chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; administered dose of Moderna Primary vaccine that was expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered dose of Moderna Primary vaccine that was expired) and NO ADVERSE EVENT (No adverse event) in a 45-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 055A22A and 055A22A) for COVID-19 prophylaxis.     Patient did not received any other vaccines in the four weeks prior to COVID-19 vaccine.  The patient's past medical history included Sepsis and Anxiety. Concurrent medical conditions included Drug allergy (Allergic to hydroxyzine) and Seizures.   On 25-Jan-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Feb-2023, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered dose of Moderna Primary vaccine that was expired). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered dose of Moderna Primary vaccine that was expired) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered dose of Moderna Primary vaccine that was expired).    No concomitant information was reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-714215 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Mar-2023: Live follow information contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714215:Same reporter
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Atrial fibrillation, Cardiac pharmacologic stress test, Condition aggravated, Electrocardiogram ambulatory, Ultrasound Doppler
Clinical narrative: In November I had an A-fib episode that did not last very long, about a day or two. I made an appointment to see my Electrophysiologist who ran a twenty-four hour Holter monitor, an ultrasound of my aorta. Persantine stress test. I am currently awaiting the results of all the test. My doctor has chosen to keep me on the current strength and dosage of all medications.
Age: 66.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: COVID-19, Ear pain, Nasopharyngitis, Oropharyngeal pain, Pain
Clinical narrative: I tested positive for COVID-19 on 12/10/2022. It started with body aches and the feeling of a head cold. At the peak of the symptoms, I had severe sore throat and I felt that in my ear drums. I was prescribed Paxlovid and took that. By the end of the dosage, I felt better.
Age: 66.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I tested positive for COVID-19 on 12/10/2022. It started with body aches and the feeling of a head cold. At the peak of the symptoms, I had severe sore throat and I felt that in my ear drums. I was prescribed Paxlovid and took that. By the end of the dosage, I felt better.
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cough, Headache, Influenza, Oropharyngeal pain, Pain
Clinical narrative: My Flu symptoms started on 12/21/2022 not sure what time of the day. I had sore throat, cough, runny nose, bad headaches, fever 102, chest congestions and body aches course of couple of days. On 12/28/2022 I went to the primary care office. The doctor prescribed me with an inhaler (fluticasone) and benzonatate. My cough was very intense.
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test negative
Clinical narrative: My Flu symptoms started on 12/21/2022 not sure what time of the day. I had sore throat, cough, runny nose, bad headaches, fever 102, chest congestions and body aches course of couple of days. On 12/28/2022 I went to the primary care office. The doctor prescribed me with an inhaler (fluticasone) and benzonatate. My cough was very intense.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Computerised tomogram head, Differential white blood cell count, Fatigue, Full blood count
Clinical narrative: Severe headaches, bodyaches, nausea vomiting and weakness persisting beyond the typical 2-3 days post vaccination. Today 3/9/2023, she is reporting progressive weakness in lower extremity, headache has improved and very fatigued in the second half of the day. She went to the ED on 02/27/2023 had investigations and imaging studies that were not conclusive. I have recommended that she goes to the ED ASAP again today to rule out Guillian Barre syndrome given the progressive weakness
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza A virus test, Influenza B virus test, Metabolic function test, Muscular weakness
Clinical narrative: Severe headaches, bodyaches, nausea vomiting and weakness persisting beyond the typical 2-3 days post vaccination. Today 3/9/2023, she is reporting progressive weakness in lower extremity, headache has improved and very fatigued in the second half of the day. She went to the ED on 02/27/2023 had investigations and imaging studies that were not conclusive. I have recommended that she goes to the ED ASAP again today to rule out Guillian Barre syndrome given the progressive weakness
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, SARS-CoV-2 test, Urine analysis, Vomiting
Clinical narrative: Severe headaches, bodyaches, nausea vomiting and weakness persisting beyond the typical 2-3 days post vaccination. Today 3/9/2023, she is reporting progressive weakness in lower extremity, headache has improved and very fatigued in the second half of the day. She went to the ED on 02/27/2023 had investigations and imaging studies that were not conclusive. I have recommended that she goes to the ED ASAP again today to rule out Guillian Barre syndrome given the progressive weakness
Age: 11.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient presented for 11 year well child visit.  Patient was supposed to get HPV, TDAP and Menveo.  Patient was given a Bexsero instead of Boostrix.  No adverse reactions noted.
Age: 72.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Asthenia, Atrial fibrillation, COVID-19, Condition aggravated, Cough
Clinical narrative: I was supposed to go for a colonoscopy that day, but I woke up with my heart racing and difficulty breathing. I recognized it as the symptoms of atrial fibrillation. At about 8 AM, I took about 30 mg of diltiazem. I took another at 8:30AM and another at 9:00AM, but they had no effect. I went to the ER, and an EKG was taken right away. The EKG verified that I had atrial fibrillation. They then put me in one of the room and monitored my situation. The doctor ordered a larger dose of diltiazem, which didn't have any effect. I was then given metoprolol, which got my atrial fibrillation down from 158 BPM to about 94 BPM. While I was there, a routine COVID-19 test was done, and the result was positive. I didn't have any symptoms, so this was a surprise. I was discharged at about 1:00 PM. I then went home. I had a telehealth visit with a doctor, who prescribed me PAXLOVID. I began taking it that day and took it for five days. The following Thursday, I began to have COVID-19 symptoms that included sinus congestion and coughing. I also had continuous atrial fibrillation. I felt weak and lethargic and generally awful. I tested negative on the following Sunday, 2/26/2023. I began to feel better. I still had atrial fibrillation, though, so I scheduled an appointment to see a cardiologist, which was on 3/6/2023. He has scheduled an echocardiogram for me in the near future, and he would like to perform a catheter ablation. At the time of this writing, the atrial fibrillation continues.
Age: 72.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Dyspnoea, Electrocardiogram abnormal, Feeling abnormal, Lethargy, Malaise
Clinical narrative: I was supposed to go for a colonoscopy that day, but I woke up with my heart racing and difficulty breathing. I recognized it as the symptoms of atrial fibrillation. At about 8 AM, I took about 30 mg of diltiazem. I took another at 8:30AM and another at 9:00AM, but they had no effect. I went to the ER, and an EKG was taken right away. The EKG verified that I had atrial fibrillation. They then put me in one of the room and monitored my situation. The doctor ordered a larger dose of diltiazem, which didn't have any effect. I was then given metoprolol, which got my atrial fibrillation down from 158 BPM to about 94 BPM. While I was there, a routine COVID-19 test was done, and the result was positive. I didn't have any symptoms, so this was a surprise. I was discharged at about 1:00 PM. I then went home. I had a telehealth visit with a doctor, who prescribed me PAXLOVID. I began taking it that day and took it for five days. The following Thursday, I began to have COVID-19 symptoms that included sinus congestion and coughing. I also had continuous atrial fibrillation. I felt weak and lethargic and generally awful. I tested negative on the following Sunday, 2/26/2023. I began to feel better. I still had atrial fibrillation, though, so I scheduled an appointment to see a cardiologist, which was on 3/6/2023. He has scheduled an echocardiogram for me in the near future, and he would like to perform a catheter ablation. At the time of this writing, the atrial fibrillation continues.
Age: 72.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Palpitations, SARS-CoV-2 test positive, Sinus congestion
Clinical narrative: I was supposed to go for a colonoscopy that day, but I woke up with my heart racing and difficulty breathing. I recognized it as the symptoms of atrial fibrillation. At about 8 AM, I took about 30 mg of diltiazem. I took another at 8:30AM and another at 9:00AM, but they had no effect. I went to the ER, and an EKG was taken right away. The EKG verified that I had atrial fibrillation. They then put me in one of the room and monitored my situation. The doctor ordered a larger dose of diltiazem, which didn't have any effect. I was then given metoprolol, which got my atrial fibrillation down from 158 BPM to about 94 BPM. While I was there, a routine COVID-19 test was done, and the result was positive. I didn't have any symptoms, so this was a surprise. I was discharged at about 1:00 PM. I then went home. I had a telehealth visit with a doctor, who prescribed me PAXLOVID. I began taking it that day and took it for five days. The following Thursday, I began to have COVID-19 symptoms that included sinus congestion and coughing. I also had continuous atrial fibrillation. I felt weak and lethargic and generally awful. I tested negative on the following Sunday, 2/26/2023. I began to feel better. I still had atrial fibrillation, though, so I scheduled an appointment to see a cardiologist, which was on 3/6/2023. He has scheduled an echocardiogram for me in the near future, and he would like to perform a catheter ablation. At the time of this writing, the atrial fibrillation continues.
Age: 54.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cough, Fatigue, Lower respiratory tract infection, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: After a family gathering on 12/26/2022 following evening I began having symptoms of a chest cold. Following day I developed a minor sore throat with congestion that lasted several days. After the congestion and sore throat subsided but I was still felt the chest cold. I started feeling better for a week, then 1 week later started feeling fatigue and the chest cold again. Had appointment with online urgent care doctor and was prescribed prednisone, albuterol inhaler, and ADVAIR inhaler and a ZPAK. Only took ZPAK and ADVAIR inhaler. Started feeling better after 5 day course of ZPAK, but was left with a dry cough.
Age: 31.0
Sex: M
Vaccine: COVID19-2
Symptoms: Audiogram abnormal, Deafness neurosensory, Deafness unilateral, Sudden hearing loss
Clinical narrative: Developed Sudden Sensorineural Hearing Loss (SSHL). Lost more than 30 decibels in the right ear for 3 consecutive frequencies. Started taking prednisone orally and started hyperbaric oxygen treatment. So far no resolution...
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: Ageusia, Anosmia, Arthritis, COVID-19, Inflammation
Clinical narrative: I am experiencing left leg pain from my thigh down to my shin. It has gotten progressively worse over time. I had an x-ray and a nerve conduction test which verified I had a pinched L4 and L5 nerve due to inflation. My primary doctor sent me to an orthopedic doctor who wants to conduct an MRI. My orthopedic doctor prescribed me an anti-inflammatory drug. I also caught COVID-19 in November of 2022. I experienced all upper respiratory symptoms. I lost my taste and smell but slowly regained them both over time.
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: Nerve compression, Nerve conduction studies abnormal, Pain in extremity, Respiratory symptom, X-ray abnormal
Clinical narrative: I am experiencing left leg pain from my thigh down to my shin. It has gotten progressively worse over time. I had an x-ray and a nerve conduction test which verified I had a pinched L4 and L5 nerve due to inflation. My primary doctor sent me to an orthopedic doctor who wants to conduct an MRI. My orthopedic doctor prescribed me an anti-inflammatory drug. I also caught COVID-19 in November of 2022. I experienced all upper respiratory symptoms. I lost my taste and smell but slowly regained them both over time.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: none.  I was alerted that because the child was 14 days shy of being 6, it was considered an adverse event to have given him the Moderna for age 6-11.  He is fine, no problems whatsoever.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: no adverse event, I received an email that because the child was 14 days short of being 6, but was given the Moderna for ages 6-11, this was considered an adverse event.  The child is fine, no problems whatsoever.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19 pneumonia, Cardiac failure congestive, SARS-CoV-2 test positive
Clinical narrative: Patient received Pfizer COVID vaccine on 2/12/21 and 3/9/21. On 2/28/23, patient admitted to our inpatient facility (med/surg unit) with acute hypoxic respiratory failure secondary to acute CHF and COVID-19 pneumonia. Patient discharged home on 3/6/23.
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema, Food allergy, Milk allergy, Paraesthesia, Pruritus
Clinical narrative: After receiving my last dose of Moderna Bivalent, within the same month. I had hives all over body. It was red, tingling sensation, red, and itchy. On 11/19/2022 I went to my doctor who prescribed me steroids, levocetirizine, and EPIPEN. My doctor also did an allergy test which stated that I have allergic reaction to dairy products and specific vegetables. He referred me to an allergist. I went to the allergist on 12/19/2022. He repeated the same and it was ruled out that I had allergic reactions to dairy products and specific vegetables which they provided a list for. They advised me to follow the list. I also went to the dermatologist for the hives I was experiencing on 11/04/2022. She prescribed me with a steroid cream but it didn't help much. As this time I am just using the medication my doctor has provided and I am also trying to avoid dairy and vegetables. The steroid made my Thyroid levels up according to my doctor. As of now I am waiting for my annual check up so I can get my test repeated again to check for Thyroid level. I never had anything like before but it all started after getting my last Moderna Bivalent COVID-19 booster shot.
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test negative, Urticaria
Clinical narrative: After receiving my last dose of Moderna Bivalent, within the same month. I had hives all over body. It was red, tingling sensation, red, and itchy. On 11/19/2022 I went to my doctor who prescribed me steroids, levocetirizine, and EPIPEN. My doctor also did an allergy test which stated that I have allergic reaction to dairy products and specific vegetables. He referred me to an allergist. I went to the allergist on 12/19/2022. He repeated the same and it was ruled out that I had allergic reactions to dairy products and specific vegetables which they provided a list for. They advised me to follow the list. I also went to the dermatologist for the hives I was experiencing on 11/04/2022. She prescribed me with a steroid cream but it didn't help much. As this time I am just using the medication my doctor has provided and I am also trying to avoid dairy and vegetables. The steroid made my Thyroid levels up according to my doctor. As of now I am waiting for my annual check up so I can get my test repeated again to check for Thyroid level. I never had anything like before but it all started after getting my last Moderna Bivalent COVID-19 booster shot.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain
Clinical narrative: Per Message: "Hi. I'm reaching out to ask if there were any concerns to headaches post vax. I got the shot on Sun, Mon I laid it bed from achiness, and am now feeling better. Although I'm still experiencing persistent headaches that I continue to take ibuprofen for. I'm going to monitor them but wanted to at least highlight this as a symptom. Thanks!"
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, COVID-19 pneumonia, Pneumonia, SARS-CoV-2 test positive
Clinical narrative: Patient received Moderna COVID vaccine on 3/27/21, 4/23/21, 11/13/21, and 6/6/22. On 3/3/23, patient admitted to our inpatient facility (med/surg unit) with acute respiratory failure with hypoxia, community acquired and COVID-19 pneumonia. Patient discharged home on 3/7/23.
Age: 4.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: Pt was given undiluted Pfizer bivalent vaccine for 6month-4years. Pt experienced no adverse events.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, COVID-19, Chest discomfort, Chest pain
Clinical narrative: When I got the shot, I had no reaction to it at all, and I felt fine. At the end of July or beginning of August 2021, I didn't feel well. When I woke one morning, I had a headache, my eyes were puffy and kind of achy, and my throat felt dry and scratchy. As the day progressed, I felt tired, and my nose began to feel stopped up. At that point, I thought I felt like I had a fever, but I took my temperature, and it was normal. I took some BENADRYL and ALEVE before going to bed that night. When I woke up the next morning, I felt even worse. It felt like my body was fighting the flu. I still had a headache, my nose was stuffier, and I was tired and achy. My voice was dry and scratchy, and my voice began cracking. It was then that I decided to get myself checked. I went to a pharmacy and underwent a PCR COVID-19 test, and the result was positive. I isolated myself from my husband and son for ten days. I immediately started doing breathing exercises in the hope that they would help me. I called my doctor, and she basically told me to take vitamin C and go to the ER if I couldn't breathe. I never developed a cough, but one night my chest felt tight and burned, and I thought that I might develop a cough. It was gone the next day, though. I also began to have stomach cramps and diarrhea, which lasted for two days and were probably the worst part of having COVID-19. I never had a fever during the daytime, but during the last couple of nights of my illness, I had a fever that never reached above 100 degrees. By the time I came out of my ten-day isolation, I felt fine. I underwent another PCR test on 8/13/2021 and got a negative result. It took a few months for me to regain my normal energy levels, though.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dry throat, Dysphonia, Fatigue, Headache
Clinical narrative: When I got the shot, I had no reaction to it at all, and I felt fine. At the end of July or beginning of August 2021, I didn't feel well. When I woke one morning, I had a headache, my eyes were puffy and kind of achy, and my throat felt dry and scratchy. As the day progressed, I felt tired, and my nose began to feel stopped up. At that point, I thought I felt like I had a fever, but I took my temperature, and it was normal. I took some BENADRYL and ALEVE before going to bed that night. When I woke up the next morning, I felt even worse. It felt like my body was fighting the flu. I still had a headache, my nose was stuffier, and I was tired and achy. My voice was dry and scratchy, and my voice began cracking. It was then that I decided to get myself checked. I went to a pharmacy and underwent a PCR COVID-19 test, and the result was positive. I isolated myself from my husband and son for ten days. I immediately started doing breathing exercises in the hope that they would help me. I called my doctor, and she basically told me to take vitamin C and go to the ER if I couldn't breathe. I never developed a cough, but one night my chest felt tight and burned, and I thought that I might develop a cough. It was gone the next day, though. I also began to have stomach cramps and diarrhea, which lasted for two days and were probably the worst part of having COVID-19. I never had a fever during the daytime, but during the last couple of nights of my illness, I had a fever that never reached above 100 degrees. By the time I came out of my ten-day isolation, I felt fine. I underwent another PCR test on 8/13/2021 and got a negative result. It took a few months for me to regain my normal energy levels, though.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise, Nasal congestion, Pain, Periorbital swelling
Clinical narrative: When I got the shot, I had no reaction to it at all, and I felt fine. At the end of July or beginning of August 2021, I didn't feel well. When I woke one morning, I had a headache, my eyes were puffy and kind of achy, and my throat felt dry and scratchy. As the day progressed, I felt tired, and my nose began to feel stopped up. At that point, I thought I felt like I had a fever, but I took my temperature, and it was normal. I took some BENADRYL and ALEVE before going to bed that night. When I woke up the next morning, I felt even worse. It felt like my body was fighting the flu. I still had a headache, my nose was stuffier, and I was tired and achy. My voice was dry and scratchy, and my voice began cracking. It was then that I decided to get myself checked. I went to a pharmacy and underwent a PCR COVID-19 test, and the result was positive. I isolated myself from my husband and son for ten days. I immediately started doing breathing exercises in the hope that they would help me. I called my doctor, and she basically told me to take vitamin C and go to the ER if I couldn't breathe. I never developed a cough, but one night my chest felt tight and burned, and I thought that I might develop a cough. It was gone the next day, though. I also began to have stomach cramps and diarrhea, which lasted for two days and were probably the worst part of having COVID-19. I never had a fever during the daytime, but during the last couple of nights of my illness, I had a fever that never reached above 100 degrees. By the time I came out of my ten-day isolation, I felt fine. I underwent another PCR test on 8/13/2021 and got a negative result. It took a few months for me to regain my normal energy levels, though.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Throat irritation
Clinical narrative: When I got the shot, I had no reaction to it at all, and I felt fine. At the end of July or beginning of August 2021, I didn't feel well. When I woke one morning, I had a headache, my eyes were puffy and kind of achy, and my throat felt dry and scratchy. As the day progressed, I felt tired, and my nose began to feel stopped up. At that point, I thought I felt like I had a fever, but I took my temperature, and it was normal. I took some BENADRYL and ALEVE before going to bed that night. When I woke up the next morning, I felt even worse. It felt like my body was fighting the flu. I still had a headache, my nose was stuffier, and I was tired and achy. My voice was dry and scratchy, and my voice began cracking. It was then that I decided to get myself checked. I went to a pharmacy and underwent a PCR COVID-19 test, and the result was positive. I isolated myself from my husband and son for ten days. I immediately started doing breathing exercises in the hope that they would help me. I called my doctor, and she basically told me to take vitamin C and go to the ER if I couldn't breathe. I never developed a cough, but one night my chest felt tight and burned, and I thought that I might develop a cough. It was gone the next day, though. I also began to have stomach cramps and diarrhea, which lasted for two days and were probably the worst part of having COVID-19. I never had a fever during the daytime, but during the last couple of nights of my illness, I had a fever that never reached above 100 degrees. By the time I came out of my ten-day isolation, I felt fine. I underwent another PCR test on 8/13/2021 and got a negative result. It took a few months for me to regain my normal energy levels, though.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, COVID-19, COVID-19 pneumonia, Leukocytosis, SARS-CoV-2 test positive
Clinical narrative: Patient received Moderna COVID vaccine on 1/20/21, 2/15/21, 11/23/21, and Moderna bivalent COVID vaccine on 1/31/23. On 3/3/23, patient admitted to our inpatient facility (med/surg unit) with acute hypoxic respiratory failure, COVID pneumonia, and leukocytosis. Patient discharged home on 3/8/23.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dyspnoea
Clinical narrative: Difficulty breathing, said later that month she would end up going to the ER for difficulty breathing
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, COVID-19, Chronic obstructive pulmonary disease, Condition aggravated, SARS-CoV-2 test positive
Clinical narrative: Patient received Moderna COVID vaccine on 2/26/21, 3/26/21, 10/27/21, 4/28/22, and Moderna Bivalent COVID vaccine on 10/29/22. On 3/4/23, patient admitted to our inpatient facility (med/surg unit) with acute respiratory failure with hypoxia due to COPD exacerbation and COVID infection/bronchitis. As of today (3/9/23), patient is still admitted in the med/surg unit.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Patient came to pharmacy to get her first dose of the Primary series of Moderna. We entered the prescription as the adult dose, but we unfortunately gave her 0.5mls of the Moderna Toddler 3-5 years vaccine. The patient has not at this time had any adverse reaction.
Age: 11.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: This nurse administered a Bivalent Pfizer vaccine that was 13 days past the use by date.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Body temperature increased, Extra dose administered, Full blood count normal, Laboratory test normal, Neutropenia
Clinical narrative: Patient diagnosed with chronic neutropenia first noted 2/15/18 which is approximately 2 months after 6 month shots. Family also expresses concern since extra dose (4 total) of hepatitis B given as also received infant birth dose along with 2, 4, and 6 month pediarix.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Neutrophil count decreased, Rash
Clinical narrative: Patient diagnosed with chronic neutropenia first noted 2/15/18 which is approximately 2 months after 6 month shots. Family also expresses concern since extra dose (4 total) of hepatitis B given as also received infant birth dose along with 2, 4, and 6 month pediarix.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Oropharyngeal pain
Clinical narrative: chilling, headache, sore throat.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Atrial fibrillation, Cardiac arrest, Cardiomyopathy, Cardioversion, Dyspnoea
Clinical narrative: Patient had a cardiac arrest.  There were no symptoms prior to, no history of heart issues, no high blood pressure, or any known cause for the cardiac arrest.  He passed his routine physical exam a week before the event.  During the event, patient's heart stopped.  He was gasping for air for a few seconds, then collapsed.  CPR and shock treatment with an AED were performed to restart his heart.  When paramedics arrived, they continued treatment.  Since the event, he has developed heart atrial fibrillation and cardiomyopathy.    Patient is on a number of new medications, has installed a defibrillator, and has been recommended for shock treatment to restore normal heart rhythm.  He will have 12 weeks of cardiac rehab.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Implantable defibrillator insertion, Multiple gated acquisition scan abnormal, Resuscitation, Syncope
Clinical narrative: Patient had a cardiac arrest.  There were no symptoms prior to, no history of heart issues, no high blood pressure, or any known cause for the cardiac arrest.  He passed his routine physical exam a week before the event.  During the event, patient's heart stopped.  He was gasping for air for a few seconds, then collapsed.  CPR and shock treatment with an AED were performed to restart his heart.  When paramedics arrived, they continued treatment.  Since the event, he has developed heart atrial fibrillation and cardiomyopathy.    Patient is on a number of new medications, has installed a defibrillator, and has been recommended for shock treatment to restore normal heart rhythm.  He will have 12 weeks of cardiac rehab.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash papular, Skin reaction, Urticaria chronic
Clinical narrative: I HAVE URTICARIA OFF AND ON SINCE I GOT THE 3 BOOSTER. I WAS DOING FINE WITH THE FIRST 2 DOSES, THE THIRD WAS TAKEN AT PHARMACY STORE. THIS URTICARIA BECAME CHRONIC AND I GET HIVES URTICARIAL PAPULES OFF AND ON, SUDDENLY SHOWS UP CAUSING LOCALIZED SYMPTOMS.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: RASH SYSTEMIC, ITCHNESS, REDNESS (FACE AND ALL OVER)
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash
Clinical narrative: Rash torso and legs
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: Felt like brain was on fire for around 10 hours.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Disability, Eczema, Insomnia, Loss of personal independence in daily activities, Pruritus
Clinical narrative: I developed a severe intensely itchy rash on my left arm. It spread to my right arm about two weeks later. Nothing over the counter helped. I tried ice and it helped calm down the itching some.  I have been to my regular doctor who prescribed cortisone shots and creams. That did not work. I finally went to a dermatologist who diagnosed me with eczema and she has been trying different things but so far nothing has stopped the itching. The medications I have tried are very expensive and I am disabled. The itching keeps me awake at night and it is very difficult if not impossible to get a good night's sleep. I am not able to do most things that I did before I got the eczema.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Sleep disorder
Clinical narrative: I developed a severe intensely itchy rash on my left arm. It spread to my right arm about two weeks later. Nothing over the counter helped. I tried ice and it helped calm down the itching some.  I have been to my regular doctor who prescribed cortisone shots and creams. That did not work. I finally went to a dermatologist who diagnosed me with eczema and she has been trying different things but so far nothing has stopped the itching. The medications I have tried are very expensive and I am disabled. The itching keeps me awake at night and it is very difficult if not impossible to get a good night's sleep. I am not able to do most things that I did before I got the eczema.
Age: 23.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Diarrhoea, Nausea, Vaccination site rash, Vomiting
Clinical narrative: Moderate Nausea, Vomiting and Diarrhea. Pt also had rash in the area of vaccination.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia oral, Vertigo
Clinical narrative: The night after the vaccine I experienced dizziness and numbness in my lips. To this day my lips are still numb and I am still suffering with vertigo. I don?t know if this was from the vaccine, but I was a perfectly healthy 44 year old before I had the vaccine. I never had any issues with vertigo before that night.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac stress test, Echocardiogram, Electrocardiogram abnormal
Clinical narrative: A Fib - starting ? date April. [May 28, 2022 & saw substitute Dr. who said heart sounded OK] continued to worsen & by Nov 8, 2022 Dr EKG abnormal & referred to Heart Dr. ECG done & Stress test done 12/8/22
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Allergy to vaccine, Hypersensitivity, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: On 3-8-23 pt. mom called to report pt. was sent home from school due to pain, redness, swelling, and injection site hot to touch Due to lack of appt. availability advised to be seen at urgent care/ER ASAP. Pt. mom reports pain, redness, swelling at injection site started on 3-7-23, the day after Fluzone was given.  Pt. was seen in urgent care center on 3-8-23, was diagnosed with an allergic reaction to vaccine. No medications were prescribed during ER visit. Pt. seen for ER follow-up on 3-9-23, Pt. mom denies any fever, chills, fatigue, lethargy in pt. Clarified pt. injection site was warm to the touch & red. Provider explained to pt. mom pt. had a normal response to injection site caused by trauma to muscle as it's an IM injection. No allergy to Fluzone. Advised to apple warm compress to area & use Children's Tylenol for pain.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site warmth, Loss of personal independence in daily activities, Muscle injury
Clinical narrative: On 3-8-23 pt. mom called to report pt. was sent home from school due to pain, redness, swelling, and injection site hot to touch Due to lack of appt. availability advised to be seen at urgent care/ER ASAP. Pt. mom reports pain, redness, swelling at injection site started on 3-7-23, the day after Fluzone was given.  Pt. was seen in urgent care center on 3-8-23, was diagnosed with an allergic reaction to vaccine. No medications were prescribed during ER visit. Pt. seen for ER follow-up on 3-9-23, Pt. mom denies any fever, chills, fatigue, lethargy in pt. Clarified pt. injection site was warm to the touch & red. Provider explained to pt. mom pt. had a normal response to injection site caused by trauma to muscle as it's an IM injection. No allergy to Fluzone. Advised to apple warm compress to area & use Children's Tylenol for pain.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Rash
Clinical narrative: Client, 4 month old, received Pediarix( DtaP, Ipv, Hep B), PCV13, and Hib. No reaction observed at the time when vaccine given. Mother of child reported that client started with rash on torso, arms and legs. No respiratory distressed observed. Symptoms re-evaluated and rash started to diminish. EMT called per clinic protocol. Transferred care at the time of arrival.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pt DOB was altered @ registration & passed verbal and written verification. Guardian stated the 11-year old was 18 years old.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Urticaria
Clinical narrative: Patients mom reported hives and swelling in hands/arms.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Paraesthesia, Paraesthesia oral, Swollen tongue
Clinical narrative: 1 HR AFTER RECEIVING THE J&J COVID-19 VACCINE PATIENT STARTED FEELING TINGLING IN LIPS. IT PROGRESSED THROUGH THE DAT TO TINGLING DOWN THE ARMS, LIP AND TONGUE SWELLING AND ABDOMINAL PAIN. PATIENT CALLED TO REPORT THE ADVERSE EVENT AT 10AM ON 18/18/2021 AND INDICATED HE DID NOT TAKE ANYHTING AND REMAINED AT HOMW, HE INDICATED HE THOUGHT THE SWELLING WAS GOING DOWN BUT COULD STILL FEEL HE WAS NOT BACK TO NORMAL. PATIENT WAS INSTRUCTED TO NOTIFY HIS PCP, TAKE BENADRYL AND CALL EMS IF EMERGENT SYMPTOMS PRESENTED (SOB, CHEST PAIN, SEVERE SWELLING). PATIENT WAS ALSO INSTRUCTED TO GO TO URGENT CARE IF SYMPTOMS DO NOT GET BETTER OR THEY GET WORSE BY THE AFTERNOON.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: pt Received dose of pFizer (child agitated-did not want vaccine). Staff went over to assist & gave syringe of medicine on Table Next to child (syringe by other nurse & was placed Next to pediatric pfizer vial) Staff Received pt info sheet from other who was vaccinating children)- parent informed.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Deep vein thrombosis, Fibrin D dimer increased, Ultrasound Doppler abnormal
Clinical narrative: Elevated D Dimer noted on routine visit to hematologist. DVT in LT calf confirmed by doppler study. Started taking Xarelto and continues to take Xarelto 20mg QD at present
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Mononucleosis heterophile test negative, Pain, Pyrexia, Rash
Clinical narrative: Normal symptoms of fever, body aches, and fatigue occurred the first 48 hours after vaccine was administered. Then and itchy, red, patchy rash appeared on patient's neck and spread over entire body over the course of several hours. The rash included patient's scalp, face, neck, thorax, abdomen, arms, legs, hands, and feet. The rash lasted approximately 48 hours. Benadryl and singulair were taken to help with symptoms. Patient ran a 100.7 degree fever for several hours about 24 hours after rash appeared.  Additional information: Patient did not have a rash after her 1st two Covid vaccines from Moderna. On difference was patient was on singulair daily when given 1st two vaccine doses & was not on singulair when 43rd dose was received.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic, Streptococcus test negative
Clinical narrative: Normal symptoms of fever, body aches, and fatigue occurred the first 48 hours after vaccine was administered. Then and itchy, red, patchy rash appeared on patient's neck and spread over entire body over the course of several hours. The rash included patient's scalp, face, neck, thorax, abdomen, arms, legs, hands, and feet. The rash lasted approximately 48 hours. Benadryl and singulair were taken to help with symptoms. Patient ran a 100.7 degree fever for several hours about 24 hours after rash appeared.  Additional information: Patient did not have a rash after her 1st two Covid vaccines from Moderna. On difference was patient was on singulair daily when given 1st two vaccine doses & was not on singulair when 43rd dose was received.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Dizziness, Headache, Nausea, Vomiting
Clinical narrative: Extreme dizziness, bad Headache, Nausea, Extreme Vomiting for 3 days (7-9 times per day) Water,  banana, applesauce was only consumed on 4th day. Adverse reaction lasted total for 5 days.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood folate normal, Blood test normal, Blood thyroid stimulating hormone normal, Gait disturbance
Clinical narrative: Transverse myelltis at about the T4 level characterized by sensory and motor disturbance and palpable tenderness at about the T4 spine in the midline. Clinically she was otherwise healthy, although obese and has had a gastric sleeve procedure in the recent past. She is continent of bowel and bladder, but since 1 sep 2021 she has had progressive motor weakness which makes it difficult walking up stairs and she sometime stumbles.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head normal, Magnetic resonance imaging spinal normal, Metabolic function test normal, Motor dysfunction, Myelitis transverse
Clinical narrative: Transverse myelltis at about the T4 level characterized by sensory and motor disturbance and palpable tenderness at about the T4 spine in the midline. Clinically she was otherwise healthy, although obese and has had a gastric sleeve procedure in the recent past. She is continent of bowel and bladder, but since 1 sep 2021 she has had progressive motor weakness which makes it difficult walking up stairs and she sometime stumbles.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Red blood cell sedimentation rate normal, Scan with contrast normal, Sensory disturbance, Serology test, Tenderness
Clinical narrative: Transverse myelltis at about the T4 level characterized by sensory and motor disturbance and palpable tenderness at about the T4 spine in the midline. Clinically she was otherwise healthy, although obese and has had a gastric sleeve procedure in the recent past. She is continent of bowel and bladder, but since 1 sep 2021 she has had progressive motor weakness which makes it difficult walking up stairs and she sometime stumbles.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vitamin B12 normal
Clinical narrative: Transverse myelltis at about the T4 level characterized by sensory and motor disturbance and palpable tenderness at about the T4 spine in the midline. Clinically she was otherwise healthy, although obese and has had a gastric sleeve procedure in the recent past. She is continent of bowel and bladder, but since 1 sep 2021 she has had progressive motor weakness which makes it difficult walking up stairs and she sometime stumbles.
Age: 18.0
Sex: M
Vaccine: COVID19-2
Symptoms: Abdominal pain, Full blood count, Metabolic function test, Red blood cell sedimentation rate, Stool analysis
Clinical narrative: abdominal pain with intermittent emesis most of the time since vaccin
Age: 18.0
Sex: M
Vaccine: COVID19-2
Symptoms: Vomiting
Clinical narrative: abdominal pain with intermittent emesis most of the time since vaccin
Sex: U
Vaccine: MENB
Symptoms: Discomfort
Clinical narrative: Discomfort; This case was reported by a other health professional via call center representative and described the occurrence of discomfort in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced discomfort. On an unknown date, the outcome of the discomfort was unknown.   It was unknown if the reporter considered the discomfort to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-FEB-2023 Reporter's comment: The reported asked about needle size recommendations as Bexsero was administered to patient who expressed discomfort.  The reported stated that they were using 25 gauge needles but since the solution was thicker she was enquiring if there were any recommendations for a larger bore needle. The reported stated that this was not really a safety issue and that most people feel discomfort with vaccines, therefore she was opting out of providing additional information or follow up. The reporter did not consented to follow up. Additional supportive information: This was 1 of the 6 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR032491:Same reporter - Bexsero US-GSK-US2023AMR032489:Same reporter - Invalid case US-GSK-US2023031934:Same reporter - Bexsero US-GSK-US2023AMR032492:Same reporter - Bexsero US-GSK-US2023031935:Same reporter - Flu vaccine
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Diarrhoea, Dyspnoea, Nausea, Vomiting
Clinical narrative: Patient presents to the ED with nausea, vomiting, diarrhea, and shortness of breath. Patient was hospitalized for further evaluation with covid and treated with remdesivir.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Pulmonary thrombosis, Seizure
Clinical narrative: strokes; seizures; lungs filled up with blood clots; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown).  An 85-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "COVID-19", "Vaccination failure". The following information was reported: PULMONARY THROMBOSIS (death, hospitalization) with onset 12Mar2021, outcome "fatal", described as "lungs filled up with blood clots"; SEIZURE (death, hospitalization) with onset 02Apr2021, outcome "fatal", described as "seizures"; CEREBROVASCULAR ACCIDENT (death, hospitalization) with onset 19Apr2021, outcome "fatal", described as "strokes". The patient was hospitalized for pulmonary thrombosis, seizure, cerebrovascular accident (hospitalization duration: 30 day(s)). Therapeutic measures were taken as a result of pulmonary thrombosis, seizure, cerebrovascular accident. The patient date of death was unknown. Reported cause of death: "lungs filled up with blood clots", "seizures", "strokes". It was not reported if an autopsy was performed. Additional information: Reporter stated, "My mother started having seizures and strokes after receiving the vaccine second dose, she has never in her life had blood clots in her lungs or even had a stroke or a seizure!! She has had continual attacks and I became her primary caregiver and the seizures and stroke wouldn't stop. She got COVID-19 on 03Jan2023 they gave her Paxlovid. They couldn't stop the seizures and she was bleeding and they couldn't stop the bleeding and she died. I was given Paxlovid as well from the same doctor. I started bleeding as well."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300032137 same patient, different dose/event;; Reported Cause(s) of Death: lungs filled up with blood clots; seizures; strokes