chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Joint swelling, Laboratory test, Oedema, Peripheral swelling
Clinical narrative: Severe Swollen lower extremities lower legs and ankles ongoing for 4 days. Still swollen, swelling has not subsided; Severe Swollen lower extremities lower legs and ankles ongoing for 4 days. Still swollen, swelling has not subsided; Bilateral pitting edema ongoing; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient herself).   A 31-years-old non-pregnant female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8732), dose 1 via an unspecified route of administration, administered in Arm Left on 31Mar2021 12:00 PM (at the age of 31-years-old) as dose 1, single for covid-19 immunisation at Pharmacy or Drug Store. The patient's medical history was not reported. The patient's concomitant medications included buprenorphine HCL (BUPRENORPHINE HCL) 8 mg taken for an unspecified indication and phenylephrine hydrochloride (SINEX [PHENYLEPHRINE HYDROCHLORIDE]) nose spray taken for an unspecified indication. The patient previously took Cephalosporin medications and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not tested for COVID-19. On 06Apr2021, Bilateral pitting edema ongoing since, She had seen primary care, vascular specialists, and a cardiologist and incurred over a thousand dollars in medical bills due to this event. No hospitalization required for the event. On 07Apr2021, the patient experienced severe Swollen lower extremities lower legs and ankles ongoing for 4 days. Still swollen, swelling has not subsided. The patient did not receive treatment for event severe Swollen lower extremities lower legs and ankles. For bilateral pitting edema ongoing she has been prescribed Lasix which causes a severe disruption to her everyday life due to urination frequency while taking the medication. The patient also had radiology testing, lab work and results were not reported. The adverse event result in doctor or other healthcare professional office/clinic visit. The outcome of the events were not resolved.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Cough, Decreased appetite, Diarrhoea, Dizziness
Clinical narrative: Dizziness; No appetite for 2 days; Jaw pain; Cough; leg pain; not able to get up from bed (one day); Felt like vomiting; Fever; Chills; Headache; Sore arm; diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN5318) via an unspecified route of administration in the left arm on 23Feb2021 at 13:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included multi vitamin (MANUFACTURER UNKNOWN) and calcium carbonate; colecalciferol (CALCIUM +D) for unknown indications from unknown dates. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN5318), via an unspecified route of administration in the left arm on 02Feb2021 at 13:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) and procaine hydrochloride (NOVOCAINE) and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Feb2021 at 03:00, the patient experienced fever, chills, headache (nine days), sore arm, dizziness (several days), jaw and leg pain. The patient also felt like vomiting, had diarrhea, cough and no appetite for two days. The patient was not able to get up from bed (one day). The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events fever, chills, headache, sore arm, dizziness, jaw pain, leg pain, felt like vomiting, diarrhea, cough, no appetite for two days and not able to get up from bed (one day). The clinical outcomes of the events fever, chills, headache, sore arm, dizziness, jaw pain, leg pain, felt like vomiting, diarrhea, cough, no appetite for two days and not able to get up from bed (one day) were recovering at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Heart rate increased, Muscle spasms, Nausea, Nervousness
Clinical narrative: Dizziness; No appetite for 2 days; Jaw pain; Cough; leg pain; not able to get up from bed (one day); Felt like vomiting; Fever; Chills; Headache; Sore arm; diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN5318) via an unspecified route of administration in the left arm on 23Feb2021 at 13:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included multi vitamin (MANUFACTURER UNKNOWN) and calcium carbonate; colecalciferol (CALCIUM +D) for unknown indications from unknown dates. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN5318), via an unspecified route of administration in the left arm on 02Feb2021 at 13:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) and procaine hydrochloride (NOVOCAINE) and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Feb2021 at 03:00, the patient experienced fever, chills, headache (nine days), sore arm, dizziness (several days), jaw and leg pain. The patient also felt like vomiting, had diarrhea, cough and no appetite for two days. The patient was not able to get up from bed (one day). The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events fever, chills, headache, sore arm, dizziness, jaw pain, leg pain, felt like vomiting, diarrhea, cough, no appetite for two days and not able to get up from bed (one day). The clinical outcomes of the events fever, chills, headache, sore arm, dizziness, jaw pain, leg pain, felt like vomiting, diarrhea, cough, no appetite for two days and not able to get up from bed (one day) were recovering at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Respiratory tract congestion
Clinical narrative: Dizziness; No appetite for 2 days; Jaw pain; Cough; leg pain; not able to get up from bed (one day); Felt like vomiting; Fever; Chills; Headache; Sore arm; diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN5318) via an unspecified route of administration in the left arm on 23Feb2021 at 13:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included multi vitamin (MANUFACTURER UNKNOWN) and calcium carbonate; colecalciferol (CALCIUM +D) for unknown indications from unknown dates. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN5318), via an unspecified route of administration in the left arm on 02Feb2021 at 13:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) and procaine hydrochloride (NOVOCAINE) and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Feb2021 at 03:00, the patient experienced fever, chills, headache (nine days), sore arm, dizziness (several days), jaw and leg pain. The patient also felt like vomiting, had diarrhea, cough and no appetite for two days. The patient was not able to get up from bed (one day). The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events fever, chills, headache, sore arm, dizziness, jaw pain, leg pain, felt like vomiting, diarrhea, cough, no appetite for two days and not able to get up from bed (one day). The clinical outcomes of the events fever, chills, headache, sore arm, dizziness, jaw pain, leg pain, felt like vomiting, diarrhea, cough, no appetite for two days and not able to get up from bed (one day) were recovering at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Cough, Decreased appetite, Diarrhoea
Clinical narrative: Dizziness; No appetite for 2 days; Jaw pain; Cough; leg pain; not able to get up from bed (one day); Felt like vomiting; Fever; Chills; Headache; Sore arm; diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN5318) via an unspecified route of administration in the left arm on 23Feb2021 at 13:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included multi vitamin (MANUFACTURER UNKNOWN) and calcium carbonate; colecalciferol (CALCIUM +D) for unknown indications from unknown dates. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN5318), via an unspecified route of administration in the left arm on 02Feb2021 at 13:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) and procaine hydrochloride (NOVOCAINE) and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Feb2021 at 03:00, the patient experienced fever, chills, headache (nine days), sore arm, dizziness (several days), jaw and leg pain. The patient also felt like vomiting, had diarrhea, cough and no appetite for two days. The patient was not able to get up from bed (one day). The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events fever, chills, headache, sore arm, dizziness, jaw pain, leg pain, felt like vomiting, diarrhea, cough, no appetite for two days and not able to get up from bed (one day). The clinical outcomes of the events fever, chills, headache, sore arm, dizziness, jaw pain, leg pain, felt like vomiting, diarrhea, cough, no appetite for two days and not able to get up from bed (one day) were recovering at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Headache, Pain in extremity, Pain in jaw, Pyrexia
Clinical narrative: Dizziness; No appetite for 2 days; Jaw pain; Cough; leg pain; not able to get up from bed (one day); Felt like vomiting; Fever; Chills; Headache; Sore arm; diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN5318) via an unspecified route of administration in the left arm on 23Feb2021 at 13:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included multi vitamin (MANUFACTURER UNKNOWN) and calcium carbonate; colecalciferol (CALCIUM +D) for unknown indications from unknown dates. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN5318), via an unspecified route of administration in the left arm on 02Feb2021 at 13:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) and procaine hydrochloride (NOVOCAINE) and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Feb2021 at 03:00, the patient experienced fever, chills, headache (nine days), sore arm, dizziness (several days), jaw and leg pain. The patient also felt like vomiting, had diarrhea, cough and no appetite for two days. The patient was not able to get up from bed (one day). The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events fever, chills, headache, sore arm, dizziness, jaw pain, leg pain, felt like vomiting, diarrhea, cough, no appetite for two days and not able to get up from bed (one day). The clinical outcomes of the events fever, chills, headache, sore arm, dizziness, jaw pain, leg pain, felt like vomiting, diarrhea, cough, no appetite for two days and not able to get up from bed (one day) were recovering at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Dizziness; No appetite for 2 days; Jaw pain; Cough; leg pain; not able to get up from bed (one day); Felt like vomiting; Fever; Chills; Headache; Sore arm; diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN5318) via an unspecified route of administration in the left arm on 23Feb2021 at 13:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included multi vitamin (MANUFACTURER UNKNOWN) and calcium carbonate; colecalciferol (CALCIUM +D) for unknown indications from unknown dates. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN5318), via an unspecified route of administration in the left arm on 02Feb2021 at 13:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) and procaine hydrochloride (NOVOCAINE) and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Feb2021 at 03:00, the patient experienced fever, chills, headache (nine days), sore arm, dizziness (several days), jaw and leg pain. The patient also felt like vomiting, had diarrhea, cough and no appetite for two days. The patient was not able to get up from bed (one day). The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events fever, chills, headache, sore arm, dizziness, jaw pain, leg pain, felt like vomiting, diarrhea, cough, no appetite for two days and not able to get up from bed (one day). The clinical outcomes of the events fever, chills, headache, sore arm, dizziness, jaw pain, leg pain, felt like vomiting, diarrhea, cough, no appetite for two days and not able to get up from bed (one day) were recovering at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Carotid artery occlusion, Carotid artery thrombosis, Cerebrovascular accident, Computerised tomogram, Ear pain
Clinical narrative: ICA stroke; headache; earache; sinus issue; had sudden onset stroke symptoms while hiking; This is a spontaneous report from a contactable pharmacist. A 45-years-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular on 23Feb2021 (Batch/Lot number was not reported) at age of 45-year-old as DOSE 2, SINGLE for covid-19 immunisation.  Facility where the most recent COVID-19 vaccine was administered was Workplace clinic. The patient was not Pregnant at Time of Vaccination. Medical history included acne, eczema, HPV (had resolved in 2018); anxiety/depression, Known alleries Latex. The patient's concomitant medications were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received First dose of bnt162b2 on 29Jan2021 at age of 45-year-old for covid-19 immunisation. Patient was with complaints of headache and earache. She was seen by urgent care twice (03Mar2021 and 10Mar2021) thinking it was a sinus issue. She then had sudden onset stroke symptoms while hiking and went to ED on 13Mar2021. she was transferred to a larger hospital and diagnosed with ICA stroke. She had no risk factors for stroke previously and her only prescription medication (norethindrone-EE) was discontinued 03Mar2021 thinking it was causing her headaches. Patient now is still having paralysis and is unable to independently manage ADLs. The adverse events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care.The onset date of ICA stroke was unknown, of other events was 03Mar2021. Stroke treatment Received. Duration of Hospitalization was 5 days. The events were assessed serious as Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, The outcome of events was Recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information about batch/Lot number has been requested.; Sender's Comments: Based on available information, particularly prolonged onset latency, it appears unlikely that vaccine BNT162B2 contributed to the reported events. These are probably intercurrent medical conditions. This case will be reassessed upon receipt of the follow-up information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Headache, Magnetic resonance imaging
Clinical narrative: ICA stroke; headache; earache; sinus issue; had sudden onset stroke symptoms while hiking; This is a spontaneous report from a contactable pharmacist. A 45-years-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular on 23Feb2021 (Batch/Lot number was not reported) at age of 45-year-old as DOSE 2, SINGLE for covid-19 immunisation.  Facility where the most recent COVID-19 vaccine was administered was Workplace clinic. The patient was not Pregnant at Time of Vaccination. Medical history included acne, eczema, HPV (had resolved in 2018); anxiety/depression, Known alleries Latex. The patient's concomitant medications were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received First dose of bnt162b2 on 29Jan2021 at age of 45-year-old for covid-19 immunisation. Patient was with complaints of headache and earache. She was seen by urgent care twice (03Mar2021 and 10Mar2021) thinking it was a sinus issue. She then had sudden onset stroke symptoms while hiking and went to ED on 13Mar2021. she was transferred to a larger hospital and diagnosed with ICA stroke. She had no risk factors for stroke previously and her only prescription medication (norethindrone-EE) was discontinued 03Mar2021 thinking it was causing her headaches. Patient now is still having paralysis and is unable to independently manage ADLs. The adverse events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care.The onset date of ICA stroke was unknown, of other events was 03Mar2021. Stroke treatment Received. Duration of Hospitalization was 5 days. The events were assessed serious as Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, The outcome of events was Recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information about batch/Lot number has been requested.; Sender's Comments: Based on available information, particularly prolonged onset latency, it appears unlikely that vaccine BNT162B2 contributed to the reported events. These are probably intercurrent medical conditions. This case will be reassessed upon receipt of the follow-up information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebral infarction, Cerebrovascular accident, Ear pain, Headache, Sinus disorder
Clinical narrative: ICA stroke; headache; earache; sinus issue; had sudden onset stroke symptoms while hiking; This is a spontaneous report from a contactable pharmacist. A 45-years-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular on 23Feb2021 (Batch/Lot number was not reported) at age of 45-year-old as DOSE 2, SINGLE for covid-19 immunisation.  Facility where the most recent COVID-19 vaccine was administered was Workplace clinic. The patient was not Pregnant at Time of Vaccination. Medical history included acne, eczema, HPV (had resolved in 2018); anxiety/depression, Known alleries Latex. The patient's concomitant medications were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received First dose of bnt162b2 on 29Jan2021 at age of 45-year-old for covid-19 immunisation. Patient was with complaints of headache and earache. She was seen by urgent care twice (03Mar2021 and 10Mar2021) thinking it was a sinus issue. She then had sudden onset stroke symptoms while hiking and went to ED on 13Mar2021. she was transferred to a larger hospital and diagnosed with ICA stroke. She had no risk factors for stroke previously and her only prescription medication (norethindrone-EE) was discontinued 03Mar2021 thinking it was causing her headaches. Patient now is still having paralysis and is unable to independently manage ADLs. The adverse events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care.The onset date of ICA stroke was unknown, of other events was 03Mar2021. Stroke treatment Received. Duration of Hospitalization was 5 days. The events were assessed serious as Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, The outcome of events was Recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information about batch/Lot number has been requested.; Sender's Comments: Based on available information, particularly prolonged onset latency, it appears unlikely that vaccine BNT162B2 contributed to the reported events. These are probably intercurrent medical conditions. This case will be reassessed upon receipt of the follow-up information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anti-thyroid antibody, Asthenia, Blood iron, Blood thyroid stimulating hormone, Electrocardiogram
Clinical narrative: HIGH BLOOD PRESSURE; FAST HEART BEAT; TWITCHING ON LEFT LEG; DIZZINESS; CHILLS; HEADACHES; NAUSEA; DULL ACHE ON LEFT LEG; BIT OF SLOW CLOTTING; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, non alcohol use, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced bit of slow clotting. On MAR-2021, the subject experienced dull ache on left leg. Laboratory data included: Blood test (NR: not provided) Normal Platelet, CT brain scan (NR: not provided) did not show abnormal clotting but a bit of slow clotting, and Investigation (NR: not provided) Negative for blood clots. On 16-MAR-2021, the subject experienced dizziness. On 16-MAR-2021, the subject experienced chills. On 16-MAR-2021, the subject experienced headaches. On 16-MAR-2021, the subject experienced nausea. On 25-MAR-2021, the subject experienced twitching on left leg. On 30-MAR-2021, the subject experienced high blood pressure. On 30-MAR-2021, the subject experienced fast heart beat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, chills, headaches, and nausea on 06-APR-2021, had not recovered from twitching on left leg, and dull ache on left leg, and the outcome of high blood pressure, fast heart beat and bit of slow clotting was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Full blood count, Headache, Lipids, Metabolic function test, Muscle twitching
Clinical narrative: HIGH BLOOD PRESSURE; FAST HEART BEAT; TWITCHING ON LEFT LEG; DIZZINESS; CHILLS; HEADACHES; NAUSEA; DULL ACHE ON LEFT LEG; BIT OF SLOW CLOTTING; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, non alcohol use, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced bit of slow clotting. On MAR-2021, the subject experienced dull ache on left leg. Laboratory data included: Blood test (NR: not provided) Normal Platelet, CT brain scan (NR: not provided) did not show abnormal clotting but a bit of slow clotting, and Investigation (NR: not provided) Negative for blood clots. On 16-MAR-2021, the subject experienced dizziness. On 16-MAR-2021, the subject experienced chills. On 16-MAR-2021, the subject experienced headaches. On 16-MAR-2021, the subject experienced nausea. On 25-MAR-2021, the subject experienced twitching on left leg. On 30-MAR-2021, the subject experienced high blood pressure. On 30-MAR-2021, the subject experienced fast heart beat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, chills, headaches, and nausea on 06-APR-2021, had not recovered from twitching on left leg, and dull ache on left leg, and the outcome of high blood pressure, fast heart beat and bit of slow clotting was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Neurological examination, Palpitations, Serum ferritin, Thyroxine free
Clinical narrative: HIGH BLOOD PRESSURE; FAST HEART BEAT; TWITCHING ON LEFT LEG; DIZZINESS; CHILLS; HEADACHES; NAUSEA; DULL ACHE ON LEFT LEG; BIT OF SLOW CLOTTING; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, non alcohol use, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced bit of slow clotting. On MAR-2021, the subject experienced dull ache on left leg. Laboratory data included: Blood test (NR: not provided) Normal Platelet, CT brain scan (NR: not provided) did not show abnormal clotting but a bit of slow clotting, and Investigation (NR: not provided) Negative for blood clots. On 16-MAR-2021, the subject experienced dizziness. On 16-MAR-2021, the subject experienced chills. On 16-MAR-2021, the subject experienced headaches. On 16-MAR-2021, the subject experienced nausea. On 25-MAR-2021, the subject experienced twitching on left leg. On 30-MAR-2021, the subject experienced high blood pressure. On 30-MAR-2021, the subject experienced fast heart beat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, chills, headaches, and nausea on 06-APR-2021, had not recovered from twitching on left leg, and dull ache on left leg, and the outcome of high blood pressure, fast heart beat and bit of slow clotting was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urine analysis, Vision blurred
Clinical narrative: HIGH BLOOD PRESSURE; FAST HEART BEAT; TWITCHING ON LEFT LEG; DIZZINESS; CHILLS; HEADACHES; NAUSEA; DULL ACHE ON LEFT LEG; BIT OF SLOW CLOTTING; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, non alcohol use, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced bit of slow clotting. On MAR-2021, the subject experienced dull ache on left leg. Laboratory data included: Blood test (NR: not provided) Normal Platelet, CT brain scan (NR: not provided) did not show abnormal clotting but a bit of slow clotting, and Investigation (NR: not provided) Negative for blood clots. On 16-MAR-2021, the subject experienced dizziness. On 16-MAR-2021, the subject experienced chills. On 16-MAR-2021, the subject experienced headaches. On 16-MAR-2021, the subject experienced nausea. On 25-MAR-2021, the subject experienced twitching on left leg. On 30-MAR-2021, the subject experienced high blood pressure. On 30-MAR-2021, the subject experienced fast heart beat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, chills, headaches, and nausea on 06-APR-2021, had not recovered from twitching on left leg, and dull ache on left leg, and the outcome of high blood pressure, fast heart beat and bit of slow clotting was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Blood immunoglobulin G, Blood pressure measurement, Dizziness, Headache
Clinical narrative: HIGH BLOOD PRESSURE; FAST HEART BEAT; TWITCHING ON LEFT LEG; DIZZINESS; CHILLS; HEADACHES; NAUSEA; DULL ACHE ON LEFT LEG; BIT OF SLOW CLOTTING; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, non alcohol use, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced bit of slow clotting. On MAR-2021, the subject experienced dull ache on left leg. Laboratory data included: Blood test (NR: not provided) Normal Platelet, CT brain scan (NR: not provided) did not show abnormal clotting but a bit of slow clotting, and Investigation (NR: not provided) Negative for blood clots. On 16-MAR-2021, the subject experienced dizziness. On 16-MAR-2021, the subject experienced chills. On 16-MAR-2021, the subject experienced headaches. On 16-MAR-2021, the subject experienced nausea. On 25-MAR-2021, the subject experienced twitching on left leg. On 30-MAR-2021, the subject experienced high blood pressure. On 30-MAR-2021, the subject experienced fast heart beat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, chills, headaches, and nausea on 06-APR-2021, had not recovered from twitching on left leg, and dull ache on left leg, and the outcome of high blood pressure, fast heart beat and bit of slow clotting was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypertension, Nausea, Therapy non-responder
Clinical narrative: HIGH BLOOD PRESSURE; FAST HEART BEAT; TWITCHING ON LEFT LEG; DIZZINESS; CHILLS; HEADACHES; NAUSEA; DULL ACHE ON LEFT LEG; BIT OF SLOW CLOTTING; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, non alcohol use, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced bit of slow clotting. On MAR-2021, the subject experienced dull ache on left leg. Laboratory data included: Blood test (NR: not provided) Normal Platelet, CT brain scan (NR: not provided) did not show abnormal clotting but a bit of slow clotting, and Investigation (NR: not provided) Negative for blood clots. On 16-MAR-2021, the subject experienced dizziness. On 16-MAR-2021, the subject experienced chills. On 16-MAR-2021, the subject experienced headaches. On 16-MAR-2021, the subject experienced nausea. On 25-MAR-2021, the subject experienced twitching on left leg. On 30-MAR-2021, the subject experienced high blood pressure. On 30-MAR-2021, the subject experienced fast heart beat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, chills, headaches, and nausea on 06-APR-2021, had not recovered from twitching on left leg, and dull ache on left leg, and the outcome of high blood pressure, fast heart beat and bit of slow clotting was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Chills, Coagulation time prolonged, Computerised tomogram head, Dizziness
Clinical narrative: HIGH BLOOD PRESSURE; FAST HEART BEAT; TWITCHING ON LEFT LEG; DIZZINESS; CHILLS; HEADACHES; NAUSEA; DULL ACHE ON LEFT LEG; BIT OF SLOW CLOTTING; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, non alcohol use, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced bit of slow clotting. On MAR-2021, the subject experienced dull ache on left leg. Laboratory data included: Blood test (NR: not provided) Normal Platelet, CT brain scan (NR: not provided) did not show abnormal clotting but a bit of slow clotting, and Investigation (NR: not provided) Negative for blood clots. On 16-MAR-2021, the subject experienced dizziness. On 16-MAR-2021, the subject experienced chills. On 16-MAR-2021, the subject experienced headaches. On 16-MAR-2021, the subject experienced nausea. On 25-MAR-2021, the subject experienced twitching on left leg. On 30-MAR-2021, the subject experienced high blood pressure. On 30-MAR-2021, the subject experienced fast heart beat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, chills, headaches, and nausea on 06-APR-2021, had not recovered from twitching on left leg, and dull ache on left leg, and the outcome of high blood pressure, fast heart beat and bit of slow clotting was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Heart rate increased, Hypertension, Investigation, Muscle twitching
Clinical narrative: HIGH BLOOD PRESSURE; FAST HEART BEAT; TWITCHING ON LEFT LEG; DIZZINESS; CHILLS; HEADACHES; NAUSEA; DULL ACHE ON LEFT LEG; BIT OF SLOW CLOTTING; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, non alcohol use, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced bit of slow clotting. On MAR-2021, the subject experienced dull ache on left leg. Laboratory data included: Blood test (NR: not provided) Normal Platelet, CT brain scan (NR: not provided) did not show abnormal clotting but a bit of slow clotting, and Investigation (NR: not provided) Negative for blood clots. On 16-MAR-2021, the subject experienced dizziness. On 16-MAR-2021, the subject experienced chills. On 16-MAR-2021, the subject experienced headaches. On 16-MAR-2021, the subject experienced nausea. On 25-MAR-2021, the subject experienced twitching on left leg. On 30-MAR-2021, the subject experienced high blood pressure. On 30-MAR-2021, the subject experienced fast heart beat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, chills, headaches, and nausea on 06-APR-2021, had not recovered from twitching on left leg, and dull ache on left leg, and the outcome of high blood pressure, fast heart beat and bit of slow clotting was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: HIGH BLOOD PRESSURE; FAST HEART BEAT; TWITCHING ON LEFT LEG; DIZZINESS; CHILLS; HEADACHES; NAUSEA; DULL ACHE ON LEFT LEG; BIT OF SLOW CLOTTING; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, non alcohol use, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced bit of slow clotting. On MAR-2021, the subject experienced dull ache on left leg. Laboratory data included: Blood test (NR: not provided) Normal Platelet, CT brain scan (NR: not provided) did not show abnormal clotting but a bit of slow clotting, and Investigation (NR: not provided) Negative for blood clots. On 16-MAR-2021, the subject experienced dizziness. On 16-MAR-2021, the subject experienced chills. On 16-MAR-2021, the subject experienced headaches. On 16-MAR-2021, the subject experienced nausea. On 25-MAR-2021, the subject experienced twitching on left leg. On 30-MAR-2021, the subject experienced high blood pressure. On 30-MAR-2021, the subject experienced fast heart beat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, chills, headaches, and nausea on 06-APR-2021, had not recovered from twitching on left leg, and dull ache on left leg, and the outcome of high blood pressure, fast heart beat and bit of slow clotting was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as the case assessed as non-serious.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID after first dose of the vaccine; This is a spontaneous report from a contactable consumer (patient). A 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EN6206), via an unspecified route of administration, administered in the left arm on 21Mar2021 (at the age of 24 years old) as dose 1, single for COVID-19 immunisation. Medical history included asthma since he was a kid and BMI high. There were no concomitant medications. On 03Apr2021, the patient experienced loss of taste and loss of smell. The patient went and got tested for COVID-19 PCR test and tested positive for COVID after first dose of the vaccine on 03Apr2021. The patient reported that it was his first day he started showing symptoms. Since the patient was due for his second dose on 11Apr2021 and his quarantine would be over on 13Apr2021, he called an infectious disease doctor and was advised that the patient is allowed to go for his second vaccine after quarantine if he doesn't have any symptoms. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID after first dose of the vaccine; This is a spontaneous report from a contactable consumer (patient). A 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EN6206), via an unspecified route of administration, administered in the left arm on 21Mar2021 (at the age of 24 years old) as dose 1, single for COVID-19 immunisation. Medical history included asthma since he was a kid and BMI high. There were no concomitant medications. On 03Apr2021, the patient experienced loss of taste and loss of smell. The patient went and got tested for COVID-19 PCR test and tested positive for COVID after first dose of the vaccine on 03Apr2021. The patient reported that it was his first day he started showing symptoms. Since the patient was due for his second dose on 11Apr2021 and his quarantine would be over on 13Apr2021, he called an infectious disease doctor and was advised that the patient is allowed to go for his second vaccine after quarantine if he doesn't have any symptoms. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Patient was hospitalized multiple times within 60 days of receiving a COVID vaccine series and later passed away
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Patient was hospitalized multiple times within 60 days of receiving a COVID vaccine series and later passed away
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Patient was hospitalized  within 60 days of receiving a COVID vaccine and did pass away
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Patient was hospitalized  within 60 days of receiving a COVID vaccine and did pass away
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Head injury, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Loss of consciousness; Head injury; Immediate post-injection reaction; This case was received via  FDA VAERS (Reference number: 1251223) on 22-Jun-2021 and was forwarded to Moderna on 22-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), HEAD INJURY (Head injury) and IMMEDIATE POST-INJECTION REACTION (Immediate post-injection reaction). At the time of the report, LOSS OF CONSCIOUSNESS (Loss of consciousness), HEAD INJURY (Head injury) and IMMEDIATE POST-INJECTION REACTION (Immediate post-injection reaction) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided No treatment product information was provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.