chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased, Chills, Fatigue, Headache, Pain
Clinical narrative: BODY ACHE; CHILLS; FEVER; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to food and latex allergy, and no chronic or long-term health conditions. The patient experienced drug allergy when treated with acetylsalicylic acid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered to left arm on 15-MAR-2021 approximately at 10:30 am for prophylactic vaccination. Concomitant medications included megestrol acetate. On 15-MAR-2021 approximately at 5:00pm, the subject experienced fever. On 15-MAR-2021 approximately at 5:00pm, the subject experienced fatigue. On 15-MAR-2021 approximately at 5:00pm, the subject experienced head ache. On 15-MAR-2021 approximately at 5:00pm, the subject experienced chills. On 15-MAR-2021 approximately at 5:00pm, the subject experienced body ache. Laboratory data included: Body temperature increased (NR: not provided) Temperature increased to 99.6 degree F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, head ache, and body ache, and the outcome of chills and fever was not reported. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: BODY ACHE; CHILLS; FEVER; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to food and latex allergy, and no chronic or long-term health conditions. The patient experienced drug allergy when treated with acetylsalicylic acid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered to left arm on 15-MAR-2021 approximately at 10:30 am for prophylactic vaccination. Concomitant medications included megestrol acetate. On 15-MAR-2021 approximately at 5:00pm, the subject experienced fever. On 15-MAR-2021 approximately at 5:00pm, the subject experienced fatigue. On 15-MAR-2021 approximately at 5:00pm, the subject experienced head ache. On 15-MAR-2021 approximately at 5:00pm, the subject experienced chills. On 15-MAR-2021 approximately at 5:00pm, the subject experienced body ache. Laboratory data included: Body temperature increased (NR: not provided) Temperature increased to 99.6 degree F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, head ache, and body ache, and the outcome of chills and fever was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Dysgeusia, Fatigue, Headache, Immediate post-injection reaction
Clinical narrative: NAUSEA; SEVERE FATIGUE; HEADACHE; SWOLLEN LYMPH NODES IN NECK; RUNNY NOSE; WATERY EYES; FLU LIKE/BAD COLD; SWOLLEN LIPS; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight was 190 pounds, and height was 62 inches. The patient's past medical history included chf, asthma, and congestive heart failure, and concurrent conditions included seasonal allergy, penicillin allergy, alcoholic, no smoking, and nonsmoker, and other pre-existing medical conditions included the patient has no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with clarithromycin, and erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced swollen lips. On 14-MAR-2021, the subject experienced swollen lymph nodes in neck. On 14-MAR-2021, the subject experienced runny nose. On 14-MAR-2021, the subject experienced watery eyes. On 14-MAR-2021, the subject experienced flu like/bad cold. On 14-MAR-2021, the subject experienced severe fatigue. On 14-MAR-2021, the subject experienced headache. On 15-MAR-2021, the subject experienced nausea. Treatment medications included: diphenhydramine hydrochloride. Additional treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from runny nose, and flu like/bad cold, and had not recovered from headache, swollen lymph nodes in neck, nausea, severe fatigue, watery eyes, and swollen lips. This report was non-serious.  Version created to amend the previously reported information on 15-MAR-2021. Upon review, following information was amended: Medically confirmed field was unchecked.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Lacrimation increased, Lip swelling, Lymphadenopathy, Nasopharyngitis
Clinical narrative: NAUSEA; SEVERE FATIGUE; HEADACHE; SWOLLEN LYMPH NODES IN NECK; RUNNY NOSE; WATERY EYES; FLU LIKE/BAD COLD; SWOLLEN LIPS; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight was 190 pounds, and height was 62 inches. The patient's past medical history included chf, asthma, and congestive heart failure, and concurrent conditions included seasonal allergy, penicillin allergy, alcoholic, no smoking, and nonsmoker, and other pre-existing medical conditions included the patient has no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with clarithromycin, and erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced swollen lips. On 14-MAR-2021, the subject experienced swollen lymph nodes in neck. On 14-MAR-2021, the subject experienced runny nose. On 14-MAR-2021, the subject experienced watery eyes. On 14-MAR-2021, the subject experienced flu like/bad cold. On 14-MAR-2021, the subject experienced severe fatigue. On 14-MAR-2021, the subject experienced headache. On 15-MAR-2021, the subject experienced nausea. Treatment medications included: diphenhydramine hydrochloride. Additional treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from runny nose, and flu like/bad cold, and had not recovered from headache, swollen lymph nodes in neck, nausea, severe fatigue, watery eyes, and swollen lips. This report was non-serious.  Version created to amend the previously reported information on 15-MAR-2021. Upon review, following information was amended: Medically confirmed field was unchecked.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, Peripheral swelling, Pyrexia, Rhinorrhoea
Clinical narrative: NAUSEA; SEVERE FATIGUE; HEADACHE; SWOLLEN LYMPH NODES IN NECK; RUNNY NOSE; WATERY EYES; FLU LIKE/BAD COLD; SWOLLEN LIPS; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight was 190 pounds, and height was 62 inches. The patient's past medical history included chf, asthma, and congestive heart failure, and concurrent conditions included seasonal allergy, penicillin allergy, alcoholic, no smoking, and nonsmoker, and other pre-existing medical conditions included the patient has no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with clarithromycin, and erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced swollen lips. On 14-MAR-2021, the subject experienced swollen lymph nodes in neck. On 14-MAR-2021, the subject experienced runny nose. On 14-MAR-2021, the subject experienced watery eyes. On 14-MAR-2021, the subject experienced flu like/bad cold. On 14-MAR-2021, the subject experienced severe fatigue. On 14-MAR-2021, the subject experienced headache. On 15-MAR-2021, the subject experienced nausea. Treatment medications included: diphenhydramine hydrochloride. Additional treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from runny nose, and flu like/bad cold, and had not recovered from headache, swollen lymph nodes in neck, nausea, severe fatigue, watery eyes, and swollen lips. This report was non-serious.  Version created to amend the previously reported information on 15-MAR-2021. Upon review, following information was amended: Medically confirmed field was unchecked.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Stomatitis
Clinical narrative: NAUSEA; SEVERE FATIGUE; HEADACHE; SWOLLEN LYMPH NODES IN NECK; RUNNY NOSE; WATERY EYES; FLU LIKE/BAD COLD; SWOLLEN LIPS; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight was 190 pounds, and height was 62 inches. The patient's past medical history included chf, asthma, and congestive heart failure, and concurrent conditions included seasonal allergy, penicillin allergy, alcoholic, no smoking, and nonsmoker, and other pre-existing medical conditions included the patient has no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with clarithromycin, and erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced swollen lips. On 14-MAR-2021, the subject experienced swollen lymph nodes in neck. On 14-MAR-2021, the subject experienced runny nose. On 14-MAR-2021, the subject experienced watery eyes. On 14-MAR-2021, the subject experienced flu like/bad cold. On 14-MAR-2021, the subject experienced severe fatigue. On 14-MAR-2021, the subject experienced headache. On 15-MAR-2021, the subject experienced nausea. Treatment medications included: diphenhydramine hydrochloride. Additional treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from runny nose, and flu like/bad cold, and had not recovered from headache, swollen lymph nodes in neck, nausea, severe fatigue, watery eyes, and swollen lips. This report was non-serious.  Version created to amend the previously reported information on 15-MAR-2021. Upon review, following information was amended: Medically confirmed field was unchecked.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Influenza like illness, Lacrimation increased, Lip swelling
Clinical narrative: NAUSEA; SEVERE FATIGUE; HEADACHE; SWOLLEN LYMPH NODES IN NECK; RUNNY NOSE; WATERY EYES; FLU LIKE/BAD COLD; SWOLLEN LIPS; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight was 190 pounds, and height was 62 inches. The patient's past medical history included chf, asthma, and congestive heart failure, and concurrent conditions included seasonal allergy, penicillin allergy, alcoholic, no smoking, and nonsmoker, and other pre-existing medical conditions included the patient has no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with clarithromycin, and erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced swollen lips. On 14-MAR-2021, the subject experienced swollen lymph nodes in neck. On 14-MAR-2021, the subject experienced runny nose. On 14-MAR-2021, the subject experienced watery eyes. On 14-MAR-2021, the subject experienced flu like/bad cold. On 14-MAR-2021, the subject experienced severe fatigue. On 14-MAR-2021, the subject experienced headache. On 15-MAR-2021, the subject experienced nausea. Treatment medications included: diphenhydramine hydrochloride. Additional treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from runny nose, and flu like/bad cold, and had not recovered from headache, swollen lymph nodes in neck, nausea, severe fatigue, watery eyes, and swollen lips. This report was non-serious.  Version created to amend the previously reported information on 15-MAR-2021. Upon review, following information was amended: Medically confirmed field was unchecked.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Nausea, Rhinorrhoea
Clinical narrative: NAUSEA; SEVERE FATIGUE; HEADACHE; SWOLLEN LYMPH NODES IN NECK; RUNNY NOSE; WATERY EYES; FLU LIKE/BAD COLD; SWOLLEN LIPS; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight was 190 pounds, and height was 62 inches. The patient's past medical history included chf, asthma, and congestive heart failure, and concurrent conditions included seasonal allergy, penicillin allergy, alcoholic, no smoking, and nonsmoker, and other pre-existing medical conditions included the patient has no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with clarithromycin, and erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced swollen lips. On 14-MAR-2021, the subject experienced swollen lymph nodes in neck. On 14-MAR-2021, the subject experienced runny nose. On 14-MAR-2021, the subject experienced watery eyes. On 14-MAR-2021, the subject experienced flu like/bad cold. On 14-MAR-2021, the subject experienced severe fatigue. On 14-MAR-2021, the subject experienced headache. On 15-MAR-2021, the subject experienced nausea. Treatment medications included: diphenhydramine hydrochloride. Additional treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from runny nose, and flu like/bad cold, and had not recovered from headache, swollen lymph nodes in neck, nausea, severe fatigue, watery eyes, and swollen lips. This report was non-serious.  Version created to amend the previously reported information on 15-MAR-2021. Upon review, following information was amended: Medically confirmed field was unchecked.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Epistaxis, Feeling abnormal, Influenza like illness, Malaise, Migraine
Clinical narrative: BLOOD SHOT EYES; BLOODY NOSE; DID NOT SLEEP DUE TO FLU SYMPTOMS; FEVER; NASTY MIGRAINE/ INTENSE PAIN IN THE BACK OF NECK AND HEAD, EYES HURT; SOUR STOMACH; INTENSE BODY ACHES; STUFFY NOSE; FLU LIKE SYMPTOMS; EXTREMELY SICK; This spontaneous report received from a patient via a company representative concerned a 47 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included heart coronary artery disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 05-MAR-2021 15:30 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included atorvastatin, hydrochlorothiazide, and losartan. On 06-MAR-2021, the subject experienced extremely sick. Laboratory data included: Body temperature (NR: not provided) 102 F. On 06-MAR-2021 05:00, the subject experienced nasty migraine/ intense pain in the back of neck and head, eyes hurt. On 06-MAR-2021 05:00, the subject experienced sour stomach. On 06-MAR-2021 05:00, the subject experienced intense body aches. On 06-MAR-2021 05:00, the subject experienced stuffy nose. On 06-MAR-2021 05:00, the subject experienced flu like symptoms. On 06-MAR-2021 05:00, the subject experienced fever. On 07-MAR-2021, the subject experienced did not sleep due to flu symptoms. On 08-MAR-2021, the subject experienced blood shot eyes. On 08-MAR-2021, the subject experienced bloody nose. Laboratory data included: Body temperature (NR: not provided) 101 F. On 09-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nasty migraine/ intense pain in the back of neck and head, eyes hurt on 15-MAR-2021, sour stomach, intense body aches, stuffy nose, extremely sick, did not sleep due to flu symptoms, blood shot eyes, and bloody nose, flu like symptoms on 12-MAR-2021, and fever on 11-MAR-2021. This report was non-serious.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nasal congestion, Ocular hyperaemia, Pain, Pyrexia, Sleep disorder
Clinical narrative: BLOOD SHOT EYES; BLOODY NOSE; DID NOT SLEEP DUE TO FLU SYMPTOMS; FEVER; NASTY MIGRAINE/ INTENSE PAIN IN THE BACK OF NECK AND HEAD, EYES HURT; SOUR STOMACH; INTENSE BODY ACHES; STUFFY NOSE; FLU LIKE SYMPTOMS; EXTREMELY SICK; This spontaneous report received from a patient via a company representative concerned a 47 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included heart coronary artery disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 05-MAR-2021 15:30 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included atorvastatin, hydrochlorothiazide, and losartan. On 06-MAR-2021, the subject experienced extremely sick. Laboratory data included: Body temperature (NR: not provided) 102 F. On 06-MAR-2021 05:00, the subject experienced nasty migraine/ intense pain in the back of neck and head, eyes hurt. On 06-MAR-2021 05:00, the subject experienced sour stomach. On 06-MAR-2021 05:00, the subject experienced intense body aches. On 06-MAR-2021 05:00, the subject experienced stuffy nose. On 06-MAR-2021 05:00, the subject experienced flu like symptoms. On 06-MAR-2021 05:00, the subject experienced fever. On 07-MAR-2021, the subject experienced did not sleep due to flu symptoms. On 08-MAR-2021, the subject experienced blood shot eyes. On 08-MAR-2021, the subject experienced bloody nose. Laboratory data included: Body temperature (NR: not provided) 101 F. On 09-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nasty migraine/ intense pain in the back of neck and head, eyes hurt on 15-MAR-2021, sour stomach, intense body aches, stuffy nose, extremely sick, did not sleep due to flu symptoms, blood shot eyes, and bloody nose, flu like symptoms on 12-MAR-2021, and fever on 11-MAR-2021. This report was non-serious.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Dyspepsia, Epistaxis, Illness, Influenza like illness
Clinical narrative: BLOOD SHOT EYES; BLOODY NOSE; DID NOT SLEEP DUE TO FLU SYMPTOMS; FEVER; NASTY MIGRAINE/ INTENSE PAIN IN THE BACK OF NECK AND HEAD, EYES HURT; SOUR STOMACH; INTENSE BODY ACHES; STUFFY NOSE; FLU LIKE SYMPTOMS; EXTREMELY SICK; This spontaneous report received from a patient via a company representative concerned a 47 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included heart coronary artery disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 05-MAR-2021 15:30 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included atorvastatin, hydrochlorothiazide, and losartan. On 06-MAR-2021, the subject experienced extremely sick. Laboratory data included: Body temperature (NR: not provided) 102 F. On 06-MAR-2021 05:00, the subject experienced nasty migraine/ intense pain in the back of neck and head, eyes hurt. On 06-MAR-2021 05:00, the subject experienced sour stomach. On 06-MAR-2021 05:00, the subject experienced intense body aches. On 06-MAR-2021 05:00, the subject experienced stuffy nose. On 06-MAR-2021 05:00, the subject experienced flu like symptoms. On 06-MAR-2021 05:00, the subject experienced fever. On 07-MAR-2021, the subject experienced did not sleep due to flu symptoms. On 08-MAR-2021, the subject experienced blood shot eyes. On 08-MAR-2021, the subject experienced bloody nose. Laboratory data included: Body temperature (NR: not provided) 101 F. On 09-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nasty migraine/ intense pain in the back of neck and head, eyes hurt on 15-MAR-2021, sour stomach, intense body aches, stuffy nose, extremely sick, did not sleep due to flu symptoms, blood shot eyes, and bloody nose, flu like symptoms on 12-MAR-2021, and fever on 11-MAR-2021. This report was non-serious.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Migraine, Nasal congestion, Ocular hyperaemia, Pain
Clinical narrative: BLOOD SHOT EYES; BLOODY NOSE; DID NOT SLEEP DUE TO FLU SYMPTOMS; FEVER; NASTY MIGRAINE/ INTENSE PAIN IN THE BACK OF NECK AND HEAD, EYES HURT; SOUR STOMACH; INTENSE BODY ACHES; STUFFY NOSE; FLU LIKE SYMPTOMS; EXTREMELY SICK; This spontaneous report received from a patient via a company representative concerned a 47 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included heart coronary artery disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 05-MAR-2021 15:30 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included atorvastatin, hydrochlorothiazide, and losartan. On 06-MAR-2021, the subject experienced extremely sick. Laboratory data included: Body temperature (NR: not provided) 102 F. On 06-MAR-2021 05:00, the subject experienced nasty migraine/ intense pain in the back of neck and head, eyes hurt. On 06-MAR-2021 05:00, the subject experienced sour stomach. On 06-MAR-2021 05:00, the subject experienced intense body aches. On 06-MAR-2021 05:00, the subject experienced stuffy nose. On 06-MAR-2021 05:00, the subject experienced flu like symptoms. On 06-MAR-2021 05:00, the subject experienced fever. On 07-MAR-2021, the subject experienced did not sleep due to flu symptoms. On 08-MAR-2021, the subject experienced blood shot eyes. On 08-MAR-2021, the subject experienced bloody nose. Laboratory data included: Body temperature (NR: not provided) 101 F. On 09-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nasty migraine/ intense pain in the back of neck and head, eyes hurt on 15-MAR-2021, sour stomach, intense body aches, stuffy nose, extremely sick, did not sleep due to flu symptoms, blood shot eyes, and bloody nose, flu like symptoms on 12-MAR-2021, and fever on 11-MAR-2021. This report was non-serious.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: BLOOD SHOT EYES; BLOODY NOSE; DID NOT SLEEP DUE TO FLU SYMPTOMS; FEVER; NASTY MIGRAINE/ INTENSE PAIN IN THE BACK OF NECK AND HEAD, EYES HURT; SOUR STOMACH; INTENSE BODY ACHES; STUFFY NOSE; FLU LIKE SYMPTOMS; EXTREMELY SICK; This spontaneous report received from a patient via a company representative concerned a 47 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included heart coronary artery disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 05-MAR-2021 15:30 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included atorvastatin, hydrochlorothiazide, and losartan. On 06-MAR-2021, the subject experienced extremely sick. Laboratory data included: Body temperature (NR: not provided) 102 F. On 06-MAR-2021 05:00, the subject experienced nasty migraine/ intense pain in the back of neck and head, eyes hurt. On 06-MAR-2021 05:00, the subject experienced sour stomach. On 06-MAR-2021 05:00, the subject experienced intense body aches. On 06-MAR-2021 05:00, the subject experienced stuffy nose. On 06-MAR-2021 05:00, the subject experienced flu like symptoms. On 06-MAR-2021 05:00, the subject experienced fever. On 07-MAR-2021, the subject experienced did not sleep due to flu symptoms. On 08-MAR-2021, the subject experienced blood shot eyes. On 08-MAR-2021, the subject experienced bloody nose. Laboratory data included: Body temperature (NR: not provided) 101 F. On 09-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nasty migraine/ intense pain in the back of neck and head, eyes hurt on 15-MAR-2021, sour stomach, intense body aches, stuffy nose, extremely sick, did not sleep due to flu symptoms, blood shot eyes, and bloody nose, flu like symptoms on 12-MAR-2021, and fever on 11-MAR-2021. This report was non-serious.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: ACHY; WENT TO BED FREEZING; FATIGUE; FEVER; HEADACHE; CHILLS; This spontaneous report received from a patient concerned a 24 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: Unk) dose and site was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot number.  No concomitant medications were reported. On 15-MAR-2021, the subject experienced achy. On 15-MAR-2021, the subject experienced went to bed freezing. On 15-MAR-2021, the subject experienced fatigue. On 15-MAR-2021, the subject experienced fever. On 15-MAR-2021, the subject experienced headache. On 15-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy, went to bed freezing, fatigue, fever, headache, and chills on 16-MAR-2021. This report was non-serious.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Feeling cold, Headache, Pain
Clinical narrative: ACHY; WENT TO BED FREEZING; FATIGUE; FEVER; HEADACHE; CHILLS; This spontaneous report received from a patient concerned a 24 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: Unk) dose and site was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot number.  No concomitant medications were reported. On 15-MAR-2021, the subject experienced achy. On 15-MAR-2021, the subject experienced went to bed freezing. On 15-MAR-2021, the subject experienced fatigue. On 15-MAR-2021, the subject experienced fever. On 15-MAR-2021, the subject experienced headache. On 15-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy, went to bed freezing, fatigue, fever, headache, and chills on 16-MAR-2021. This report was non-serious.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: ACHY; WENT TO BED FREEZING; FATIGUE; FEVER; HEADACHE; CHILLS; This spontaneous report received from a patient concerned a 24 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: Unk) dose and site was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot number.  No concomitant medications were reported. On 15-MAR-2021, the subject experienced achy. On 15-MAR-2021, the subject experienced went to bed freezing. On 15-MAR-2021, the subject experienced fatigue. On 15-MAR-2021, the subject experienced fever. On 15-MAR-2021, the subject experienced headache. On 15-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy, went to bed freezing, fatigue, fever, headache, and chills on 16-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Nausea, Pain, Pyrexia
Clinical narrative: FELT LIKE DEATH; EYES BURNING; MIGRAINE HEADACHES; MENSTRUAL CYCLE AHEAD OF TIME; HEART TROUBLE; FATIGUE; BODY ACHES; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, one total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced heart trouble, felt like death, eyes burning, fever, migraine headaches, fatigue, body aches, and menstrual cycle ahead of time. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart trouble, fever, migraine headaches, fatigue, and body aches, was recovering from felt like death, and the outcome of eyes burning and menstrual cycle ahead of time was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac disorder, Eye irritation, Fatigue, Feeling abnormal, Migraine
Clinical narrative: FELT LIKE DEATH; EYES BURNING; MIGRAINE HEADACHES; MENSTRUAL CYCLE AHEAD OF TIME; HEART TROUBLE; FATIGUE; BODY ACHES; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, one total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced heart trouble, felt like death, eyes burning, fever, migraine headaches, fatigue, body aches, and menstrual cycle ahead of time. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart trouble, fever, migraine headaches, fatigue, and body aches, was recovering from felt like death, and the outcome of eyes burning and menstrual cycle ahead of time was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Polymenorrhoea, Pyrexia
Clinical narrative: FELT LIKE DEATH; EYES BURNING; MIGRAINE HEADACHES; MENSTRUAL CYCLE AHEAD OF TIME; HEART TROUBLE; FATIGUE; BODY ACHES; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, one total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced heart trouble, felt like death, eyes burning, fever, migraine headaches, fatigue, body aches, and menstrual cycle ahead of time. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart trouble, fever, migraine headaches, fatigue, and body aches, was recovering from felt like death, and the outcome of eyes burning and menstrual cycle ahead of time was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Muscular weakness, Nausea, Vomiting
Clinical narrative: NYSTAGMUS; VERTIGO, NAUSEA, VOMITING AND DIZZINESS; FLU-LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a 28 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, alcohol user, non-smoker, and no known allergies. The patient was previously treated with levocetirizine dihydrochloride for seasonal allergies, and budesonide for seasonal allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 16:30 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: dimenhydrinate. On 16-MAR-2021, the subject experienced flu-like symptoms. On 17-MAR-2021, the subject experienced nystagmus. On 17-MAR-2021, the subject experienced vertigo, nausea, vomiting and dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms on 17-MAR-2021, and had not recovered from vertigo, nausea, vomiting and dizziness, and nystagmus. 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: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Nystagmus, Vertigo
Clinical narrative: NYSTAGMUS; VERTIGO, NAUSEA, VOMITING AND DIZZINESS; FLU-LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a 28 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, alcohol user, non-smoker, and no known allergies. The patient was previously treated with levocetirizine dihydrochloride for seasonal allergies, and budesonide for seasonal allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 16:30 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: dimenhydrinate. On 16-MAR-2021, the subject experienced flu-like symptoms. On 17-MAR-2021, the subject experienced nystagmus. On 17-MAR-2021, the subject experienced vertigo, nausea, vomiting and dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms on 17-MAR-2021, and had not recovered from vertigo, nausea, vomiting and dizziness, and nystagmus. 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: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Dyspnoea, Musculoskeletal chest pain, Pain, Painful respiration
Clinical narrative: LEFT RIB CAGE PAIN; MUSCLE TIGHTNESS; DIFFICULTY BREATHING; COUGH; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune hepatitis. The patient experienced drug allergy when treated with erythromycin, and morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 13:50 on left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced cough. On MAR-2021, the subject experienced difficulty breathing. On 14-MAR-2021, the subject experienced left rib cage pain. On 14-MAR-2021, the subject experienced muscle tightness. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from left rib cage pain, and difficulty breathing, and the outcome of cough and muscle tightness was not reported. This report was non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: LEFT RIB CAGE PAIN; MUSCLE TIGHTNESS; DIFFICULTY BREATHING; COUGH; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune hepatitis. The patient experienced drug allergy when treated with erythromycin, and morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 13:50 on left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced cough. On MAR-2021, the subject experienced difficulty breathing. On 14-MAR-2021, the subject experienced left rib cage pain. On 14-MAR-2021, the subject experienced muscle tightness. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from left rib cage pain, and difficulty breathing, and the outcome of cough and muscle tightness was not reported. This report was non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Dyspnoea, Muscle tightness, Musculoskeletal chest pain
Clinical narrative: LEFT RIB CAGE PAIN; MUSCLE TIGHTNESS; DIFFICULTY BREATHING; COUGH; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune hepatitis. The patient experienced drug allergy when treated with erythromycin, and morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 13:50 on left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced cough. On MAR-2021, the subject experienced difficulty breathing. On 14-MAR-2021, the subject experienced left rib cage pain. On 14-MAR-2021, the subject experienced muscle tightness. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from left rib cage pain, and difficulty breathing, and the outcome of cough and muscle tightness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Headache, Sudden onset of sleep
Clinical narrative: DIZZINESS; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 17-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 subject experienced dizziness, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue and dizziness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: DIZZINESS; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 17-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 subject experienced dizziness, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue and dizziness was not reported. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: TIRED; MUSCLE ACHES; HEADACHE; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's past medical history included obesity, depression, gerd, and urinary retention due to lisinopril use:, and concurrent conditions included hypertension, and sulfa allergies, and other pre-existing medical conditions included reaction to flu vaccine some years prior. The patient was previously treated with bupropion for depression, obesity, duloxetine, cetirizine for gerd, pantoprazole for hypertension, lisinopril for urinary retention, and tamsulosin for multi-vitamin maintenance. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029) dose was not reported, administered on 17-MAR-2021 13:45 at right arm for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced tired. On 17-MAR-2021, the subject experienced muscle aches. On 17-MAR-2021, the subject experienced headache. On 17-MAR-2021 21:30:00, treatment medications included: naproxen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired, muscle aches, and headache on 18-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dyspnoea, Pulmonary pain, Tremor
Clinical narrative: SENSATION IN LUNGS; SUDDEN ONSET OF CHILLS; SUDDEN ONSET OF SHAKING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022,expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported.  On 14-MAR-2021, the subject experienced sudden onset of shaking. On 14-MAR-2021, the subject experienced sudden onset of chills. On an unspecified date, the subject experienced sensation in lungs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sudden onset of shaking, and sudden onset of chills, and the outcome of sensation in lungs was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Sensory disturbance, Tremor
Clinical narrative: SENSATION IN LUNGS; SUDDEN ONSET OF CHILLS; SUDDEN ONSET OF SHAKING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022,expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported.  On 14-MAR-2021, the subject experienced sudden onset of shaking. On 14-MAR-2021, the subject experienced sudden onset of chills. On an unspecified date, the subject experienced sensation in lungs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sudden onset of shaking, and sudden onset of chills, and the outcome of sensation in lungs was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: PAINFUL RASH; This spontaneous report received from a patient concerned a 31 year old female. The patient's weight was 155 pounds, and height was 167.64 centimeters. The patient's concurrent conditions included autoimmune celiac, gluten intolerant, and alcohol use, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient had no known allergies. 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 16-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On 21-MAR-2021, the subject experienced painful rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from painful rash. This report was non-serious. Additional information received from patient on 25-Mar-2021. The following information was updated and incorporated into the case narrative: patient (weight, height, age at time of vaccination, patient history text), product (frequency time, vaccine military information) and due diligence correction made.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious