chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood pressure measurement, Dizziness, Dyspnoea, Heart rate, Nausea
Clinical narrative: SHORTNESS OF BREATH; LIGHT HEADED; NECK PAIN; TACHYCARDIA; BURNING IN THROAT; THROAT SWELLING; NAUSEA; This spontaneous report received from a health care professional concerned a 33 year old female. The patient's height, and weight were not reported. The patient's past medical history included tubes tied, and ablation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: 21-JUN-2021) dose was not reported,1 total administered on 07-APR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021,15 to 20 minutes after getting vaccinated the patient experienced shortness of breath, nausea, light headed, and neck pain and there was a burning inside the throat and swelling started as well. The patient also reported tachycardia at 119. Laboratory data included: Blood pressure (NR: not provided) 98/60, Heart rate (NR: not provided) 119, and Pulse oximetry (NR: not provided) 99. Treatment medications (dates unspecified) included: glucose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shortness of breath, nausea, light headed, neck pain, tachycardia, burning in throat, and throat swelling. This report was serious (Life Threatening). This case, from the same reporter is linked to 20210414577.; Sender's Comments: V0: 20210414557-covid-19 vaccine ad26.cov2.s-shortness of breath, light headed, neck pain, tachycardia, burning in throat, and throat swelling. This event(s) is considered related. The event(s) 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(s).
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Neck pain, Oxygen saturation, Pharyngeal swelling, Tachycardia, Throat irritation
Clinical narrative: SHORTNESS OF BREATH; LIGHT HEADED; NECK PAIN; TACHYCARDIA; BURNING IN THROAT; THROAT SWELLING; NAUSEA; This spontaneous report received from a health care professional concerned a 33 year old female. The patient's height, and weight were not reported. The patient's past medical history included tubes tied, and ablation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: 21-JUN-2021) dose was not reported,1 total administered on 07-APR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021,15 to 20 minutes after getting vaccinated the patient experienced shortness of breath, nausea, light headed, and neck pain and there was a burning inside the throat and swelling started as well. The patient also reported tachycardia at 119. Laboratory data included: Blood pressure (NR: not provided) 98/60, Heart rate (NR: not provided) 119, and Pulse oximetry (NR: not provided) 99. Treatment medications (dates unspecified) included: glucose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shortness of breath, nausea, light headed, neck pain, tachycardia, burning in throat, and throat swelling. This report was serious (Life Threatening). This case, from the same reporter is linked to 20210414577.; Sender's Comments: V0: 20210414557-covid-19 vaccine ad26.cov2.s-shortness of breath, light headed, neck pain, tachycardia, burning in throat, and throat swelling. This event(s) is considered related. The event(s) 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(s).
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Apnoea, Cold sweat, Dizziness, Rash, Seizure
Clinical narrative: SHORTNESS OF BREATH; LIGHT HEADED; NECK PAIN; TACHYCARDIA; BURNING IN THROAT; THROAT SWELLING; NAUSEA; This spontaneous report received from a health care professional concerned a 33 year old female. The patient's height, and weight were not reported. The patient's past medical history included tubes tied, and ablation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: 21-JUN-2021) dose was not reported,1 total administered on 07-APR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021,15 to 20 minutes after getting vaccinated the patient experienced shortness of breath, nausea, light headed, and neck pain and there was a burning inside the throat and swelling started as well. The patient also reported tachycardia at 119. Laboratory data included: Blood pressure (NR: not provided) 98/60, Heart rate (NR: not provided) 119, and Pulse oximetry (NR: not provided) 99. Treatment medications (dates unspecified) included: glucose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shortness of breath, nausea, light headed, neck pain, tachycardia, burning in throat, and throat swelling. This report was serious (Life Threatening). This case, from the same reporter is linked to 20210414577.; Sender's Comments: V0: 20210414557-covid-19 vaccine ad26.cov2.s-shortness of breath, light headed, neck pain, tachycardia, burning in throat, and throat swelling. This event(s) is considered related. The event(s) 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(s).
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Speech disorder
Clinical narrative: SHORTNESS OF BREATH; LIGHT HEADED; NECK PAIN; TACHYCARDIA; BURNING IN THROAT; THROAT SWELLING; NAUSEA; This spontaneous report received from a health care professional concerned a 33 year old female. The patient's height, and weight were not reported. The patient's past medical history included tubes tied, and ablation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: 21-JUN-2021) dose was not reported,1 total administered on 07-APR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021,15 to 20 minutes after getting vaccinated the patient experienced shortness of breath, nausea, light headed, and neck pain and there was a burning inside the throat and swelling started as well. The patient also reported tachycardia at 119. Laboratory data included: Blood pressure (NR: not provided) 98/60, Heart rate (NR: not provided) 119, and Pulse oximetry (NR: not provided) 99. Treatment medications (dates unspecified) included: glucose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shortness of breath, nausea, light headed, neck pain, tachycardia, burning in throat, and throat swelling. This report was serious (Life Threatening). This case, from the same reporter is linked to 20210414577.; Sender's Comments: V0: 20210414557-covid-19 vaccine ad26.cov2.s-shortness of breath, light headed, neck pain, tachycardia, burning in throat, and throat swelling. This event(s) is considered related. The event(s) 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(s).
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cyanosis, Dizziness, Respiratory arrest, Seizure, Syncope
Clinical narrative: SHORTNESS OF BREATH; LIGHT HEADED; NECK PAIN; TACHYCARDIA; BURNING IN THROAT; THROAT SWELLING; NAUSEA; This spontaneous report received from a health care professional concerned a 33 year old female. The patient's height, and weight were not reported. The patient's past medical history included tubes tied, and ablation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: 21-JUN-2021) dose was not reported,1 total administered on 07-APR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021,15 to 20 minutes after getting vaccinated the patient experienced shortness of breath, nausea, light headed, and neck pain and there was a burning inside the throat and swelling started as well. The patient also reported tachycardia at 119. Laboratory data included: Blood pressure (NR: not provided) 98/60, Heart rate (NR: not provided) 119, and Pulse oximetry (NR: not provided) 99. Treatment medications (dates unspecified) included: glucose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shortness of breath, nausea, light headed, neck pain, tachycardia, burning in throat, and throat swelling. This report was serious (Life Threatening). This case, from the same reporter is linked to 20210414577.; Sender's Comments: V0: 20210414557-covid-19 vaccine ad26.cov2.s-shortness of breath, light headed, neck pain, tachycardia, burning in throat, and throat swelling. This event(s) is considered related. The event(s) 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(s).
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Dizziness, Pain
Clinical narrative: SHORTNESS OF BREATH; LIGHT HEADED; NECK PAIN; TACHYCARDIA; BURNING IN THROAT; THROAT SWELLING; NAUSEA; This spontaneous report received from a health care professional concerned a 33 year old female. The patient's height, and weight were not reported. The patient's past medical history included tubes tied, and ablation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: 21-JUN-2021) dose was not reported,1 total administered on 07-APR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021,15 to 20 minutes after getting vaccinated the patient experienced shortness of breath, nausea, light headed, and neck pain and there was a burning inside the throat and swelling started as well. The patient also reported tachycardia at 119. Laboratory data included: Blood pressure (NR: not provided) 98/60, Heart rate (NR: not provided) 119, and Pulse oximetry (NR: not provided) 99. Treatment medications (dates unspecified) included: glucose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shortness of breath, nausea, light headed, neck pain, tachycardia, burning in throat, and throat swelling. This report was serious (Life Threatening). This case, from the same reporter is linked to 20210414577.; Sender's Comments: V0: 20210414557-covid-19 vaccine ad26.cov2.s-shortness of breath, light headed, neck pain, tachycardia, burning in throat, and throat swelling. This event(s) is considered related. The event(s) 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(s).
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood pressure measurement, Dizziness, Dyspnoea, Heart rate, Nausea
Clinical narrative: DIFFICULTY IN SPEAKING; RASH; STOPPED BREATHING; SEIZURES; DIZZINESS; CLAMMY; This spontaneous report received from a health care professional concerned a patient of unspecified age, sex, ethnic origin, and race. 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: 043A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 07-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the patient experienced dizziness, clammy, seizures, stopped breathing, and rash.  On an unspecified date, the patient experienced difficulty in speaking. The patient was seen by EMS and was taken to the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash, dizziness, clammy, seizures, and stopped breathing, and the outcome of difficulty in speaking was not reported. This report was serious (Life Threatening). This case, from the same reporter is linked to 20210414577.; Sender's Comments: v0 This report involves a patient of unspecified age, sex who experienced rash after 5 minutes after receiving Janssen COVID-19 Vaccine Ad26.COV2.S for prophylactic vaccination then the patient developed light headed associated with dizziness and later had difficult in speaking. Events also reported included clammy, seizures, "stopped breathing", however details of these events were not provided. Medical history and concomitant medications were not reported. Given the close temporal relationship and the nature of the events, the events of lightheaded associated with dizziness and later had difficult in speaking are considered possibly related to the vaccination. The insufficient information precludes a meaningful medical assessment of the events of clammy, seizures, stopped breathing.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Neck pain, Oxygen saturation, Pharyngeal swelling, Tachycardia, Throat irritation
Clinical narrative: DIFFICULTY IN SPEAKING; RASH; STOPPED BREATHING; SEIZURES; DIZZINESS; CLAMMY; This spontaneous report received from a health care professional concerned a patient of unspecified age, sex, ethnic origin, and race. 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: 043A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 07-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the patient experienced dizziness, clammy, seizures, stopped breathing, and rash.  On an unspecified date, the patient experienced difficulty in speaking. The patient was seen by EMS and was taken to the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash, dizziness, clammy, seizures, and stopped breathing, and the outcome of difficulty in speaking was not reported. This report was serious (Life Threatening). This case, from the same reporter is linked to 20210414577.; Sender's Comments: v0 This report involves a patient of unspecified age, sex who experienced rash after 5 minutes after receiving Janssen COVID-19 Vaccine Ad26.COV2.S for prophylactic vaccination then the patient developed light headed associated with dizziness and later had difficult in speaking. Events also reported included clammy, seizures, "stopped breathing", however details of these events were not provided. Medical history and concomitant medications were not reported. Given the close temporal relationship and the nature of the events, the events of lightheaded associated with dizziness and later had difficult in speaking are considered possibly related to the vaccination. The insufficient information precludes a meaningful medical assessment of the events of clammy, seizures, stopped breathing.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Apnoea, Cold sweat, Dizziness, Rash, Seizure
Clinical narrative: DIFFICULTY IN SPEAKING; RASH; STOPPED BREATHING; SEIZURES; DIZZINESS; CLAMMY; This spontaneous report received from a health care professional concerned a patient of unspecified age, sex, ethnic origin, and race. 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: 043A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 07-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the patient experienced dizziness, clammy, seizures, stopped breathing, and rash.  On an unspecified date, the patient experienced difficulty in speaking. The patient was seen by EMS and was taken to the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash, dizziness, clammy, seizures, and stopped breathing, and the outcome of difficulty in speaking was not reported. This report was serious (Life Threatening). This case, from the same reporter is linked to 20210414577.; Sender's Comments: v0 This report involves a patient of unspecified age, sex who experienced rash after 5 minutes after receiving Janssen COVID-19 Vaccine Ad26.COV2.S for prophylactic vaccination then the patient developed light headed associated with dizziness and later had difficult in speaking. Events also reported included clammy, seizures, "stopped breathing", however details of these events were not provided. Medical history and concomitant medications were not reported. Given the close temporal relationship and the nature of the events, the events of lightheaded associated with dizziness and later had difficult in speaking are considered possibly related to the vaccination. The insufficient information precludes a meaningful medical assessment of the events of clammy, seizures, stopped breathing.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Speech disorder
Clinical narrative: DIFFICULTY IN SPEAKING; RASH; STOPPED BREATHING; SEIZURES; DIZZINESS; CLAMMY; This spontaneous report received from a health care professional concerned a patient of unspecified age, sex, ethnic origin, and race. 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: 043A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 07-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the patient experienced dizziness, clammy, seizures, stopped breathing, and rash.  On an unspecified date, the patient experienced difficulty in speaking. The patient was seen by EMS and was taken to the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash, dizziness, clammy, seizures, and stopped breathing, and the outcome of difficulty in speaking was not reported. This report was serious (Life Threatening). This case, from the same reporter is linked to 20210414577.; Sender's Comments: v0 This report involves a patient of unspecified age, sex who experienced rash after 5 minutes after receiving Janssen COVID-19 Vaccine Ad26.COV2.S for prophylactic vaccination then the patient developed light headed associated with dizziness and later had difficult in speaking. Events also reported included clammy, seizures, "stopped breathing", however details of these events were not provided. Medical history and concomitant medications were not reported. Given the close temporal relationship and the nature of the events, the events of lightheaded associated with dizziness and later had difficult in speaking are considered possibly related to the vaccination. The insufficient information precludes a meaningful medical assessment of the events of clammy, seizures, stopped breathing.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cyanosis, Dizziness, Respiratory arrest, Seizure, Syncope
Clinical narrative: DIFFICULTY IN SPEAKING; RASH; STOPPED BREATHING; SEIZURES; DIZZINESS; CLAMMY; This spontaneous report received from a health care professional concerned a patient of unspecified age, sex, ethnic origin, and race. 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: 043A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 07-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the patient experienced dizziness, clammy, seizures, stopped breathing, and rash.  On an unspecified date, the patient experienced difficulty in speaking. The patient was seen by EMS and was taken to the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash, dizziness, clammy, seizures, and stopped breathing, and the outcome of difficulty in speaking was not reported. This report was serious (Life Threatening). This case, from the same reporter is linked to 20210414577.; Sender's Comments: v0 This report involves a patient of unspecified age, sex who experienced rash after 5 minutes after receiving Janssen COVID-19 Vaccine Ad26.COV2.S for prophylactic vaccination then the patient developed light headed associated with dizziness and later had difficult in speaking. Events also reported included clammy, seizures, "stopped breathing", however details of these events were not provided. Medical history and concomitant medications were not reported. Given the close temporal relationship and the nature of the events, the events of lightheaded associated with dizziness and later had difficult in speaking are considered possibly related to the vaccination. The insufficient information precludes a meaningful medical assessment of the events of clammy, seizures, stopped breathing.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Dizziness, Pain
Clinical narrative: DIFFICULTY IN SPEAKING; RASH; STOPPED BREATHING; SEIZURES; DIZZINESS; CLAMMY; This spontaneous report received from a health care professional concerned a patient of unspecified age, sex, ethnic origin, and race. 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: 043A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 07-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the patient experienced dizziness, clammy, seizures, stopped breathing, and rash.  On an unspecified date, the patient experienced difficulty in speaking. The patient was seen by EMS and was taken to the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash, dizziness, clammy, seizures, and stopped breathing, and the outcome of difficulty in speaking was not reported. This report was serious (Life Threatening). This case, from the same reporter is linked to 20210414577.; Sender's Comments: v0 This report involves a patient of unspecified age, sex who experienced rash after 5 minutes after receiving Janssen COVID-19 Vaccine Ad26.COV2.S for prophylactic vaccination then the patient developed light headed associated with dizziness and later had difficult in speaking. Events also reported included clammy, seizures, "stopped breathing", however details of these events were not provided. Medical history and concomitant medications were not reported. Given the close temporal relationship and the nature of the events, the events of lightheaded associated with dizziness and later had difficult in speaking are considered possibly related to the vaccination. The insufficient information precludes a meaningful medical assessment of the events of clammy, seizures, stopped breathing.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Dyspnoea, Eye pain, Headache
Clinical narrative: DIFFICULTY BREATHING; SWOLLEN NOSE(STUFFY NOSE); THROWING UP/VOMITING; PAIN IN SIDE OF NECK; PAIN IN EYE SOCKET; DIARRHEA; TREMOR; WEAKNESS; BIG HEADACHE; This spontaneous report received from a pharmacist concerned a female patient of unspecified age. The patient's height, and weight were not reported.  The patient was not pregnant at the time of reporting and had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, expiry: 21-JUN-2021) 0.5 ml, 1 total administered on 05-APR-2021 18:00 to left arm for prophylactic vaccination. Concomitant medications included ascorbic acid, cyanocobalamin, and vitamin b complex. On 06-APR-2021, next morning after vaccination the patient woke up with a big headache, her nose was swollen and stuffy and she had difficulty breathing. On 06-APR-2021 16:00, she threw up/vomited. The patient had difficulty breathing and went to chiropractor who adjusted her pressure points. She still had stuffy nose and headache at the time of this report and difficulty breathing was somewhat better but not completely gone. The patient's nose was blocked and had pain in the left side of neck and eye socket. She also had weakness, diarrhea and tremor after getting the vaccine shot. The nurse came to her house and gave her a bag saline, magnesium and ketorolac each. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from difficulty breathing, and swollen nose, had not recovered from big headache, and the outcome of vomiting/throwing up, pain in side of neck, pain in eye socket, weakness, diarrhea and tremor was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210414709-covid-19 vaccine ad26.cov2.s-difficulty breathing. 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: Nasal oedema, Neck pain, Tremor, Vomiting
Clinical narrative: DIFFICULTY BREATHING; SWOLLEN NOSE(STUFFY NOSE); THROWING UP/VOMITING; PAIN IN SIDE OF NECK; PAIN IN EYE SOCKET; DIARRHEA; TREMOR; WEAKNESS; BIG HEADACHE; This spontaneous report received from a pharmacist concerned a female patient of unspecified age. The patient's height, and weight were not reported.  The patient was not pregnant at the time of reporting and had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, expiry: 21-JUN-2021) 0.5 ml, 1 total administered on 05-APR-2021 18:00 to left arm for prophylactic vaccination. Concomitant medications included ascorbic acid, cyanocobalamin, and vitamin b complex. On 06-APR-2021, next morning after vaccination the patient woke up with a big headache, her nose was swollen and stuffy and she had difficulty breathing. On 06-APR-2021 16:00, she threw up/vomited. The patient had difficulty breathing and went to chiropractor who adjusted her pressure points. She still had stuffy nose and headache at the time of this report and difficulty breathing was somewhat better but not completely gone. The patient's nose was blocked and had pain in the left side of neck and eye socket. She also had weakness, diarrhea and tremor after getting the vaccine shot. The nurse came to her house and gave her a bag saline, magnesium and ketorolac each. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from difficulty breathing, and swollen nose, had not recovered from big headache, and the outcome of vomiting/throwing up, pain in side of neck, pain in eye socket, weakness, diarrhea and tremor was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210414709-covid-19 vaccine ad26.cov2.s-difficulty breathing. 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: Chills, Dehydration, Dizziness, Fatigue, Headache
Clinical narrative: DEHYDRATION; FEEL NAUSEOUS; VERY LOW ENERGY AND CANT STAND FOR LONG; STRUGGLING TO SLEEP; RESTLESS NIGHT WITH TOSSING AND TURNING; CHILLS; FEVER; FEELING SHAKY; BODY ACHE / PAIN; LIGHT HEADED; LIGHT AND SOUND SENSITIVITY/HEADACHE; ARM STIFFNESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included strong reaction to vaccine. 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 05-APR-2021 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 05-APR-2021, the subject experienced arm stiffness. On 05-APR-2021 19:00, the subject experienced body ache / pain. On 05-APR-2021 19:00, the subject experienced light headed. On 05-APR-2021 19:00, the subject experienced light and sound sensitivity/headache. On 05-APR-2021 20:40, the subject experienced feeling shaky. On 05-APR-2021 20:40, the subject experienced fever. On 05-APR-2021 23:00, the subject experienced chills. On 06-APR-2021, the subject experienced restless night with tossing and turning. On 06-APR-2021 00:40, the subject experienced struggling to sleep. On 06-APR-2021 09:30, the subject experienced very low energy and cant stand for long. On 06-APR-2021 13:00, the subject experienced feel nauseous. On 06-APR-2021 17:40, the subject experienced dehydration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, was recovering from light and sound sensitivity/headache, and dehydration, had not recovered from arm stiffness, and feel nauseous, and the outcome of body ache / pain, feeling shaky, light headed, chills, struggling to sleep, restless night with tossing and turning and very low energy and cant stand for long was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Musculoskeletal stiffness, Nausea, Nervousness, Pain
Clinical narrative: DEHYDRATION; FEEL NAUSEOUS; VERY LOW ENERGY AND CANT STAND FOR LONG; STRUGGLING TO SLEEP; RESTLESS NIGHT WITH TOSSING AND TURNING; CHILLS; FEVER; FEELING SHAKY; BODY ACHE / PAIN; LIGHT HEADED; LIGHT AND SOUND SENSITIVITY/HEADACHE; ARM STIFFNESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included strong reaction to vaccine. 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 05-APR-2021 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 05-APR-2021, the subject experienced arm stiffness. On 05-APR-2021 19:00, the subject experienced body ache / pain. On 05-APR-2021 19:00, the subject experienced light headed. On 05-APR-2021 19:00, the subject experienced light and sound sensitivity/headache. On 05-APR-2021 20:40, the subject experienced feeling shaky. On 05-APR-2021 20:40, the subject experienced fever. On 05-APR-2021 23:00, the subject experienced chills. On 06-APR-2021, the subject experienced restless night with tossing and turning. On 06-APR-2021 00:40, the subject experienced struggling to sleep. On 06-APR-2021 09:30, the subject experienced very low energy and cant stand for long. On 06-APR-2021 13:00, the subject experienced feel nauseous. On 06-APR-2021 17:40, the subject experienced dehydration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, was recovering from light and sound sensitivity/headache, and dehydration, had not recovered from arm stiffness, and feel nauseous, and the outcome of body ache / pain, feeling shaky, light headed, chills, struggling to sleep, restless night with tossing and turning and very low energy and cant stand for long was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality sleep, Pyrexia
Clinical narrative: DEHYDRATION; FEEL NAUSEOUS; VERY LOW ENERGY AND CANT STAND FOR LONG; STRUGGLING TO SLEEP; RESTLESS NIGHT WITH TOSSING AND TURNING; CHILLS; FEVER; FEELING SHAKY; BODY ACHE / PAIN; LIGHT HEADED; LIGHT AND SOUND SENSITIVITY/HEADACHE; ARM STIFFNESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included strong reaction to vaccine. 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 05-APR-2021 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 05-APR-2021, the subject experienced arm stiffness. On 05-APR-2021 19:00, the subject experienced body ache / pain. On 05-APR-2021 19:00, the subject experienced light headed. On 05-APR-2021 19:00, the subject experienced light and sound sensitivity/headache. On 05-APR-2021 20:40, the subject experienced feeling shaky. On 05-APR-2021 20:40, the subject experienced fever. On 05-APR-2021 23:00, the subject experienced chills. On 06-APR-2021, the subject experienced restless night with tossing and turning. On 06-APR-2021 00:40, the subject experienced struggling to sleep. On 06-APR-2021 09:30, the subject experienced very low energy and cant stand for long. On 06-APR-2021 13:00, the subject experienced feel nauseous. On 06-APR-2021 17:40, the subject experienced dehydration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, was recovering from light and sound sensitivity/headache, and dehydration, had not recovered from arm stiffness, and feel nauseous, and the outcome of body ache / pain, feeling shaky, light headed, chills, struggling to sleep, restless night with tossing and turning and very low energy and cant stand for long was not reported. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Injection site pain, Urticaria
Clinical narrative: SWOLLEN EYES; HIVES; BURNING SENSATION IN THE ARM; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, cat allergy, and bee sting allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced burning sensation in the arm. On 06-APR-2021, the subject experienced swollen eyes. On 06-APR-2021, the subject experienced hives.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from hives, swollen eyes, and burning sensation in the arm. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain
Clinical narrative: BODY ACHE; DIZZINESS; HEADACHE; This spontaneous report received from a consumer concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal pollen allergy, non alcoholic, and non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 19:30 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced body ache. On 07-APR-2021, the subject experienced dizziness. On 07-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, body ache, and dizziness. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Diarrhoea, Diverticulitis, Influenza like illness, Pollakiuria, Poor quality sleep
Clinical narrative: DIVERTICULITIS ATTACKS; FLU- LIKE SYMPTOMS; FREQUENT URINATION; NOT SLEEPING WELL; DIARRHEA; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 95.5 kilograms, and height was not reported. The patient's concurrent conditions included primary pulmonary hypertension.  The patient received Selexipag (form of admin and route of admin were not reported, batch number: UNKNOWN expiry: UNKNOWN) dose, frequency, and therapy dates were not reported for drug used for unknown indication; and Macitentan (tablet, route of admin not reported, batch number: ZE019B0101 expiry: 31-JUL-2024) 10 mg, 1 time every 1 day, therapy dates were not reported for primary pulmonary hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in 2021, the patient had diarrhea, flu- like symptoms, body aches, nausea, fatigue, short of breath frequent urination and was not sleeping well. She was unsure if this was due to the vaccine or a combination of the Uptravi and the vaccine. The patient also had short of breath when she took her garbage out and that she had occasional diverticulitis attacks.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the diverticulitis attacks, diarrhea, flu- like symptoms, frequent urination and not sleeping well was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210414881-Covid-19 vaccine ad26.cov2.s-Diverticulitis . This event is considered unassessable. The event 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. V0:20210414881-UPTRAVI-Diverticulitis. This event is considered unassessable. The event 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. V0:20210414881-OPSUMIT-Diverticulitis. 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: Diarrhoea, Fatigue
Clinical narrative: DIARRHEA; FATIGUE; 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, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced fatigue. On 07-APR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the diarrhea and fatigue was not reported. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Autopsy, Deep vein thrombosis, Pulmonary embolism
Clinical narrative: Individual received the first dose of Moderna, Lot # 030A021A on 3/4/2021 and the second dose on 4/1/2021 at hospital. Health department was called by Dr., the county coroner that this individual died of a pulmonary embolism due to a right left deep vein thrombosis on 4/14/21. Coroner reported the individual had not been feeling well and had no history of clotting issues.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Deep vein thrombosis, Malaise, Pulmonary embolism
Clinical narrative: Individual received the first dose of Moderna, Lot # 030A021A on 3/4/2021 and the second dose on 4/1/2021 at hospital. Health department was called by Dr., the county coroner that this individual died of a pulmonary embolism due to a right left deep vein thrombosis on 4/14/21. Coroner reported the individual had not been feeling well and had no history of clotting issues.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pyrexia
Clinical narrative: BACK PAIN; FEVER; This spontaneous report received from a patient concerned a 41 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 not reported, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced back pain. On 06-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and back pain was not reported. This report was non-serious.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Eye disorder, Fatigue, Hot flush, Hypotension
Clinical narrative: SLOWING DOWN; ARM WEAKNESS; FEVER; FATIGUE; ARM TINGLING; PALE HANDS; HOT FLASHES; DROOPY EYES; LOW BLOOD PRESSURE; This spontaneous report received from a patient concerned a 34 year old male. 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 07-APR-2021 13:30 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced arm tingling. On 07-APR-2021, the subject experienced pale hands. On 07-APR-2021, the subject experienced hot flashes. On 07-APR-2021, the subject experienced droopy eyes. On 07-APR-2021, the subject experienced low blood pressure. On 07-APR-2021, the subject experienced arm weakness. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced fatigue. On 07-APR-2021 20:30, the subject experienced slowing down. Laboratory data included: Body temperature (NR: not provided) 103.9 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm tingling on 07-APR-2021 19:30, and arm weakness, had not recovered from fever, fatigue, hot flashes, and droopy eyes, and the outcome of pale hands, low blood pressure and slowing down was not reported. This report was non-serious.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Pallor, Paraesthesia, Pyrexia, Sluggishness
Clinical narrative: SLOWING DOWN; ARM WEAKNESS; FEVER; FATIGUE; ARM TINGLING; PALE HANDS; HOT FLASHES; DROOPY EYES; LOW BLOOD PRESSURE; This spontaneous report received from a patient concerned a 34 year old male. 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 07-APR-2021 13:30 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced arm tingling. On 07-APR-2021, the subject experienced pale hands. On 07-APR-2021, the subject experienced hot flashes. On 07-APR-2021, the subject experienced droopy eyes. On 07-APR-2021, the subject experienced low blood pressure. On 07-APR-2021, the subject experienced arm weakness. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced fatigue. On 07-APR-2021 20:30, the subject experienced slowing down. Laboratory data included: Body temperature (NR: not provided) 103.9 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm tingling on 07-APR-2021 19:30, and arm weakness, had not recovered from fever, fatigue, hot flashes, and droopy eyes, and the outcome of pale hands, low blood pressure and slowing down was not reported. This report was non-serious.
Age: 74.0
Sex: M
Vaccine: UNK, COVID19, COVID19
Symptoms: Cardiac arrest, Death
Clinical narrative: 3/18/21  Patient is a 74-year-old man with a history of coronary artery disease who presents via ground EMS as a trauma 1.  Per reports, the patient was shopping when he suddenly lost consciousness resulting in him falling forward and striking his forehead.  En route, the patient's blood systolic blood pressure dropped to the 90's and he became more confused.  Primary survey was notable for an intact airway, bilateral breath sounds, weak femoral pulses, GCS 15.  Secondary survey is notable for abrasions of the forehead and cool/clammy extremities.  The patient's initial heart rate was in the 70s and systolic blood pressure in the 60s.  A chest x-ray was performed showing no significant abnormalities. FAST exam showed no free fluid in the abdomen, no pericardial tamponade, but severely/globally depressed cardiac function without discrete wall motion abnormalities.  Shortly after arrival patient lost pulses and was found to be in PEA arrest.  ACLS was initiated and CPR performed for approximately 16 minutes.  The patient was administered multiple doses of epinephrine, amiodarone, bicarb, and calcium.  A Cordis catheter was inserted into the right femoral vein and an arterial line into the left femoral artery.  Repeat evaluation revealed ventricular fibrillation for which multiple shocks were administered.  Return of spontaneous circulation was obtained but lost minutes later.  Ultimately, the patient was pronounced dead.
Age: 74.0
Sex: M
Vaccine: UNK, COVID19, COVID19
Symptoms: Blood pressure decreased, Breath sounds, Catheter placement, Chest X-ray normal, Cold sweat
Clinical narrative: 3/18/21  Patient is a 74-year-old man with a history of coronary artery disease who presents via ground EMS as a trauma 1.  Per reports, the patient was shopping when he suddenly lost consciousness resulting in him falling forward and striking his forehead.  En route, the patient's blood systolic blood pressure dropped to the 90's and he became more confused.  Primary survey was notable for an intact airway, bilateral breath sounds, weak femoral pulses, GCS 15.  Secondary survey is notable for abrasions of the forehead and cool/clammy extremities.  The patient's initial heart rate was in the 70s and systolic blood pressure in the 60s.  A chest x-ray was performed showing no significant abnormalities. FAST exam showed no free fluid in the abdomen, no pericardial tamponade, but severely/globally depressed cardiac function without discrete wall motion abnormalities.  Shortly after arrival patient lost pulses and was found to be in PEA arrest.  ACLS was initiated and CPR performed for approximately 16 minutes.  The patient was administered multiple doses of epinephrine, amiodarone, bicarb, and calcium.  A Cordis catheter was inserted into the right femoral vein and an arterial line into the left femoral artery.  Repeat evaluation revealed ventricular fibrillation for which multiple shocks were administered.  Return of spontaneous circulation was obtained but lost minutes later.  Ultimately, the patient was pronounced dead.