EVER. And I've taken Fluconazole 150 mg in the past years with no side effects. My fixed Drig Eruption markings have not left my body. It's been nearly 11 months I've suffered with these markings. Please advise.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Skin lesion, Skin swelling, Tenderness, Urticaria
Clinical narrative: This is my 3rd time take Fluconazole 150 mg tablet and had a severe allergic reaction. Within 1 hour of ingestion my face began to burn. Then the edema lesions that were on my face and body began hugely enlarged with a red outer circle. My lip became chuffed and underneath the lips skin swelled then ripped. The lesions are very itchy and painful to touch. This is my 3rd time taking this tablet and I finally realized my body has rejected it. My first pill This year was February 2 weeks after my 2nd Moderna vaccination. Since being vaccinated I've become allergic to shell fish as well and randomly I break out and small hives coving my entire body. I've visited the Dermatologist around June 2021 who performed a punch biopsy and determined it was a Fixed Deug Eruption. I've visited the allergist who results were the same yet he found no additional allergies to be noted. And finally I visited a Hematologist who took over 15 blood samples and all he found was low Iron counts. Ultimately, I've been warned to consider not taking the booster shot fearing what reaction it may cause to my blood. I turned 40 March 2021 and I've never had a pimple or a blemish EVER. And I've taken Fluconazole 150 mg in the past years with no side effects. My fixed Drig Eruption markings have not left my body. It's been nearly 11 months I've suffered with these markings. Please advise.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Chest pain, Colitis, Colonoscopy abnormal
Clinical narrative: I started Lialda 1.2 g tablets, 4 tabs daily on December 10. Around the 18th I had urgent diarrhea abdominal cramps weakness fatigue. Did not have diarrhea before I started it. I stopped it on the 20th once I realized and after talking to pharmacist and doctor. Symptoms improved after stopping it. I restarted the half dose on the 23rd to the 25th. The morning of the 25th I had a sore throat , neck and upper chest aching and increased pain with inhalation or with lying down. My last dose is the 25th. By the 26th afternoon I was feeling better and the 27th I was back to normal. My GI symptoms started around 2 months after the 2nd Moderna Vaccine. Colonoscopy on 10/21 showed mild inflammation of my colon.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Gastrointestinal disorder, Neck pain, Oropharyngeal pain
Clinical narrative: I started Lialda 1.2 g tablets, 4 tabs daily on December 10. Around the 18th I had urgent diarrhea abdominal cramps weakness fatigue. Did not have diarrhea before I started it. I stopped it on the 20th once I realized and after talking to pharmacist and doctor. Symptoms improved after stopping it. I restarted the half dose on the 23rd to the 25th. The morning of the 25th I had a sore throat , neck and upper chest aching and increased pain with inhalation or with lying down. My last dose is the 25th. By the 26th afternoon I was feeling better and the 27th I was back to normal. My GI symptoms started around 2 months after the 2nd Moderna Vaccine. Colonoscopy on 10/21 showed mild inflammation of my colon.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Painful respiration
Clinical narrative: I started Lialda 1.2 g tablets, 4 tabs daily on December 10. Around the 18th I had urgent diarrhea abdominal cramps weakness fatigue. Did not have diarrhea before I started it. I stopped it on the 20th once I realized and after talking to pharmacist and doctor. Symptoms improved after stopping it. I restarted the half dose on the 23rd to the 25th. The morning of the 25th I had a sore throat , neck and upper chest aching and increased pain with inhalation or with lying down. My last dose is the 25th. By the 26th afternoon I was feeling better and the 27th I was back to normal. My GI symptoms started around 2 months after the 2nd Moderna Vaccine. Colonoscopy on 10/21 showed mild inflammation of my colon.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: COVID-19 Lot#- FE3590 Vial PAA165969 Exp 2/22 was placed in the freezer after we received it. It should have been pulled out of the freezer on 10/19/21 at 12:00PM according to the storage guidelines and placed in the refrigerator for 31 days.  Our staff did not pull the vial out of the freezer on this date. The staff noticed the date this morning, November 2, 2021 at 0830.  There were 22 patients who received the COVID vaccination during this time frame. The vials were pulled out of the freezer, thawed, and diluted per instructions during 10/19/21 through November 1, 2021. There are 27 vials that were not used and have been set aside to waste.
Age: 12.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: COVID-19 Lot # FE3590 Vial PAA165959 Exp 2/22 was placed in the freezer after we received it.  It should have been pulled out of the freezer on 10/19/21 at 12:00PM according to the storage guidelines and placed in the refrigerator for 31 days.  Our staff did not pull the vial out of the freezer on this date. The staff noticed the date this morning, November 2, 2021 at 0830.  There was 22 patients who received COVID vaccination during this time frame.  The vials were pulled out the freezer, thawed, and diluted per instructions during 10/19/21 through November 1, 2021. There are 27 vials that were not used and have been set aside to waste.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, In vitro fertilisation
Clinical narrative: Patient called 1-3-22 to report she was experiencing a rapid heart rate of 120-130 for about 5 hours at that point. Patient takes labetolol for blood pressure and states no history of arrhythmia. She had an invitrofertilization procedure last week on 12/24/2021.   I spoke with patient again at 12:45pm 1-3-22. She said heart rate was now in the 107-113 range
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: COVID-19 Lot # FE3590 Vial PAA165969 Exp 2/22 was placed in the freezer after we received it. It should have been pulled out of the freezer on 10/19/21 at 12:00PM according to the storage guidelines and placed in the refrigerator for 31 days.  Our staff did not pull the vial out of the freezer on this date. The staff noticed the date this morning, November 2, 2021 at 0830.   There were 22 patients who received the COVID vaccination during this time frame. The vials were pulled out of the freezer, thawed, and diluted per Instructions during 10/19/21 through November 1, 2021. There are 27 vials that were not used and have been set aside to waste.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: COVID-19 Lot # FE3590 Vial PAA165969 Exp 2/22 was placed in the freezer after we received it.  It should have been pulled out of the freezer on 10/19/21 at 12:00PM according to the storage guidelines and placed in the refrigerator for 31 days.  Our staff did not pull the vial out of the freezer on this date. The staff noticied the date this morning, November 2, 2021 at 0830.  There were 22 patients who received the COVID vaccination during this time frame.  The vials were pulled out of the freezer, thawed, and diluted per instructions during 10/19/21 through November 1, 2021. There are 27 vial that were not used and have been set aside to waste.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: COVID-19 Lot # FE3590 Vial PAA165969 Exp 2/22 was placed in the freezer after we received it. It should have been pulled out of the freezer on 10/19.21 at 12:00PM according to the storage guidelines and placed in the refrigerator for 31 days.  Our staff did not pull the vial out of the freezer on this date. The staff noticed the date this morning, November 2, 2021 at 0830.    There were 22 patients who received the COVID vaccination during this time frame.  The vials were pulled out of the freezer, thawed, and diluted per instructions during 10/19/21 through November 1, 2021. There are 27 vials that were not used and have been set aside to waste.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: COVID-19 Lot# FE3590 Vial PAA165969 Exp 2/22 was placed in the freezer after we received it. It should have been pulled out of the freezer on 10/19/2021 at 12:00PM according to the storage guidelines and placed in the refrigerator for 31 days. Our staff did not pull the vial out of the freezer on this date. The staff noticed the date this morning, November 2, 2021 at 0830.  There were 22 patients who received the COVID vaccination during this time frame. The vials were pulled out of the freezer, thawed, and diluted per instructions during 10/19/2021 through November 1, 2021. There are 27 vials that were not used and have been set aside to waste.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Covid-19 Lot FE3590 Vial PAA165969 Exp 2/22 was placed in the freezer after we received it. It should have been pulled out of the freezer on 10/19/21 at 12:00pm according to the storage guidelines and placed in the refrigerator for 31 days,  Our staff did not pull the vial out of the freezer on this date.  The staff noticed the date this morning, November 2, 2021 at 0830.   There were 22 patients who received the COVID vaccination during this time frame. The vials were pulled out of the freezer, thawed, and diluted per Instructions during 10/19/21 through November 1,  2021. There are 27 vials that were not used and have been set aside to waste.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: COVID-19 Lot # FE3590 Vial PAA165969 Exp 2/22 was placed in the freezer after we received it. It should have been pulled out of the freezer on 10/19/21 at 12:00PM according to the storage guidelines and placed in the refrigerator for 31 days. Our staff did not pull the vial out of the freezer on this date. The staff noticed the date this morning, November 2,2021 at 0830.  There were 22 patients who received the COVID vaccination during this time frame. The vials were pulled out of the freezer, thawed, and dulled per instructions during 10/19/21 through November 1,2021. There are 27 vials that were not used and have been set aside to waste.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Covid-19 Lot # FE3590 Vial PAA165969 Exp 2/22 was placed in the freezer after we received it. It should have been pulled out of the freezer on 10/19/21 at 12:00PM according to the storage guidelines and placed in the refrigerator for 31 days.  Our staff did not pull the vial out of the freezer on this date. The staff noticed the date this morning, November 2, 2021 at 0830.  There were 22 patients who received the COVID vaccination during this time frame. The vials were pulled out of the freezer, thawed, and diluted per instructions during 10/19/21 through November 1, 2021. There are 27 vials that were not used and have been set aside to waste.
Age: 13.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: COVID-19 Lot# FE3590 Vial PAA165969 Exp 2/22 was placed in the freezer after we received it. It should have been pulled out of the freezer on 10/19/21 at 12:00PM according to the storage guidelines and placed in the refrigerator for 31 days.  Our staff did not pull the vial out of the freezer on this date. The staff noticed the date this morning, November 2, 2021 at 0830.   There were 22 patients who received the COVID vaccination during this time frame. The vials were pulled out of the freezer, thawed, and diluted per instructions during 10/19/21 through November 1, 2021. There are 27 vials that were not used and have been set aside to waste.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: COVID-19 Lot # FE3590 Vial PAA165959 Exp 2/22 was placed in the freezer after we received it.  It should have been pulled out of the freezer on 10/19/21 at 12:00PM according to the storage guidelines and placed in the refrigerator for 31 days.  Our staff did not pull the vial out of the freezer on this date. The staff noticed the date this morning, November 2, 2022 at 0830.  There were 22 patients who received the COVID vaccination during this time frame.  The vials were pulled out of the freezer, thawed, and diluted per instructions during 10/19/21 through November 1, 2021. There are 27 vials that were not used and have been set aside to waste.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: COVID-19 Lot # FE3590 Vial PAA165969 Exp 2/22 was placed in the freezer after we received it. It should have been pulled out of the freezer on 10/19/21 at 12:00PM according to the storage guidelines and placed in the refrigerator for 31 days.  Our staff did not pull the vial out of the freezer on this date. The staff noticed the date this morning, November 2, 2021 at 0830.    There were 22 patients who received the COVID vaccination during this time frame. The vials were pulled out of the freezer, thawed, and diluted per Instructions during 10/19/21 through November 1, 2021. There are 27 vials that were not used and have been set aside to waste.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Temprature excursion occurred due to the  vials not being pulled out of the freezer on 10/19/21 according to storage guidelines vials were not pulled out until November 2, 2021 @ 0800.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: COVID-19 Lot # FE3590 Vial PAA165969 Exp 2/22 was placed in the freezer after we received it. It should have been pulled out of the freezer on 10/19/21 at 12:00PM according to the storage guidelines and placed in the refrigerator for 31 days.  Our staff did not pull the vial out of the freezer on this date. The staff noticed the date this morning, November 2, 2021 at 0830.   There are 22 patients who received the COVID vaccination during this time frame.  The vials were pulled out of the freezer, thawed, and diluted per instructions during 10/19/21 through November 1, 2021. There are 27 vials that were not used and have been set aside to waste.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: COVID-19 Lot # FE3590 Vial PAA165959 Exp 2/22 was placed in the freezer after we received it.  It should have been pulled out of the freezer on 10/19/21 at 12:00PM according to the storage guidelines and placed in the refrigerator for 31 days.  Our staff did not pull the vial out of the freezer on this date. The staff noticed the date this morning, November 2, 2022 at 0830.  There were 22 patients who received the COVID vaccination during this time frame.  The vials were pulled out of the freezer, thawed, and diluted per instructions during 10/19/21 through November 1, 2021. There are 21 vials that were not used and have been set aside to waste.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: COVID-19 Lot # FE3590 Vial PAA165969 Exp 2/22 was placed in the freezer after we received it. It should have been pulled out of the freezer on 10/19/21 at 12:00PM according to the storage guidelines and placed in the refrigerator for 31 days.   Our staff did not pull the vial out of the freezer on this date. The staff noticed the date this morning, November 2, 2021 at 0830.    There were 22 patients who received the COVID vaccination during this time frame. The vials were pulled out of the freezer, thawed, and dilluted per Instructions during 10/19/21 through November 1, 2021. There are 27 vials that were not used and have been set aside to waste.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: COVID-19 Lot # FE3590 Vial PAA165969 Exp was placed in the freezer after we received it. It should have been pulled out of the freezer on 10/19/2021 at 12:00PM according to the storage guidelines and place in the refrigerator for 31 days. Our staff did not pull the vial out of the freezer on this date. The staff noticed the date this morning, November 2, 2021 at 0830.  There were 22 patients who received the covid vaccination during this time frame. The vials were pulled out of the freezer, thawed, and diluted per instructions during 10/19/21 through November 1, 2021. There are 27 vials that were not used and have been set aside to waste.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: COVID-19 Lot # FE3590 Vial PAA165969 Exp 2/22 was placed in the freezer after we received it. It should have been pulled out of the freezer on 10/19/21 at 12:00PM according to the storage guidelines and placed in the refrigerator for 31 days.  Our staff did not pull the vial out of the freezer on the date. The staff noticed the date this morning, November 2, 2021 at 0830.   There were 22 patients who received the COVID vaccination during this time frame. The vials were pulled out of the freezer, thawed, and diluted per instructions during 10/19/2021 through November 1, 2021. There are 27 vials that were not used and have been set aside to waste.
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: COVID-19 Lot # FE3590 Vial PAA165969 Exp 2/22 was placed in the freezer after we received it. It should have been pulled out of the freezer on 10/19/21 at 12:00PM according to the storage guidelines and placed in the refrigerator or 31 days.  Our staff did not pull the vial out of the freezer on this date. The staff noticed the date this morning, November 2, 2021 at 0830.  There were 22 patients who received the COVID vaccination during this time frame. The vials were pulled out of the freezer, thawed, and diluted per instructions during 10/19/21 through November 1, 2021. There are 27 vials that were not used and have been set aside to waste.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Narrative:  Patient developed dizziness/lightheadedness that resolved with time.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Narrative: He reports having experienced nausea after the initial vaccination. This started a day afterwards and resolved without treatment or intervention within 3 days (no therapies were tried). He denied other common adverse effects including vomiting, abdominal pain, and rash. He did not feeling hotter than normal during that time, but did not have a thermometer. He was able to eat and drink.
Age: 100.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Confusional state, Death, Klebsiella infection, Urinary tract infection
Clinical narrative: Narrative:  Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 98 and started having confusion on 2/11/21 due to a suspected UTI but daughter had difficulty bringing him in for urinalysis. She eventually brought him to facility on 2/15/21 where he had a Klebsiella UTI. Patient eventually became bedridden and required home hospice. Other comorbidities included COPD, DM, HTN, and HLD.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Bradycardia, Hyperhidrosis, Hypotension, Loss of consciousness
Clinical narrative: Narrative: Patient developed diaphoresis, 4-5 seconds of loss of consciousness with pulse, was bradycardic, hypotensive, and a medical evaluation team was called. Patient was alert and oriented x 3, became normotensive, with normal  pulse, and did not require any medical treatment. Patient was stable and able leave  on their own.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Headache, Hypoaesthesia, Movement disorder
Clinical narrative: Narrative: Patient states rash present for 3-4 weeks "from neck down" described as "itching" especially at night "red bumpy rash scattered from neck down has areas on abd, involvement of groins anterior and posterior knees and has had lesions between his fingers" Patient instructed to monitor for the following symptoms over the course of three weeks after the vaccination. * A headache that occurs 6 days or more after vaccination * A headache that is different from other headaches you have had * Confusion or trouble thinking clearly * Visual changes, such as blurry vision * Weakness, numbness, or trouble moving one or more parts of your body of your body, trouble speaking or seizures * Tiny spots under the skin away from the area where you had the infection (this is a sign of low platelets) Patient instructed to contact their health care provider if one or more of these symptoms develop. If symptoms are severe, seek immediate medical attention at the closest emergency department or call 9-1-1
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash erythematous, Seizure, Skin lesion
Clinical narrative: Narrative: Patient states rash present for 3-4 weeks "from neck down" described as "itching" especially at night "red bumpy rash scattered from neck down has areas on abd, involvement of groins anterior and posterior knees and has had lesions between his fingers" Patient instructed to monitor for the following symptoms over the course of three weeks after the vaccination. * A headache that occurs 6 days or more after vaccination * A headache that is different from other headaches you have had * Confusion or trouble thinking clearly * Visual changes, such as blurry vision * Weakness, numbness, or trouble moving one or more parts of your body of your body, trouble speaking or seizures * Tiny spots under the skin away from the area where you had the infection (this is a sign of low platelets) Patient instructed to contact their health care provider if one or more of these symptoms develop. If symptoms are severe, seek immediate medical attention at the closest emergency department or call 9-1-1
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Speech disorder, Thinking abnormal, Vision blurred, Visual impairment
Clinical narrative: Narrative: Patient states rash present for 3-4 weeks "from neck down" described as "itching" especially at night "red bumpy rash scattered from neck down has areas on abd, involvement of groins anterior and posterior knees and has had lesions between his fingers" Patient instructed to monitor for the following symptoms over the course of three weeks after the vaccination. * A headache that occurs 6 days or more after vaccination * A headache that is different from other headaches you have had * Confusion or trouble thinking clearly * Visual changes, such as blurry vision * Weakness, numbness, or trouble moving one or more parts of your body of your body, trouble speaking or seizures * Tiny spots under the skin away from the area where you had the infection (this is a sign of low platelets) Patient instructed to contact their health care provider if one or more of these symptoms develop. If symptoms are severe, seek immediate medical attention at the closest emergency department or call 9-1-1
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Asthenia, COVID-19, Confusional state, Deep vein thrombosis
Clinical narrative: Narrative: Patient reports no signs and symptoms currently from the vaccine. Patient instructed to monitor for the following symptoms over the course of three weeks after the vaccination. *A headache that occurs 6 days or more after vaccination * A headache that is different from other headaches you have had * Confusion or trouble thinking clearly * Visual changes, such as blurry vision * Weakness, numbness, or trouble moving one or move parts of your body of your body, trouble speaking or seizures * Tiny spots under the skin away from the area where you have the infection (this is a sign of low platelets) Patient instructed to contact their health care provider if one or more of these symptoms develop. If symptoms are severe, seek immediate medical attention at the closest emergency department or call 9-1-1 **** Patient answered phone very short of breath. He had his wife talk on the phone for him. Wife stated that he had been in the hospital for COVID-19 with dx of DVT, and bilat PE's prior to receiving the vaccine. She stated he is on blood thinners and has concerns about his recent blood clots and the potential of additional blood clots from the vaccine. She stated that he has some confusion and trouble thinking but it has been like that since he had COVID and does not know if there would be a change with the vaccine. Patient has appointment with PCP tomorrow @ 1100. Patient and wife will discuss further with PCP of their concerns. Patients wife advised that if there are any changes or any increased SOB she is to call 911 or go to the closest emergency department
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Hypoaesthesia, Infection, Mental impairment
Clinical narrative: Narrative: Patient reports no signs and symptoms currently from the vaccine. Patient instructed to monitor for the following symptoms over the course of three weeks after the vaccination. *A headache that occurs 6 days or more after vaccination * A headache that is different from other headaches you have had * Confusion or trouble thinking clearly * Visual changes, such as blurry vision * Weakness, numbness, or trouble moving one or move parts of your body of your body, trouble speaking or seizures * Tiny spots under the skin away from the area where you have the infection (this is a sign of low platelets) Patient instructed to contact their health care provider if one or more of these symptoms develop. If symptoms are severe, seek immediate medical attention at the closest emergency department or call 9-1-1 **** Patient answered phone very short of breath. He had his wife talk on the phone for him. Wife stated that he had been in the hospital for COVID-19 with dx of DVT, and bilat PE's prior to receiving the vaccine. She stated he is on blood thinners and has concerns about his recent blood clots and the potential of additional blood clots from the vaccine. She stated that he has some confusion and trouble thinking but it has been like that since he had COVID and does not know if there would be a change with the vaccine. Patient has appointment with PCP tomorrow @ 1100. Patient and wife will discuss further with PCP of their concerns. Patients wife advised that if there are any changes or any increased SOB she is to call 911 or go to the closest emergency department
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Movement disorder, Platelet count decreased, Rash macular, Seizure, Speech disorder
Clinical narrative: Narrative: Patient reports no signs and symptoms currently from the vaccine. Patient instructed to monitor for the following symptoms over the course of three weeks after the vaccination. *A headache that occurs 6 days or more after vaccination * A headache that is different from other headaches you have had * Confusion or trouble thinking clearly * Visual changes, such as blurry vision * Weakness, numbness, or trouble moving one or move parts of your body of your body, trouble speaking or seizures * Tiny spots under the skin away from the area where you have the infection (this is a sign of low platelets) Patient instructed to contact their health care provider if one or more of these symptoms develop. If symptoms are severe, seek immediate medical attention at the closest emergency department or call 9-1-1 **** Patient answered phone very short of breath. He had his wife talk on the phone for him. Wife stated that he had been in the hospital for COVID-19 with dx of DVT, and bilat PE's prior to receiving the vaccine. She stated he is on blood thinners and has concerns about his recent blood clots and the potential of additional blood clots from the vaccine. She stated that he has some confusion and trouble thinking but it has been like that since he had COVID and does not know if there would be a change with the vaccine. Patient has appointment with PCP tomorrow @ 1100. Patient and wife will discuss further with PCP of their concerns. Patients wife advised that if there are any changes or any increased SOB she is to call 911 or go to the closest emergency department