chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Troponin, Vomiting
Clinical narrative: Went to ER and was diagnosed with bilateral pulmonary emboli; Pain on left lung/torso/Severe pain on Left lung/torso, pain starting at collar bone down the torso; increased difficulty breathing; Vomiting; fever 99.2/fever 99.6; Tired; Nausea; This is a spontaneous report from a contactable consumer. A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER 8727), via an unspecified route of administration, at the age of 46 years, administered on the left arm on 23Mar2021 10:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity to PCN from an unknown date and unknown if ongoing. Concomitant medications included ethinylestradiol, norgestimate (TRI-SPRINTEC) and fluoxetine (FLUOXETINE); both taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicilin and experienced drug hypersensitivity. The patient went to ER and was diagnosed with bilateral pulmonary emboli on 23Mar2021 21:30, pain on left lung/torso/severe pain on left lung/torso, pain starting at collar bone down the torso on 23Mar2021 21:30, increased difficulty breathing on 23Mar2021 21:30, nausea, vomiting, fever 99.2/ 99.6, tired on 23Mar2021 21:30. The patient underwent lab tests and procedures which included body temperature: 99.2 on Mar2021, body temperature: 99.6 on Mar2021, sars-cov-2 test: negative on 01Apr2021. Therapeutic measures (Eliquis (blood thinners)) were taken as a result of the events. The events were reported as Life threatening. The outcome of the events was recovering.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Dyspnoea, Fatigue, Nausea, Pain
Clinical narrative: Went to ER and was diagnosed with bilateral pulmonary emboli; Pain on left lung/torso/Severe pain on Left lung/torso, pain starting at collar bone down the torso; increased difficulty breathing; Vomiting; fever 99.2/fever 99.6; Tired; Nausea; This is a spontaneous report from a contactable consumer. A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER 8727), via an unspecified route of administration, at the age of 46 years, administered on the left arm on 23Mar2021 10:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity to PCN from an unknown date and unknown if ongoing. Concomitant medications included ethinylestradiol, norgestimate (TRI-SPRINTEC) and fluoxetine (FLUOXETINE); both taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicilin and experienced drug hypersensitivity. The patient went to ER and was diagnosed with bilateral pulmonary emboli on 23Mar2021 21:30, pain on left lung/torso/severe pain on left lung/torso, pain starting at collar bone down the torso on 23Mar2021 21:30, increased difficulty breathing on 23Mar2021 21:30, nausea, vomiting, fever 99.2/ 99.6, tired on 23Mar2021 21:30. The patient underwent lab tests and procedures which included body temperature: 99.2 on Mar2021, body temperature: 99.6 on Mar2021, sars-cov-2 test: negative on 01Apr2021. Therapeutic measures (Eliquis (blood thinners)) were taken as a result of the events. The events were reported as Life threatening. The outcome of the events was recovering.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary embolism, Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: Went to ER and was diagnosed with bilateral pulmonary emboli; Pain on left lung/torso/Severe pain on Left lung/torso, pain starting at collar bone down the torso; increased difficulty breathing; Vomiting; fever 99.2/fever 99.6; Tired; Nausea; This is a spontaneous report from a contactable consumer. A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER 8727), via an unspecified route of administration, at the age of 46 years, administered on the left arm on 23Mar2021 10:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity to PCN from an unknown date and unknown if ongoing. Concomitant medications included ethinylestradiol, norgestimate (TRI-SPRINTEC) and fluoxetine (FLUOXETINE); both taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicilin and experienced drug hypersensitivity. The patient went to ER and was diagnosed with bilateral pulmonary emboli on 23Mar2021 21:30, pain on left lung/torso/severe pain on left lung/torso, pain starting at collar bone down the torso on 23Mar2021 21:30, increased difficulty breathing on 23Mar2021 21:30, nausea, vomiting, fever 99.2/ 99.6, tired on 23Mar2021 21:30. The patient underwent lab tests and procedures which included body temperature: 99.2 on Mar2021, body temperature: 99.6 on Mar2021, sars-cov-2 test: negative on 01Apr2021. Therapeutic measures (Eliquis (blood thinners)) were taken as a result of the events. The events were reported as Life threatening. The outcome of the events was recovering.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute myocardial infarction
Clinical narrative: STEMI w symptoms beginning ~36 hours after second dose
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute myocardial infarction, Electrocardiogram
Clinical narrative: STEMI w symptoms beginning ~36 hours after second dose
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Cough, Eye irritation, Eye pruritus, Headache
Clinical narrative: BODY ACHES; SORE THROAT; RUNNING NOSE; COUGH; VOMITING; WATERY EYES; ITCHY EYES; BURNING EYES; CHILLS; NAUSEA; SEVERE HEADACHE; This spontaneous report received from a health care professional concerned a 52 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism, diabetes, hypertension, gastroesophageal reflux diseases, hyperlipidemia, seasonal allergies, and bph, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 06-APR-2021 08:15 to left arm for prophylactic vaccination. Concomitant medications included atorvastatin, carvedilol, fluticasone, levothyroxine, losartan, metformin, and omeprazole. On 06-APR-2021, the subject experienced body aches. On 06-APR-2021, the subject experienced sore throat. On 06-APR-2021, the subject experienced running nose. On 06-APR-2021, the subject experienced cough. On 06-APR-2021, the subject experienced vomiting. On 06-APR-2021, the subject experienced watery eyes. On 06-APR-2021, the subject experienced itchy eyes. On 06-APR-2021, the subject experienced burning eyes. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced nausea. On 06-APR-2021, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, chills, body aches, sore throat, running nose, cough, nausea, vomiting, watery eyes, itchy eyes, and burning eyes. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lacrimation increased, Nausea, Oropharyngeal pain, Pain, Rhinorrhoea
Clinical narrative: BODY ACHES; SORE THROAT; RUNNING NOSE; COUGH; VOMITING; WATERY EYES; ITCHY EYES; BURNING EYES; CHILLS; NAUSEA; SEVERE HEADACHE; This spontaneous report received from a health care professional concerned a 52 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism, diabetes, hypertension, gastroesophageal reflux diseases, hyperlipidemia, seasonal allergies, and bph, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 06-APR-2021 08:15 to left arm for prophylactic vaccination. Concomitant medications included atorvastatin, carvedilol, fluticasone, levothyroxine, losartan, metformin, and omeprazole. On 06-APR-2021, the subject experienced body aches. On 06-APR-2021, the subject experienced sore throat. On 06-APR-2021, the subject experienced running nose. On 06-APR-2021, the subject experienced cough. On 06-APR-2021, the subject experienced vomiting. On 06-APR-2021, the subject experienced watery eyes. On 06-APR-2021, the subject experienced itchy eyes. On 06-APR-2021, the subject experienced burning eyes. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced nausea. On 06-APR-2021, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, chills, body aches, sore throat, running nose, cough, nausea, vomiting, watery eyes, itchy eyes, and burning eyes. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: BODY ACHES; SORE THROAT; RUNNING NOSE; COUGH; VOMITING; WATERY EYES; ITCHY EYES; BURNING EYES; CHILLS; NAUSEA; SEVERE HEADACHE; This spontaneous report received from a health care professional concerned a 52 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism, diabetes, hypertension, gastroesophageal reflux diseases, hyperlipidemia, seasonal allergies, and bph, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 06-APR-2021 08:15 to left arm for prophylactic vaccination. Concomitant medications included atorvastatin, carvedilol, fluticasone, levothyroxine, losartan, metformin, and omeprazole. On 06-APR-2021, the subject experienced body aches. On 06-APR-2021, the subject experienced sore throat. On 06-APR-2021, the subject experienced running nose. On 06-APR-2021, the subject experienced cough. On 06-APR-2021, the subject experienced vomiting. On 06-APR-2021, the subject experienced watery eyes. On 06-APR-2021, the subject experienced itchy eyes. On 06-APR-2021, the subject experienced burning eyes. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced nausea. On 06-APR-2021, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, chills, body aches, sore throat, running nose, cough, nausea, vomiting, watery eyes, itchy eyes, and burning eyes. This report was non-serious.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope
Clinical narrative: WITHIN 30 SECONDS OF VACCINE GOING IN HER ARM SHE STARTED TO SWEAT AND GET VERY HOT. SHE  SAT IN A CHAIR AND SAID SHE DIDN'T FEEL WELL AND IMMEDIATELY PASSED OUT. HER COLOR DRAINED AND SHE THENGOT VERY COLD AND SWEATY. THE MAN WHO ADMINISTERED THE VACCINE AND I RUBBED HER FACE, NECK AND CHEST WITH RUBBING ALCOHOL AND A LADY HELD VAPOR BEADS UNDER HER NOSE SHE WAS UNRESPONSIVE AND COMPLETELY OUT ALMOST 4 MINUTES. PHARMACY STAFF CALLED 911. PARAMEDICS CAME RIGHT AFTER SHE WOKE UP AND TOOK BLOOD PRESSURE AND SAID IT WAS VERY LOW AND TRANSPORTED HER TO HOSPITAL TO BE EVALUATED. SHE WAS GIVEN AN IV, HAD BLOODWORK AND AN EKG, HAD A URINALYSIS. WAS DISCHARGED LATER THAT AM. STARTED FEVER & CHILLS SAME DAY 5PM, DID NOT FEEL
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood test, Chills, Electrocardiogram, Feeling cold
Clinical narrative: WITHIN 30 SECONDS OF VACCINE GOING IN HER ARM SHE STARTED TO SWEAT AND GET VERY HOT. SHE  SAT IN A CHAIR AND SAID SHE DIDN'T FEEL WELL AND IMMEDIATELY PASSED OUT. HER COLOR DRAINED AND SHE THENGOT VERY COLD AND SWEATY. THE MAN WHO ADMINISTERED THE VACCINE AND I RUBBED HER FACE, NECK AND CHEST WITH RUBBING ALCOHOL AND A LADY HELD VAPOR BEADS UNDER HER NOSE SHE WAS UNRESPONSIVE AND COMPLETELY OUT ALMOST 4 MINUTES. PHARMACY STAFF CALLED 911. PARAMEDICS CAME RIGHT AFTER SHE WOKE UP AND TOOK BLOOD PRESSURE AND SAID IT WAS VERY LOW AND TRANSPORTED HER TO HOSPITAL TO BE EVALUATED. SHE WAS GIVEN AN IV, HAD BLOODWORK AND AN EKG, HAD A URINALYSIS. WAS DISCHARGED LATER THAT AM. STARTED FEVER & CHILLS SAME DAY 5PM, DID NOT FEEL
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Hyperhidrosis, Hypotension, Immediate post-injection reaction, Injection site pain
Clinical narrative: WITHIN 30 SECONDS OF VACCINE GOING IN HER ARM SHE STARTED TO SWEAT AND GET VERY HOT. SHE  SAT IN A CHAIR AND SAID SHE DIDN'T FEEL WELL AND IMMEDIATELY PASSED OUT. HER COLOR DRAINED AND SHE THENGOT VERY COLD AND SWEATY. THE MAN WHO ADMINISTERED THE VACCINE AND I RUBBED HER FACE, NECK AND CHEST WITH RUBBING ALCOHOL AND A LADY HELD VAPOR BEADS UNDER HER NOSE SHE WAS UNRESPONSIVE AND COMPLETELY OUT ALMOST 4 MINUTES. PHARMACY STAFF CALLED 911. PARAMEDICS CAME RIGHT AFTER SHE WOKE UP AND TOOK BLOOD PRESSURE AND SAID IT WAS VERY LOW AND TRANSPORTED HER TO HOSPITAL TO BE EVALUATED. SHE WAS GIVEN AN IV, HAD BLOODWORK AND AN EKG, HAD A URINALYSIS. WAS DISCHARGED LATER THAT AM. STARTED FEVER & CHILLS SAME DAY 5PM, DID NOT FEEL
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Malaise, Pyrexia, Skin discolouration, Syncope
Clinical narrative: WITHIN 30 SECONDS OF VACCINE GOING IN HER ARM SHE STARTED TO SWEAT AND GET VERY HOT. SHE  SAT IN A CHAIR AND SAID SHE DIDN'T FEEL WELL AND IMMEDIATELY PASSED OUT. HER COLOR DRAINED AND SHE THENGOT VERY COLD AND SWEATY. THE MAN WHO ADMINISTERED THE VACCINE AND I RUBBED HER FACE, NECK AND CHEST WITH RUBBING ALCOHOL AND A LADY HELD VAPOR BEADS UNDER HER NOSE SHE WAS UNRESPONSIVE AND COMPLETELY OUT ALMOST 4 MINUTES. PHARMACY STAFF CALLED 911. PARAMEDICS CAME RIGHT AFTER SHE WOKE UP AND TOOK BLOOD PRESSURE AND SAID IT WAS VERY LOW AND TRANSPORTED HER TO HOSPITAL TO BE EVALUATED. SHE WAS GIVEN AN IV, HAD BLOODWORK AND AN EKG, HAD A URINALYSIS. WAS DISCHARGED LATER THAT AM. STARTED FEVER & CHILLS SAME DAY 5PM, DID NOT FEEL
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unresponsive to stimuli, Urine analysis
Clinical narrative: WITHIN 30 SECONDS OF VACCINE GOING IN HER ARM SHE STARTED TO SWEAT AND GET VERY HOT. SHE  SAT IN A CHAIR AND SAID SHE DIDN'T FEEL WELL AND IMMEDIATELY PASSED OUT. HER COLOR DRAINED AND SHE THENGOT VERY COLD AND SWEATY. THE MAN WHO ADMINISTERED THE VACCINE AND I RUBBED HER FACE, NECK AND CHEST WITH RUBBING ALCOHOL AND A LADY HELD VAPOR BEADS UNDER HER NOSE SHE WAS UNRESPONSIVE AND COMPLETELY OUT ALMOST 4 MINUTES. PHARMACY STAFF CALLED 911. PARAMEDICS CAME RIGHT AFTER SHE WOKE UP AND TOOK BLOOD PRESSURE AND SAID IT WAS VERY LOW AND TRANSPORTED HER TO HOSPITAL TO BE EVALUATED. SHE WAS GIVEN AN IV, HAD BLOODWORK AND AN EKG, HAD A URINALYSIS. WAS DISCHARGED LATER THAT AM. STARTED FEVER & CHILLS SAME DAY 5PM, DID NOT FEEL
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Anaphylactic shock, Asthenia, Dizziness, Dry mouth
Clinical narrative: tremors; legs felt hot; legs felt hot to the touch and ached; weak; tired; anaphylactic shock; went unconscious; neck pain; heavy dry mouth; profuse sweating; saw odd colors and dashboard of car coming at me in design; very cold; light headed; trouble breathing; throat felt swelled; bowels and bladder felt they were going to let loose; bowels and bladder felt they were going to let loose; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 02Apr2021 at 14:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies (sometimes seafood and some fresh fruits) from an unknown date and unknown if ongoing. Concomitant medication included lisdexamfetamine mesilate (VYVANSE), lisinopril and lamotrigine (LAMICTAL), all taken for an unspecified indication, start and stop dates were not reported. The patient experienced anaphylactic shock which began with neck pain on left side, heavy dry mouth, profuse sweating, saw odd colors and dashboard of car coming at him in design, very cold and light headed, trouble breathing, throat felt swelled, bowels and bladder felt they were going to let loose. The patient then went unconscious. After recovery, the patient had tremors for a few hours such that he could not hold a glass of water, legs felt hot to the touch and ached for several days. Still feel weak and tired. Reaction began about 18 minutes (also reported as 14:15) after the shot. Therapeutic measures were taken as a result of all events. The outcome of the events was recovering. The events were assessed as serious and life-threatening by the regulatory authority.  Information on the lot/batch number has been requested.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Fatigue, Hyperhidrosis, Loss of consciousness, Nasopharyngitis
Clinical narrative: tremors; legs felt hot; legs felt hot to the touch and ached; weak; tired; anaphylactic shock; went unconscious; neck pain; heavy dry mouth; profuse sweating; saw odd colors and dashboard of car coming at me in design; very cold; light headed; trouble breathing; throat felt swelled; bowels and bladder felt they were going to let loose; bowels and bladder felt they were going to let loose; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 02Apr2021 at 14:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies (sometimes seafood and some fresh fruits) from an unknown date and unknown if ongoing. Concomitant medication included lisdexamfetamine mesilate (VYVANSE), lisinopril and lamotrigine (LAMICTAL), all taken for an unspecified indication, start and stop dates were not reported. The patient experienced anaphylactic shock which began with neck pain on left side, heavy dry mouth, profuse sweating, saw odd colors and dashboard of car coming at him in design, very cold and light headed, trouble breathing, throat felt swelled, bowels and bladder felt they were going to let loose. The patient then went unconscious. After recovery, the patient had tremors for a few hours such that he could not hold a glass of water, legs felt hot to the touch and ached for several days. Still feel weak and tired. Reaction began about 18 minutes (also reported as 14:15) after the shot. Therapeutic measures were taken as a result of all events. The outcome of the events was recovering. The events were assessed as serious and life-threatening by the regulatory authority.  Information on the lot/batch number has been requested.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Neck pain, Pain in extremity, Skin warm, Throat tightness, Tremor
Clinical narrative: tremors; legs felt hot; legs felt hot to the touch and ached; weak; tired; anaphylactic shock; went unconscious; neck pain; heavy dry mouth; profuse sweating; saw odd colors and dashboard of car coming at me in design; very cold; light headed; trouble breathing; throat felt swelled; bowels and bladder felt they were going to let loose; bowels and bladder felt they were going to let loose; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 02Apr2021 at 14:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies (sometimes seafood and some fresh fruits) from an unknown date and unknown if ongoing. Concomitant medication included lisdexamfetamine mesilate (VYVANSE), lisinopril and lamotrigine (LAMICTAL), all taken for an unspecified indication, start and stop dates were not reported. The patient experienced anaphylactic shock which began with neck pain on left side, heavy dry mouth, profuse sweating, saw odd colors and dashboard of car coming at him in design, very cold and light headed, trouble breathing, throat felt swelled, bowels and bladder felt they were going to let loose. The patient then went unconscious. After recovery, the patient had tremors for a few hours such that he could not hold a glass of water, legs felt hot to the touch and ached for several days. Still feel weak and tired. Reaction began about 18 minutes (also reported as 14:15) after the shot. Therapeutic measures were taken as a result of all events. The outcome of the events was recovering. The events were assessed as serious and life-threatening by the regulatory authority.  Information on the lot/batch number has been requested.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urinary tract discomfort, Visual impairment
Clinical narrative: tremors; legs felt hot; legs felt hot to the touch and ached; weak; tired; anaphylactic shock; went unconscious; neck pain; heavy dry mouth; profuse sweating; saw odd colors and dashboard of car coming at me in design; very cold; light headed; trouble breathing; throat felt swelled; bowels and bladder felt they were going to let loose; bowels and bladder felt they were going to let loose; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 02Apr2021 at 14:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies (sometimes seafood and some fresh fruits) from an unknown date and unknown if ongoing. Concomitant medication included lisdexamfetamine mesilate (VYVANSE), lisinopril and lamotrigine (LAMICTAL), all taken for an unspecified indication, start and stop dates were not reported. The patient experienced anaphylactic shock which began with neck pain on left side, heavy dry mouth, profuse sweating, saw odd colors and dashboard of car coming at him in design, very cold and light headed, trouble breathing, throat felt swelled, bowels and bladder felt they were going to let loose. The patient then went unconscious. After recovery, the patient had tremors for a few hours such that he could not hold a glass of water, legs felt hot to the touch and ached for several days. Still feel weak and tired. Reaction began about 18 minutes (also reported as 14:15) after the shot. Therapeutic measures were taken as a result of all events. The outcome of the events was recovering. The events were assessed as serious and life-threatening by the regulatory authority.  Information on the lot/batch number has been requested.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Anaphylactic shock, Asthenia, Bladder discomfort, Dizziness
Clinical narrative: tremors; legs felt hot; legs felt hot to the touch and ached; weak; tired; anaphylactic shock; went unconscious; neck pain; heavy dry mouth; profuse sweating; saw odd colors and dashboard of car coming at me in design; very cold; light headed; trouble breathing; throat felt swelled; bowels and bladder felt they were going to let loose; bowels and bladder felt they were going to let loose; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 02Apr2021 at 14:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies (sometimes seafood and some fresh fruits) from an unknown date and unknown if ongoing. Concomitant medication included lisdexamfetamine mesilate (VYVANSE), lisinopril and lamotrigine (LAMICTAL), all taken for an unspecified indication, start and stop dates were not reported. The patient experienced anaphylactic shock which began with neck pain on left side, heavy dry mouth, profuse sweating, saw odd colors and dashboard of car coming at him in design, very cold and light headed, trouble breathing, throat felt swelled, bowels and bladder felt they were going to let loose. The patient then went unconscious. After recovery, the patient had tremors for a few hours such that he could not hold a glass of water, legs felt hot to the touch and ached for several days. Still feel weak and tired. Reaction began about 18 minutes (also reported as 14:15) after the shot. Therapeutic measures were taken as a result of all events. The outcome of the events was recovering. The events were assessed as serious and life-threatening by the regulatory authority.  Information on the lot/batch number has been requested.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dry mouth, Dyspnoea, Fatigue, Feeling cold, Feeling hot
Clinical narrative: tremors; legs felt hot; legs felt hot to the touch and ached; weak; tired; anaphylactic shock; went unconscious; neck pain; heavy dry mouth; profuse sweating; saw odd colors and dashboard of car coming at me in design; very cold; light headed; trouble breathing; throat felt swelled; bowels and bladder felt they were going to let loose; bowels and bladder felt they were going to let loose; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 02Apr2021 at 14:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies (sometimes seafood and some fresh fruits) from an unknown date and unknown if ongoing. Concomitant medication included lisdexamfetamine mesilate (VYVANSE), lisinopril and lamotrigine (LAMICTAL), all taken for an unspecified indication, start and stop dates were not reported. The patient experienced anaphylactic shock which began with neck pain on left side, heavy dry mouth, profuse sweating, saw odd colors and dashboard of car coming at him in design, very cold and light headed, trouble breathing, throat felt swelled, bowels and bladder felt they were going to let loose. The patient then went unconscious. After recovery, the patient had tremors for a few hours such that he could not hold a glass of water, legs felt hot to the touch and ached for several days. Still feel weak and tired. Reaction began about 18 minutes (also reported as 14:15) after the shot. Therapeutic measures were taken as a result of all events. The outcome of the events was recovering. The events were assessed as serious and life-threatening by the regulatory authority.  Information on the lot/batch number has been requested.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Loss of consciousness, Neck pain, Pain in extremity, Pharyngeal swelling
Clinical narrative: tremors; legs felt hot; legs felt hot to the touch and ached; weak; tired; anaphylactic shock; went unconscious; neck pain; heavy dry mouth; profuse sweating; saw odd colors and dashboard of car coming at me in design; very cold; light headed; trouble breathing; throat felt swelled; bowels and bladder felt they were going to let loose; bowels and bladder felt they were going to let loose; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 02Apr2021 at 14:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies (sometimes seafood and some fresh fruits) from an unknown date and unknown if ongoing. Concomitant medication included lisdexamfetamine mesilate (VYVANSE), lisinopril and lamotrigine (LAMICTAL), all taken for an unspecified indication, start and stop dates were not reported. The patient experienced anaphylactic shock which began with neck pain on left side, heavy dry mouth, profuse sweating, saw odd colors and dashboard of car coming at him in design, very cold and light headed, trouble breathing, throat felt swelled, bowels and bladder felt they were going to let loose. The patient then went unconscious. After recovery, the patient had tremors for a few hours such that he could not hold a glass of water, legs felt hot to the touch and ached for several days. Still feel weak and tired. Reaction began about 18 minutes (also reported as 14:15) after the shot. Therapeutic measures were taken as a result of all events. The outcome of the events was recovering. The events were assessed as serious and life-threatening by the regulatory authority.  Information on the lot/batch number has been requested.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tremor, Visual impairment
Clinical narrative: tremors; legs felt hot; legs felt hot to the touch and ached; weak; tired; anaphylactic shock; went unconscious; neck pain; heavy dry mouth; profuse sweating; saw odd colors and dashboard of car coming at me in design; very cold; light headed; trouble breathing; throat felt swelled; bowels and bladder felt they were going to let loose; bowels and bladder felt they were going to let loose; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 02Apr2021 at 14:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies (sometimes seafood and some fresh fruits) from an unknown date and unknown if ongoing. Concomitant medication included lisdexamfetamine mesilate (VYVANSE), lisinopril and lamotrigine (LAMICTAL), all taken for an unspecified indication, start and stop dates were not reported. The patient experienced anaphylactic shock which began with neck pain on left side, heavy dry mouth, profuse sweating, saw odd colors and dashboard of car coming at him in design, very cold and light headed, trouble breathing, throat felt swelled, bowels and bladder felt they were going to let loose. The patient then went unconscious. After recovery, the patient had tremors for a few hours such that he could not hold a glass of water, legs felt hot to the touch and ached for several days. Still feel weak and tired. Reaction began about 18 minutes (also reported as 14:15) after the shot. Therapeutic measures were taken as a result of all events. The outcome of the events was recovering. The events were assessed as serious and life-threatening by the regulatory authority.  Information on the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Dizziness, Hyperhidrosis, Loss of consciousness, Nausea
Clinical narrative: History of anxiety around injectables Symptoms: diaphoretic, pale, light headed, husband stated she had first syncope episode after receiving the vaccine. As EMT arrived to assess the patient she had a second syncope episode that presented as seizure activity that lasted for 40-50 seconds. After the second episode patient came alert stated she felt much better, which she state she didn?t feel well after the first syncope episode. We witnessed patient ambulate to the stretcher and loaded into ambulance for further assessment and transport then patient refused transport. VS: BP 140/95, RR, 18, pulse 70, Oxygen 98%
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Presyncope, Seizure
Clinical narrative: History of anxiety around injectables Symptoms: diaphoretic, pale, light headed, husband stated she had first syncope episode after receiving the vaccine. As EMT arrived to assess the patient she had a second syncope episode that presented as seizure activity that lasted for 40-50 seconds. After the second episode patient came alert stated she felt much better, which she state she didn?t feel well after the first syncope episode. We witnessed patient ambulate to the stretcher and loaded into ambulance for further assessment and transport then patient refused transport. VS: BP 140/95, RR, 18, pulse 70, Oxygen 98%
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Hyperhidrosis, Pallor, Syncope
Clinical narrative: History of anxiety around injectables Symptoms: diaphoretic, pale, light headed, husband stated she had first syncope episode after receiving the vaccine. As EMT arrived to assess the patient she had a second syncope episode that presented as seizure activity that lasted for 40-50 seconds. After the second episode patient came alert stated she felt much better, which she state she didn?t feel well after the first syncope episode. We witnessed patient ambulate to the stretcher and loaded into ambulance for further assessment and transport then patient refused transport. VS: BP 140/95, RR, 18, pulse 70, Oxygen 98%
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Hypotension, Nausea, Vomiting
Clinical narrative: Shortly after the vaccine I fainted which came on quite quickly and upon waking within a minute I felt sick and vomited.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Syncope, Vomiting
Clinical narrative: Shortly after the vaccine I fainted which came on quite quickly and upon waking within a minute I felt sick and vomited.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dizziness, Feeling hot, Headache, Hypoaesthesia
Clinical narrative: BODY ACHES; BRAIN FOG; ARM WAS EXTREMELY SORE FROM SHOULDER TO ELBOW; CHILLS; FEVER; CHEST PAIN; HEAD FELT HOT; RACING HEART; BODY TINGLING; LIGHTHEADED; LIP AND TONGUE TINGLING; LIP SWELLING; FACE FEELS TIGHT; WHOLE BODY NUMBNESS; TONGUE SWELLING; This spontaneous report received from a patient concerned a 44 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, intramuscular, batch number: 041A21A, and  expiry: 21-JUN-2021) dose was not reported, administered on 06-APR-2021 around 12:15 at left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced lip and tongue tingling. On 06-APR-2021, the subject experienced lip swelling. On 06-APR-2021, the subject experienced face feels tight. On 06-APR-2021, the subject experienced whole body numbness. On 06-APR-2021, the subject experienced tongue swelling. On 06-APR-2021 12:30, the subject experienced racing heart. On 06-APR-2021 12:30, the subject experienced body tingling. On 06-APR-2021 12:30, the subject experienced lightheaded. On 06-APR-2021 15:30, the subject experienced head felt hot. On 06-APR-2021 16:30, the subject experienced chest pain. On 07-APR-2021, the subject experienced body aches. On 07-APR-2021, the subject experienced brain fog. On 07-APR-2021, the subject experienced arm was extremely sore from shoulder to elbow. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) more than 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from racing heart, body tingling, lightheaded, lip and tongue tingling, lip swelling, face feels tight, whole body numbness, head felt hot, chest pain, and tongue swelling on 06-APR-2021, and had not recovered from fever, body aches, chills, brain fog, and arm was extremely sore from shoulder to elbow. This report was non-serious. This case, from the same reporter is linked to 20210415021.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Palpitations, Paraesthesia, Paraesthesia oral, Pyrexia
Clinical narrative: BODY ACHES; BRAIN FOG; ARM WAS EXTREMELY SORE FROM SHOULDER TO ELBOW; CHILLS; FEVER; CHEST PAIN; HEAD FELT HOT; RACING HEART; BODY TINGLING; LIGHTHEADED; LIP AND TONGUE TINGLING; LIP SWELLING; FACE FEELS TIGHT; WHOLE BODY NUMBNESS; TONGUE SWELLING; This spontaneous report received from a patient concerned a 44 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, intramuscular, batch number: 041A21A, and  expiry: 21-JUN-2021) dose was not reported, administered on 06-APR-2021 around 12:15 at left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced lip and tongue tingling. On 06-APR-2021, the subject experienced lip swelling. On 06-APR-2021, the subject experienced face feels tight. On 06-APR-2021, the subject experienced whole body numbness. On 06-APR-2021, the subject experienced tongue swelling. On 06-APR-2021 12:30, the subject experienced racing heart. On 06-APR-2021 12:30, the subject experienced body tingling. On 06-APR-2021 12:30, the subject experienced lightheaded. On 06-APR-2021 15:30, the subject experienced head felt hot. On 06-APR-2021 16:30, the subject experienced chest pain. On 07-APR-2021, the subject experienced body aches. On 07-APR-2021, the subject experienced brain fog. On 07-APR-2021, the subject experienced arm was extremely sore from shoulder to elbow. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) more than 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from racing heart, body tingling, lightheaded, lip and tongue tingling, lip swelling, face feels tight, whole body numbness, head felt hot, chest pain, and tongue swelling on 06-APR-2021, and had not recovered from fever, body aches, chills, brain fog, and arm was extremely sore from shoulder to elbow. This report was non-serious. This case, from the same reporter is linked to 20210415021.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin tightness, Swollen tongue
Clinical narrative: BODY ACHES; BRAIN FOG; ARM WAS EXTREMELY SORE FROM SHOULDER TO ELBOW; CHILLS; FEVER; CHEST PAIN; HEAD FELT HOT; RACING HEART; BODY TINGLING; LIGHTHEADED; LIP AND TONGUE TINGLING; LIP SWELLING; FACE FEELS TIGHT; WHOLE BODY NUMBNESS; TONGUE SWELLING; This spontaneous report received from a patient concerned a 44 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, intramuscular, batch number: 041A21A, and  expiry: 21-JUN-2021) dose was not reported, administered on 06-APR-2021 around 12:15 at left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced lip and tongue tingling. On 06-APR-2021, the subject experienced lip swelling. On 06-APR-2021, the subject experienced face feels tight. On 06-APR-2021, the subject experienced whole body numbness. On 06-APR-2021, the subject experienced tongue swelling. On 06-APR-2021 12:30, the subject experienced racing heart. On 06-APR-2021 12:30, the subject experienced body tingling. On 06-APR-2021 12:30, the subject experienced lightheaded. On 06-APR-2021 15:30, the subject experienced head felt hot. On 06-APR-2021 16:30, the subject experienced chest pain. On 07-APR-2021, the subject experienced body aches. On 07-APR-2021, the subject experienced brain fog. On 07-APR-2021, the subject experienced arm was extremely sore from shoulder to elbow. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) more than 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from racing heart, body tingling, lightheaded, lip and tongue tingling, lip swelling, face feels tight, whole body numbness, head felt hot, chest pain, and tongue swelling on 06-APR-2021, and had not recovered from fever, body aches, chills, brain fog, and arm was extremely sore from shoulder to elbow. This report was non-serious. This case, from the same reporter is linked to 20210415021.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chest pain, Chills, Dizziness, Feeling abnormal
Clinical narrative: BODY ACHES; BRAIN FOG; ARM WAS EXTREMELY SORE FROM SHOULDER TO ELBOW; CHILLS; FEVER; CHEST PAIN; HEAD FELT HOT; RACING HEART; BODY TINGLING; LIGHTHEADED; LIP AND TONGUE TINGLING; LIP SWELLING; FACE FEELS TIGHT; WHOLE BODY NUMBNESS; TONGUE SWELLING; This spontaneous report received from a patient concerned a 44 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, intramuscular, batch number: 041A21A, and  expiry: 21-JUN-2021) dose was not reported, administered on 06-APR-2021 around 12:15 at left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced lip and tongue tingling. On 06-APR-2021, the subject experienced lip swelling. On 06-APR-2021, the subject experienced face feels tight. On 06-APR-2021, the subject experienced whole body numbness. On 06-APR-2021, the subject experienced tongue swelling. On 06-APR-2021 12:30, the subject experienced racing heart. On 06-APR-2021 12:30, the subject experienced body tingling. On 06-APR-2021 12:30, the subject experienced lightheaded. On 06-APR-2021 15:30, the subject experienced head felt hot. On 06-APR-2021 16:30, the subject experienced chest pain. On 07-APR-2021, the subject experienced body aches. On 07-APR-2021, the subject experienced brain fog. On 07-APR-2021, the subject experienced arm was extremely sore from shoulder to elbow. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) more than 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from racing heart, body tingling, lightheaded, lip and tongue tingling, lip swelling, face feels tight, whole body numbness, head felt hot, chest pain, and tongue swelling on 06-APR-2021, and had not recovered from fever, body aches, chills, brain fog, and arm was extremely sore from shoulder to elbow. This report was non-serious. This case, from the same reporter is linked to 20210415021.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Hypoaesthesia, Lip swelling, Pain, Pain in extremity
Clinical narrative: BODY ACHES; BRAIN FOG; ARM WAS EXTREMELY SORE FROM SHOULDER TO ELBOW; CHILLS; FEVER; CHEST PAIN; HEAD FELT HOT; RACING HEART; BODY TINGLING; LIGHTHEADED; LIP AND TONGUE TINGLING; LIP SWELLING; FACE FEELS TIGHT; WHOLE BODY NUMBNESS; TONGUE SWELLING; This spontaneous report received from a patient concerned a 44 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, intramuscular, batch number: 041A21A, and  expiry: 21-JUN-2021) dose was not reported, administered on 06-APR-2021 around 12:15 at left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced lip and tongue tingling. On 06-APR-2021, the subject experienced lip swelling. On 06-APR-2021, the subject experienced face feels tight. On 06-APR-2021, the subject experienced whole body numbness. On 06-APR-2021, the subject experienced tongue swelling. On 06-APR-2021 12:30, the subject experienced racing heart. On 06-APR-2021 12:30, the subject experienced body tingling. On 06-APR-2021 12:30, the subject experienced lightheaded. On 06-APR-2021 15:30, the subject experienced head felt hot. On 06-APR-2021 16:30, the subject experienced chest pain. On 07-APR-2021, the subject experienced body aches. On 07-APR-2021, the subject experienced brain fog. On 07-APR-2021, the subject experienced arm was extremely sore from shoulder to elbow. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) more than 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from racing heart, body tingling, lightheaded, lip and tongue tingling, lip swelling, face feels tight, whole body numbness, head felt hot, chest pain, and tongue swelling on 06-APR-2021, and had not recovered from fever, body aches, chills, brain fog, and arm was extremely sore from shoulder to elbow. This report was non-serious. This case, from the same reporter is linked to 20210415021.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Paraesthesia, Paraesthesia oral, Pyrexia, Skin tightness
Clinical narrative: BODY ACHES; BRAIN FOG; ARM WAS EXTREMELY SORE FROM SHOULDER TO ELBOW; CHILLS; FEVER; CHEST PAIN; HEAD FELT HOT; RACING HEART; BODY TINGLING; LIGHTHEADED; LIP AND TONGUE TINGLING; LIP SWELLING; FACE FEELS TIGHT; WHOLE BODY NUMBNESS; TONGUE SWELLING; This spontaneous report received from a patient concerned a 44 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, intramuscular, batch number: 041A21A, and  expiry: 21-JUN-2021) dose was not reported, administered on 06-APR-2021 around 12:15 at left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced lip and tongue tingling. On 06-APR-2021, the subject experienced lip swelling. On 06-APR-2021, the subject experienced face feels tight. On 06-APR-2021, the subject experienced whole body numbness. On 06-APR-2021, the subject experienced tongue swelling. On 06-APR-2021 12:30, the subject experienced racing heart. On 06-APR-2021 12:30, the subject experienced body tingling. On 06-APR-2021 12:30, the subject experienced lightheaded. On 06-APR-2021 15:30, the subject experienced head felt hot. On 06-APR-2021 16:30, the subject experienced chest pain. On 07-APR-2021, the subject experienced body aches. On 07-APR-2021, the subject experienced brain fog. On 07-APR-2021, the subject experienced arm was extremely sore from shoulder to elbow. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) more than 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from racing heart, body tingling, lightheaded, lip and tongue tingling, lip swelling, face feels tight, whole body numbness, head felt hot, chest pain, and tongue swelling on 06-APR-2021, and had not recovered from fever, body aches, chills, brain fog, and arm was extremely sore from shoulder to elbow. This report was non-serious. This case, from the same reporter is linked to 20210415021.