chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Generalised tonic-clonic seizure, Laboratory test, Magnetic resonance imaging, Pyrexia, Resuscitation
Clinical narrative: Had grand mal seizure; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 12Mar2021 08:00 (Lot Number: EN6205) as SINGLE DOSE for COVID-19 immunisation; and pefloxacin mesilate (PEFCID), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included, iodine allergy, yellow dye allergy and dysautonomia; all from an unknown date and unknown if ongoing. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant at time of vaccination. The patient previously had first dose of BNT162B2 (lot number: EN6200,) on 19Feb2021 13:15 in left arm for COVID-19 immunization. On 13Mar2021 05:30, the patient had grand mal seizure reported as serious and life threatening since in an immediate risk of death. The event resulted in visit to emergency room/department or urgent care. The facility where the most recent COVID-19 vaccine was administered was in the Vaccine Clinic. 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. The outcome of the event was recovering. The patient underwent lab tests and procedures which included COVID-19: negative on 13Mar2021. The patient received treatment for the event. The action taken in response to pefloxacin mesylate for the event was unknown.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: SARS-CoV-2 test negative, Vomiting
Clinical narrative: Had grand mal seizure; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 12Mar2021 08:00 (Lot Number: EN6205) as SINGLE DOSE for COVID-19 immunisation; and pefloxacin mesilate (PEFCID), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included, iodine allergy, yellow dye allergy and dysautonomia; all from an unknown date and unknown if ongoing. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant at time of vaccination. The patient previously had first dose of BNT162B2 (lot number: EN6200,) on 19Feb2021 13:15 in left arm for COVID-19 immunization. On 13Mar2021 05:30, the patient had grand mal seizure reported as serious and life threatening since in an immediate risk of death. The event resulted in visit to emergency room/department or urgent care. The facility where the most recent COVID-19 vaccine was administered was in the Vaccine Clinic. 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. The outcome of the event was recovering. The patient underwent lab tests and procedures which included COVID-19: negative on 13Mar2021. The patient received treatment for the event. The action taken in response to pefloxacin mesylate for the event was unknown.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Generalised tonic-clonic seizure, SARS-CoV-1 test
Clinical narrative: Had grand mal seizure; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 12Mar2021 08:00 (Lot Number: EN6205) as SINGLE DOSE for COVID-19 immunisation; and pefloxacin mesilate (PEFCID), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included, iodine allergy, yellow dye allergy and dysautonomia; all from an unknown date and unknown if ongoing. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant at time of vaccination. The patient previously had first dose of BNT162B2 (lot number: EN6200,) on 19Feb2021 13:15 in left arm for COVID-19 immunization. On 13Mar2021 05:30, the patient had grand mal seizure reported as serious and life threatening since in an immediate risk of death. The event resulted in visit to emergency room/department or urgent care. The facility where the most recent COVID-19 vaccine was administered was in the Vaccine Clinic. 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. The outcome of the event was recovering. The patient underwent lab tests and procedures which included COVID-19: negative on 13Mar2021. The patient received treatment for the event. The action taken in response to pefloxacin mesylate for the event was unknown.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Malaise, Nasopharyngitis, Nausea, Pain
Clinical narrative: FEVER (Fever, Pyrexia) VOMITING (Vomiting, Vomiting) BODY ACHES (Generalised aching, Pain) COLD (Cold, Nasopharyngitis) BOTH ARMS WERE "REAL SORE" (Painful arm, Pain in extremity) FELT SICK FOR 11 TO 12 HOURS (Feeling sick, Malaise) NAUSEA (Nausea, Nausea)  This spontaneous report received from a consumer concerned a female (reporter's wife) or unspecified age. The patient's weight, height, and medical history were not reported. The patient received COVID-19 vaccine Ad26.COV2.S (suspension for injection, route of administration was not reported, batch number: unknown) dose was not reported, administered on 05-MAR-2021 at around 17:00 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 06-MAR-2021, at 2:00. the subject experienced fever with a body temperature between 103-105 F. The pharmacist advised the patient to the Tylenol / Advil for fever. On 06-MAR-2021, the subject experienced vomiting, body aches, nausea, cold and both her arms were sore. On an unspecified date in MAR-2021, the subject felt sick for 11 to 12 hours and then felt fine. The action taken with COVID-19 vaccine Ad26.COV2.S was not applicable. The patient recovered from vomiting on 06-MAR-2021, and felt sick for 11 to 12 hours on MAR-2021, had not recovered from fever, and the outcome of nausea, cold, body aches and both arms were "real sore" was not reported. The reporter considered the events (vomiting, fever, nausea, cold, body aches and both arms were 'real sore') as related to COVID-19 vaccine AD26.COV2 as possible. This report was serious (Other Medically Important Condition).  Additional Information received on 17-Mar-2021: Start time for event fever updated from 3:00 to 2:00, pharmacist advised patient could take Tylenol / Advil for fever (added in treatment text and narrative), event verbatim updated from 'sore' to 'both her arms were real sore', event added (felt sick for 11 to 12 hours) and narrative updated with additional information received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: FEVER (Fever, Pyrexia) VOMITING (Vomiting, Vomiting) BODY ACHES (Generalised aching, Pain) COLD (Cold, Nasopharyngitis) BOTH ARMS WERE "REAL SORE" (Painful arm, Pain in extremity) FELT SICK FOR 11 TO 12 HOURS (Feeling sick, Malaise) NAUSEA (Nausea, Nausea)  This spontaneous report received from a consumer concerned a female (reporter's wife) or unspecified age. The patient's weight, height, and medical history were not reported. The patient received COVID-19 vaccine Ad26.COV2.S (suspension for injection, route of administration was not reported, batch number: unknown) dose was not reported, administered on 05-MAR-2021 at around 17:00 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 06-MAR-2021, at 2:00. the subject experienced fever with a body temperature between 103-105 F. The pharmacist advised the patient to the Tylenol / Advil for fever. On 06-MAR-2021, the subject experienced vomiting, body aches, nausea, cold and both her arms were sore. On an unspecified date in MAR-2021, the subject felt sick for 11 to 12 hours and then felt fine. The action taken with COVID-19 vaccine Ad26.COV2.S was not applicable. The patient recovered from vomiting on 06-MAR-2021, and felt sick for 11 to 12 hours on MAR-2021, had not recovered from fever, and the outcome of nausea, cold, body aches and both arms were "real sore" was not reported. The reporter considered the events (vomiting, fever, nausea, cold, body aches and both arms were 'real sore') as related to COVID-19 vaccine AD26.COV2 as possible. This report was serious (Other Medically Important Condition).  Additional Information received on 17-Mar-2021: Start time for event fever updated from 3:00 to 2:00, pharmacist advised patient could take Tylenol / Advil for fever (added in treatment text and narrative), event verbatim updated from 'sore' to 'both her arms were real sore', event added (felt sick for 11 to 12 hours) and narrative updated with additional information received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Nasopharyngitis, Nausea, Pain, Pain in extremity
Clinical narrative: FEVER (Fever, Pyrexia) VOMITING (Vomiting, Vomiting) BODY ACHES (Generalised aching, Pain) COLD (Cold, Nasopharyngitis) BOTH ARMS WERE "REAL SORE" (Painful arm, Pain in extremity) FELT SICK FOR 11 TO 12 HOURS (Feeling sick, Malaise) NAUSEA (Nausea, Nausea)  This spontaneous report received from a consumer concerned a female (reporter's wife) or unspecified age. The patient's weight, height, and medical history were not reported. The patient received COVID-19 vaccine Ad26.COV2.S (suspension for injection, route of administration was not reported, batch number: unknown) dose was not reported, administered on 05-MAR-2021 at around 17:00 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 06-MAR-2021, at 2:00. the subject experienced fever with a body temperature between 103-105 F. The pharmacist advised the patient to the Tylenol / Advil for fever. On 06-MAR-2021, the subject experienced vomiting, body aches, nausea, cold and both her arms were sore. On an unspecified date in MAR-2021, the subject felt sick for 11 to 12 hours and then felt fine. The action taken with COVID-19 vaccine Ad26.COV2.S was not applicable. The patient recovered from vomiting on 06-MAR-2021, and felt sick for 11 to 12 hours on MAR-2021, had not recovered from fever, and the outcome of nausea, cold, body aches and both arms were "real sore" was not reported. The reporter considered the events (vomiting, fever, nausea, cold, body aches and both arms were 'real sore') as related to COVID-19 vaccine AD26.COV2 as possible. This report was serious (Other Medically Important Condition).  Additional Information received on 17-Mar-2021: Start time for event fever updated from 3:00 to 2:00, pharmacist advised patient could take Tylenol / Advil for fever (added in treatment text and narrative), event verbatim updated from 'sore' to 'both her arms were real sore', event added (felt sick for 11 to 12 hours) and narrative updated with additional information received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: FEVER (Fever, Pyrexia) VOMITING (Vomiting, Vomiting) BODY ACHES (Generalised aching, Pain) COLD (Cold, Nasopharyngitis) BOTH ARMS WERE "REAL SORE" (Painful arm, Pain in extremity) FELT SICK FOR 11 TO 12 HOURS (Feeling sick, Malaise) NAUSEA (Nausea, Nausea)  This spontaneous report received from a consumer concerned a female (reporter's wife) or unspecified age. The patient's weight, height, and medical history were not reported. The patient received COVID-19 vaccine Ad26.COV2.S (suspension for injection, route of administration was not reported, batch number: unknown) dose was not reported, administered on 05-MAR-2021 at around 17:00 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 06-MAR-2021, at 2:00. the subject experienced fever with a body temperature between 103-105 F. The pharmacist advised the patient to the Tylenol / Advil for fever. On 06-MAR-2021, the subject experienced vomiting, body aches, nausea, cold and both her arms were sore. On an unspecified date in MAR-2021, the subject felt sick for 11 to 12 hours and then felt fine. The action taken with COVID-19 vaccine Ad26.COV2.S was not applicable. The patient recovered from vomiting on 06-MAR-2021, and felt sick for 11 to 12 hours on MAR-2021, had not recovered from fever, and the outcome of nausea, cold, body aches and both arms were "real sore" was not reported. The reporter considered the events (vomiting, fever, nausea, cold, body aches and both arms were 'real sore') as related to COVID-19 vaccine AD26.COV2 as possible. This report was serious (Other Medically Important Condition).  Additional Information received on 17-Mar-2021: Start time for event fever updated from 3:00 to 2:00, pharmacist advised patient could take Tylenol / Advil for fever (added in treatment text and narrative), event verbatim updated from 'sore' to 'both her arms were real sore', event added (felt sick for 11 to 12 hours) and narrative updated with additional information received.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Tinnitus
Clinical narrative: This spontaneous report received from a patient concerned an 86 year old female. The patient's weight was 153 pounds, and height was 67 inches. the patient's past medical history included strokes but the last one was a  long time ago. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-Mar-2021 for prophylactic vaccination. The batch number was reported and has been requested. No concomitant medications were reported. The reporter state that, the patient was taking two vaccine shots and was halfway between the two vaccines (2 weeks) second one would be on 29-Mar-2021. On 9-Mar-2021, the experienced TIA symptoms (feeling fuzzy, batch of color lights in her left eye, very slurred speech, difficulty understanding in communication) and stated she was having a stroke. Patient also informed that she already had this a lot of time before, and her doctor told her to lay down, take an aspirin. Treatment medications (date unspecified) include: acetylsalicylic acid. On 2021, the subject experienced always ringing in the ears. The reporter stated that, the patient her severe hearing impairment as patient continuously complained that her ears were "always ringing an patient was unable to answer all the questions as she stated that she had to go for some physical therapy exercise and could not continue the discussion. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 ad26.cov2.s was not applicable The patient had not recovered from stroke, and the outcome of always ringing in the ears was not reported. This report was serious (Other Medically Important Condition).  Version created to amend previously reported information 18-Mar-2021. Upon review the following information was amended: patient's age updated, age at the time of vaccination updated and the causality statement removed in version one.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Communication disorder, Condition aggravated, Dysarthria, Feeling abnormal
Clinical narrative: This spontaneous report received from a patient concerned an 86 year old female. The patient's weight was 153 pounds, and height was 67 inches. the patient's past medical history included strokes but the last one was a  long time ago. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-Mar-2021 for prophylactic vaccination. The batch number was reported and has been requested. No concomitant medications were reported. The reporter state that, the patient was taking two vaccine shots and was halfway between the two vaccines (2 weeks) second one would be on 29-Mar-2021. On 9-Mar-2021, the experienced TIA symptoms (feeling fuzzy, batch of color lights in her left eye, very slurred speech, difficulty understanding in communication) and stated she was having a stroke. Patient also informed that she already had this a lot of time before, and her doctor told her to lay down, take an aspirin. Treatment medications (date unspecified) include: acetylsalicylic acid. On 2021, the subject experienced always ringing in the ears. The reporter stated that, the patient her severe hearing impairment as patient continuously complained that her ears were "always ringing an patient was unable to answer all the questions as she stated that she had to go for some physical therapy exercise and could not continue the discussion. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 ad26.cov2.s was not applicable The patient had not recovered from stroke, and the outcome of always ringing in the ears was not reported. This report was serious (Other Medically Important Condition).  Version created to amend previously reported information 18-Mar-2021. Upon review the following information was amended: patient's age updated, age at the time of vaccination updated and the causality statement removed in version one.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoacusis, Photopsia, Tinnitus, Transient ischaemic attack
Clinical narrative: This spontaneous report received from a patient concerned an 86 year old female. The patient's weight was 153 pounds, and height was 67 inches. the patient's past medical history included strokes but the last one was a  long time ago. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-Mar-2021 for prophylactic vaccination. The batch number was reported and has been requested. No concomitant medications were reported. The reporter state that, the patient was taking two vaccine shots and was halfway between the two vaccines (2 weeks) second one would be on 29-Mar-2021. On 9-Mar-2021, the experienced TIA symptoms (feeling fuzzy, batch of color lights in her left eye, very slurred speech, difficulty understanding in communication) and stated she was having a stroke. Patient also informed that she already had this a lot of time before, and her doctor told her to lay down, take an aspirin. Treatment medications (date unspecified) include: acetylsalicylic acid. On 2021, the subject experienced always ringing in the ears. The reporter stated that, the patient her severe hearing impairment as patient continuously complained that her ears were "always ringing an patient was unable to answer all the questions as she stated that she had to go for some physical therapy exercise and could not continue the discussion. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 ad26.cov2.s was not applicable The patient had not recovered from stroke, and the outcome of always ringing in the ears was not reported. This report was serious (Other Medically Important Condition).  Version created to amend previously reported information 18-Mar-2021. Upon review the following information was amended: patient's age updated, age at the time of vaccination updated and the causality statement removed in version one.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hallucination, Influenza like illness
Clinical narrative: This spontaneous report received from a patient concerned a 70 year old female. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route not reported, batch number: 1805018, expiry: 20/MAY/2021) dose was not reported, administered on 06-MAR-2021 to left deltoid. No concomitant medications were reported. On 06-MAR-2021, the patient experienced hallucination, headache, muscle aches, flu like symptoms and fatigue. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable.  The patient recovered from hallucination on 07-MAR-2021, and remaining flu like symptoms like fatigue were much better, not completely back to normal but better than a week before and close to normal. The reporter considered the causality between Covid-19 vaccine ad26.cov2.s and hallucination as related . This report was serious (Other Medically Important Condition). As per follow-up information received on 16-Mar-2021: Added and updated: The outcome of flu like symptoms was updated to recovering/resolving and narrative.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Hallucination, Headache, Influenza like illness, Myalgia
Clinical narrative: This spontaneous report received from a patient concerned a 70 year old female. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route not reported, batch number: 1805018, expiry: 20/MAY/2021) dose was not reported, administered on 06-MAR-2021 to left deltoid. No concomitant medications were reported. On 06-MAR-2021, the patient experienced hallucination, headache, muscle aches, flu like symptoms and fatigue. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable.  The patient recovered from hallucination on 07-MAR-2021, and remaining flu like symptoms like fatigue were much better, not completely back to normal but better than a week before and close to normal. The reporter considered the causality between Covid-19 vaccine ad26.cov2.s and hallucination as related . This report was serious (Other Medically Important Condition). As per follow-up information received on 16-Mar-2021: Added and updated: The outcome of flu like symptoms was updated to recovering/resolving and narrative.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Chest discomfort, Cough
Clinical narrative: This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included vasculitis, alcohol allergy2, cinnamon allergy, immunocompromised, no smoking, and no alcohol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 11:10 at left arm for prophylactic vaccination. Concomitant medications included methotrexate for vasculitis. On unspecified date in MAR-2021, the patient's regularly blood pressure was 90/62 mmHg but at hospital blood pressure increased to 157/90 mmHg. The patient had experienced bad reaction. The patient had nap after work on 11-Mar-2021. The patient had first noticed chills, fever, fast heart rate. On 11-MAR-2021 17:30, the patient  pulse was over 100 for 5 hrs. On 11-MAR-2021 17:30, the patient pulse was over 100. The patient heart rate was 100 for for 5 hrs. On 11-Mar-2021, the patient experienced flu-like symptoms. On 11-MAR-2021 10:00 pm, the patient's temperature was 102 F. The entire was hurting for patient. The patient was treated with fluids and antibiotics to treat fever and monitored heart rate in hospital. The blood pressure was returned to normal and temperature to 99 F at discharge. The patient felt flu like symptoms, body aches and chest tightness even on 14-Mar-2021. The patient had cough at the time of reporting. Treatment medications (date unspecified) included: azithromycin non-company, and ceftriaxone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. the patient recovered from increased heart rate on 12-MAR-2021 and blood pressure increased on MAR-2021, and had not recovered from chest tightness, flu-like symptoms and cough. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate, Heart rate increased, Influenza like illness, Pyrexia
Clinical narrative: This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included vasculitis, alcohol allergy2, cinnamon allergy, immunocompromised, no smoking, and no alcohol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 11:10 at left arm for prophylactic vaccination. Concomitant medications included methotrexate for vasculitis. On unspecified date in MAR-2021, the patient's regularly blood pressure was 90/62 mmHg but at hospital blood pressure increased to 157/90 mmHg. The patient had experienced bad reaction. The patient had nap after work on 11-Mar-2021. The patient had first noticed chills, fever, fast heart rate. On 11-MAR-2021 17:30, the patient  pulse was over 100 for 5 hrs. On 11-MAR-2021 17:30, the patient pulse was over 100. The patient heart rate was 100 for for 5 hrs. On 11-Mar-2021, the patient experienced flu-like symptoms. On 11-MAR-2021 10:00 pm, the patient's temperature was 102 F. The entire was hurting for patient. The patient was treated with fluids and antibiotics to treat fever and monitored heart rate in hospital. The blood pressure was returned to normal and temperature to 99 F at discharge. The patient felt flu like symptoms, body aches and chest tightness even on 14-Mar-2021. The patient had cough at the time of reporting. Treatment medications (date unspecified) included: azithromycin non-company, and ceftriaxone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. the patient recovered from increased heart rate on 12-MAR-2021 and blood pressure increased on MAR-2021, and had not recovered from chest tightness, flu-like symptoms and cough. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Chest discomfort, Chills, Cough, Heart rate increased
Clinical narrative: This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included vasculitis, alcohol allergy2, cinnamon allergy, immunocompromised, no smoking, and no alcohol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 11:10 at left arm for prophylactic vaccination. Concomitant medications included methotrexate for vasculitis. On unspecified date in MAR-2021, the patient's regularly blood pressure was 90/62 mmHg but at hospital blood pressure increased to 157/90 mmHg. The patient had experienced bad reaction. The patient had nap after work on 11-Mar-2021. The patient had first noticed chills, fever, fast heart rate. On 11-MAR-2021 17:30, the patient  pulse was over 100 for 5 hrs. On 11-MAR-2021 17:30, the patient pulse was over 100. The patient heart rate was 100 for for 5 hrs. On 11-Mar-2021, the patient experienced flu-like symptoms. On 11-MAR-2021 10:00 pm, the patient's temperature was 102 F. The entire was hurting for patient. The patient was treated with fluids and antibiotics to treat fever and monitored heart rate in hospital. The blood pressure was returned to normal and temperature to 99 F at discharge. The patient felt flu like symptoms, body aches and chest tightness even on 14-Mar-2021. The patient had cough at the time of reporting. Treatment medications (date unspecified) included: azithromycin non-company, and ceftriaxone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. the patient recovered from increased heart rate on 12-MAR-2021 and blood pressure increased on MAR-2021, and had not recovered from chest tightness, flu-like symptoms and cough. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included vasculitis, alcohol allergy2, cinnamon allergy, immunocompromised, no smoking, and no alcohol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 11:10 at left arm for prophylactic vaccination. Concomitant medications included methotrexate for vasculitis. On unspecified date in MAR-2021, the patient's regularly blood pressure was 90/62 mmHg but at hospital blood pressure increased to 157/90 mmHg. The patient had experienced bad reaction. The patient had nap after work on 11-Mar-2021. The patient had first noticed chills, fever, fast heart rate. On 11-MAR-2021 17:30, the patient  pulse was over 100 for 5 hrs. On 11-MAR-2021 17:30, the patient pulse was over 100. The patient heart rate was 100 for for 5 hrs. On 11-Mar-2021, the patient experienced flu-like symptoms. On 11-MAR-2021 10:00 pm, the patient's temperature was 102 F. The entire was hurting for patient. The patient was treated with fluids and antibiotics to treat fever and monitored heart rate in hospital. The blood pressure was returned to normal and temperature to 99 F at discharge. The patient felt flu like symptoms, body aches and chest tightness even on 14-Mar-2021. The patient had cough at the time of reporting. Treatment medications (date unspecified) included: azithromycin non-company, and ceftriaxone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. the patient recovered from increased heart rate on 12-MAR-2021 and blood pressure increased on MAR-2021, and had not recovered from chest tightness, flu-like symptoms and cough. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: This spontaneous report received from a patient concerned an 84 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfonamide allergy, non alcoholic, and cigarette smoker (one pack per day). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry date: unknown) dose was not reported, administered on 03-MAR-2021, 13:36 right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 04-MAR-2021, Patient experienced a stroke. Patient was sent to the ER. The patient was treated per stroke treatment guidelines, The patient was hospitalized for two days. The patient returned to hospital a week later. Health Care Professionals at the hospital found reason for blood loss, but could not find reason for the stroke. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. the patient recovered from stroke on 06-MAR-2021. The reporter causality assessment for stroke was not related. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abstains from alcohol, Cerebrovascular accident, Drug hypersensitivity, Haemorrhage, Tobacco user
Clinical narrative: This spontaneous report received from a patient concerned an 84 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfonamide allergy, non alcoholic, and cigarette smoker (one pack per day). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry date: unknown) dose was not reported, administered on 03-MAR-2021, 13:36 right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 04-MAR-2021, Patient experienced a stroke. Patient was sent to the ER. The patient was treated per stroke treatment guidelines, The patient was hospitalized for two days. The patient returned to hospital a week later. Health Care Professionals at the hospital found reason for blood loss, but could not find reason for the stroke. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. the patient recovered from stroke on 06-MAR-2021. The reporter causality assessment for stroke was not related. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Chills, Dizziness
Clinical narrative: This spontaneous report received from a patient concerned a 38 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:  1805018, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 10:00. No concomitant medications were reported. On 09-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 106 F. The patient stated that Immediately after injection, she experienced slight pain/burning at injection site, dizziness followed. The patient reported that at 6:00 pm, she was feeling weak, lethargic, fever, severe chills, body aches, headache and joint pain. The patient stated that her fever rose to 106 degrees fahrenheit by 9:00 pm and she couldn't move; at this point, she decided to take a single dose of Ibuprofen and on the morning of 3/10/2021, at about 8:30 am she took another single dose of Ibuprofen to keep her fever down and that helped with her body pain. The patient also stated that she stayed in bed most of the day and had general weakness and dizziness that lasted all day. On the morning of 3/11/2021, the patient reported that her fever was gone but muscle aches and body aches persist. Pain at injection site and headache persist. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high fever, had not recovered from pain at injection site, body aches, headache, and muscle aches, and the outcome of dizziness, feeling weak, severe chills and joint pain was not reported. This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 11-MAR-2021. Upon review following information was amended: The event high grade fever was recoded with pyrexia. Labeling of feeling weak was corrected to labeled  .  Labeling of pyrexia was corrected to labeled.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Injection site pain, Myalgia, Pain, Pyrexia
Clinical narrative: This spontaneous report received from a patient concerned a 38 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:  1805018, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 10:00. No concomitant medications were reported. On 09-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 106 F. The patient stated that Immediately after injection, she experienced slight pain/burning at injection site, dizziness followed. The patient reported that at 6:00 pm, she was feeling weak, lethargic, fever, severe chills, body aches, headache and joint pain. The patient stated that her fever rose to 106 degrees fahrenheit by 9:00 pm and she couldn't move; at this point, she decided to take a single dose of Ibuprofen and on the morning of 3/10/2021, at about 8:30 am she took another single dose of Ibuprofen to keep her fever down and that helped with her body pain. The patient also stated that she stayed in bed most of the day and had general weakness and dizziness that lasted all day. On the morning of 3/11/2021, the patient reported that her fever was gone but muscle aches and body aches persist. Pain at injection site and headache persist. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high fever, had not recovered from pain at injection site, body aches, headache, and muscle aches, and the outcome of dizziness, feeling weak, severe chills and joint pain was not reported. This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 11-MAR-2021. Upon review following information was amended: The event high grade fever was recoded with pyrexia. Labeling of feeling weak was corrected to labeled  .  Labeling of pyrexia was corrected to labeled.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test, Tuberculin test
Clinical narrative: This spontaneous report received from a patient concerned a 38 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:  1805018, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 10:00. No concomitant medications were reported. On 09-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 106 F. The patient stated that Immediately after injection, she experienced slight pain/burning at injection site, dizziness followed. The patient reported that at 6:00 pm, she was feeling weak, lethargic, fever, severe chills, body aches, headache and joint pain. The patient stated that her fever rose to 106 degrees fahrenheit by 9:00 pm and she couldn't move; at this point, she decided to take a single dose of Ibuprofen and on the morning of 3/10/2021, at about 8:30 am she took another single dose of Ibuprofen to keep her fever down and that helped with her body pain. The patient also stated that she stayed in bed most of the day and had general weakness and dizziness that lasted all day. On the morning of 3/11/2021, the patient reported that her fever was gone but muscle aches and body aches persist. Pain at injection site and headache persist. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high fever, had not recovered from pain at injection site, body aches, headache, and muscle aches, and the outcome of dizziness, feeling weak, severe chills and joint pain was not reported. This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 11-MAR-2021. Upon review following information was amended: The event high grade fever was recoded with pyrexia. Labeling of feeling weak was corrected to labeled  .  Labeling of pyrexia was corrected to labeled.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Headache
Clinical narrative: This spontaneous report received from a patient concerned a 38 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:  1805018, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 10:00. No concomitant medications were reported. On 09-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 106 F. The patient stated that Immediately after injection, she experienced slight pain/burning at injection site, dizziness followed. The patient reported that at 6:00 pm, she was feeling weak, lethargic, fever, severe chills, body aches, headache and joint pain. The patient stated that her fever rose to 106 degrees fahrenheit by 9:00 pm and she couldn't move; at this point, she decided to take a single dose of Ibuprofen and on the morning of 3/10/2021, at about 8:30 am she took another single dose of Ibuprofen to keep her fever down and that helped with her body pain. The patient also stated that she stayed in bed most of the day and had general weakness and dizziness that lasted all day. On the morning of 3/11/2021, the patient reported that her fever was gone but muscle aches and body aches persist. Pain at injection site and headache persist. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high fever, had not recovered from pain at injection site, body aches, headache, and muscle aches, and the outcome of dizziness, feeling weak, severe chills and joint pain was not reported. This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 11-MAR-2021. Upon review following information was amended: The event high grade fever was recoded with pyrexia. Labeling of feeling weak was corrected to labeled  .  Labeling of pyrexia was corrected to labeled.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Immediate post-injection reaction, Injection site pain, Lethargy, Mobility decreased, Myalgia
Clinical narrative: This spontaneous report received from a patient concerned a 38 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:  1805018, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 10:00. No concomitant medications were reported. On 09-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 106 F. The patient stated that Immediately after injection, she experienced slight pain/burning at injection site, dizziness followed. The patient reported that at 6:00 pm, she was feeling weak, lethargic, fever, severe chills, body aches, headache and joint pain. The patient stated that her fever rose to 106 degrees fahrenheit by 9:00 pm and she couldn't move; at this point, she decided to take a single dose of Ibuprofen and on the morning of 3/10/2021, at about 8:30 am she took another single dose of Ibuprofen to keep her fever down and that helped with her body pain. The patient also stated that she stayed in bed most of the day and had general weakness and dizziness that lasted all day. On the morning of 3/11/2021, the patient reported that her fever was gone but muscle aches and body aches persist. Pain at injection site and headache persist. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high fever, had not recovered from pain at injection site, body aches, headache, and muscle aches, and the outcome of dizziness, feeling weak, severe chills and joint pain was not reported. This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 11-MAR-2021. Upon review following information was amended: The event high grade fever was recoded with pyrexia. Labeling of feeling weak was corrected to labeled  .  Labeling of pyrexia was corrected to labeled.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: This spontaneous report received from a patient concerned a 38 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:  1805018, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 10:00. No concomitant medications were reported. On 09-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 106 F. The patient stated that Immediately after injection, she experienced slight pain/burning at injection site, dizziness followed. The patient reported that at 6:00 pm, she was feeling weak, lethargic, fever, severe chills, body aches, headache and joint pain. The patient stated that her fever rose to 106 degrees fahrenheit by 9:00 pm and she couldn't move; at this point, she decided to take a single dose of Ibuprofen and on the morning of 3/10/2021, at about 8:30 am she took another single dose of Ibuprofen to keep her fever down and that helped with her body pain. The patient also stated that she stayed in bed most of the day and had general weakness and dizziness that lasted all day. On the morning of 3/11/2021, the patient reported that her fever was gone but muscle aches and body aches persist. Pain at injection site and headache persist. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high fever, had not recovered from pain at injection site, body aches, headache, and muscle aches, and the outcome of dizziness, feeling weak, severe chills and joint pain was not reported. This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 11-MAR-2021. Upon review following information was amended: The event high grade fever was recoded with pyrexia. Labeling of feeling weak was corrected to labeled  .  Labeling of pyrexia was corrected to labeled.