chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Wound
Clinical narrative: BLEEDING BUMPS/HIVES; TERRIBLE ITCHING; HIVES ALL OVER BODY; This spontaneous report received from a consumer concerned a male 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: 1805031 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 14:00 on right arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: diphenhydramine hydrochloride, hydrocortisone acetate, and paraffin, liquid/petrolatum/wool fat. On 13-MAR-2021, the subject experienced bleeding bumps/hives. On 13-MAR-2021, the subject experienced terrible itching. On 13-MAR-2021, the subject experienced hives all over body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hives all over body, terrible itching, and bleeding bumps/hives. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SERIOUS REACTIONS; This spontaneous report received from a vaccine facility 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 was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 16-MAR-2021, the subject experienced serious reactions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of serious reactions was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Gait disturbance, Pain
Clinical narrative: ACHES; DIFFICULTY WALKING; JOINT PAIN; TIRED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's past medical history included several joint replacements, and flu, and concurrent conditions included severe arthritis, and scoliosis. The patient had no known allergies. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 15-MAR-2021, the subject experienced aches. On 15-MAR-2021, the subject experienced difficulty walking. On 15-MAR-2021, the subject experienced joint pain. On 15-MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from aches, joint pain, tired, and difficulty walking. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: RASH ON THIGH AND UPPER CALF; DULL ACHING IN SAME LEG AS RASH; This spontaneous report received from a patient concerned an adult female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered in left deltoid on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 14-MAR-2021, the subject experienced rash on thigh and upper calf. On 14-MAR-2021, the subject experienced dull aching in same leg as rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash on thigh and upper calf and dull aching in same leg as rash was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Dizziness, Feeling hot, Mobility decreased
Clinical narrative: FIDGEDITY/NERVOUSNESS; PAIN IN SHOULDER DOWN HIS SIDES; NAUSEA; COUGH; FEELS HOT ON THE INSIDE; DIZZINESS; MOBILITY PROBLEM AT SITE OF INJECTION; 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 COPD, stent, defibrillator, and hay fever. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unkown) dose was not reported, administered on 17-MAR-2021,14:25 at right arm for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number.   No concomitant medications were reported. On 17-MAR-2021, the subject experienced cough. On 17-MAR-2021, the subject experienced feels hot on the inside. On 17-MAR-2021, the subject experienced dizziness. On 17-MAR-2021, the subject experienced mobility problem at site of injection. On 17-MAR-2021, the subject experienced pain in shoulder down his sides. On 17-MAR-2021, the subject experienced nausea. On an unspecified date, the subject experienced fidgedity/nervousness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in shoulder down his sides, nausea, cough, feels hot on the inside, dizziness, and fidgedity/nervousness, and the outcome of mobility problem at site of injection was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Nervousness
Clinical narrative: FIDGEDITY/NERVOUSNESS; PAIN IN SHOULDER DOWN HIS SIDES; NAUSEA; COUGH; FEELS HOT ON THE INSIDE; DIZZINESS; MOBILITY PROBLEM AT SITE OF INJECTION; 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 COPD, stent, defibrillator, and hay fever. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unkown) dose was not reported, administered on 17-MAR-2021,14:25 at right arm for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number.   No concomitant medications were reported. On 17-MAR-2021, the subject experienced cough. On 17-MAR-2021, the subject experienced feels hot on the inside. On 17-MAR-2021, the subject experienced dizziness. On 17-MAR-2021, the subject experienced mobility problem at site of injection. On 17-MAR-2021, the subject experienced pain in shoulder down his sides. On 17-MAR-2021, the subject experienced nausea. On an unspecified date, the subject experienced fidgedity/nervousness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in shoulder down his sides, nausea, cough, feels hot on the inside, dizziness, and fidgedity/nervousness, and the outcome of mobility problem at site of injection was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: MILD HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 17-MAR-2021, the subject experienced mild headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mild headache. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: VERY HIGH FEVER; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced very high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of very high fever was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea, Vertigo
Clinical narrative: VERTIGO; NAUSEA; FREEZING/CHILLS; This spontaneous report received from a patient concerned a 30 year old white male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no relevant medical history. 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 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced freezing/chills. On 15-MAR-2021, the subject experienced vertigo. On 15-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from freezing/chills on 13-MAR-2021, and was recovering from vertigo, and nausea. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest discomfort, Chills, Cold sweat, Dehydration
Clinical narrative: HIVES; RASH; FATIGUE; CHILLS; HEADACHE; 101F FEVER; COLD SWEATS; SHORTNESS OF BREATH; DIZZINESS; TINGLINESS; SEVERE BODY PAIN; DEHYDRATION; CHEST TIGHTNESS; FINGERS CURLING UP; TOES CURLING UP; SWEATING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: 25-MAY-2021) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced cold sweats. On 13-MAR-2021, the subject experienced shortness of breath. On 13-MAR-2021, the subject experienced dizziness. On 13-MAR-2021, the subject experienced tingliness. On 13-MAR-2021, the subject experienced severe body pain. On 13-MAR-2021, the subject experienced dehydration. On 13-MAR-2021, the subject experienced chest tightness. On 13-MAR-2021, the subject experienced fingers curling up. On 13-MAR-2021, the subject experienced toes curling up. On 13-MAR-2021, the subject experienced sweating. On 13-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced 101f fever. Laboratory data included: Body temperature (NR: not provided) 101 F. On 14-MAR-2021, the subject experienced fatigue. On 15-MAR-2021, the subject experienced rash. On 15-MAR-2021, the subject experienced hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold sweats, shortness of breath, dizziness, tingliness, and chest tightness on 13-MAR-2021, and severe body pain, dehydration, fingers curling up, toes curling up, sweating, chills, headache, and 101f fever on 14-MAR-2021, and was recovering from fatigue, rash, and hives. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Finger deformity, Foot deformity
Clinical narrative: HIVES; RASH; FATIGUE; CHILLS; HEADACHE; 101F FEVER; COLD SWEATS; SHORTNESS OF BREATH; DIZZINESS; TINGLINESS; SEVERE BODY PAIN; DEHYDRATION; CHEST TIGHTNESS; FINGERS CURLING UP; TOES CURLING UP; SWEATING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: 25-MAY-2021) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced cold sweats. On 13-MAR-2021, the subject experienced shortness of breath. On 13-MAR-2021, the subject experienced dizziness. On 13-MAR-2021, the subject experienced tingliness. On 13-MAR-2021, the subject experienced severe body pain. On 13-MAR-2021, the subject experienced dehydration. On 13-MAR-2021, the subject experienced chest tightness. On 13-MAR-2021, the subject experienced fingers curling up. On 13-MAR-2021, the subject experienced toes curling up. On 13-MAR-2021, the subject experienced sweating. On 13-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced 101f fever. Laboratory data included: Body temperature (NR: not provided) 101 F. On 14-MAR-2021, the subject experienced fatigue. On 15-MAR-2021, the subject experienced rash. On 15-MAR-2021, the subject experienced hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold sweats, shortness of breath, dizziness, tingliness, and chest tightness on 13-MAR-2021, and severe body pain, dehydration, fingers curling up, toes curling up, sweating, chills, headache, and 101f fever on 14-MAR-2021, and was recovering from fatigue, rash, and hives. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Pain, Paraesthesia, Pyrexia
Clinical narrative: HIVES; RASH; FATIGUE; CHILLS; HEADACHE; 101F FEVER; COLD SWEATS; SHORTNESS OF BREATH; DIZZINESS; TINGLINESS; SEVERE BODY PAIN; DEHYDRATION; CHEST TIGHTNESS; FINGERS CURLING UP; TOES CURLING UP; SWEATING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: 25-MAY-2021) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced cold sweats. On 13-MAR-2021, the subject experienced shortness of breath. On 13-MAR-2021, the subject experienced dizziness. On 13-MAR-2021, the subject experienced tingliness. On 13-MAR-2021, the subject experienced severe body pain. On 13-MAR-2021, the subject experienced dehydration. On 13-MAR-2021, the subject experienced chest tightness. On 13-MAR-2021, the subject experienced fingers curling up. On 13-MAR-2021, the subject experienced toes curling up. On 13-MAR-2021, the subject experienced sweating. On 13-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced 101f fever. Laboratory data included: Body temperature (NR: not provided) 101 F. On 14-MAR-2021, the subject experienced fatigue. On 15-MAR-2021, the subject experienced rash. On 15-MAR-2021, the subject experienced hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold sweats, shortness of breath, dizziness, tingliness, and chest tightness on 13-MAR-2021, and severe body pain, dehydration, fingers curling up, toes curling up, sweating, chills, headache, and 101f fever on 14-MAR-2021, and was recovering from fatigue, rash, and hives. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: HIVES; RASH; FATIGUE; CHILLS; HEADACHE; 101F FEVER; COLD SWEATS; SHORTNESS OF BREATH; DIZZINESS; TINGLINESS; SEVERE BODY PAIN; DEHYDRATION; CHEST TIGHTNESS; FINGERS CURLING UP; TOES CURLING UP; SWEATING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: 25-MAY-2021) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced cold sweats. On 13-MAR-2021, the subject experienced shortness of breath. On 13-MAR-2021, the subject experienced dizziness. On 13-MAR-2021, the subject experienced tingliness. On 13-MAR-2021, the subject experienced severe body pain. On 13-MAR-2021, the subject experienced dehydration. On 13-MAR-2021, the subject experienced chest tightness. On 13-MAR-2021, the subject experienced fingers curling up. On 13-MAR-2021, the subject experienced toes curling up. On 13-MAR-2021, the subject experienced sweating. On 13-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced 101f fever. Laboratory data included: Body temperature (NR: not provided) 101 F. On 14-MAR-2021, the subject experienced fatigue. On 15-MAR-2021, the subject experienced rash. On 15-MAR-2021, the subject experienced hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold sweats, shortness of breath, dizziness, tingliness, and chest tightness on 13-MAR-2021, and severe body pain, dehydration, fingers curling up, toes curling up, sweating, chills, headache, and 101f fever on 14-MAR-2021, and was recovering from fatigue, rash, and hives. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: HALF AND INCH LUMP UNDER VACCINATION SITE; SORENESS AT INJECTION SITE; SWELLING AT INJECTION SITE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: 25-MAY-2021) dose was not reported, administered on 10-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced swelling at injection site. On 18-MAR-2021, the subject experienced half and inch lump under vaccination site. On 18-MAR-2021, the subject experienced soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from half and inch lump under vaccination site, and soreness at injection site, and the outcome of swelling at injection site was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash macular
Clinical narrative: RED BLOTCHES LIKE RASH (APPROXIMATELY DOZEN AND A HALF ON BODY THAT ARE UPTO AN INCH ACROSS IN APPEARANCE); RASH; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, 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: 1805029) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced red blotches like rash (approximately dozen and a half on body that are upto an inch across in appearance). On 13-MAR-2021, the subject experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the red blotches like rash (approximately dozen and a half on body that are upto an inch across in appearance) and rash was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: SYMPTOMS LIKE COLD AND RUNNY NOSE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 17-MAR-2021, the subject experienced symptoms like cold and runny nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of symptoms like cold and runny nose was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: FEELING WEAK AND DRAINED; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included crohn's disease. 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 no was not known and has been requested. Concomitant medications included adalimumab for crohn's disease.  On MAR-2021, the subject experienced feeling weak and drained. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient had not recovered from feeling weak and drained. This report was non-serious.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Tinnitus
Clinical narrative: EAR RINGING; FATIGUE; This spontaneous report received from a consumer concerned a 90 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included unspecified medical issues, and fatigued.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,) dose was not reported, administered on 14-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 14-MAR-2021, the subject experienced ear ringing. On 14-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, and the outcome of ear ringing was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Ear pain, Headache, Nasopharyngitis, Pain in extremity
Clinical narrative: EARACHE; COLD; SORE ARM; HEADACHE; 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 12-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 earache. On MAR-2021, the subject experienced cold. On MAR-2021, the subject experienced sore arm. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, sore arm, cold and earache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: LITTLE BIT SORE ARM; LITTLE TIRED; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 16-MAR-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 MAR-2021, the subject experienced little bit sore arm. On MAR-2021, the subject experienced little tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the little bit sore arm and little tired was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: MILD HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-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 an unspecified date, the subject experienced mild headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild headache was not reported. This report was non-serious.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Breath sounds abnormal, Chest X-ray, Condition aggravated, Dyspnoea
Clinical narrative: FULLNESS; OXYGEN LEVEL NOT GREAT; TROUBLE BREATHING; NOT SLEEPING WELL; FELT WORSE; RASPING; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included copd, cigarette smoking, thyroid disorder, hip replacement, brain tumor, high cholesterol, alcohol user, dry mouth, anaphylactic reaction from carboplatin, drugged feeling like floating at full strength, and exhaustion, and other pre-existing medical conditions included no thyroid but takes thyroid replacement. The patient experienced drug allergy when treated with moxifloxacin hydrochloride for drug use for unknown indication, and drug allergy when treated with venlafaxine hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 at right arm for prophylactic vaccination.  Concomitant medications included salbutamol for copd. On MAR-2021, the subject experienced rasping. On 10-MAR-2021, the subject experienced trouble breathing. On 10-MAR-2021, the subject experienced not sleeping well. On 10-MAR-2021, the subject experienced felt worse. On 15-MAR-2021, the subject experienced oxygen level not great.  Laboratory data included: Chest X-ray (NR: not provided) clear, and Oxygen saturation decreased (NR: not provided) not great. Treatment medications included: erythromycin, and fluticasone propionate. On an unspecified date, the subject experienced fullness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from trouble breathing on 18-MAR-2021, and not sleeping well, felt worse, and rasping on 15-MAR-2021, and the outcome of fullness and oxygen level not great was not reported. This report was non-serious.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Poor quality sleep
Clinical narrative: FULLNESS; OXYGEN LEVEL NOT GREAT; TROUBLE BREATHING; NOT SLEEPING WELL; FELT WORSE; RASPING; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included copd, cigarette smoking, thyroid disorder, hip replacement, brain tumor, high cholesterol, alcohol user, dry mouth, anaphylactic reaction from carboplatin, drugged feeling like floating at full strength, and exhaustion, and other pre-existing medical conditions included no thyroid but takes thyroid replacement. The patient experienced drug allergy when treated with moxifloxacin hydrochloride for drug use for unknown indication, and drug allergy when treated with venlafaxine hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 at right arm for prophylactic vaccination.  Concomitant medications included salbutamol for copd. On MAR-2021, the subject experienced rasping. On 10-MAR-2021, the subject experienced trouble breathing. On 10-MAR-2021, the subject experienced not sleeping well. On 10-MAR-2021, the subject experienced felt worse. On 15-MAR-2021, the subject experienced oxygen level not great.  Laboratory data included: Chest X-ray (NR: not provided) clear, and Oxygen saturation decreased (NR: not provided) not great. Treatment medications included: erythromycin, and fluticasone propionate. On an unspecified date, the subject experienced fullness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from trouble breathing on 18-MAR-2021, and not sleeping well, felt worse, and rasping on 15-MAR-2021, and the outcome of fullness and oxygen level not great was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: BODY ACHING; HEADACHE; 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 17-MAR-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 MAR-2021, the subject experienced body aching. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and body aching was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Nausea, Taste disorder
Clinical narrative: NAUSEA; LOSS OF APPETITE; TASTE WAS OFF; CHILLS AROUND 11-12 PM AT NIGHT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight was 130 pounds, and height was 67 inches. The patient's concurrent conditions included egg allergy, sulfa drugs allergy, and anaphylactic to pcn/sulfa drugs, and other pre-existing medical conditions included no drug abuse or illicit drug use. For antibiotics, she can only take zpack/ erythromycin due to reported allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered at around 16:15 on left arm on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced chills around 11-12 pm at night. On 18-MAR-2021, the subject experienced loss of appetite. On 18-MAR-2021, the subject experienced taste was off. On 18-MAR-2021 08:00, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 18-MAR-2021, and was recovering from chills around 11-12 pm at night, loss of appetite, and taste was off. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: TOOK ME DOWN FOR A DAY; 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, 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 2021, the subject experienced took me down for a day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from took me down for a day on 2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Faeces discoloured, Headache, Nausea
Clinical narrative: HEADACHE; BLACK STOOL; NAUSEA; 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 non smoker, and other pre-existing medical conditions included the patient did not had no known drug allergies. The caller did not wish to provide medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on right arm on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced black stool. On 14-MAR-2021, the subject experienced nausea. On 15-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, and headache on MAR-2021, and had not recovered from black stool. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: FATIGUE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, 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 fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fatigue was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dyspnoea, Injection site pain, Nasopharyngitis
Clinical narrative: HARD TIME BREATHING; COLD; CHILLS; FEVER; PAIN AT INJECTION SITE; This spontaneous report received from a parent concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 14-MAR-2021 10:15 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 14-MAR-2021, the subject experienced cold. On 14-MAR-2021, the subject experienced chills. On 14-MAR-2021, the subject experienced fever. On 14-MAR-2021, the subject experienced pain at injection site. Laboratory data included: Body temperature (NR: not provided) 101 F. On an unspecified date, the subject experienced hard time breathing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, chills, cold, pain at injection site, and hard time breathing. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: HARD TIME BREATHING; COLD; CHILLS; FEVER; PAIN AT INJECTION SITE; This spontaneous report received from a parent concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 14-MAR-2021 10:15 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 14-MAR-2021, the subject experienced cold. On 14-MAR-2021, the subject experienced chills. On 14-MAR-2021, the subject experienced fever. On 14-MAR-2021, the subject experienced pain at injection site. Laboratory data included: Body temperature (NR: not provided) 101 F. On an unspecified date, the subject experienced hard time breathing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, chills, cold, pain at injection site, and hard time breathing. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: SORENESS FROM THE NECK DOWN AND AT THE ADMINISTRATION SITE AND STILL WITH A LOT OF PAIN; 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: UNKNOWN, expiry date: UNKNOWN) dose was not reported, administered on 17-MAR-2021 around 12:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 18-MAR-2021, around 06:00 the subject experienced soreness from the neck down and at the administration site and still with a lot of pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness from the neck down and at the administration site and still with a lot of pain. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Headache, Injection site pain
Clinical narrative: HEADACHE; BURNING PAIN IN ARM/ARM PAIN; This spontaneous report received from a patient 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: 1805022, expiry: 25-MAY-2021) dose was not reported, once a total administered, vaccinated on right deltoid on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced burning pain in arm/arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and burning pain in arm/arm pain. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Chills, Myalgia
Clinical narrative: HEADACHE; BURNING PAIN IN ARM/ARM PAIN; This spontaneous report received from a patient 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: 1805022, expiry: 25-MAY-2021) dose was not reported, once a total administered, vaccinated on right deltoid on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced burning pain in arm/arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and burning pain in arm/arm pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: FATIGUE; HEADACHE; 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 was not reported, administered on 2021 for prophylactic vaccination. No follow up required as the case received from social media. No concomitant medications were reported. On an unspecified date, the subject experienced fatigue, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chapped lips, Lip disorder, Lip injury, Lip pain, Lip swelling
Clinical narrative: BUMP ON UPPER RIGHT LIP; CUT ON LOWER LIP; VERY SORE LIP; SWOLLEN LIP; LIPS WERE DRY AND CHAPPED; This spontaneous report received from a patient concerned a 65 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: 1802068) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced lips were dry and chapped. On 15-MAR-2021, the subject experienced very sore lip. On 15-MAR-2021, the subject experienced swollen lip. On 15-MAR-2021 07:15, the subject experienced cut on lower lip. On 16-MAR-2021, the subject experienced bump on upper right lip. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lips were dry and chapped, cut on lower lip, very sore lip, and swollen lip on 18-MAR-2021, and had not recovered from bump on upper right lip. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Mastication disorder, Swelling face
Clinical narrative: RIGHT EAR PAIN; HURTS TO CHEW; RIGHT SIDE FACE SWELLING; 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 past medical history included 13 years breast cancer free, and concurrent conditions included diabeties, 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: Unk) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination on left arm. 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 16-MAR-2021, the subject experienced right ear pain. On 16-MAR-2021, the subject experienced hurts to chew. On 16-MAR-2021, the subject experienced right side face swelling. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from right side face swelling on 18-MAR-2021, was recovering from right ear pain, and had not recovered from hurts to chew. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain in extremity, Swelling
Clinical narrative: SWELLING; BURNT SENSATION; SORE ARM; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, non smoker, and codeine allergy, and other pre-existing medical conditions included the patient was not pregnant at time of reporting and had no drug abuse or illicit use. The patient experienced drug allergy when treated with hydrocodone bitartrate/paracetamol for drug used for unknown indication. 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 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAR-2021, the subject experienced burnt sensation. On 13-MAR-2021, the subject experienced sore arm. On 15-MAR-2021, the subject experienced swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burnt sensation, and had not recovered from sore arm, and swelling. This report was non-serious.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, SARS-CoV-2 test, Vaginal ulceration
Clinical narrative: SEVERE VAGINAL ULCERS; SEVERE HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 19 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid positive, and concurrent conditions included vaginal ulcers not related to sexually transmitted infections, and not sexually active, 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, and batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination on right arm. No concomitant medications were reported. On AUG-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100 F. On 15-MAR-2021, the subject experienced severe headache. On 15-MAR-2021, the subject experienced fatigue. On 17-MAR-2021, the subject experienced severe vaginal ulcers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from severe headache, and had not recovered from severe vaginal ulcers, and fatigue. This report was non-serious.; Sender's Comments: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a patient via a company representative concerned a male 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,) dose was not reported, administered on 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 MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: FEVER; BODY ACHE; SORED ARM; HURTING ARM; 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: Unk) dose was not reported, in her right arm on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 17-MAR-2021, the subject experienced sored arm. On 17-MAR-2021, the subject experienced hurting arm. On 18-MAR-2021, the subject experienced fever. On 18-MAR-2021, the subject experienced body ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sored arm, and the outcome of hurting arm, fever and body ache was not reported. This report was non-serious.