chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Myalgia
Clinical narrative: HEART BEATS STRONGLY; MINOR MUSCLE ACHE; SHAKING WITH CHILLS; NAGGING HEADACHE; FOGGY FEELING; EAR PROBLEM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient was previously treated with influenza vaccine for prophylactic vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number :unknown) dose was not reported, administered on 07-APR-2021 12:45 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced ear problem. On 07-APR-2021, treatment medications included: paracetamol. On 07-APR-2021 17:30, the subject experienced foggy feeling. On 07-APR-2021 17:30, the subject experienced nagging headache. On 07-APR-2021 20:15, the subject experienced shaking with chills. On 08-APR-2021, the subject experienced minor muscle ache. Laboratory data included: Heart rate (NR: not provided) 125-130 bpm. On 08-APR-2021 00:15, the subject experienced heart beats strongly. Laboratory data included: Heart rate (NR: not provided) 152 bpm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart beats strongly, foggy feeling, and shaking with chills on APR-2021, and had not recovered from nagging headache, minor muscle ache, and ear problem. This report was non-serious. This case, from the same reporter is linked to 20210420580 and 20210420637.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Dysstasia, Mobility decreased, Musculoskeletal stiffness, Myalgia
Clinical narrative: IMMOBILITY AROUND ANKLES AND FEET; STIFFNESS; DIFFICULTY IN STANDING; JOINT PAIN; MUSCLE PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced immobility around ankles and feet. On APR-2021, the subject experienced stiffness. On APR-2021, the subject experienced difficulty in standing. On APR-2021, the subject experienced joint pain. On APR-2021, the subject experienced muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle pain, joint pain, stiffness, difficulty in standing, and immobility around ankles and feet. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: IMMOBILITY AROUND ANKLES AND FEET; STIFFNESS; DIFFICULTY IN STANDING; JOINT PAIN; MUSCLE PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced immobility around ankles and feet. On APR-2021, the subject experienced stiffness. On APR-2021, the subject experienced difficulty in standing. On APR-2021, the subject experienced joint pain. On APR-2021, the subject experienced muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle pain, joint pain, stiffness, difficulty in standing, and immobility around ankles and feet. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blindness, Dizziness, Seizure
Clinical narrative: LOSS OF VISION; SEIZURE; DIZZINESS; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. 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: 1805031, and expiry: UNKNOWN) dose was not reported, 1 total administered on 07-APR-2021 on right deltoid for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the patient experienced loss of vision, seizure and dizziness. The seizure was for few seconds. The patient was not sent to hospital.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, loss of vision and seizure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210417256, 20210417122, 20210417456, 20210417469, 20210417550, 20210417620 and 20210418457.; Sender's Comments: 20210417209-covid-19 vaccine ad26.cov2.s-Loss of vision, seizure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported.  The patient's concurrent conditions included seasonal allergy, pain killer allergy, medical marijuana abuse/medical marijuana smoker, alcohol use, rheumatoid arthritis, and lymphoma, and other pre-existing medical conditions included the patient had a retoxic treatment in MAY-2020. The patient was previously treated with methotrexate for immunosuppressive drugs five days prior to the vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 to left deltoid for prophylactic vaccination. Concomitant medications included leflunomide (20 mg once daily) for rheumatoid arthritis.  On 25-MAR-2021, the patient's first antibody test was negative (non reactive). On 08-APR-2021, the second antibody test was also negative (non reactive). Test results suggested that the patient experienced confirmed immunological vaccination failure (coded to- therapy non-responder). The patient did not develop antibody, which he was suspecting because he read an article about it, the reason of this was that he was taking leflunomide. He did not develop any side effects after getting the vaccination and he mentioned that it was difficult to say if he experienced a side effect because he had a medical condition that could be the cause.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210417253-covid-19 vaccine ad26.cov2.s-confirmed immunological vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS, SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Fall, Head injury, Hyperhidrosis, Pallor, Unresponsive to stimuli
Clinical narrative: UNRESPONSIVE FOR 30 SECONDS; HIT HEAD ON THE CONCRETE WALL; FELL TO THE SIDE, FELL OFF THE CHAIR; PALE; DIAPHORETIC; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. 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: 201A21A and expiry: UNKNOWN) dose was not reported, once total administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported The reporter stated that, the patient while sitting in the observation area, fell to the side, fell off the chair and hit head on the concrete wall on 07-APR-2021. On the same day, the patient was unresponsive for 30 seconds, pale and diaphoretic. Transported and evaluated by emergency medical services (EMS). Patient refused transport to hospital.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the unresponsive for 30 seconds, pale, diaphoretic, fell to the side, fell off the chair and hit head on the concrete wall was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210417256, 20210417209, 20210417456 and 20210417122.; Sender's Comments: V0:20210417469- covid-19 vaccine ad26.cov2.s-unresponsive for 30 seconds. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Body temperature, Chills, Dizziness
Clinical narrative: LIGHT-HEADED AND DIZZY; BODY ACHE; LEFT LEG THROBBING; INCREASE HEART RATE; HIGH BLOOD PRESSURE; NAUSEOUS; FEVER; HEART RACING; CHILLS; WEAKNESS; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, non-alcoholic, and non-smoker, 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, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 11:30 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced heart racing. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced weakness. On 07-APR-2021, the subject experienced increase heart rate. On 07-APR-2021, the subject experienced high blood pressure. On 07-APR-2021, the subject experienced light-headed and dizzy. On 07-APR-2021, the subject experienced body ache. On 07-APR-2021, the subject experienced left leg throbbing. On 07-APR-2021, the subject experienced nauseous. On 07-APR-2021, the subject experienced fever. Laboratory data included: Blood pressure (NR: not provided) 130/105 mmHg, and Heart rate (NR: not provided) 110bpm. On 08-APR-2021, Laboratory data included: Blood pressure (NR: not provided) 140/103 bpm, and Body temperature (NR: not provided) 99.5 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from increase heart rate, and had not recovered from light-headed and dizzy, nauseous, body ache, fever, high blood pressure, left leg throbbing, weakness, heart racing, and chills. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Hypertension, Nausea, Pain
Clinical narrative: LIGHT-HEADED AND DIZZY; BODY ACHE; LEFT LEG THROBBING; INCREASE HEART RATE; HIGH BLOOD PRESSURE; NAUSEOUS; FEVER; HEART RACING; CHILLS; WEAKNESS; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, non-alcoholic, and non-smoker, 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, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 11:30 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced heart racing. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced weakness. On 07-APR-2021, the subject experienced increase heart rate. On 07-APR-2021, the subject experienced high blood pressure. On 07-APR-2021, the subject experienced light-headed and dizzy. On 07-APR-2021, the subject experienced body ache. On 07-APR-2021, the subject experienced left leg throbbing. On 07-APR-2021, the subject experienced nauseous. On 07-APR-2021, the subject experienced fever. Laboratory data included: Blood pressure (NR: not provided) 130/105 mmHg, and Heart rate (NR: not provided) 110bpm. On 08-APR-2021, Laboratory data included: Blood pressure (NR: not provided) 140/103 bpm, and Body temperature (NR: not provided) 99.5 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from increase heart rate, and had not recovered from light-headed and dizzy, nauseous, body ache, fever, high blood pressure, left leg throbbing, weakness, heart racing, and chills. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Palpitations, Pyrexia
Clinical narrative: LIGHT-HEADED AND DIZZY; BODY ACHE; LEFT LEG THROBBING; INCREASE HEART RATE; HIGH BLOOD PRESSURE; NAUSEOUS; FEVER; HEART RACING; CHILLS; WEAKNESS; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, non-alcoholic, and non-smoker, 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, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 11:30 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced heart racing. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced weakness. On 07-APR-2021, the subject experienced increase heart rate. On 07-APR-2021, the subject experienced high blood pressure. On 07-APR-2021, the subject experienced light-headed and dizzy. On 07-APR-2021, the subject experienced body ache. On 07-APR-2021, the subject experienced left leg throbbing. On 07-APR-2021, the subject experienced nauseous. On 07-APR-2021, the subject experienced fever. Laboratory data included: Blood pressure (NR: not provided) 130/105 mmHg, and Heart rate (NR: not provided) 110bpm. On 08-APR-2021, Laboratory data included: Blood pressure (NR: not provided) 140/103 bpm, and Body temperature (NR: not provided) 99.5 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from increase heart rate, and had not recovered from light-headed and dizzy, nauseous, body ache, fever, high blood pressure, left leg throbbing, weakness, heart racing, and chills. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure measurement, Dyspepsia, Dyspnoea, Fatigue
Clinical narrative: HIGH BLOOD PRESSURE; FAST HEART BEAT; FELT LIKE BODY WAS SHUTTING DOWN; VOMITING; DIFFICULTY BREATHING; FATIGUE; GAS WENT BACK TO CHEST/CANNOT PASS GAS OR BURP; DIGESTION ISSUES; FELT ANXIOUS; COULD NOT SLEEP; This spontaneous report received from a patient, a 40-year-old female. The patient's height, and weight were not reported. The patient did not consume alcohol, did not smoke and had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 042A21A and expiry: unknown) dose was not reported, 1 total, administered on left arm on 02-APR-2021 at 14:00 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, at night, the patient experienced fatigue but, it was not extreme. On 03-APR-2021, the patient woke up vomiting, had difficulty breathing, fast heartbeats and felt like her body was shutting down following which her mother called the ambulance. On the same day, the patient was admitted to the emergency room (ER) of a hospital where her blood pressure was found to be very high and she was also given an intravenous (IV) as she had difficulty breathing. The patient was given Miralax (macrogol 3350) and was discharged on 03-APR-2021 itself. On 04-APR-2021, patient went to urgent care with the same symptoms. The doctor advised her to take magnesium citrate as she had digestion issues and the gas went back to her chest which made it difficult for her to breath. She could not pass gas/burp or eat whole foods. On an unspecified date in APR-2021, she felt anxious and could not sleep. At the time of report, her digestion issues persisted and the difficulty in breathing comes and goes. The patient was hospitalized for 1 day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high blood pressure, and fast heart beat on APR-2021, had not recovered from difficulty breathing, gas went back to chest/cannot pass gas or burp, and digestion issues, and the outcome of fatigue, vomiting, felt anxious, could not sleep and felt like body was shutting down was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210417726.; Sender's Comments: V0: 20210417680-Covid-19 vaccine .ad26.cov2.s- Difficuty breathing, High blood pressure, Fast heartbeat, Felt like body was shutting down, Vomiting,. This event(s) is considered Unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20210417680-Covid-19 vaccine .ad26.cov2.s-Fatigue. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Flatulence, Heart rate increased, Hypertension, Insomnia
Clinical narrative: HIGH BLOOD PRESSURE; FAST HEART BEAT; FELT LIKE BODY WAS SHUTTING DOWN; VOMITING; DIFFICULTY BREATHING; FATIGUE; GAS WENT BACK TO CHEST/CANNOT PASS GAS OR BURP; DIGESTION ISSUES; FELT ANXIOUS; COULD NOT SLEEP; This spontaneous report received from a patient, a 40-year-old female. The patient's height, and weight were not reported. The patient did not consume alcohol, did not smoke and had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 042A21A and expiry: unknown) dose was not reported, 1 total, administered on left arm on 02-APR-2021 at 14:00 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, at night, the patient experienced fatigue but, it was not extreme. On 03-APR-2021, the patient woke up vomiting, had difficulty breathing, fast heartbeats and felt like her body was shutting down following which her mother called the ambulance. On the same day, the patient was admitted to the emergency room (ER) of a hospital where her blood pressure was found to be very high and she was also given an intravenous (IV) as she had difficulty breathing. The patient was given Miralax (macrogol 3350) and was discharged on 03-APR-2021 itself. On 04-APR-2021, patient went to urgent care with the same symptoms. The doctor advised her to take magnesium citrate as she had digestion issues and the gas went back to her chest which made it difficult for her to breath. She could not pass gas/burp or eat whole foods. On an unspecified date in APR-2021, she felt anxious and could not sleep. At the time of report, her digestion issues persisted and the difficulty in breathing comes and goes. The patient was hospitalized for 1 day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high blood pressure, and fast heart beat on APR-2021, had not recovered from difficulty breathing, gas went back to chest/cannot pass gas or burp, and digestion issues, and the outcome of fatigue, vomiting, felt anxious, could not sleep and felt like body was shutting down was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210417726.; Sender's Comments: V0: 20210417680-Covid-19 vaccine .ad26.cov2.s- Difficuty breathing, High blood pressure, Fast heartbeat, Felt like body was shutting down, Vomiting,. This event(s) is considered Unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20210417680-Covid-19 vaccine .ad26.cov2.s-Fatigue. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: HIGH BLOOD PRESSURE; FAST HEART BEAT; FELT LIKE BODY WAS SHUTTING DOWN; VOMITING; DIFFICULTY BREATHING; FATIGUE; GAS WENT BACK TO CHEST/CANNOT PASS GAS OR BURP; DIGESTION ISSUES; FELT ANXIOUS; COULD NOT SLEEP; This spontaneous report received from a patient, a 40-year-old female. The patient's height, and weight were not reported. The patient did not consume alcohol, did not smoke and had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 042A21A and expiry: unknown) dose was not reported, 1 total, administered on left arm on 02-APR-2021 at 14:00 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, at night, the patient experienced fatigue but, it was not extreme. On 03-APR-2021, the patient woke up vomiting, had difficulty breathing, fast heartbeats and felt like her body was shutting down following which her mother called the ambulance. On the same day, the patient was admitted to the emergency room (ER) of a hospital where her blood pressure was found to be very high and she was also given an intravenous (IV) as she had difficulty breathing. The patient was given Miralax (macrogol 3350) and was discharged on 03-APR-2021 itself. On 04-APR-2021, patient went to urgent care with the same symptoms. The doctor advised her to take magnesium citrate as she had digestion issues and the gas went back to her chest which made it difficult for her to breath. She could not pass gas/burp or eat whole foods. On an unspecified date in APR-2021, she felt anxious and could not sleep. At the time of report, her digestion issues persisted and the difficulty in breathing comes and goes. The patient was hospitalized for 1 day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high blood pressure, and fast heart beat on APR-2021, had not recovered from difficulty breathing, gas went back to chest/cannot pass gas or burp, and digestion issues, and the outcome of fatigue, vomiting, felt anxious, could not sleep and felt like body was shutting down was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210417726.; Sender's Comments: V0: 20210417680-Covid-19 vaccine .ad26.cov2.s- Difficuty breathing, High blood pressure, Fast heartbeat, Felt like body was shutting down, Vomiting,. This event(s) is considered Unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20210417680-Covid-19 vaccine .ad26.cov2.s-Fatigue. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 17 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: Unk) dose, start therapy date were not reported for prophylactic vaccination.The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 2021, the subject experienced off label use. On an unspecified date, the subject experienced product administered to subject of inappropriate age. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and product administered to patient of inappropriate age was not reported. This report was non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: Sudden hearing loss, Right ear only. Ruled out physical blockage of external ear canal. No medical history for SHL. Onset was textbook: Overnight development, Acute onset, Nearly total hearing loss in R ear. Accompanied by minor tinnitus / low frequency.  No recent history of injury or illness.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Injection site pain, Neck pain, Pain
Clinical narrative: Left shoulder/upper arm swelling with redness/erythema developing over 2-3 days with initial painful injection with radiation of pain to left neck, left shoulder and left leg.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Left shoulder/upper arm swelling with redness/erythema developing over 2-3 days with initial painful injection with radiation of pain to left neck, left shoulder and left leg.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Chest pain, Electrocardiogram, Laboratory test, Myocarditis
Clinical narrative: On 4/17/21 (ie within 48 hours of receiving COVID 19 Pfizer Shot #2 (4/15/21), my daughter began experiencing chest pain in the PM (PM of 4/17).  It was initially mild so we did a watch and wait overnight but when it did not go away by morning of 4/18/21 we went to Urgent Care  .  Upon presentation at urgent care, she had an irregular EKG, we were advised to immediately do to a Hospital ER , upon arrival she presented with same EKG findings from urgent care, BW was run and her troponin level was a 7, this hospital recommended (after consultation with their cardiologist) that based on her age and urgency of the heart condition, we should be transported to a pediatric hospital with cardiology expertise.  She was transported by ambulance to another Hospital, Cardiology Unit. .  After a scary 24 hour overnight stay at the hospital she was released on 4/19/21.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Troponin increased, Ultrasound scan
Clinical narrative: On 4/17/21 (ie within 48 hours of receiving COVID 19 Pfizer Shot #2 (4/15/21), my daughter began experiencing chest pain in the PM (PM of 4/17).  It was initially mild so we did a watch and wait overnight but when it did not go away by morning of 4/18/21 we went to Urgent Care  .  Upon presentation at urgent care, she had an irregular EKG, we were advised to immediately do to a Hospital ER , upon arrival she presented with same EKG findings from urgent care, BW was run and her troponin level was a 7, this hospital recommended (after consultation with their cardiologist) that based on her age and urgency of the heart condition, we should be transported to a pediatric hospital with cardiology expertise.  She was transported by ambulance to another Hospital, Cardiology Unit. .  After a scary 24 hour overnight stay at the hospital she was released on 4/19/21.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Electrocardiogram, Electrocardiogram abnormal, Troponin, Troponin increased
Clinical narrative: On 4/17/21 (ie within 48 hours of receiving COVID 19 Pfizer Shot #2 (4/15/21), my daughter began experiencing chest pain in the PM (PM of 4/17).  It was initially mild so we did a watch and wait overnight but when it did not go away by morning of 4/18/21 we went to Urgent Care  .  Upon presentation at urgent care, she had an irregular EKG, we were advised to immediately do to a Hospital ER , upon arrival she presented with same EKG findings from urgent care, BW was run and her troponin level was a 7, this hospital recommended (after consultation with their cardiologist) that based on her age and urgency of the heart condition, we should be transported to a pediatric hospital with cardiology expertise.  She was transported by ambulance to another Hospital, Cardiology Unit. .  After a scary 24 hour overnight stay at the hospital she was released on 4/19/21.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site warmth, Urticaria
Clinical narrative: Large welt at injection site, approximately 4? in diameter, itching, tenderness, warm to touch
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Headache, Musculoskeletal stiffness, Myalgia
Clinical narrative: symptoms began appearing about 2.5 hours after injection.  moderate dizziness (fell 4-5 times - like being real tipsy, had to adjust how I moved); mild to moderate headache. 80% resolved after 36 hours. moderate stiffness and general muscle/joint aches and pain; mild chills. Resolved after 4 days. injection site soreness and swelling. Resolved after 8 days.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Epistaxis, Headache, Influenza like illness, Pyrexia
Clinical narrative: 24 hours after the shot I got a horrible nosebleed and headache, felt flu like and ran a fever. The fever broke within 6 hours but I felt horrible for 5 days. I began getting red bumps on my chest that pop up really red and then take weeks to heal. I have had 5 nosebleeds low energy and on again off again times of extremely low energy
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: 24 hours after the shot I got a horrible nosebleed and headache, felt flu like and ran a fever. The fever broke within 6 hours but I felt horrible for 5 days. I began getting red bumps on my chest that pop up really red and then take weeks to heal. I have had 5 nosebleeds low energy and on again off again times of extremely low energy
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Lymphadenopathy, Mobility decreased, Pain
Clinical narrative: Return of injection site soreness at rest but increasing with range of motion,  swollen lymph nodes in axilla injection side (L).  And limited range of motion due to pain.  Pain continues currently but lymph node seem to have returned to normal.  Pain mainly with movement today but does intermittently occur at rest.   I haven?t seen the physician because I felt this would resolve after researching the side effect awesome online medical resource sites.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Conjunctival haemorrhage
Clinical narrative: Sub-conjunctival hemorrhage, left sided. Never had  been observed before, according to the patient. Started 2 days after he got a second dose of COVID vaccine.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Adverse event, Headache
Clinical narrative: Adverse event: Extreme severe headache lasting over 6 hours. Led to ER visit after advise from nurse on-call. Treatment attempted at home: 1000mg of Tylenol. Treatment at ER: Toradol (ketorolac), Reglan (metoclopramide). Dosage unknown. [Administered via IV, I am the patient] Outcome: Pain subsided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Nausea, Pain in extremity
Clinical narrative: Severe chills days1-5, severe headaches days1-10 and still occasionally,  increased ringing in right ear, sore right arm days1-21 and again 4-18, itchy arm days 7-14, nausea days 3-10, tingling if right arm, right side of face, right side of neck, joint pain in right elbow 4/18
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus, Tinnitus
Clinical narrative: Severe chills days1-5, severe headaches days1-10 and still occasionally,  increased ringing in right ear, sore right arm days1-21 and again 4-18, itchy arm days 7-14, nausea days 3-10, tingling if right arm, right side of face, right side of neck, joint pain in right elbow 4/18
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Death
Clinical narrative: Unknown onset of adverse events.  PT received second COVID vaccine on 3/26/21.  She was found deceased in her residence (where she lives alone) by family on 3/28/21.  She was found in bed, appropriately covered with blankets.  Son last spoke with PT around 17:30 hours on 3/26 after receiving the vaccine, and reported the PT did not complain of any symptoms, did not sound short of breath, and did not complain of any breathing difficulty.  Based on postmortem presentation, believed PT died late night of 3/26/early morning of 3/27.  Suspect death is likely due to PT's heart disease, Medical Examiner agreed with the assessment.I spoke with the clinic that administered the second dose, and was informed that the PT did not exhibit any signs/symptoms during the observation period immediately following the vaccine being given.  PT's PCP was contacted, and agreed to certify DC based on known medical history.  PCP also agreed that the death did not sound related to the vaccine based on lack of symptoms as reported by the administering clinic and family.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Heart rate increased, Hypersensitivity, Paraesthesia
Clinical narrative: Within 5 minutes of receiving the vaccine, patient developed tingling and warmth in her chest and she felt like her heart rate was increasing.  She also felt short of breath.  She stated she had no difficulty swallowing but that she felt like the sensation in her chest was moving towards her throat.  She states this felt similar to the reaction she had after a bee sting.  Patient was given a dose of IM epinephrine and was advised to go to the ED.  At the ED she was given IV methylprednisolone 125 mg, IV diphenhydramine 50 mg and IV famotidine 20 mg.  Patient's symptoms resolved and she was observed for 3 hours with no return of symptoms and was released.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Sensory disturbance
Clinical narrative: Within 5 minutes of receiving the vaccine, patient developed tingling and warmth in her chest and she felt like her heart rate was increasing.  She also felt short of breath.  She stated she had no difficulty swallowing but that she felt like the sensation in her chest was moving towards her throat.  She states this felt similar to the reaction she had after a bee sting.  Patient was given a dose of IM epinephrine and was advised to go to the ED.  At the ED she was given IV methylprednisolone 125 mg, IV diphenhydramine 50 mg and IV famotidine 20 mg.  Patient's symptoms resolved and she was observed for 3 hours with no return of symptoms and was released.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Myalgia, Pain
Clinical narrative: Chills, fever, muscle/body ache, headache, pain at injection point.   Took Ibuprofen
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chills, fever, muscle/body ache, headache, pain at injection point.   Took Ibuprofen
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Lip swelling, Swelling face
Clinical narrative: My lips became extremely red and swollen a couple of hours after the shot.  I think there was some other minor face swelling around the nose, but the lips were the main issue.  I took Benadryl for a few days and the lips were back to normal in about a week.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: I had my second Covid vaccine and woke up with vertigo today, two days after. I have not had any treatment. I searched online and found out other individuals have been reporting vertigo as a side effect of the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Injection site haemorrhage, Pain in extremity, Wrong technique in product usage process
Clinical narrative: A LOT OF BLOOD DRIPPING DOWN THE ARM WITH SHOT; NEEDLE WENT TOO FAR IN TO THE ARM; SORE ARM; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight was 100 pounds, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-APR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced a lot of blood dripping down the arm with shot. On 08-APR-2021, the subject experienced needle went too far in to the arm. On 08-APR-2021, the subject experienced sore arm. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from a lot of blood dripping down the arm with shot on 08-APR-2021, had not recovered from sore arm, and the outcome of needle went too far in to the arm was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a female of 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 admin not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced covid-19 test positive. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: VOMITING; NAUSEA; DIZZINESS/LIGHT HEADEDNESS; This spontaneous report received from a health care professional concerned multiple patients. 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: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced dizziness/light headedness. On 07-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, dizziness/light headedness and vomiting was not reported. This report was non-serious. This case is a duplicate of 20210417771.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Head discomfort, Headache, Heart rate
Clinical narrative: HIGH PULSE RATE, RAGING HEART RATE; CLINCHING PRESSURE ON TEMPLE FOREHEAD, HEAD PRESSURE; SENSITIVE NARES, PRESSURE FEELING; SLEEP LOSS; SHAKING; CHILLS; FEVER; EXCRUCIATING HEADACHE; This spontaneous report received from a patient concerned a 52 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced high pulse rate, raging heart rate, clinching pressure on temple forehead, head pressure, sensitive nares, pressure feeling, sleep loss, shaking, chills, fever, and excruciating headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103 F, and Heart rate (NR: not provided) 100-112 {beats}/min. Treatment medications (dates unspecified) included: zolpidem tartrate, paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, chills, and fever, had not recovered from sleep loss, and the outcome of high pulse rate, raging heart rate, clinching pressure on temple forehead, head pressure, sensitive nares, pressure feeling and excruciating headache was not reported. This report was non-serious.; Sender's Comments: V0-  Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Insomnia, Nasal discomfort, Pyrexia, Tremor
Clinical narrative: HIGH PULSE RATE, RAGING HEART RATE; CLINCHING PRESSURE ON TEMPLE FOREHEAD, HEAD PRESSURE; SENSITIVE NARES, PRESSURE FEELING; SLEEP LOSS; SHAKING; CHILLS; FEVER; EXCRUCIATING HEADACHE; This spontaneous report received from a patient concerned a 52 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced high pulse rate, raging heart rate, clinching pressure on temple forehead, head pressure, sensitive nares, pressure feeling, sleep loss, shaking, chills, fever, and excruciating headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103 F, and Heart rate (NR: not provided) 100-112 {beats}/min. Treatment medications (dates unspecified) included: zolpidem tartrate, paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, chills, and fever, had not recovered from sleep loss, and the outcome of high pulse rate, raging heart rate, clinching pressure on temple forehead, head pressure, sensitive nares, pressure feeling and excruciating headache was not reported. This report was non-serious.; Sender's Comments: V0-  Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Hallucination, Headache, Hyperhidrosis
Clinical narrative: MUSCLE ACHES; NO APPETITE; CHILLS/FREEZING; SEVERE HEADACHE; NAUSEA; INJECTION SITE PAIN; FEVERISH; HALLUCINATIONS; HEART PALPITATIONS; HOT/COLD SWEATS; BODY ACHES; UNABLE TO SLEEP; This spontaneous report received from a patient concerned an 18 year old white female. The patient's height, and weight were not reported. The patient's concurrent conditions included migraines. 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, 1 total administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the patient experienced severe headache (described as beyond 10 positive), hallucination (feeling of being in a vivid dream but unable to sleep), heart palpitations, nausea, body aches, feverish, hot/cold sweats, and mild injection site pain approximately 9 hours post covid-19 vaccine ad26.cov2.s. As of 19:30 pm on 08-MAR-2021, approximately 21 hours from start symptoms, patient still had headache (5/10), mild injection site pain, minor muscle aches and no appetite. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hallucinations (feeling of being in a vivid dream), unable to sleep, heart palpitations, chills/freezing, and feverish on an unspecified date in APR-2021, was recovering from severe headache (described as beyond 10 positive), nausea, body aches, and mild injection site pain, and the outcome of hot/cold sweats, minor muscle aches and no appetite was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210417878-Covid-19 vaccine ad26.cov2.s-Hallucinations. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Insomnia, Myalgia, Nausea, Pain
Clinical narrative: MUSCLE ACHES; NO APPETITE; CHILLS/FREEZING; SEVERE HEADACHE; NAUSEA; INJECTION SITE PAIN; FEVERISH; HALLUCINATIONS; HEART PALPITATIONS; HOT/COLD SWEATS; BODY ACHES; UNABLE TO SLEEP; This spontaneous report received from a patient concerned an 18 year old white female. The patient's height, and weight were not reported. The patient's concurrent conditions included migraines. 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, 1 total administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the patient experienced severe headache (described as beyond 10 positive), hallucination (feeling of being in a vivid dream but unable to sleep), heart palpitations, nausea, body aches, feverish, hot/cold sweats, and mild injection site pain approximately 9 hours post covid-19 vaccine ad26.cov2.s. As of 19:30 pm on 08-MAR-2021, approximately 21 hours from start symptoms, patient still had headache (5/10), mild injection site pain, minor muscle aches and no appetite. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hallucinations (feeling of being in a vivid dream), unable to sleep, heart palpitations, chills/freezing, and feverish on an unspecified date in APR-2021, was recovering from severe headache (described as beyond 10 positive), nausea, body aches, and mild injection site pain, and the outcome of hot/cold sweats, minor muscle aches and no appetite was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210417878-Covid-19 vaccine ad26.cov2.s-Hallucinations. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.