chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Angiogram normal, Cerebrovascular accident, Computerised tomogram head, Computerised tomogram head normal
Clinical narrative: LUE and LLE weakness, Dysarthia, headache
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Gait disturbance, Haemoglobin decreased, Headache, Hemiparesis
Clinical narrative: LUE and LLE weakness, Dysarthia, headache
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Intensive care, Magnetic resonance imaging head normal, Nausea, Peritonsillar abscess
Clinical narrative: LUE and LLE weakness, Dysarthia, headache
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Platelet count normal, Pyrexia, Speech disorder, Tonsillar cyst, Ultrasound Doppler normal
Clinical narrative: LUE and LLE weakness, Dysarthia, headache
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Venogram, Venogram normal, White blood cell count normal
Clinical narrative: LUE and LLE weakness, Dysarthia, headache
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Dysarthria, Headache, Muscular weakness
Clinical narrative: LUE and LLE weakness, Dysarthia, headache
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Gait disturbance, Head discomfort, Headache, Hemiparesis
Clinical narrative: LUE and LLE weakness, Dysarthia, headache
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging, Nausea, Neurological symptom
Clinical narrative: LUE and LLE weakness, Dysarthia, headache
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Lip pruritus, Pruritus, Throat tightness
Clinical narrative: 6:07 Vaccine Injected 6:12 Itching and tingling around lips. The following proceeds in order.          - Itching around nose.          - Tingling along left side of face.          - Unable to swallow          - Epi and Benadryl provided           - Symptoms decrease           - During ambulance ride, itching and tingling of lips, nose, and face return.             - Inability to swallow returns, 2nd epi given.             - At ER monitoring and  additional medications given              - Increased thirst              -Released with epi and allergy meds.              -Occasional slight facial swelling (eyes), tingling, itching, mild swallowing issues, and increased thirst 1-current days; not severe enough for epi or return visit to ER. Also, lightheaded, weak, and tired.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dizziness, Dysphagia, Fatigue, Paraesthesia
Clinical narrative: 6:07 Vaccine Injected 6:12 Itching and tingling around lips. The following proceeds in order.          - Itching around nose.          - Tingling along left side of face.          - Unable to swallow          - Epi and Benadryl provided           - Symptoms decrease           - During ambulance ride, itching and tingling of lips, nose, and face return.             - Inability to swallow returns, 2nd epi given.             - At ER monitoring and  additional medications given              - Increased thirst              -Released with epi and allergy meds.              -Occasional slight facial swelling (eyes), tingling, itching, mild swallowing issues, and increased thirst 1-current days; not severe enough for epi or return visit to ER. Also, lightheaded, weak, and tired.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Swelling face, Thirst
Clinical narrative: 6:07 Vaccine Injected 6:12 Itching and tingling around lips. The following proceeds in order.          - Itching around nose.          - Tingling along left side of face.          - Unable to swallow          - Epi and Benadryl provided           - Symptoms decrease           - During ambulance ride, itching and tingling of lips, nose, and face return.             - Inability to swallow returns, 2nd epi given.             - At ER monitoring and  additional medications given              - Increased thirst              -Released with epi and allergy meds.              -Occasional slight facial swelling (eyes), tingling, itching, mild swallowing issues, and increased thirst 1-current days; not severe enough for epi or return visit to ER. Also, lightheaded, weak, and tired.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Jugular vein thrombosis
Clinical narrative: head blood clot
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebral thrombosis, Magnetic resonance imaging abnormal
Clinical narrative: head blood clot
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: CSF culture negative, CSF glucose normal, CSF lymphocyte count increased, CSF protein normal, CSF red blood cell count positive
Clinical narrative: Transverse Myelitis
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gram stain, Hemiparesis, Herpes simplex test negative, Hyperintensity in brain deep nuclei, Hyperreflexia
Clinical narrative: Transverse Myelitis
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal abnormal, Myelitis transverse, Urinary retention
Clinical narrative: Transverse Myelitis
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Lumbar puncture, Magnetic resonance imaging, Myelitis transverse
Clinical narrative: Transverse Myelitis
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myelitis transverse, SARS-CoV-2 test
Clinical narrative: Transverse Myelitis
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram cerebral, Blood culture, Chest X-ray, Computerised tomogram head, Full blood count
Clinical narrative: After shot patient had sore arm and felt unwell, next morning patient had no short term memory, could not make new memories, repeatedly asked same questions, could not remember daily routine or where things were in house, was taken to ER for fear of stroke, no stroke but ER stated they believed vaccine reaction, patient improved but still having memory issues and does not recall the day after shot
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head, Metabolic function test, Transient global amnesia, Urine analysis
Clinical narrative: After shot patient had sore arm and felt unwell, next morning patient had no short term memory, could not make new memories, repeatedly asked same questions, could not remember daily routine or where things were in house, was taken to ER for fear of stroke, no stroke but ER stated they believed vaccine reaction, patient improved but still having memory issues and does not recall the day after shot
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Computerised tomogram, Fibrin D dimer, Full blood count, Hepatic enzyme
Clinical narrative: After shot patient had sore arm and felt unwell, next morning patient had no short term memory, could not make new memories, repeatedly asked same questions, could not remember daily routine or where things were in house, was taken to ER for fear of stroke, no stroke but ER stated they believed vaccine reaction, patient improved but still having memory issues and does not recall the day after shot
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Malaise, Pain in extremity
Clinical narrative: After shot patient had sore arm and felt unwell, next morning patient had no short term memory, could not make new memories, repeatedly asked same questions, could not remember daily routine or where things were in house, was taken to ER for fear of stroke, no stroke but ER stated they believed vaccine reaction, patient improved but still having memory issues and does not recall the day after shot
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Portal vein thrombosis, Vomiting
Clinical narrative: I was having severe stomach pains. A CT scan showed a blood clot in the portal vein.   I?ve been hospitalized now for four days administering Heperin. No history or risk factors for blood clotting. Could this be vaccine related?
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Anticoagulant therapy, Blood test, Computerised tomogram abnormal, Portal vein thrombosis
Clinical narrative: I was having severe stomach pains. A CT scan showed a blood clot in the portal vein.   I?ve been hospitalized now for four days administering Heperin. No history or risk factors for blood clotting. Could this be vaccine related?
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Facial paralysis
Clinical narrative: Headache all day at the base of my skull, burning pain across my scalp, right ear and jaw. The following morning I awoke to find that I had right facial droop later diagnosed at the Emergency room as Bell's Palsy.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Ear discomfort, Facial paralysis, Headache, Skin burning sensation
Clinical narrative: Headache all day at the base of my skull, burning pain across my scalp, right ear and jaw. The following morning I awoke to find that I had right facial droop later diagnosed at the Emergency room as Bell's Palsy.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Dizziness, Flushing, Immediate post-injection reaction, Paraesthesia
Clinical narrative: At the time of injection, I started to feel extremely dizzy and my lips started tingling. I was sweating a lot and got red. I think because I was panicking at some point it was hard to breath. I laid on the floor for a while until I felt better. My pressure was taken and it was 150/90. I felt dizzy and lightheaded the rest of the day.   At night and the next day I had a joint pain and a sore throat. I got a mild fever at night the next day and on the third day I just had a sore throat.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral
Clinical narrative: At the time of injection, I started to feel extremely dizzy and my lips started tingling. I was sweating a lot and got red. I think because I was panicking at some point it was hard to breath. I laid on the floor for a while until I felt better. My pressure was taken and it was 150/90. I felt dizzy and lightheaded the rest of the day.   At night and the next day I had a joint pain and a sore throat. I got a mild fever at night the next day and on the third day I just had a sore throat.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Dizziness, Dyspnoea, Hyperhidrosis, Oropharyngeal pain
Clinical narrative: At the time of injection, I started to feel extremely dizzy and my lips started tingling. I was sweating a lot and got red. I think because I was panicking at some point it was hard to breath. I laid on the floor for a while until I felt better. My pressure was taken and it was 150/90. I felt dizzy and lightheaded the rest of the day.   At night and the next day I had a joint pain and a sore throat. I got a mild fever at night the next day and on the third day I just had a sore throat.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Panic attack, Paraesthesia
Clinical narrative: At the time of injection, I started to feel extremely dizzy and my lips started tingling. I was sweating a lot and got red. I think because I was panicking at some point it was hard to breath. I laid on the floor for a while until I felt better. My pressure was taken and it was 150/90. I felt dizzy and lightheaded the rest of the day.   At night and the next day I had a joint pain and a sore throat. I got a mild fever at night the next day and on the third day I just had a sore throat.
Age: 61.0
Sex: M
Vaccine: COVID19, EBZR
Symptoms: Dyspnoea, Echocardiogram abnormal, Pericardial effusion
Clinical narrative: Significant shortness of breath, increasing on a gradual basis to the point where I could not complete walks with any sort of incline. After a severe issue with shortness of breath on a golf course April 1, I was scheduled for an echocardiogram April 7. The echo showed pericardial effusion. A follow-up echo April 14 showed the effusion had reduced to trivial amounts. My ability to climb inclines and stairs has improved and continues to improve daily, but I am not back to the performance level prior to my Covid shot. The cardiology team asked me to monitor my condition in the weeks following my second Covid vaccine dose April 12 in case there is a repeat of the issues that arose after Dose 1.
Age: 61.0
Sex: M
Vaccine: COVID19, EBZR
Symptoms: Dyspnoea, Echocardiogram, Pericardial effusion
Clinical narrative: Significant shortness of breath, increasing on a gradual basis to the point where I could not complete walks with any sort of incline. After a severe issue with shortness of breath on a golf course April 1, I was scheduled for an echocardiogram April 7. The echo showed pericardial effusion. A follow-up echo April 14 showed the effusion had reduced to trivial amounts. My ability to climb inclines and stairs has improved and continues to improve daily, but I am not back to the performance level prior to my Covid shot. The cardiology team asked me to monitor my condition in the weeks following my second Covid vaccine dose April 12 in case there is a repeat of the issues that arose after Dose 1.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dry throat, Hypoaesthesia, Ocular hyperaemia, Paraesthesia
Clinical narrative: Patient started to feel dizzy and lightheaded about 15 minutes post vaccine and became pale. Patient was sitting the entire time. Kept him seated, provided a cold cloth, grabbed some water if needed, and monitored the patient until he felt better.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Thirst, Visual impairment
Clinical narrative: Patient started to feel dizzy and lightheaded about 15 minutes post vaccine and became pale. Patient was sitting the entire time. Kept him seated, provided a cold cloth, grabbed some water if needed, and monitored the patient until he felt better.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Pallor
Clinical narrative: Patient started to feel dizzy and lightheaded about 15 minutes post vaccine and became pale. Patient was sitting the entire time. Kept him seated, provided a cold cloth, grabbed some water if needed, and monitored the patient until he felt better.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, Pain in extremity, Ultrasound Doppler abnormal
Clinical narrative: Blood clot DVT in left leg.; Blood clot DVT in left leg.; This is a spontaneous report from a contactable consumer. A 48-year-old non -pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE),  at the age of 48 years, via an unspecified route of administration, administered in the left arm on 01Apr2021 10:45 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient has no medical history. Patient has not had Covid prior to vaccination. The patient has no known allergies. The patient's concomitant medications were not reported. The patient experienced blood clot DVT in left leg on 02Apr2021 at 09:00. Treatment for the event includes blood thinners. It was reported that the AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included nasal swab for covid test on 02Apr2021 which had a negative result. The outcome of the event was not recovered.  Information about Lot/batch number is requested.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, SARS-CoV-2 test, Thrombosis
Clinical narrative: Blood clot DVT in left leg.; Blood clot DVT in left leg.; This is a spontaneous report from a contactable consumer. A 48-year-old non -pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE),  at the age of 48 years, via an unspecified route of administration, administered in the left arm on 01Apr2021 10:45 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient has no medical history. Patient has not had Covid prior to vaccination. The patient has no known allergies. The patient's concomitant medications were not reported. The patient experienced blood clot DVT in left leg on 02Apr2021 at 09:00. Treatment for the event includes blood thinners. It was reported that the AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included nasal swab for covid test on 02Apr2021 which had a negative result. The outcome of the event was not recovered.  Information about Lot/batch number is requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: FEVER; This spontaneous report was received from a consumer, and concerned a female patient of an unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose and vaccination site not reported, administered on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-MAR-2021, the patient experienced a fever. Laboratory data included: body temperature: 9 degrees Fahrenheit (F).  The caller mentioned that her mother received the Janssen COVID-19 vaccine today, and started developing a low-grade fever.  Action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: FEVER; BODY ACHES; CHILLS; This spontaneous report received from a consumer (patient's wife) concerned a patient 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, intramuscular, batch number: 1805022, expiry: 25-03-2021) dose was not reported, administered on 07-MAR-2021 at 01:00 am, to left arm for prophylactic vaccination. No concomitant medications were reported.  On 07-MAR-2021 at 10:00 am, the subject experienced fever, body aches, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, body aches and chills was not reported. This report was non-serious.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Chills, Delirium, Diarrhoea
Clinical narrative: DELIRIOUS; LEG CRAMPS; STOMACH KILLING; EXPLOSIVE DIARRHEA; SWEATS; SOUNDED LIKE MOANING; CHILLS; FEVER 101 F/BURNING UP; This spontaneous report received from a parent concerned a 34 year old female. The patient's height, and weight were not reported. The patient's past medical history included endometriosis (reporter thought the patient may had endometriosis), and other pre-existing medical conditions included no known allergies. The patient was not pregnant. 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, 1 total administered on 06-APR-2021 13:30 to right arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in APR-2021, the patient woke with diarrhea during night (unsure if before or after midnight). Patient also experienced leg cramps, fever (101 F), chills, stomach killing the patient, explosive diarrhea, sweats, and burning up. The patient had drank Gatorade, but did not eat anything else. Patients mother thought that the patient was delirious as she was talking out of her head. The patient was making sounds that sounded like moaning. The patient did not received any treatment at the time of reporting. She was fine on vaccination day. Laboratory data included body temperature 101 F on APR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from leg cramps, fever 101 F/burning up, chills, stomach killing, explosive diarrhea, sweats, sounded like moaning and delirious. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210414111- Covid-19 vaccine ad26.cov2.s-delirious. 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: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Moaning, Muscle spasms, Pyrexia
Clinical narrative: DELIRIOUS; LEG CRAMPS; STOMACH KILLING; EXPLOSIVE DIARRHEA; SWEATS; SOUNDED LIKE MOANING; CHILLS; FEVER 101 F/BURNING UP; This spontaneous report received from a parent concerned a 34 year old female. The patient's height, and weight were not reported. The patient's past medical history included endometriosis (reporter thought the patient may had endometriosis), and other pre-existing medical conditions included no known allergies. The patient was not pregnant. 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, 1 total administered on 06-APR-2021 13:30 to right arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in APR-2021, the patient woke with diarrhea during night (unsure if before or after midnight). Patient also experienced leg cramps, fever (101 F), chills, stomach killing the patient, explosive diarrhea, sweats, and burning up. The patient had drank Gatorade, but did not eat anything else. Patients mother thought that the patient was delirious as she was talking out of her head. The patient was making sounds that sounded like moaning. The patient did not received any treatment at the time of reporting. She was fine on vaccination day. Laboratory data included body temperature 101 F on APR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from leg cramps, fever 101 F/burning up, chills, stomach killing, explosive diarrhea, sweats, sounded like moaning and delirious. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210414111- Covid-19 vaccine ad26.cov2.s-delirious. 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Dizziness, Dyspnoea, Flushing, Gait disturbance
Clinical narrative: ELEVATED BLOOD PRESSURE 200 PLUS; FLUTTERING HEART; DIFFICULTY BREATHING; DIZZINES AND LIGHTHEADED; AFTER STANDING GOT A RUSH AND STARTED TO STUMBLE; FLUSHED; FELT VERY THIRSTY; NAUSEA; This spontaneous report received from a patient concerned a 50 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, frequency once total, administered on 31-MAR-2021 for prophylactic vaccination on left deltoid. No concomitant medications were reported.  On 31-MAR-2021, within 15 minutes, the patient experienced lightheaded, difficulty breathing, after standing up got a rush and started to stumble, fluttering heart, nauseous, dizziness, flushed and elevated blood pressure 200 plus. It was stated that all symptoms went away that evening. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty breathing, elevated blood pressure 200 plus, after standing up got a rush and started to stumble, flushed, fluttering heart, light headed and dizziness, nausea on 31-MAR-2021, and the outcome of felt very thirsty was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210415219-Covid-19 vaccine ad26.cov2.s-Elevated blood pressure 200 plus And Fluttering Heart. 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Nausea, Thirst
Clinical narrative: ELEVATED BLOOD PRESSURE 200 PLUS; FLUTTERING HEART; DIFFICULTY BREATHING; DIZZINES AND LIGHTHEADED; AFTER STANDING GOT A RUSH AND STARTED TO STUMBLE; FLUSHED; FELT VERY THIRSTY; NAUSEA; This spontaneous report received from a patient concerned a 50 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, frequency once total, administered on 31-MAR-2021 for prophylactic vaccination on left deltoid. No concomitant medications were reported.  On 31-MAR-2021, within 15 minutes, the patient experienced lightheaded, difficulty breathing, after standing up got a rush and started to stumble, fluttering heart, nauseous, dizziness, flushed and elevated blood pressure 200 plus. It was stated that all symptoms went away that evening. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty breathing, elevated blood pressure 200 plus, after standing up got a rush and started to stumble, flushed, fluttering heart, light headed and dizziness, nausea on 31-MAR-2021, and the outcome of felt very thirsty was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210415219-Covid-19 vaccine ad26.cov2.s-Elevated blood pressure 200 plus And Fluttering Heart. 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: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Chest pain, Dizziness, Dysgeusia, Feeling drunk
Clinical narrative: TUNNEL VISION; CHEST PAIN/PRESSURE; WEIRD TASTE IN MOUTH; DRUNK FEELLING; CRAZY DREAMS; DIZZINESS; NAUSEA; SHOOTING INJECTION SITE PAIN; MUSCLE ACHE; HEADACHE; 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, and batch number: 041A21A expiry: UNKNOWN) 1 total, dose was not reported, administered on 07-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, after vaccination the patient immediately felt dizzy and nausea. Later, she developed tunnel vision, chest pain/pressure, shooting  pain in arm of injection up into jaw (left side) and weird taste in mouth for 6-7 hours. She felt drunk and developed muscle aches. She had crazy dreams and headache. She took Tylenol (paracetamol) about  3-4 hours after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain/pressure, chemical taste in mouth, and shooting injection site pain on 07-APR-2021, tunnel vision, drunk feeling, nausea, and muscle ache on 08-APR-2021, and headache, was recovering from dizziness, and had not recovered from crazy dreams. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210416274-Covid-19 vaccine ad26.cov2.s-TUNNEL VISION . 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: Headache, Injection site pain, Myalgia, Nausea, Tunnel vision
Clinical narrative: TUNNEL VISION; CHEST PAIN/PRESSURE; WEIRD TASTE IN MOUTH; DRUNK FEELLING; CRAZY DREAMS; DIZZINESS; NAUSEA; SHOOTING INJECTION SITE PAIN; MUSCLE ACHE; HEADACHE; 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, and batch number: 041A21A expiry: UNKNOWN) 1 total, dose was not reported, administered on 07-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, after vaccination the patient immediately felt dizzy and nausea. Later, she developed tunnel vision, chest pain/pressure, shooting  pain in arm of injection up into jaw (left side) and weird taste in mouth for 6-7 hours. She felt drunk and developed muscle aches. She had crazy dreams and headache. She took Tylenol (paracetamol) about  3-4 hours after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain/pressure, chemical taste in mouth, and shooting injection site pain on 07-APR-2021, tunnel vision, drunk feeling, nausea, and muscle ache on 08-APR-2021, and headache, was recovering from dizziness, and had not recovered from crazy dreams. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210416274-Covid-19 vaccine ad26.cov2.s-TUNNEL VISION . 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: Antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced confirmed immunological vaccine failure. The patient had took vaccine five week ago and when tested showed no antibodies to covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with PQMS no.90000176109.; Sender's Comments: V0:20210416558-Covid-19 vaccine ad26.cov2.s-Confirmed Immunological vaccine 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: SPECIAL SITUATIONS.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise, Mobility decreased, Myalgia, Nausea
Clinical narrative: FAINTED; NOT ABLE TO GET UP OUT OF CHAIR; NAUSEA; HEADACHE; FEELS UNDER THE WEATHER; MUSCLE ACHE; This spontaneous report received from a parent 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: 041A21A expiry: unknown) dose was not reported, 1 total, administered on 07-APR-2021 14:45 at right arm for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, after getting vaccine, patient fainted (dizziness) and immediately woke up. On the same day, he experienced nausea, headache, feels under the weather, muscle ache and he was not able to get up out of chair. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted on 07-APR-2021, and nausea, and muscle ache in APR-2021, was recovering from headache, and feels under the weather, and the outcome of not able to get up out of chair was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210416848-Covid-19 vaccine ad26.cov2.s-FAINTED. 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: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: FAINTED; NOT ABLE TO GET UP OUT OF CHAIR; NAUSEA; HEADACHE; FEELS UNDER THE WEATHER; MUSCLE ACHE; This spontaneous report received from a parent 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: 041A21A expiry: unknown) dose was not reported, 1 total, administered on 07-APR-2021 14:45 at right arm for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, after getting vaccine, patient fainted (dizziness) and immediately woke up. On the same day, he experienced nausea, headache, feels under the weather, muscle ache and he was not able to get up out of chair. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted on 07-APR-2021, and nausea, and muscle ache in APR-2021, was recovering from headache, and feels under the weather, and the outcome of not able to get up out of chair was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210416848-Covid-19 vaccine ad26.cov2.s-FAINTED. 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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure, Death, Pain
Clinical narrative: PAIN; DEATH; HEART FAILURE; This spontaneous report received from a consumer concerned a 57 year old female. The reporter obtained the information from news/media.  The patient's height, and weight were not reported. The patient's concurrent conditions included bronchitis.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total 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 an unspecified date, the patient took vaccine and experienced pain. On 09-MAR-2021, the patient experienced wet cough; she said her cough was different. On 11-MAR-2021, the patient went to work and sweat profusely and blamed the A/C in her office. On 12-MAR-2021, the night before the patient passed, she was exhausted and went to bed. On 13-MAR-2021 08:00, the patient made a horrible noise, tried to revive in her bed to no avail. The paramedics worked on her on the floor of her bedroom, ambulance and finally the hospital. On 13-MAR-2021, the patient experienced heart failure. On 13-MAR-2021 09:00, the patient died from unknown cause of death. An autopsy was performed on an unspecified date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart failure and pain was not reported. This report was serious (Death, Other Medically Important Condition).; Sender's Comments: V0: 20210417613 -covid-19 vaccine ad26.cov2.s -Death and heart failure. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: FEVER (105 F); BODY ACHES; CHILLS; This spontaneous report received from a parent concerned an 18 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: unknown, expiry: unknown) dose was not reported, 1 total administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-APR-2021, Laboratory data included: Body temperature (NR: not provided) 105 F. The patient experienced fever 105 F, body aches and chills, 12 hours after receiving the covid-19 vaccine ad26.cov2.s. The reporter did not have any additional details about the patient's vaccination experience and did not had access to the vaccine card. The patient was with patient's mother at another location at the time of the reporting. The reporter had seen patient at the emergency room and requested would call back with the additional information needed to document the experience. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, body aches, and fever. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210417614-covid-19 vaccine ad26.cov2.s -Fever. This event is labeled and is therefore considered potentially related.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Fatigue, Feeling hot, Pain, Paraesthesia
Clinical narrative: feeling like passing out; Clamminess; Fatigue; Waves of intense heat, diff. places; Waves of pain; Waves of pins and needles; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, in arm left on 24Mar2021 14:45 (Batch/Lot Number: ENG207) as single dose for Covid-19 immunisation (age at vaccination was 62-years). Patient was not pregnant at the time of vaccination. Medical history included autoimmune disorder and previous cancer. She has dust, pollen, fur allergies. The patient's concomitant medications were not reported. There was no covid prior vaccination and no other vaccine within 4 weeks prior to the COVID vaccine and she was not covid tested post vaccination. Medications the patient received within 2 weeks of vaccination were not reported (she mentioned not enough room here). On 24Mar2021 16:00, the patient experienced waves of intense heat, diff. places (every day so far), waves of pain (first day only) waves of pins and needles (1st 3 days). On 25Mar2021, the patient experienced fatigue, clamminess, feeling like passing out (2nd day only). No treatment was received for any of the event. The outcome of the waves of intense heat, diff. places was not recovered, waves of pain recovered on 24Mar2021, fatigue, clamminess, feeling like passing out recovered on 25Mar2021 and waves of pins and needles recovered on 26Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope
Clinical narrative: feeling like passing out; Clamminess; Fatigue; Waves of intense heat, diff. places; Waves of pain; Waves of pins and needles; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, in arm left on 24Mar2021 14:45 (Batch/Lot Number: ENG207) as single dose for Covid-19 immunisation (age at vaccination was 62-years). Patient was not pregnant at the time of vaccination. Medical history included autoimmune disorder and previous cancer. She has dust, pollen, fur allergies. The patient's concomitant medications were not reported. There was no covid prior vaccination and no other vaccine within 4 weeks prior to the COVID vaccine and she was not covid tested post vaccination. Medications the patient received within 2 weeks of vaccination were not reported (she mentioned not enough room here). On 24Mar2021 16:00, the patient experienced waves of intense heat, diff. places (every day so far), waves of pain (first day only) waves of pins and needles (1st 3 days). On 25Mar2021, the patient experienced fatigue, clamminess, feeling like passing out (2nd day only). No treatment was received for any of the event. The outcome of the waves of intense heat, diff. places was not recovered, waves of pain recovered on 24Mar2021, fatigue, clamminess, feeling like passing out recovered on 25Mar2021 and waves of pins and needles recovered on 26Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Muscle spasms, Pain, Sleep disorder
Clinical narrative: After the first shot, I was lightheaded and dizzy; After the first shot, I was lightheaded and dizzy; muscle spasms in my chest, back, left calf and neck for over 24 hours/The chest and leg spasms were so painful; The pain was not constant and was sporadic; The evening of the 27th I was awakened out of my sleep; This is a spontaneous report from a contactable other hcp for herself. A 57-years-old female patient (not pregnant) received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration (at the age of 57-years-old), administered in Arm Left on 06Mar2021 09:00 (Batch/Lot Number: EN6202) as SINGLE DOSE, dose 2 via an unspecified route of administration (at the age of 57-years-old), administered in Arm Left on 27Mar2021 (Batch/Lot Number: ER2613) as SINGLE DOSE for covid-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medication(s) included telmisartan. The patient was reported to have allergy to lisinopril. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with covid-19 prior or post to the vaccination. Patient reported that after the first shot, she was lightheaded and dizzy for about an hour after. After the second shot, she experienced muscle spasms in her chest, back, left calf and neck for over 24 hours. The pain was not constant and was sporadic. The chest and leg spasms were so painful on 28Mar2021 02:00. And the evening of the 27th she was awakened out of my sleep. Treatment was not received for any event. Events were considered non-serious as reported. Outcome of all events was reported as recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: a rash on upper back.; This is a spontaneous report from a contactable consumer (patient) and physician. A 63-years-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot# EN6208), via an unspecified route of administration in the left arm on 27Mar2021 13:00 at a single dose for COVID-19 immunization.The patient medical history included allergic rash after a Flu Shot in 1996.The concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications were received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 after the vaccination. On 28Mar2021 (Sunday) at 08:00 AM, patient experienced a rash on upper back which resulted in Doctor or other healthcare professional office/clinic visit. Most of the rash is on the left side. Throughout the day, the rash had begun to spread on left shoulder and towards middle of upper back. It was reported that the location of injection information is available for all vaccines received on the same date. The outcome of the event rash is not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Flushing, Heart rate increased, Pharyngeal swelling, Vaccination site paraesthesia
Clinical narrative: tingling in the arm at site of injection; face felt hot and flushed; heart started racing; throat seemed to swell which made it hard to swallow; throat seemed to swell which made it hard to swallow; This is a Spontaneous report from a contactable consumer (patient, self-reported). A 64-year-old female patient (non pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration dates were not reported), via unspecified route of administration in left arm on 13Mar2021 at 10:30AM (at the age of 64-year-old), as single dose for COVID-19 immunization. The patient had medical history of migraine, psoriasis, high blood pressure and allergies to penicillin, sulfa and codone medications. The concomitant medication included Nortriptyline, Bupropion, Propranolol and Vitamin D2. It reported that, on 13Mar2021 at 11:30 AM, within first hour of receiving dose, the patient experienced tingling in the arm at site of injection, face felt hot and flushed, heart started racing and throat seemed to swell which made it hard to swallow and symptoms lessened after 15 minutes. The patient did not receive any treatment for the adverse event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: I have a bald spot, size of dime, in the top of my head.; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female consumer (Patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6204), via an unspecified route of administration in left arm on 9Mar2021 07:00 PM at single dose for COVID-19 prevention.The medical history included Penicillin allergy. concomitant medications were not reported. The patient had a bald spot, size of dime, in the top of my head on 28Mar2021 at 10:00 AM. The patient was not diagnosed with COVID-19 prior to vaccination and the patient has not been tested for COVID-19 since the vaccination. The outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lacrimation increased, Pain
Clinical narrative: Chills; headakc; tiers; body acks; This is a spontaneous report received from a contactable consumer. A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Em6203), via an unspecified route of administration on 27Mar2021 at 11:00 and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Em6203), via an unspecified route of administration on 27Feb2021 at 11:00, both on left arm as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient was pregnant during time of vaccination. On 28Mar2021, the patient experienced Chills, headache, tiers, body aches. Outcome of events reported as recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.