chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: INTERMITTENT SHORT OF BREATH; UNCONTROLLABLE CHILLS; SEVERE HEADACHE; FEVER; FATIGUE; LIGHT-HEADED; EXCORIATING BACK PAIN; PROFUSE SWEATING; VOMITING; STOMACH PAIN; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced light-headed. On 20-MAR-2021, the subject experienced excoriating back pain. On 20-MAR-2021, the subject experienced profuse sweating. On 20-MAR-2021, the subject experienced vomiting. On 20-MAR-2021, the subject experienced stomach pain. On 20-MAR-2021, the subject experienced severe headache. On 20-MAR-2021, the subject experienced fever. On 20-MAR-2021, the subject experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 103 F. On 20-MAR-2021 20:00, the subject experienced uncontrollable chills. On 21-MAR-2021, the subject experienced intermittent short of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light-headed, and uncontrollable chills on 20-MAR-2021, excoriating back pain, profuse sweating, severe headache, and fever on 22-MAR-2021, vomiting on 21-MAR-2021, and intermittent short of breath, and fatigue on MAR-2021, and had not recovered from stomach pain. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Headache, Muscle spasms, Muscular weakness, Pain in extremity
Clinical narrative: CHEST PAIN; MUSCLE CRAMPS; MUSCLE WEAKNESS; LEG PAIN; SHARP PAINS IN HEAD/HEADACHES; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included alcoholic, and smoker, and other pre-existing medical conditions included the patient was healthy. The patient had no known allergies. The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced chest pain. On APR-2021, the subject experienced muscle cramps. On APR-2021, the subject experienced muscle weakness. On APR-2021, the subject experienced leg pain. On APR-2021, the subject experienced sharp pains in head/headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sharp pains in head/headaches, muscle weakness, muscle cramps, chest pain, and leg pain. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard operating procedures.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Hypertension, Nasal congestion, Pain
Clinical narrative: BODY ACHES; ARM SORENESS; HEADACHE; HIGH BLOOD PRESSURE; NASAL CONGESTION; This spontaneous report received from a patient concerned a 50 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced high blood pressure. On APR-2021, the subject experienced nasal congestion. On APR-2021, the subject experienced headache. Laboratory data included: Blood pressure (NR: not provided) 130/85 mmHg, 160/100 mmHg.  On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced arm soreness. On 15-APR-2021, Laboratory data included: Blood pressure (NR: not provided) 145/95 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and arm soreness on 08-APR-2021, and had not recovered from high blood pressure, headache, and nasal congestion. This report was non-serious.; Sender's Comments: v0-Medical assessment comment is not required as per standard operating procedures, as the case was assessed as non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: BODY ACHES; ARM SORENESS; HEADACHE; HIGH BLOOD PRESSURE; NASAL CONGESTION; This spontaneous report received from a patient concerned a 50 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced high blood pressure. On APR-2021, the subject experienced nasal congestion. On APR-2021, the subject experienced headache. Laboratory data included: Blood pressure (NR: not provided) 130/85 mmHg, 160/100 mmHg.  On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced arm soreness. On 15-APR-2021, Laboratory data included: Blood pressure (NR: not provided) 145/95 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and arm soreness on 08-APR-2021, and had not recovered from high blood pressure, headache, and nasal congestion. This report was non-serious.; Sender's Comments: v0-Medical assessment comment is not required as per standard operating procedures, as the case was assessed as non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure measurement, Blood test, Chills, Feeling hot
Clinical narrative: WARM RUSH FEELING IN HEAD; SWEATING; BLOOD PRESSURE HIGH; HEART RATE INCREASED; CANNOT SLEEP; TENDERNESS TO ARM ELBOW TO WRIST; CHILLS; SWOLLEN ARM ELBOW TO WRIST; ANXIOUS; MUSCLE STRAIN; This spontaneous report received from a patient concerned a 31 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced muscle strain. Laboratory data included: Blood test (NR: not provided) did not find anything, and Diagnostic ultrasound (NR: not provided) did not find anything. On 11-APR-2021, the subject experienced swollen arm elbow to wrist. On 11-APR-2021, the subject experienced anxious. On 11-APR-2021, the subject experienced sweating. On 11-APR-2021, the subject experienced blood pressure high. On 11-APR-2021, the subject experienced heart rate increased. On 11-APR-2021, the subject experienced cannot sleep. On 11-APR-2021, the subject experienced tenderness to arm elbow to wrist. On 11-APR-2021, the subject experienced chills. Laboratory data included: Blood pressure (NR: not provided) High, and Heart rate (NR: not provided) Increased. On 13-APR-2021, the subject experienced warm rush feeling in head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen arm elbow to wrist, tenderness to arm elbow to wrist, anxious, chills, sweating, blood pressure high, heart rate increased, cannot sleep, warm rush feeling in head, and muscle strain. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Hyperhidrosis, Hypertension, Insomnia
Clinical narrative: WARM RUSH FEELING IN HEAD; SWEATING; BLOOD PRESSURE HIGH; HEART RATE INCREASED; CANNOT SLEEP; TENDERNESS TO ARM ELBOW TO WRIST; CHILLS; SWOLLEN ARM ELBOW TO WRIST; ANXIOUS; MUSCLE STRAIN; This spontaneous report received from a patient concerned a 31 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced muscle strain. Laboratory data included: Blood test (NR: not provided) did not find anything, and Diagnostic ultrasound (NR: not provided) did not find anything. On 11-APR-2021, the subject experienced swollen arm elbow to wrist. On 11-APR-2021, the subject experienced anxious. On 11-APR-2021, the subject experienced sweating. On 11-APR-2021, the subject experienced blood pressure high. On 11-APR-2021, the subject experienced heart rate increased. On 11-APR-2021, the subject experienced cannot sleep. On 11-APR-2021, the subject experienced tenderness to arm elbow to wrist. On 11-APR-2021, the subject experienced chills. Laboratory data included: Blood pressure (NR: not provided) High, and Heart rate (NR: not provided) Increased. On 13-APR-2021, the subject experienced warm rush feeling in head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen arm elbow to wrist, tenderness to arm elbow to wrist, anxious, chills, sweating, blood pressure high, heart rate increased, cannot sleep, warm rush feeling in head, and muscle strain. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle strain, Pain in extremity, Peripheral swelling, Ultrasound scan
Clinical narrative: WARM RUSH FEELING IN HEAD; SWEATING; BLOOD PRESSURE HIGH; HEART RATE INCREASED; CANNOT SLEEP; TENDERNESS TO ARM ELBOW TO WRIST; CHILLS; SWOLLEN ARM ELBOW TO WRIST; ANXIOUS; MUSCLE STRAIN; This spontaneous report received from a patient concerned a 31 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced muscle strain. Laboratory data included: Blood test (NR: not provided) did not find anything, and Diagnostic ultrasound (NR: not provided) did not find anything. On 11-APR-2021, the subject experienced swollen arm elbow to wrist. On 11-APR-2021, the subject experienced anxious. On 11-APR-2021, the subject experienced sweating. On 11-APR-2021, the subject experienced blood pressure high. On 11-APR-2021, the subject experienced heart rate increased. On 11-APR-2021, the subject experienced cannot sleep. On 11-APR-2021, the subject experienced tenderness to arm elbow to wrist. On 11-APR-2021, the subject experienced chills. Laboratory data included: Blood pressure (NR: not provided) High, and Heart rate (NR: not provided) Increased. On 13-APR-2021, the subject experienced warm rush feeling in head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen arm elbow to wrist, tenderness to arm elbow to wrist, anxious, chills, sweating, blood pressure high, heart rate increased, cannot sleep, warm rush feeling in head, and muscle strain. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Full blood count abnormal, Immunoglobulin therapy, Petechiae, Platelet count decreased
Clinical narrative: Morning of April 16th, had a massive nosebleed (first one I?ve experienced in my life, no previous nosebleeds). It lasted about an hour. Petechiae covered my body. Went in to see my doctor for a previously scheduled  routine checkup. While there, mentioned the nosebleed and ?spots?. He took some blood work and found out that my platelet count was only 1,, when it?s supposed to be 400. He admitted me into the hospital  where I stayed until 04/19/2021 after receiving platelets, immunoglobulins, and prednisone.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Breast pain, Pain in extremity
Clinical narrative: LEFT  BREAST OR CHEST PAIN/BURNING; BACK PAIN; BILATERAL LEG PAIN; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient have no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced left breast or chest pain/burning. On 10-APR-2021, the subject experienced back pain. On 10-APR-2021, the subject experienced bilateral leg pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bilateral leg pain, left breast or chest pain/burning, and back pain. This report was non-serious.; Sender's Comments: V0:As per standard protocol, MAC comment is not required for non-serious cases.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Rectal haemorrhage
Clinical narrative: Approximately 4-5 days after second dose patient reported spontaneous rectal hemorrhage after bowel movement unrelated to any known prior issues. No pain reported.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vomiting
Clinical narrative: Patient received vaccine, was told to wait 15 minutes for observation. After about 10 minutes she said she felt dizzy. I had her sit and elevate her feet. She said she felt a bit better, then a minute later felt nauseous. She vomited a small amount and said she felt a little better. I took her blood pressure and it was 118/79 mmHg and 91 for pulse. She said she was feeling better but she'd wait around some more. She left about 10-15 minutes after she said that.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Pain, Pyrexia
Clinical narrative: Later of the day I got the shot, I started feel flu-like symptoms: fatigue, bodyaches and a fever (about 100 F). I took Tylenol next morning and rested all morning, then I was feeling okay in the afternoon.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram, SARS-CoV-2 test, Throat irritation, X-ray
Clinical narrative: Heavy drainage. Inflamed throat severe  burning  In chest area behind brests to back. I thought I had bronchial pneumonia. Chest hurt do bad for 24 days
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperaesthesia teeth, Insomnia
Clinical narrative: Tooth sensitivity that felt like spread through the gums. Lasted several hours. Bad enough to keep awake from sleep and consider going to a hospital. Laying down feels better than sitting or standing up. Tried oragel  to numb the effected area. Did not alleviate pain. Did not try to treat otherwise.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: By 14:30 on April 21 I started to get body aches, nausea, a headache, and felt off. At 07:00 April 22 I woke up with severe body pain, a headache and a temperature of 102*. I utilized Tylenol to bring the fever down to 100* by 10:00. It rose again at 14:00 and 18:00 to 102* requiring more Tylenol. The fever broke around 02:00 on April 23. Body aches continue but not as severe. My injection side was sore April 21 and by 20:00 on April 22 it was very painful and became a large lump about the size of a golf ball. By 07:00 April 23, the injection site was still very swollen and painful but now is warm to the touch, and bright red.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth, Nausea, Pain, Pyrexia
Clinical narrative: By 14:30 on April 21 I started to get body aches, nausea, a headache, and felt off. At 07:00 April 22 I woke up with severe body pain, a headache and a temperature of 102*. I utilized Tylenol to bring the fever down to 100* by 10:00. It rose again at 14:00 and 18:00 to 102* requiring more Tylenol. The fever broke around 02:00 on April 23. Body aches continue but not as severe. My injection side was sore April 21 and by 20:00 on April 22 it was very painful and became a large lump about the size of a golf ball. By 07:00 April 23, the injection site was still very swollen and painful but now is warm to the touch, and bright red.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness
Clinical narrative: Patient was very lightheaded after second dose. Blood pressure was elevated which was unusual for patient .
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Fast heartbeat
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Heart rate increased
Clinical narrative: For shot #1 - Pain in left arm where shot was given. For shot #2 - Severe pain in entire body including injection site. Inability to move easily, Headache, Dizziness, Fever of 99.5, Fatigue, Insomnia, Elevated Heart Rate, and Chills
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Insomnia, Mobility decreased, Pain, Pyrexia
Clinical narrative: For shot #1 - Pain in left arm where shot was given. For shot #2 - Severe pain in entire body including injection site. Inability to move easily, Headache, Dizziness, Fever of 99.5, Fatigue, Insomnia, Elevated Heart Rate, and Chills
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site swelling, Rash macular
Clinical narrative: Beginning 4 hours post injection some swelling was noticed at the injection site. Upon waking (roughly 8 hours later) the swelling at the injection site had intensified and red spots appeared from shoulder to thumb on the injected arm.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Irritable bowel syndrome, Malaise, Pyrexia
Clinical narrative: Approximately twelve hours after receiving my second vaccination (2:45 AM 4/23), I was not able to sleep because of extreme chills. I figured it was mild fever, but quickly began to shake in uncontrollable tremors. I thought I might break my teeth it was terrible. I suffered through this for maybe an hour, and this triggered my IBS. So I had bowel pain and a small bowel movement. Feeling a little better, but still having tremors, I took my temperature.  At approximately 4:00 AM , 4/23, the temperature in my left armpit read 106 degrees. The temperature in my right armpit was 103. My forehead was 97.  I then took Ibubrofin-800mg, and acetaminophen-500mg. I sat on the couch with a cold compress on my left wrist for about an hour.  The tremors did subside and I took my temperature again at 7:00AM. My left armpit was still 106, and right armpit was 102 and forehead was 96. I pointed the meter at my open mouth and it read 103.  I did not feel like it was a medical emergency, but I was feeling very ill with fever.  At 10:00AM the temperature in my left armpit dropped to 102. I did take more tylenol and rested uncomfortably.  It is now 8:00PM 4/23, and i have been ill all day, and my temperature is down.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Approximately twelve hours after receiving my second vaccination (2:45 AM 4/23), I was not able to sleep because of extreme chills. I figured it was mild fever, but quickly began to shake in uncontrollable tremors. I thought I might break my teeth it was terrible. I suffered through this for maybe an hour, and this triggered my IBS. So I had bowel pain and a small bowel movement. Feeling a little better, but still having tremors, I took my temperature.  At approximately 4:00 AM , 4/23, the temperature in my left armpit read 106 degrees. The temperature in my right armpit was 103. My forehead was 97.  I then took Ibubrofin-800mg, and acetaminophen-500mg. I sat on the couch with a cold compress on my left wrist for about an hour.  The tremors did subside and I took my temperature again at 7:00AM. My left armpit was still 106, and right armpit was 102 and forehead was 96. I pointed the meter at my open mouth and it read 103.  I did not feel like it was a medical emergency, but I was feeling very ill with fever.  At 10:00AM the temperature in my left armpit dropped to 102. I did take more tylenol and rested uncomfortably.  It is now 8:00PM 4/23, and i have been ill all day, and my temperature is down.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature fluctuation, Erythema, Feeling abnormal, Pruritus, Urticaria
Clinical narrative: Immediate temperature fluctuation, fogginess, it lifted fast and was able to drive home. About 30 minutes after I was home hives on my scalp, they disappeared in about an hour. 6 hours after the vaccine my hands broke out, and then I checked the rest of me, my chest was sunburn red, which is usually my first symptom when I?m having a reaction. I took an antihistamine and it all calmed down. No hives today, but I?m itchy. Pretty wicked headache. The antihistamine is almost out of my system.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Gingival bleeding, Gingival swelling, Headache
Clinical narrative: High fever, chills, headache frontal lobe, nauseated, severe upper teeth pain -severe numbness in my upper teeth same teeth and same area, which then became swollen bleeding gums .  This is still continuing. Extremely fatigued. All symptoms have gone EXCEPT teeth upper palate area. Dr. Said to report this and My Dentist said to report this. Their medical expertise this is related to the Injection.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oral pain, Pyrexia, Toothache
Clinical narrative: High fever, chills, headache frontal lobe, nauseated, severe upper teeth pain -severe numbness in my upper teeth same teeth and same area, which then became swollen bleeding gums .  This is still continuing. Extremely fatigued. All symptoms have gone EXCEPT teeth upper palate area. Dr. Said to report this and My Dentist said to report this. Their medical expertise this is related to the Injection.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dysphagia, Dyspnoea
Clinical narrative: Tightness in chest, difficulty breathing, difficulty swallowing
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: Shortly after patient received an injection patient felt dizzy and fainted. Patient never lost consciousness. Patient promptly sat down and paramedics were called for evaluation. After evaluation patient was able to go home.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain, Sleep disorder
Clinical narrative: Felt like the vaccine was burning through my veins in both of my arms....woke up in the middle of the night with it and could not get comfortable due to pain and due to burning sensation.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Red arm
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest X-ray abnormal, Extra dose administered, Interchange of vaccine products, Lethargy, Pyrexia
Clinical narrative: Resident developed 101 F fever and lethargy  5 days after receiving a dose of Moderna erroneously. Patient has been completely vaccinated with Pfizer prior. Patient was sent to hospital for further evaluation
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urine analysis normal
Clinical narrative: Resident developed 101 F fever and lethargy  5 days after receiving a dose of Moderna erroneously. Patient has been completely vaccinated with Pfizer prior. Patient was sent to hospital for further evaluation
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in jaw, Toothache, Vision blurred
Clinical narrative: Jaw pain, ongoing headache, blurred vision in one eye, tooth pain
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Had the shot on Friday afternoon. It felt hot in my arm at first then that feeling went away. Stayed 15 min and left. Was fine just a sore arm. Went to bed that night and woke up with a rash on my right arm and very sore. Had chills and a real bad headache. All day Saturday I was worthless. Rash had spreaded across my arm very sore. I slept for 17 hours that is not me at all! headache bad! Woke up Sunday was much better. Rash stayed for a week.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoacusis, Tinnitus
Clinical narrative: Tinnitus in both ears. It has impacted hearing and is nonstop in both ears. Going to audiologist next week. Ringing in ears nonstop since the first Moderna dose.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Tachycardia, Tinnitus
Clinical narrative: Ongoing crackling in ear and dizziness (vertigo-like), tachycardia (elevated heart rate)  around 36 hours  post vaccine and ongoing symptoms now for 72 hours.
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Dyspnoea, Headache, Injection site pain
Clinical narrative: SHORTNESS  OF BREATH; CHEST TIGHTNESS; NON-PRODUCTIVE COUGH; HAND  TINGLING; HEAVY ARM; PAIN IN HAND; INJECTION SITE PAIN; HEADACHE; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 13:15 for prophylactic vaccination.  No concomitant medications were reported.  On 07-APR-2021, the subject experienced hand tingling. On 07-APR-2021, the subject experienced heavy arm. On 07-APR-2021, the subject experienced pain in hand. On 07-APR-2021, the subject experienced injection site pain. On 07-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced shortness of breath. On 09-APR-2021, the subject experienced chest tightness. On 09-APR-2021, the subject experienced non-productive cough. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain, and headache on 07-APR-2021, was recovering from heavy arm, pain in hand, and hand tingling, and had not recovered from shortness of breath, non-productive cough, and chest tightness. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity, Paraesthesia
Clinical narrative: SHORTNESS  OF BREATH; CHEST TIGHTNESS; NON-PRODUCTIVE COUGH; HAND  TINGLING; HEAVY ARM; PAIN IN HAND; INJECTION SITE PAIN; HEADACHE; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 13:15 for prophylactic vaccination.  No concomitant medications were reported.  On 07-APR-2021, the subject experienced hand tingling. On 07-APR-2021, the subject experienced heavy arm. On 07-APR-2021, the subject experienced pain in hand. On 07-APR-2021, the subject experienced injection site pain. On 07-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced shortness of breath. On 09-APR-2021, the subject experienced chest tightness. On 09-APR-2021, the subject experienced non-productive cough. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain, and headache on 07-APR-2021, was recovering from heavy arm, pain in hand, and hand tingling, and had not recovered from shortness of breath, non-productive cough, and chest tightness. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Bloody nose about 3 hours after 2nd dose shot of Moderna.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain, Nausea, Pyrexia
Clinical narrative: 102 fever, chills, nausea, fatigue, sore at injection site
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Nausea, Pollakiuria, Syncope
Clinical narrative: Fainted, urinated, nauseated, chest pain start @ 2010. Evaluated by EMS- Transported to Emergency room/department or urgent care.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Malaise
Clinical narrative: A felt sick Thursday night going into Friday morning, I've had diarrhea throughout the day and feeling tired even though I've been staying at home.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Headache, Injection site pain, Oversensing
Clinical narrative: Light headedness, headache, sore arm where vaccine was innected, feeling "off", and sensitivity to noise.  Started following morning after vaccine.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Electrocardiogram ambulatory, Fatigue, Palpitations
Clinical narrative: Palpitations, fatigue. Has persisted for months
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hot flush, Hypoaesthesia, Palpitations, Paraesthesia
Clinical narrative: 20-25 minutes after-facial numbness and tingling, shortness of breath, heart racing, hot flashes. These continued for 3-4 hours after shot. 24 hours later still have shortness of breath and periodic heart racing.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Feeling cold, Headache, Respiratory tract congestion, Thrombophlebitis superficial
Clinical narrative: SUPERFICIAL LEG THROMBOSIS; CHEST CONGESTION; TERRIBLE HEADACHE; LEGS WERE FROZEN; BRUISES ON HER LEGS; This spontaneous self-report was received from a patient and concerns a 68 year old female of unspecified race and ethnicity. Initial information received from the patient on 13-APR-2021 was processed with additional information received from the patient on 14-APR-2021 and telephone follow up with the patient on 20-APR-2021. The patient's weight and height were not reported. The patient had tuberculosis and had completed TB medication course. The patient does not have hypertension or diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, date, vaccination site, and batch number were not reported) for prophylactic vaccination. The batch number will be requested in follow up. The patient was not taking any concomitant medications. On the third day after vaccination, the patient experienced terrible headache. Two days later, both her legs were frozen, and she had bruises on her legs. She went to a physician who advised her to go to the Emergency Room (ER), where they did an ultrasound on her legs. The physician told her that she had superficial leg thrombosis and asked her to take aspirin. No labs or any other diagnostic tests were performed. On the fifth day post-vaccination, the patient had chest congestion for 1 day. At the time of report, the patient was feeling better, and her bruises were disappearing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest congestion and terrible headache, and was recovering from superficial leg thrombosis, legs were frozen, and bruises on her legs. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  This 68-year-old female patient of unspecified ethnicity was found to have superficial blood clots in both legs 5 days after receiving COVID-19 VACCINE AD26.COV2.S intramuscularly for the prevention of symptomatic SARS-CoV-2 virus infection.  The patient reported "terrible" headache 3 days after vaccination, "chest congestion" and that both her legs were "frozen" and with bruises 5 days after vaccination.  Ultrasound on both legs showed superficial leg thrombosis during emergency room consultation and was advised to take asprin as treatment.  The event is recovering. Based on the information that is available, the event is assessed as plausible per the causality classification for adverse events.  Considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.  Additional information has been requested for further assessment.
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: SUPERFICIAL LEG THROMBOSIS; CHEST CONGESTION; TERRIBLE HEADACHE; LEGS WERE FROZEN; BRUISES ON HER LEGS; This spontaneous self-report was received from a patient and concerns a 68 year old female of unspecified race and ethnicity. Initial information received from the patient on 13-APR-2021 was processed with additional information received from the patient on 14-APR-2021 and telephone follow up with the patient on 20-APR-2021. The patient's weight and height were not reported. The patient had tuberculosis and had completed TB medication course. The patient does not have hypertension or diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, date, vaccination site, and batch number were not reported) for prophylactic vaccination. The batch number will be requested in follow up. The patient was not taking any concomitant medications. On the third day after vaccination, the patient experienced terrible headache. Two days later, both her legs were frozen, and she had bruises on her legs. She went to a physician who advised her to go to the Emergency Room (ER), where they did an ultrasound on her legs. The physician told her that she had superficial leg thrombosis and asked her to take aspirin. No labs or any other diagnostic tests were performed. On the fifth day post-vaccination, the patient had chest congestion for 1 day. At the time of report, the patient was feeling better, and her bruises were disappearing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest congestion and terrible headache, and was recovering from superficial leg thrombosis, legs were frozen, and bruises on her legs. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  This 68-year-old female patient of unspecified ethnicity was found to have superficial blood clots in both legs 5 days after receiving COVID-19 VACCINE AD26.COV2.S intramuscularly for the prevention of symptomatic SARS-CoV-2 virus infection.  The patient reported "terrible" headache 3 days after vaccination, "chest congestion" and that both her legs were "frozen" and with bruises 5 days after vaccination.  Ultrasound on both legs showed superficial leg thrombosis during emergency room consultation and was advised to take asprin as treatment.  The event is recovering. Based on the information that is available, the event is assessed as plausible per the causality classification for adverse events.  Considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.  Additional information has been requested for further assessment.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Eye swelling, Fatigue, Hypersensitivity, Lacrimation increased
Clinical narrative: 24 hours after receiving vaccine, the left side of my face experienced mild swelling (it should be noted I received the injection in my left arm). I experienced heavy allergy symptoms including redness and swelling in left eye, watery eyes particularly in left eye, runny nose and pain particularly in left nostril, heaviness of breath, tiredness.  I think it is of note that as of writing this, I have not received commonly reported symptoms of fever, chills and nausea in conjunction with the reported adverse symptoms.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Pain, Rhinorrhoea, Swelling face
Clinical narrative: 24 hours after receiving vaccine, the left side of my face experienced mild swelling (it should be noted I received the injection in my left arm). I experienced heavy allergy symptoms including redness and swelling in left eye, watery eyes particularly in left eye, runny nose and pain particularly in left nostril, heaviness of breath, tiredness.  I think it is of note that as of writing this, I have not received commonly reported symptoms of fever, chills and nausea in conjunction with the reported adverse symptoms.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dysphagia, Fatigue, Feeling hot, Hyperhidrosis
Clinical narrative: Sore arm, medicine taste in the mouth, very hot and sweaty over the night, itchy foot and arm, hard to swallow my saliva, and the following day diarrhea, vertigo, nausea, fatigue.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pruritus, Taste disorder, Vertigo
Clinical narrative: Sore arm, medicine taste in the mouth, very hot and sweaty over the night, itchy foot and arm, hard to swallow my saliva, and the following day diarrhea, vertigo, nausea, fatigue.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head, Haematoma, Head injury, Influenza like illness, Syncope
Clinical narrative: Severe flu symptoms, fainted at 5:15 am on 4/22/21, hematoma head injury
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Electrocardiogram normal, Syncope
Clinical narrative: Fainted for 30 seconds after standing up and walking. Ambulance came to the house and recommended a trip to the ER where I received an IV.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Chills, headache
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Injection site pain, Neck pain
Clinical narrative: Patient states pain at injection site beginning the day after injection. Pain has moved from the left arm to shoulder and then to the neck.  Patient is also experiencing dizziness.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT; This spontaneous report was received from a female patient of an unspecified age.   The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine Ad26.COV2.S (suspension for injection, route of administration, and batch number were not reported) dose, vaccination site, and start therapy date were not provided, for prophylactic vaccination; and was treated with XARELTO (rivaroxaban; film-coated tablet, oral, batch number was not reported) dose, frequency, and therapy dates were not provided, for an unknown indication. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced a blood clot. The patient reported she got a blood clot after receiving her vaccine, and that she had just started taking rivaroxaban.  Action taken with Covid-19 vaccine Ad26.COV2.S was not applicable, and action taken with rivaroxaban was not reported. The patient outcome for the event of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: v0 This report involves a female patient of unspecified age who experienced a blood clot on an unspecified date after receiving the Janssen COVID-19 Vaccine Ad26.COV2. Concomitant medications included rivaroxaban (recently started). The patient's past medical history and details of the event were not reported. The recent starting of rivaroxaban infers a recent clot or a condition that would predispose the patient to develop a clot, however this case has insufficient information to make a meaningful medical assessment.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Syncope - Pt fainted when attempting to stand ~10 minutes after vaccination.  Pt regained consciousness w/i ~1 min and was oriented to person, place, and time.  Pt stated that he was fine afterwards and refused EMS transport.
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Adverse drug reaction, Biopsy skin, Chills, Fatigue, Headache
Clinical narrative: Day of vaccine- buzzing/vibrating headache, fatigue 22 hours after vaccine- fingers went numb, chills, aches, fever and fatigue 6 days after vaccine - skin rash that started on my left arm (not by the shot site) the next day the severe rash spread to both arms, both legs and eventually my abdomen, chest, breasts, neck and side of my left face.
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Hypoaesthesia, Pain, Pyrexia, Rash
Clinical narrative: Day of vaccine- buzzing/vibrating headache, fatigue 22 hours after vaccine- fingers went numb, chills, aches, fever and fatigue 6 days after vaccine - skin rash that started on my left arm (not by the shot site) the next day the severe rash spread to both arms, both legs and eventually my abdomen, chest, breasts, neck and side of my left face.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Rash papular
Clinical narrative: Itchy, red, raised area surrounding injection site. 8 days post vaccination. Painful to touch
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: Extreme weakness and fatigue
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Chills, Dizziness, Electrocardiogram
Clinical narrative: -2nd dose pfizer given at 4:39pm. -Vaccine given in EMS area d/t light headedness with 1st dose.  -Reported h(x) anxiety.  -4:43pm 2nd dose post vaccine tingling in arm and slight spinning sensation. Patient talkative. -5pm patient continues to engage convestation with others and share stories. -5:15pm headache, joints aching, & constricted feeling on body.  tingling feeling gone. States feeling worse.  Safety officer asked EMS to take vitals.  BP 114/75.  SaO2 97%, 99/min.  -Encouraged relaxing breathing techniques.  -5:28pm crying, stated not feeling good, very slight flushing noted on neck, lips pink, chills noted, SaO2 99% -5:38pm chest tightness verbalized, Safety officer grabbed EpiPen and suggested Epi to EMS.  He stated to hold and medic called.  -5:40pm SaO2 98%, chills, 102/min HR, BP 144/88 talking clearly and appeared to be breathing comfortably.  chest tightness verbalized.  slight flushing on chest appeared the same.  -5:45pm EKG started.   -5:47pm Medic unit arrived. IV benadryl given.   -6:02pm left site with medic unit to ER.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Flushing, Headache, Logorrhoea, Paraesthesia
Clinical narrative: -2nd dose pfizer given at 4:39pm. -Vaccine given in EMS area d/t light headedness with 1st dose.  -Reported h(x) anxiety.  -4:43pm 2nd dose post vaccine tingling in arm and slight spinning sensation. Patient talkative. -5pm patient continues to engage convestation with others and share stories. -5:15pm headache, joints aching, & constricted feeling on body.  tingling feeling gone. States feeling worse.  Safety officer asked EMS to take vitals.  BP 114/75.  SaO2 97%, 99/min.  -Encouraged relaxing breathing techniques.  -5:28pm crying, stated not feeling good, very slight flushing noted on neck, lips pink, chills noted, SaO2 99% -5:38pm chest tightness verbalized, Safety officer grabbed EpiPen and suggested Epi to EMS.  He stated to hold and medic called.  -5:40pm SaO2 98%, chills, 102/min HR, BP 144/88 talking clearly and appeared to be breathing comfortably.  chest tightness verbalized.  slight flushing on chest appeared the same.  -5:45pm EKG started.   -5:47pm Medic unit arrived. IV benadryl given.   -6:02pm left site with medic unit to ER.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccine positive rechallenge, Vertigo, Vital signs measurement
Clinical narrative: -2nd dose pfizer given at 4:39pm. -Vaccine given in EMS area d/t light headedness with 1st dose.  -Reported h(x) anxiety.  -4:43pm 2nd dose post vaccine tingling in arm and slight spinning sensation. Patient talkative. -5pm patient continues to engage convestation with others and share stories. -5:15pm headache, joints aching, & constricted feeling on body.  tingling feeling gone. States feeling worse.  Safety officer asked EMS to take vitals.  BP 114/75.  SaO2 97%, 99/min.  -Encouraged relaxing breathing techniques.  -5:28pm crying, stated not feeling good, very slight flushing noted on neck, lips pink, chills noted, SaO2 99% -5:38pm chest tightness verbalized, Safety officer grabbed EpiPen and suggested Epi to EMS.  He stated to hold and medic called.  -5:40pm SaO2 98%, chills, 102/min HR, BP 144/88 talking clearly and appeared to be breathing comfortably.  chest tightness verbalized.  slight flushing on chest appeared the same.  -5:45pm EKG started.   -5:47pm Medic unit arrived. IV benadryl given.   -6:02pm left site with medic unit to ER.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: PATIENT GOT 1ST DOSE OF MODERNA ON 04/09/21 AND BELIEVED THE SECOND ONE WAS DUE 04/23/21, ARRIVED AT FACILITY AND WHEN BEING PROCESSED IT APPEARS COORDINATOR AND THE LIST WAS MISSED.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: rash on abdomen, very itchy, small bumps all over abdomen shortly after vaccine administration.  on 4/22 (the day after the vaccine) breastfeeding infant developed rash also -- she has NEVER had a rash. ever.