chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain, Pyrexia, Somnolence, Vomiting
Clinical narrative: WEAKNESS; SEVERE HEADACHE; FEVER; STOMACH ACHE; VOMITING; BODY ACHES; DROWSINESS; CHILLS; DID NOT SLEEP WELL; VERY FATIGUE; This spontaneous report received from a patient concerned a 29 year old female. The patient's weight was 170 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: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced did not sleep well. On APR-2021, the subject experienced very fatigue. On 08-APR-2021, the subject experienced stomach ache. On 08-APR-2021, the subject experienced vomiting. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced drowsiness. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced severe headache. On 08-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and fever on 10-APR-2021, and body aches, drowsiness, chills, and weakness on 09-APR-2021, was recovering from stomach ache, had not recovered from severe headache, and the outcome of did not sleep well and very fatigue was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: LITTLE BIT TIREDNESS; This spontaneous report received from a consumer 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: 180Z068, and  expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced little bit tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little bit tiredness was not reported. This report was non-serious. This case, from the same reporter is linked to 20210422535.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Back pain, Biopsy, Cyst
Clinical narrative: JOINT PAIN; INFLAMMATION OF THE RIBS; VAGINAL BLEEDING/CLOTS; CYSTS ABOVE THE LEFT ELBOW; FATIGUE; ANXIETY (TINGLING ALL OVER THE BODY ESPECIALLY THE WAIST, SHORTNESS OF BREATH, WEAKNESS); BACK PAIN; NECK PAIN; This spontaneous report received from a patient. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol consumer, and non-smoker, and other pre-existing medical conditions included patient had no known drug allergies, no relevant medical history prior to the start of these symptoms. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUL-2020, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative, Negative. On 2021, Laboratory data included: Biopsy (NR: not provided) Not reported.  On 28-MAR-2021, the subject experienced anxiety (tingling all over the body especially the waist, shortness of breath, weakness). On 28-MAR-2021, the subject experienced back pain. On 28-MAR-2021, the subject experienced neck pain. On 30-MAR-2021, the subject experienced fatigue. On 31-MAR-2021, the subject experienced vaginal bleeding/clots. On 31-MAR-2021, the subject experienced cysts above the left elbow. On 05-APR-2021, the subject experienced inflammation of the ribs. On 06-APR-2021, the subject experienced joint pain. Treatment medications (dates unspecified) included: paracetamol, salbutamol, norethisterone acetate, trazodone, and hydroxyzine embonate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from cysts above the left elbow, and had not recovered from back pain, neck pain, anxiety (tingling all over the body especially the waist, shortness of breath, weakness), vaginal bleeding/clots, joint pain, fatigue, and inflammation of the ribs. This report was non-serious.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inflammation, Neck pain, SARS-CoV-2 test, Vaginal haemorrhage
Clinical narrative: JOINT PAIN; INFLAMMATION OF THE RIBS; VAGINAL BLEEDING/CLOTS; CYSTS ABOVE THE LEFT ELBOW; FATIGUE; ANXIETY (TINGLING ALL OVER THE BODY ESPECIALLY THE WAIST, SHORTNESS OF BREATH, WEAKNESS); BACK PAIN; NECK PAIN; This spontaneous report received from a patient. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol consumer, and non-smoker, and other pre-existing medical conditions included patient had no known drug allergies, no relevant medical history prior to the start of these symptoms. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUL-2020, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative, Negative. On 2021, Laboratory data included: Biopsy (NR: not provided) Not reported.  On 28-MAR-2021, the subject experienced anxiety (tingling all over the body especially the waist, shortness of breath, weakness). On 28-MAR-2021, the subject experienced back pain. On 28-MAR-2021, the subject experienced neck pain. On 30-MAR-2021, the subject experienced fatigue. On 31-MAR-2021, the subject experienced vaginal bleeding/clots. On 31-MAR-2021, the subject experienced cysts above the left elbow. On 05-APR-2021, the subject experienced inflammation of the ribs. On 06-APR-2021, the subject experienced joint pain. Treatment medications (dates unspecified) included: paracetamol, salbutamol, norethisterone acetate, trazodone, and hydroxyzine embonate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from cysts above the left elbow, and had not recovered from back pain, neck pain, anxiety (tingling all over the body especially the waist, shortness of breath, weakness), vaginal bleeding/clots, joint pain, fatigue, and inflammation of the ribs. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Energy increased, Fatigue, Headache, Hot flush
Clinical narrative: RUNNY NOSE; SLIGHT CONFUSION; HOT FLASHES; HEADACHE; NAUSEA; TIREDNESS; INSOMNIA; EXTRA ENERGY; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 56 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: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced insomnia. On 12-APR-2021, the subject experienced extra energy. On 12-APR-2021, the subject experienced injection site pain. On 13-APR-2021, the subject experienced runny nose. On 13-APR-2021, the subject experienced slight confusion. On 13-APR-2021, the subject experienced hot flashes. On 13-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from insomnia, slight confusion, hot flashes, and nausea on 13-APR-2021, and extra energy, headache, and tiredness on APR-2021, was recovering from injection site pain, and had not recovered from runny nose. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Insomnia, Nausea, Rhinorrhoea
Clinical narrative: RUNNY NOSE; SLIGHT CONFUSION; HOT FLASHES; HEADACHE; NAUSEA; TIREDNESS; INSOMNIA; EXTRA ENERGY; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 56 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: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced insomnia. On 12-APR-2021, the subject experienced extra energy. On 12-APR-2021, the subject experienced injection site pain. On 13-APR-2021, the subject experienced runny nose. On 13-APR-2021, the subject experienced slight confusion. On 13-APR-2021, the subject experienced hot flashes. On 13-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from insomnia, slight confusion, hot flashes, and nausea on 13-APR-2021, and extra energy, headache, and tiredness on APR-2021, was recovering from injection site pain, and had not recovered from runny nose. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Dizziness, Dyspnoea, Headache
Clinical narrative: COUGH; SHORTNESS OF BREATH; SORE THROAT; DIZZY; CHILLS; HEADACHE; NAUSEA; FEVER; This spontaneous report received from a patient via a company representative concerned a 59 year old female. 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 known allergies. the patient had no history of drug abuse or illicit drug.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 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced dizzy. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced sore throat. On 10-APR-2021, the subject experienced cough. On 10-APR-2021, the subject experienced shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy, chills, and nausea on 10-APR-2021, and fever on APR-2021, and had not recovered from headache, sore throat, cough, and shortness of breath. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: COUGH; SHORTNESS OF BREATH; SORE THROAT; DIZZY; CHILLS; HEADACHE; NAUSEA; FEVER; This spontaneous report received from a patient via a company representative concerned a 59 year old female. 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 known allergies. the patient had no history of drug abuse or illicit drug.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 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced dizzy. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced sore throat. On 10-APR-2021, the subject experienced cough. On 10-APR-2021, the subject experienced shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy, chills, and nausea on 10-APR-2021, and fever on APR-2021, and had not recovered from headache, sore throat, cough, and shortness of breath. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling, Ultrasound scan
Clinical narrative: SWELLING OF LEGS; SWELLING FROM BOTTOM TO TOP OF KNEE; This spontaneous report received from a patient concerned a patient 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 was not reported, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced swelling of legs. On 2021, the subject experienced swelling from bottom to top of knee. Laboratory data included: Diagnostic ultrasound (NR: not provided) swelling from bottom to top of knee. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swelling of legs and swelling from bottom to top of knee was not reported. This report was non-serious. This report was associated with a product quality complaint:  The suspected product quality complaint has been confirmed to be void (does not meet criteria) based on the PQC evaluation/investigation performed.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Illness
Clinical narrative: This spontaneous report received from a consumer via a company representative concerned a 20 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 was not reported, administered on APR-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 APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced sickness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, and sickness. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Frequent bowel movements
Clinical narrative: DIARRHEA; STOMACH ACHE; INCREASED BOWEL MOVEMENT; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa-based allergy, non smoker, and abstains from alcohol, and other pre-existing medical conditions included patient has no known medical history and patient has 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: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination.  No concomitant medications were reported. On 13-APR-2021, the subject experienced stomach ache. On 13-APR-2021, the subject experienced increased bowel movement. On 14-APR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stomach ache, and the outcome of increased bowel movement and diarrhea was not reported. This report was non-serious.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: FELT NAUSEOUS; This spontaneous report received from a consumer concerned a 79 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and other pre-existing medical conditions included the patient had no allergies.  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 01-APR-2021 for prophylactic vaccination on right arm. The batch number was not reported and has been requested. No concomitant medications were reported.  On 01-APR-2021, the subject experienced felt nauseous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt nauseous on 07-APR-2021. This report was non-serious.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Eye pain, Fatigue, Headache
Clinical narrative: DIARRHEA; INJECTION SITE REACTION; EYE PAIN; TEETH PAIN; CHILLS; TIREDNESS; HEADACHE; GENERALISED ACHING; This spontaneous report received from a patient concerned a 51 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A and expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced generalised aching. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced tiredness. On 09-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced eye pain. On 10-APR-2021, the subject experienced teeth pain. On 14-APR-2021, the subject experienced injection site reaction. On 14-APR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from generalised aching, and chills on 11-APR-2021, was recovering from tiredness, had not recovered from headache, injection site reaction, eye pain, and teeth pain, and the outcome of diarrhea was not reported. This report was non-serious.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site reaction, Pain, Toothache
Clinical narrative: DIARRHEA; INJECTION SITE REACTION; EYE PAIN; TEETH PAIN; CHILLS; TIREDNESS; HEADACHE; GENERALISED ACHING; This spontaneous report received from a patient concerned a 51 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A and expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced generalised aching. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced tiredness. On 09-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced eye pain. On 10-APR-2021, the subject experienced teeth pain. On 14-APR-2021, the subject experienced injection site reaction. On 14-APR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from generalised aching, and chills on 11-APR-2021, was recovering from tiredness, had not recovered from headache, injection site reaction, eye pain, and teeth pain, and the outcome of diarrhea was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: BODY PAIN; FEVER; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, anxiety, hiv positive, cigarette smoker, half a box daily, and non alcoholic, and other pre-existing medical conditions included patient had no known allergies and no 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: 043A21A, and  expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced body pain. On 10-APR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: naproxen sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body pain, and fever on APR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Urticaria
Clinical narrative: URTICARIA/ITCHY FEELING ALL OVER HIS BODY/HIVES/RED, RAISED BUMPS THAT WAS ALL OVER ARMS, LEGS, BACK, AND BUTTOCKS/ RASH; SORE ARM WHERE GOT THE SHOT; FELT TIRED; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included 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: 1802070, and expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-MAR-2021, the subject experienced sore arm where got the shot. On 05-MAR-2021, the subject experienced felt tired. On 12-APR-2021, the subject experienced urticaria/itchy feeling all over his body/hives/red, raised bumps that was all over arms, legs, back, and buttocks/ rash.  Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, cetirizine hydrochloride, fexofenadine hydrochloride, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm where got the shot, and felt tired on 08-MAR-2021, and had not recovered from urticaria/itchy feeling all over his body/hives/red, raised bumps that was all over arms, legs, back, and buttocks/ rash. This report was non-serious.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: DIARRHEA; This spontaneous report received from a patient concerned a 66 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included cancer.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 02:00 for prophylactic vaccination. Concomitant medications included ibrutinib for cancer.  On 09-APR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: PAINS IN MY LEGS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced pains in my legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pains in my legs was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Drug hypersensitivity, Nasopharyngitis, Pain, Pruritus, Rash
Clinical narrative: COLD SYMPTOMS; STINGING; ITCHING; TYLENOL ALLERGY; FULL-BODY RASH; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received tylenol (form of admin, route of admin, and batch number were not reported) dose and frequency were not reported from APR-2021 for an unspecified indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) 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 APR-2021, the subject experienced cold symptoms. On APR-2021, the subject experienced stinging. On APR-2021, the subject experienced itching. On APR-2021, the subject experienced tylenol allergy. On APR-2021, the subject experienced full-body rash. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with tylenol was not reported. The outcome of the cold symptoms, stinging, itching, full-body rash and tylenol allergy was not reported. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: PAIN ON LEFT SHOULDER; PAIN IN LEFT ARM; This spontaneous report received from a patient concerned a 56 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 and batch number: 185020 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced pain in left arm. On 13-MAR-2021, the subject experienced pain on left shoulder. On 23-MAR-2021, treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain on left shoulder, and pain in left arm. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chest pain, Decreased appetite, Diarrhoea, Dizziness
Clinical narrative: DIZZINESS; DIARRHEA; LOSS OF APPETITE; VOMITING; HEADACHE; NAUSEA; CHEST PAIN; DRY MOUTH; STOMACH PAIN; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and other pre-existing medical conditions included 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: 043A21A expiry: 21-JUN-2021) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. Concomitant medications included metformin for diabetes. On 07-APR-2021, the subject experienced chest pain. On 07-APR-2021, the subject experienced dry mouth. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced stomach pain. On 07-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced dizziness. On 12-APR-2021, the subject experienced diarrhea. On 12-APR-2021, the subject experienced loss of appetite. On 12-APR-2021, the subject experienced vomiting. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from dizziness, and dry mouth, and had not recovered from nausea, headache, vomiting, diarrhea, stomach pain, chest pain, and loss of appetite. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Headache, Nausea, Vomiting
Clinical narrative: DIZZINESS; DIARRHEA; LOSS OF APPETITE; VOMITING; HEADACHE; NAUSEA; CHEST PAIN; DRY MOUTH; STOMACH PAIN; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and other pre-existing medical conditions included 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: 043A21A expiry: 21-JUN-2021) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. Concomitant medications included metformin for diabetes. On 07-APR-2021, the subject experienced chest pain. On 07-APR-2021, the subject experienced dry mouth. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced stomach pain. On 07-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced dizziness. On 12-APR-2021, the subject experienced diarrhea. On 12-APR-2021, the subject experienced loss of appetite. On 12-APR-2021, the subject experienced vomiting. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from dizziness, and dry mouth, and had not recovered from nausea, headache, vomiting, diarrhea, stomach pain, chest pain, and loss of appetite. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Formication, Headache, Injection site bruising
Clinical narrative: NERVE TINGLING; BLISTER UNDER THE TONGUE; TIRED; FATIGUE; HEADACHE; MUSCLE ACHE; INJECTION SITE SORE; INJECTION SITE BRUISED; CRAWLING UNDER THE SKIN; BUZZING; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's past medical history included menopausal, and concurrent conditions included penicilline allergy, sulfa allergy, wheat allergy, alcohol abstain, and non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included paracetamol for spinal stenosis. The batch number was not reported. The Company is unable to perform  follow-up to request batch/lot numbers. On APR-2021, the subject experienced injection site bruised. On APR-2021, the subject experienced crawling under the skin. On APR-2021, the subject experienced buzzing. On APR-2021, the subject experienced injection site sore. On 07-APR-2021, the subject experienced nerve tingling. On 07-APR-2021, the subject experienced blister under the tongue. On 07-APR-2021, the subject experienced tired. On 07-APR-2021, the subject experienced fatigue. On 07-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nerve tingling, blister under the tongue, and headache on 09-APR-2021, and injection site bruised, and injection site sore on APR-2021, and the outcome of tired, fatigue, muscle ache, crawling under the skin and buzzing was not reported. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia, Paraesthesia, Tongue blistering
Clinical narrative: NERVE TINGLING; BLISTER UNDER THE TONGUE; TIRED; FATIGUE; HEADACHE; MUSCLE ACHE; INJECTION SITE SORE; INJECTION SITE BRUISED; CRAWLING UNDER THE SKIN; BUZZING; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's past medical history included menopausal, and concurrent conditions included penicilline allergy, sulfa allergy, wheat allergy, alcohol abstain, and non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included paracetamol for spinal stenosis. The batch number was not reported. The Company is unable to perform  follow-up to request batch/lot numbers. On APR-2021, the subject experienced injection site bruised. On APR-2021, the subject experienced crawling under the skin. On APR-2021, the subject experienced buzzing. On APR-2021, the subject experienced injection site sore. On 07-APR-2021, the subject experienced nerve tingling. On 07-APR-2021, the subject experienced blister under the tongue. On 07-APR-2021, the subject experienced tired. On 07-APR-2021, the subject experienced fatigue. On 07-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nerve tingling, blister under the tongue, and headache on 09-APR-2021, and injection site bruised, and injection site sore on APR-2021, and the outcome of tired, fatigue, muscle ache, crawling under the skin and buzzing was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Pyrexia
Clinical narrative: DIZZY; CHILLS; FEVER; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included antiphospholipid syndrome.  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 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced dizzy. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy, chills, and fever on 09-APR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: SORE ARM; TIREDNESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced sore arm. On 11-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tiredness, and had not recovered from sore arm. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Illness, Insomnia
Clinical narrative: EATING DIFFICULTY; COULDN'T KEEP FOOD DOWN; COULDN'T SLEEP; SORE ACHING BODY; SEVERVELY SICK; CHILLS; BAD HEADACHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not 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 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced eating difficulty. On MAR-2021, the subject experienced couldn't keep food down. On MAR-2021, the subject experienced couldn't sleep. On MAR-2021, the subject experienced sore aching body. On MAR-2021, the subject experienced severvely sick. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced bad headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the eating difficulty, chills, couldn't keep food down, bad headaches, couldn't sleep, sore aching body and severvely sick was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Vomiting
Clinical narrative: EATING DIFFICULTY; COULDN'T KEEP FOOD DOWN; COULDN'T SLEEP; SORE ACHING BODY; SEVERVELY SICK; CHILLS; BAD HEADACHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not 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 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced eating difficulty. On MAR-2021, the subject experienced couldn't keep food down. On MAR-2021, the subject experienced couldn't sleep. On MAR-2021, the subject experienced sore aching body. On MAR-2021, the subject experienced severvely sick. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced bad headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the eating difficulty, chills, couldn't keep food down, bad headaches, couldn't sleep, sore aching body and severvely sick was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Feeling abnormal, Hypokinesia, Pharyngeal disorder, Rash
Clinical narrative: RASH ON CHEST/BACK/SHOULDER/UPPER ARM/NECK/BEHIND EAR/SCALP; HOARSENESS IN VOICE; CLEARING THROAT MORE THAN USUAL; TROUBLE MOVING LEGS; FELT OFF; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included blood sugar, neurological issues, and seasonal allergy. 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 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced felt off. On 25-MAR-2021, the subject experienced hoarseness in voice. On 25-MAR-2021, the subject experienced clearing throat more than usual. On 25-MAR-2021, the subject experienced trouble moving legs. On APR-2021, the subject experienced rash on chest/back/shoulder/upper arm/neck/behind ear/scalp. Treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hoarseness in voice, and clearing throat more than usual on 25-MAR-2021, had not recovered from trouble moving legs, and rash on chest/back/shoulder/upper arm/neck/behind ear/scalp, and the outcome of felt off was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Anxiety, Apathy, Asthenia, Back pain
Clinical narrative: EMOTIONALLY DOWN; BACK PAIN; STOMACH PAIN; ANXIETY; DEPRESSED; NO MOTIVATION TO DO ANYTHING; LEG PAIN; WEAK; HEADACHE; TIRED; BAD BODY PAIN; HIGH FEVER; QUEASY; 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: 042A21A, expiry: 21-JUN-2021) dose was not reported, administered on 07-APR-2021 09:35 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced bad body pain. On 07-APR-2021, the subject experienced high fever. On 07-APR-2021, the subject experienced queasy. Laboratory data included: Body temperature (NR: not provided) 99.9 F. On 09-APR-2021, the subject experienced emotionally down. On 09-APR-2021, the subject experienced back pain. On 09-APR-2021, the subject experienced stomach pain. On 09-APR-2021, the subject experienced anxiety. On 09-APR-2021, the subject experienced depressed. On 09-APR-2021, the subject experienced no motivation to do anything. On 09-APR-2021, the subject experienced leg pain. On 09-APR-2021, the subject experienced weak. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced tired. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bad body pain, high fever, and queasy on 08-APR-2021, had not recovered from weak, headache, depressed, anxiety, stomach pain, leg pain, and back pain, and the outcome of tired, emotionally down and no motivation to do anything was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Depressed mood, Depression, Fatigue, Headache
Clinical narrative: EMOTIONALLY DOWN; BACK PAIN; STOMACH PAIN; ANXIETY; DEPRESSED; NO MOTIVATION TO DO ANYTHING; LEG PAIN; WEAK; HEADACHE; TIRED; BAD BODY PAIN; HIGH FEVER; QUEASY; 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: 042A21A, expiry: 21-JUN-2021) dose was not reported, administered on 07-APR-2021 09:35 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced bad body pain. On 07-APR-2021, the subject experienced high fever. On 07-APR-2021, the subject experienced queasy. Laboratory data included: Body temperature (NR: not provided) 99.9 F. On 09-APR-2021, the subject experienced emotionally down. On 09-APR-2021, the subject experienced back pain. On 09-APR-2021, the subject experienced stomach pain. On 09-APR-2021, the subject experienced anxiety. On 09-APR-2021, the subject experienced depressed. On 09-APR-2021, the subject experienced no motivation to do anything. On 09-APR-2021, the subject experienced leg pain. On 09-APR-2021, the subject experienced weak. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced tired. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bad body pain, high fever, and queasy on 08-APR-2021, had not recovered from weak, headache, depressed, anxiety, stomach pain, leg pain, and back pain, and the outcome of tired, emotionally down and no motivation to do anything was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: EMOTIONALLY DOWN; BACK PAIN; STOMACH PAIN; ANXIETY; DEPRESSED; NO MOTIVATION TO DO ANYTHING; LEG PAIN; WEAK; HEADACHE; TIRED; BAD BODY PAIN; HIGH FEVER; QUEASY; 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: 042A21A, expiry: 21-JUN-2021) dose was not reported, administered on 07-APR-2021 09:35 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced bad body pain. On 07-APR-2021, the subject experienced high fever. On 07-APR-2021, the subject experienced queasy. Laboratory data included: Body temperature (NR: not provided) 99.9 F. On 09-APR-2021, the subject experienced emotionally down. On 09-APR-2021, the subject experienced back pain. On 09-APR-2021, the subject experienced stomach pain. On 09-APR-2021, the subject experienced anxiety. On 09-APR-2021, the subject experienced depressed. On 09-APR-2021, the subject experienced no motivation to do anything. On 09-APR-2021, the subject experienced leg pain. On 09-APR-2021, the subject experienced weak. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced tired. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bad body pain, high fever, and queasy on 08-APR-2021, had not recovered from weak, headache, depressed, anxiety, stomach pain, leg pain, and back pain, and the outcome of tired, emotionally down and no motivation to do anything was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: MILD SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced mild side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild side effects was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Bedridden
Clinical narrative: BEEN IN BED SINCE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not 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 APR-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 an unspecified date, the subject experienced bedridden. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bedridden was not reported. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Pyrexia
Clinical narrative: LETHARGIC; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 58 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, and batch number: 1808973 expiry: 13-JUN-2021) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-MAR-2021, the subject experienced lethargic. On 30-MAR-2021, the subject experienced low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargic, and low grade fever. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cardiovascular disorder, Chills, Dyspnoea, Lethargy, Migraine
Clinical narrative: SHORTNESS OF BREATH; MIGRAINES; CIRCULATION ISSUES; LETHARGY; BODY ACHING; NEUROPATHY PAIN; CHILLS; ARM SORENESS; 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 diabetes, and hypertension.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 2021, the subject experienced migraines. On 2021, the subject experienced circulation issues. On 2021, the subject experienced lethargy. On 2021, the subject experienced body aching. On 2021, the subject experienced neuropathy pain. On 2021, the subject experienced chills. On an unspecified date, the subject experienced shortness of breath, and arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 2021, and arm soreness, and had not recovered from migraines, circulation issues, lethargy, body aching, neuropathy pain, and shortness of breath. This report was non-serious.