chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amylase normal, C-reactive protein increased, Culture urine positive, Drug screen negative, Escherichia infection
Clinical narrative: Ten minutes after shot she began complaining of tightness in throat and chest.  Monitored for 45 min and then began throwing up at 7 pm.  Vomited rest of evening and all the next day.  Went to ER and given an injection of epinephrine.  Sent home.  Continued to vomit and went back into ER and admitted to hospital.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count normal, Lipase normal, Metabolic function test normal, Nausea, Respiratory viral panel
Clinical narrative: Ten minutes after shot she began complaining of tightness in throat and chest.  Monitored for 45 min and then began throwing up at 7 pm.  Vomited rest of evening and all the next day.  Went to ER and given an injection of epinephrine.  Sent home.  Continued to vomit and went back into ER and admitted to hospital.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness, Urine analysis normal, Vomiting
Clinical narrative: Ten minutes after shot she began complaining of tightness in throat and chest.  Monitored for 45 min and then began throwing up at 7 pm.  Vomited rest of evening and all the next day.  Went to ER and given an injection of epinephrine.  Sent home.  Continued to vomit and went back into ER and admitted to hospital.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Skin exfoliation
Clinical narrative: Itching, swelling on hands with skin peeling
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Pallor, Syncope
Clinical narrative: PATIENT RECEIVED 1ST DOSE, THEN SAT IN OBSERVATION AREA WITH HIS MOM. PATIENT SLUMPED IN CHAIR AND HAD FAINTED - MOM YELLED FOR HELP. I CAME OVER TO HELP THE PATIENT DOWN TO THE GROUND AND ASSESS. A BYSTANDER CALLED 911.  PATIENT WAS PALE, HAD A PULSE. PATIENT HAD A PULSE AND WAS BREATHING, COLOR STARTED TO COME BACK TO HIS FACE. HE WOKE UP AND PULSE WAS ABOUT 60-64BPM. PATIENT KNEW WHERE HE WAS. THE AMBULANCE CAME AND TOOK HIM TO THE HOSPITAL.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Confusional state, Dizziness, Feeling drunk, Feeling of body temperature change
Clinical narrative: Less than an hour after I received the shot, I started feeling nauseous, dizzy, lightheaded, confused/brain fog (I literally felt drunk), hot and cold flashes and generally unwell. The next day, I woke up with a sore throat and a head cold. The brain fog, bad nausea, internal temp issues and general unwell feeling lasted through Saturday. The SCARIEST part was that it felt like my heart hurt when I was breathing on the third day. I currently have a shoulder injury, so I took ibuprofen and the heart pain went away.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nasopharyngitis, Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: Less than an hour after I received the shot, I started feeling nauseous, dizzy, lightheaded, confused/brain fog (I literally felt drunk), hot and cold flashes and generally unwell. The next day, I woke up with a sore throat and a head cold. The brain fog, bad nausea, internal temp issues and general unwell feeling lasted through Saturday. The SCARIEST part was that it felt like my heart hurt when I was breathing on the third day. I currently have a shoulder injury, so I took ibuprofen and the heart pain went away.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chest pain, Myocarditis, Troponin increased
Clinical narrative: Chest Pain due to Myocarditis
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chest pain, Electrocardiogram normal, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: Chest Pain due to Myocarditis
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Troponin increased
Clinical narrative: Chest Pain due to Myocarditis
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Confusional state, Dizziness, Dyspnoea, Feeling abnormal
Clinical narrative: Less than an hour after I received the shot, I started feeling nauseous, dizzy, lightheaded, confused/brain fog (I literally felt drunk), hot and cold flashes and generally unwell. The next day, I woke up with a sore throat and a head cold. The brain fog, bad nausea, internal temp issues and general unwell feeling lasted through Saturday. The SCARIEST part was that it felt like my heart hurt when I was breathing on the fourth day. The entire experience was the exact same as the first shot, except that it took a little longer to feel sick and that my heart hurt MUCH worse. It was terrifying, because it hurt to breathe and I literally feared for my life. I currently have a shoulder injury, so I took ibuprofen (800 mg) and the heart pain went away and stayed away. I also experienced visual hallucinations!! It was kind of scary because I live alone. I strongly believe my body responded to the vaccine with inflammation - hence the heart issues and hallucinations. I'm really concerned about these things for future covid vaccines, so please contact me about this. Thanks!
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Feeling drunk, Hallucination, Hot flush, Inflammation
Clinical narrative: Less than an hour after I received the shot, I started feeling nauseous, dizzy, lightheaded, confused/brain fog (I literally felt drunk), hot and cold flashes and generally unwell. The next day, I woke up with a sore throat and a head cold. The brain fog, bad nausea, internal temp issues and general unwell feeling lasted through Saturday. The SCARIEST part was that it felt like my heart hurt when I was breathing on the fourth day. The entire experience was the exact same as the first shot, except that it took a little longer to feel sick and that my heart hurt MUCH worse. It was terrifying, because it hurt to breathe and I literally feared for my life. I currently have a shoulder injury, so I took ibuprofen (800 mg) and the heart pain went away and stayed away. I also experienced visual hallucinations!! It was kind of scary because I live alone. I strongly believe my body responded to the vaccine with inflammation - hence the heart issues and hallucinations. I'm really concerned about these things for future covid vaccines, so please contact me about this. Thanks!
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nasopharyngitis, Nausea, Oropharyngeal pain
Clinical narrative: Less than an hour after I received the shot, I started feeling nauseous, dizzy, lightheaded, confused/brain fog (I literally felt drunk), hot and cold flashes and generally unwell. The next day, I woke up with a sore throat and a head cold. The brain fog, bad nausea, internal temp issues and general unwell feeling lasted through Saturday. The SCARIEST part was that it felt like my heart hurt when I was breathing on the fourth day. The entire experience was the exact same as the first shot, except that it took a little longer to feel sick and that my heart hurt MUCH worse. It was terrifying, because it hurt to breathe and I literally feared for my life. I currently have a shoulder injury, so I took ibuprofen (800 mg) and the heart pain went away and stayed away. I also experienced visual hallucinations!! It was kind of scary because I live alone. I strongly believe my body responded to the vaccine with inflammation - hence the heart issues and hallucinations. I'm really concerned about these things for future covid vaccines, so please contact me about this. Thanks!
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Rash at injection site 1 week after vaccine received. Rash about 3 inches in diameter, warm to the touch, slightly itchy.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eye pain, Head discomfort, Headache, Injection site pain
Clinical narrative: Started as a slight headache and soar arm and increased  to a pulsating headache with so much pressure it caused me to vomit, arm swelled a little with 2 red spots and pain increase quite a bit at spot the shot was given and arm was shaking a bit and hurt to put it straight. Headache persisted for almost 8 hours and felt immense pressure, hurt to keep my left eye open when headache was at its most severe. Took 2-Excedrin  extra strength and a hour later took 4-200mg ibuprofen. The pressure from the headache started to subside and it getting better now. When finally open my left eye again it was blurry and unable to focus for about 5 mins
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Peripheral swelling, Tremor, Vision blurred
Clinical narrative: Started as a slight headache and soar arm and increased  to a pulsating headache with so much pressure it caused me to vomit, arm swelled a little with 2 red spots and pain increase quite a bit at spot the shot was given and arm was shaking a bit and hurt to put it straight. Headache persisted for almost 8 hours and felt immense pressure, hurt to keep my left eye open when headache was at its most severe. Took 2-Excedrin  extra strength and a hour later took 4-200mg ibuprofen. The pressure from the headache started to subside and it getting better now. When finally open my left eye again it was blurry and unable to focus for about 5 mins
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Started as a slight headache and soar arm and increased  to a pulsating headache with so much pressure it caused me to vomit, arm swelled a little with 2 red spots and pain increase quite a bit at spot the shot was given and arm was shaking a bit and hurt to put it straight. Headache persisted for almost 8 hours and felt immense pressure, hurt to keep my left eye open when headache was at its most severe. Took 2-Excedrin  extra strength and a hour later took 4-200mg ibuprofen. The pressure from the headache started to subside and it getting better now. When finally open my left eye again it was blurry and unable to focus for about 5 mins
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chest pain, Dyspnoea, Electrocardiogram
Clinical narrative: Sharp pain in chest especially when inhaling; clicking at left of sternum with heart beat; unable to get deep breath. Given IV anti-inflammatory.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Sensory disturbance
Clinical narrative: Sharp pain in chest especially when inhaling; clicking at left of sternum with heart beat; unable to get deep breath. Given IV anti-inflammatory.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeding disorder, Feeling abnormal, Headache
Clinical narrative: symptoms: fever (up to 102) chills  headache  dizziness  naesous  body aches   treatment: ibuprofen   outcome:  miserable, couldn?t sleep or eat and the fever wouldn?t break. the ibuprofen made the headache go away
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Nausea, Pain, Pyrexia
Clinical narrative: symptoms: fever (up to 102) chills  headache  dizziness  naesous  body aches   treatment: ibuprofen   outcome:  miserable, couldn?t sleep or eat and the fever wouldn?t break. the ibuprofen made the headache go away
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Cardiac imaging procedure abnormal, Chest pain, Dyspnoea, Echocardiogram normal
Clinical narrative: Patient started having generalized weakness, fatigue, fever and headache after the second dose of his Moderna Covid-19 vaccine. These symptoms persisted throughout the next day. However, two days after the second Covid-19 shot patient developed severe chest pain that resulted in presentation in the ED. There was associated shortness of breath and diaphoresis. He was treated with Colchicine and Ibuprofen. He was also started on metoprolol because he had an 11-beat run of non-sustained ventricular tachycardia. He was discharged home on the fourth day to follow up with cardiology as outpatient.
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Patient started having generalized weakness, fatigue, fever and headache after the second dose of his Moderna Covid-19 vaccine. These symptoms persisted throughout the next day. However, two days after the second Covid-19 shot patient developed severe chest pain that resulted in presentation in the ED. There was associated shortness of breath and diaphoresis. He was treated with Colchicine and Ibuprofen. He was also started on metoprolol because he had an 11-beat run of non-sustained ventricular tachycardia. He was discharged home on the fourth day to follow up with cardiology as outpatient.
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocardial oedema, Pyrexia, Troponin increased, Ventricular tachycardia
Clinical narrative: Patient started having generalized weakness, fatigue, fever and headache after the second dose of his Moderna Covid-19 vaccine. These symptoms persisted throughout the next day. However, two days after the second Covid-19 shot patient developed severe chest pain that resulted in presentation in the ED. There was associated shortness of breath and diaphoresis. He was treated with Colchicine and Ibuprofen. He was also started on metoprolol because he had an 11-beat run of non-sustained ventricular tachycardia. He was discharged home on the fourth day to follow up with cardiology as outpatient.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: patient experienced syncope, fainted 5 minutes after recieving vaccinefor 1 minute then came back conscious
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Headache, Herpes zoster, Nausea
Clinical narrative: Headaches, nausea, shingles
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Lip swelling, Rash pruritic, Swelling face
Clinical narrative: Allergy all over the body, swollen lips and face, itchy rash.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia
Clinical narrative: Extreme fatigue. Slept for 18 hours after receiving the vaccination.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Rash, Swelling, Urticaria
Clinical narrative: welts began to appear on arm and shoulder  within about 1.5 hours -2 hours after injection. Hot, swollen, welts
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Body tinea, Chills, Dehydration, Influenza like illness, Pyrexia
Clinical narrative: The day of my first shot I felt sick for a few days normal symptoms then when I got the second shot I had severe symptoms and was in bed for four days with fever chills high temperature dehydration horrible flu like symptoms. Since I have had the second vaccination I have been sick Pretty continuous and have had some weird issues such as ringworm that has spread all over my body
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Fatigue, Feeling abnormal, Headache
Clinical narrative: At first only moderate arm pain and soreness, fatigue and nausea and headache lasting 24 hours. Then two weeks of being totally fine. Then suddenly woke up on the 14th day feeling like I had been shot in the arm by a gun. Limited mobility in arm and shoulder, extreme pain at injection side and in shoulder. Range of motion that hurts feels similar to rotator cuff injury (which I?ve had before and therefore can identify.) The two weeks in between there were no symptoms. I don?t know if these are related, but just in case- I also woke up with a headache and rib pain on my right side. My elbow on injection site side now feels painful but I do have pain there sometimes anyway. Soreness from shoulder down to wrist. I am a bartender and had to go home early from work due to the pain. I am concerned this will not go away. Could it be SIRVA? Could SIRVA suddenly show up two weeks *after* an injection? Thank you.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Injection site joint movement impairment, Injection site pain, Musculoskeletal chest pain, Nausea
Clinical narrative: At first only moderate arm pain and soreness, fatigue and nausea and headache lasting 24 hours. Then two weeks of being totally fine. Then suddenly woke up on the 14th day feeling like I had been shot in the arm by a gun. Limited mobility in arm and shoulder, extreme pain at injection side and in shoulder. Range of motion that hurts feels similar to rotator cuff injury (which I?ve had before and therefore can identify.) The two weeks in between there were no symptoms. I don?t know if these are related, but just in case- I also woke up with a headache and rib pain on my right side. My elbow on injection site side now feels painful but I do have pain there sometimes anyway. Soreness from shoulder down to wrist. I am a bartender and had to go home early from work due to the pain. I am concerned this will not go away. Could it be SIRVA? Could SIRVA suddenly show up two weeks *after* an injection? Thank you.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Sleep disorder
Clinical narrative: At first only moderate arm pain and soreness, fatigue and nausea and headache lasting 24 hours. Then two weeks of being totally fine. Then suddenly woke up on the 14th day feeling like I had been shot in the arm by a gun. Limited mobility in arm and shoulder, extreme pain at injection side and in shoulder. Range of motion that hurts feels similar to rotator cuff injury (which I?ve had before and therefore can identify.) The two weeks in between there were no symptoms. I don?t know if these are related, but just in case- I also woke up with a headache and rib pain on my right side. My elbow on injection site side now feels painful but I do have pain there sometimes anyway. Soreness from shoulder down to wrist. I am a bartender and had to go home early from work due to the pain. I am concerned this will not go away. Could it be SIRVA? Could SIRVA suddenly show up two weeks *after* an injection? Thank you.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Swelling in my lower body- legs swelled so much, my knees disappeared.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Pain, Palpitations, Pyrexia, Somnolence
Clinical narrative: Fever, muscle aches, dizziness, drowsiness, heart palpitations,
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Genital ulceration, Gout, Herpes zoster, Mouth ulceration
Clinical narrative: Shingles area appeared two days after the second shot. Didn't connect what it was thought maybe an insect sting. After a week of getting worse I went to a clinic and said it was shingles. Was prescribed Valtrex and later developed gout flare-up and sores in my mouth and on my private area. Getting better but not all side-effects have gone away yet.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Hypoacusis, Pyrexia
Clinical narrative: Fever, chills, headache, difficulty hearing  starting the night of the shot and so far the next day as well.  Given Tylenol every 6 hours.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: At 1540 RN came to Lead office and informed Co-Lead  that she had erroneously vaccinated client  two days before his second dose of Moderna was due. Co-Lead went to the vaccination room, verified client's identity, and confirmed Client's first dose of Moderna was given on 5/12/2021, and therefore, his second dose was due 6/9/2021.  On the back of the vaccination card, the reminder erroneously listed today, June 7, 2021, as the return date and this is why Ancillary and Vaccinator proceeded with the vaccination.  Moderna, lot# 027C21A vaccine was given to client at 1536. Using vaccinator to translate into Spanish, the RN informed client that a VAERS and VERP report would be filed, and client verbalized understanding. RN then educated the vaccination team  that client's info should always be screened for the appropriateness of receiving a second dose by verifying when the first dose was received, and not to rely on what the vaccination card says.  Co-lead also educated check-in RN, Co-Lead Ancillaries, and Ancillary working with vaccinator regarding the importance of verifying each client's first vaccination date before sending them upstairs for their second dose.  Co-lead verified that she would reiterate the importance of date verifications with all ancillary staff.  Client was informed VAERS and VERP would be submitted.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test, Chest pain, Electrocardiogram, Heart rate increased
Clinical narrative: Rapid heart rate. 120 standing, 100 resting for first few days. Chest pain since second shot.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was given vaccine that was mixed >6 hours prior to injection but less than <24 hours. It was stored in the refrigerator before administration.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: Body rash. Diagnosis: Shingles
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: The patient stated that he needed his second vaccine and at first said the thought he first received the Pfizer injextion.  I spoke to him and told him we have all 3 vaccines but the only 2 vaccines that required 2 shots was the Pfizer and then Moderna.  I told him he needed to get the same vaccine for both and he then stated Moderna.  I asked him if her was sure and he said yes.  He didn't have his card upon the initial visit.  We vaccinated him with Moderna and when he returned with his card it indicated he received the Pfizer for the first vaccine.  We observed his for the 15 minutes without any adverse reactions.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Red & Itchy Rash on arms & torso
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Face injury, Loss of consciousness
Clinical narrative: Patient collapsed a few minutes after receiving the vaccine and injured his chin.  Patient was up walking around until time of collapse, and remained laying down until paramedics came.  Patient was transported to the hospital via ambulance.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: The vaccine was given about 1/2 hour past the 6 hour window tine frame.  The Pfizer vial was mixed at 10:50am and the vaccine was given between 5:10 and 5:30pm.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was given vaccine that was mixed >6 hours prior to injection but less than <24 hours. It was stored in the refrigerator before administration.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia eye, Hypoaesthesia oral, Paraesthesia, Paraesthesia oral
Clinical narrative: Tingling/numb feeling on left side of face only. Forehead, cheek, left eye, left side of my lips.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ear (mostly left ear) since (more or less) receiving the second dose of the Moderna Covid19 vaccine.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac monitoring abnormal, Cerebral infarction, Cognitive disorder, Echocardiogram normal, Grip strength decreased
Clinical narrative: Patient developed weakness in his left hand the following morning, with inability to move or manipulate with hand such as pick up utensils starting morning of 3/5/2021.  This did slowly improve and pt underwent PT for this.  He has had changes in energy and cognition as well.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Magnetic resonance imaging abnormal, Muscular weakness, Supraventricular extrasystoles, Ultrasound Doppler
Clinical narrative: Patient developed weakness in his left hand the following morning, with inability to move or manipulate with hand such as pick up utensils starting morning of 3/5/2021.  This did slowly improve and pt underwent PT for this.  He has had changes in energy and cognition as well.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Ventricular extrasystoles
Clinical narrative: Patient developed weakness in his left hand the following morning, with inability to move or manipulate with hand such as pick up utensils starting morning of 3/5/2021.  This did slowly improve and pt underwent PT for this.  He has had changes in energy and cognition as well.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Aura, Cerebrovascular accident, Computerised tomogram, Dysarthria, Echocardiogram
Clinical narrative: Emblematic stroke in vision and language centers of brain causing blurred vision and aura as well as facial droop and slurred speach.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis, Magnetic resonance imaging, Scan with contrast, Ultrasound Doppler, Vision blurred
Clinical narrative: Emblematic stroke in vision and language centers of brain causing blurred vision and aura as well as facial droop and slurred speach.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was given vaccine that was mixed >6 hours prior to injection but less than <24 hours. It was stored in the refrigerator before administration.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: The vaccine was administered after the 6 hour expiration window.  The vial was mixed that day at 10:50am and administered between 5:00-5:10pm.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Urticaria
Clinical narrative: My arm broke out in red rash and hives. Over the next couple days it spread all the way to my ankles.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was given vaccine that was mixed >6 hours prior to injection but less than <24 hours. It was stored in the refrigerator before administration.
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: Joint swelling, Peripheral swelling, Rash, Swelling face
Clinical narrative: Not sure what maker, received together Dtap and MCV4 (Meningococcal). One in each arm
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was given vaccine that was mixed >6 hours prior to injection but less than <24 hours. It was stored in the refrigerator before administration.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pain, redness, swelling, itching, and heat around the injection site
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Crying, Depression, Dysgeusia, Heavy menstrual bleeding
Clinical narrative: 4/30 - Five minutes after the vaccine, I passed out. I felt uncontrollably shaky and my vision went white. I was not anxious prior to getting the vaccine and felt terror afterwards. 5/1 - I developed severe depression and suicidal ideation. I reported to those around me that I did not feel safe. I am not diagnosed with depression and did not experience depression prior to the vaccine. I felt suicidal, completely hopeless, anxious, and was uncontrollably bursting into tears without an identifiable trigger. 5/2 - I developed shooting pain in my legs and arms. It felt like a pulsating, stabbing pain that throbbed. It was unlike any pain I had experienced ever before. 5/3 - I developed a metallic taste in my mouth that could not be washed away with water or food. It was extremely noticeable. 5/4  - My period came a week early. I have been on birth control for seven years and have never experienced any changes in my menstrual cycle. I made no other lifestyle or health changes other than the vaccine. The period was extremely heavy, full of clots, and was painful. It lasted longer than usual, until about 5/9. 5/16 - I developed another period only a week after the first period. This period was equally as heavy and long-lasting. It remained until about 5/21.  Following the vaccine, I began suffering from heart palpitations, leg cramps, and random pains. I did not experience these prior to the vaccine. I cannot identify the date these symptoms began, but it was within the first week of taking the vaccine.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Menstruation irregular, Muscle spasms, Nervousness, Pain
Clinical narrative: 4/30 - Five minutes after the vaccine, I passed out. I felt uncontrollably shaky and my vision went white. I was not anxious prior to getting the vaccine and felt terror afterwards. 5/1 - I developed severe depression and suicidal ideation. I reported to those around me that I did not feel safe. I am not diagnosed with depression and did not experience depression prior to the vaccine. I felt suicidal, completely hopeless, anxious, and was uncontrollably bursting into tears without an identifiable trigger. 5/2 - I developed shooting pain in my legs and arms. It felt like a pulsating, stabbing pain that throbbed. It was unlike any pain I had experienced ever before. 5/3 - I developed a metallic taste in my mouth that could not be washed away with water or food. It was extremely noticeable. 5/4  - My period came a week early. I have been on birth control for seven years and have never experienced any changes in my menstrual cycle. I made no other lifestyle or health changes other than the vaccine. The period was extremely heavy, full of clots, and was painful. It lasted longer than usual, until about 5/9. 5/16 - I developed another period only a week after the first period. This period was equally as heavy and long-lasting. It remained until about 5/21.  Following the vaccine, I began suffering from heart palpitations, leg cramps, and random pains. I did not experience these prior to the vaccine. I cannot identify the date these symptoms began, but it was within the first week of taking the vaccine.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Suicidal ideation, Thrombosis, Tremor, Visual impairment
Clinical narrative: 4/30 - Five minutes after the vaccine, I passed out. I felt uncontrollably shaky and my vision went white. I was not anxious prior to getting the vaccine and felt terror afterwards. 5/1 - I developed severe depression and suicidal ideation. I reported to those around me that I did not feel safe. I am not diagnosed with depression and did not experience depression prior to the vaccine. I felt suicidal, completely hopeless, anxious, and was uncontrollably bursting into tears without an identifiable trigger. 5/2 - I developed shooting pain in my legs and arms. It felt like a pulsating, stabbing pain that throbbed. It was unlike any pain I had experienced ever before. 5/3 - I developed a metallic taste in my mouth that could not be washed away with water or food. It was extremely noticeable. 5/4  - My period came a week early. I have been on birth control for seven years and have never experienced any changes in my menstrual cycle. I made no other lifestyle or health changes other than the vaccine. The period was extremely heavy, full of clots, and was painful. It lasted longer than usual, until about 5/9. 5/16 - I developed another period only a week after the first period. This period was equally as heavy and long-lasting. It remained until about 5/21.  Following the vaccine, I began suffering from heart palpitations, leg cramps, and random pains. I did not experience these prior to the vaccine. I cannot identify the date these symptoms began, but it was within the first week of taking the vaccine.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Bladder pain, Blood test, Chest X-ray abnormal, Computerised tomogram thorax abnormal
Clinical narrative: Bladder pain went to er(meds given) Superficial blood clot on right thigh(meds given) Calf pain right leg ***Er with bilateral pulmonary embolism ( hospital 3 nights) ***Dvt right leg(on warfarin)
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pain in extremity, Pulmonary embolism, Thrombophlebitis superficial, Ultrasound Doppler abnormal
Clinical narrative: Bladder pain went to er(meds given) Superficial blood clot on right thigh(meds given) Calf pain right leg ***Er with bilateral pulmonary embolism ( hospital 3 nights) ***Dvt right leg(on warfarin)
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count normal, Heart rate increased, Metabolic function test normal, Nausea, Vomiting
Clinical narrative: Nausea and vomiting started just after midnight, every 30 minutes, then increased to constant every 5 minutes by 0500. 0630 intractable and heart rate in 130s. Taken to ER where 2 boluses of fluids and Zofran given. 1200 she still could not get an ice chip down without vomiting and heart rate remained between 110-140. Admitted to pediatric floor for observation and fluids. About 1600 she was able to hold down spoonful of fluids. By 1900 she was totally back to feeling good and was able to hold down mac-n-cheese, ice cream, crackers with no nausea.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Product storage error
Clinical narrative: Patient was given vaccine that was mixed >6 hours prior to injection but less than <24 hours. It was stored in the refrigerator before administration.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Condition aggravated, Joint swelling, Psoriatic arthropathy, Weight bearing difficulty
Clinical narrative: Severe psoriatic arthritis inflammation in left knee leading to swelling, difficulty in bearing weight and walking, pain with any pressure on the knee.   The adverse event continues to worsen rather than resolve.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Herpes zoster, Pruritus
Clinical narrative: shingles with blisters on left side of neck and left side of head and face down to the front of my neck. I was treated with Valtrex 3 times and am suffering with the nerve endings itching. Very unpleasant.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: Client's Mother asked EMTs  to assess daughter as she was falling asleep on chair. Vitals at 1819: blood pressure 118/80, pulse 90, oxygen 99%. PHN joined shortly after. Upon arrival client sitting upright on chair, awake, alert and oriented x4. Mother stated not knowing if it was normal for client to feel fatigued shortly after vaccine. Per Mother client had already waited 15 mins and no reactions to first dose. Client currently on antibiotic treatment for throat infection. Mother stated client has been up since 0800, went to school and has been out all day. Client stated she just feels tired. Client denied shortness of breath, chest pain, headache, dizziness, or blurry vision. Client awake and alert x4 during time PHN was with client. Mother advised to monitor client at home, ER precautions also given. Last vitals at 1825: blood pressure 116/82, pulse 88, oxygen 99%. Client left facility with steady gait at 1830, Mother was driving client home
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Dyspnoea, Echocardiogram normal, Laboratory test
Clinical narrative: I have been feeling very lightheaded and dizzy ever since. This occurs every day.  I cannot drink caffeine anymore because I get extra dizzy. My balance is off. I got my heart checked in which I had to wear a heart monitor and get an echo. It came back and nothing is wrong with my heart. I also cannot take a deep breath. I always have shortness of breath. I had three episodes in which I thought I was actually going to pass out and my arms and legs were tingly and I was nauseated. I went to the emergency room and nothing came back from my labs. I am lightheaded when I get up fast. I no longer have nausea and appendages tingle.  All of this occurred on the first dose and I did not receive the second dose.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Paraesthesia
Clinical narrative: I have been feeling very lightheaded and dizzy ever since. This occurs every day.  I cannot drink caffeine anymore because I get extra dizzy. My balance is off. I got my heart checked in which I had to wear a heart monitor and get an echo. It came back and nothing is wrong with my heart. I also cannot take a deep breath. I always have shortness of breath. I had three episodes in which I thought I was actually going to pass out and my arms and legs were tingly and I was nauseated. I went to the emergency room and nothing came back from my labs. I am lightheaded when I get up fast. I no longer have nausea and appendages tingle.  All of this occurred on the first dose and I did not receive the second dose.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Rheumatoid arthritis
Clinical narrative: After receiving 2 doses of pfizer covid-19 vaccine. patient was directed by MD to get Janseen vaccine as well, due to not having immunity.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Malaise, Nausea, Seizure, Syncope
Clinical narrative: Patient told us that she has passed out and vomited after receiving vaccines in the past. After getting the vaccine, she didn't feel well. We monitored her in the vaccine room for about 5 minutes. She had a drink of water, then when she was ready, her family helped her into the lobby I returned to the pharmacy, and continued to watch her. The patient's mom came to the window and said patient had fainted. I went to her, and said we need to lower her to the floor. At that point, mom said patient was not breathing I quickly lowered her to the floor, while dad supported her head. I didn't have time to verify that she wasn't breathing, because as soon as she touched the floor, she began convulsing, then sat up and w was immediately awake. She sat up, and we explained that she had passed out and I had her lie down. I stayed with her for a few minutes, asking if they wanted an ambulance (which mom and dad declined) while making sure she was ok. She was just resting at this point, so I returned to the pharmacy, and ask them to let me know if anything changed I continued to watch her from the pharmacy window, and the patient said she was nauseated. We gave mom a bag, and patient vomited in the bag. After a couple more minutes, she seemed to be recovering, and mom and dad helped her out of the store. I followed up with mom at 4:15pm, and mom said patient was still nauseated and had vomited a couple more times. I followed up one last time at 4:45pm, and patient was feeling a bit better, but mom was going to keep an eye on her I recommended that mom take her to a doctor to be evaluated, but mom said she would just keep an eye on her through the night. I told mom that I would follow up again in the morning.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Patient told us that she has passed out and vomited after receiving vaccines in the past. After getting the vaccine, she didn't feel well. We monitored her in the vaccine room for about 5 minutes. She had a drink of water, then when she was ready, her family helped her into the lobby I returned to the pharmacy, and continued to watch her. The patient's mom came to the window and said patient had fainted. I went to her, and said we need to lower her to the floor. At that point, mom said patient was not breathing I quickly lowered her to the floor, while dad supported her head. I didn't have time to verify that she wasn't breathing, because as soon as she touched the floor, she began convulsing, then sat up and w was immediately awake. She sat up, and we explained that she had passed out and I had her lie down. I stayed with her for a few minutes, asking if they wanted an ambulance (which mom and dad declined) while making sure she was ok. She was just resting at this point, so I returned to the pharmacy, and ask them to let me know if anything changed I continued to watch her from the pharmacy window, and the patient said she was nauseated. We gave mom a bag, and patient vomited in the bag. After a couple more minutes, she seemed to be recovering, and mom and dad helped her out of the store. I followed up with mom at 4:15pm, and mom said patient was still nauseated and had vomited a couple more times. I followed up one last time at 4:45pm, and patient was feeling a bit better, but mom was going to keep an eye on her I recommended that mom take her to a doctor to be evaluated, but mom said she would just keep an eye on her through the night. I told mom that I would follow up again in the morning.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram, Injection site abscess, Sinus rhythm
Clinical narrative: Patient reported to Urgent Care with Left sided chest pain with Left arm weakness. Patient evaluated by Dr., called emergency number and sent to hospital via ambulance. Follow-up appontment scheduled.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Pallor
Clinical narrative: About 5 minutes after vaccine patient turned pale, got nauseous , & almost passed out. She also threw up a small amount twice. We provided water & patient ate saltines for the nausea after some improvement.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Eye movement disorder, Immediate post-injection reaction, Musculoskeletal stiffness, Nausea, Posture abnormal
Clinical narrative: Patient had adverse event/reaction to 2nd dose of COVID-19 (Pfizer) vaccine on Sat. 6/5/21 at about 245PM. Immediately after receiving dose, patient began to tremor eyes rolled back in head, stiffened body, slid down chair into indian style sitting. Nauseous. Called EMS.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Patient had adverse event/reaction to 2nd dose of COVID-19 (Pfizer) vaccine on Sat. 6/5/21 at about 245PM. Immediately after receiving dose, patient began to tremor eyes rolled back in head, stiffened body, slid down chair into indian style sitting. Nauseous. Called EMS.
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth, Peripheral swelling, Pruritus
Clinical narrative: Red warm injection site, itching & swelling in arm, hands, feet
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dizziness postural, Dry mouth, Eye irritation, Feeling hot
Clinical narrative: He got really dizzy and lightheaded immediately after. Started throwing up constantly. Went home. Had diarrhea, fever, stomach pain. Chills and headache next day. Went to emergency room for 104 fever. Injected with Zofram.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Rhinorrhoea, Tinnitus
Clinical narrative: He got really dizzy and lightheaded immediately after. Started throwing up constantly. Went home. Had diarrhea, fever, stomach pain. Chills and headache next day. Went to emergency room for 104 fever. Injected with Zofram.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Blood test, Chills, Diarrhoea, Dizziness
Clinical narrative: He got really dizzy and lightheaded immediately after. Started throwing up constantly. Went home. Had diarrhea, fever, stomach pain. Chills and headache next day. Went to emergency room for 104 fever. Injected with Zofram.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Immediate post-injection reaction, Pyrexia, Vomiting
Clinical narrative: He got really dizzy and lightheaded immediately after. Started throwing up constantly. Went home. Had diarrhea, fever, stomach pain. Chills and headache next day. Went to emergency room for 104 fever. Injected with Zofram.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Exhausted; Feeling Strange; Eye floaters; Dizzy/Dizzy so bad I had crawl so I didn't fall; headache; Nauseaus/nauseous - felt like vomiting; Joint Pain; achy pain/achy all over; Flu; Chills; This is a spontaneous report received from a contactable consumer (patient). A 77-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL8982) via an unspecified route of administration, administered in arm right on 29Jan2021 14:00 (at the age of 77-years-old) as 1st dose, single; dose 2 (lot no: EL9267) on 19Feb2021 11:00 as 2nd dose, single for COVID-19 immunization. The medical history included digestion problems, ongoing coeliac disease and allergic to gluten, lesion in pancreas. Concomitant medications included vitamin b complex (VITAMIN B), zinc, ascorbic acid (VITAMIN C), cholecalciferol (VITAMIN D), Bifidobacterium lactis (PROBIOTIC BIFIDOBACTERIUM LACTIS). The patient was not pregnant at the time of vaccination. The patient had not received other vaccine in four weeks. On 29Jan2021 18:00 the patient experienced chills; on 29Jan2021 20:00 the patient experienced joint pain achy pain/achy all over, flu; on 29Jan2021 21:00, the patient experienced headache and nauseous/nauseous - felt like vomiting; on 30Jan2021 06:00 the patient experienced eye floaters and dizzy/dizzy so bad I had crawl so I did not fall; on 30Jan2021 08:00, the patient experienced feeling strange; on 05Feb2021 18:00 the patient experienced exhausted. The patient did not take any treatment. The patient was not tested for covid prior vaccination and post vaccination. The outcome of the events was recovered as of 07May2021. Follow up attempts are completed. No further information is expected. Follow-up (07May2021): This is a follow-up spontaneous report from a Pfizer sponsored program. A 77-years-old female consumer (patient) reported in response to follow up that reporter contact information was available and "after shot, had some side effects" was coded as event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow up (18May2021): This is a follow up spontaneous report from a contactable Consumer. This Consumer reported in response to the non-HCP letter sent that included: events outcome has been updated.   Follow up (19May2021): New information received from contactable consumer included: dose 1 vaccination details and medical history (lesions in pancreas), date and time of the events was added.  Follow up attempts are completed. No further information is expected.  Amendment: This follow-up is being submitted to amend the previously reported information: To add the latest significant FUP 18May2021