chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dyspnoea, Electrocardiogram, Fatigue
Clinical narrative: TIREDNESS/GENERAL FATIGUE; BACK PAIN; CHEST PAIN; INABILITY TO TAKE DEEP BREATHS/BREATHING DIFFICULTIES; FEVER; WEIRD SENSATION; TINGLING IN  FEET AND HANDS; CHILLS; This spontaneous report received from a consumer concerned a 22 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included exercise induced asthma, non smoker, and non alcoholic, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 13-JUL-2021 for prophylactic vaccination. Concomitant medications included salbutamol for exercise induced asthma. On JUL-2021, the subject experienced chills. On 13-JUL-2021, the subject experienced weird sensation. On 13-JUL-2021, the subject experienced tingling in feet and hands. On 13-JUL-2021, the subject experienced fever. On 26-JUL-2021, the subject experienced inability to take deep breaths/breathing difficulties. On 29-JUL-2021, the subject experienced back pain. On 29-JUL-2021, the subject experienced chest pain. Laboratory data included: B-type natriuretic peptide (NR: not provided) no significant findings. Results were considered normal, Bilirubin (NR: not provided) significant results and results were normal, Chest X-ray (NR: not provided) significant results and results were normal, Complete blood count (NR: not provided) no significant findings. Results were considered normal, Comprehensive metabolic panel (NR: not provided) no significant findings. Results were considered normal, Creatine kinase total normal (NR: not provided) no significant findings. Results were considered normal, EKG (NR: not provided) significant results and results were normal, Fibrin D dimer (NR: not provided) no significant findings. Results were considered normal, Respiratory viral panel (NR: not provided) Unknown, SARS-CoV-2 RT-PCR test (NR: not provided) negative, Troponin (NR: not provided) no significant findings. Results were considered normal., and Urinalysis (NR: not provided) no significant findings. Results were considered normal. On an unspecified date, the subject experienced tiredness/general fatigue. Treatment medications (dates unspecified) included: methylprednisolone, and salbutamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from back pain on JUL-2021, and chills, and fever on 19-JUL-2021, had not recovered from inability to take deep breaths/breathing difficulties, and chest pain, and the outcome of tiredness/general fatigue, tingling in feet and hands and weird sensation was not reported. This report was non-serious.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Fibrin D dimer, Full blood count, Metabolic function test, Paraesthesia
Clinical narrative: TIREDNESS/GENERAL FATIGUE; BACK PAIN; CHEST PAIN; INABILITY TO TAKE DEEP BREATHS/BREATHING DIFFICULTIES; FEVER; WEIRD SENSATION; TINGLING IN  FEET AND HANDS; CHILLS; This spontaneous report received from a consumer concerned a 22 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included exercise induced asthma, non smoker, and non alcoholic, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 13-JUL-2021 for prophylactic vaccination. Concomitant medications included salbutamol for exercise induced asthma. On JUL-2021, the subject experienced chills. On 13-JUL-2021, the subject experienced weird sensation. On 13-JUL-2021, the subject experienced tingling in feet and hands. On 13-JUL-2021, the subject experienced fever. On 26-JUL-2021, the subject experienced inability to take deep breaths/breathing difficulties. On 29-JUL-2021, the subject experienced back pain. On 29-JUL-2021, the subject experienced chest pain. Laboratory data included: B-type natriuretic peptide (NR: not provided) no significant findings. Results were considered normal, Bilirubin (NR: not provided) significant results and results were normal, Chest X-ray (NR: not provided) significant results and results were normal, Complete blood count (NR: not provided) no significant findings. Results were considered normal, Comprehensive metabolic panel (NR: not provided) no significant findings. Results were considered normal, Creatine kinase total normal (NR: not provided) no significant findings. Results were considered normal, EKG (NR: not provided) significant results and results were normal, Fibrin D dimer (NR: not provided) no significant findings. Results were considered normal, Respiratory viral panel (NR: not provided) Unknown, SARS-CoV-2 RT-PCR test (NR: not provided) negative, Troponin (NR: not provided) no significant findings. Results were considered normal., and Urinalysis (NR: not provided) no significant findings. Results were considered normal. On an unspecified date, the subject experienced tiredness/general fatigue. Treatment medications (dates unspecified) included: methylprednisolone, and salbutamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from back pain on JUL-2021, and chills, and fever on 19-JUL-2021, had not recovered from inability to take deep breaths/breathing difficulties, and chest pain, and the outcome of tiredness/general fatigue, tingling in feet and hands and weird sensation was not reported. This report was non-serious.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory viral panel, SARS-CoV-2 test, Troponin, Urine analysis
Clinical narrative: TIREDNESS/GENERAL FATIGUE; BACK PAIN; CHEST PAIN; INABILITY TO TAKE DEEP BREATHS/BREATHING DIFFICULTIES; FEVER; WEIRD SENSATION; TINGLING IN  FEET AND HANDS; CHILLS; This spontaneous report received from a consumer concerned a 22 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included exercise induced asthma, non smoker, and non alcoholic, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 13-JUL-2021 for prophylactic vaccination. Concomitant medications included salbutamol for exercise induced asthma. On JUL-2021, the subject experienced chills. On 13-JUL-2021, the subject experienced weird sensation. On 13-JUL-2021, the subject experienced tingling in feet and hands. On 13-JUL-2021, the subject experienced fever. On 26-JUL-2021, the subject experienced inability to take deep breaths/breathing difficulties. On 29-JUL-2021, the subject experienced back pain. On 29-JUL-2021, the subject experienced chest pain. Laboratory data included: B-type natriuretic peptide (NR: not provided) no significant findings. Results were considered normal, Bilirubin (NR: not provided) significant results and results were normal, Chest X-ray (NR: not provided) significant results and results were normal, Complete blood count (NR: not provided) no significant findings. Results were considered normal, Comprehensive metabolic panel (NR: not provided) no significant findings. Results were considered normal, Creatine kinase total normal (NR: not provided) no significant findings. Results were considered normal, EKG (NR: not provided) significant results and results were normal, Fibrin D dimer (NR: not provided) no significant findings. Results were considered normal, Respiratory viral panel (NR: not provided) Unknown, SARS-CoV-2 RT-PCR test (NR: not provided) negative, Troponin (NR: not provided) no significant findings. Results were considered normal., and Urinalysis (NR: not provided) no significant findings. Results were considered normal. On an unspecified date, the subject experienced tiredness/general fatigue. Treatment medications (dates unspecified) included: methylprednisolone, and salbutamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from back pain on JUL-2021, and chills, and fever on 19-JUL-2021, had not recovered from inability to take deep breaths/breathing difficulties, and chest pain, and the outcome of tiredness/general fatigue, tingling in feet and hands and weird sensation was not reported. This report was non-serious.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain assessment, Pain in extremity
Clinical narrative: LEFT LEG PAIN BEHIND THE KNEE AND HURTS TO WALK ON IT; TIREDNESS; This spontaneous report received from a consumer concerned a 51 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no medical history, no allergies and no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 21-JUL-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 22-JUL-2021, the subject experienced tiredness.  On 01-AUG-2021, the subject experienced left leg pain behind the knee and hurts to walk on it. Laboratory data included: Pain scale (NR: not provided) pain 3/10 to leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tiredness and had not recovered from left leg pain behind the knee and hurts to walk on it. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: PUNCTURED VIAL BACK WHICH REMAINED IN THE REFRIGERATOR OVERNIGHT AND WAS USED IN A PATIENT; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 30-JUL-2021, the subject experienced punctured vial back which remained in the refrigerator overnight and was used in a subject. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of punctured vial back which remained in the refrigerator overnight and was used in a patient was not reported. This report was non-serious.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Induration, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: STILL WARM/HOT; CENTRAL AREA IS ABOUT 1.5CM HARD; INJECTION SITE SWELLING; TENDER TO TOUCH; INJECTION SITE REDNESS; INJECTION SITE REACTION; This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included controlled mild hypertension, controlled mild cholesterol, and mild reactive airway disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A and expiry: UNKNOWN) dose was not reported, administered on 27-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-JUL-2021, the subject experienced injection site reaction. On 27-JUL-2021, the subject experienced injection site swelling. On 27-JUL-2021, the subject experienced tender to touch. On 27-JUL-2021, the subject experienced injection site redness. On an unspecified date, the subject experienced still warm/hot, and central area is about 1.5cm hard. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site reaction, injection site redness, still warm/hot, injection site swelling, tender to touch, and central area is about 1.5cm hard. This report was non-serious.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: STILL WARM/HOT; CENTRAL AREA IS ABOUT 1.5CM HARD; INJECTION SITE SWELLING; TENDER TO TOUCH; INJECTION SITE REDNESS; INJECTION SITE REACTION; This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included controlled mild hypertension, controlled mild cholesterol, and mild reactive airway disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A and expiry: UNKNOWN) dose was not reported, administered on 27-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-JUL-2021, the subject experienced injection site reaction. On 27-JUL-2021, the subject experienced injection site swelling. On 27-JUL-2021, the subject experienced tender to touch. On 27-JUL-2021, the subject experienced injection site redness. On an unspecified date, the subject experienced still warm/hot, and central area is about 1.5cm hard. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site reaction, injection site redness, still warm/hot, injection site swelling, tender to touch, and central area is about 1.5cm hard. This report was non-serious.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Electrocardiogram, Seizure
Clinical narrative: SEIZURES; This spontaneous report received from a health care professional concerned a 22 year old. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 02-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 02-AUG-2021, after the vaccination the patient experienced seizures, and also undergone blood pressure and Electrocardiogram (EKG) and was hospitalized for 1 day. The results for blood pressure and EKG were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of seizures was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210802724 -Covid-19 vaccine ad26.cov2.s-Seizures. 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: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Injection site pain, Pruritus, Rash erythematous, Rash pruritic
Clinical narrative: ITCHING ALL OVER BODY; FELT HEAT ALL OVER BODY; ITCHY RASH; RED RASH WITH DIAMETER AS 1/2 INCH TO 1 INCH ON SHOULDERS LEGS AND ARMS WITH NO SWELLING; ACHE ON LEFT ARM WHERE VACCINE GIVEN; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included abnormal cholesterol, and other pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: UNKNOWN) dose was not reported, administered on 28-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-JUL-2021, the subject experienced ache on left arm where vaccine given. On 01-AUG-2021, the subject experienced itching all over body. On 01-AUG-2021, the subject experienced felt heat all over body. On 01-AUG-2021, the subject experienced itchy rash. On 01-AUG-2021, the subject experienced red rash with diameter as 1/2 inch to 1 inch on shoulders legs and arms with no swelling. On 02-AUG-2021, treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching all over body, red rash with diameter as 1/2 inch to 1 inch on shoulders legs and arms with no swelling, felt heat all over body, and itchy rash, and the outcome of ache on left arm where vaccine given was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: NORMAL REACTIONS AFTER BEING VACCINATED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination.  The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported.  On an unspecified date, the subject experienced normal reactions after being vaccinated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of normal reactions after being vaccinated was not reported. This report was non-serious.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chest pain, Dyspnoea, Influenza like illness, Sputum increased
Clinical narrative: STOMACH HURT; SHORTNESS OF BREATH; CHEST PAIN; FLU LIKE SYMPTOMS(COLD, CHILLS, HEADACHE, HEAD CONGESTION AND SICK); LOT OF MUCUS; This spontaneous report received from a consumer concerned a 56 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and low platelet count. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 21-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-JUL-2021, the subject experienced flu like symptoms (cold, chills, headache, head congestion and sick). On 21-JUL-2021, the subject experienced lot of mucus. On 25-JUL-2021, the subject experienced chest pain. On 25-JUL-2021, the subject experienced shortness of breath. On an unspecified date, the subject experienced stomach hurt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu like symptoms(cold, chills, headache, head congestion and sick), lot of mucus, stomach hurt, chest pain, and shortness of breath. 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: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE ADMINISTERED 35 MINUTES AFTER 2 HOUR LIMIT AT ROOM TEMPERATURE; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a 59 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, the subject experienced vaccine administered 35 minutes after 2 hour limit at room temperature. On 02-AUG-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered 35 minutes after 2 hour limit at room temperature and incorrect product storage was not reported. This report was non-serious.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Exposure during pregnancy, Pyrexia, Vomiting
Clinical narrative: Maternal exposure during pregnancy; Vomiting; Chills; Fever 101.5 degrees Fahrenheit; This solicited pregnancy report received from a consumer concerned a 30 year old female. The patient was enrolled in a non-company sponsored study  Registryt number: C06669). The patient's weight was 47.62 kilograms, and height was 152 centimeters. No past medical history or concurrent conditions were reported. The patient was gravida 1, para 0. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 05-APR-2021 for covid-19 immunisation. No concomitant medications were reported.  On 05-APR-2021, the patient experienced maternal exposure during pregnancy. On 05-APR-2021, the patient experienced vomiting. On 05-APR-2021, the patient experienced chills. On 05-APR-2021, the patient experienced fever 101.5 degrees fahrenheit. The date of the patient's last menstrual period was 30-JAN-2021. Laboratory data (dates unspecified) included: Fever (NR: not provided) 101.5 degrees Fahrenheit. The pregnancy was continuing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, chills, and fever 101.5 degrees fahrenheit on 06-APR-2021, and the outcome of maternal exposure during pregnancy was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and vomiting, chills, and fever 101.5 degrees fahrenheit as related. The reporter did not provide a causality assessment between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy. Company causality between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy was not related and company causality between covid-19 vaccine ad26.cov2.s, and vomiting, chills, and fever 101.5 degrees fahrenheit as related. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Oropharyngeal pain, Poor quality product administered, Pyrexia
Clinical narrative: SORE THROAT; HEADACHE; FEVER; PAIN AT THE INJECTION SITE; VACCINES WERE GIVEN OUTSIDE OF THE 6 HOUR TIME FRAME; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 29-JUL-2021, the subject experienced vaccines were given outside of the 6 hour time frame. On an unspecified date, the subject experienced sore throat, headache, fever, and pain at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, sore throat, fever, pain at the injection site and vaccines were given outside of the 6 hour time frame was not reported. This report was non-serious. This case, from the same reporter is linked to 20210802909 and 20210803269.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pain, Pyrexia
Clinical narrative: TERRIBLE PAIN; FEEL ROTTEN/SICK; NAUSEA; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 31-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 01-AUG-2021, the subject experienced terrible pain. On 01-AUG-2021, the subject experienced feel rotten/sick. On 01-AUG-2021, the subject experienced nausea. On 01-AUG-2021, the subject experienced fever. Laboratory data included: Fever (NR: not provided) 102.4 (unit not reported). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, terrible pain, fever, and feel rotten/sick. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: USED SHORTER THAN RECOMMENDED NEEDLE LENGTH FOR ADMINISTRATION; This spontaneous report received from a pharmacist concerned a male of unspecified age. The patient's weight was 294 pounds, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-AUG-2021, the subject experienced used shorter than recommended needle length for administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of used shorter than recommended needle length for administration was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Oropharyngeal pain, Poor quality product administered, Product storage error
Clinical narrative: SORE THROAT; HEADACHE; FEVER; PAIN AT THE INJECTION SITE; VACCINE ADMINISTERED OUTSIDE OF THE 6 HOUR TIME FRAME OF STORAGE CONDITION; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 29-JUL-2021, the subject experienced vaccine administered outside of the 6 hour time frame of storage condition. On 29-JUL-2021, the subject experienced out of specification product use. On an unspecified date, the subject experienced sore throat, headache, fever, and pain at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, sore throat, fever, pain at the injection site, vaccine administered outside of the 6 hour time frame of storage condition and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210802801.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: SORE THROAT; HEADACHE; FEVER; PAIN AT THE INJECTION SITE; VACCINE ADMINISTERED OUTSIDE OF THE 6 HOUR TIME FRAME OF STORAGE CONDITION; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 29-JUL-2021, the subject experienced vaccine administered outside of the 6 hour time frame of storage condition. On 29-JUL-2021, the subject experienced out of specification product use. On an unspecified date, the subject experienced sore throat, headache, fever, and pain at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, sore throat, fever, pain at the injection site, vaccine administered outside of the 6 hour time frame of storage condition and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210802801.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Palpitations
Clinical narrative: PALPITATIONS; DIZZINESS; SLIGHT HEADACHE; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 08-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-JUL-2021, the subject experienced palpitations. On 08-JUL-2021, the subject experienced dizziness. On 08-JUL-2021, the subject experienced slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from palpitations, dizziness, and slight headache on 08-JUL-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: HIGHLY SENSITIVE SKIN; CHILLS; FEVER AT 101 DEGREES; EXTREME FATIGUE(COULDN'T GET OUT OF BED OR EAT FOR 8 HOURS); HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced highly sensitive skin, chills, fever at 101 degrees, extreme fatigue (couldn't get out of bed or eat for 8 hours), and headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, highly sensitive skin, fever at 101 degrees, extreme fatigue(couldn't get out of bed or eat for 8 hours) and headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Sensitive skin
Clinical narrative: HIGHLY SENSITIVE SKIN; CHILLS; FEVER AT 101 DEGREES; EXTREME FATIGUE(COULDN'T GET OUT OF BED OR EAT FOR 8 HOURS); HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced highly sensitive skin, chills, fever at 101 degrees, extreme fatigue (couldn't get out of bed or eat for 8 hours), and headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, highly sensitive skin, fever at 101 degrees, extreme fatigue(couldn't get out of bed or eat for 8 hours) and headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: FEVER; TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced fever, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and tired. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypoaesthesia, Injection site warmth, Insomnia
Clinical narrative: NUMBNESS; MINOR TINGLING; SHARP PAIN IN THE LEFT SIDE OF NECK; UNABLE TO GET LONG PERIOD OF SLEEP; WARM AT THE SITE OF INJECTION; VOMITING; NAUSEA; FATIGUE; BLINDING HEADACHE; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 27-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 27-JUL-2021, the subject experienced unable to get long period of sleep. On 27-JUL-2021, the subject experienced warm at the site of injection. On 27-JUL-2021, the subject experienced vomiting. On 27-JUL-2021, the subject experienced nausea. On 27-JUL-2021, the subject experienced fatigue. On 27-JUL-2021, the subject experienced blinding headache. On an unspecified date, the subject experienced sharp pain in the left side of neck, numbness, and minor tingling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from warm at the site of injection on 31-JUL-2021, was recovering from blinding headache, fatigue, unable to get long period of sleep, nausea, and vomiting, had not recovered from minor tingling, and numbness, and the outcome of sharp pain in the left side of neck was not reported. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Paraesthesia, Vomiting
Clinical narrative: NUMBNESS; MINOR TINGLING; SHARP PAIN IN THE LEFT SIDE OF NECK; UNABLE TO GET LONG PERIOD OF SLEEP; WARM AT THE SITE OF INJECTION; VOMITING; NAUSEA; FATIGUE; BLINDING HEADACHE; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 27-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 27-JUL-2021, the subject experienced unable to get long period of sleep. On 27-JUL-2021, the subject experienced warm at the site of injection. On 27-JUL-2021, the subject experienced vomiting. On 27-JUL-2021, the subject experienced nausea. On 27-JUL-2021, the subject experienced fatigue. On 27-JUL-2021, the subject experienced blinding headache. On an unspecified date, the subject experienced sharp pain in the left side of neck, numbness, and minor tingling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from warm at the site of injection on 31-JUL-2021, was recovering from blinding headache, fatigue, unable to get long period of sleep, nausea, and vomiting, had not recovered from minor tingling, and numbness, and the outcome of sharp pain in the left side of neck was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: HURTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced hurts. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hurts was not reported. This report was non-serious.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Injection site hypersensitivity, Injection site pruritus, Injection site reaction, Pain
Clinical narrative: INJECTION SITE REACTION ALONG WITH BODY; TINGLING ARM; SENSITIVE AT THE SITE OF INJECTION; BODY ACHES; ITCHINESS AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included alcohol use, and non smoker, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A23A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Concomitant medications included vitamins nos.  On JUL-2021, Laboratory data included: Blood test (NR: not provided) reports were not received., and COVID-19 virus test (NR: not provided) Negative.  On 26-JUL-2021, the subject experienced body aches. On 26-JUL-2021, the subject experienced itchiness at the injection site. On 26-JUL-2021, the subject experienced tingling arm. On 26-JUL-2021, the subject experienced sensitive at the site of injection. On an unspecified date, the subject experienced injection site reaction along with body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site reaction along with body, and was recovering from body aches, itchiness at the injection site, tingling arm, and sensitive at the site of injection. This report was non-serious.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, SARS-CoV-2 test
Clinical narrative: INJECTION SITE REACTION ALONG WITH BODY; TINGLING ARM; SENSITIVE AT THE SITE OF INJECTION; BODY ACHES; ITCHINESS AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included alcohol use, and non smoker, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A23A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Concomitant medications included vitamins nos.  On JUL-2021, Laboratory data included: Blood test (NR: not provided) reports were not received., and COVID-19 virus test (NR: not provided) Negative.  On 26-JUL-2021, the subject experienced body aches. On 26-JUL-2021, the subject experienced itchiness at the injection site. On 26-JUL-2021, the subject experienced tingling arm. On 26-JUL-2021, the subject experienced sensitive at the site of injection. On an unspecified date, the subject experienced injection site reaction along with body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site reaction along with body, and was recovering from body aches, itchiness at the injection site, tingling arm, and sensitive at the site of injection. This report was non-serious.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Insomnia, Myalgia, Pain in extremity
Clinical narrative: NOT ABLE TO SLEEP; LEFT ARM SORENESS; SHOULDER AND UNDER NECK MUSCLE SORENESS; CHILLS; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid. On 11-MAY-2021, the subject experienced chills. On 24-MAY-2021, the subject experienced shoulder and under neck muscle soreness. On 07-JUN-2021, the subject experienced not able to sleep. On 07-JUN-2021, the subject experienced left arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from not able to sleep, and left arm soreness on 14-JUN-2021, chills on 11-MAY-2021, and shoulder and under neck muscle soreness on 24-MAY-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: UNEXPECTED THERAPEUTIC BENEFIT; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included latex allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A2IA expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, the subject experienced unexpected therapeutic benefit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unexpected therapeutic benefit was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Adverse event, Chest pain, Chills, Diarrhoea
Clinical narrative: STRONG COUGH WITH PHLEGM; DIARRHEA; SHIVERS; FEVER; HEADACHE; CHEST HURT; STOMACH HURT; NASAL SECRETION; VACCINE ALMOST KILLED ME; UNKNOWN SIDE EFFECTS; IN BED ALL THE TIME; COUGH FOR 10 DAYS AND NOW WITH BLOOD; This spontaneous report received from a patient concerned a 22 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was healthy young man with no previous health conditions. the patient was taking antibiotics, inhalers and expectorants. 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 07-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On JUL-2021, the subject experienced cough for 10 days and now with blood. On JUL-2021, the subject experienced chest hurt. On JUL-2021, the subject experienced stomach hurt. On JUL-2021, the subject experienced nasal secretion. On JUL-2021, the subject experienced vaccine almost killed me. On JUL-2021, the subject experienced unknown side effects. On JUL-2021, the subject experienced in bed all the time. On JUL-2021, the subject experienced headache. On 08-JUL-2021, the subject experienced strong cough with phlegm. On 08-JUL-2021, the subject experienced diarrhea. On 08-JUL-2021, the subject experienced shivers. On 08-JUL-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, shivers, diarrhea, strong cough with phlegm, cough for 10 days and now with blood, chest hurt, stomach hurt, nasal secretion, headache, vaccine almost killed me, unknown side effects and in bed all the time was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Haemoptysis, Headache, Productive cough, Pyrexia, Rhinorrhoea
Clinical narrative: STRONG COUGH WITH PHLEGM; DIARRHEA; SHIVERS; FEVER; HEADACHE; CHEST HURT; STOMACH HURT; NASAL SECRETION; VACCINE ALMOST KILLED ME; UNKNOWN SIDE EFFECTS; IN BED ALL THE TIME; COUGH FOR 10 DAYS AND NOW WITH BLOOD; This spontaneous report received from a patient concerned a 22 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was healthy young man with no previous health conditions. the patient was taking antibiotics, inhalers and expectorants. 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 07-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On JUL-2021, the subject experienced cough for 10 days and now with blood. On JUL-2021, the subject experienced chest hurt. On JUL-2021, the subject experienced stomach hurt. On JUL-2021, the subject experienced nasal secretion. On JUL-2021, the subject experienced vaccine almost killed me. On JUL-2021, the subject experienced unknown side effects. On JUL-2021, the subject experienced in bed all the time. On JUL-2021, the subject experienced headache. On 08-JUL-2021, the subject experienced strong cough with phlegm. On 08-JUL-2021, the subject experienced diarrhea. On 08-JUL-2021, the subject experienced shivers. On 08-JUL-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, shivers, diarrhea, strong cough with phlegm, cough for 10 days and now with blood, chest hurt, stomach hurt, nasal secretion, headache, vaccine almost killed me, unknown side effects and in bed all the time was not reported. This report was non-serious.