chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: FEVER; VOMITING; BODY ACHES; COLD; BOTH ARMS WERE "REAL SORE"; NAUSEA; FELT SICK FOR 11 TO 12 HOURS; This spontaneous report received from a consumer concerned a female (reporter's wife) of unspecified age. The patient's weight, height, and medical history were not reported. The patient received COVID-19 vaccine Ad26.COV2.S (suspension for injection, route of 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 take 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.S. The reporter considered the causality of event 'felt sick for 11 to 12 hours' 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 the additional information received.; Sender's Comments: V.2: The follow up information in this version updates event verbatim, event addition, other AE characteristics and treatment for fever. This updated information does not alter the causality of previously reported event fever.   20210312384-COVID-19 vaccine Ad26.COV2.S-Fever. This event is labeled and is therefore considered potentially related.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Nasopharyngitis, Nausea, Pain, Pain in extremity
Clinical narrative: FEVER; VOMITING; BODY ACHES; COLD; BOTH ARMS WERE "REAL SORE"; NAUSEA; FELT SICK FOR 11 TO 12 HOURS; This spontaneous report received from a consumer concerned a female (reporter's wife) of unspecified age. The patient's weight, height, and medical history were not reported. The patient received COVID-19 vaccine Ad26.COV2.S (suspension for injection, route of 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 take 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.S. The reporter considered the causality of event 'felt sick for 11 to 12 hours' 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 the additional information received.; Sender's Comments: V.2: The follow up information in this version updates event verbatim, event addition, other AE characteristics and treatment for fever. This updated information does not alter the causality of previously reported event fever.   20210312384-COVID-19 vaccine Ad26.COV2.S-Fever. This event is labeled and is therefore considered potentially related.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: FEVER; VOMITING; BODY ACHES; COLD; BOTH ARMS WERE "REAL SORE"; NAUSEA; FELT SICK FOR 11 TO 12 HOURS; This spontaneous report received from a consumer concerned a female (reporter's wife) of unspecified age. The patient's weight, height, and medical history were not reported. The patient received COVID-19 vaccine Ad26.COV2.S (suspension for injection, route of 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 take 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.S. The reporter considered the causality of event 'felt sick for 11 to 12 hours' 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 the additional information received.; Sender's Comments: V.2: The follow up information in this version updates event verbatim, event addition, other AE characteristics and treatment for fever. This updated information does not alter the causality of previously reported event fever.   20210312384-COVID-19 vaccine Ad26.COV2.S-Fever. This event is labeled and is therefore considered potentially related.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Tinnitus
Clinical narrative: STROKE; ALWAYS RINGING IN THE EARS; This spontaneous report received from a patient concerned an 87 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 not 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 09-Mar-2021, the patient experienced TIA symptoms (feeling fuzzy, batch of color lights in her left eye, very slurred speech, difficulty understanding and difficulty 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 (dates unspecified) included: acetylsalicylic acid.  On 2021, the subject experienced always ringing in the ears. The reporter stated that, the patient had 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 vaccine 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).   Additional information was received on 18-Mar-2021. The following information was updated and incorporated into the narrative: The patient's demographics details (age and age group),event (Always ringing in the ears), reporter address details and other reference number.; Sender's Comments: V1:  The following information updates addition of event (always ringing in the ears),  patient's demographics details (age and age group), reporter details and other reference number. This updated information does not alter prior causality assessment of reported event.  20210316871-Covid-19 vaccine ad26.cov2.s-Stroke. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Communication disorder, Condition aggravated, Dysarthria, Feeling abnormal
Clinical narrative: STROKE; ALWAYS RINGING IN THE EARS; This spontaneous report received from a patient concerned an 87 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 not 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 09-Mar-2021, the patient experienced TIA symptoms (feeling fuzzy, batch of color lights in her left eye, very slurred speech, difficulty understanding and difficulty 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 (dates unspecified) included: acetylsalicylic acid.  On 2021, the subject experienced always ringing in the ears. The reporter stated that, the patient had 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 vaccine 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).   Additional information was received on 18-Mar-2021. The following information was updated and incorporated into the narrative: The patient's demographics details (age and age group),event (Always ringing in the ears), reporter address details and other reference number.; Sender's Comments: V1:  The following information updates addition of event (always ringing in the ears),  patient's demographics details (age and age group), reporter details and other reference number. This updated information does not alter prior causality assessment of reported event.  20210316871-Covid-19 vaccine ad26.cov2.s-Stroke. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoacusis, Photopsia, Tinnitus, Transient ischaemic attack
Clinical narrative: STROKE; ALWAYS RINGING IN THE EARS; This spontaneous report received from a patient concerned an 87 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 not 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 09-Mar-2021, the patient experienced TIA symptoms (feeling fuzzy, batch of color lights in her left eye, very slurred speech, difficulty understanding and difficulty 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 (dates unspecified) included: acetylsalicylic acid.  On 2021, the subject experienced always ringing in the ears. The reporter stated that, the patient had 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 vaccine 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).   Additional information was received on 18-Mar-2021. The following information was updated and incorporated into the narrative: The patient's demographics details (age and age group),event (Always ringing in the ears), reporter address details and other reference number.; Sender's Comments: V1:  The following information updates addition of event (always ringing in the ears),  patient's demographics details (age and age group), reporter details and other reference number. This updated information does not alter prior causality assessment of reported event.  20210316871-Covid-19 vaccine ad26.cov2.s-Stroke. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hallucination, Influenza like illness
Clinical narrative: HALLUCINATION; FLU LIKE SYMPTOMS, HEADACHE, MUSCLE ACHES AND FATIGUE; This spontaneous report received from a patient concerned a 70 year old white 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 for prophylactic vaccination. 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.; Sender's Comments: V.1: The follow up information in this version updates outcome of flu like symptoms. This updated information does not alter the causality of previously reported event .  20210320317- Covid-19 vaccine ad26.cov2.s-Hallucination. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Hallucination, Headache, Influenza like illness, Myalgia
Clinical narrative: HALLUCINATION; FLU LIKE SYMPTOMS, HEADACHE, MUSCLE ACHES AND FATIGUE; This spontaneous report received from a patient concerned a 70 year old white 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 for prophylactic vaccination. 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.; Sender's Comments: V.1: The follow up information in this version updates outcome of flu like symptoms. This updated information does not alter the causality of previously reported event .  20210320317- Covid-19 vaccine ad26.cov2.s-Hallucination. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: Hemiplegia, Injection site pain, Pain in extremity
Clinical narrative: SORE ARM; INJECTION SITE STINGING; MILD HEMIPLEGIA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced mild hemiplegia. On 08-MAR-2021, the subject experienced sore arm. On 08-MAR-2021, the subject experienced injection site stinging. The patient had mild hemiplegic on side where got the shot of the vaccine was given in Right Deltoid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and injection site stinging on 11-MAR-2021, and the outcome of mild hemiplegia was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210328827-COVID-19 VACCINE AD26.COV2.S-Mild Hemiplegia. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dehydration, Dizziness, Feeding disorder, Fluid intake reduced
Clinical narrative: DEHYDRATION; CANNOT EAT DUE TO BLISTERS AND INFLAMED GUMS; CANNOT DRINK DUE TO BLISTERS AND INFLAMED GUMS; DIZZY/LIGHTHEADED; INFLAMED GUMS; MOUTH BLISTERS; INFLAMED, SWOLLEN AND SORE THROAT; SWEATS; CHILLS; FEVER; MUSCLE ACHES; NAUSEA; This spontaneous report received from a patient concerned a 29 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user (Social once in a month), and non smoker, and other pre-existing medical conditions included patient had no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-MAR-2021, the patient experienced sweats, chills, fever, muscle aches, nausea. On 12-MAR-2021, the patient experienced mouth blisters, inflamed, swollen and sore throat and the patient was given steroid shot. On 13-MAR-2021, the patient experienced dizzy/lightheaded, inflamed gums. On an unspecified date, the patient experienced dehydration, cannot eat due to blisters and inflamed gums, and cannot drink due to blisters and inflamed gums. The patient was given IV for dehydration. Laboratory data (dates unspecified) included: Streptococcal sore throat (NR: not provided) Negetive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from inflamed, swollen and sore throat on 13-MAR-2021, and sweats, chills, fever, muscle aches, and nausea on 12-MAR-2021, had not recovered from mouth blisters, dizzy/lightheaded, and inflamed gums, and the outcome of dehydration, cannot eat due to blisters and inflamed gums and cannot drink due to blisters and inflamed gums was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210329079-covid-19 vaccine ad26.cov2.s -Mouth blisters, Inflamed Swollen and sore throat, Cannot eat due to blister, Cannot drink due to blisters, Dizziness, Dehydration, Inflamed gums, Sweats, Chills. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20210329079-covid-19 vaccine ad26.cov2.s -Fever, Muscle aches, Nausea. These events are labeled and are therefore considered potentially related.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Myalgia, Nausea, Noninfective gingivitis, Oral mucosal blistering
Clinical narrative: DEHYDRATION; CANNOT EAT DUE TO BLISTERS AND INFLAMED GUMS; CANNOT DRINK DUE TO BLISTERS AND INFLAMED GUMS; DIZZY/LIGHTHEADED; INFLAMED GUMS; MOUTH BLISTERS; INFLAMED, SWOLLEN AND SORE THROAT; SWEATS; CHILLS; FEVER; MUSCLE ACHES; NAUSEA; This spontaneous report received from a patient concerned a 29 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user (Social once in a month), and non smoker, and other pre-existing medical conditions included patient had no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-MAR-2021, the patient experienced sweats, chills, fever, muscle aches, nausea. On 12-MAR-2021, the patient experienced mouth blisters, inflamed, swollen and sore throat and the patient was given steroid shot. On 13-MAR-2021, the patient experienced dizzy/lightheaded, inflamed gums. On an unspecified date, the patient experienced dehydration, cannot eat due to blisters and inflamed gums, and cannot drink due to blisters and inflamed gums. The patient was given IV for dehydration. Laboratory data (dates unspecified) included: Streptococcal sore throat (NR: not provided) Negetive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from inflamed, swollen and sore throat on 13-MAR-2021, and sweats, chills, fever, muscle aches, and nausea on 12-MAR-2021, had not recovered from mouth blisters, dizzy/lightheaded, and inflamed gums, and the outcome of dehydration, cannot eat due to blisters and inflamed gums and cannot drink due to blisters and inflamed gums was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210329079-covid-19 vaccine ad26.cov2.s -Mouth blisters, Inflamed Swollen and sore throat, Cannot eat due to blister, Cannot drink due to blisters, Dizziness, Dehydration, Inflamed gums, Sweats, Chills. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20210329079-covid-19 vaccine ad26.cov2.s -Fever, Muscle aches, Nausea. These events are labeled and are therefore considered potentially related.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngitis, Pharyngitis streptococcal, Pyrexia
Clinical narrative: DEHYDRATION; CANNOT EAT DUE TO BLISTERS AND INFLAMED GUMS; CANNOT DRINK DUE TO BLISTERS AND INFLAMED GUMS; DIZZY/LIGHTHEADED; INFLAMED GUMS; MOUTH BLISTERS; INFLAMED, SWOLLEN AND SORE THROAT; SWEATS; CHILLS; FEVER; MUSCLE ACHES; NAUSEA; This spontaneous report received from a patient concerned a 29 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user (Social once in a month), and non smoker, and other pre-existing medical conditions included patient had no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-MAR-2021, the patient experienced sweats, chills, fever, muscle aches, nausea. On 12-MAR-2021, the patient experienced mouth blisters, inflamed, swollen and sore throat and the patient was given steroid shot. On 13-MAR-2021, the patient experienced dizzy/lightheaded, inflamed gums. On an unspecified date, the patient experienced dehydration, cannot eat due to blisters and inflamed gums, and cannot drink due to blisters and inflamed gums. The patient was given IV for dehydration. Laboratory data (dates unspecified) included: Streptococcal sore throat (NR: not provided) Negetive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from inflamed, swollen and sore throat on 13-MAR-2021, and sweats, chills, fever, muscle aches, and nausea on 12-MAR-2021, had not recovered from mouth blisters, dizzy/lightheaded, and inflamed gums, and the outcome of dehydration, cannot eat due to blisters and inflamed gums and cannot drink due to blisters and inflamed gums was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210329079-covid-19 vaccine ad26.cov2.s -Mouth blisters, Inflamed Swollen and sore throat, Cannot eat due to blister, Cannot drink due to blisters, Dizziness, Dehydration, Inflamed gums, Sweats, Chills. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20210329079-covid-19 vaccine ad26.cov2.s -Fever, Muscle aches, Nausea. These events are labeled and are therefore considered potentially related.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Chest discomfort, Cough
Clinical narrative: INCREASED HEART RATE; FLU-LIKE SYMPTOMS; BLOOD PRESSURE INCREASED; COUGH; CHEST TIGHTNESS; 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 allergy, 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 90/60 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. The patient heart rate was 100 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 (dates 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 symptom and cough. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: 20210329139 -JANSSEN COVID-19 VACCINE Ad26.COV2.S - Increased Heart Rate. This event is labeled and is therefore considered potentially related.  20210329139 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- Flu Like Symptoms. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY.  20210329139 -JANSSEN COVID-19 VACCINE Ad26.COV2.S - Blood Pressure Increased. This event is considered Unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate, Heart rate increased, Influenza like illness, Pyrexia
Clinical narrative: INCREASED HEART RATE; FLU-LIKE SYMPTOMS; BLOOD PRESSURE INCREASED; COUGH; CHEST TIGHTNESS; 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 allergy, 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 90/60 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. The patient heart rate was 100 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 (dates 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 symptom and cough. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: 20210329139 -JANSSEN COVID-19 VACCINE Ad26.COV2.S - Increased Heart Rate. This event is labeled and is therefore considered potentially related.  20210329139 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- Flu Like Symptoms. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY.  20210329139 -JANSSEN COVID-19 VACCINE Ad26.COV2.S - Blood Pressure Increased. This event is considered Unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Chest discomfort, Chills, Cough, Heart rate increased
Clinical narrative: INCREASED HEART RATE; FLU-LIKE SYMPTOMS; BLOOD PRESSURE INCREASED; COUGH; CHEST TIGHTNESS; 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 allergy, 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 90/60 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. The patient heart rate was 100 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 (dates 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 symptom and cough. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: 20210329139 -JANSSEN COVID-19 VACCINE Ad26.COV2.S - Increased Heart Rate. This event is labeled and is therefore considered potentially related.  20210329139 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- Flu Like Symptoms. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY.  20210329139 -JANSSEN COVID-19 VACCINE Ad26.COV2.S - Blood Pressure Increased. This event is considered Unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: INCREASED HEART RATE; FLU-LIKE SYMPTOMS; BLOOD PRESSURE INCREASED; COUGH; CHEST TIGHTNESS; 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 allergy, 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 90/60 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. The patient heart rate was 100 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 (dates 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 symptom and cough. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: 20210329139 -JANSSEN COVID-19 VACCINE Ad26.COV2.S - Increased Heart Rate. This event is labeled and is therefore considered potentially related.  20210329139 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- Flu Like Symptoms. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY.  20210329139 -JANSSEN COVID-19 VACCINE Ad26.COV2.S - Blood Pressure Increased. This event is considered Unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: MAJOR HEART ATTACK; This spontaneous report received from a consumer concerned a 50 year old female. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, she had major heart attack and died. It was unknown if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The reporter and company provided causality between Covid-19 vaccine ad26.cov2.s and major heart attack as possible. This report was serious (Death).; Sender's Comments: - covid-19 vaccine ad26.cov2.s -Heart attack. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: MAJOR HEART ATTACK
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Hypoxia, Limb discomfort, Nausea
Clinical narrative: HYPOXIC; LIGHTHEADED; FELT LIKE BRAIN DID A BACKFLIP/FEEL LIKE HE WAS ON A BOAT IN HEAVY SEAS AND HEAD IS FLOATING; ARMS AND LEGS FEELS CONCRETE; NAUSEOUS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. After the administration of vaccine patient felt fine and left after the 15 minutes. On 16-MAR-2021, the patient experienced hypoxic, lightheaded, felt like brain did a backflip/feel like he was on a boat in heavy seas and head is floating, arms and legs feels concrete and nauseous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nauseous, lightheaded, hypoxic, felt like brain did a backflip/feel like he was on a boat in heavy seas and head is floating and arms and legs feels concrete was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210331371-covid-19 vaccine ad26.cov2.s-Hypoxia. This event is considered Unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest discomfort, Diplopia, Eye disorder, Headache
Clinical narrative: ELEVATED BLOOD PRESSURE; ELEVATED HEART RATE; CHEST TIGHTNESS; COATING OVER EYES; VERTIGO; BLURRY VISION; SEEING DOUBLE; HEADACHE; NAUSEA; SLEEPY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 to Right Deltoid for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, Laboratory data included: Blood pressure (NR: not provided) High Blood pressure. On 12-MAR-2021, the patient experienced elevated blood pressure. On the same day, the patient experienced coating over her eyes, vertigo, elevated blood pressure and heart rate 5 minutes within receiving the vaccine, headache, nausea, and sleepy. The patient felt heart racing fast. Ambulance was called and on the same day, the patient was hospitalized for 8-9 hours until blood pressure stabilized. Laboratory data included: Heart rate (NR: not provided) elevated Heart rate. It was not known if patient was discharged or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurry vision, and seeing double on MAR-2021, was recovering from coating over eyes, chest tightness, and elevated heart rate, and had not recovered from elevated blood pressure, vertigo, headache, nausea, and sleepy. The reporter and company causality considered between covid-19 vaccine ad26.cov2.s and blurry vision, seeing double, coating over eyes, chest tightness, elevated heart rate, blood pressure, vertigo, headache, nausea, and sleepy as possible. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210332091-Covid-19 vaccine ad26.cov2.s-Elevated blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Hypertension, Nausea, Somnolence
Clinical narrative: ELEVATED BLOOD PRESSURE; ELEVATED HEART RATE; CHEST TIGHTNESS; COATING OVER EYES; VERTIGO; BLURRY VISION; SEEING DOUBLE; HEADACHE; NAUSEA; SLEEPY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 to Right Deltoid for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, Laboratory data included: Blood pressure (NR: not provided) High Blood pressure. On 12-MAR-2021, the patient experienced elevated blood pressure. On the same day, the patient experienced coating over her eyes, vertigo, elevated blood pressure and heart rate 5 minutes within receiving the vaccine, headache, nausea, and sleepy. The patient felt heart racing fast. Ambulance was called and on the same day, the patient was hospitalized for 8-9 hours until blood pressure stabilized. Laboratory data included: Heart rate (NR: not provided) elevated Heart rate. It was not known if patient was discharged or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurry vision, and seeing double on MAR-2021, was recovering from coating over eyes, chest tightness, and elevated heart rate, and had not recovered from elevated blood pressure, vertigo, headache, nausea, and sleepy. The reporter and company causality considered between covid-19 vaccine ad26.cov2.s and blurry vision, seeing double, coating over eyes, chest tightness, elevated heart rate, blood pressure, vertigo, headache, nausea, and sleepy as possible. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210332091-Covid-19 vaccine ad26.cov2.s-Elevated blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).