chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Patient fainted moments after vaccination.  Staff helped move him from the chair to sit on the floor.  He came to within a minute of fainting episode.  He refused to lay down, but remained seated on the floor for a few minutes and was given a glass of water.  Stated he felt fine and noted he had had a similar reaction years ago to a shot in his buttocks.  Staff had him remain seated in the waiting area for 30 minutes to monitor for any other reaction.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash papular
Clinical narrative: I began itching about 45 mins after the shot, mostly my nose.  Then different areas of my body would itch and when I would scratch it, raised white bumps would appear in a a patch.  While the itching started fairly early, the raised bumpy patch did not appear until 7:30 pm .  The itching and raised bumps have continued off and on for over 2 weeks.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Ear discomfort, Neck pain, Pain, Paraesthesia
Clinical narrative: Pain in right arm began about 7 hours after injection.  I slept on my left side all night because right arm hurt.  It especially hurts when I lift my arm.  It also aches and tingles up and down entire arm and up through my neck, around to back shoulder blade and up through cheek.  My ear is "congested" and hearing is impaired and my ear tingles also.  I slept the entire night on my left side so it wouldn't be that fluid settled there over night.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Skin warm
Clinical narrative: 6 days after receiving vaccine, developed large red itchy rash at vaccination site size 3x 2 inches. Red and hot to touch, itchy, borders irregular but well defined.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash vesicular
Clinical narrative: Facial outbreak of blister like rash 3 days after jab of second dose.  Not itchy.  But woke up with little white heads over face...took a shower and they all burst like chicken pox. Very red.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Hyperhidrosis
Clinical narrative: Around 7:00 pm I started having aching joints, particularly my knees; had slight chills; and in general felt like I was coming down with something. My temperature was 99.2 at bedtime   These feelings lasted until I went to bed aroung 10:30 PM.  Whatever I had I sweated out overnight.  The next morning I felt fine.  I'm not convinced this is COVID related but thought I should let you know.  NOTE:  I was unable to complete #8 in the additional section below. It should read: Brilinta-60mg. Tamsulosin-0.8mg
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Flushing, Hyperhidrosis, Hypotension
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Mild, Additional Details: Pt was sitting for observation, after 8min, pt suddenly fell to lateral side, pt denies head trauma. IM Rx and Technician responded immediately.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Nausea, Syncope, Unresponsive to stimuli
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Mild, Additional Details: Pt was sitting for observation, after 8min, pt suddenly fell to lateral side, pt denies head trauma. IM Rx and Technician responded immediately.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: rash at vaccination site
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiogenic shock, Coronary artery occlusion, Myocardial infarction, Thrombosis
Clinical narrative: "widow maker" type heart attack where the LAD artery suddenly became 100% blocked by a blood clot; "widow maker" type heart attack where the LAD artery suddenly became 100% blocked by a blood clot; "widow maker" type heart attack where the LAD artery suddenly became 100% blocked by a blood clot; Cardiogenic shock; Anterior myocardial infarction; This is a spontaneous report from a contactable consumer.  An 81-years-old female patient received BNT162B2, dose 2 via an unspecified route of administration, administered in left arm on 06Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included very sensitive to medication effects (usually takes only 1/2 dose with strong efficacy to avoid side effects). Breast cancer survivor (2014 onset, 2019 declared permanent remission) and mild blood pressure treated successfully with medication for about 10 years. Concomitant medications included spironolactone and valsartan, both taken for blood pressure. The patient previously received first dose of BNT162B2 on 16Jan2021 in left arm for COVID-19 immunization. The reporter's mother died 3 weeks and 6 days after having received the second dose of the Pfizer covid vaccine. The cause of death was a "widow maker" type heart attack where the LAD artery suddenly became 100% blocked by a blood clot; the event began about 11:45pm on 04Mar2021. The blockage was confirmed via cardiac cath procedure performed within 2 hours of the onset by Doctor, he removed the clot and placed a stent. However her heart was too damaged and could not recover. Doctor confirmed to us that she did not have excessive or evidence of any prior blockage and not excessive plaque. The blood clot likely came on and caused the cardiac event within roughly an hour, he explained. The patient had no prior symptoms and no comorbidities for blood clotting and was full of life and energy on 05Mar up to when she went to bed that night. She died 06Mar at 4:04 am at hospital. The strat date of the events was reported as 04Mar2021 at 11:45 PM. AE resulted in emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). The patient died on 06Mar2021. An autopsy was not performed. The death cause: Triggered by the sudden 100% blockage of the LAD by a blood clot, the cause of death is listed as (A) Cardiogenic shock (B) Anterior myocardial infarction. Treatment was received for the events which included multiple resuscitations and angioplasty surgery. No covid prior vaccination, no covid tested post vaccination. The outcome of the events was fatal.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: "widow maker" type heart attack where the LAD artery suddenly became 100% blocked by a blood clot; "widow maker" type heart attack where the LAD artery suddenly became 100% blocked by a blood clot; "widow maker" type heart attack where the LAD artery
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: Pt c/o tongue swelling.  NP evaluation:  No SOB; No Chest Pain; No Aphagia; VS Stable & WNL.  Benadryl 50 mg PO @ 1604.  Pt state felt better @ 1610.  Advised to say additional 30 minutes post Benadryl.  Pt advised to f/;u with ER if s/s return or worsen.  Pt left department @ 1615.   Stated VS no longer swollen and s/s had resolved
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lethargy, Musculoskeletal stiffness
Clinical narrative: Significant joint pain in the hips for two days after the shot. Pain/stiffness at the injection site for two days after shot. Lethargy day after shot.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Anti-platelet antibody positive, Computerised tomogram normal, Contusion, International normalised ratio normal, Platelet count decreased
Clinical narrative: Blood work from a routine PE done approximately 1 month post covid-19 booster shot, (first shot was 1/29/21 and second given on 2/22/21) showed platelet level of 9,000 on 3/22/21. It was 7,000 on 3/24. Patient went to ER and was admitted on 3/25/21. Recently started Losartan was held for admission due to hematology recommendations as rare side effect of thrombocytopenia and not restarted while at the hospital. Multiple bruises on body noted in different stages of healing. Platelet count was 8,000 on 3/25/21. Platelet antibody tests positive, no platelet clumps on smear, denies HA, chest pain, SOB, n/v or fever. Denies hematochezia and hematemesis, blood in urine or epistaxis. CT scan negative. PT/INR results normal
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Prothrombin time normal, Thrombocytopenia
Clinical narrative: Blood work from a routine PE done approximately 1 month post covid-19 booster shot, (first shot was 1/29/21 and second given on 2/22/21) showed platelet level of 9,000 on 3/22/21. It was 7,000 on 3/24. Patient went to ER and was admitted on 3/25/21. Recently started Losartan was held for admission due to hematology recommendations as rare side effect of thrombocytopenia and not restarted while at the hospital. Multiple bruises on body noted in different stages of healing. Platelet count was 8,000 on 3/25/21. Platelet antibody tests positive, no platelet clumps on smear, denies HA, chest pain, SOB, n/v or fever. Denies hematochezia and hematemesis, blood in urine or epistaxis. CT scan negative. PT/INR results normal
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Sleep disorder, Vomiting
Clinical narrative: I began vomitting in the middle of the night. This continued every 15 minutes for 13 hours straight. I was seen in the ED and was treated with IV fluids and nausea medication.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hypoaesthesia, Hypoaesthesia oral, Influenza like illness, Muscle tightness
Clinical narrative: I had a 9:15 am appointment, received the shot about 9:30 am. Shopped in store for 10-min and drove to run more errands. About 9:45 am driving, I noticed my face starting to numb on my right hand side beginning with my upper lip, around my nostril, cheek and jaw line. After an hour of numbness, I called my doctors office and spoke with a nurse. The nurse had not heard of these symptoms before and sent me to the local ER at the hospital. As we drove to the ER, I noticed my jaw muscles getting tighter, but not so over powering that it felt like it would lock up. While under observation for an an hour or so, a Physician?s Assistant did neurological exams as my symptoms looked like a potential mild stroke. I passed the exams and sent home to observe any changes. The morning of day two (today), I have strong flu like symptoms with chills, shivering, aching muscles and the skin on my back and neck have a pins and needles feeling. What?s more, I have a present ringing in my ears today.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Neurological examination normal, Paraesthesia, Tinnitus
Clinical narrative: I had a 9:15 am appointment, received the shot about 9:30 am. Shopped in store for 10-min and drove to run more errands. About 9:45 am driving, I noticed my face starting to numb on my right hand side beginning with my upper lip, around my nostril, cheek and jaw line. After an hour of numbness, I called my doctors office and spoke with a nurse. The nurse had not heard of these symptoms before and sent me to the local ER at the hospital. As we drove to the ER, I noticed my jaw muscles getting tighter, but not so over powering that it felt like it would lock up. While under observation for an an hour or so, a Physician?s Assistant did neurological exams as my symptoms looked like a potential mild stroke. I passed the exams and sent home to observe any changes. The morning of day two (today), I have strong flu like symptoms with chills, shivering, aching muscles and the skin on my back and neck have a pins and needles feeling. What?s more, I have a present ringing in my ears today.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death
Clinical narrative: Death
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Moderna COVID-19 vaccine inadvertently given to 17 year old as first dose. Recipient of vaccine and parent notified by  Manager before leaving the facility. Appointment scheduled for recipient to receive the second dose of Moderna after 28 days as off-label use. Recipient left facility after the 15 minute monitoring time, no adverse events reported at that time.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Low Grade Fever (~99.0 degrees F) for about 8 hours following vaccination. Noticed low grade fever same day as vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Ductus arteriosus premature closure, Maternal exposure during pregnancy, Neutropenia neonatal, Pulmonary arterial pressure abnormal, Ventricular hypertrophy
Clinical narrative: is pregnant: Yes; severe neutropenia; premature closure of the ductus arteriosus; severe right ventricular hypertrophy and pulmonary arterial pressures; severe right ventricular hypertrophy and pulmonary arterial pressures; This is spontaneous report from a contactable Physician. This Physician reported information for both mother and baby. This report is for baby. The parent received first dose of BNT162B2 (So-lution for injection; Lot number: EL 1283) via Intramuscular in left arm on 29Dec2020 at 08:30 at single dose for COVID-19 immunisation, a baby received second dose of BNT162B2 (Solution for injection; Lot number: EL 1283) on via Transmammary route on 19-JAN-2021 08:45 at single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. On 18-MAR-2021 07:45 the Baby was born at (Withheld) with premature closure of the ductus arteriosus and severe neutropenia. Baby has been in NICU for the last 5 days with severe right ventricular hypertrophy and pulmonary arterial pressures and has been placed on Neupogen, is pregnant: Yes [Hospitalization, Life threatening, Disability, Congenital anomaly), Treatment received for the events. The outcome of the events was unknown.; Sender's Comments: Based on available information a contributory  of BNT162B2 to the reported neutropenia  cannot  be totally excluded.  The reported  premature closure of the ductus arteriosus with severe right ventricular hypertrophy and pulmonary arterial pressures are unrelated to BNT162B2.  The premature closure of the ductus arteriosus is a developmental complication and the  right ventricular hypertrophy and pulmonary arterial pressures are probably due to the premature closure of the ductus arteriosus.  Case will be reassessed if additional information is received.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021314932 same drug, different AE and patient, baby and mother
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Headache, Mobility decreased, Pain, Peripheral swelling
Clinical narrative: Fever, headache, aching neck, arms and hands. Fingers felt stiff and swollen, hard to move, but still looked normal size. Developed an egg size lump under left armpit that was very painful.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever, headache, aching neck, arms and hands. Fingers felt stiff and swollen, hard to move, but still looked normal size. Developed an egg size lump under left armpit that was very painful.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood pressure measurement, Chest pain, Dizziness, Headache
Clinical narrative: Patient started to experience dizziness a couple seconds after the shot.  Provided patient with water and he waited another 30-45 minutes and he started to experience nausea and chest pain that was rated a 3/10.  911 was called and his blood pressure was measured at 210/110 (previous blood pressure was 190's/110.  Nitroglycerin was given but it did not help with his chest pain and he began to have a headache.  He was taken to the hospital.   He stated that he was not feeling good a couple days before today.  He felt better today and received his J&J vaccine.  Fired his cardiologist and was looking for a new one.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Nausea
Clinical narrative: Patient started to experience dizziness a couple seconds after the shot.  Provided patient with water and he waited another 30-45 minutes and he started to experience nausea and chest pain that was rated a 3/10.  911 was called and his blood pressure was measured at 210/110 (previous blood pressure was 190's/110.  Nitroglycerin was given but it did not help with his chest pain and he began to have a headache.  He was taken to the hospital.   He stated that he was not feeling good a couple days before today.  He felt better today and received his J&J vaccine.  Fired his cardiologist and was looking for a new one.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Lethargy, Pain in extremity, Pyrexia, Vertigo
Clinical narrative: Soreness in arm within minutes lasting several days, mild fever and lethargy within 24 hours, ibs and stomach intestinal issues resulting in diarrhea that lasted several weeks, vertigo starting 2 weeks after and lasting 5 days and is ongoing at the time of this submission.   Slept the first day as soon as I started feeling anything to rest my body. Used pepto bismol liquid and capsules for GI issues. Drank water with electrolytes tabs dissolved in it to restore balance from diarrhea. Don't know how to treat the vertigo. It does not feel like it's because of dehydration but because of certain movements bring it on.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Peripheral swelling, Pyrexia
Clinical narrative: Swollen Lymph nodes in left neck and shoulder, Right hand swollen to the point could not bend fingers. Fever, chills Hand resolved in a couple hours.  Neck and shoulder still swollen as of today but has gone down considerably.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Headache, Nausea
Clinical narrative: Severe headache, severe body aches, shortness of breath,  fever, chills, severe fatigue and nausea
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Severe headache, severe body aches, shortness of breath,  fever, chills, severe fatigue and nausea
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Pruritus, Rash macular
Clinical narrative: Itchy, red splotch at injection site. That started a few days after the injection.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: passed away; This is a spontaneous report received from a contactable consumer reporting for a male patient of unspecified age that received second dose of BNT162B2 via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that the patient passed away late Saturday night after receiving his second COVID-19 Vaccine on Friday. An autopsy was not performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained; Reported Cause(s) of Death: passed away
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Headache, Injection site warmth, Nodule, Pain
Clinical narrative: Dull headache nagging headache starting a couple hours after vaccine that has not let up after taking headache medicine and a green bruise on my left forearm with a raised knot and hotspot down from the injection site. The knot hurts to touch and has my arm hurting to raise or use it. My arm was sore after the shot and has continued  to hurt, the knot developed 3 days after the vaccine, As of today it is still green and hot.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin
Clinical narrative: Dull headache nagging headache starting a couple hours after vaccine that has not let up after taking headache medicine and a green bruise on my left forearm with a raised knot and hotspot down from the injection site. The knot hurts to touch and has my arm hurting to raise or use it. My arm was sore after the shot and has continued  to hurt, the knot developed 3 days after the vaccine, As of today it is still green and hot.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient got J&J Covid Vaccine 1 week prior.  He now has COVID one week later and has received monoclonal antibodies treatment at our facility. Is there any recommendation to revaccinate?
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests normal, Tinnitus
Clinical narrative: Ringing in Left ear
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Musculoskeletal stiffness
Clinical narrative: PATIENT PRESENTED TO CLINIC FOR DOSE 2 OF COVID-19 AT 0920 (PFIZER LOT NUMBER ER8734 EXP 07/2021).  AFTER RECEIVING COVID VACCINE DOSE 2, PATIENT COMPLAINT OF "STIFFNESS" ON RIGHT NECK AND "DIFFICULTY TAKING DEEP BREATHS".  PATIENT DENIES OTHER S/S.  PATIENT TRANSPORTED TO ED BY WHEELCHAIR FOR FURTHER EVALUATION.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Red, slightly swollen and itchy patch near the injection site. Irregular shaped, about the size of my palm. 12 days past my first dose. No other symptoms or reactions prior.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: She died in the bathroom on the second day.; This is a spontaneous report from a contactable consumer.  This reporter reported similar events for 3 patients. This is 2nd of 3 patients.   A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported. It is reported the patient died in upstate. Waiting on the autopsy. She died in the bathroom on the second day. It was not expected. The patient died on an unspecified date.  It was not reported if an autopsy was performed. The outcome of the event was fatal.  Information on Lot/Batch has been requested.; Reported Cause(s) of Death: She died in the bathroom on the second day.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cerebrovascular accident, Chest discomfort, Chest pain, Chills
Clinical narrative: Extreme nausea; My symptoms were so severe I felt like I was going to die; I mean literally die; I thought I am going to have a stroke; My chest is still tight; I still feel low congestion; having hard time taking a deep breath; Chills; Headache; The chest pain was horrible; The joint and muscle pain were so severe; I am still little real nauseous; I feel like I mean like acid coming up constantly making me more nauseous; Unable to eat; The joint and muscle pain were so severe; My chest is still tight; I still feel low congestion; having hard time taking a deep breath; My chest is still tight; I still feel low congestion; having hard time taking a deep breath; This is a spontaneous report from a contactable nurse (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Deltoid Left on 19Mar2021 (Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient previously had first dose of BNT162B2 for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication includes supplements and multivitamins. The patient stated "I wanted to ask you and I have some horrible concerns I got my second COVID shot last Friday, and by Saturday night, I am not exaggerating, my symptoms were so severe I felt like I was going to die I mean literally die on 20Mar2021. I couldn't get to emergency room, I figured out I am just going to die, I just laid down and let my door open down so somebody could find me, the symptoms I was having was extreme nausea, chills, headache, the chest pain was horrible, horrible, the headache I mean I thought I am going to have a stroke, the joint and muscle pain were so severe. So I have been taking Tylenol, Advil (Treatment) finally this morning, yesterday was tiny, tiny bit better, this morning its little bit better but I am still little real nauseous and I feel like I mean like acid coming up constantly making me more nauseous and almost like unable to eat. Ever since Saturday all I will have been doing is three bites of chicken soup three times a day. What in the world is going on with this vaccine that it would cause those severe symptoms and my chest is still tight I still feel low congestion having hard time taking a deep breath in Mar2021". The outcome of the event "my symptoms were so severe I felt like I was going to die I mean literally die" was recovered on unspecified date. The outcome of the event unable to eat was unknown. The outcome of the rest of the events was recovering.  Information on lot/ batch number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeding disorder, Gastrooesophageal reflux disease, Headache, Myalgia
Clinical narrative: Extreme nausea; My symptoms were so severe I felt like I was going to die; I mean literally die; I thought I am going to have a stroke; My chest is still tight; I still feel low congestion; having hard time taking a deep breath; Chills; Headache; The chest pain was horrible; The joint and muscle pain were so severe; I am still little real nauseous; I feel like I mean like acid coming up constantly making me more nauseous; Unable to eat; The joint and muscle pain were so severe; My chest is still tight; I still feel low congestion; having hard time taking a deep breath; My chest is still tight; I still feel low congestion; having hard time taking a deep breath; This is a spontaneous report from a contactable nurse (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Deltoid Left on 19Mar2021 (Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient previously had first dose of BNT162B2 for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication includes supplements and multivitamins. The patient stated "I wanted to ask you and I have some horrible concerns I got my second COVID shot last Friday, and by Saturday night, I am not exaggerating, my symptoms were so severe I felt like I was going to die I mean literally die on 20Mar2021. I couldn't get to emergency room, I figured out I am just going to die, I just laid down and let my door open down so somebody could find me, the symptoms I was having was extreme nausea, chills, headache, the chest pain was horrible, horrible, the headache I mean I thought I am going to have a stroke, the joint and muscle pain were so severe. So I have been taking Tylenol, Advil (Treatment) finally this morning, yesterday was tiny, tiny bit better, this morning its little bit better but I am still little real nauseous and I feel like I mean like acid coming up constantly making me more nauseous and almost like unable to eat. Ever since Saturday all I will have been doing is three bites of chicken soup three times a day. What in the world is going on with this vaccine that it would cause those severe symptoms and my chest is still tight I still feel low congestion having hard time taking a deep breath in Mar2021". The outcome of the event "my symptoms were so severe I felt like I was going to die I mean literally die" was recovered on unspecified date. The outcome of the event unable to eat was unknown. The outcome of the rest of the events was recovering.  Information on lot/ batch number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Near death experience, Pulmonary congestion
Clinical narrative: Extreme nausea; My symptoms were so severe I felt like I was going to die; I mean literally die; I thought I am going to have a stroke; My chest is still tight; I still feel low congestion; having hard time taking a deep breath; Chills; Headache; The chest pain was horrible; The joint and muscle pain were so severe; I am still little real nauseous; I feel like I mean like acid coming up constantly making me more nauseous; Unable to eat; The joint and muscle pain were so severe; My chest is still tight; I still feel low congestion; having hard time taking a deep breath; My chest is still tight; I still feel low congestion; having hard time taking a deep breath; This is a spontaneous report from a contactable nurse (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Deltoid Left on 19Mar2021 (Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient previously had first dose of BNT162B2 for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication includes supplements and multivitamins. The patient stated "I wanted to ask you and I have some horrible concerns I got my second COVID shot last Friday, and by Saturday night, I am not exaggerating, my symptoms were so severe I felt like I was going to die I mean literally die on 20Mar2021. I couldn't get to emergency room, I figured out I am just going to die, I just laid down and let my door open down so somebody could find me, the symptoms I was having was extreme nausea, chills, headache, the chest pain was horrible, horrible, the headache I mean I thought I am going to have a stroke, the joint and muscle pain were so severe. So I have been taking Tylenol, Advil (Treatment) finally this morning, yesterday was tiny, tiny bit better, this morning its little bit better but I am still little real nauseous and I feel like I mean like acid coming up constantly making me more nauseous and almost like unable to eat. Ever since Saturday all I will have been doing is three bites of chicken soup three times a day. What in the world is going on with this vaccine that it would cause those severe symptoms and my chest is still tight I still feel low congestion having hard time taking a deep breath in Mar2021". The outcome of the event "my symptoms were so severe I felt like I was going to die I mean literally die" was recovered on unspecified date. The outcome of the event unable to eat was unknown. The outcome of the rest of the events was recovering.  Information on lot/ batch number has been requested.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Bladder catheterisation, COVID-19, Death, Decubitus ulcer
Clinical narrative: death Narrative: Pt has been declining prior to starting COVID vaccine doses; then he got COVID after first dose (VAER reported); and then was admitted to hospice for dyspnea, chronic pain, pressure ulcers, urinary incontinence with foley catheter in place, bedbound, dysphagia.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Pain, Urinary incontinence
Clinical narrative: death Narrative: Pt has been declining prior to starting COVID vaccine doses; then he got COVID after first dose (VAER reported); and then was admitted to hospice for dyspnea, chronic pain, pressure ulcers, urinary incontinence with foley catheter in place, bedbound, dysphagia.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: patient passed away Narrative: Family member reported patient passed away day after receiving the covid vaccine
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Death, Hypoxia, Respiratory failure
Clinical narrative: death Narrative: Pt received COVID vaccine dose #1 on 2/27 at facility. Pt admitted to Hospital d/t COPD exacerbation and severe hypoxia. Pt with longstanding hx respiratory complications including air hunger, use of continuous oxygen, panic attacks and pain requiring narcotics (also impacted respiratory drive). Pt evaluated by palliative care/hospice services at Hospital and was deemed appropriate for end-of-life care. Pt unable to discharge home for home hospice services, therefore remained at Hospital where he later passed away. Pt's wife called facility 3/29 to report the death of patient, exact date of death was 3/13. Anticipated cause of death includes respiratory failure d/t severe COPD, hypoxia and narcotic use. Was pt previously covid positive? No Are there any predisposing factors (i.e. PMH, HPI, allergy history etc) for patient experiencing adverse drug event? No Any occurrence of an ADR at time of administration or during time of observation? No Was there and ADR between observation period and date of death? No Was patient hospitalized prior to vaccination? No Was patient hospitalized between vaccination and date of death? Yes - d/t severe hypoxia and COPD exacerbation Was hospitalization attributable to ADE ? No Was patient hospitalized prior to death Yes What are the possible cause of death? severe COPD, hypoxia, reduced respiratory drive d/t narcotic use (chronic pain)
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperaesthesia, Pyrexia, Rash erythematous
Clinical narrative: First noticed half-dollar-sized red ?rash? on left arm Thursday 3/25/21. The ?rash? grew in size  each day, and now covers half of the outer facing portion of my upper left arm. The edges are slightly raised. The ?rash? is feverish and the edges are sometimes sensitive to touch.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Nausea, headache,
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Increased upper airway secretion, Pharyngeal swelling, Throat irritation
Clinical narrative: at 1105am T=98.1, R=16, c/o feeling as though she has mild rt. throat swelling, itchy throat and mucous starting to build up in her throat.  Denies tongue swelling or SOB.   Water given.  at 1108 reports that the sensation that her right throat was swollen has disappeared and she now has the same sensation on the left throat. Continues to deny SOB or tongue swelling.  at 1120 this RN having difficulty getting the BP machine to reading patient BP.  Left Forearm BP163/97, P=86, R=16 O2 sat = 98%.  At 1125 reports that her mild lt throat swelling remains the same.  Denies tongue swelling or SOB.  1142 reviewed with Physician who evaluated the patient and instructed her to take Benadryl once she gets home.  Instructed the patient that if her symptoms worsen she should go the ER or call 911 if symptoms life threatening.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pain
Clinical narrative: pt says after getting the vax he developed pain in left arm in the muscle at the injection site.  Pt says the pain has been lingering every since he got the vaccine.  He used his arm some and said it seem to aggravate the pain.  H he is still having pain to this day in the muscle at the injection site.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous
Clinical narrative: severe Itching all over the body with small red rashes all over
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: There were no adverse reactions, however pt was 17 years old at time of administration.  When the vaccine was given the computer system was not working and the pt was was given his dose via a paper form. After the second dose was administered on 1/28/2021 Moderna Lot #029L20A Left Arm, into a computer chart our IIS rejected administration due to age. Pt was called to verify age, pt confirmed he was 17 at time of administration but did not report any adverse reactions to vaccine.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Nausea
Clinical narrative: Pt States  "Feels funny".  Nausea.  No SOB; Pulse strong and regular.  Oriented x 3 Color normal.   @ 1615 states feels better.  Instructed to f/u with PCP if needed.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Pruritus, Rash erythematous
Clinical narrative: Red rash around injection site that appeared 8 days after the injection. Itchy but not sore
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Constipation, Headache, Impaired work ability
Clinical narrative: I had slight itching after injection while waiting the 15 minutes in the store after injection.  I started next day feeling slight sore throat, then under-the-weather, so unable to work at computer.. fever in evening 99.6.  Took  1 tylenol 500. and went to bed ca 7 p.m.   Slept fitfully, joints hurting: back, neck, ribs, knees, hands.  No sweating.  Slight persistent headache.  Feeling of discomfort in bowels all night (constipation not diarrhea).   Injection site hurts to touch. 30 March 2021, today: slight sore throat, headache, right arm injection site --3" redness and swelling around site.  still slight sore throat.  No temperature (97.5).  Feel
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Oropharyngeal pain, Pruritus
Clinical narrative: I had slight itching after injection while waiting the 15 minutes in the store after injection.  I started next day feeling slight sore throat, then under-the-weather, so unable to work at computer.. fever in evening 99.6.  Took  1 tylenol 500. and went to bed ca 7 p.m.   Slept fitfully, joints hurting: back, neck, ribs, knees, hands.  No sweating.  Slight persistent headache.  Feeling of discomfort in bowels all night (constipation not diarrhea).   Injection site hurts to touch. 30 March 2021, today: slight sore throat, headache, right arm injection site --3" redness and swelling around site.  still slight sore throat.  No temperature (97.5).  Feel
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I had slight itching after injection while waiting the 15 minutes in the store after injection.  I started next day feeling slight sore throat, then under-the-weather, so unable to work at computer.. fever in evening 99.6.  Took  1 tylenol 500. and went to bed ca 7 p.m.   Slept fitfully, joints hurting: back, neck, ribs, knees, hands.  No sweating.  Slight persistent headache.  Feeling of discomfort in bowels all night (constipation not diarrhea).   Injection site hurts to touch. 30 March 2021, today: slight sore throat, headache, right arm injection site --3" redness and swelling around site.  still slight sore throat.  No temperature (97.5).  Feel
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Red itchy rash with bumps on arm that vaccine was given in.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abscess drainage, Antinuclear antibody negative, C-reactive protein increased, Computerised tomogram neck, Pain
Clinical narrative: Bilateral parotid and submandibular gland sialoadenitis ? intense swelling, purulent drainage, pain, overlying skin edema requiring multiple antibiotics (bactrim, azithromycin, clindamycin) and steroids including ER visit
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pantoea agglomerans test positive, Parotitis, Red blood cell sedimentation rate increased, Rheumatoid factor negative, Sialoadenitis
Clinical narrative: Bilateral parotid and submandibular gland sialoadenitis ? intense swelling, purulent drainage, pain, overlying skin edema requiring multiple antibiotics (bactrim, azithromycin, clindamycin) and steroids including ER visit
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Skin oedema, Swelling
Clinical narrative: Bilateral parotid and submandibular gland sialoadenitis ? intense swelling, purulent drainage, pain, overlying skin edema requiring multiple antibiotics (bactrim, azithromycin, clindamycin) and steroids including ER visit
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: I had typical flu like symptoms beginning 12 hours after my second dose of Moderna- fever, chills, body aches, and headache.   Two days later I had a flair of hives covering my legs, torso, and arms that is still ongoing.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: I had typical flu like symptoms beginning 12 hours after my second dose of Moderna- fever, chills, body aches, and headache.   Two days later I had a flair of hives covering my legs, torso, and arms that is still ongoing.
Age: 75.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Unevaluable event
Clinical narrative: none from DTaP+IPV
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Hypoaesthesia oral
Clinical narrative: Patient experienced numbness in tongue, SOB, and heavy chest following vaccination. Patient given Benadryl. Patient vitals taken all within normal limits. Patients symptoms absent after 1 hour from Benadryl taken.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood glucose normal, Blood thyroid stimulating hormone, Chills, Cough, Diarrhoea
Clinical narrative: Had fever x 1 day, cough, body aches, fatigue, vomiting with first vaccine  Had fever x 6 days, cough, body aches, fatigue, diarrhea, vomiting, chills with second vaccine. Also had incontinence (urine & feces) for first 3 days after vaccine. Had arm swelling in axilla that began 3 days after vaccine (same side as vaccine). Continues currently, Not painful or red.  Also realized after reported illness after 2nd dose that her doses were timed at 13 days apart, not the recommended 19-42 days.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Full blood count normal, Inappropriate schedule of product administration, Incontinence, Pain
Clinical narrative: Had fever x 1 day, cough, body aches, fatigue, vomiting with first vaccine  Had fever x 6 days, cough, body aches, fatigue, diarrhea, vomiting, chills with second vaccine. Also had incontinence (urine & feces) for first 3 days after vaccine. Had arm swelling in axilla that began 3 days after vaccine (same side as vaccine). Continues currently, Not painful or red.  Also realized after reported illness after 2nd dose that her doses were timed at 13 days apart, not the recommended 19-42 days.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Pyrexia, Vomiting
Clinical narrative: Had fever x 1 day, cough, body aches, fatigue, vomiting with first vaccine  Had fever x 6 days, cough, body aches, fatigue, diarrhea, vomiting, chills with second vaccine. Also had incontinence (urine & feces) for first 3 days after vaccine. Had arm swelling in axilla that began 3 days after vaccine (same side as vaccine). Continues currently, Not painful or red.  Also realized after reported illness after 2nd dose that her doses were timed at 13 days apart, not the recommended 19-42 days.
Age: 48.0
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Rash, Throat tightness
Clinical narrative: rash - rapid spreading; breathing problems, throat constriction.  Epi-Pen self-administered.  EMS called and transported with standard Benadryl via PO).
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Injection site reaction, Injection site swelling, Pain
Clinical narrative: Fatigue, headache, soreness, sore arm about 12-24 hours post injection.  Swollen, red, blotchy painful rash at injection site about 2.5 days post injection.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Rash, Rash macular
Clinical narrative: Fatigue, headache, soreness, sore arm about 12-24 hours post injection.  Swollen, red, blotchy painful rash at injection site about 2.5 days post injection.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swelling of Lymph node above left clavicle and in left arm pit.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Headache, Myalgia
Clinical narrative: Adverse symptoms began about 9 am. on 3/27.  symptoms were low grade fever, chills, headache, muscle aches, very tired, cough. Symptoms subsided sometime after going to bed at 7:30. I felt ok when I woke up at 5:00 am.  I did not feel 100% but symptoms were gone. Felt a little off all day 3/27 but by #/28 felt fine
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Adverse symptoms began about 9 am. on 3/27.  symptoms were low grade fever, chills, headache, muscle aches, very tired, cough. Symptoms subsided sometime after going to bed at 7:30. I felt ok when I woke up at 5:00 am.  I did not feel 100% but symptoms were gone. Felt a little off all day 3/27 but by #/28 felt fine
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Pruritus, Skin warm
Clinical narrative: Moderna COVID 19 Vaccine EUA.  Large round raised rash on upper left arm at injection site, hot and slightly itchy.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Hyponatraemia, SARS-CoV-2 test positive
Clinical narrative: Patient hospitalized for sever hyponatremia and tested COVID-19 positive upon admission.  No COVID-19 symptoms, no known exposure.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Fatigue
Clinical narrative: Patient states he received 2nd Pfizer shot 3/26 at approximately 10:40am, approximately 2 hours after developed fatigue. At approximately 2:00pm on 3/29 developed chest pain and shortness of breath. Patient was referred to local emergency room for further evaluation.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin abnormal, Injection site erythema, Injection site swelling, Squamous cell carcinoma
Clinical narrative: Patient received 2nd dose of Pfizer Series on 01/06/2021. That following Monday 01/11/2021 the patient noted a very red, raised whelp on the arm that they had received the vaccination. They also  noted a center or core in the middle of the whelp. This type of reaction was not noted with the first vaccine and the area was not present prior to the vaccine per the patient's report.  Since the whelp persisted for numerous days the patient reached out the medical colleges for advice. Eventually in late January she sought the opinion of a dermatologist since the area of concern had not improved. The dermatologist was unsure if this reaction was caused by the vaccine but did  prescribe steroids to help with redness/swelling. Despite steroids the area did not improve. On a repeat visit to the dermatologist in late February a tissue sample of the whelp was taken and sent off for analysis. The analysis returned back as squamous cell carcinoma.  The patient reports that after this finding a 1.2CM area was considered to be squamous cell carcinoma. The dermatologist removed the carcinoma and repeat samples have returned back showing clear margins.  The patient does not report having a diagnosis of squamous cell carcinoma in the past.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immediate post-injection reaction, Injection site rash, Lymphadenopathy, Pyrexia
Clinical narrative: Headache (3 hours after shot, lasted 3 days) , fever (started 20 hours after shot, lasted 24 hours), rash on arm of injection site (started 30 hours after) , rash on face(immediately following injection, went away within hour), swollen lymph nodes in armpit of arm that received injection (started 40 hours after shot), tinnitus (started 24 hours after shot)
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Tinnitus
Clinical narrative: Headache (3 hours after shot, lasted 3 days) , fever (started 20 hours after shot, lasted 24 hours), rash on arm of injection site (started 30 hours after) , rash on face(immediately following injection, went away within hour), swollen lymph nodes in armpit of arm that received injection (started 40 hours after shot), tinnitus (started 24 hours after shot)