chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: A LITTLE TIRED; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 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 a little tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from a little tired. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain in extremity, Pyrexia
Clinical narrative: LEGS ACHY/LEGS HURT MY BODY; SLIGHT FEVER; SLEPT A COUPLE OF HOURS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-MAY-2021, the subject experienced slept a couple of hours. On 27-MAY-2021, the subject experienced legs achy/legs hurt my body. On 27-MAY-2021, the subject experienced slight fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the slight fever, legs achy/legs hurt my body and slept a couple of hours was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Myelitis transverse
Clinical narrative: TRANSVERSE MYELITIS; This spontaneous report received from a physician concerned a 52-year-old female patient of unspecified race and ethnic origin. 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 administration was not reported, batch number and expiry date were unknown) dose was not reported, 1 total, administered on 09-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 22-APR-2021, the patient experienced headache, numbness in feet, could not void/have a bowel movements, could not ambulate, had paralysis from the chest to the feet, and burning/numbness in ribcage and in chest to the feet. On the same day, she presented to the hospital with these symptoms and was admitted. She was diagnosed with transverse myelitis following which she was treated with intravenous (IV) steroids (unspecified) and was also started on gabapentin and carbamazepine. Since then, the patient was transferred to a rehabilitation facility and has reportedly partially improved. Recently, she could stand and step a few steps. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from transverse myelitis. This report was serious (Hospitalization Caused / Prolonged). This case, from the Others is linked to 20201203588.; Sender's Comments: V0: 20210554951-Covid-19 vaccine ad26.cov2.s-Transverse myelitis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Product use issue, Wrong technique in product usage process
Clinical narrative: WRONG TECHNIQUE IN PRODUCT USAGE PROCESS; PRODUCT USE FOR UNAPPROVED COMBINATION; TThis spontaneous report received from a health care professional 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. The batch number was not provided and it has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced wrong technique in product usage process, and product use for unapproved combination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the wrong technique in product usage process and product use for unapproved combination was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: LESS THAN HALF A DOSE ADMINISTERED; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, 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 less than half a dose administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of less than half a dose administered was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; 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 g6pd carrier. 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 and has been requested. No concomitant medications were reported. On an unspecified date, 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.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Muscle contracture, Myalgia, Nervous system disorder
Clinical narrative: SEVERE NERVE INFLAMMATION; RESTLESS LEG SYNDROME; MUSCLE CONTRACTIONS; PAIN FROM HEAD TO TOE, INCLUDES FINGERS, TOES, EYELIDS, CHEEKS, ABDOMEN; SLEPT INTERMITTENTLY 5 TO15 MINUTES AT A TIME; CHILLS; EXTREME BURNING OF MUSCLES; MUSCLE PAIN THROUGHOUT BODY; SEVERE HEADACHE; This spontaneous report received from a patient by a Business partner on 27-MAY-2021 was received on 27-MAY-2021 and concerned a 44 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included codeine allergy, and other pre-existing medical conditions included the patient had codeine allergy and no other illness. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 10:30 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021 23:30, the subject experienced severe nerve inflammation. On 25-MAY-2021 23:30, the subject experienced restless leg syndrome. On 25-MAY-2021 23:30, the subject experienced muscle contractions. On 25-MAY-2021 23:30, the subject experienced pain from head to toe, includes fingers, toes, eyelids, cheeks, abdomen. On 25-MAY-2021 23:30, the subject experienced slept intermittently 5 to15 minutes at a time. On 25-MAY-2021 23:30, the subject experienced chills. On 25-MAY-2021 23:30, the subject experienced extreme burning of muscles. On 25-MAY-2021 23:30, the subject experienced muscle pain throughout body. On 25-MAY-2021 23:30, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe nerve inflammation, restless leg syndrome, and extreme burning of muscles on 26-MAY-2021 11:30, muscle contractions, and muscle pain throughout body on 26-MAY-2021 15:00, and severe headache on 26-MAY-2021 20:00, and the outcome of chills, pain from head to toe, includes fingers, toes, eyelids, cheeks, abdomen and slept intermittently 5 to15 minutes at a time was not reported. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Restless legs syndrome, Sleep disorder
Clinical narrative: SEVERE NERVE INFLAMMATION; RESTLESS LEG SYNDROME; MUSCLE CONTRACTIONS; PAIN FROM HEAD TO TOE, INCLUDES FINGERS, TOES, EYELIDS, CHEEKS, ABDOMEN; SLEPT INTERMITTENTLY 5 TO15 MINUTES AT A TIME; CHILLS; EXTREME BURNING OF MUSCLES; MUSCLE PAIN THROUGHOUT BODY; SEVERE HEADACHE; This spontaneous report received from a patient by a Business partner on 27-MAY-2021 was received on 27-MAY-2021 and concerned a 44 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included codeine allergy, and other pre-existing medical conditions included the patient had codeine allergy and no other illness. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 10:30 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021 23:30, the subject experienced severe nerve inflammation. On 25-MAY-2021 23:30, the subject experienced restless leg syndrome. On 25-MAY-2021 23:30, the subject experienced muscle contractions. On 25-MAY-2021 23:30, the subject experienced pain from head to toe, includes fingers, toes, eyelids, cheeks, abdomen. On 25-MAY-2021 23:30, the subject experienced slept intermittently 5 to15 minutes at a time. On 25-MAY-2021 23:30, the subject experienced chills. On 25-MAY-2021 23:30, the subject experienced extreme burning of muscles. On 25-MAY-2021 23:30, the subject experienced muscle pain throughout body. On 25-MAY-2021 23:30, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe nerve inflammation, restless leg syndrome, and extreme burning of muscles on 26-MAY-2021 11:30, muscle contractions, and muscle pain throughout body on 26-MAY-2021 15:00, and severe headache on 26-MAY-2021 20:00, and the outcome of chills, pain from head to toe, includes fingers, toes, eyelids, cheeks, abdomen and slept intermittently 5 to15 minutes at a time was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Feeling hot
Clinical narrative: FACE FELT VERY HOT; CHEEKS AND FOREHEAD TURNED RED; 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: Unk) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAY-2021, the subject experienced face felt very hot. On 12-MAY-2021, the subject experienced cheeks and forehead turned red. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from face felt very hot, and cheeks and forehead turned red. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Nodule
Clinical narrative: LEFT WRIST HAS A BONY KNOT (LOOKS LIKE MOSQUITO BITE BUT BONE); NERVE PAIN; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's past medical history included car accident, and concurrent conditions included plate in right upper arm and left lower arm. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: 13-JUN-2021) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced left wrist has a bony knot (looks like mosquito bite but bone). On 12-APR-2021, the subject experienced nerve pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left wrist has a bony knot (looks like mosquito bite but bone), and the outcome of nerve pain was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy
Clinical narrative: SWOLLEN GLANDS IN JAW; HEADACHE WAS AFFECTING BOTH SIDES OF THE HEAD; FATIGUE; 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: E04AZ1A,  expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAY-2021, the subject experienced swollen glands in jaw. On 18-MAY-2021, the subject experienced headache was affecting both sides of the head. On 18-MAY-2021, the subject experienced fatigue. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache was affecting both sides of the head, fatigue, and swollen glands in jaw. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: TASTE LESSENING ABOUT 3 WEEKS AFTER RECEIVING VACCINE  AND OVER THE LAST 3 WEEKS IT LOST COMPLETELY; 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: UNKNOWN expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced taste lessening about 3 weeks after receiving vaccine and over the last 3 weeks it lost completely. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of taste lessening about 3 weeks after receiving vaccine and over the last 3 weeks it lost completely was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: ADMINISTERED 1 VIAL (2.5ML) DOSE IN ERROR; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) 2.5 ml, administered on 26-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-MAY-2021, the subject experienced administered 1 vial (2.5ml) dose in error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered 1 vial (2.5ml) dose in error was not reported. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cold sweat, Ear discomfort, Headache, Nasal congestion
Clinical narrative: COLD SWEATS; WEIRD FEELING IN THROAT; LEFT EAR POPPING LIKE GOING UP IN ELEVATION; SINUS CAVITY PRESSURE IN THE  RIGHT EYE; STUFFY NOSE; FEVER 101.3 F; HEADACHE; LITTLE NAUSEOUS; This spontaneous report received from a patient concerned a 49 year old female. The patient's weight was 165 pounds, and height was 63 centimeters. The patient's concurrent conditions included barrett's esophagus, high blood pressure, premature heart beat, hypothyroidism, sulfa drugs allergy, non smoker, and non-alcohol user, and other pre-existing medical conditions included the patient was not pregnant at the time of the reporting. the patient had 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: 201A21A, and  expiry: 23-JUN-2021) dose was not reported, administered on 27-MAY-2021 11:45 for prophylactic vaccination. Concomitant medications included amlodipine, carvedilol, levothyroxine, and losartan.  On 27-MAY-2021, the subject experienced cold sweats. On 27-MAY-2021, the subject experienced weird feeling in throat. On 27-MAY-2021, the subject experienced left ear popping like going up in elevation. On 27-MAY-2021, the subject experienced sinus cavity pressure in the right eye. On 27-MAY-2021, the subject experienced stuffy nose. On 27-MAY-2021, the subject experienced fever 101.3 f. On 27-MAY-2021, the subject experienced headache. On 27-MAY-2021, the subject experienced little nauseous. Laboratory data included: Body temperature (NR: not provided) 101.3 F, 101.0 F, 97.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold sweats, weird feeling in throat, and left ear popping like going up in elevation on 27-MAY-2021, had not recovered from headache, stuffy nose, and fever 101.3 f, and the outcome of sinus cavity pressure in the right eye and little nauseous was not reported. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Paranasal sinus discomfort, Pyrexia, Sensory disturbance
Clinical narrative: COLD SWEATS; WEIRD FEELING IN THROAT; LEFT EAR POPPING LIKE GOING UP IN ELEVATION; SINUS CAVITY PRESSURE IN THE  RIGHT EYE; STUFFY NOSE; FEVER 101.3 F; HEADACHE; LITTLE NAUSEOUS; This spontaneous report received from a patient concerned a 49 year old female. The patient's weight was 165 pounds, and height was 63 centimeters. The patient's concurrent conditions included barrett's esophagus, high blood pressure, premature heart beat, hypothyroidism, sulfa drugs allergy, non smoker, and non-alcohol user, and other pre-existing medical conditions included the patient was not pregnant at the time of the reporting. the patient had 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: 201A21A, and  expiry: 23-JUN-2021) dose was not reported, administered on 27-MAY-2021 11:45 for prophylactic vaccination. Concomitant medications included amlodipine, carvedilol, levothyroxine, and losartan.  On 27-MAY-2021, the subject experienced cold sweats. On 27-MAY-2021, the subject experienced weird feeling in throat. On 27-MAY-2021, the subject experienced left ear popping like going up in elevation. On 27-MAY-2021, the subject experienced sinus cavity pressure in the right eye. On 27-MAY-2021, the subject experienced stuffy nose. On 27-MAY-2021, the subject experienced fever 101.3 f. On 27-MAY-2021, the subject experienced headache. On 27-MAY-2021, the subject experienced little nauseous. Laboratory data included: Body temperature (NR: not provided) 101.3 F, 101.0 F, 97.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold sweats, weird feeling in throat, and left ear popping like going up in elevation on 27-MAY-2021, had not recovered from headache, stuffy nose, and fever 101.3 f, and the outcome of sinus cavity pressure in the right eye and little nauseous was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: PIN AND NEEDLED PAIN ON LEFT SIDE OF FACE; 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: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-MAY-2021, the subject experienced pin and needled pain on left side of face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pin and needled pain on left side of face was not reported. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Chills, Decreased appetite, Dyspnoea
Clinical narrative: NO APPETITE AND NOT EATING; SHORTNESS OF BREATH; CHILLS; BLOATED; STOMACH FEELS FUNNY; THROAT FEELS SWOLLEN; HEAD COLD; TIRED; BREATHING FEELS FASTER WHEN LAYING DOWN; ACHY; BACK OF CALVES AND LEG ACHING; 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 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: 203A21A, and  expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, and ibuprofen.  On 24-MAY-2021, the subject experienced breathing feels faster when laying down. On 24-MAY-2021, the subject experienced achy. On 24-MAY-2021, the subject experienced back of calves and leg aching. On 24-MAY-2021, the subject experienced tired. On 26-MAY-2021, the subject experienced head cold. On 26-MAY-2021, the subject experienced throat feels swollen. On 27-MAY-2021, the subject experienced bloated. On 27-MAY-2021, the subject experienced stomach feels funny. On an unspecified date, the subject experienced no appetite and not eating, shortness of breath, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from no appetite and not eating, had not recovered from head cold, stomach feels funny, throat feels swollen, breathing feels faster when laying down, back of calves and leg aching, achy, and tired, and the outcome of bloated, chills and shortness of breath was not reported. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nasopharyngitis, Pain, Pain in extremity, Pharyngeal swelling
Clinical narrative: NO APPETITE AND NOT EATING; SHORTNESS OF BREATH; CHILLS; BLOATED; STOMACH FEELS FUNNY; THROAT FEELS SWOLLEN; HEAD COLD; TIRED; BREATHING FEELS FASTER WHEN LAYING DOWN; ACHY; BACK OF CALVES AND LEG ACHING; 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 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: 203A21A, and  expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, and ibuprofen.  On 24-MAY-2021, the subject experienced breathing feels faster when laying down. On 24-MAY-2021, the subject experienced achy. On 24-MAY-2021, the subject experienced back of calves and leg aching. On 24-MAY-2021, the subject experienced tired. On 26-MAY-2021, the subject experienced head cold. On 26-MAY-2021, the subject experienced throat feels swollen. On 27-MAY-2021, the subject experienced bloated. On 27-MAY-2021, the subject experienced stomach feels funny. On an unspecified date, the subject experienced no appetite and not eating, shortness of breath, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from no appetite and not eating, had not recovered from head cold, stomach feels funny, throat feels swollen, breathing feels faster when laying down, back of calves and leg aching, achy, and tired, and the outcome of bloated, chills and shortness of breath was not reported. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory rate increased
Clinical narrative: NO APPETITE AND NOT EATING; SHORTNESS OF BREATH; CHILLS; BLOATED; STOMACH FEELS FUNNY; THROAT FEELS SWOLLEN; HEAD COLD; TIRED; BREATHING FEELS FASTER WHEN LAYING DOWN; ACHY; BACK OF CALVES AND LEG ACHING; 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 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: 203A21A, and  expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, and ibuprofen.  On 24-MAY-2021, the subject experienced breathing feels faster when laying down. On 24-MAY-2021, the subject experienced achy. On 24-MAY-2021, the subject experienced back of calves and leg aching. On 24-MAY-2021, the subject experienced tired. On 26-MAY-2021, the subject experienced head cold. On 26-MAY-2021, the subject experienced throat feels swollen. On 27-MAY-2021, the subject experienced bloated. On 27-MAY-2021, the subject experienced stomach feels funny. On an unspecified date, the subject experienced no appetite and not eating, shortness of breath, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from no appetite and not eating, had not recovered from head cold, stomach feels funny, throat feels swollen, breathing feels faster when laying down, back of calves and leg aching, achy, and tired, and the outcome of bloated, chills and shortness of breath was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain, Pain in extremity, Pyrexia
Clinical narrative: DIFFICULTY IN SLEEPING; BODY ACHE; LEG HURT; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, the subject experienced body ache. On MAY-2021, the subject experienced leg hurt. On MAY-2021, the subject experienced fever. On 26-MAY-2021, the subject experienced difficulty in sleeping. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the difficulty in sleeping, fever, leg hurt and body ache was not reported. This report was non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Depression, Impaired work ability, Mobility decreased
Clinical narrative: DECREASE MOBILITY IN SHOULDER; UNABLE TO WORK; DEPRESSED; SEVERE SHOULDER PAIN; This spontaneous report received from a consumer concerned a 66 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient was in good health. patient had undergo physical therapy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry: UNKNOWN) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 2021, the subject experienced decrease mobility in shoulder. On 2021, the subject experienced unable to work. On 2021, the subject experienced depressed. On 2021, the subject experienced severe shoulder pain. Treatment medications (dates unspecified) included: ibuprofen, paracetamol, cortisone, prednisone, and hydrocodone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe shoulder pain, decrease mobility in shoulder, unable to work and depressed was not reported. This report was non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain
Clinical narrative: DECREASE MOBILITY IN SHOULDER; UNABLE TO WORK; DEPRESSED; SEVERE SHOULDER PAIN; This spontaneous report received from a consumer concerned a 66 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient was in good health. patient had undergo physical therapy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry: UNKNOWN) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 2021, the subject experienced decrease mobility in shoulder. On 2021, the subject experienced unable to work. On 2021, the subject experienced depressed. On 2021, the subject experienced severe shoulder pain. Treatment medications (dates unspecified) included: ibuprofen, paracetamol, cortisone, prednisone, and hydrocodone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe shoulder pain, decrease mobility in shoulder, unable to work and depressed was not reported. This report was non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site pain, Magnetic resonance imaging, Mobility decreased, X-ray
Clinical narrative: DECREASE MOBILITY IN SHOULDER; UNABLE TO WORK; DEPRESSED; SEVERE SHOULDER PAIN; This spontaneous report received from a consumer concerned a 66 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient was in good health. patient had undergo physical therapy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry: UNKNOWN) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 2021, the subject experienced decrease mobility in shoulder. On 2021, the subject experienced unable to work. On 2021, the subject experienced depressed. On 2021, the subject experienced severe shoulder pain. Treatment medications (dates unspecified) included: ibuprofen, paracetamol, cortisone, prednisone, and hydrocodone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe shoulder pain, decrease mobility in shoulder, unable to work and depressed was not reported. This report was non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Depression, Impaired work ability, Mobility decreased
Clinical narrative: EXCRUCIATING PAIN; This spontaneous report received from a patient concerned a 66 year old male. The patient's weight was 160 pounds, and height was 73 inches. The patient's concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-APR-2021, the subject experienced excruciating pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from excruciating pain. This report was non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain
Clinical narrative: EXCRUCIATING PAIN; This spontaneous report received from a patient concerned a 66 year old male. The patient's weight was 160 pounds, and height was 73 inches. The patient's concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-APR-2021, the subject experienced excruciating pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from excruciating pain. This report was non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site pain, Magnetic resonance imaging, Mobility decreased, X-ray
Clinical narrative: EXCRUCIATING PAIN; This spontaneous report received from a patient concerned a 66 year old male. The patient's weight was 160 pounds, and height was 73 inches. The patient's concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-APR-2021, the subject experienced excruciating pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from excruciating pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: INJECTION SITE WARMTH; INJECTION SITE RASH ABOUT 3 TO 4 INCHES LONG 1 INCH WIDE; 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: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced injection site warmth, and injection site rash about 3 to 4 inches long 1 inch wide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from injection site rash about 3 to 4 inches long 1 inch wide, and the outcome of injection site warmth was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Hyperhidrosis, Memory impairment
Clinical narrative: PROBLEMS WITH MEMORY AND TROUBLE REMEMBERING; FELT LIKE HE IS IN A CLOUD; SWEATING; CHILLS; VERY TIRED/FATIGUE; FEVER; This spontaneous report received from a parent concerned a 37 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 25-MAY-2021, the subject experienced sweating. On 25-MAY-2021, the subject experienced chills. On 25-MAY-2021, the subject experienced very tired/fatigue. On 25-MAY-2021, the subject experienced fever. On 27-MAY-2021, the subject experienced problems with memory and trouble remembering. On 27-MAY-2021, the subject experienced felt like he is in a cloud.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, chills, and fever on 27-MAY-2021, had not recovered from very tired/fatigue, and problems with memory and trouble remembering, and the outcome of felt like he is in a cloud was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: PROBLEMS WITH MEMORY AND TROUBLE REMEMBERING; FELT LIKE HE IS IN A CLOUD; SWEATING; CHILLS; VERY TIRED/FATIGUE; FEVER; This spontaneous report received from a parent concerned a 37 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 25-MAY-2021, the subject experienced sweating. On 25-MAY-2021, the subject experienced chills. On 25-MAY-2021, the subject experienced very tired/fatigue. On 25-MAY-2021, the subject experienced fever. On 27-MAY-2021, the subject experienced problems with memory and trouble remembering. On 27-MAY-2021, the subject experienced felt like he is in a cloud.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, chills, and fever on 27-MAY-2021, had not recovered from very tired/fatigue, and problems with memory and trouble remembering, and the outcome of felt like he is in a cloud was not reported. This report was non-serious.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea
Clinical narrative: DIARRHEA; UPSET STOMACH; This spontaneous report received from a patient concerned an 82 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included 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: Unknown) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced diarrhea. On MAY-2021, the subject experienced upset stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on MAY-2021, and the outcome of upset stomach was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: MAGNET STICKING TO VACCINATION SITE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-MAY-2021, the subject experienced magnet sticking to vaccination site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of magnet sticking to vaccination site was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity
Clinical narrative: CHILLS; SORE ARM; PINGS OF A HEADACHE; 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: 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 an unspecified date, the subject experienced chills, sore arm, and pings of a headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pings of a headache, chills and sore arm was not reported. This report was non-serious.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Eye haemorrhage, Headache, Injection site pain
Clinical narrative: LEFT EYE WITH BLOOD SPOT IN THE EYEBALL; PAIN IN THE CENTRAL PART OF THE CHEST; DIFFICULTY BREATHING WHEN DOING  ACTIVITIES; HEADACHE; LEFT ARM PAIN WHERE SHOT WAS ADMINISTERED; COULDNT SLEEP THE DAY OF THE VACCINE; BODY TREMBLING; This spontaneous report received from a 48-year-old, male patient The patient's weight was 184 pounds, and height was 74 inches. The patient's past medical history included gallbladder removal. The patient was non-smoker, social drinker (only in holidays mostly), and the patient had no known allergies. The patient did not have any drug abuse or illicit drug use.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 207A21A and expiry: 23-JUN-2021) dose was not reported, 1 total administered on 14-MAY-2021 around 13:15 to left arm for prophylactic vaccination.  No concomitant medications were reported.  On 14-MAY-2021, the patient experienced left arm pain where shot was administered, body trembling and couldn't sleep on the day of vaccine. On 17-MAY-2021, the patient experienced headache which had diminished, but suddenly they were like stabbing, left eye with blood spot in the eyeball and pain in the central part of the chest, which on occasions varies from right to left with breathing difficulty when doing activities.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body trembling, couldn't sleep, and left arm pain where shot was administered on 18-MAY-2021, was recovering from headache, and left eye with blood spot in the eyeball, and had not recovered from pain in the central part of the chest, and difficulty breathing when doing activities. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 : 20210555889-COVID-19 VACCINE AD26.COV2.S -Left eye with blood spot in the eye ball. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Tremor
Clinical narrative: LEFT EYE WITH BLOOD SPOT IN THE EYEBALL; PAIN IN THE CENTRAL PART OF THE CHEST; DIFFICULTY BREATHING WHEN DOING  ACTIVITIES; HEADACHE; LEFT ARM PAIN WHERE SHOT WAS ADMINISTERED; COULDNT SLEEP THE DAY OF THE VACCINE; BODY TREMBLING; This spontaneous report received from a 48-year-old, male patient The patient's weight was 184 pounds, and height was 74 inches. The patient's past medical history included gallbladder removal. The patient was non-smoker, social drinker (only in holidays mostly), and the patient had no known allergies. The patient did not have any drug abuse or illicit drug use.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 207A21A and expiry: 23-JUN-2021) dose was not reported, 1 total administered on 14-MAY-2021 around 13:15 to left arm for prophylactic vaccination.  No concomitant medications were reported.  On 14-MAY-2021, the patient experienced left arm pain where shot was administered, body trembling and couldn't sleep on the day of vaccine. On 17-MAY-2021, the patient experienced headache which had diminished, but suddenly they were like stabbing, left eye with blood spot in the eyeball and pain in the central part of the chest, which on occasions varies from right to left with breathing difficulty when doing activities.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body trembling, couldn't sleep, and left arm pain where shot was administered on 18-MAY-2021, was recovering from headache, and left eye with blood spot in the eyeball, and had not recovered from pain in the central part of the chest, and difficulty breathing when doing activities. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 : 20210555889-COVID-19 VACCINE AD26.COV2.S -Left eye with blood spot in the eye ball. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: CONSTANT HEADACHES; 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: 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 an unspecified date, the subject experienced constant headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from constant headaches. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: UNEXPECTED THERAPEUTIC BENEFIT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin were not reported) 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 unexpected therapeutic benefit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unexpected therapeutic benefit was not reported. This report was non-serious.