chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, Syncope, Urticaria
Clinical narrative: HEADACHE; FAINTED; POTASSIUM LOW; FALL; GENERALIZED ITCH OVER BODY; RASH OVER LEFT EYE; HIVES; FELT WEAK; This spontaneous report was received from a patient, a 55-year-old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included thyroid (sic), high blood pressure, cholesterol (sic) and penicillin allergy. The patient does not smoke and consumes alcohol only on special occasions. The patient had no history of drug abuse or illicit drug usage. The patient experienced drug allergy when treated with atorvastatin, and lisinopril. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: JJ041AZ1A, and expiry: unknown) dose was not reported, 1 total, administered on right arm on 01-APR-2021 at 10:08 for prophylactic vaccination. Concomitant medications included ezetimibe for 'cholesterol', diltiazem for high blood pressure, nebivolol hydrochloride for high blood pressure, levothyroxine/liothyronine for 'thyroid', liothyronine for 'thyroid', cetirizine hydrochloride, and hydrochlorothiazide.   On 01-APR-2021, post-vaccination, the patient felt weak initially. On the same day, approximately after 1-2 hours, she developed generalized itching over her body, hives and a rash developed over her left eye. On 02-APR-2021, the patient experienced dizziness, had a fall and fainted following which she visited the emergency room (ER) for further assessment. At the ER, she was given Benadryl (diphenhydramine hydrochloride), an unspecified drug for dizziness and her potassium level (NR: not provided) was found to be low at 3.1 (unit not provided). On 03-APR-2021, the patient experienced headache. On 06-APR-2021, she had a follow-up with her healthcare professional for the headache. On 08-APR-2021, she was seen by an eye doctor for the rash over her left eye. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted, and fall on 03-APR-2021, had not recovered from potassium low, rash over left eye, headache, and hives, and the outcome of generalized itch over body and felt weak was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210417823-COVID-19 VACCINE AD26.COV2.S -Fainted. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Dysarthria, Eye movement disorder, Facial paralysis, Headache
Clinical narrative: HEADACHE; BELL'S PALSY/ FACE WAS SAGGING; This spontaneous report received from a patient concerned a male 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) dose was not reported, 1 total, administered on right deltoid muscle on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-MAR-2021 (at 1 AM), the patient experienced headache that had since resolved. On 10-MAR-2021, the patient experienced face sagging and visited urgent care where he was diagnosed with Bell's palsy. The patient was treated with prednisone and unspecified antiviral treatments. According to the patient, his facial sagging was improving and getting better. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 10-MAR-2021, and was recovering from bell's palsy/ face was sagging. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210420533-covid-19 vaccine ad26.cov2.s -bell's palsy/ face was sagging. 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).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Sleep disorder
Clinical narrative: HEADACHE; BELL'S PALSY/ FACE WAS SAGGING; This spontaneous report received from a patient concerned a male 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) dose was not reported, 1 total, administered on right deltoid muscle on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-MAR-2021 (at 1 AM), the patient experienced headache that had since resolved. On 10-MAR-2021, the patient experienced face sagging and visited urgent care where he was diagnosed with Bell's palsy. The patient was treated with prednisone and unspecified antiviral treatments. According to the patient, his facial sagging was improving and getting better. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 10-MAR-2021, and was recovering from bell's palsy/ face was sagging. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210420533-covid-19 vaccine ad26.cov2.s -bell's palsy/ face was sagging. 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).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Headache
Clinical narrative: HEADACHE; BELL'S PALSY/ FACE WAS SAGGING; This spontaneous report received from a patient concerned a male 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) dose was not reported, 1 total, administered on right deltoid muscle on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-MAR-2021 (at 1 AM), the patient experienced headache that had since resolved. On 10-MAR-2021, the patient experienced face sagging and visited urgent care where he was diagnosed with Bell's palsy. The patient was treated with prednisone and unspecified antiviral treatments. According to the patient, his facial sagging was improving and getting better. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 10-MAR-2021, and was recovering from bell's palsy/ face was sagging. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210420533-covid-19 vaccine ad26.cov2.s -bell's palsy/ face was sagging. 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: 92.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, COVID-19 pneumonia, SARS-CoV-2 test positive
Clinical narrative: Hospital admission due to COVID-19 positive result. Patient tested positive on 4/7/2021. Patient was hypoxic and had a cough on admission. Patient was diagnosed with COVID pneumonia, was given Remdesivir and decradon. Patient was discharged on 4/17/2021
Age: 92.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Cough, Hypoxia, Pneumonia, SARS-CoV-2 test positive
Clinical narrative: Hospital admission due to COVID-19 positive result. Patient tested positive on 4/7/2021. Patient was hypoxic and had a cough on admission. Patient was diagnosed with COVID pneumonia, was given Remdesivir and decradon. Patient was discharged on 4/17/2021
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Eye swelling, Feeling hot, Pyrexia, Swelling face
Clinical narrative: Went to bed few hours after vaccine woke up with a swollen face and low grade fever . Monday woke up my eyes were swollen shut face was worse went to walk in clinic. And they gave me 50 mg steroids for 3 days . Still puffy for 2 weeks with headache
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye swelling, Headache, Pyrexia, Swelling face
Clinical narrative: Went to bed few hours after vaccine woke up with a swollen face and low grade fever . Monday woke up my eyes were swollen shut face was worse went to walk in clinic. And they gave me 50 mg steroids for 3 days . Still puffy for 2 weeks with headache
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lung opacity
Clinical narrative: noises in lungs
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breath sounds abnormal, Computerised tomogram, SARS-CoV-2 test negative
Clinical narrative: noises in lungs
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deafness unilateral, Loss of consciousness, Paraesthesia, Road traffic accident
Clinical narrative: UNCONSCIOUS WHILE DRIVING BACK HOME; ACCIDENT; This spontaneous report received from a consumer concerned a male 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: Unknown, expiry: Unknown) dose was not reported, frequency 1 total administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 06-APR-2021, after vaccination, the patient waited in the vaccine facility for 15 minutes and left. While driving back to home, the patient became unconscious and had an accident. Customer confirmed that the patient was alive but customer was extremely disappointed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the unconscious while driving back home and accident was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210420258-covid-19 vaccine ad26.cov2.s -Unconscious while driving back home. 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).
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deafness, Dizziness, Feeling hot, Heart rate increased, Injection site pain
Clinical narrative: UNCONSCIOUS WHILE DRIVING BACK HOME; ACCIDENT; This spontaneous report received from a consumer concerned a male 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: Unknown, expiry: Unknown) dose was not reported, frequency 1 total administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 06-APR-2021, after vaccination, the patient waited in the vaccine facility for 15 minutes and left. While driving back to home, the patient became unconscious and had an accident. Customer confirmed that the patient was alive but customer was extremely disappointed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the unconscious while driving back home and accident was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210420258-covid-19 vaccine ad26.cov2.s -Unconscious while driving back home. 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).
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Loss of consciousness, Pain, Paraesthesia, Road traffic accident
Clinical narrative: UNCONSCIOUS WHILE DRIVING BACK HOME; ACCIDENT; This spontaneous report received from a consumer concerned a male 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: Unknown, expiry: Unknown) dose was not reported, frequency 1 total administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 06-APR-2021, after vaccination, the patient waited in the vaccine facility for 15 minutes and left. While driving back to home, the patient became unconscious and had an accident. Customer confirmed that the patient was alive but customer was extremely disappointed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the unconscious while driving back home and accident was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210420258-covid-19 vaccine ad26.cov2.s -Unconscious while driving back home. 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).
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Accident, Loss of consciousness
Clinical narrative: UNCONSCIOUS WHILE DRIVING BACK HOME; ACCIDENT; This spontaneous report received from a consumer concerned a male 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: Unknown, expiry: Unknown) dose was not reported, frequency 1 total administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 06-APR-2021, after vaccination, the patient waited in the vaccine facility for 15 minutes and left. While driving back to home, the patient became unconscious and had an accident. Customer confirmed that the patient was alive but customer was extremely disappointed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the unconscious while driving back home and accident was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210420258-covid-19 vaccine ad26.cov2.s -Unconscious while driving back home. 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: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue, Peripheral coldness, Tachycardia
Clinical narrative: HEART PALPITATIONS; FAST HEART RATE; SHORTNESS OF BREATH; SHAKINESS; WEAK FEET; This spontaneous report received from a patient concerned a 42 year old male. 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: 1808980,expiry: 20/JUN/2021) dose was not reported, administered on 07-APR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced heart palpitations. On 07-APR-2021, the subject experienced fast heart rate. On 07-APR-2021, the subject experienced shortness of breath. On 07-APR-2021, the subject experienced shakiness. On 07-APR-2021, the subject experienced weak feet. Treatment medications included: paracetamol. On 08-APR-2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart palpitations, shakiness, shortness of breath, and fast heart rate, and the outcome of weak feet 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.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Heart rate increased, Muscular weakness, Palpitations, Tremor
Clinical narrative: HEART PALPITATIONS; FAST HEART RATE; SHORTNESS OF BREATH; SHAKINESS; WEAK FEET; This spontaneous report received from a patient concerned a 42 year old male. 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: 1808980,expiry: 20/JUN/2021) dose was not reported, administered on 07-APR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced heart palpitations. On 07-APR-2021, the subject experienced fast heart rate. On 07-APR-2021, the subject experienced shortness of breath. On 07-APR-2021, the subject experienced shakiness. On 07-APR-2021, the subject experienced weak feet. Treatment medications included: paracetamol. On 08-APR-2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart palpitations, shakiness, shortness of breath, and fast heart rate, and the outcome of weak feet 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.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthma, Chest pain, Cough, Dizziness, Headache
Clinical narrative: Within 5 minutes of receiving shot started to have wheeze, treated with prednisone burst, low dose, Albuterol HFA, and Symbicort. Better until prednisone finished, then more cough, although lung function was OK with FEV1 97%. Treated with larger dose of prednisone on 4/6/21 amoxicillin/clavulanate 875/125 and albuterol HFA and Symbicort 80/4.5 continued. On visit of 4/20/21, asthma had improved. Not short of breath, and cough was gone.  After shot had chest pain, could be heart, seeing a cardiologist in a few days. Likely had some preexisting coronary artery disease, triggered by asthma attack but we are not sure right now.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Loss of consciousness, Muscle spasms, Tremor, X-ray normal
Clinical narrative: Within 5 minutes of receiving shot started to have wheeze, treated with prednisone burst, low dose, Albuterol HFA, and Symbicort. Better until prednisone finished, then more cough, although lung function was OK with FEV1 97%. Treated with larger dose of prednisone on 4/6/21 amoxicillin/clavulanate 875/125 and albuterol HFA and Symbicort 80/4.5 continued. On visit of 4/20/21, asthma had improved. Not short of breath, and cough was gone.  After shot had chest pain, could be heart, seeing a cardiologist in a few days. Likely had some preexisting coronary artery disease, triggered by asthma attack but we are not sure right now.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Cough, Immediate post-injection reaction, Wheezing
Clinical narrative: Within 5 minutes of receiving shot started to have wheeze, treated with prednisone burst, low dose, Albuterol HFA, and Symbicort. Better until prednisone finished, then more cough, although lung function was OK with FEV1 97%. Treated with larger dose of prednisone on 4/6/21 amoxicillin/clavulanate 875/125 and albuterol HFA and Symbicort 80/4.5 continued. On visit of 4/20/21, asthma had improved. Not short of breath, and cough was gone.  After shot had chest pain, could be heart, seeing a cardiologist in a few days. Likely had some preexisting coronary artery disease, triggered by asthma attack but we are not sure right now.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: DEAD ON ARRIVAL; This spontaneous report received from a health care professional (nurse) concerned a 69 year old not female. The patient's height, and weight were not reported. The patient was home bound, denied being on blood thinners and had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: 25-MAY-2021) dose was not reported, 1 total, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  It was reported that, the patient was last spoken on 03-APR-2021. On 08-APR-2021, the patient was dead on arrival. The patient died from an unknown cause of death. It was unknown if an autopsy was performed. The reporter has submitted a report with VAERS and reference number for her report was 421285. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210420513-COVID-19 VACCINE AD26.COV2.S - Dead On Arrival. 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.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Fatigue, Headache, Hypertension, Panic attack
Clinical narrative: I have already reported the events that have happened on the day of the vaccine and the following morning.  Muscle aches and pains were horrendous for 3 days. Severe flu symptoms for 1 day. It has been 12 days now and I still have muscle aches, lightheaded, cold sweats, fast heart beat, anxiety and insomnia. I have not been able to work since. Blood pressure has been up and down and doesn't seem to want to regulate itself like normal.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anxiety, Arthralgia, Blood pressure increased, Blood pressure measurement, Dizziness
Clinical narrative: I have already reported the events that have happened on the day of the vaccine and the following morning.  Muscle aches and pains were horrendous for 3 days. Severe flu symptoms for 1 day. It has been 12 days now and I still have muscle aches, lightheaded, cold sweats, fast heart beat, anxiety and insomnia. I have not been able to work since. Blood pressure has been up and down and doesn't seem to want to regulate itself like normal.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Influenza like illness, Muscle spasms, Nausea, Neuralgia, Pruritus
Clinical narrative: I have already reported the events that have happened on the day of the vaccine and the following morning.  Muscle aches and pains were horrendous for 3 days. Severe flu symptoms for 1 day. It has been 12 days now and I still have muscle aches, lightheaded, cold sweats, fast heart beat, anxiety and insomnia. I have not been able to work since. Blood pressure has been up and down and doesn't seem to want to regulate itself like normal.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Sinus congestion, Spinal pain, Swelling face, Tremor, Vision blurred
Clinical narrative: I have already reported the events that have happened on the day of the vaccine and the following morning.  Muscle aches and pains were horrendous for 3 days. Severe flu symptoms for 1 day. It has been 12 days now and I still have muscle aches, lightheaded, cold sweats, fast heart beat, anxiety and insomnia. I have not been able to work since. Blood pressure has been up and down and doesn't seem to want to regulate itself like normal.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anxiety, Blood pressure fluctuation, Cold sweat, Dizziness, Heart rate increased
Clinical narrative: I have already reported the events that have happened on the day of the vaccine and the following morning.  Muscle aches and pains were horrendous for 3 days. Severe flu symptoms for 1 day. It has been 12 days now and I still have muscle aches, lightheaded, cold sweats, fast heart beat, anxiety and insomnia. I have not been able to work since. Blood pressure has been up and down and doesn't seem to want to regulate itself like normal.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Influenza, Insomnia, Myalgia
Clinical narrative: I have already reported the events that have happened on the day of the vaccine and the following morning.  Muscle aches and pains were horrendous for 3 days. Severe flu symptoms for 1 day. It has been 12 days now and I still have muscle aches, lightheaded, cold sweats, fast heart beat, anxiety and insomnia. I have not been able to work since. Blood pressure has been up and down and doesn't seem to want to regulate itself like normal.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cold sweat, Cough, Flushing, Hypertension, Sensation of foreign body
Clinical narrative: Approximately 5-10 minutes after receiving the vaccine, pt started having itching and felt the need to cough due to feeling like something was stuck in her throat. BP 181/85, HR 112 and 99% on RA. Pt in no obvious distress. Pt reports that she took Benadryl at lunch approximately 4-5 hours ago in anticipation of the vaccine. Benadryl 50mg administered at 4:45.  Pt continues to report feeling like something is stuck in her throat.  RN remained with pt and continued to monitor for 30 minutes. Pt in no obvious respiratory distress but symptoms not resolving. Pt refused to go to ED and requested I not call EMS. Pt agreeable to be seen at immediate care clinic in same building.  RN handed off care to walk-in clinic.  Per notes from visit, no additional testing completed and pt discharged to home.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia, Throat irritation
Clinical narrative: Approximately 5-10 minutes after receiving the vaccine, pt started having itching and felt the need to cough due to feeling like something was stuck in her throat. BP 181/85, HR 112 and 99% on RA. Pt in no obvious distress. Pt reports that she took Benadryl at lunch approximately 4-5 hours ago in anticipation of the vaccine. Benadryl 50mg administered at 4:45.  Pt continues to report feeling like something is stuck in her throat.  RN remained with pt and continued to monitor for 30 minutes. Pt in no obvious respiratory distress but symptoms not resolving. Pt refused to go to ED and requested I not call EMS. Pt agreeable to be seen at immediate care clinic in same building.  RN handed off care to walk-in clinic.  Per notes from visit, no additional testing completed and pt discharged to home.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Heart rate, Pruritus, Throat irritation
Clinical narrative: Approximately 5-10 minutes after receiving the vaccine, pt started having itching and felt the need to cough due to feeling like something was stuck in her throat. BP 181/85, HR 112 and 99% on RA. Pt in no obvious distress. Pt reports that she took Benadryl at lunch approximately 4-5 hours ago in anticipation of the vaccine. Benadryl 50mg administered at 4:45.  Pt continues to report feeling like something is stuck in her throat.  RN remained with pt and continued to monitor for 30 minutes. Pt in no obvious respiratory distress but symptoms not resolving. Pt refused to go to ED and requested I not call EMS. Pt agreeable to be seen at immediate care clinic in same building.  RN handed off care to walk-in clinic.  Per notes from visit, no additional testing completed and pt discharged to home.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Headache, Malaise, Nausea, Pain
Clinical narrative: DELIRIUM; FLUSHED TO FACE; UNCONTROLLED SHAKING; VOMITING; CHILLS; FEVER; This spontaneous report received from a patient concerned a female of 60 year old. The patient's height, and weight were not reported.  The patient's concurrent conditions included allergy to latex (adhesives band aids leave a welt on skin), non-alcohol use, and nonsmoker, and other pre-existing medical conditions included patient did not have any history of drug abuse or illicit drug. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 05-APR-2021 at 13:00 on left arm for prophylactic vaccination. No concomitant medications were reported. The patient was not pregnant at the time of report.  On 05-APR-2021 at 21:00, the patient experienced delirium, flushed to face, uncontrolled shaking, vomiting, fever and chills. Body temperature (NR: not provided) at 103.5 F. The patient has received paracetamol for fever. The patient consulted a physician at emergency room and physician suggested her to use alternate paracetamol, and ibuprofen to manage symptoms.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, uncontrolled shaking, flushed to face, vomiting, chills, and delirium. This report was serious (Other Medically Important Condition).; Sender's Comments: v0;20210417227-covid-19 vaccine ad26.cov2. s-Delirium. 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
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Tremor, Vomiting
Clinical narrative: DELIRIUM; FLUSHED TO FACE; UNCONTROLLED SHAKING; VOMITING; CHILLS; FEVER; This spontaneous report received from a patient concerned a female of 60 year old. The patient's height, and weight were not reported.  The patient's concurrent conditions included allergy to latex (adhesives band aids leave a welt on skin), non-alcohol use, and nonsmoker, and other pre-existing medical conditions included patient did not have any history of drug abuse or illicit drug. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 05-APR-2021 at 13:00 on left arm for prophylactic vaccination. No concomitant medications were reported. The patient was not pregnant at the time of report.  On 05-APR-2021 at 21:00, the patient experienced delirium, flushed to face, uncontrolled shaking, vomiting, fever and chills. Body temperature (NR: not provided) at 103.5 F. The patient has received paracetamol for fever. The patient consulted a physician at emergency room and physician suggested her to use alternate paracetamol, and ibuprofen to manage symptoms.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, uncontrolled shaking, flushed to face, vomiting, chills, and delirium. This report was serious (Other Medically Important Condition).; Sender's Comments: v0;20210417227-covid-19 vaccine ad26.cov2. s-Delirium. 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
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Delirium, Flushing, Pyrexia
Clinical narrative: DELIRIUM; FLUSHED TO FACE; UNCONTROLLED SHAKING; VOMITING; CHILLS; FEVER; This spontaneous report received from a patient concerned a female of 60 year old. The patient's height, and weight were not reported.  The patient's concurrent conditions included allergy to latex (adhesives band aids leave a welt on skin), non-alcohol use, and nonsmoker, and other pre-existing medical conditions included patient did not have any history of drug abuse or illicit drug. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 05-APR-2021 at 13:00 on left arm for prophylactic vaccination. No concomitant medications were reported. The patient was not pregnant at the time of report.  On 05-APR-2021 at 21:00, the patient experienced delirium, flushed to face, uncontrolled shaking, vomiting, fever and chills. Body temperature (NR: not provided) at 103.5 F. The patient has received paracetamol for fever. The patient consulted a physician at emergency room and physician suggested her to use alternate paracetamol, and ibuprofen to manage symptoms.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, uncontrolled shaking, flushed to face, vomiting, chills, and delirium. This report was serious (Other Medically Important Condition).; Sender's Comments: v0;20210417227-covid-19 vaccine ad26.cov2. s-Delirium. 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
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: DELIRIUM; FLUSHED TO FACE; UNCONTROLLED SHAKING; VOMITING; CHILLS; FEVER; This spontaneous report received from a patient concerned a female of 60 year old. The patient's height, and weight were not reported.  The patient's concurrent conditions included allergy to latex (adhesives band aids leave a welt on skin), non-alcohol use, and nonsmoker, and other pre-existing medical conditions included patient did not have any history of drug abuse or illicit drug. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 05-APR-2021 at 13:00 on left arm for prophylactic vaccination. No concomitant medications were reported. The patient was not pregnant at the time of report.  On 05-APR-2021 at 21:00, the patient experienced delirium, flushed to face, uncontrolled shaking, vomiting, fever and chills. Body temperature (NR: not provided) at 103.5 F. The patient has received paracetamol for fever. The patient consulted a physician at emergency room and physician suggested her to use alternate paracetamol, and ibuprofen to manage symptoms.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, uncontrolled shaking, flushed to face, vomiting, chills, and delirium. This report was serious (Other Medically Important Condition).; Sender's Comments: v0;20210417227-covid-19 vaccine ad26.cov2. s-Delirium. 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
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Herpes zoster, Pruritus
Clinical narrative: Pt received Pfizer Covid-19 vaccine 4/4/21 and starting 4/8/21 began to have low back pain with tingling. Pt's pain became worse and lesion developed along her right trunk. She went to urgent care 4/11/21 and was diagnosed with shingles. Pt  completed 7 days treatment with antiviral and symptoms have improved. She is delaying her second Covid-19 shot one week to allow for complete resolution of symptoms.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Herpes zoster, Paraesthesia, Skin lesion
Clinical narrative: Pt received Pfizer Covid-19 vaccine 4/4/21 and starting 4/8/21 began to have low back pain with tingling. Pt's pain became worse and lesion developed along her right trunk. She went to urgent care 4/11/21 and was diagnosed with shingles. Pt  completed 7 days treatment with antiviral and symptoms have improved. She is delaying her second Covid-19 shot one week to allow for complete resolution of symptoms.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood test, Chest pain, Dizziness, Electrocardiogram, Heart rate increased
Clinical narrative: She states about 30 minutes later she developed throat tightness, chest tightness and tingling to her lips. She rates her chest discomfort as a 1/10. She denies difficulty with swallowing, lip or facial swelling, nausea, vomiting, neck discomfort, or shortness of breath. No angioedema
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Lip swelling, Pharyngeal swelling
Clinical narrative: She states about 30 minutes later she developed throat tightness, chest tightness and tingling to her lips. She rates her chest discomfort as a 1/10. She denies difficulty with swallowing, lip or facial swelling, nausea, vomiting, neck discomfort, or shortness of breath. No angioedema
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Throat tightness
Clinical narrative: She states about 30 minutes later she developed throat tightness, chest tightness and tingling to her lips. She rates her chest discomfort as a 1/10. She denies difficulty with swallowing, lip or facial swelling, nausea, vomiting, neck discomfort, or shortness of breath. No angioedema
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chest pain, Dizziness, Heart rate increased, Lip swelling, Pharyngeal swelling
Clinical narrative: She states about 30 minutes later she developed throat tightness, chest tightness and tingling to her lips. She rates her chest discomfort as a 1/10. She denies difficulty with swallowing, lip or facial swelling, nausea, vomiting, neck discomfort, or shortness of breath. No angioedema
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Full blood count, Metabolic function test, Paraesthesia oral, Throat tightness
Clinical narrative: She states about 30 minutes later she developed throat tightness, chest tightness and tingling to her lips. She rates her chest discomfort as a 1/10. She denies difficulty with swallowing, lip or facial swelling, nausea, vomiting, neck discomfort, or shortness of breath. No angioedema
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Troponin
Clinical narrative: She states about 30 minutes later she developed throat tightness, chest tightness and tingling to her lips. She rates her chest discomfort as a 1/10. She denies difficulty with swallowing, lip or facial swelling, nausea, vomiting, neck discomfort, or shortness of breath. No angioedema
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Hereditary angioedema, Menstruation delayed
Clinical narrative: EXCESSIVE MENSTRUAL FLOW; LATE PERIOD; HARD TO FOCUS; BLURRED VISION; ABDOMINAL PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included hereditary angioedema. 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 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the subject experienced abdominal pain. On 02-APR-2021, the subject experienced blurred vision. On 02-APR-2021, the subject experienced difficulty focusing eyes. On 08-APR-2021, the subject experienced menorrhagia. On 08-APR-2021, the subject experienced late period. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from abdominal pain on 08-APR-2021, and menorrhagia, and late period on APR-2021, and had not recovered from blurred vision, and difficulty focusing eyes. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Heavy menstrual bleeding, Menstruation delayed, Vision blurred
Clinical narrative: EXCESSIVE MENSTRUAL FLOW; LATE PERIOD; HARD TO FOCUS; BLURRED VISION; ABDOMINAL PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included hereditary angioedema. 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 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the subject experienced abdominal pain. On 02-APR-2021, the subject experienced blurred vision. On 02-APR-2021, the subject experienced difficulty focusing eyes. On 08-APR-2021, the subject experienced menorrhagia. On 08-APR-2021, the subject experienced late period. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from abdominal pain on 08-APR-2021, and menorrhagia, and late period on APR-2021, and had not recovered from blurred vision, and difficulty focusing eyes. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Brain death, Cerebral venous sinus thrombosis, Death, Dizziness, Headache
Clinical narrative: CEREBRAL VENOUS SINUS THROMBOSIS; SEVERE HEADACHE; DIZZINESS; VOMITING; This spontaneous report received from a consumer's sister via (1198162-1) concerned a 45-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, and batch number were not reported) dose was not reported, administered once on 13-MAR-2021 as prophylactic vaccination. No concomitant medications were reported.  On 20-MAR-2021, (one-week post-vaccination), the patient experienced severe headache, dizziness, and vomiting. The patient visited an emergency room (ER) as the symptoms continued.  On an unspecified date, in the ER, the patient experienced cerebral venous sinus thrombosis. She was pronounced brain death, and the same day she was pronounced dead. It was unspecified if an autopsy was performed.  The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient died of cerebral venous sinus thrombosis, and had not recovered from dizziness, vomiting, and severe headache. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: V0: This case concerns a 45-year-old female patient who experienced a fatal cerebral venous sinus thrombosis (CVST) 7 days after receiving covid-19 vaccine ad26.cov2.s for prevention of symptomatic SARS-CoV-2 virus infection. The patient experienced severe headache, dizziness, and vomiting 7 days after vaccination which prompted a visit to the emergency department where she was diagnosed with the cerebral venous sinus thrombosis. On an unspecified date she was pronounced brain dead and subsequently died the same day. It was unspecified if an autopsy was performed. Information is limited in this case, but the CVST could represent background incidence of such event in general population, however a relationship with Janssen Covid-19 vaccine cannot be ruled out.  Therefore, the relationship is indeterminant. Additional information has been requested.; Reported Cause(s) of Death: CEREBRAL VENOUS SINUS THROMBOSIS
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: CEREBRAL VENOUS SINUS THROMBOSIS; SEVERE HEADACHE; DIZZINESS; VOMITING; This spontaneous report received from a consumer's sister via (1198162-1) concerned a 45-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, and batch number were not reported) dose was not reported, administered once on 13-MAR-2021 as prophylactic vaccination. No concomitant medications were reported.  On 20-MAR-2021, (one-week post-vaccination), the patient experienced severe headache, dizziness, and vomiting. The patient visited an emergency room (ER) as the symptoms continued.  On an unspecified date, in the ER, the patient experienced cerebral venous sinus thrombosis. She was pronounced brain death, and the same day she was pronounced dead. It was unspecified if an autopsy was performed.  The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient died of cerebral venous sinus thrombosis, and had not recovered from dizziness, vomiting, and severe headache. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: V0: This case concerns a 45-year-old female patient who experienced a fatal cerebral venous sinus thrombosis (CVST) 7 days after receiving covid-19 vaccine ad26.cov2.s for prevention of symptomatic SARS-CoV-2 virus infection. The patient experienced severe headache, dizziness, and vomiting 7 days after vaccination which prompted a visit to the emergency department where she was diagnosed with the cerebral venous sinus thrombosis. On an unspecified date she was pronounced brain dead and subsequently died the same day. It was unspecified if an autopsy was performed. Information is limited in this case, but the CVST could represent background incidence of such event in general population, however a relationship with Janssen Covid-19 vaccine cannot be ruled out.  Therefore, the relationship is indeterminant. Additional information has been requested.; Reported Cause(s) of Death: CEREBRAL VENOUS SINUS THROMBOSIS
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebral venous sinus thrombosis, Dizziness, Headache, Vomiting
Clinical narrative: CEREBRAL VENOUS SINUS THROMBOSIS; SEVERE HEADACHE; DIZZINESS; VOMITING; This spontaneous report received from a consumer's sister via (1198162-1) concerned a 45-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, and batch number were not reported) dose was not reported, administered once on 13-MAR-2021 as prophylactic vaccination. No concomitant medications were reported.  On 20-MAR-2021, (one-week post-vaccination), the patient experienced severe headache, dizziness, and vomiting. The patient visited an emergency room (ER) as the symptoms continued.  On an unspecified date, in the ER, the patient experienced cerebral venous sinus thrombosis. She was pronounced brain death, and the same day she was pronounced dead. It was unspecified if an autopsy was performed.  The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient died of cerebral venous sinus thrombosis, and had not recovered from dizziness, vomiting, and severe headache. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: V0: This case concerns a 45-year-old female patient who experienced a fatal cerebral venous sinus thrombosis (CVST) 7 days after receiving covid-19 vaccine ad26.cov2.s for prevention of symptomatic SARS-CoV-2 virus infection. The patient experienced severe headache, dizziness, and vomiting 7 days after vaccination which prompted a visit to the emergency department where she was diagnosed with the cerebral venous sinus thrombosis. On an unspecified date she was pronounced brain dead and subsequently died the same day. It was unspecified if an autopsy was performed. Information is limited in this case, but the CVST could represent background incidence of such event in general population, however a relationship with Janssen Covid-19 vaccine cannot be ruled out.  Therefore, the relationship is indeterminant. Additional information has been requested.; Reported Cause(s) of Death: CEREBRAL VENOUS SINUS THROMBOSIS