chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Restlessness, Skin irritation
Clinical narrative: BELL'S PALSY; NUMBNESS IN ARMS, LEGS, LOWER ABDOMEN AND BUTTLOCKS; ITCHING THROUGHOUT; TINGLING IN ARM, LEGS, FEET AND HAND; This spontaneous report received from a patient concerned a 53 year old male. The patient's weight was 240 (unit unspecified), and height was 182.88 centimeters. The patient's concurrent conditions included hypertension, and other pre-existing medical conditions included patient had family history of any disease (relevant to vaccination) or allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the patient experienced bell's palsy, numbness in arms, legs, lower abdomen and buttlocks, itching throughout, tingling in arm, legs, feet and hand. Laboratory data (dates unspecified) included: Blood test (NR: not provided) nothing out of range, CT scan (NR: not provided) negative, Chest X-ray (NR: not provided) negative, and Urinalysis (NR: not provided) nothing out of range. Treatment medications (dates unspecified) included: hydrochlorothiazide/lisinopril. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itching throughout on 23-MAR-2021, was recovering from numbness in arms, legs, lower abdomen and buttlocks, and tingling in arm, legs, feet and hand and bell's palsy. This report was serious (Other Medically Important Condition).  Additional information was received from patient on 31/03/2021. The following information was updated and incorporated into the case narrative: Reporter (HCP), Patient demographics (Gender, weight, height, Concomitant condition), Event (Bell's Palsy), Lab Test : CT Scan (Head and Torso), Blood work, Urinalysis, Chest X-ray- negative, Suspect product: (Route of administration), drug used to treat AE (Lisinopril) was added.; Sender's Comments: V1: Additional information received in this version is regarding patient demographics, serious event Bell's palsy, lab test, medical history of the patient. This information changes the seriousness of the case from V0 nonserious to V1 serious.  20210357779-Covid-19 vaccine ad26.cov2.s-Bell's palsy. 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).
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Blood test, Chest X-ray, Computerised tomogram, Hypoaesthesia
Clinical narrative: BELL'S PALSY; NUMBNESS IN ARMS, LEGS, LOWER ABDOMEN AND BUTTLOCKS; ITCHING THROUGHOUT; TINGLING IN ARM, LEGS, FEET AND HAND; This spontaneous report received from a patient concerned a 53 year old male. The patient's weight was 240 (unit unspecified), and height was 182.88 centimeters. The patient's concurrent conditions included hypertension, and other pre-existing medical conditions included patient had family history of any disease (relevant to vaccination) or allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the patient experienced bell's palsy, numbness in arms, legs, lower abdomen and buttlocks, itching throughout, tingling in arm, legs, feet and hand. Laboratory data (dates unspecified) included: Blood test (NR: not provided) nothing out of range, CT scan (NR: not provided) negative, Chest X-ray (NR: not provided) negative, and Urinalysis (NR: not provided) nothing out of range. Treatment medications (dates unspecified) included: hydrochlorothiazide/lisinopril. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itching throughout on 23-MAR-2021, was recovering from numbness in arms, legs, lower abdomen and buttlocks, and tingling in arm, legs, feet and hand and bell's palsy. This report was serious (Other Medically Important Condition).  Additional information was received from patient on 31/03/2021. The following information was updated and incorporated into the case narrative: Reporter (HCP), Patient demographics (Gender, weight, height, Concomitant condition), Event (Bell's Palsy), Lab Test : CT Scan (Head and Torso), Blood work, Urinalysis, Chest X-ray- negative, Suspect product: (Route of administration), drug used to treat AE (Lisinopril) was added.; Sender's Comments: V1: Additional information received in this version is regarding patient demographics, serious event Bell's palsy, lab test, medical history of the patient. This information changes the seriousness of the case from V0 nonserious to V1 serious.  20210357779-Covid-19 vaccine ad26.cov2.s-Bell's palsy. 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).
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Pruritus, Urine analysis
Clinical narrative: BELL'S PALSY; NUMBNESS IN ARMS, LEGS, LOWER ABDOMEN AND BUTTLOCKS; ITCHING THROUGHOUT; TINGLING IN ARM, LEGS, FEET AND HAND; This spontaneous report received from a patient concerned a 53 year old male. The patient's weight was 240 (unit unspecified), and height was 182.88 centimeters. The patient's concurrent conditions included hypertension, and other pre-existing medical conditions included patient had family history of any disease (relevant to vaccination) or allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the patient experienced bell's palsy, numbness in arms, legs, lower abdomen and buttlocks, itching throughout, tingling in arm, legs, feet and hand. Laboratory data (dates unspecified) included: Blood test (NR: not provided) nothing out of range, CT scan (NR: not provided) negative, Chest X-ray (NR: not provided) negative, and Urinalysis (NR: not provided) nothing out of range. Treatment medications (dates unspecified) included: hydrochlorothiazide/lisinopril. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itching throughout on 23-MAR-2021, was recovering from numbness in arms, legs, lower abdomen and buttlocks, and tingling in arm, legs, feet and hand and bell's palsy. This report was serious (Other Medically Important Condition).  Additional information was received from patient on 31/03/2021. The following information was updated and incorporated into the case narrative: Reporter (HCP), Patient demographics (Gender, weight, height, Concomitant condition), Event (Bell's Palsy), Lab Test : CT Scan (Head and Torso), Blood work, Urinalysis, Chest X-ray- negative, Suspect product: (Route of administration), drug used to treat AE (Lisinopril) was added.; Sender's Comments: V1: Additional information received in this version is regarding patient demographics, serious event Bell's palsy, lab test, medical history of the patient. This information changes the seriousness of the case from V0 nonserious to V1 serious.  20210357779-Covid-19 vaccine ad26.cov2.s-Bell's palsy. 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).
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event, patient was underage for vaccine administration recommendations.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event, patient was underage for vaccine administration recommendations.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: On 03/01/2021, I received dose 1 of the Moderna vaccine.  I was scheduled to received my dose 2 of Moderna on 03/30/2021.  On 03/30/2021, I was given a COVID-19 vaccination card indicating that I would be receiving the 2nd dose of Moderna.  I received my shot at approx. 4:40pm on 03/30/2021.  On April 1, 2021, I received a voicemail message from the pharmacy asking me to return her call regarding the vaccine I received.  When I returned the call, the manager informed me that the person who administered the vaccine accidentally administered Pfizer vaccine to me (she picked up the wrong vaccine).  This meant that I received my 1st dose as Moderna, and 2nd dose as Pfizer.  I do not know whether I am experiencing any adverse side-effects.  I experienced commonly reported side effects such as fatigue, headache, and slow cognition for approx. 1 week following second vaccine.  Currently I am experiencing gastrointestinal discomfort lasting several days.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Bradyphrenia, Fatigue, Headache, Interchange of vaccine products
Clinical narrative: On 03/01/2021, I received dose 1 of the Moderna vaccine.  I was scheduled to received my dose 2 of Moderna on 03/30/2021.  On 03/30/2021, I was given a COVID-19 vaccination card indicating that I would be receiving the 2nd dose of Moderna.  I received my shot at approx. 4:40pm on 03/30/2021.  On April 1, 2021, I received a voicemail message from the pharmacy asking me to return her call regarding the vaccine I received.  When I returned the call, the manager informed me that the person who administered the vaccine accidentally administered Pfizer vaccine to me (she picked up the wrong vaccine).  This meant that I received my 1st dose as Moderna, and 2nd dose as Pfizer.  I do not know whether I am experiencing any adverse side-effects.  I experienced commonly reported side effects such as fatigue, headache, and slow cognition for approx. 1 week following second vaccine.  Currently I am experiencing gastrointestinal discomfort lasting several days.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antibody test negative, Asthenia, Blood test normal, Chills, Diarrhoea
Clinical narrative: LACK OF APPETITE; DIARRHEA; ACHES; EXCESSIVE SWEATING; CHILLS; NAUSEA ON AND OFF; FEVER; LIGHT HEADED; LETHARGIC; FELT HORRIBLE; This spontaneous report received from a patient concerned a 55 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: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced light headed. On 23-MAR-2021, the subject experienced lethargic. On 23-MAR-2021, the subject experienced felt horrible. On 23-MAR-2021, the subject experienced excessive sweating. On 23-MAR-2021, the subject experienced chills. On 23-MAR-2021, the subject experienced nausea on and off. On 23-MAR-2021, the subject experienced fever. Treatment medications included: ondansetron. On 24-MAR-2021, the subject experienced lack of appetite. On 24-MAR-2021, the subject experienced diarrhea. On 24-MAR-2021, the subject experienced aches. On 30-MAR-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) Normal, Complete blood count (NR: not provided) Normal, and Culture nose (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light headed, felt horrible, chills, nausea on and off, and fever on 04-APR-2021, diarrhea, and aches on 24-MAR-2021, and excessive sweating on 23-MAR-2021, was recovering from lack of appetite, and had not recovered from lethargic. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Full blood count normal, Headache, Hyperhidrosis, Impaired work ability
Clinical narrative: LACK OF APPETITE; DIARRHEA; ACHES; EXCESSIVE SWEATING; CHILLS; NAUSEA ON AND OFF; FEVER; LIGHT HEADED; LETHARGIC; FELT HORRIBLE; This spontaneous report received from a patient concerned a 55 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: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced light headed. On 23-MAR-2021, the subject experienced lethargic. On 23-MAR-2021, the subject experienced felt horrible. On 23-MAR-2021, the subject experienced excessive sweating. On 23-MAR-2021, the subject experienced chills. On 23-MAR-2021, the subject experienced nausea on and off. On 23-MAR-2021, the subject experienced fever. Treatment medications included: ondansetron. On 24-MAR-2021, the subject experienced lack of appetite. On 24-MAR-2021, the subject experienced diarrhea. On 24-MAR-2021, the subject experienced aches. On 30-MAR-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) Normal, Complete blood count (NR: not provided) Normal, and Culture nose (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light headed, felt horrible, chills, nausea on and off, and fever on 04-APR-2021, diarrhea, and aches on 24-MAR-2021, and excessive sweating on 23-MAR-2021, was recovering from lack of appetite, and had not recovered from lethargic. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, SARS-CoV-2 test negative
Clinical narrative: LACK OF APPETITE; DIARRHEA; ACHES; EXCESSIVE SWEATING; CHILLS; NAUSEA ON AND OFF; FEVER; LIGHT HEADED; LETHARGIC; FELT HORRIBLE; This spontaneous report received from a patient concerned a 55 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: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced light headed. On 23-MAR-2021, the subject experienced lethargic. On 23-MAR-2021, the subject experienced felt horrible. On 23-MAR-2021, the subject experienced excessive sweating. On 23-MAR-2021, the subject experienced chills. On 23-MAR-2021, the subject experienced nausea on and off. On 23-MAR-2021, the subject experienced fever. Treatment medications included: ondansetron. On 24-MAR-2021, the subject experienced lack of appetite. On 24-MAR-2021, the subject experienced diarrhea. On 24-MAR-2021, the subject experienced aches. On 30-MAR-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) Normal, Complete blood count (NR: not provided) Normal, and Culture nose (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light headed, felt horrible, chills, nausea on and off, and fever on 04-APR-2021, diarrhea, and aches on 24-MAR-2021, and excessive sweating on 23-MAR-2021, was recovering from lack of appetite, and had not recovered from lethargic. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Culture, Decreased appetite, Diarrhoea, Dizziness
Clinical narrative: LACK OF APPETITE; DIARRHEA; ACHES; EXCESSIVE SWEATING; CHILLS; NAUSEA ON AND OFF; FEVER; LIGHT HEADED; LETHARGIC; FELT HORRIBLE; This spontaneous report received from a patient concerned a 55 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: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced light headed. On 23-MAR-2021, the subject experienced lethargic. On 23-MAR-2021, the subject experienced felt horrible. On 23-MAR-2021, the subject experienced excessive sweating. On 23-MAR-2021, the subject experienced chills. On 23-MAR-2021, the subject experienced nausea on and off. On 23-MAR-2021, the subject experienced fever. Treatment medications included: ondansetron. On 24-MAR-2021, the subject experienced lack of appetite. On 24-MAR-2021, the subject experienced diarrhea. On 24-MAR-2021, the subject experienced aches. On 30-MAR-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) Normal, Complete blood count (NR: not provided) Normal, and Culture nose (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light headed, felt horrible, chills, nausea on and off, and fever on 04-APR-2021, diarrhea, and aches on 24-MAR-2021, and excessive sweating on 23-MAR-2021, was recovering from lack of appetite, and had not recovered from lethargic. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Full blood count, Hyperhidrosis, Lethargy, Nausea
Clinical narrative: LACK OF APPETITE; DIARRHEA; ACHES; EXCESSIVE SWEATING; CHILLS; NAUSEA ON AND OFF; FEVER; LIGHT HEADED; LETHARGIC; FELT HORRIBLE; This spontaneous report received from a patient concerned a 55 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: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced light headed. On 23-MAR-2021, the subject experienced lethargic. On 23-MAR-2021, the subject experienced felt horrible. On 23-MAR-2021, the subject experienced excessive sweating. On 23-MAR-2021, the subject experienced chills. On 23-MAR-2021, the subject experienced nausea on and off. On 23-MAR-2021, the subject experienced fever. Treatment medications included: ondansetron. On 24-MAR-2021, the subject experienced lack of appetite. On 24-MAR-2021, the subject experienced diarrhea. On 24-MAR-2021, the subject experienced aches. On 30-MAR-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) Normal, Complete blood count (NR: not provided) Normal, and Culture nose (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light headed, felt horrible, chills, nausea on and off, and fever on 04-APR-2021, diarrhea, and aches on 24-MAR-2021, and excessive sweating on 23-MAR-2021, was recovering from lack of appetite, and had not recovered from lethargic. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: LACK OF APPETITE; DIARRHEA; ACHES; EXCESSIVE SWEATING; CHILLS; NAUSEA ON AND OFF; FEVER; LIGHT HEADED; LETHARGIC; FELT HORRIBLE; This spontaneous report received from a patient concerned a 55 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: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced light headed. On 23-MAR-2021, the subject experienced lethargic. On 23-MAR-2021, the subject experienced felt horrible. On 23-MAR-2021, the subject experienced excessive sweating. On 23-MAR-2021, the subject experienced chills. On 23-MAR-2021, the subject experienced nausea on and off. On 23-MAR-2021, the subject experienced fever. Treatment medications included: ondansetron. On 24-MAR-2021, the subject experienced lack of appetite. On 24-MAR-2021, the subject experienced diarrhea. On 24-MAR-2021, the subject experienced aches. On 30-MAR-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) Normal, Complete blood count (NR: not provided) Normal, and Culture nose (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light headed, felt horrible, chills, nausea on and off, and fever on 04-APR-2021, diarrhea, and aches on 24-MAR-2021, and excessive sweating on 23-MAR-2021, was recovering from lack of appetite, and had not recovered from lethargic. This report was non-serious.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral, Dizziness, Gait disturbance, Nausea
Clinical narrative: Sudden profound hearing loss on the right with severe vertigo.  Hearing loss did not respond to transtympanic dexamethasone injections times two.  Vertigo resolving but not gone.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vertigo, Vomiting, Walking aid user
Clinical narrative: Sudden profound hearing loss on the right with severe vertigo.  Hearing loss did not respond to transtympanic dexamethasone injections times two.  Vertigo resolving but not gone.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Audiogram abnormal, Deafness unilateral, Magnetic resonance imaging head, Vertigo
Clinical narrative: Sudden profound hearing loss on the right with severe vertigo.  Hearing loss did not respond to transtympanic dexamethasone injections times two.  Vertigo resolving but not gone.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Myalgia
Clinical narrative: Pt developed chest pain and dyspnea on exertion about 3 days after vaccine. It lasted for about 3 weeks with exertion
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea exertional
Clinical narrative: Pt developed chest pain and dyspnea on exertion about 3 days after vaccine. It lasted for about 3 weeks with exertion
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Immediate post-injection reaction, Swollen tongue, Urticaria, Vomiting
Clinical narrative: FEELING COLD; PAIN IN LEFT ARMPIT; PAIN IN LEFT SIDE OF NECK; BODY ACHE; PAIN IN THE INJECTED ARM (LEFT SIDE); ANAPHYLAXIS; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection on an unspecified date in MAY-2020.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency 1 total, administered on 03-APR-2021 around 11:00 a.m. on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in MAY-2020, Laboratory data included: COVID-19 antibody test (NR: not provided) positive, (3.72). On an unspecified date in 2021, Laboratory data included: COVID-19 antibody test (NR: not provided) level of 0.2.  On 03-APR-2021, the patient experienced anaphylaxis. It was reported that within 5 minutes after vaccination patient experienced tongue was swollen, throat started closing, throat breaking in hives. The pharmacy called the emergency service, and the consumer was taken to the hospital. On 04-APR-2021, the patient experienced feeling cold, pain in left armpit, pain in left side of neck, body ache and pain in the injected arm (left side). She was treated with routine treatment for anaphylaxis, and she was put on prednisone and Benadryl. It was reported that, the treatment was still on.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from anaphylaxis, and had not recovered from feeling cold, pain in the injected arm (left side), pain in left armpit, body ache, and pain in left side of neck. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to AER20210409478.; Sender's Comments: V0 20210410075-Covid-19 vaccine ad26.cov2.s Anaphylaxis. 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: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Axillary pain, Feeling cold, Neck pain, Pain
Clinical narrative: FEELING COLD; PAIN IN LEFT ARMPIT; PAIN IN LEFT SIDE OF NECK; BODY ACHE; PAIN IN THE INJECTED ARM (LEFT SIDE); ANAPHYLAXIS; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection on an unspecified date in MAY-2020.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency 1 total, administered on 03-APR-2021 around 11:00 a.m. on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in MAY-2020, Laboratory data included: COVID-19 antibody test (NR: not provided) positive, (3.72). On an unspecified date in 2021, Laboratory data included: COVID-19 antibody test (NR: not provided) level of 0.2.  On 03-APR-2021, the patient experienced anaphylaxis. It was reported that within 5 minutes after vaccination patient experienced tongue was swollen, throat started closing, throat breaking in hives. The pharmacy called the emergency service, and the consumer was taken to the hospital. On 04-APR-2021, the patient experienced feeling cold, pain in left armpit, pain in left side of neck, body ache and pain in the injected arm (left side). She was treated with routine treatment for anaphylaxis, and she was put on prednisone and Benadryl. It was reported that, the treatment was still on.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from anaphylaxis, and had not recovered from feeling cold, pain in the injected arm (left side), pain in left armpit, body ache, and pain in left side of neck. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to AER20210409478.; Sender's Comments: V0 20210410075-Covid-19 vaccine ad26.cov2.s Anaphylaxis. 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: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, SARS-CoV-2 antibody test
Clinical narrative: FEELING COLD; PAIN IN LEFT ARMPIT; PAIN IN LEFT SIDE OF NECK; BODY ACHE; PAIN IN THE INJECTED ARM (LEFT SIDE); ANAPHYLAXIS; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection on an unspecified date in MAY-2020.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency 1 total, administered on 03-APR-2021 around 11:00 a.m. on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in MAY-2020, Laboratory data included: COVID-19 antibody test (NR: not provided) positive, (3.72). On an unspecified date in 2021, Laboratory data included: COVID-19 antibody test (NR: not provided) level of 0.2.  On 03-APR-2021, the patient experienced anaphylaxis. It was reported that within 5 minutes after vaccination patient experienced tongue was swollen, throat started closing, throat breaking in hives. The pharmacy called the emergency service, and the consumer was taken to the hospital. On 04-APR-2021, the patient experienced feeling cold, pain in left armpit, pain in left side of neck, body ache and pain in the injected arm (left side). She was treated with routine treatment for anaphylaxis, and she was put on prednisone and Benadryl. It was reported that, the treatment was still on.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from anaphylaxis, and had not recovered from feeling cold, pain in the injected arm (left side), pain in left armpit, body ache, and pain in left side of neck. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to AER20210409478.; Sender's Comments: V0 20210410075-Covid-19 vaccine ad26.cov2.s Anaphylaxis. 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: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: 22 y/o previously healthy male who presents after a covid vaccine at 0940 with left sided facial weakness and numbness since shortly after that time. He stated that originally his entire left side of his face felt numb and was weak but it's been improving since that time, now only his lower face. He denies any other acute symptoms including fevers, chills, chest pain, shortness of breath, nausea, vomiting, diarrhea or any other acute concerns. VS wnl. PE remarkable for weakness in V2-V3 distribution of face with some sensation loss in the V3 distribution of the left side of the face. While forehead is spared, this appears to be more of a bell's palsy that's resolving rather than an acute central process. During evaluation his symptoms completely resolved Will discharge home with return precautions. (released at 1411pm) 04/01/2021 12:13 BP: 115/70. MAP: 85. HR: 61. RR: 12. O2 saturation: 100%. Temp: 98.2 F. CLINICAL IMPRESSION  Bell's Palsy on the left side.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Facial paresis, Hypoaesthesia, Vital signs measurement
Clinical narrative: 22 y/o previously healthy male who presents after a covid vaccine at 0940 with left sided facial weakness and numbness since shortly after that time. He stated that originally his entire left side of his face felt numb and was weak but it's been improving since that time, now only his lower face. He denies any other acute symptoms including fevers, chills, chest pain, shortness of breath, nausea, vomiting, diarrhea or any other acute concerns. VS wnl. PE remarkable for weakness in V2-V3 distribution of face with some sensation loss in the V3 distribution of the left side of the face. While forehead is spared, this appears to be more of a bell's palsy that's resolving rather than an acute central process. During evaluation his symptoms completely resolved Will discharge home with return precautions. (released at 1411pm) 04/01/2021 12:13 BP: 115/70. MAP: 85. HR: 61. RR: 12. O2 saturation: 100%. Temp: 98.2 F. CLINICAL IMPRESSION  Bell's Palsy on the left side.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: 10 minutes after receiving  the vaccination she started having chest pain, Sweating, numbness and tingling throughout entire body, headache. She started getting wheezing. She developed a rash on arms and legs. She went to the ER on 4/5/2021. She was discharged home with albuterol. Her shortness of breath got progressively worse and she was advised to return to the ER. She went back on 04/08/2021. She was given toradol and discharged home. Followed up with primary care on 4/15/20, still having shortness of breath, but improved from the last ER visit. She has significant exertional dyspnea. Her exercise capacity has reduced from 3-4 blocks, to barely able to make it across her house without stopping.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chest pain, Dyspnoea, Headache, Hyperhidrosis
Clinical narrative: 10 minutes after receiving  the vaccination she started having chest pain, Sweating, numbness and tingling throughout entire body, headache. She started getting wheezing. She developed a rash on arms and legs. She went to the ER on 4/5/2021. She was discharged home with albuterol. Her shortness of breath got progressively worse and she was advised to return to the ER. She went back on 04/08/2021. She was given toradol and discharged home. Followed up with primary care on 4/15/20, still having shortness of breath, but improved from the last ER visit. She has significant exertional dyspnea. Her exercise capacity has reduced from 3-4 blocks, to barely able to make it across her house without stopping.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Rash, Wheezing
Clinical narrative: 10 minutes after receiving  the vaccination she started having chest pain, Sweating, numbness and tingling throughout entire body, headache. She started getting wheezing. She developed a rash on arms and legs. She went to the ER on 4/5/2021. She was discharged home with albuterol. Her shortness of breath got progressively worse and she was advised to return to the ER. She went back on 04/08/2021. She was given toradol and discharged home. Followed up with primary care on 4/15/20, still having shortness of breath, but improved from the last ER visit. She has significant exertional dyspnea. Her exercise capacity has reduced from 3-4 blocks, to barely able to make it across her house without stopping.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chest pain, Fatigue, Hyperhidrosis, Migraine
Clinical narrative: BODY ACHES; TINNIUTS; HEART RACING; TACHYCARDIA; DIZZINESS; SWEATING; CHEST TIGHTNESS/CHEST PRESSURE; BRUISING AT INJECTION SITE; HEADACHE; MYALGIA; FATIGUE; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to bees.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 01-APR-2021 11:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021, the subject experienced tachycardia. On 01-APR-2021, the subject experienced dizziness. On 01-APR-2021, the subject experienced sweating. On 01-APR-2021, the subject experienced chest tightness/chest pressure. On 01-APR-2021, the subject experienced bruising at injection site. On 01-APR-2021, the subject experienced headache. On 01-APR-2021, the subject experienced myalgia. On 01-APR-2021, the subject experienced fatigue. On 01-APR-2021 14:00, the subject experienced tinniuts. On 01-APR-2021 14:00, the subject experienced heart racing. On an unspecified date, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tachycardia, sweating, chest tightness/chest pressure, bruising at injection site, myalgia, and fatigue on 04-APR-2021, dizziness on 01-APR-2021, and headache on 03-APR-2021, was recovering from heart racing, had not recovered from tinniuts, and the outcome of body aches was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Neck pain, Palpitations, Tinnitus
Clinical narrative: BODY ACHES; TINNIUTS; HEART RACING; TACHYCARDIA; DIZZINESS; SWEATING; CHEST TIGHTNESS/CHEST PRESSURE; BRUISING AT INJECTION SITE; HEADACHE; MYALGIA; FATIGUE; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to bees.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 01-APR-2021 11:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021, the subject experienced tachycardia. On 01-APR-2021, the subject experienced dizziness. On 01-APR-2021, the subject experienced sweating. On 01-APR-2021, the subject experienced chest tightness/chest pressure. On 01-APR-2021, the subject experienced bruising at injection site. On 01-APR-2021, the subject experienced headache. On 01-APR-2021, the subject experienced myalgia. On 01-APR-2021, the subject experienced fatigue. On 01-APR-2021 14:00, the subject experienced tinniuts. On 01-APR-2021 14:00, the subject experienced heart racing. On an unspecified date, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tachycardia, sweating, chest tightness/chest pressure, bruising at injection site, myalgia, and fatigue on 04-APR-2021, dizziness on 01-APR-2021, and headache on 03-APR-2021, was recovering from heart racing, had not recovered from tinniuts, and the outcome of body aches was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dizziness, Fatigue, Headache, Hyperhidrosis
Clinical narrative: BODY ACHES; TINNIUTS; HEART RACING; TACHYCARDIA; DIZZINESS; SWEATING; CHEST TIGHTNESS/CHEST PRESSURE; BRUISING AT INJECTION SITE; HEADACHE; MYALGIA; FATIGUE; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to bees.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 01-APR-2021 11:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021, the subject experienced tachycardia. On 01-APR-2021, the subject experienced dizziness. On 01-APR-2021, the subject experienced sweating. On 01-APR-2021, the subject experienced chest tightness/chest pressure. On 01-APR-2021, the subject experienced bruising at injection site. On 01-APR-2021, the subject experienced headache. On 01-APR-2021, the subject experienced myalgia. On 01-APR-2021, the subject experienced fatigue. On 01-APR-2021 14:00, the subject experienced tinniuts. On 01-APR-2021 14:00, the subject experienced heart racing. On an unspecified date, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tachycardia, sweating, chest tightness/chest pressure, bruising at injection site, myalgia, and fatigue on 04-APR-2021, dizziness on 01-APR-2021, and headache on 03-APR-2021, was recovering from heart racing, had not recovered from tinniuts, and the outcome of body aches was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site bruising, Myalgia, Pain, Palpitations, Tachycardia
Clinical narrative: BODY ACHES; TINNIUTS; HEART RACING; TACHYCARDIA; DIZZINESS; SWEATING; CHEST TIGHTNESS/CHEST PRESSURE; BRUISING AT INJECTION SITE; HEADACHE; MYALGIA; FATIGUE; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to bees.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 01-APR-2021 11:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021, the subject experienced tachycardia. On 01-APR-2021, the subject experienced dizziness. On 01-APR-2021, the subject experienced sweating. On 01-APR-2021, the subject experienced chest tightness/chest pressure. On 01-APR-2021, the subject experienced bruising at injection site. On 01-APR-2021, the subject experienced headache. On 01-APR-2021, the subject experienced myalgia. On 01-APR-2021, the subject experienced fatigue. On 01-APR-2021 14:00, the subject experienced tinniuts. On 01-APR-2021 14:00, the subject experienced heart racing. On an unspecified date, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tachycardia, sweating, chest tightness/chest pressure, bruising at injection site, myalgia, and fatigue on 04-APR-2021, dizziness on 01-APR-2021, and headache on 03-APR-2021, was recovering from heart racing, had not recovered from tinniuts, and the outcome of body aches was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: BODY ACHES; TINNIUTS; HEART RACING; TACHYCARDIA; DIZZINESS; SWEATING; CHEST TIGHTNESS/CHEST PRESSURE; BRUISING AT INJECTION SITE; HEADACHE; MYALGIA; FATIGUE; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to bees.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 01-APR-2021 11:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021, the subject experienced tachycardia. On 01-APR-2021, the subject experienced dizziness. On 01-APR-2021, the subject experienced sweating. On 01-APR-2021, the subject experienced chest tightness/chest pressure. On 01-APR-2021, the subject experienced bruising at injection site. On 01-APR-2021, the subject experienced headache. On 01-APR-2021, the subject experienced myalgia. On 01-APR-2021, the subject experienced fatigue. On 01-APR-2021 14:00, the subject experienced tinniuts. On 01-APR-2021 14:00, the subject experienced heart racing. On an unspecified date, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tachycardia, sweating, chest tightness/chest pressure, bruising at injection site, myalgia, and fatigue on 04-APR-2021, dizziness on 01-APR-2021, and headache on 03-APR-2021, was recovering from heart racing, had not recovered from tinniuts, and the outcome of body aches was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Dysarthria, Fall, Impaired driving ability, Posture abnormal
Clinical narrative: DEATH
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pulmonary embolism
Clinical narrative: DEATH
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Life support
Clinical narrative: DEATH
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test, Pulmonary embolism
Clinical narrative: DEATH
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: Per the Health Agency- a VAERS is required for dosing errors - see below.  (2) A VAERS report is also required for vaccine administration errors per the CDC and the corresponding VAERS report number must be included in the associated report.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Per the Health Agency- a VAERS is required for dosing errors - see below.  (2) A VAERS report is also required for vaccine administration errors per the CDC and the corresponding VAERS report number must be included in the associated report.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Feeling of body temperature change, Spinal pain, Tremor, Vision blurred
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Shakiness-Mild, Systemic: Tachycardia-Mild, Additional Details: Pt had labored breathing, shakiness, pulse 98.  Gave her Benadryl Liquid 25mg in the store. Called 911 and they took her to the ER.  I followed up with the patient four hours later and at the ER they gave her Benadryl and famotidine.  Pt. was much better and all symptoms subsided.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Confusional state, Dizziness, Dysphagia, Dyspnoea
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Shakiness-Mild, Systemic: Tachycardia-Mild, Additional Details: Pt had labored breathing, shakiness, pulse 98.  Gave her Benadryl Liquid 25mg in the store. Called 911 and they took her to the ER.  I followed up with the patient four hours later and at the ER they gave her Benadryl and famotidine.  Pt. was much better and all symptoms subsided.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia, Throat tightness, Tremor
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Shakiness-Mild, Systemic: Tachycardia-Mild, Additional Details: Pt had labored breathing, shakiness, pulse 98.  Gave her Benadryl Liquid 25mg in the store. Called 911 and they took her to the ER.  I followed up with the patient four hours later and at the ER they gave her Benadryl and famotidine.  Pt. was much better and all symptoms subsided.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Rash, Throat tightness, Wheezing
Clinical narrative: What: Anaphylaxis reaction. Vaccine administered around 0850, approximately at 0854 patient notified provider with symptoms of anaphylaxis reaction. Patient brought to private room, notice symptoms of generalize rash. Vital signs taken at 0902 BP: 142/82 HR:102 O2: 100%. Administered Benadryl 50mg/mL  at 0902 Lot number: 6020111 Exp: 07/21. After administration of Benadryl patient expressed tightness of throat with audible wheezing, immediately administer EPI Pen 0.3 mg/mL  Lot number: 0FN1407 Exp: FEB2022 on the left thigh at 0903. Patient improving symptoms. FED FIRE was called at 0901, arrived at 0908, transported at the Hospital at 0912.   When: Shot given at 0850, reported symptoms at 0854   Why: Reaction to Pfizer COVID-19 first dose ( Lot number: ER8729 Exp: 07/2021) Patient has history of anaphylaxis reaction.