chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Pain
Clinical narrative: BODY SORENESS; SHORTNESS OF BREATH; 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 concurrent conditions included diabetes, problems with kidneys, and ovarian cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination in left arm. No concomitant medications were reported.  On 17-MAR-2021, the subject experienced body soreness. On 17-MAR-2021, the subject experienced shortness of breath. On 17-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, and headache on 19-MAR-2021, and was recovering from body soreness. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: CHILLS; FEVER; HEADACHE; This spontaneous report received from a parent 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: 1805020, expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 14:00 to right arm for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021 04:00, the subject experienced chills. On 20-MAR-2021 04:00, the subject experienced fever. On 20-MAR-2021 04:00, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills and headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site discomfort
Clinical narrative: DISCOMFORT AT THE INJECTION SITE; 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) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. On an unspecified date, the subject experienced discomfort at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of discomfort at the injection site was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: ARM SORENESS; FEVER; TIREDNESS; This spontaneous report received from a patient 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: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. On an unspecified date, the subject experienced fever, tiredness, and arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, tiredness and arm soreness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Feeling cold
Clinical narrative: COLDNESS; CHILLS; WEAKNESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on right arm on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced coldness. On 19-MAR-2021, the subject experienced chills. On 19-MAR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from weakness on MAR-2021, had not recovered from chills, and the outcome of coldness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Sinus congestion, Swelling face
Clinical narrative: SWELLING AROUND NOSE AND CHEEKBONES; SINUS CONGESTION; DIFFICULTY  BREATHING; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, borderline emphysema, and allergic reaction to MRI/ CAT scan injections. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: 25-MAY-2021) dose was not reported, administered on right arm on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced swelling around nose and cheekbones. On 20-MAR-2021, the subject experienced sinus congestion. On 20-MAR-2021, the subject experienced difficulty breathing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling around nose and cheekbones, sinus congestion, and difficulty breathing. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SIDE EFFECTS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, 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 number. No concomitant medications were reported. On an unspecified date, the subject experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: FEVER OF 101.5; This spontaneous report received from a parent concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: unknown) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 21-MAR-2021, the subject experienced fever 101.5. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever 101.5. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Axillary pain, Dizziness, Dysgeusia, Dyspepsia
Clinical narrative: FELT REALLY/REALLY BAD AND FELT OUT OF SORT; SORENESS IN LEFT ARM; WEAKNESS; HEADACHE; RAPID HEART BEAT; INDIGESTION; DIZZINESS; ITCHING BEHIND NECK; MEDICINAL TASTE/SLIGHTLY SALTY TASTE/FELT TASTE OF VACCINE IN MOUTH; SORENESS UNDER LEFT ARMPIT; TO FEEL VACCINE GOING THROUGH HER BODY/FELT REALLY/REALLY BAD AND FELT OUT OF SORT; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included managed high blood pressure, non alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced rapid heart beat. On 15-MAR-2021, the subject experienced indigestion. On 15-MAR-2021, the subject experienced dizziness. On 15-MAR-2021, the subject experienced itching behind neck. On 15-MAR-2021, the subject experienced medicinal taste/slightly salty taste/felt taste of vaccine in mouth. On 15-MAR-2021, the subject experienced soreness under left armpit. On 15-MAR-2021, the subject experienced to feel vaccine going through her body/felt really/really bad and felt out of sort. On 15-MAR-2021, the subject experienced soreness in left arm. On 15-MAR-2021, the subject experienced weakness. On 15-MAR-2021, the subject experienced headache. On 18-MAR-2021, the subject experienced felt really/really bad and felt out of sort. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, had not recovered from weakness, soreness in left arm, medicinal taste/slightly salty taste/felt taste of vaccine in mouth, soreness under left armpit, and felt really/really bad and felt out of sort, and the outcome of indigestion, rapid heart beat, dizziness, itching behind neck and to feel vaccine going through her body/felt really/really bad and felt out of sort was not reported. This report was non-serious.; Sender's Comments: MAC not required as per standard procedure as case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Heart rate increased, Pain in extremity, Pruritus
Clinical narrative: FELT REALLY/REALLY BAD AND FELT OUT OF SORT; SORENESS IN LEFT ARM; WEAKNESS; HEADACHE; RAPID HEART BEAT; INDIGESTION; DIZZINESS; ITCHING BEHIND NECK; MEDICINAL TASTE/SLIGHTLY SALTY TASTE/FELT TASTE OF VACCINE IN MOUTH; SORENESS UNDER LEFT ARMPIT; TO FEEL VACCINE GOING THROUGH HER BODY/FELT REALLY/REALLY BAD AND FELT OUT OF SORT; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included managed high blood pressure, non alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced rapid heart beat. On 15-MAR-2021, the subject experienced indigestion. On 15-MAR-2021, the subject experienced dizziness. On 15-MAR-2021, the subject experienced itching behind neck. On 15-MAR-2021, the subject experienced medicinal taste/slightly salty taste/felt taste of vaccine in mouth. On 15-MAR-2021, the subject experienced soreness under left armpit. On 15-MAR-2021, the subject experienced to feel vaccine going through her body/felt really/really bad and felt out of sort. On 15-MAR-2021, the subject experienced soreness in left arm. On 15-MAR-2021, the subject experienced weakness. On 15-MAR-2021, the subject experienced headache. On 18-MAR-2021, the subject experienced felt really/really bad and felt out of sort. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, had not recovered from weakness, soreness in left arm, medicinal taste/slightly salty taste/felt taste of vaccine in mouth, soreness under left armpit, and felt really/really bad and felt out of sort, and the outcome of indigestion, rapid heart beat, dizziness, itching behind neck and to feel vaccine going through her body/felt really/really bad and felt out of sort was not reported. This report was non-serious.; Sender's Comments: MAC not required as per standard procedure as case was assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Swelling
Clinical narrative: SWELLING; LOCALIZED PAIN AT SITE OF INJECTION; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced swelling. On 18-MAR-2021, the subject experienced localized pain at site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling on 19-MAR-2021, and had not recovered from localized pain at site of injection. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Ear pain, Headache
Clinical narrative: EARACHE; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced earache, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the earache and headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: FEVER; BODY ACHES; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 fever, and body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and body aches was not reporter This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Visual impairment
Clinical narrative: SEEING FLOATING TINY CIRCLES, LINES AND DOTS IN FIELD OF VISION; FEELING 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: 1805022, and batch number: 1805022 expiry: 31-MAY-2021) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced seeing floating tiny circles, lines and dots in field of vision. On 15-MAR-2021, the subject experienced feeling tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from seeing floating tiny circles, lines and dots in field of vision, and the outcome of feeling tired was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Dizziness, Facial pain
Clinical narrative: LIGHT HEADED; FEELING LIKE WAS RUN OVER BY A  TRAIN (LOWER BACK PAIN); PRE-EXISTING LEFT SIDED FACE PAIN  MADE WORSE BY VACCINE (IN LEFT  EYE, CHEEK AND EAR); FEELING STRANGE NOT COMFORTABLE; CHILLS; FEELING LIKE WAS RUN OVER BY A  TRAIN (HIP PAIN); FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included thalassemia trait, and previous neck injury that causes pain on left side. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for to right deltoid prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced light headed. On 20-MAR-2021, the subject experienced feeling like was run over by a train (lower back pain). On 20-MAR-2021, the subject experienced pre-existing left sided face pain made worse by vaccine (in left eye, cheek and ear). On 20-MAR-2021, the subject experienced feeling strange not comfortable. On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced feeling like was run over by a train (hip pain). On 20-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, and feeling like was run over by a train (lower back pain), and had not recovered from fever, light headed, feeling like was run over by a train (hip pain), pre-existing left sided face pain made worse by vaccine (in left eye, cheek and ear), and feeling strange not comfortable. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pyrexia
Clinical narrative: LIGHT HEADED; FEELING LIKE WAS RUN OVER BY A  TRAIN (LOWER BACK PAIN); PRE-EXISTING LEFT SIDED FACE PAIN  MADE WORSE BY VACCINE (IN LEFT  EYE, CHEEK AND EAR); FEELING STRANGE NOT COMFORTABLE; CHILLS; FEELING LIKE WAS RUN OVER BY A  TRAIN (HIP PAIN); FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included thalassemia trait, and previous neck injury that causes pain on left side. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for to right deltoid prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced light headed. On 20-MAR-2021, the subject experienced feeling like was run over by a train (lower back pain). On 20-MAR-2021, the subject experienced pre-existing left sided face pain made worse by vaccine (in left eye, cheek and ear). On 20-MAR-2021, the subject experienced feeling strange not comfortable. On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced feeling like was run over by a train (hip pain). On 20-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, and feeling like was run over by a train (lower back pain), and had not recovered from fever, light headed, feeling like was run over by a train (hip pain), pre-existing left sided face pain made worse by vaccine (in left eye, cheek and ear), and feeling strange not comfortable. This report was non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: NUMBNESS IN HANDS, FINGERS AND FACE; CONGESTION; SORE THROAT; DIZZINESS; CHILLS; WEAKNESS; FEVER; FATIGUE; NAUSEA; HEADACHE; MUSCLE PAIN IN BACK; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced numbness in hands, fingers and face. On 09-MAR-2021, the subject experienced congestion. On 09-MAR-2021, the subject experienced sore throat. On 09-MAR-2021, the subject experienced dizziness. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced weakness. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced fatigue. On 09-MAR-2021, the subject experienced nausea. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced muscle pain in back. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, chills, weakness, fever, and headache on 10-MAR-2021, and had not recovered from fatigue, nausea, muscle pain in back, numbness in hands, fingers and face, congestion, and sore throat. This report was non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Myalgia, Nasal congestion, Nausea, Oropharyngeal pain
Clinical narrative: NUMBNESS IN HANDS, FINGERS AND FACE; CONGESTION; SORE THROAT; DIZZINESS; CHILLS; WEAKNESS; FEVER; FATIGUE; NAUSEA; HEADACHE; MUSCLE PAIN IN BACK; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced numbness in hands, fingers and face. On 09-MAR-2021, the subject experienced congestion. On 09-MAR-2021, the subject experienced sore throat. On 09-MAR-2021, the subject experienced dizziness. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced weakness. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced fatigue. On 09-MAR-2021, the subject experienced nausea. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced muscle pain in back. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, chills, weakness, fever, and headache on 10-MAR-2021, and had not recovered from fatigue, nausea, muscle pain in back, numbness in hands, fingers and face, congestion, and sore throat. This report was non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: NUMBNESS IN HANDS, FINGERS AND FACE; CONGESTION; SORE THROAT; DIZZINESS; CHILLS; WEAKNESS; FEVER; FATIGUE; NAUSEA; HEADACHE; MUSCLE PAIN IN BACK; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced numbness in hands, fingers and face. On 09-MAR-2021, the subject experienced congestion. On 09-MAR-2021, the subject experienced sore throat. On 09-MAR-2021, the subject experienced dizziness. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced weakness. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced fatigue. On 09-MAR-2021, the subject experienced nausea. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced muscle pain in back. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, chills, weakness, fever, and headache on 10-MAR-2021, and had not recovered from fatigue, nausea, muscle pain in back, numbness in hands, fingers and face, congestion, and sore throat. This report was non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthropod bite, Biopsy, Dermatitis allergic
Clinical narrative: NUMBNESS IN HANDS, FINGERS AND FACE; CONGESTION; SORE THROAT; DIZZINESS; CHILLS; WEAKNESS; FEVER; FATIGUE; NAUSEA; HEADACHE; MUSCLE PAIN IN BACK; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced numbness in hands, fingers and face. On 09-MAR-2021, the subject experienced congestion. On 09-MAR-2021, the subject experienced sore throat. On 09-MAR-2021, the subject experienced dizziness. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced weakness. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced fatigue. On 09-MAR-2021, the subject experienced nausea. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced muscle pain in back. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, chills, weakness, fever, and headache on 10-MAR-2021, and had not recovered from fatigue, nausea, muscle pain in back, numbness in hands, fingers and face, congestion, and sore throat. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Breast feeding
Clinical narrative: BREASTFEEDING; This spontaneous report received from a parent 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, transmammary, batch number: Unknown) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced breastfeeding. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of breastfeeding was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: HIGH FEVER WHICH GOT SPIKED AND WAS STILL AT 101 IN THE MORNING AND 99.86 AT THE TIME OF REPORTING; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no medical history, no known 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: 1805025, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 09:06 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, Laboratory data included: Fever (NR: not provided) 103 F. On 20-MAR-2021 15:00, the subject experienced high fever which got spiked and was still at 101 in the morning and 99.86 at the time of reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from high fever which got spiked and was still at 101 in the morning and 99.86 at the time of reporting. This report was non-serious.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Headache
Clinical narrative: DRY COUGH; CHILLS; HEADACHE; TIRED; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and other pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced tired. On 13-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced headache. On 16-MAR-2021, the subject experienced dry cough. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, tired, chills, and dry cough. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: CHILLS; FEVER; This spontaneous report received from a parent concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) 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 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and chills. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Fatigue, Feeling cold
Clinical narrative: HOT TO THE TOUCH; FEELING COLD; FATIGUE; TEMPERATURE; CHILLS WITH SHAKING; ARM PAIN AT INJECTION; This spontaneous report received from a consumer concerned a 28 year old female. The patient's height, and weight were not reported. The patient's past medical history included non smoker, and concurrent conditions included 4 times per year alcohol use, cats/dogs allergy, pollen allergy, and different metals allergy, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 to right arm as prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced arm pain at injection. On 18-MAR-2021, the subject experienced temperature. On 18-MAR-2021, the subject experienced chills with shaking. On an unspecified date, the subject experienced hot to the touch, feeling cold, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm pain at injection on 19-MAR-2021, was recovering from chills with shaking, had not recovered from temperature, fatigue, and hot to the touch, and the outcome of feeling cold was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Skin warm
Clinical narrative: HOT TO THE TOUCH; FEELING COLD; FATIGUE; TEMPERATURE; CHILLS WITH SHAKING; ARM PAIN AT INJECTION; This spontaneous report received from a consumer concerned a 28 year old female. The patient's height, and weight were not reported. The patient's past medical history included non smoker, and concurrent conditions included 4 times per year alcohol use, cats/dogs allergy, pollen allergy, and different metals allergy, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 to right arm as prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced arm pain at injection. On 18-MAR-2021, the subject experienced temperature. On 18-MAR-2021, the subject experienced chills with shaking. On an unspecified date, the subject experienced hot to the touch, feeling cold, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm pain at injection on 19-MAR-2021, was recovering from chills with shaking, had not recovered from temperature, fatigue, and hot to the touch, and the outcome of feeling cold was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: 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 not reported) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch number. No concomitant medications were reported. On MAR-2021, the subject experienced arm was little sore. On MAR-2021, the subject experienced mild headache. On MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm was little sore, mild headache, and tired on 14-MAR-2021. This report was non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: WEAK; EXTREME TIREDNESS; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight was 125 pounds, and height was 64 inches. The patient's concurrent conditions included high blood pressure, non alcohol user, smoking, penicillin allergy, and sleep disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on left arm on 14-MAR-2021 09:30 for prophylactic vaccination. Concomitant medications included trazodone for for sleep, furosemide, and potassium. On 15-MAR-2021, the subject experienced weak. On 15-MAR-2021, the subject experienced extreme tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme tiredness, and weak. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: INJECTION SITE HOT; INJECTION SITE ITCHY; FATIGUE; INJECTIONS SITE SORE; INJECTION SITE FEELS SWOLLEN; 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, intramuscular, batch number: Unknown) dose was not reported, administered on 13-MAR-2021 to right deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-MAR-2021, the subject experienced injection site hot. On 14-MAR-2021, the subject experienced injection site itchy. On 14-MAR-2021, the subject experienced fatigue. On 14-MAR-2021, the subject experienced injections site sore. On 14-MAR-2021, the subject experienced injection site feels swollen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, injection site hot, injections site sore, injection site itchy, and injection site feels swollen. This report was non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Pain
Clinical narrative: STOMACH UPSET; SLIGHT HEADACHE; SLIGHT PAIN; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's past medical history included stomach issue, and concurrent conditions included high blood pressure.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, on left arm administered on 07-MAR-2021 15:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced slight pain. On 08-MAR-2021, the subject experienced slight headache. On 11-MAR-2021, the subject experienced stomach upset. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight headache on 08-MAR-2021, had not recovered from stomach upset, and the outcome of slight pain was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: SORENESS; TIRED; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. On 16-MAR-2021, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry date : 26-MAY-2021) dose was not reported, vaccinated on right deltoid, once a total administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the patient experienced tired, soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired, and soreness on 19-MAR-2021. This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Chills, Fatigue, Feeling abnormal, Influenza
Clinical narrative: This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included wasp sting, and non-smoker, and other pre-existing medical conditions included unknown. The patient was previously treated with varicella zoster vaccine rge (cho) for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) .5 ml, administered on AUG-2020 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2020, Laboratory data included: Antibody test (NR: not provided) antibodies present. On AUG-2020, the subject experienced flu. On AUG-2020, the subject experienced shivers. On AUG-2020, the subject experienced rib cage ache. On AUG-2020, the subject experienced felt lousy. On AUG-2020, the subject experienced muscle aches. On AUG-2020, the subject experienced stung at arm. On AUG-2020, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu, shivers, rib cage ache, felt lousy, muscle aches, and stung at arm on AUG-2020, and had not recovered from fatigue. Product Quality Complaint number:90000173522 This report was non-serious. The suspected product quality complaint has been confirmed to be voided (did not meet pqc criteria)- , this report does not contain any indication of a pqc but only mentions pure ae's which are outside of the scope of quality investigation. Based on the PQC evaluation/investigation performed.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Musculoskeletal chest pain, Myalgia
Clinical narrative: This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included wasp sting, and non-smoker, and other pre-existing medical conditions included unknown. The patient was previously treated with varicella zoster vaccine rge (cho) for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) .5 ml, administered on AUG-2020 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2020, Laboratory data included: Antibody test (NR: not provided) antibodies present. On AUG-2020, the subject experienced flu. On AUG-2020, the subject experienced shivers. On AUG-2020, the subject experienced rib cage ache. On AUG-2020, the subject experienced felt lousy. On AUG-2020, the subject experienced muscle aches. On AUG-2020, the subject experienced stung at arm. On AUG-2020, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu, shivers, rib cage ache, felt lousy, muscle aches, and stung at arm on AUG-2020, and had not recovered from fatigue. Product Quality Complaint number:90000173522 This report was non-serious. The suspected product quality complaint has been confirmed to be voided (did not meet pqc criteria)- , this report does not contain any indication of a pqc but only mentions pure ae's which are outside of the scope of quality investigation. Based on the PQC evaluation/investigation performed.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nasopharyngitis
Clinical narrative: COLD; EXTREME TIREDNESS; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included paracetamol. On 2021, the subject experienced cold. On 2021, the subject experienced extreme tiredness. On 2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold, extreme tiredness, and fatigue on 2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pyrexia
Clinical narrative: TIRED; CHILLS; FEVER; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029) dose was not reported, administered on 19-MAR-2021 10:15 at left arm for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced tired. On 19-MAR-2021, the subject experienced chills. On 19-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills and tired was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: RASHES ALL THE BODY,GETTING WORSE AND STARTED ON ARM, LEG, NECK AND FACE; ITCHY; 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, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced rashes all the body, getting worse and started on arm, leg, neck and face. On MAR-2021, the subject experienced itchy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rashes all the body,getting worse and started on arm, leg, neck and face, and the outcome of itchy was not reported. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Glassy eyes, Heart rate increased, Hypersensitivity, Lethargy
Clinical narrative: ALLERGIC REACTION; HEART BEAT ELEVATED; FATIGUE; GLASSY EYES; LETHARGIC; RUNNY NOSE; This spontaneous report received from a consumer concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included advanced multiple sclerosis, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination at her right arm. No concomitant medications were reported. On 14-MAR-2021, the subject experienced glassy eyes. On 14-MAR-2021, the subject experienced lethargic. On 14-MAR-2021, the subject experienced runny nose. On 14-MAR-2021, the subject experienced fatigue. On 15-MAR-2021, the subject experienced heart beat elevated. On 17-MAR-2021, treatment medications included: loratadine. On an unspecified date, the subject experienced allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, had not recovered from glassy eyes, runny nose, heart beat elevated, and allergic reaction, and the outcome of lethargic was not reported. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: ALLERGIC REACTION; HEART BEAT ELEVATED; FATIGUE; GLASSY EYES; LETHARGIC; RUNNY NOSE; This spontaneous report received from a consumer concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included advanced multiple sclerosis, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination at her right arm. No concomitant medications were reported. On 14-MAR-2021, the subject experienced glassy eyes. On 14-MAR-2021, the subject experienced lethargic. On 14-MAR-2021, the subject experienced runny nose. On 14-MAR-2021, the subject experienced fatigue. On 15-MAR-2021, the subject experienced heart beat elevated. On 17-MAR-2021, treatment medications included: loratadine. On an unspecified date, the subject experienced allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, had not recovered from glassy eyes, runny nose, heart beat elevated, and allergic reaction, and the outcome of lethargic was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: CHILLS; HEADACHE; FATIGUE TIRED AND SLEPT A LOT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced headache. On 20-MAR-2021, the subject experienced fatigue tired and slept a lot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, and headache, and the outcome of fatigue tired and slept a lot was not reported. This report was non-serious.