chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Skin laceration, Speech disorder, Throat tightness
Clinical narrative: dizzy and pass out while cleaning; CAN NOT WORK; CAN NOT SPEAK PROPERLY; ALMOST BROKE ARM AND SHOULDER; FELL; WRIST TO ELBOW A CUT; DIZZINESS; THROAT FEELS SMALLER CAN'T EAT, DRINK AND TALK; CAN NOT BREATH WELL WHILE DRINKING OR EATING; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included: high blood pressure, and breast implants removed, and concurrent conditions included: non alcohol user, and smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient did not have any history of drug abuse or illicit drug use. The patient was not on medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 18-MAR-2021 10:30 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 19-MAR-2021, the patient got up at 5:00 and her head was dizzy, same thing the following day and her throat felt smaller she could not eat, drink or talk. She could not breath well while drinking or eating. On 20-MAR-2021, the patient got dizzy and fell and almost broke her shoulder and arm when she hit the big bed (the post on there) and got wrist to elbow a cut. On an unspecified date, the patient experienced could not speak properly, dizzy and pass out while cleaning, and could not work and have to come back home and go to bed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from wrist to elbow a cut, had not recovered from dizziness, throat feels smaller can't eat and drink, i can't breath well, and can't work, and the outcome of fell and almost broke arm/fell and almost broke shoulder and dizzy and pass out while cleaning was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210849156-covid-19 vaccine ad26.cov2.s-Dizzy and pass out while cleaning. 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: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: dizzy and pass out while cleaning; CAN NOT WORK; CAN NOT SPEAK PROPERLY; ALMOST BROKE ARM AND SHOULDER; FELL; WRIST TO ELBOW A CUT; DIZZINESS; THROAT FEELS SMALLER CAN'T EAT, DRINK AND TALK; CAN NOT BREATH WELL WHILE DRINKING OR EATING; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included: high blood pressure, and breast implants removed, and concurrent conditions included: non alcohol user, and smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient did not have any history of drug abuse or illicit drug use. The patient was not on medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 18-MAR-2021 10:30 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 19-MAR-2021, the patient got up at 5:00 and her head was dizzy, same thing the following day and her throat felt smaller she could not eat, drink or talk. She could not breath well while drinking or eating. On 20-MAR-2021, the patient got dizzy and fell and almost broke her shoulder and arm when she hit the big bed (the post on there) and got wrist to elbow a cut. On an unspecified date, the patient experienced could not speak properly, dizzy and pass out while cleaning, and could not work and have to come back home and go to bed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from wrist to elbow a cut, had not recovered from dizziness, throat feels smaller can't eat and drink, i can't breath well, and can't work, and the outcome of fell and almost broke arm/fell and almost broke shoulder and dizzy and pass out while cleaning was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210849156-covid-19 vaccine ad26.cov2.s-Dizzy and pass out while cleaning. 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: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: VACCINE ADMINISTERED FROM VIAL THAT WAS PUNCTURED FOR 14 HOURS; VACCINE KEPT OPEN FOR LONGER TIME; This spontaneous report received from a health care professional concerned a 36 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288, and expiry: UNKNOWN) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUN-2021, the patient experienced vaccine administered from vial that was punctured for 14 hours. On 01-JUN-2021, the patient experienced vaccine kept open for longer time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered from vial that was punctured for 14 hours and vaccine kept open for longer time was not reported. This report was non-serious.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE ADMINISTERED FROM VIAL THAT WAS PUNCTURED FOR 14 HOURS; VACCINE KEPT OPEN FOR LONGER TIME; This spontaneous report received from a health care professional concerned a 36 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288, and expiry: UNKNOWN) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUN-2021, the patient experienced vaccine administered from vial that was punctured for 14 hours. On 01-JUN-2021, the patient experienced vaccine kept open for longer time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered from vial that was punctured for 14 hours and vaccine kept open for longer time was not reported. This report was non-serious.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Diarrhoea, Disorientation, Fatigue, Gait disturbance
Clinical narrative: Extreme diarrhea for 10 days.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Extreme diarrhea for 10 days.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea
Clinical narrative: Extreme diarrhea for 10 days.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough, Dyspnoea, Echocardiogram, Echocardiogram normal, Electrocardiogram repolarisation abnormality
Clinical narrative: chest pain, shortness of breath, elevated troponin levels, myocarditis on MRI
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pleuritic pain, Sinus rhythm, Troponin increased
Clinical narrative: chest pain, shortness of breath, elevated troponin levels, myocarditis on MRI
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Echocardiogram, Electrocardiogram, Magnetic resonance imaging abnormal
Clinical narrative: chest pain, shortness of breath, elevated troponin levels, myocarditis on MRI
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging heart, Myocarditis, Troponin increased
Clinical narrative: chest pain, shortness of breath, elevated troponin levels, myocarditis on MRI
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Seizure like phenomena
Clinical narrative: I went to the waiting room after getting my first dose of the COVID vaccine and fainted in the chair and then began to shake.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Syncope, Tremor
Clinical narrative: I went to the waiting room after getting my first dose of the COVID vaccine and fainted in the chair and then began to shake.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: approximately 15 minutes post vaccine administration patient started feeling dizzy.  The dizziness has persisted through the time of this report.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Middle ear effusion, Vestibular disorder
Clinical narrative: approximately 15 minutes post vaccine administration patient started feeling dizzy.  The dizziness has persisted through the time of this report.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood gases, Full blood count, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: Guillain Barre Syndrome diagnosed 2 days after Covid vaccine given. Required hospitalization.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Intensive care, Lumbar puncture abnormal, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Metabolic function test
Clinical narrative: Guillain Barre Syndrome diagnosed 2 days after Covid vaccine given. Required hospitalization.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Muscular weakness, Paraesthesia, Pulmonary function test, Scan with contrast
Clinical narrative: Guillain Barre Syndrome diagnosed 2 days after Covid vaccine given. Required hospitalization.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre Syndrome diagnosed 2 days after Covid vaccine given. Required hospitalization.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, CSF protein increased, Guillain-Barre syndrome, Hypoaesthesia, Lumbar puncture
Clinical narrative: Guillain Barre Syndrome diagnosed 2 days after Covid vaccine given. Required hospitalization.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging head, Magnetic resonance imaging spinal, Paraesthesia, Protein total, SARS-CoV-2 test
Clinical narrative: Guillain Barre Syndrome diagnosed 2 days after Covid vaccine given. Required hospitalization.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Pain on my left arm; Diarrhea; literally defecated water while standing up showering; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain on my left arm) and DIARRHOEA (Diarrhea; literally defecated water while standing up showering) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jun-2021, the patient experienced PAIN IN EXTREMITY (Pain on my left arm) and DIARRHOEA (Diarrhea; literally defecated water while standing up showering). At the time of the report, PAIN IN EXTREMITY (Pain on my left arm) and DIARRHOEA (Diarrhea; literally defecated water while standing up showering) outcome was unknown.            This case was linked to MOD-2021-144428 (Patient Link).
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Pain in extremity
Clinical narrative: Pain on my left arm; Diarrhea; literally defecated water while standing up showering; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain on my left arm) and DIARRHOEA (Diarrhea; literally defecated water while standing up showering) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jun-2021, the patient experienced PAIN IN EXTREMITY (Pain on my left arm) and DIARRHOEA (Diarrhea; literally defecated water while standing up showering). At the time of the report, PAIN IN EXTREMITY (Pain on my left arm) and DIARRHOEA (Diarrhea; literally defecated water while standing up showering) outcome was unknown.            This case was linked to MOD-2021-144428 (Patient Link).
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Impaired work ability, Injection site pain, Mobility decreased, Paraesthesia
Clinical narrative: Left arm tingles and goes numb. for 10-20 minutes different times during the day. sharp pain from injection site down to hand. Hurts like pin needles , sometimes a burning feeling.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Hypoaesthesia, Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: Left arm tingles and goes numb. for 10-20 minutes different times during the day. sharp pain from injection site down to hand. Hurts like pin needles , sometimes a burning feeling.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19 pneumonia, SARS-CoV-2 test
Clinical narrative: COVID-19 PNEUMONIA; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a health care professional concerned a 57 year old male of unknown race and ethnicity.  Initial information was processed along with the additional information received on 24-AUG-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, frequency one total, administered at left arm on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced covid-19 pneumonia, suspected clinical vaccination failure, headache, fever, nasal congestion, and diarrhea, and was hospitalized. The patient was admitted to the hospital ICU on 09-AUG-2021. Laboratory data (dates unspecified) included: COVID-19 virus test positive (NR: not provided) Positive confirmed by PCR test. On 18-AUG-2021, the patient died from covid-19 pneumonia. 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 covid-19 pneumonia on 18-AUG-2021, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210846435.; Sender's Comments: V0: 20210846822-Covid-19 vaccine ad26.cov2.s- covid-19 pneumonia . 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). 20210846822-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. 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: SPECIAL SITUATIONS; Reported Cause(s) of Death: COVID-19 PNEUMONIA
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19 pneumonia, Vaccination failure
Clinical narrative: COVID-19 PNEUMONIA; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a health care professional concerned a 57 year old male of unknown race and ethnicity.  Initial information was processed along with the additional information received on 24-AUG-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, frequency one total, administered at left arm on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced covid-19 pneumonia, suspected clinical vaccination failure, headache, fever, nasal congestion, and diarrhea, and was hospitalized. The patient was admitted to the hospital ICU on 09-AUG-2021. Laboratory data (dates unspecified) included: COVID-19 virus test positive (NR: not provided) Positive confirmed by PCR test. On 18-AUG-2021, the patient died from covid-19 pneumonia. 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 covid-19 pneumonia on 18-AUG-2021, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210846435.; Sender's Comments: V0: 20210846822-Covid-19 vaccine ad26.cov2.s- covid-19 pneumonia . 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). 20210846822-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. 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: SPECIAL SITUATIONS; Reported Cause(s) of Death: COVID-19 PNEUMONIA
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 PNEUMONIA; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a health care professional concerned a 57 year old male of unknown race and ethnicity.  Initial information was processed along with the additional information received on 24-AUG-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, frequency one total, administered at left arm on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced covid-19 pneumonia, suspected clinical vaccination failure, headache, fever, nasal congestion, and diarrhea, and was hospitalized. The patient was admitted to the hospital ICU on 09-AUG-2021. Laboratory data (dates unspecified) included: COVID-19 virus test positive (NR: not provided) Positive confirmed by PCR test. On 18-AUG-2021, the patient died from covid-19 pneumonia. 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 covid-19 pneumonia on 18-AUG-2021, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210846435.; Sender's Comments: V0: 20210846822-Covid-19 vaccine ad26.cov2.s- covid-19 pneumonia . 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). 20210846822-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. 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: SPECIAL SITUATIONS; Reported Cause(s) of Death: COVID-19 PNEUMONIA
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest, Death
Clinical narrative: Patient was found down, CPR initiated, TOD called at 0723.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Resuscitation
Clinical narrative: Patient was found down, CPR initiated, TOD called at 0723.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Palpitations
Clinical narrative: Patient recieved COVID 19 vaccine at 7:23AM on 8/24/2021 on 8/24/21 patient developed a cough, chest tightness with difficulty breathing. She went to Hospital. it was crowded she left & went to urgent care following city, urgent care sent patient via ambulance to hospital.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Cough, Dyspnoea
Clinical narrative: Patient recieved COVID 19 vaccine at 7:23AM on 8/24/2021 on 8/24/21 patient developed a cough, chest tightness with difficulty breathing. She went to Hospital. it was crowded she left & went to urgent care following city, urgent care sent patient via ambulance to hospital.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Pneumonia
Clinical narrative: Patients wife states patient woke up gasping for air and couldn't breathe so she called 911. His eyes became fixated so she initiated CPR and patient was transported to the hospital and is  where he is in the ICU and has coded another 5 times per wife. She says he has double pneumonia which has led to myocarditis and kidney failure. They are still unsure if there has been any brain damage from lack of oxygen. Wife reports patient had no symptoms whatsoever before or after the vaccine until the onset Wednesday morning, besides a little soreness the day afterwards.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardio-respiratory arrest, Dyspnoea, Intensive care, Myocarditis, Pain
Clinical narrative: Patients wife states patient woke up gasping for air and couldn't breathe so she called 911. His eyes became fixated so she initiated CPR and patient was transported to the hospital and is  where he is in the ICU and has coded another 5 times per wife. She says he has double pneumonia which has led to myocarditis and kidney failure. They are still unsure if there has been any brain damage from lack of oxygen. Wife reports patient had no symptoms whatsoever before or after the vaccine until the onset Wednesday morning, besides a little soreness the day afterwards.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pneumonia, Renal failure, Respiratory arrest, Resuscitation, Staring
Clinical narrative: Patients wife states patient woke up gasping for air and couldn't breathe so she called 911. His eyes became fixated so she initiated CPR and patient was transported to the hospital and is  where he is in the ICU and has coded another 5 times per wife. She says he has double pneumonia which has led to myocarditis and kidney failure. They are still unsure if there has been any brain damage from lack of oxygen. Wife reports patient had no symptoms whatsoever before or after the vaccine until the onset Wednesday morning, besides a little soreness the day afterwards.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Sharp shooting pain that started mid body then went out to her extremities, tiredness, and random pains throughout body, severe back, neck and upper shoulder pains, unable to stand due to pain.  Upper back, shoulder, and neck are stiff.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Dysstasia, Fatigue, Musculoskeletal stiffness
Clinical narrative: Sharp shooting pain that started mid body then went out to her extremities, tiredness, and random pains throughout body, severe back, neck and upper shoulder pains, unable to stand due to pain.  Upper back, shoulder, and neck are stiff.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neck pain, Pain, Pain in extremity
Clinical narrative: Sharp shooting pain that started mid body then went out to her extremities, tiredness, and random pains throughout body, severe back, neck and upper shoulder pains, unable to stand due to pain.  Upper back, shoulder, and neck are stiff.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product preparation issue
Clinical narrative: The Pfizer Covid injection was mixed incorrectly instead of 1.8 mL of 0.9% normal saline it was diluted with 0.9 mL. .  I called the pharmacy and they directed me to call Pfizer which I did and there recommendation is what the CDC recommends and according to the CDC it says no harm will come to the patient.  Also they reported to me that  The  Journal states no adverse reaction and the only reaction reported was a very sore arm for 3-4 days at the site of the injection was given.  They also recommend for patient to come for 2nd Pfizer dose in 3 week  I also notified patient of this.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Pain in extremity, Product preparation issue
Clinical narrative: The Pfizer Covid injection was mixed incorrectly instead of 1.8 mL of 0.9% normal saline it was diluted with 0.9 mL. .  I called the pharmacy and they directed me to call Pfizer which I did and there recommendation is what the CDC recommends and according to the CDC it says no harm will come to the patient.  Also they reported to me that  The  Journal states no adverse reaction and the only reaction reported was a very sore arm for 3-4 days at the site of the injection was given.  They also recommend for patient to come for 2nd Pfizer dose in 3 week  I also notified patient of this.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a consumer concerned a 27 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: type 1 diabetes, non-smoker, and non alcohol user, and other pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, expiry: 29-SEP-2021) dose was not reported, administered on 23-AUG-2021 for prophylactic vaccination. Concomitant medications included insulin glargine for type 1 diabetes, and insulin lispro for type 1 diabetes. On 23-AUG-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.8 F, 102.4 F, 101.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling cold, Pain in extremity, Pollakiuria, Pyrexia
Clinical narrative: INCREASED THIRST; MORE FREQUENT URINATION; SHARP SHOOTING RIGHT LEG PAIN; FEELING COLD; FEVER 100.8F; This spontaneous report received from a consumer concerned a 39 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient did not have any significant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1816022 expiry: 29-SEP-2021) dose was not reported, administered on 23-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-AUG-2021, the patient experienced increased thirst. On 23-AUG-2021, the patient experienced more frequent urination. On 23-AUG-2021, the patient experienced sharp shooting right leg pain. On 23-AUG-2021, the patient experienced feeling cold. On 23-AUG-2021, the patient experienced fever 100.8f. Laboratory data included: Body temperature (NR: not provided) 100.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever 100.8f, sharp shooting right leg pain, feeling cold, increased thirst, and more frequent urination. This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Thirst
Clinical narrative: INCREASED THIRST; MORE FREQUENT URINATION; SHARP SHOOTING RIGHT LEG PAIN; FEELING COLD; FEVER 100.8F; This spontaneous report received from a consumer concerned a 39 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient did not have any significant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1816022 expiry: 29-SEP-2021) dose was not reported, administered on 23-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-AUG-2021, the patient experienced increased thirst. On 23-AUG-2021, the patient experienced more frequent urination. On 23-AUG-2021, the patient experienced sharp shooting right leg pain. On 23-AUG-2021, the patient experienced feeling cold. On 23-AUG-2021, the patient experienced fever 100.8f. Laboratory data included: Body temperature (NR: not provided) 100.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever 100.8f, sharp shooting right leg pain, feeling cold, increased thirst, and more frequent urination. This report was non-serious.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test abnormal, Chest discomfort, Chest pain, Computerised tomogram normal, Eye disorder
Clinical narrative: Around July 29, 2021 noticed a sharp pain in my right calf.  I thought it was likely a superficial blood clot.  I had two other superficial blood clots in my right calf on 11/18/2020 and  12/13/2020 that felt the same.  In Nov and Dec I was also checked for DVT, but it was negative.  I believe these were my first blood clots.  In Jan 2021, I was diagnosed with Factor V Leiden.  On  Aug 6, I had another xolair injection at 10:30 am.  Around 4:30 pm I developed a moderately painful headache localized on the right side of my head - especially around my eye.  Around 6:30 my husband noticed that my right eye was pointing inward unless I was consciously focusing my eye.  I did have a lazy eye in my right eye when I was 4-6 years old.  I have had localized headaches in the past, but never with the odd eye movement.  I observed it in the mirror as well.  Although, it stopped.  I'm not sure when, but before 9:00 pm.  I went to the ER around 7:00 pm, but wasn't seen for a few hours.  I was given lots of blood work and a CAT scan with and without contrast in my head and neck.  They came back negative.  They sent me home (around 1:30 am) with instructions to return at 8:00 am for Lower Limb Venous Duplex.  I came back as instructed.  The doppler showed a superficial blood clot in my right calf.  The ER doctor, noting I still had a localized headache around my right eye, ordered a MRI of my head and neck.  They also came back negative.  In coordination with my hemotologist, I was prescribed 2*10mg xarelto (1 tablet morning, 1 tablet evening) for 12 days.  I was given tylenol and discharged.  The headache went away after about 24 hours.  And the superficial blood clot stopped hurting within a few days.  Note - I have had a tight chest since around June 1.  I was tested for COVID with PCR test on June 3, but it was negative.   For the next few weeks, my chest felt tight and hurt mildly, especially when breathing deeply.  I had a spirometry test on 6/11/2021 that showed a slightly reduced FEF25-75.   I went to the ER on 6/17/21 for the breathing problems.  They did a ECG and CAT scan of my chest, but didn't find an aneurysm or pulmonary embolism.  I followed up with a pulmonologist on 7/21/21 and they prescribed Flovent HFA 220 mcg/actuation inhaler (2 puffs twice a day) for two months.  We think the problem was likely dust caused by having the siding replaced at my house.   My tight chest is mostly better now.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Magnetic resonance imaging head normal, Magnetic resonance imaging neck, Pain in extremity, SARS-CoV-2 test negative
Clinical narrative: Around July 29, 2021 noticed a sharp pain in my right calf.  I thought it was likely a superficial blood clot.  I had two other superficial blood clots in my right calf on 11/18/2020 and  12/13/2020 that felt the same.  In Nov and Dec I was also checked for DVT, but it was negative.  I believe these were my first blood clots.  In Jan 2021, I was diagnosed with Factor V Leiden.  On  Aug 6, I had another xolair injection at 10:30 am.  Around 4:30 pm I developed a moderately painful headache localized on the right side of my head - especially around my eye.  Around 6:30 my husband noticed that my right eye was pointing inward unless I was consciously focusing my eye.  I did have a lazy eye in my right eye when I was 4-6 years old.  I have had localized headaches in the past, but never with the odd eye movement.  I observed it in the mirror as well.  Although, it stopped.  I'm not sure when, but before 9:00 pm.  I went to the ER around 7:00 pm, but wasn't seen for a few hours.  I was given lots of blood work and a CAT scan with and without contrast in my head and neck.  They came back negative.  They sent me home (around 1:30 am) with instructions to return at 8:00 am for Lower Limb Venous Duplex.  I came back as instructed.  The doppler showed a superficial blood clot in my right calf.  The ER doctor, noting I still had a localized headache around my right eye, ordered a MRI of my head and neck.  They also came back negative.  In coordination with my hemotologist, I was prescribed 2*10mg xarelto (1 tablet morning, 1 tablet evening) for 12 days.  I was given tylenol and discharged.  The headache went away after about 24 hours.  And the superficial blood clot stopped hurting within a few days.  Note - I have had a tight chest since around June 1.  I was tested for COVID with PCR test on June 3, but it was negative.   For the next few weeks, my chest felt tight and hurt mildly, especially when breathing deeply.  I had a spirometry test on 6/11/2021 that showed a slightly reduced FEF25-75.   I went to the ER on 6/17/21 for the breathing problems.  They did a ECG and CAT scan of my chest, but didn't find an aneurysm or pulmonary embolism.  I followed up with a pulmonologist on 7/21/21 and they prescribed Flovent HFA 220 mcg/actuation inhaler (2 puffs twice a day) for two months.  We think the problem was likely dust caused by having the siding replaced at my house.   My tight chest is mostly better now.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Scan with contrast, Thrombosis, Ultrasound Doppler abnormal
Clinical narrative: Around July 29, 2021 noticed a sharp pain in my right calf.  I thought it was likely a superficial blood clot.  I had two other superficial blood clots in my right calf on 11/18/2020 and  12/13/2020 that felt the same.  In Nov and Dec I was also checked for DVT, but it was negative.  I believe these were my first blood clots.  In Jan 2021, I was diagnosed with Factor V Leiden.  On  Aug 6, I had another xolair injection at 10:30 am.  Around 4:30 pm I developed a moderately painful headache localized on the right side of my head - especially around my eye.  Around 6:30 my husband noticed that my right eye was pointing inward unless I was consciously focusing my eye.  I did have a lazy eye in my right eye when I was 4-6 years old.  I have had localized headaches in the past, but never with the odd eye movement.  I observed it in the mirror as well.  Although, it stopped.  I'm not sure when, but before 9:00 pm.  I went to the ER around 7:00 pm, but wasn't seen for a few hours.  I was given lots of blood work and a CAT scan with and without contrast in my head and neck.  They came back negative.  They sent me home (around 1:30 am) with instructions to return at 8:00 am for Lower Limb Venous Duplex.  I came back as instructed.  The doppler showed a superficial blood clot in my right calf.  The ER doctor, noting I still had a localized headache around my right eye, ordered a MRI of my head and neck.  They also came back negative.  In coordination with my hemotologist, I was prescribed 2*10mg xarelto (1 tablet morning, 1 tablet evening) for 12 days.  I was given tylenol and discharged.  The headache went away after about 24 hours.  And the superficial blood clot stopped hurting within a few days.  Note - I have had a tight chest since around June 1.  I was tested for COVID with PCR test on June 3, but it was negative.   For the next few weeks, my chest felt tight and hurt mildly, especially when breathing deeply.  I had a spirometry test on 6/11/2021 that showed a slightly reduced FEF25-75.   I went to the ER on 6/17/21 for the breathing problems.  They did a ECG and CAT scan of my chest, but didn't find an aneurysm or pulmonary embolism.  I followed up with a pulmonologist on 7/21/21 and they prescribed Flovent HFA 220 mcg/actuation inhaler (2 puffs twice a day) for two months.  We think the problem was likely dust caused by having the siding replaced at my house.   My tight chest is mostly better now.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cough, Dyspnoea, Headache, Oropharyngeal pain
Clinical narrative: COVID-19 infection identified by lab test on 8/9/2021 after symptom development (headache) on 8/7/2021, progressing to cough on 8/8/2021, and subsequently with added sore throat, congestion, fever, and breathing difficulty on 8/9/2021.  Infection resulted in hospitalization 8/14/2021 through 8/19/2021.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: COVID-19 infection identified by lab test on 8/9/2021 after symptom development (headache) on 8/7/2021, progressing to cough on 8/8/2021, and subsequently with added sore throat, congestion, fever, and breathing difficulty on 8/9/2021.  Infection resulted in hospitalization 8/14/2021 through 8/19/2021.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Atrial fibrillation, Cardiac failure congestive, Cardiac monitoring, Chest X-ray abnormal
Clinical narrative: Patient had extremely high blood pressure (284/188) and was sent from her Doctors office to the ER at Hospital. She remains in Afib and on increased blood pressure medications and blood thinners. She has had EKGs and Chest XRays determining CHF. Currently she is on a heart monitor and scheduled for a CAT scan.  She is now scheduled with cardiologist. Doctor and patient believe this was a reaction to the vaccine as pt was previously stable. Patient will not be getting second dose of vaccine due to high risk and potential worsening of condition.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Electrocardiogram abnormal, Hypertension, Incomplete course of vaccination
Clinical narrative: Patient had extremely high blood pressure (284/188) and was sent from her Doctors office to the ER at Hospital. She remains in Afib and on increased blood pressure medications and blood thinners. She has had EKGs and Chest XRays determining CHF. Currently she is on a heart monitor and scheduled for a CAT scan.  She is now scheduled with cardiologist. Doctor and patient believe this was a reaction to the vaccine as pt was previously stable. Patient will not be getting second dose of vaccine due to high risk and potential worsening of condition.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration, Vitiligo
Clinical narrative: developed skin discoloration - vitiligo on arms and legs
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain
Clinical narrative: Within a week of having the first injection, I began having upper back pain on the left side of my back.  I don't know if it is related to the vaccine, however was advised by the CDC to report it.  After 7 months, the pain continues at various times throughout the day.  I haven't had any tests or labs to find out the source of the pain.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Myalgia, Pain
Clinical narrative: About 12 hours after the vaccine at night. Fatigue came first and then the body aches and chills. The chills caused severe shivering that hurt and felt as if I had a high temperature when that was not true. I took a 1-2 500mg Tylenol every 4-6 hours. My temperature when chills were so bad was taken even when I had not taken any medication and did not reach a dangerously high level. Tylenol seemed to have little effect on the shakes and muscle aches. I weigh 100 pounds. A 1000mg of Tylenol usually works. Temperature was taken through the night about 3 hour intervals and did not reach above 100.1 F. However the chills and shakes were rough and lasted only about another 12 hours. Throughout the next day I felt severe fatigue as if I?ve had high fever but the fever has subsided within the same time period as the chills. That night (a little after 24 hours) I sweated enough to drench the sheets at night time. By around 32-36 hours after the vaccine I felt better maybe still a little tired. I wanted to report this symptoms because I had a tetnus booster 16 days prior to the vaccine. I wanted to not make an assumption but an observation that the chills cause such shivers that my muscles felt almost as if they were becoming fatigued from being tense for so long. Similar to how tetnus resides. Just an observation and to report as a good cause and effect. I have since a month later going to get my second vaccine soon have not yet seen any other adverse reaction.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness
Clinical narrative: guillain-barre- progressive numbness, weakness lower extremities starting about 6 days after vaccination
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Oedema, Rash, Skin exfoliation, Thermal burn
Clinical narrative: Burn shed skin rashes Cellulitis and edema
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose normal, Disorientation, Dyskinesia, Fall, Loss of consciousness
Clinical narrative: Patient was siting in the observation area after received J&J vaccine. 2 minutes after talked to him and walked away from him, a  noise was heard and found patient on the flood in prone position unconscious. Quickly  reached to his side and noticed he has mild ( not violent) jerking movement.  911 was called. His ABC ( airway, breathing, circulation ) intact. No external injury was found. Patient regained consciousness   He was disoriented for a moment but soon became oriented. His initial vital signs  P 95; BP 146/64; Second one P96; BP 118/64; O2 Sat 98%. Paramedic arrived and patient was traported to hospital to be evaluated.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Chest X-ray normal, Chest discomfort, Dyspnoea, Electrocardiogram normal
Clinical narrative: Feeling of tightness in the chest and difficulty getting a full breath.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: redness, swelling, tenderness and heat under the skin at injection site; about 1.5 in in diameter.  Tenderness. began the evening of day of the injection. Swelling, redness, and heat were noticed by the patient two days after injection.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris
Clinical narrative: Heart aches
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Feeling hot, Injection site pain, Nausea
Clinical narrative: FC3182, I think was the lot number.  It was hard to read.  Nausea-same day through day 4.  Light headedness- day 2-4. Pain at injection site-day1-still going. Redness and swelling; hot to the touch- day 2- still going, although the sWelling is going down a little.  Itchiness around the red area; day 3 and still going. The red area is about 3 inches across.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: FC3182, I think was the lot number.  It was hard to read.  Nausea-same day through day 4.  Light headedness- day 2-4. Pain at injection site-day1-still going. Redness and swelling; hot to the touch- day 2- still going, although the sWelling is going down a little.  Itchiness around the red area; day 3 and still going. The red area is about 3 inches across.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test normal, Burning sensation, Erythema, Feeling hot, Hot flush
Clinical narrative: The last 4 months have been the most difficult phase of my life.  I started facing the below symptoms after nearly 10-15 days of receiving  1st covid shot.   Some parts of my body burn for several hours every day, feel warm throughout the day, almost as if smoke comes out of my ears,  get a red rash, sometimes followed by low-grade fever (99 degrees).   I feel extremely warm throughout the day and night (almost feeling of burns, hot flashes is an understatement. These are burns occurring throughout the day and night and sometimes smoke coming out of the ear). A lot of times my ears, arms, neck, and cheeks become blood red and I have done a series of tests to find out. All my tests are normal and they don't explain symptoms. In the last 4 months, I have got a lot of blood tests/urine tests done but none of them explain the symptoms.   I had sleepless nights because I am extremely warm. I switch on the AC throughout the day and night but still very warm. Is there a way, I can unvaccinated myself? I am unable to sleep at night.   So far, I was not sure what is causing this but since all my reports are normal. I now believe this is because of covid 1st shot. Let me know how you can help.   Thanks in advance!
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Insomnia, Urine analysis normal
Clinical narrative: The last 4 months have been the most difficult phase of my life.  I started facing the below symptoms after nearly 10-15 days of receiving  1st covid shot.   Some parts of my body burn for several hours every day, feel warm throughout the day, almost as if smoke comes out of my ears,  get a red rash, sometimes followed by low-grade fever (99 degrees).   I feel extremely warm throughout the day and night (almost feeling of burns, hot flashes is an understatement. These are burns occurring throughout the day and night and sometimes smoke coming out of the ear). A lot of times my ears, arms, neck, and cheeks become blood red and I have done a series of tests to find out. All my tests are normal and they don't explain symptoms. In the last 4 months, I have got a lot of blood tests/urine tests done but none of them explain the symptoms.   I had sleepless nights because I am extremely warm. I switch on the AC throughout the day and night but still very warm. Is there a way, I can unvaccinated myself? I am unable to sleep at night.   So far, I was not sure what is causing this but since all my reports are normal. I now believe this is because of covid 1st shot. Let me know how you can help.   Thanks in advance!