chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Body temperature increased, Chills, Headache
Clinical narrative: This spontaneous report received from a patient concerned a 38 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number:  1805018, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 10:00. No concomitant medications were reported. On 09-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 106 F. The patient stated that Immediately after injection, she experienced slight pain/burning at injection site, dizziness followed. The patient reported that at 6:00 pm, she was feeling weak, lethargic, fever, severe chills, body aches, headache and joint pain. The patient stated that her fever rose to 106 degrees fahrenheit by 9:00 pm and she couldn't move; at this point, she decided to take a single dose of Ibuprofen and on the morning of 3/10/2021, at about 8:30 am she took another single dose of Ibuprofen to keep her fever down and that helped with her body pain. The patient also stated that she stayed in bed most of the day and had general weakness and dizziness that lasted all day. On the morning of 3/11/2021, the patient reported that her fever was gone but muscle aches and body aches persist. Pain at injection site and headache persist. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high fever, had not recovered from pain at injection site, body aches, headache, and muscle aches, and the outcome of dizziness, feeling weak, severe chills and joint pain was not reported. This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 11-MAR-2021. Upon review following information was amended: The event high grade fever was recoded with pyrexia. Labeling of feeling weak was corrected to labeled  .  Labeling of pyrexia was corrected to labeled.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pain
Clinical narrative: This spontaneous report received from a patient concerned a 38 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number:  1805018, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 10:00. No concomitant medications were reported. On 09-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 106 F. The patient stated that Immediately after injection, she experienced slight pain/burning at injection site, dizziness followed. The patient reported that at 6:00 pm, she was feeling weak, lethargic, fever, severe chills, body aches, headache and joint pain. The patient stated that her fever rose to 106 degrees fahrenheit by 9:00 pm and she couldn't move; at this point, she decided to take a single dose of Ibuprofen and on the morning of 3/10/2021, at about 8:30 am she took another single dose of Ibuprofen to keep her fever down and that helped with her body pain. The patient also stated that she stayed in bed most of the day and had general weakness and dizziness that lasted all day. On the morning of 3/11/2021, the patient reported that her fever was gone but muscle aches and body aches persist. Pain at injection site and headache persist. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high fever, had not recovered from pain at injection site, body aches, headache, and muscle aches, and the outcome of dizziness, feeling weak, severe chills and joint pain was not reported. This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 11-MAR-2021. Upon review following information was amended: The event high grade fever was recoded with pyrexia. Labeling of feeling weak was corrected to labeled  .  Labeling of pyrexia was corrected to labeled.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: This spontaneous report received from a patient concerned a 38 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number:  1805018, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 10:00. No concomitant medications were reported. On 09-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 106 F. The patient stated that Immediately after injection, she experienced slight pain/burning at injection site, dizziness followed. The patient reported that at 6:00 pm, she was feeling weak, lethargic, fever, severe chills, body aches, headache and joint pain. The patient stated that her fever rose to 106 degrees fahrenheit by 9:00 pm and she couldn't move; at this point, she decided to take a single dose of Ibuprofen and on the morning of 3/10/2021, at about 8:30 am she took another single dose of Ibuprofen to keep her fever down and that helped with her body pain. The patient also stated that she stayed in bed most of the day and had general weakness and dizziness that lasted all day. On the morning of 3/11/2021, the patient reported that her fever was gone but muscle aches and body aches persist. Pain at injection site and headache persist. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high fever, had not recovered from pain at injection site, body aches, headache, and muscle aches, and the outcome of dizziness, feeling weak, severe chills and joint pain was not reported. This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 11-MAR-2021. Upon review following information was amended: The event high grade fever was recoded with pyrexia. Labeling of feeling weak was corrected to labeled  .  Labeling of pyrexia was corrected to labeled.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest, Death
Clinical narrative: ASYSTOLE (Asystole, Cardiac arrest) PASSED AWAY (Death, Death) This spontaneous report received from a physician concerned their mother-in-law, 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).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest, Death, Pyelonephritis, SARS-CoV-2 test negative, Unresponsive to stimuli
Clinical narrative: ASYSTOLE (Asystole, Cardiac arrest) PASSED AWAY (Death, Death) This spontaneous report received from a physician concerned their mother-in-law, 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).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pyrexia, Stomatitis
Clinical narrative: SORES IN MOUTH (Sores mouth, Stomatitis) FATIGUE (Fatigue, Fatigue) Fever (Fever, Pyrexia) 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.covd2.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 sore 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 sore in mouth, and the outcome of fever was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s and fatigue, sore in mouth and fever as possible. This report was serious (Hospitalization / Caused / Prolonged).
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Feeling abnormal, Hypotension, Syncope
Clinical narrative: FAINTED (Faint, Syncope) LOW BLOOD PRESSURE (Low blood pressure, Hypotension) FEELING FUNNY (Feeling abnormal, Feeling abnormal) This spontaneous report received from a patient concerned a 51 year old female. The patient's weight was 72.7 kilograms, and height was not reported. The patient's concurrent conditions included primary pulmonary                                                        Cont...
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Hypotension, Syncope
Clinical narrative: FAINTED (Faint, Syncope) LOW BLOOD PRESSURE (Low blood pressure, Hypotension) FEELING FUNNY (Feeling abnormal, Feeling abnormal) This spontaneous report received from a patient concerned a 51 year old female. The patient's weight was 72.7 kilograms, and height was not reported. The patient's concurrent conditions included primary pulmonary                                                        Cont...
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Amylase normal, Chills, Dizziness, Headache
Clinical narrative: After administration of vaccine patient developed lightheaded, nausea and loss of consciousness for less than a minute; associated to self-limited hypotension. Patient with spontaneous recovery, was alert and oriented with normal blood pressure although in the normal lower limit. Since patient continued to complain of dizziness and headache, patient was recommended ER evaluation but patient refused several times.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immediate post-injection reaction, Myalgia, Nausea, Pyrexia, SARS-CoV-2 antibody test negative
Clinical narrative: After administration of vaccine patient developed lightheaded, nausea and loss of consciousness for less than a minute; associated to self-limited hypotension. Patient with spontaneous recovery, was alert and oriented with normal blood pressure although in the normal lower limit. Since patient continued to complain of dizziness and headache, patient was recommended ER evaluation but patient refused several times.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope
Clinical narrative: After administration of vaccine patient developed lightheaded, nausea and loss of consciousness for less than a minute; associated to self-limited hypotension. Patient with spontaneous recovery, was alert and oriented with normal blood pressure although in the normal lower limit. Since patient continued to complain of dizziness and headache, patient was recommended ER evaluation but patient refused several times.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Headache, Hypotension, Loss of consciousness, Nausea
Clinical narrative: After administration of vaccine patient developed lightheaded, nausea and loss of consciousness for less than a minute; associated to self-limited hypotension. Patient with spontaneous recovery, was alert and oriented with normal blood pressure although in the normal lower limit. Since patient continued to complain of dizziness and headache, patient was recommended ER evaluation but patient refused several times.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Paraesthesia oral, Tongue disorder
Clinical narrative: I started to pass out and had tingling on the back of my tongue and the tips of my fingers.  My heart rate went over 120 and then my BP shot to 218/110.  I was taken to the ER and was given epinephrine and fluids in an IV.  It took a few hours for my BP to get to within normal range.  I had no  other effects after being dismissed from the ER other than fatigue and a rapid heart rate off and on for a few days.  My oxygen rate always stayed high throughout.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Paraesthesia oral
Clinical narrative: I started to pass out and had tingling on the back of my tongue and the tips of my fingers.  My heart rate went over 120 and then my BP shot to 218/110.  I was taken to the ER and was given epinephrine and fluids in an IV.  It took a few hours for my BP to get to within normal range.  I had no  other effects after being dismissed from the ER other than fatigue and a rapid heart rate off and on for a few days.  My oxygen rate always stayed high throughout.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fall, Loss of consciousness
Clinical narrative: This spontaneous report received from a health care professional 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, intramuscular, batch number: Unknown, and batch number:  1805031 expiry:  UNKNOWN)  0.5 ml, administered on 05-MAR-2021, the patient blacked out and fell down but came around quickly within 15 to 30 seconds and sat down on the chair.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the she blacked out and fell down but came around quickly within 15 to 30 seconds and sat down on the chair was not reported.  The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and blacked out and fell down as related. Company causality between covid-19 vaccine ad26.cov2.s,blacked out and fell down was possible. This report was serious (Other Medically Important Condition) .
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Body temperature, Chest pain, Erythema
Clinical narrative: BLOOD PRESSURE ABNORMAL (Blood pressure abnormal, Blood pressure abnormal) CHESt PAIN (BELOW the BREAST) AFTER AN HOUR OF VACCINATION (Chest pain, chest pain) AFTER AN HOUR OF VACCINATION REDNESS OF FACE AND CHEST (Redness, erythema) FEVER (Fever, Pyrexia) FATIGUED (Fatigue, Fatigue) 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 reproted. 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 09-MAR-2021 08:00:00 a.m. in left arm for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the patient experienced blood pressure abnormal, chest pain (below the breast , after an hour of vaccination redness of face and chest, had fever and was fatigued. Laboratory data included: Blood pressure (NR: not provided) 185/88 (units unspecified) , 177/80 (units unspecified) , and Body temperature (NR: not provided) 98.9. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 141/78 (units unspecified). Treatment medications (dates unspecified) included: ibuprofen. Nurse suggested to get Benadryl. Came home rested. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood pressure abnormal, chest pain, after an hour of vaccination redness of face and chest, and fever, and had not recovered from fatigued. This report was serious (Other Medically Important Condition).  Version created to amend previously reported information on 09-MAR-2021. Upon review, the following information was amended. Vaccination site: Site as "eft arm", Suggested treatment was incorporated in narrative and causality statement was removed from the narrative.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: BLOOD PRESSURE ABNORMAL (Blood pressure abnormal, Blood pressure abnormal) CHESt PAIN (BELOW the BREAST) AFTER AN HOUR OF VACCINATION (Chest pain, chest pain) AFTER AN HOUR OF VACCINATION REDNESS OF FACE AND CHEST (Redness, erythema) FEVER (Fever, Pyrexia) FATIGUED (Fatigue, Fatigue) 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 reproted. 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 09-MAR-2021 08:00:00 a.m. in left arm for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the patient experienced blood pressure abnormal, chest pain (below the breast , after an hour of vaccination redness of face and chest, had fever and was fatigued. Laboratory data included: Blood pressure (NR: not provided) 185/88 (units unspecified) , 177/80 (units unspecified) , and Body temperature (NR: not provided) 98.9. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 141/78 (units unspecified). Treatment medications (dates unspecified) included: ibuprofen. Nurse suggested to get Benadryl. Came home rested. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood pressure abnormal, chest pain, after an hour of vaccination redness of face and chest, and fever, and had not recovered from fatigued. This report was serious (Other Medically Important Condition).  Version created to amend previously reported information on 09-MAR-2021. Upon review, the following information was amended. Vaccination site: Site as "eft arm", Suggested treatment was incorporated in narrative and causality statement was removed from the narrative.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood pressure abnormal, Chest pain, Erythema, Fatigue, Pyrexia
Clinical narrative: BLOOD PRESSURE ABNORMAL (Blood pressure abnormal, Blood pressure abnormal) CHESt PAIN (BELOW the BREAST) AFTER AN HOUR OF VACCINATION (Chest pain, chest pain) AFTER AN HOUR OF VACCINATION REDNESS OF FACE AND CHEST (Redness, erythema) FEVER (Fever, Pyrexia) FATIGUED (Fatigue, Fatigue) 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 reproted. 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 09-MAR-2021 08:00:00 a.m. in left arm for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the patient experienced blood pressure abnormal, chest pain (below the breast , after an hour of vaccination redness of face and chest, had fever and was fatigued. Laboratory data included: Blood pressure (NR: not provided) 185/88 (units unspecified) , 177/80 (units unspecified) , and Body temperature (NR: not provided) 98.9. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 141/78 (units unspecified). Treatment medications (dates unspecified) included: ibuprofen. Nurse suggested to get Benadryl. Came home rested. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood pressure abnormal, chest pain, after an hour of vaccination redness of face and chest, and fever, and had not recovered from fatigued. This report was serious (Other Medically Important Condition).  Version created to amend previously reported information on 09-MAR-2021. Upon review, the following information was amended. Vaccination site: Site as "eft arm", Suggested treatment was incorporated in narrative and causality statement was removed from the narrative.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature decreased, Chills, Fatigue, Hypoaesthesia, Pain
Clinical narrative: BODY ACHE; LEFT ARM NUMBNESS IS ON AND OFF; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 33 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 administration not reported, batch number: 043A21A, expiry: unknown) dose was not reported, administered on 01-APR-2021 10:00 a.m. on left arm (left deltoid) for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, Laboratory data included: Body temperature (NR: not provided) 104.2 F.  On 01-APR-2021 14:00:00 p.m., the subject experienced body ache. On 01-APR-2021 14:00:00 p.m., the subject experienced left arm numbness is on and off. On 01-APR-2021 14:00:00 p.m., the subject experienced chills. On 01-APR-2021 14:00:00 p.m., the subject experienced fever. On 01-APR-2021 14:00:00 p.m., the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, chills, body ache, and left arm numbness is on and off. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: BODY ACHE; LEFT ARM NUMBNESS IS ON AND OFF; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 33 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 administration not reported, batch number: 043A21A, expiry: unknown) dose was not reported, administered on 01-APR-2021 10:00 a.m. on left arm (left deltoid) for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, Laboratory data included: Body temperature (NR: not provided) 104.2 F.  On 01-APR-2021 14:00:00 p.m., the subject experienced body ache. On 01-APR-2021 14:00:00 p.m., the subject experienced left arm numbness is on and off. On 01-APR-2021 14:00:00 p.m., the subject experienced chills. On 01-APR-2021 14:00:00 p.m., the subject experienced fever. On 01-APR-2021 14:00:00 p.m., the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, chills, body ache, and left arm numbness is on and off. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: BODY ACHE; LEFT ARM NUMBNESS IS ON AND OFF; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 33 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 administration not reported, batch number: 043A21A, expiry: unknown) dose was not reported, administered on 01-APR-2021 10:00 a.m. on left arm (left deltoid) for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, Laboratory data included: Body temperature (NR: not provided) 104.2 F.  On 01-APR-2021 14:00:00 p.m., the subject experienced body ache. On 01-APR-2021 14:00:00 p.m., the subject experienced left arm numbness is on and off. On 01-APR-2021 14:00:00 p.m., the subject experienced chills. On 01-APR-2021 14:00:00 p.m., the subject experienced fever. On 01-APR-2021 14:00:00 p.m., the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, chills, body ache, and left arm numbness is on and off. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Hypoaesthesia, Injection site pain, Neck pain
Clinical narrative: NECK PAIN; TINGLING IN LEFT FOREARM AND HAND; NUMBNESS IN LEFT FOREARM AND HAND; FOREARM PAIN; PINCH AT LEFT ELBOW; PINCH AT INJECTION SITE; This spontaneous report received from a consumer concerned a 54 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  On 24-MAR-2021, the subject experienced neck pain. On 24-MAR-2021, the subject experienced tingling in left forearm and hand. On 24-MAR-2021, the subject experienced numbness in left forearm and hand. On 24-MAR-2021, the subject experienced forearm pain. On 24-MAR-2021, the subject experienced pinch at left elbow. On 24-MAR-2021, the subject experienced pinch at injection site. On 30-MAR-2021, treatment medications included: diclofenac. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from forearm pain, pinch at injection site, tingling in left forearm and hand, numbness in left forearm and hand, neck pain, and pinch at left elbow. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: NECK PAIN; TINGLING IN LEFT FOREARM AND HAND; NUMBNESS IN LEFT FOREARM AND HAND; FOREARM PAIN; PINCH AT LEFT ELBOW; PINCH AT INJECTION SITE; This spontaneous report received from a consumer concerned a 54 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  On 24-MAR-2021, the subject experienced neck pain. On 24-MAR-2021, the subject experienced tingling in left forearm and hand. On 24-MAR-2021, the subject experienced numbness in left forearm and hand. On 24-MAR-2021, the subject experienced forearm pain. On 24-MAR-2021, the subject experienced pinch at left elbow. On 24-MAR-2021, the subject experienced pinch at injection site. On 30-MAR-2021, treatment medications included: diclofenac. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from forearm pain, pinch at injection site, tingling in left forearm and hand, numbness in left forearm and hand, neck pain, and pinch at left elbow. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Hypoaesthesia, Injection site pain, Neck pain, Pain in extremity
Clinical narrative: NECK PAIN; TINGLING IN LEFT FOREARM AND HAND; NUMBNESS IN LEFT FOREARM AND HAND; FOREARM PAIN; PINCH AT LEFT ELBOW; PINCH AT INJECTION SITE; This spontaneous report received from a consumer concerned a 54 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  On 24-MAR-2021, the subject experienced neck pain. On 24-MAR-2021, the subject experienced tingling in left forearm and hand. On 24-MAR-2021, the subject experienced numbness in left forearm and hand. On 24-MAR-2021, the subject experienced forearm pain. On 24-MAR-2021, the subject experienced pinch at left elbow. On 24-MAR-2021, the subject experienced pinch at injection site. On 30-MAR-2021, treatment medications included: diclofenac. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from forearm pain, pinch at injection site, tingling in left forearm and hand, numbness in left forearm and hand, neck pain, and pinch at left elbow. This report was non-serious.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: This spontaneous report received from a patient concerned a 40 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included pollen allergy, alcohol use (socially), no smoking, and no drug abuse or illicit drug usage.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022) dose was not reported, administered on 06-MAR-2021;11:00 am, into left arm, for prophylactic vaccination.  No concomitant medications were reported. On 06-MAR-2021, the patient experienced chest tightness and shortness or breath.  Patient complained of chest tightness which began approx.  2 min after injection.  Patient also stated that he had to breathe slowly and "not heavy", and felt short of breath. The dose of covid-19 vaccine ad26.cov2.s was not changed. The patient had not recovered from chest tightness, and shortness of breath. This report was serious (Other Medically Important Condition) .
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Respiratory rate decreased
Clinical narrative: This spontaneous report received from a patient concerned a 40 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included pollen allergy, alcohol use (socially), no smoking, and no drug abuse or illicit drug usage.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022) dose was not reported, administered on 06-MAR-2021;11:00 am, into left arm, for prophylactic vaccination.  No concomitant medications were reported. On 06-MAR-2021, the patient experienced chest tightness and shortness or breath.  Patient complained of chest tightness which began approx.  2 min after injection.  Patient also stated that he had to breathe slowly and "not heavy", and felt short of breath. The dose of covid-19 vaccine ad26.cov2.s was not changed. The patient had not recovered from chest tightness, and shortness of breath. This report was serious (Other Medically Important Condition) .
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Pyrexia, Tremor, Vomiting
Clinical narrative: This spontaneous report received from a health care professional  .  The patient's weight, height, and medical history were not reported. It was not asked if the patient had any allergies.  It was unknown if the patient consume alcohol, smoke and if there was any drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 05-MAR-2021; 04:45 pm, vaccination site not reported, for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On 06-MAR-2021, the patient experienced vomiting, severe shaking, high heart rate, and fever over 100.2. Patient was given injection around 4.45 pm on 05-MAR-2021 and adverse events of severe shaking, fever over 100.2, high heart rate and vomiting started about 45 minutes ago. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting, severe shaking, and fever over 100.2, and the outcome of high heart rate was not reported. This report was serious (Other Medically Important Condition).  Additional Information received on 10-MAR-2021: Non-significant information received (The reporter abruptly disconnected)
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Respiratory rate increased, SARS-CoV-2 test
Clinical narrative: This spontaneous report received from a patient concerned an 85 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number:  Unknown)  dose was not reported, administered on 05-MAR-2021;  08:40 am, into left arm, for covid-19 prevention. The batch number was not reported and has been requested.  No concomitant medications were reported.  On 05-MAR-2021, the patient experienced increased heart rate and breathing increase.  Patient had covid screening a couple of days ago and it was negative. Patient reported that she got the shot at about 20 minutes to 9 am today and was fine till after dinner around 1:30 and her heart rate increased by 10 beats per minute (bpm) and she had increased breathing. Patient wanted to know if that was a bad reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increased heart rate, and breathing increase on 05-MAR-2021. This report was serious (Other Medically Important Condition).
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Respiratory rate increased, SARS-CoV-2 test negative
Clinical narrative: This spontaneous report received from a patient concerned an 85 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number:  Unknown)  dose was not reported, administered on 05-MAR-2021;  08:40 am, into left arm, for covid-19 prevention. The batch number was not reported and has been requested.  No concomitant medications were reported.  On 05-MAR-2021, the patient experienced increased heart rate and breathing increase.  Patient had covid screening a couple of days ago and it was negative. Patient reported that she got the shot at about 20 minutes to 9 am today and was fine till after dinner around 1:30 and her heart rate increased by 10 beats per minute (bpm) and she had increased breathing. Patient wanted to know if that was a bad reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increased heart rate, and breathing increase on 05-MAR-2021. This report was serious (Other Medically Important Condition).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, Cont... administered on 06-MAR-2021, vaccination site was not reported, for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On 06-MAR-2021, the patient experienced fever. Patient reported that she received the covid vaccination last night around midnight. Next morning patient started to have a fever. Patient was referred to seek medical advice from health care practitioner as patient asked what she should take for fever, as health care practitioner know her medical history. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was serious (Other Medically Important Condition).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature fluctuation, Chills, Dizziness, Loss of consciousness, Sensitive skin
Clinical narrative: This spontaneous report received from a female of unspecified  age reporting on self via social media. 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: Unknown) dose not reported, administered on 10-MAR-2021. The batch number was not reported and has been requested. No concomitant were reported. On 11-MAR-2021, the subject experienced sensitive skin. On an unspecified date, the patient stated that the side effects for her were bad short lived, got light headed and passed out in her kitchen, if she felt light headed, sat or lay down so she could not fall, her body also had a hard time regulating its temperature. The patient was shivering uncontrollably for about an hour, and then overheated very quickly under all blankets. On 11-MAR-2021 the patient mentioned that her skin feel sensitive, otherwise she was fine. She got the shot yesterday. The action taken with covid-19 ad26.cov2.s was not applicable. The patient recovered from light headed, was recovering from shivering, and sensitive skin, the outcome of passed out and temperature regulation disorder was not reported. The reporter considered the causality between JNJ-78436735, and light headed, shivering, sensitive skin, passed out and temperature regulation disorder as related. Company causality between JNJ-78436735, and light headed, shivering, sensitive skin, passed out and temperature regulation disorder was possible This report was serious (Other Medically Important Condition).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Loss of consciousness, Sensitive skin, Temperature regulation disorder
Clinical narrative: This spontaneous report received from a female of unspecified  age reporting on self via social media. 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: Unknown) dose not reported, administered on 10-MAR-2021. The batch number was not reported and has been requested. No concomitant were reported. On 11-MAR-2021, the subject experienced sensitive skin. On an unspecified date, the patient stated that the side effects for her were bad short lived, got light headed and passed out in her kitchen, if she felt light headed, sat or lay down so she could not fall, her body also had a hard time regulating its temperature. The patient was shivering uncontrollably for about an hour, and then overheated very quickly under all blankets. On 11-MAR-2021 the patient mentioned that her skin feel sensitive, otherwise she was fine. She got the shot yesterday. The action taken with covid-19 ad26.cov2.s was not applicable. The patient recovered from light headed, was recovering from shivering, and sensitive skin, the outcome of passed out and temperature regulation disorder was not reported. The reporter considered the causality between JNJ-78436735, and light headed, shivering, sensitive skin, passed out and temperature regulation disorder as related. Company causality between JNJ-78436735, and light headed, shivering, sensitive skin, passed out and temperature regulation disorder was possible This report was serious (Other Medically Important Condition).
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Influenza like illness, Seizure
Clinical narrative: This spontaneous report received from a consumer concerned a 67 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAR-2021. Batch number was not reported has been requested No concomitant medications were reported. No concomitant medications were reported. On MAR-2021, On an unspecified date, the patient experienced seizure, shaking, chills, high temperature, feels hot, and stuffy nose. patient daughter report she was suffering from seizure symptoms include extremely stiff ,extreme dizziness, shaking, and eyes rolling in back of head, also reported her mother did not lost consciousness and has been coherent .Daughter stated symptoms seem almost like a stroke ,upon follow call she clarify about seizure which subsided. seizure occurred 3 times over past 5 days prior to call (first night of vaccine, next morning, and reporting day.) Daughter also reported mother had flu-like symptoms for the first 3 days after vaccine,  including chills, high temperature, feels hot, and stuffy nose, but these have resolved. Daughter reports mother has not had symptoms like these prior to vaccine. she also report pharmacist who gave vaccine is aware of symptoms. patient body temperature was high, patient not performed covid 19 test. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms ( chills, high temperature, feels hot ,stuffy nose.), and the outcome of seizure was not reported. This report was serious (Other Medically Important Condition).
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Feeling hot, Gaze palsy, Influenza like illness
Clinical narrative: This spontaneous report received from a consumer concerned a 67 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAR-2021. Batch number was not reported has been requested No concomitant medications were reported. No concomitant medications were reported. On MAR-2021, On an unspecified date, the patient experienced seizure, shaking, chills, high temperature, feels hot, and stuffy nose. patient daughter report she was suffering from seizure symptoms include extremely stiff ,extreme dizziness, shaking, and eyes rolling in back of head, also reported her mother did not lost consciousness and has been coherent .Daughter stated symptoms seem almost like a stroke ,upon follow call she clarify about seizure which subsided. seizure occurred 3 times over past 5 days prior to call (first night of vaccine, next morning, and reporting day.) Daughter also reported mother had flu-like symptoms for the first 3 days after vaccine,  including chills, high temperature, feels hot, and stuffy nose, but these have resolved. Daughter reports mother has not had symptoms like these prior to vaccine. she also report pharmacist who gave vaccine is aware of symptoms. patient body temperature was high, patient not performed covid 19 test. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms ( chills, high temperature, feels hot ,stuffy nose.), and the outcome of seizure was not reported. This report was serious (Other Medically Important Condition).
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal stiffness, Nasal congestion, Pyrexia, Seizure, Tremor
Clinical narrative: This spontaneous report received from a consumer concerned a 67 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAR-2021. Batch number was not reported has been requested No concomitant medications were reported. No concomitant medications were reported. On MAR-2021, On an unspecified date, the patient experienced seizure, shaking, chills, high temperature, feels hot, and stuffy nose. patient daughter report she was suffering from seizure symptoms include extremely stiff ,extreme dizziness, shaking, and eyes rolling in back of head, also reported her mother did not lost consciousness and has been coherent .Daughter stated symptoms seem almost like a stroke ,upon follow call she clarify about seizure which subsided. seizure occurred 3 times over past 5 days prior to call (first night of vaccine, next morning, and reporting day.) Daughter also reported mother had flu-like symptoms for the first 3 days after vaccine,  including chills, high temperature, feels hot, and stuffy nose, but these have resolved. Daughter reports mother has not had symptoms like these prior to vaccine. she also report pharmacist who gave vaccine is aware of symptoms. patient body temperature was high, patient not performed covid 19 test. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms ( chills, high temperature, feels hot ,stuffy nose.), and the outcome of seizure was not reported. This report was serious (Other Medically Important Condition).
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal
Clinical narrative: Initial information received on 03-MAR-2021 was processed with additional information received on 09-MAR-2021. The case was reassessed as serious based upon new information received on 09-MAR-2021. This spontaneous case was received from a patient and concerned a 76 year old female. The patient's weight was reported as 90 kilograms, and height was not reported. The patient's concurrent conditions included pulmonary arterial hypertension. The patient received treatment with COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported; the Company is unable to perform follow-up to request batch/lot numbers), dose was not reported for prophylactic vaccination on 02-MAR-2021. The concomitant medications included macitentan and apixaban. On 03-MAR-2021, the patient reported feeling bad after taking the COVID shot and was considering going to the hospital. On an unspecified date in MAR-2021, the patient was hospitalized. No details were provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feels bad was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, involving the same patient is linked to 20210108619.