chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Injection site pain, Myalgia, Pain, Pyrexia
Clinical narrative: HIGH GRADE FEVER; BODY ACHES; SEVERE CHILLS; JOINT PAIN; FEELING WEAK; MUSCLE ACHES; HEADACHE; PAIN AT INJECTION SITE; DIZZINESS; This spontaneous report received from a patient concerned a 38 year old female. The patient's weight, height, and medical history were not reported. On an unknown date in NOV-2020, she had a negative COVID-19 test result. On 08-MAR-2021, she had a SubQ TB test done (results not provided). The patient received COVID-19 vaccine AD26.COV2.s (suspension for injection, intramuscular, batch number: 1805018, expiry: unknown) dose was not reported, administered on right arm on 09-MAR-2021 approximately at 10:00 for vaccination. No concomitant medications were reported. Six hours post vaccination, all her symptoms started. On 09-MAR-2021, immediately post vaccination, she experienced slight pain/burning at injection site, followed by dizziness. On 09-MAR-2021, at 18:00 in the evening, she was feeling weak, lethargic, had fever, severe chills, body aches, headache and joint pain. The patient stated that her fever rose to 106 degrees Fahrenheit by 20:00 and she couldn't move. At this point, she took 200mg of Ibuprofen per oral every 6 hours for approximately 24 hours. On 10-MAR-2021, at about 8:30, she took another single dose of ibuprofen to keep her fever down and help with the 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 11-MAR-2021, the patient reported that her fever was gone but muscle aches, body aches and pain at injection site persisted. On an unknown date in MAR-2021, after 2 weeks from initial date of vaccination, the patient had full resolution of his symptoms. The action taken with COVID-19 vaccine AD26.COV2.s was not applicable. The patient recovered from high grade fever, pain at injection site, body aches, headache, muscle aches, dizziness, feeling weak, severe chills and joint pain. This report was serious (Other Medically Important Condition).  Additional information was received from reporter on 22-Mar-2021. The following information was updated and incorporated into the case narrative: Onset and end date for all the events, Laboratory tests and Treatment drug.; Sender's Comments: V2: Additional information received updates : event details (Onset and end dates for all the events), Laboratory tests and Treatment drug. This updated information does not alter prior causality assessment of reported event. 20210323883-COVID-19 VACCINE AD26.COV2.s-High grade fever. This event is considered related. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test, Tuberculin test
Clinical narrative: HIGH GRADE FEVER; BODY ACHES; SEVERE CHILLS; JOINT PAIN; FEELING WEAK; MUSCLE ACHES; HEADACHE; PAIN AT INJECTION SITE; DIZZINESS; This spontaneous report received from a patient concerned a 38 year old female. The patient's weight, height, and medical history were not reported. On an unknown date in NOV-2020, she had a negative COVID-19 test result. On 08-MAR-2021, she had a SubQ TB test done (results not provided). The patient received COVID-19 vaccine AD26.COV2.s (suspension for injection, intramuscular, batch number: 1805018, expiry: unknown) dose was not reported, administered on right arm on 09-MAR-2021 approximately at 10:00 for vaccination. No concomitant medications were reported. Six hours post vaccination, all her symptoms started. On 09-MAR-2021, immediately post vaccination, she experienced slight pain/burning at injection site, followed by dizziness. On 09-MAR-2021, at 18:00 in the evening, she was feeling weak, lethargic, had fever, severe chills, body aches, headache and joint pain. The patient stated that her fever rose to 106 degrees Fahrenheit by 20:00 and she couldn't move. At this point, she took 200mg of Ibuprofen per oral every 6 hours for approximately 24 hours. On 10-MAR-2021, at about 8:30, she took another single dose of ibuprofen to keep her fever down and help with the 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 11-MAR-2021, the patient reported that her fever was gone but muscle aches, body aches and pain at injection site persisted. On an unknown date in MAR-2021, after 2 weeks from initial date of vaccination, the patient had full resolution of his symptoms. The action taken with COVID-19 vaccine AD26.COV2.s was not applicable. The patient recovered from high grade fever, pain at injection site, body aches, headache, muscle aches, dizziness, feeling weak, severe chills and joint pain. This report was serious (Other Medically Important Condition).  Additional information was received from reporter on 22-Mar-2021. The following information was updated and incorporated into the case narrative: Onset and end date for all the events, Laboratory tests and Treatment drug.; Sender's Comments: V2: Additional information received updates : event details (Onset and end dates for all the events), Laboratory tests and Treatment drug. This updated information does not alter prior causality assessment of reported event. 20210323883-COVID-19 VACCINE AD26.COV2.s-High grade fever. This event is considered related. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Headache
Clinical narrative: HIGH GRADE FEVER; BODY ACHES; SEVERE CHILLS; JOINT PAIN; FEELING WEAK; MUSCLE ACHES; HEADACHE; PAIN AT INJECTION SITE; DIZZINESS; This spontaneous report received from a patient concerned a 38 year old female. The patient's weight, height, and medical history were not reported. On an unknown date in NOV-2020, she had a negative COVID-19 test result. On 08-MAR-2021, she had a SubQ TB test done (results not provided). The patient received COVID-19 vaccine AD26.COV2.s (suspension for injection, intramuscular, batch number: 1805018, expiry: unknown) dose was not reported, administered on right arm on 09-MAR-2021 approximately at 10:00 for vaccination. No concomitant medications were reported. Six hours post vaccination, all her symptoms started. On 09-MAR-2021, immediately post vaccination, she experienced slight pain/burning at injection site, followed by dizziness. On 09-MAR-2021, at 18:00 in the evening, she was feeling weak, lethargic, had fever, severe chills, body aches, headache and joint pain. The patient stated that her fever rose to 106 degrees Fahrenheit by 20:00 and she couldn't move. At this point, she took 200mg of Ibuprofen per oral every 6 hours for approximately 24 hours. On 10-MAR-2021, at about 8:30, she took another single dose of ibuprofen to keep her fever down and help with the 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 11-MAR-2021, the patient reported that her fever was gone but muscle aches, body aches and pain at injection site persisted. On an unknown date in MAR-2021, after 2 weeks from initial date of vaccination, the patient had full resolution of his symptoms. The action taken with COVID-19 vaccine AD26.COV2.s was not applicable. The patient recovered from high grade fever, pain at injection site, body aches, headache, muscle aches, dizziness, feeling weak, severe chills and joint pain. This report was serious (Other Medically Important Condition).  Additional information was received from reporter on 22-Mar-2021. The following information was updated and incorporated into the case narrative: Onset and end date for all the events, Laboratory tests and Treatment drug.; Sender's Comments: V2: Additional information received updates : event details (Onset and end dates for all the events), Laboratory tests and Treatment drug. This updated information does not alter prior causality assessment of reported event. 20210323883-COVID-19 VACCINE AD26.COV2.s-High grade fever. This event is considered related. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Immediate post-injection reaction, Injection site pain, Lethargy, Mobility decreased, Myalgia
Clinical narrative: HIGH GRADE FEVER; BODY ACHES; SEVERE CHILLS; JOINT PAIN; FEELING WEAK; MUSCLE ACHES; HEADACHE; PAIN AT INJECTION SITE; DIZZINESS; This spontaneous report received from a patient concerned a 38 year old female. The patient's weight, height, and medical history were not reported. On an unknown date in NOV-2020, she had a negative COVID-19 test result. On 08-MAR-2021, she had a SubQ TB test done (results not provided). The patient received COVID-19 vaccine AD26.COV2.s (suspension for injection, intramuscular, batch number: 1805018, expiry: unknown) dose was not reported, administered on right arm on 09-MAR-2021 approximately at 10:00 for vaccination. No concomitant medications were reported. Six hours post vaccination, all her symptoms started. On 09-MAR-2021, immediately post vaccination, she experienced slight pain/burning at injection site, followed by dizziness. On 09-MAR-2021, at 18:00 in the evening, she was feeling weak, lethargic, had fever, severe chills, body aches, headache and joint pain. The patient stated that her fever rose to 106 degrees Fahrenheit by 20:00 and she couldn't move. At this point, she took 200mg of Ibuprofen per oral every 6 hours for approximately 24 hours. On 10-MAR-2021, at about 8:30, she took another single dose of ibuprofen to keep her fever down and help with the 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 11-MAR-2021, the patient reported that her fever was gone but muscle aches, body aches and pain at injection site persisted. On an unknown date in MAR-2021, after 2 weeks from initial date of vaccination, the patient had full resolution of his symptoms. The action taken with COVID-19 vaccine AD26.COV2.s was not applicable. The patient recovered from high grade fever, pain at injection site, body aches, headache, muscle aches, dizziness, feeling weak, severe chills and joint pain. This report was serious (Other Medically Important Condition).  Additional information was received from reporter on 22-Mar-2021. The following information was updated and incorporated into the case narrative: Onset and end date for all the events, Laboratory tests and Treatment drug.; Sender's Comments: V2: Additional information received updates : event details (Onset and end dates for all the events), Laboratory tests and Treatment drug. This updated information does not alter prior causality assessment of reported event. 20210323883-COVID-19 VACCINE AD26.COV2.s-High grade fever. This event is considered related. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: HIGH GRADE FEVER; BODY ACHES; SEVERE CHILLS; JOINT PAIN; FEELING WEAK; MUSCLE ACHES; HEADACHE; PAIN AT INJECTION SITE; DIZZINESS; This spontaneous report received from a patient concerned a 38 year old female. The patient's weight, height, and medical history were not reported. On an unknown date in NOV-2020, she had a negative COVID-19 test result. On 08-MAR-2021, she had a SubQ TB test done (results not provided). The patient received COVID-19 vaccine AD26.COV2.s (suspension for injection, intramuscular, batch number: 1805018, expiry: unknown) dose was not reported, administered on right arm on 09-MAR-2021 approximately at 10:00 for vaccination. No concomitant medications were reported. Six hours post vaccination, all her symptoms started. On 09-MAR-2021, immediately post vaccination, she experienced slight pain/burning at injection site, followed by dizziness. On 09-MAR-2021, at 18:00 in the evening, she was feeling weak, lethargic, had fever, severe chills, body aches, headache and joint pain. The patient stated that her fever rose to 106 degrees Fahrenheit by 20:00 and she couldn't move. At this point, she took 200mg of Ibuprofen per oral every 6 hours for approximately 24 hours. On 10-MAR-2021, at about 8:30, she took another single dose of ibuprofen to keep her fever down and help with the 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 11-MAR-2021, the patient reported that her fever was gone but muscle aches, body aches and pain at injection site persisted. On an unknown date in MAR-2021, after 2 weeks from initial date of vaccination, the patient had full resolution of his symptoms. The action taken with COVID-19 vaccine AD26.COV2.s was not applicable. The patient recovered from high grade fever, pain at injection site, body aches, headache, muscle aches, dizziness, feeling weak, severe chills and joint pain. This report was serious (Other Medically Important Condition).  Additional information was received from reporter on 22-Mar-2021. The following information was updated and incorporated into the case narrative: Onset and end date for all the events, Laboratory tests and Treatment drug.; Sender's Comments: V2: Additional information received updates : event details (Onset and end dates for all the events), Laboratory tests and Treatment drug. This updated information does not alter prior causality assessment of reported event. 20210323883-COVID-19 VACCINE AD26.COV2.s-High grade fever. This event is considered related. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Body temperature increased, Chills, Headache
Clinical narrative: HIGH GRADE FEVER; BODY ACHES; SEVERE CHILLS; JOINT PAIN; FEELING WEAK; MUSCLE ACHES; HEADACHE; PAIN AT INJECTION SITE; DIZZINESS; This spontaneous report received from a patient concerned a 38 year old female. The patient's weight, height, and medical history were not reported. On an unknown date in NOV-2020, she had a negative COVID-19 test result. On 08-MAR-2021, she had a SubQ TB test done (results not provided). The patient received COVID-19 vaccine AD26.COV2.s (suspension for injection, intramuscular, batch number: 1805018, expiry: unknown) dose was not reported, administered on right arm on 09-MAR-2021 approximately at 10:00 for vaccination. No concomitant medications were reported. Six hours post vaccination, all her symptoms started. On 09-MAR-2021, immediately post vaccination, she experienced slight pain/burning at injection site, followed by dizziness. On 09-MAR-2021, at 18:00 in the evening, she was feeling weak, lethargic, had fever, severe chills, body aches, headache and joint pain. The patient stated that her fever rose to 106 degrees Fahrenheit by 20:00 and she couldn't move. At this point, she took 200mg of Ibuprofen per oral every 6 hours for approximately 24 hours. On 10-MAR-2021, at about 8:30, she took another single dose of ibuprofen to keep her fever down and help with the 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 11-MAR-2021, the patient reported that her fever was gone but muscle aches, body aches and pain at injection site persisted. On an unknown date in MAR-2021, after 2 weeks from initial date of vaccination, the patient had full resolution of his symptoms. The action taken with COVID-19 vaccine AD26.COV2.s was not applicable. The patient recovered from high grade fever, pain at injection site, body aches, headache, muscle aches, dizziness, feeling weak, severe chills and joint pain. This report was serious (Other Medically Important Condition).  Additional information was received from reporter on 22-Mar-2021. The following information was updated and incorporated into the case narrative: Onset and end date for all the events, Laboratory tests and Treatment drug.; Sender's Comments: V2: Additional information received updates : event details (Onset and end dates for all the events), Laboratory tests and Treatment drug. This updated information does not alter prior causality assessment of reported event. 20210323883-COVID-19 VACCINE AD26.COV2.s-High grade fever. This event is considered related. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pain
Clinical narrative: HIGH GRADE FEVER; BODY ACHES; SEVERE CHILLS; JOINT PAIN; FEELING WEAK; MUSCLE ACHES; HEADACHE; PAIN AT INJECTION SITE; DIZZINESS; This spontaneous report received from a patient concerned a 38 year old female. The patient's weight, height, and medical history were not reported. On an unknown date in NOV-2020, she had a negative COVID-19 test result. On 08-MAR-2021, she had a SubQ TB test done (results not provided). The patient received COVID-19 vaccine AD26.COV2.s (suspension for injection, intramuscular, batch number: 1805018, expiry: unknown) dose was not reported, administered on right arm on 09-MAR-2021 approximately at 10:00 for vaccination. No concomitant medications were reported. Six hours post vaccination, all her symptoms started. On 09-MAR-2021, immediately post vaccination, she experienced slight pain/burning at injection site, followed by dizziness. On 09-MAR-2021, at 18:00 in the evening, she was feeling weak, lethargic, had fever, severe chills, body aches, headache and joint pain. The patient stated that her fever rose to 106 degrees Fahrenheit by 20:00 and she couldn't move. At this point, she took 200mg of Ibuprofen per oral every 6 hours for approximately 24 hours. On 10-MAR-2021, at about 8:30, she took another single dose of ibuprofen to keep her fever down and help with the 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 11-MAR-2021, the patient reported that her fever was gone but muscle aches, body aches and pain at injection site persisted. On an unknown date in MAR-2021, after 2 weeks from initial date of vaccination, the patient had full resolution of his symptoms. The action taken with COVID-19 vaccine AD26.COV2.s was not applicable. The patient recovered from high grade fever, pain at injection site, body aches, headache, muscle aches, dizziness, feeling weak, severe chills and joint pain. This report was serious (Other Medically Important Condition).  Additional information was received from reporter on 22-Mar-2021. The following information was updated and incorporated into the case narrative: Onset and end date for all the events, Laboratory tests and Treatment drug.; Sender's Comments: V2: Additional information received updates : event details (Onset and end dates for all the events), Laboratory tests and Treatment drug. This updated information does not alter prior causality assessment of reported event. 20210323883-COVID-19 VACCINE AD26.COV2.s-High grade fever. This event is considered related. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: HIGH GRADE FEVER; BODY ACHES; SEVERE CHILLS; JOINT PAIN; FEELING WEAK; MUSCLE ACHES; HEADACHE; PAIN AT INJECTION SITE; DIZZINESS; This spontaneous report received from a patient concerned a 38 year old female. The patient's weight, height, and medical history were not reported. On an unknown date in NOV-2020, she had a negative COVID-19 test result. On 08-MAR-2021, she had a SubQ TB test done (results not provided). The patient received COVID-19 vaccine AD26.COV2.s (suspension for injection, intramuscular, batch number: 1805018, expiry: unknown) dose was not reported, administered on right arm on 09-MAR-2021 approximately at 10:00 for vaccination. No concomitant medications were reported. Six hours post vaccination, all her symptoms started. On 09-MAR-2021, immediately post vaccination, she experienced slight pain/burning at injection site, followed by dizziness. On 09-MAR-2021, at 18:00 in the evening, she was feeling weak, lethargic, had fever, severe chills, body aches, headache and joint pain. The patient stated that her fever rose to 106 degrees Fahrenheit by 20:00 and she couldn't move. At this point, she took 200mg of Ibuprofen per oral every 6 hours for approximately 24 hours. On 10-MAR-2021, at about 8:30, she took another single dose of ibuprofen to keep her fever down and help with the 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 11-MAR-2021, the patient reported that her fever was gone but muscle aches, body aches and pain at injection site persisted. On an unknown date in MAR-2021, after 2 weeks from initial date of vaccination, the patient had full resolution of his symptoms. The action taken with COVID-19 vaccine AD26.COV2.s was not applicable. The patient recovered from high grade fever, pain at injection site, body aches, headache, muscle aches, dizziness, feeling weak, severe chills and joint pain. This report was serious (Other Medically Important Condition).  Additional information was received from reporter on 22-Mar-2021. The following information was updated and incorporated into the case narrative: Onset and end date for all the events, Laboratory tests and Treatment drug.; Sender's Comments: V2: Additional information received updates : event details (Onset and end dates for all the events), Laboratory tests and Treatment drug. This updated information does not alter prior causality assessment of reported event. 20210323883-COVID-19 VACCINE AD26.COV2.s-High grade fever. This event is considered related. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: Narcolepsy
Clinical narrative: BODY ACHES; NARCOLEPSY; This spontaneous report received from a consumer 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: 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.  On 08-MAR-2021, the patient was sleepy (could not stay awake) and had body ache the next day (only lasted 24 hours). The patient's narcolepsy had not improved and had stayed the same.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches on 10-MAR-2021, and had not recovered from narcolepsy. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210328585-Covid-19 vaccine ad26.cov2.s-Narcolepsy. 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: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness transient, Chills, Deafness
Clinical narrative: HEARING LOSS; CHILLS; VISION LOSS TO BOTH EYES; This spontaneous report received from a patient concerned an 87 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included polyethylene glycol (peg) allergy, and propylene glycol allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, 1 total, administered on 11-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 11-MAR-2021, patient experienced vision loss that lasted for an hour. Subject attributed it to the PEG and propylene glycol allergy. Later on the same day, she experienced chills that lasted until 14-MAR-2021. The subject also began having some hearing loss and further probing reveals she was referring to her ears feeling "stopped up" and it "sounded like she was in a deep well". She had not sought medical care at this time. Subject was encouraged to seek medical treatment for issues that won't resolve, would seem serious, or, would be bothersome. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vision loss to both eyes on 11-MAR-2021, and chills on 14-MAR-2021, and the outcome of hearing loss was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210328836-Covid-19 vaccine ad26.cov2.s-Vision loss to both eyes, Hearing loss. This events is considered unassessable. The events 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 events.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Confusional state, Heart rate increased, Hypersensitivity, Syncope
Clinical narrative: FAINT; SHAKING; CONFUSION; INCREASED HEART RATE; INCREASED BLOOD PRESSURE; ALLERGIC REACTION; This spontaneous report received from a patient concerned a not Hispanic or Latino white female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included Penicillin allergy, bee stings allergy, preservatives allergy, and MSG allergy.  The patient received Covid-19 vaccine ad26.cov2.s on left arm (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, 1 total administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 15-MAR-2021, after 10 minutes of vaccine administration, the patient experienced faint, shaking, confusion, increased heart rate, increased blood pressure and allergic reaction. The patient was sent to emergency room. The patient received dose of EpiPen for the treatment of allergic reaction and symptoms subsided and resolved as of now per caller. It was reported that HCP was notified. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from faint, shaking, confusion, increased heart rate, increased blood pressure, and allergic reaction on 15-MAR-2021. The reporter considered the causality between Janssen Covid-19 Vaccine and faint, shaking, confusion, increased heart rate, increased blood pressure, and allergic reaction was possible. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:21210328872-covid-19 vaccine ad26.cov2.s-Allergic reaction. This event is labeled and is therefore considered potentially related.  V0:21210328872-covid-19 vaccine ad26.cov2.s-Faint,shaking, confusion, increased heart rate, increase blood pressure. This event is considered unassessable. The events 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 events.
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: FAINT; SHAKING; CONFUSION; INCREASED HEART RATE; INCREASED BLOOD PRESSURE; ALLERGIC REACTION; This spontaneous report received from a patient concerned a not Hispanic or Latino white female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included Penicillin allergy, bee stings allergy, preservatives allergy, and MSG allergy.  The patient received Covid-19 vaccine ad26.cov2.s on left arm (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, 1 total administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 15-MAR-2021, after 10 minutes of vaccine administration, the patient experienced faint, shaking, confusion, increased heart rate, increased blood pressure and allergic reaction. The patient was sent to emergency room. The patient received dose of EpiPen for the treatment of allergic reaction and symptoms subsided and resolved as of now per caller. It was reported that HCP was notified. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from faint, shaking, confusion, increased heart rate, increased blood pressure, and allergic reaction on 15-MAR-2021. The reporter considered the causality between Janssen Covid-19 Vaccine and faint, shaking, confusion, increased heart rate, increased blood pressure, and allergic reaction was possible. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:21210328872-covid-19 vaccine ad26.cov2.s-Allergic reaction. This event is labeled and is therefore considered potentially related.  V0:21210328872-covid-19 vaccine ad26.cov2.s-Faint,shaking, confusion, increased heart rate, increase blood pressure. This event is considered unassessable. The events 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 events.
Sex: U
Vaccine: COVID19
Symptoms: Constipation, Pyrexia, Urinary retention
Clinical narrative: UNABLE TO URINATE; CONSTIPATION; LOW GRADE FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 was not reported) dose was not reported, administered on 14-MAR-2021 19:30 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. patient had compliant of low grade fever, unable to urinate, and constipated after receiving the Janssen Covid-19 vaccine on 3/14/21 @ 7:30pm The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the low grade fever, constipation and unable to urinate was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210329454  -COVID-19 VACCINE AD26.COV2.S-unable to urinate. 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: Cardiac arrest, Death
Clinical narrative: ASYSTOLE; PASSED AWAY; This spontaneous report received from a physician concerned their mother-in-law, an 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: Unknown) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient was in a nursing home, but was hospitalized for pyelonephritis.  The patient was not allowed back into the nursing home without a negative COVID test and the vaccine.  After discharge from the hospital, the patient's COVID test came back negative, and upon arrival to the nursing home, the patient received the Janssen COVID-19 vaccine.  Within 30 minutes, the patient was unresponsive and transported back to the hospital.  On arrival to the hospital, the patient was asystole.  She was treated at the hospital until 13-MAR-2021, when she passed away.   Asystole was reported as fatal.  Additionally, cause of death was reported as "cause unknown", therefore, an additional serious adverse event of "passed away" was captured.  An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on 13-MAR-2021. This report was serious (Death and Hospitalization).; Sender's Comments: V0:  An female of unknown age became unresponsive 30 minutes after, experienced asystole on the same day as, and died of unknown causes 2 days after receiving Janssen COVID-19 Vaccine Ad26.COV2.S (suspension for injection; route of administration and batch number unknown) for prophylactic vaccination while in a nursing home.  Medical history and concomitant medications were not reported. The patient was the mother-in-law of the reporter, an internal medicine physician. The patient had no complaints for 30 minutes after receiving the vaccine, then became unresponsive; she was transported to a hospital where she was noted to be asystolic upon arrival. Treatment and hospital course were not provided.  The patient died 2 days after receiving the vaccine, and cause of death was unknown; outcome of asystole was reported as fatal.  An autopsy was not performed. This case has insufficient information to make a meaningful medical assessment.; Reported Cause(s) of Death: ASYSTOLE; UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest, Death, Pyelonephritis, SARS-CoV-2 test negative, Unresponsive to stimuli
Clinical narrative: ASYSTOLE; PASSED AWAY; This spontaneous report received from a physician concerned their mother-in-law, an 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: Unknown) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient was in a nursing home, but was hospitalized for pyelonephritis.  The patient was not allowed back into the nursing home without a negative COVID test and the vaccine.  After discharge from the hospital, the patient's COVID test came back negative, and upon arrival to the nursing home, the patient received the Janssen COVID-19 vaccine.  Within 30 minutes, the patient was unresponsive and transported back to the hospital.  On arrival to the hospital, the patient was asystole.  She was treated at the hospital until 13-MAR-2021, when she passed away.   Asystole was reported as fatal.  Additionally, cause of death was reported as "cause unknown", therefore, an additional serious adverse event of "passed away" was captured.  An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on 13-MAR-2021. This report was serious (Death and Hospitalization).; Sender's Comments: V0:  An female of unknown age became unresponsive 30 minutes after, experienced asystole on the same day as, and died of unknown causes 2 days after receiving Janssen COVID-19 Vaccine Ad26.COV2.S (suspension for injection; route of administration and batch number unknown) for prophylactic vaccination while in a nursing home.  Medical history and concomitant medications were not reported. The patient was the mother-in-law of the reporter, an internal medicine physician. The patient had no complaints for 30 minutes after receiving the vaccine, then became unresponsive; she was transported to a hospital where she was noted to be asystolic upon arrival. Treatment and hospital course were not provided.  The patient died 2 days after receiving the vaccine, and cause of death was unknown; outcome of asystole was reported as fatal.  An autopsy was not performed. This case has insufficient information to make a meaningful medical assessment.; Reported Cause(s) of Death: ASYSTOLE; UNKNOWN CAUSE OF DEATH
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal tenderness, Aphasia, Blood pressure decreased, Blood pressure measurement, Body temperature
Clinical narrative: INFLAMMATION OF OROPHARYNX; INFLAMMATION OF OROPHARYNX; DYSPHAGIA; DYSPHASIA; DOWN-TRENDING BLOOD PRESSURE; ABDOMEN TENDERNESS; TACHYCARDIA; CHILLS; NAUSEA; HEADACHE; FEVER; This spontaneous report received from a health care professional concerned a 19 year old Hispanic or latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included glucose-6-phosphate dehydrogenase deficiency. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021; 15:30 for prophylactic vaccination. Concomitant medications included ibuprofen.  On 15-MAR-2021 11:30, the patient experienced inflammation of oropharynx, inflammation of oropharynx, dysphagia, dysphasia, down-trending blood pressure, abdomen tenderness, tachycardia, chills, nausea, headache, and fever. Laboratory data included: Body temperature >102 F, Blood pressure (NR: not provided) Increased, and Tachycardia (NR: not provided) >115.  Treatment medications included: fluid resuscitation IV, Epinephrine, steroids, Antipyretic and diphenhydramine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from inflammation of oropharynx, inflammation of oropharynx, dysphagia, dysphasia, down-trending blood pressure, abdomen tenderness, tachycardia, chills, nausea, headache, and fever. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210330272-ovid-19 vaccine ad26.cov2.s- inflammation of oropharynx, abdomen tenderness, down-trending blood pressure, tachycardia, dysphagia, dysphasia. 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). 20210330272-ovid-19 vaccine ad26.cov2.s-chills, nausea, headache and fever. This event(s) is labeled and is therefore considered potentially related.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dysphagia, Headache, Nausea, Pharyngeal inflammation
Clinical narrative: INFLAMMATION OF OROPHARYNX; INFLAMMATION OF OROPHARYNX; DYSPHAGIA; DYSPHASIA; DOWN-TRENDING BLOOD PRESSURE; ABDOMEN TENDERNESS; TACHYCARDIA; CHILLS; NAUSEA; HEADACHE; FEVER; This spontaneous report received from a health care professional concerned a 19 year old Hispanic or latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included glucose-6-phosphate dehydrogenase deficiency. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021; 15:30 for prophylactic vaccination. Concomitant medications included ibuprofen.  On 15-MAR-2021 11:30, the patient experienced inflammation of oropharynx, inflammation of oropharynx, dysphagia, dysphasia, down-trending blood pressure, abdomen tenderness, tachycardia, chills, nausea, headache, and fever. Laboratory data included: Body temperature >102 F, Blood pressure (NR: not provided) Increased, and Tachycardia (NR: not provided) >115.  Treatment medications included: fluid resuscitation IV, Epinephrine, steroids, Antipyretic and diphenhydramine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from inflammation of oropharynx, inflammation of oropharynx, dysphagia, dysphasia, down-trending blood pressure, abdomen tenderness, tachycardia, chills, nausea, headache, and fever. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210330272-ovid-19 vaccine ad26.cov2.s- inflammation of oropharynx, abdomen tenderness, down-trending blood pressure, tachycardia, dysphagia, dysphasia. 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). 20210330272-ovid-19 vaccine ad26.cov2.s-chills, nausea, headache and fever. This event(s) is labeled and is therefore considered potentially related.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Stomatitis, Tachycardia
Clinical narrative: INFLAMMATION OF OROPHARYNX; INFLAMMATION OF OROPHARYNX; DYSPHAGIA; DYSPHASIA; DOWN-TRENDING BLOOD PRESSURE; ABDOMEN TENDERNESS; TACHYCARDIA; CHILLS; NAUSEA; HEADACHE; FEVER; This spontaneous report received from a health care professional concerned a 19 year old Hispanic or latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included glucose-6-phosphate dehydrogenase deficiency. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021; 15:30 for prophylactic vaccination. Concomitant medications included ibuprofen.  On 15-MAR-2021 11:30, the patient experienced inflammation of oropharynx, inflammation of oropharynx, dysphagia, dysphasia, down-trending blood pressure, abdomen tenderness, tachycardia, chills, nausea, headache, and fever. Laboratory data included: Body temperature >102 F, Blood pressure (NR: not provided) Increased, and Tachycardia (NR: not provided) >115.  Treatment medications included: fluid resuscitation IV, Epinephrine, steroids, Antipyretic and diphenhydramine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from inflammation of oropharynx, inflammation of oropharynx, dysphagia, dysphasia, down-trending blood pressure, abdomen tenderness, tachycardia, chills, nausea, headache, and fever. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210330272-ovid-19 vaccine ad26.cov2.s- inflammation of oropharynx, abdomen tenderness, down-trending blood pressure, tachycardia, dysphagia, dysphasia. 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). 20210330272-ovid-19 vaccine ad26.cov2.s-chills, nausea, headache and fever. This event(s) is labeled and is therefore considered potentially related.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pyrexia, Stomatitis
Clinical narrative: FEVER; SORES IN MOUTH; FATIGUE; This spontaneous report received from a parent 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: Unknown) dose was not reported, 1 total, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch number.  No concomitant medications were reported. On 10-MAR-2021, patient developed fatigue and sores in mouth. She had also developed a fever. She was hospitalized twice and she was given IV fluids. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, and sores in mouth, and the outcome of fever was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s and fatigue, sores in mouth and fever as possible.  This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210331424- JANSSEN COVID-19 VACCINE Ad26.COV2.S-Sores In Mouth. 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.  20210331424-JANSSEN COVID-19 VACCINE Ad26.COV2.S-Fatigue, Fever. This event(s) is labeled and is therefore considered potentially related.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Herpes zoster, Incoherent, Myalgia
Clinical narrative: FELT INCOHERENT; SHINGLES RASH; COLLAPSED DUE TO DIZZINESS, COULDN'T STAY UP; BODY ACHE; SORE THROAT; MUSCLE ACHE; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned an 86 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included steroid allergy, shellfish allergy, and allergic to x ray dyes. The patient received JNJ78436735 (Ad26.COV2.S) (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 09:30 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the patient experienced fatigue and headache. On 14-MAR-2021, the patient experienced body ache, sore throat, muscle ache and collapsed due to dizziness as couldn't stay up. On 16-MAR-2021, the patient experienced shingles rash. On an unspecified date, the patient felt incoherent. The action taken with JNJ78436735 (Ad26.COV2.S) was not applicable. The patient had not recovered from fatigue, sore throat, headache, muscle ache, shingles rash, collapsed due to dizziness, couldn't stay up, and body ache whereas the outcome of felt incoherent was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210332591-Covid-19 Vaccine AD26.COV2.S-collapsed due to dizziness, couldn't stay up. 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.