chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram normal, Eye swelling, Facial pain, Facial paralysis, Fatigue
Clinical narrative: SHARP PAINS CONSUMING IN HER LUNGS AND HEART LIKE; INTRACRANIAL PRESSURE/ CONSTANT HEAD PRESSURE; UNABLE TO SLEEP; TEETH PAIN; BONE PAIN; TINNITUS; PALMS, LIPS AND FACE TURNED BLUE; THOUGHT SHE WAS GOING TO DIE; SHARP PAINS CONSUMING HER BODY/BODY PAIN/ ACHES/ UNBEARABLE PAIN; CHILLS; JOINT PAIN; TIRED; MUSCLE PAIN; BODY FEVER; SORENESS AT INJECTION SITE; HEAD EXPLODING; This spontaneous report received from a patient concerned a 48 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: 1805018, expiry: UNKNOWN) dose was not reported, administered on right deltoid muscle on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced sharp pains consuming in her lungs and heart like. On 2021, the subject experienced intracranial pressure/ constant head pressure. On 2021, the subject experienced unable to sleep. On 2021, the subject experienced teeth pain. On 2021, the subject experienced bone pain. On 2021, the subject experienced tinnitus. On 2021, the subject experienced palms, lips and face turned blue. On 2021, the subject experienced thought she was going to die. On 2021, the subject experienced sharp pains consuming her body/body pain/ aches/ unbearable pain. On 2021, the subject experienced chills. On 2021, the subject experienced joint pain. On 2021, the subject experienced tired. On 2021, the subject experienced muscle pain. On 2021, the subject experienced body fever. On 2021, the subject experienced soreness at injection site. On 2021, the subject experienced head exploding. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness at injection site, chills, tired, muscle pain, joint pain, body fever, unable to sleep, sharp pains consuming in her lungs and heart like, tinnitus, teeth pain, bone pain, intracranial pressure/ constant head pressure, palms, lips and face turned blue, head exploding, sharp pains consuming her body/body pain/ aches/ unbearable pain and thought she was going to die 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.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeding disorder, Feeling abnormal, Feeling cold, Feeling jittery, Grip strength decreased
Clinical narrative: SHARP PAINS CONSUMING IN HER LUNGS AND HEART LIKE; INTRACRANIAL PRESSURE/ CONSTANT HEAD PRESSURE; UNABLE TO SLEEP; TEETH PAIN; BONE PAIN; TINNITUS; PALMS, LIPS AND FACE TURNED BLUE; THOUGHT SHE WAS GOING TO DIE; SHARP PAINS CONSUMING HER BODY/BODY PAIN/ ACHES/ UNBEARABLE PAIN; CHILLS; JOINT PAIN; TIRED; MUSCLE PAIN; BODY FEVER; SORENESS AT INJECTION SITE; HEAD EXPLODING; This spontaneous report received from a patient concerned a 48 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: 1805018, expiry: UNKNOWN) dose was not reported, administered on right deltoid muscle on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced sharp pains consuming in her lungs and heart like. On 2021, the subject experienced intracranial pressure/ constant head pressure. On 2021, the subject experienced unable to sleep. On 2021, the subject experienced teeth pain. On 2021, the subject experienced bone pain. On 2021, the subject experienced tinnitus. On 2021, the subject experienced palms, lips and face turned blue. On 2021, the subject experienced thought she was going to die. On 2021, the subject experienced sharp pains consuming her body/body pain/ aches/ unbearable pain. On 2021, the subject experienced chills. On 2021, the subject experienced joint pain. On 2021, the subject experienced tired. On 2021, the subject experienced muscle pain. On 2021, the subject experienced body fever. On 2021, the subject experienced soreness at injection site. On 2021, the subject experienced head exploding. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness at injection site, chills, tired, muscle pain, joint pain, body fever, unable to sleep, sharp pains consuming in her lungs and heart like, tinnitus, teeth pain, bone pain, intracranial pressure/ constant head pressure, palms, lips and face turned blue, head exploding, sharp pains consuming her body/body pain/ aches/ unbearable pain and thought she was going to die 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.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypoaesthesia, Intracranial pressure increased, Laboratory test normal, Lacrimation increased
Clinical narrative: SHARP PAINS CONSUMING IN HER LUNGS AND HEART LIKE; INTRACRANIAL PRESSURE/ CONSTANT HEAD PRESSURE; UNABLE TO SLEEP; TEETH PAIN; BONE PAIN; TINNITUS; PALMS, LIPS AND FACE TURNED BLUE; THOUGHT SHE WAS GOING TO DIE; SHARP PAINS CONSUMING HER BODY/BODY PAIN/ ACHES/ UNBEARABLE PAIN; CHILLS; JOINT PAIN; TIRED; MUSCLE PAIN; BODY FEVER; SORENESS AT INJECTION SITE; HEAD EXPLODING; This spontaneous report received from a patient concerned a 48 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: 1805018, expiry: UNKNOWN) dose was not reported, administered on right deltoid muscle on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced sharp pains consuming in her lungs and heart like. On 2021, the subject experienced intracranial pressure/ constant head pressure. On 2021, the subject experienced unable to sleep. On 2021, the subject experienced teeth pain. On 2021, the subject experienced bone pain. On 2021, the subject experienced tinnitus. On 2021, the subject experienced palms, lips and face turned blue. On 2021, the subject experienced thought she was going to die. On 2021, the subject experienced sharp pains consuming her body/body pain/ aches/ unbearable pain. On 2021, the subject experienced chills. On 2021, the subject experienced joint pain. On 2021, the subject experienced tired. On 2021, the subject experienced muscle pain. On 2021, the subject experienced body fever. On 2021, the subject experienced soreness at injection site. On 2021, the subject experienced head exploding. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness at injection site, chills, tired, muscle pain, joint pain, body fever, unable to sleep, sharp pains consuming in her lungs and heart like, tinnitus, teeth pain, bone pain, intracranial pressure/ constant head pressure, palms, lips and face turned blue, head exploding, sharp pains consuming her body/body pain/ aches/ unbearable pain and thought she was going to die 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.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lethargy, Lip swelling, Malaise, Mobility decreased, Myalgia
Clinical narrative: SHARP PAINS CONSUMING IN HER LUNGS AND HEART LIKE; INTRACRANIAL PRESSURE/ CONSTANT HEAD PRESSURE; UNABLE TO SLEEP; TEETH PAIN; BONE PAIN; TINNITUS; PALMS, LIPS AND FACE TURNED BLUE; THOUGHT SHE WAS GOING TO DIE; SHARP PAINS CONSUMING HER BODY/BODY PAIN/ ACHES/ UNBEARABLE PAIN; CHILLS; JOINT PAIN; TIRED; MUSCLE PAIN; BODY FEVER; SORENESS AT INJECTION SITE; HEAD EXPLODING; This spontaneous report received from a patient concerned a 48 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: 1805018, expiry: UNKNOWN) dose was not reported, administered on right deltoid muscle on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced sharp pains consuming in her lungs and heart like. On 2021, the subject experienced intracranial pressure/ constant head pressure. On 2021, the subject experienced unable to sleep. On 2021, the subject experienced teeth pain. On 2021, the subject experienced bone pain. On 2021, the subject experienced tinnitus. On 2021, the subject experienced palms, lips and face turned blue. On 2021, the subject experienced thought she was going to die. On 2021, the subject experienced sharp pains consuming her body/body pain/ aches/ unbearable pain. On 2021, the subject experienced chills. On 2021, the subject experienced joint pain. On 2021, the subject experienced tired. On 2021, the subject experienced muscle pain. On 2021, the subject experienced body fever. On 2021, the subject experienced soreness at injection site. On 2021, the subject experienced head exploding. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness at injection site, chills, tired, muscle pain, joint pain, body fever, unable to sleep, sharp pains consuming in her lungs and heart like, tinnitus, teeth pain, bone pain, intracranial pressure/ constant head pressure, palms, lips and face turned blue, head exploding, sharp pains consuming her body/body pain/ aches/ unbearable pain and thought she was going to die 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.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neuropathy peripheral, Occipital neuralgia, Pain, Pain in extremity, Paraesthesia
Clinical narrative: SHARP PAINS CONSUMING IN HER LUNGS AND HEART LIKE; INTRACRANIAL PRESSURE/ CONSTANT HEAD PRESSURE; UNABLE TO SLEEP; TEETH PAIN; BONE PAIN; TINNITUS; PALMS, LIPS AND FACE TURNED BLUE; THOUGHT SHE WAS GOING TO DIE; SHARP PAINS CONSUMING HER BODY/BODY PAIN/ ACHES/ UNBEARABLE PAIN; CHILLS; JOINT PAIN; TIRED; MUSCLE PAIN; BODY FEVER; SORENESS AT INJECTION SITE; HEAD EXPLODING; This spontaneous report received from a patient concerned a 48 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: 1805018, expiry: UNKNOWN) dose was not reported, administered on right deltoid muscle on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced sharp pains consuming in her lungs and heart like. On 2021, the subject experienced intracranial pressure/ constant head pressure. On 2021, the subject experienced unable to sleep. On 2021, the subject experienced teeth pain. On 2021, the subject experienced bone pain. On 2021, the subject experienced tinnitus. On 2021, the subject experienced palms, lips and face turned blue. On 2021, the subject experienced thought she was going to die. On 2021, the subject experienced sharp pains consuming her body/body pain/ aches/ unbearable pain. On 2021, the subject experienced chills. On 2021, the subject experienced joint pain. On 2021, the subject experienced tired. On 2021, the subject experienced muscle pain. On 2021, the subject experienced body fever. On 2021, the subject experienced soreness at injection site. On 2021, the subject experienced head exploding. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness at injection site, chills, tired, muscle pain, joint pain, body fever, unable to sleep, sharp pains consuming in her lungs and heart like, tinnitus, teeth pain, bone pain, intracranial pressure/ constant head pressure, palms, lips and face turned blue, head exploding, sharp pains consuming her body/body pain/ aches/ unbearable pain and thought she was going to die 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.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral coldness, Pyrexia, Scalloped tongue, Sinus pain, Sleep disorder
Clinical narrative: SHARP PAINS CONSUMING IN HER LUNGS AND HEART LIKE; INTRACRANIAL PRESSURE/ CONSTANT HEAD PRESSURE; UNABLE TO SLEEP; TEETH PAIN; BONE PAIN; TINNITUS; PALMS, LIPS AND FACE TURNED BLUE; THOUGHT SHE WAS GOING TO DIE; SHARP PAINS CONSUMING HER BODY/BODY PAIN/ ACHES/ UNBEARABLE PAIN; CHILLS; JOINT PAIN; TIRED; MUSCLE PAIN; BODY FEVER; SORENESS AT INJECTION SITE; HEAD EXPLODING; This spontaneous report received from a patient concerned a 48 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: 1805018, expiry: UNKNOWN) dose was not reported, administered on right deltoid muscle on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced sharp pains consuming in her lungs and heart like. On 2021, the subject experienced intracranial pressure/ constant head pressure. On 2021, the subject experienced unable to sleep. On 2021, the subject experienced teeth pain. On 2021, the subject experienced bone pain. On 2021, the subject experienced tinnitus. On 2021, the subject experienced palms, lips and face turned blue. On 2021, the subject experienced thought she was going to die. On 2021, the subject experienced sharp pains consuming her body/body pain/ aches/ unbearable pain. On 2021, the subject experienced chills. On 2021, the subject experienced joint pain. On 2021, the subject experienced tired. On 2021, the subject experienced muscle pain. On 2021, the subject experienced body fever. On 2021, the subject experienced soreness at injection site. On 2021, the subject experienced head exploding. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness at injection site, chills, tired, muscle pain, joint pain, body fever, unable to sleep, sharp pains consuming in her lungs and heart like, tinnitus, teeth pain, bone pain, intracranial pressure/ constant head pressure, palms, lips and face turned blue, head exploding, sharp pains consuming her body/body pain/ aches/ unbearable pain and thought she was going to die 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.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face, Throat irritation, Tinnitus, Toothache, Tremor
Clinical narrative: SHARP PAINS CONSUMING IN HER LUNGS AND HEART LIKE; INTRACRANIAL PRESSURE/ CONSTANT HEAD PRESSURE; UNABLE TO SLEEP; TEETH PAIN; BONE PAIN; TINNITUS; PALMS, LIPS AND FACE TURNED BLUE; THOUGHT SHE WAS GOING TO DIE; SHARP PAINS CONSUMING HER BODY/BODY PAIN/ ACHES/ UNBEARABLE PAIN; CHILLS; JOINT PAIN; TIRED; MUSCLE PAIN; BODY FEVER; SORENESS AT INJECTION SITE; HEAD EXPLODING; This spontaneous report received from a patient concerned a 48 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: 1805018, expiry: UNKNOWN) dose was not reported, administered on right deltoid muscle on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced sharp pains consuming in her lungs and heart like. On 2021, the subject experienced intracranial pressure/ constant head pressure. On 2021, the subject experienced unable to sleep. On 2021, the subject experienced teeth pain. On 2021, the subject experienced bone pain. On 2021, the subject experienced tinnitus. On 2021, the subject experienced palms, lips and face turned blue. On 2021, the subject experienced thought she was going to die. On 2021, the subject experienced sharp pains consuming her body/body pain/ aches/ unbearable pain. On 2021, the subject experienced chills. On 2021, the subject experienced joint pain. On 2021, the subject experienced tired. On 2021, the subject experienced muscle pain. On 2021, the subject experienced body fever. On 2021, the subject experienced soreness at injection site. On 2021, the subject experienced head exploding. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness at injection site, chills, tired, muscle pain, joint pain, body fever, unable to sleep, sharp pains consuming in her lungs and heart like, tinnitus, teeth pain, bone pain, intracranial pressure/ constant head pressure, palms, lips and face turned blue, head exploding, sharp pains consuming her body/body pain/ aches/ unbearable pain and thought she was going to die 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.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vertigo, Vision blurred, Visual impairment
Clinical narrative: SHARP PAINS CONSUMING IN HER LUNGS AND HEART LIKE; INTRACRANIAL PRESSURE/ CONSTANT HEAD PRESSURE; UNABLE TO SLEEP; TEETH PAIN; BONE PAIN; TINNITUS; PALMS, LIPS AND FACE TURNED BLUE; THOUGHT SHE WAS GOING TO DIE; SHARP PAINS CONSUMING HER BODY/BODY PAIN/ ACHES/ UNBEARABLE PAIN; CHILLS; JOINT PAIN; TIRED; MUSCLE PAIN; BODY FEVER; SORENESS AT INJECTION SITE; HEAD EXPLODING; This spontaneous report received from a patient concerned a 48 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: 1805018, expiry: UNKNOWN) dose was not reported, administered on right deltoid muscle on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced sharp pains consuming in her lungs and heart like. On 2021, the subject experienced intracranial pressure/ constant head pressure. On 2021, the subject experienced unable to sleep. On 2021, the subject experienced teeth pain. On 2021, the subject experienced bone pain. On 2021, the subject experienced tinnitus. On 2021, the subject experienced palms, lips and face turned blue. On 2021, the subject experienced thought she was going to die. On 2021, the subject experienced sharp pains consuming her body/body pain/ aches/ unbearable pain. On 2021, the subject experienced chills. On 2021, the subject experienced joint pain. On 2021, the subject experienced tired. On 2021, the subject experienced muscle pain. On 2021, the subject experienced body fever. On 2021, the subject experienced soreness at injection site. On 2021, the subject experienced head exploding. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness at injection site, chills, tired, muscle pain, joint pain, body fever, unable to sleep, sharp pains consuming in her lungs and heart like, tinnitus, teeth pain, bone pain, intracranial pressure/ constant head pressure, palms, lips and face turned blue, head exploding, sharp pains consuming her body/body pain/ aches/ unbearable pain and thought she was going to die 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: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: NOT FEELING WELL; 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 31-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the patient experienced not feeling well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of not feeling well was not reported. This report was non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Hypokinesia, Pyrexia
Clinical narrative: UNABLE TO MOVE OUT OF BED; VERY WEAK; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a 42 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included food allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 14:00 on right arm for prophylactic vaccination. No concomitant medications were reported.  On 01-APR-2021, the subject experienced unable to move out of bed. On 01-APR-2021, the subject experienced very weak. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, unable to move out of bed, and very weak. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: BODY ACHES; SLIGHT FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced body aches. On 01-APR-2021, the subject experienced slight fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body aches and slight fever was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administration error
Clinical narrative: PRODUCT ADMINISTRATION ERROR; VACCINE LEAKAGE AT THE SITE OF INJECTION; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The Batch number was not reported and has been requested.  No concomitant medications were reported. On 01-APR-2021, the subject experienced product administration error. On 01-APR-2021, the subject experienced vaccine leakage at the site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from product administration error, and vaccine leakage at the site of injection. This report was non-serious.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: INJECTION SITE RASH; This spontaneous report received from a patient concerned a 64 year old of unspecified 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 and batch number: 1805018 Expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced injection site rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site rash on 22-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Feeling abnormal, Injection site pain, Nausea
Clinical narrative: DIARRHEA; DOESNOT FEEL RIGHT; ARM WAS SORE AT THE INJECTION SITE; NAUSEA; TIRED; 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: Unknown) dose was not reported, administered on 01-APR-2021 10:30 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 02-APR-2021, the subject experienced diarrhea. On 02-APR-2021, the subject experienced does not feel right. On 02-APR-2021, the subject experienced arm was sore at the injection site. On 02-APR-2021, the subject experienced nausea. On 02-APR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm is sore at the injection site, diarrhea, nausea, does not feel right and tired was not reported. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Nausea
Clinical narrative: FLU LIKE SYMPTOMS; SHIVERING/CHILLS; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 58 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the subject experienced flu like symptoms. On 21-MAR-2021, the subject experienced shivering. On 21-MAR-2021, the subject experienced nausea. On 21-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, shivering, nausea, and headache on 22-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: LOSS OF APPETITE; FATIGUE; FEVER; HEADACHE; NAUSEA; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient refused to provide allergies history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A expiry: 21/JUN/2021) dose was not reported, administered on 02-APR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced loss of appetite. On 03-APR-2021, the subject experienced fatigue. On 03-APR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced headache. On 03-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, fever, headache, nausea, and loss of appetite. This report was non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nasal congestion
Clinical narrative: MILD STUFFY NOSE; DIARRHEA; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included primary pulmonary hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included sildenafil citrate for drug used for unknown indication. On 2021, the subject experienced mild stuffy nose. On 2021, the subject experienced diarrhea. Treatment medications (dates unspecified) included: fluticasone propionate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the diarrhea and mild stuffy nose was not reported. This report was non-serious. This case, involving the same patient is linked.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity
Clinical narrative: REDNESS ON ARM; SORE ARM; 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case  No concomitant medications were reported. On an unspecified date, the subject experienced redness on arm, and sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm and redness on arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Injection site erythema, Injection site mass, Nausea, Pruritus
Clinical narrative: BURN PAIN IN BETWEEN BREAST; PAINFUL BUMP ON LEFT ARM; ITCHY; RASH; NAUSEA; FEVER; REDNESS LEFT ARM; 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, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced rash. On 01-APR-2021, the subject experienced nausea. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced redness left arm. Treatment medications included: ibuprofen, and paracetamol. On 02-APR-2021, the subject experienced burn pain in between breast. On 02-APR-2021, the subject experienced painful bump on left arm. On 02-APR-2021, the subject experienced itchy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burn pain in between breast, rash, nausea, and fever on 02-APR-2021, and had not recovered from redness left arm, painful bump on left arm, and itchy. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: BURN PAIN IN BETWEEN BREAST; PAINFUL BUMP ON LEFT ARM; ITCHY; RASH; NAUSEA; FEVER; REDNESS LEFT ARM; 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, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced rash. On 01-APR-2021, the subject experienced nausea. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced redness left arm. Treatment medications included: ibuprofen, and paracetamol. On 02-APR-2021, the subject experienced burn pain in between breast. On 02-APR-2021, the subject experienced painful bump on left arm. On 02-APR-2021, the subject experienced itchy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burn pain in between breast, rash, nausea, and fever on 02-APR-2021, and had not recovered from redness left arm, painful bump on left arm, and itchy. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Nausea, Pyrexia
Clinical narrative: DIZZNESS; VOMITTING; DIARRHEA; CHILLS; NUASEA; FEVER; This spontaneous report received from a patient concerned a 46 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: 1808980 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced dizziness. On 02-APR-2021, the subject experienced vomiting. On 02-APR-2021, the subject experienced diarrhea. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced nausea. On 02-APR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, nausea, vomiting, fever, chills and diarrhea was not reported. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: DIZZNESS; VOMITTING; DIARRHEA; CHILLS; NUASEA; FEVER; This spontaneous report received from a patient concerned a 46 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: 1808980 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced dizziness. On 02-APR-2021, the subject experienced vomiting. On 02-APR-2021, the subject experienced diarrhea. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced nausea. On 02-APR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, nausea, vomiting, fever, chills and diarrhea was not reported. This report was non-serious.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Therapeutic response unexpected
Clinical narrative: IMPROVEMENT IN HIS BRONCHITIS; SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included bronchitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 to left arm  for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced soreness at injection site. On 23-MAR-2021, the subject experienced improvement in his bronchitis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness at injection site on 11-MAR-2021, and the outcome of improvement in his bronchitis was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: GENERAL SORENESS; HEADACHE; FATIGUE; This spontaneous report received from a consumer 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, expiry; unknown) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-APR-2021, the subject experienced general soreness. On 02-APR-2021, the subject experienced headache. On 02-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, fatigue, and general soreness. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Disorientation, Flank pain, Nasopharyngitis, Tremor
Clinical narrative: COLD; SHAKY; PAIN IN HIS RIGHT SIDE; DISORIENTED; CHILLS; This spontaneous report received from a patient concerned a 71 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, expiry: UNKNOWN) dose was not reported, administered to left arm on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-APR-2021, the subject experienced cold. On 04-APR-2021, the subject experienced shaky. On 04-APR-2021, the subject experienced pain in his right side. On 04-APR-2021, the subject experienced disoriented. On 04-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, cold, shaky, pain in his right side, and disoriented. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: SORENESS; FEVER; NAUSEA; 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, and batch number were not reported) dose was not reported, administered on 01-APR-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 fever, nausea, and soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and the outcome of nausea and soreness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea
Clinical narrative: DIFFICULTY BREATHING/SHORTNESS OF BREATH; CHILLS; 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: 1805025, and  expiry: 01-APR-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced difficulty breathing/shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and difficulty breathing/shortness of breath 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: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH ON RIGHT LEG; This spontaneous report received from a consumer concerned a 70 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on left arm on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced rash on right leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rash on right leg was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site rash, Tenderness
Clinical narrative: BUMP UNDER SKIN AT INJECTION SITE; TENDERNESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination .  The batch number was not reported and has been requested.  No concomitant medications were reported. On an unspecified date, the subject experienced bump under skin at injection site, and tenderness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bump under skin at injection site and tenderness was not reported. This report was non-serious.
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Injection site pain, Pain, Pyrexia
Clinical narrative: BODY ACHE; FEVER; INJECTION SITE PAIN; This spontaneous report received from a consumer concerned a 20 year old of unspecified 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: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 12:20 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced injection site pain. Treatment medications included: ibuprofen, and paracetamol. On 02-APR-2021 20:00, the subject experienced body ache. On 02-APR-2021 20:00, the subject experienced fever. On 03-APR-2021, Laboratory data included: Body temperature (NR: not provided) 102. On 04-APR-2021, Laboratory data included: Body temperature (NR: not provided) 102. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and the outcome of body ache and injection site pain was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Vomiting
Clinical narrative: VOMITING; FEELING SICK; 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 03-APR-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 03-APR-2021, the subject experienced vomiting. On 03-APR-2021, the subject experienced feeling sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting, and the outcome of feeling sick 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: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: VOMITING; FEVER; POUNDING IN HEAD; NAUSEA; This spontaneous report received from a patient concerned a 26 year old female. The patient's height, and weight were not reported. The patient's past medical history included irritable bowel syndrome, and concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included patient do not have known allergies, patient do not have any 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: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 13:30 for prophylactic vaccination on right arm. Concomitant medications included cannabis sativa for irritable bowel syndrome.  On 02-APR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 101 degree F. On 02-APR-2021 14:30, the subject experienced pounding in head. On 02-APR-2021 15:30, the subject experienced fever. On 02-APR-2021 17:30, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 02-APR-2021 17:30, and pounding in head, was recovering from nausea, and had not recovered from vomiting. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Head discomfort, Insomnia, Malaise
Clinical narrative: TROUBLE SLEEPING; LITTLE BIT OF HEAD PRESSURE; A GENERAL FEELING OF BEING "OFF"; SHOULDER HURT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination.  The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers.   No concomitant medications were reported. On 31-MAR-2021, the subject experienced trouble sleeping. On 31-MAR-2021, the subject experienced little bit of head pressure. On 31-MAR-2021, the subject experienced a general feeling of being "off". On 31-MAR-2021, the subject experienced shoulder hurt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shoulder hurt, trouble sleeping, little bit of head pressure and a general feeling of being "off" was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; SLIGHT FEVER; 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 past medical history included knot from flu vaccine.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number 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 body aches, chills, and slight fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the slight fever, body aches and chills was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pyrexia
Clinical narrative: DIFFICULTY BREATHING; HIGH FEVER; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy .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 03-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included hydroxyzine for allergy.  On APR-2021, the subject experienced difficulty breathing. On APR-2021, the subject experienced high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high fever and difficulty breathing was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard operating procedure as the case was assessed as non-serious.