chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Body temperature, Chills, Dehydration
Clinical narrative: SWOLLEN MOUTH; BLISTERS ON LIPS; HIGH BLOOD PRESSURE; DEHYDRATION; SWOLLEN GUMS; SORE GUM; WEAKNESS; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and high cholesterol, 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: 1808609 expiry: UNKNOWN) dose was not reported, administered on left arm on 26-MAR-2021 11:30 for prophylactic vaccination. Concomitant medications included simvastatin for high cholesterol, and hydrochlorothiazide/lisinopril for hypertension, and hypertension. On MAR-2021, treatment medications included: paracetamol. On 27-MAR-2021, the subject experienced weakness. On 27-MAR-2021, the subject experienced chills. On 27-MAR-2021, the subject experienced headache. On 27-MAR-2021, the subject experienced fever. On 29-MAR-2021, the subject experienced swollen mouth. On 29-MAR-2021, the subject experienced blisters on lips. On 29-MAR-2021, the subject experienced high blood pressure. On 29-MAR-2021, the subject experienced dehydration. On 29-MAR-2021, the subject experienced swollen gums. On 29-MAR-2021, the subject experienced sore gum. Laboratory data included: Blood pressure (NR: not provided) 143/94 mmHg, 122/63 mmHg, and Body temperature (NR: not provided) 97.6 degree F. Additional treatment medications (dates unspecified) included: allantoin/camphor/phenol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high blood pressure on 29-MAR-2021, and weakness, chills, and fever on 28-MAR-2021, was recovering from headache, had not recovered from swollen mouth, blisters on lips, swollen gums, and sore gum, and the outcome of dehydration was not reported. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival pain, Gingival swelling, Headache, Hypertension, Lip blister
Clinical narrative: SWOLLEN MOUTH; BLISTERS ON LIPS; HIGH BLOOD PRESSURE; DEHYDRATION; SWOLLEN GUMS; SORE GUM; WEAKNESS; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and high cholesterol, 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: 1808609 expiry: UNKNOWN) dose was not reported, administered on left arm on 26-MAR-2021 11:30 for prophylactic vaccination. Concomitant medications included simvastatin for high cholesterol, and hydrochlorothiazide/lisinopril for hypertension, and hypertension. On MAR-2021, treatment medications included: paracetamol. On 27-MAR-2021, the subject experienced weakness. On 27-MAR-2021, the subject experienced chills. On 27-MAR-2021, the subject experienced headache. On 27-MAR-2021, the subject experienced fever. On 29-MAR-2021, the subject experienced swollen mouth. On 29-MAR-2021, the subject experienced blisters on lips. On 29-MAR-2021, the subject experienced high blood pressure. On 29-MAR-2021, the subject experienced dehydration. On 29-MAR-2021, the subject experienced swollen gums. On 29-MAR-2021, the subject experienced sore gum. Laboratory data included: Blood pressure (NR: not provided) 143/94 mmHg, 122/63 mmHg, and Body temperature (NR: not provided) 97.6 degree F. Additional treatment medications (dates unspecified) included: allantoin/camphor/phenol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high blood pressure on 29-MAR-2021, and weakness, chills, and fever on 28-MAR-2021, was recovering from headache, had not recovered from swollen mouth, blisters on lips, swollen gums, and sore gum, and the outcome of dehydration was not reported. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth swelling, Pyrexia
Clinical narrative: SWOLLEN MOUTH; BLISTERS ON LIPS; HIGH BLOOD PRESSURE; DEHYDRATION; SWOLLEN GUMS; SORE GUM; WEAKNESS; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and high cholesterol, 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: 1808609 expiry: UNKNOWN) dose was not reported, administered on left arm on 26-MAR-2021 11:30 for prophylactic vaccination. Concomitant medications included simvastatin for high cholesterol, and hydrochlorothiazide/lisinopril for hypertension, and hypertension. On MAR-2021, treatment medications included: paracetamol. On 27-MAR-2021, the subject experienced weakness. On 27-MAR-2021, the subject experienced chills. On 27-MAR-2021, the subject experienced headache. On 27-MAR-2021, the subject experienced fever. On 29-MAR-2021, the subject experienced swollen mouth. On 29-MAR-2021, the subject experienced blisters on lips. On 29-MAR-2021, the subject experienced high blood pressure. On 29-MAR-2021, the subject experienced dehydration. On 29-MAR-2021, the subject experienced swollen gums. On 29-MAR-2021, the subject experienced sore gum. Laboratory data included: Blood pressure (NR: not provided) 143/94 mmHg, 122/63 mmHg, and Body temperature (NR: not provided) 97.6 degree F. Additional treatment medications (dates unspecified) included: allantoin/camphor/phenol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high blood pressure on 29-MAR-2021, and weakness, chills, and fever on 28-MAR-2021, was recovering from headache, had not recovered from swollen mouth, blisters on lips, swollen gums, and sore gum, and the outcome of dehydration was not reported. This report was non-serious.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Back pain, Ear pain, Erythema
Clinical narrative: lower back pain; NECK ACHING; ALL OVER BODY ACHE; EARS RINGING; INSOMNIA; BACK ACHING; ANXIOUS; SHARP PAIN IN LEFT CALF; WEAKNESS; FATIGUE; PAIN AT INJECTION SITE; FACE GOT PRETTY RED; FACE STARTED ITCHING; LEFT EAR ACHING; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included uterus removed, ovaries removed, surgery for internal bleeding, and gall bladder removed, and concurrent conditions included sulfa allergy, latex allergy, paper tape allergy, pollen allergy, high blood pressure (temporary), fibromyalgia, and sleep apnea, and other pre-existing medical conditions included patient had allergies with medication which used to put under.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: 13-JUN-2021) dose was not reported, administered on 28-MAR-2021 11:00 to left deltoid for prophylactic vaccination. Concomitant medications included cetirizine hydrochloride, cyanocobalamin, famotidine, probiotics nos, and propranolol. On 28-MAR-2021, the subject experienced face got pretty red. On 28-MAR-2021, the subject experienced face started itching. On 28-MAR-2021, the subject experienced left ear aching. On 28-MAR-2021, the subject experienced sharp pain in left calf. On 28-MAR-2021, the subject experienced weakness. On 28-MAR-2021, the subject experienced fatigue. On 28-MAR-2021, the subject experienced pain at injection site. On 29-MAR-2021, the subject experienced neck aching. On 29-MAR-2021, the subject experienced all over body ache. On 29-MAR-2021, the subject experienced ears ringing. On 29-MAR-2021, the subject experienced insomnia. On 29-MAR-2021, the subject experienced back aching. On 29-MAR-2021, the subject experienced anxious. On an unspecified date, the subject experienced lower back pain. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, and oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from face started itching, and left ear aching on 28-MAR-2021, and sharp pain in left calf, weakness, and fatigue on 02-APR-2021, was recovering from face got pretty red, neck aching, all over body ache, ears ringing, insomnia, anxious, and pain at injection site, had not recovered from back aching, and the outcome of lower back pain was not reported. This report was non-serious.   The additional information received on 2-APR-2021 The following information was updated and incorporated into the case narrative: reporter address, patient details (age, birth date, sex, race, ethnic origin), medical history, events(lower back pain, weakness, fatigue, injection site pain) concomitant medication (famotidine, propranolol, Zyrtec, probiotics, vitamin), dose of drug used to treat AE.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Insomnia, Neck pain, Pain
Clinical narrative: lower back pain; NECK ACHING; ALL OVER BODY ACHE; EARS RINGING; INSOMNIA; BACK ACHING; ANXIOUS; SHARP PAIN IN LEFT CALF; WEAKNESS; FATIGUE; PAIN AT INJECTION SITE; FACE GOT PRETTY RED; FACE STARTED ITCHING; LEFT EAR ACHING; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included uterus removed, ovaries removed, surgery for internal bleeding, and gall bladder removed, and concurrent conditions included sulfa allergy, latex allergy, paper tape allergy, pollen allergy, high blood pressure (temporary), fibromyalgia, and sleep apnea, and other pre-existing medical conditions included patient had allergies with medication which used to put under.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: 13-JUN-2021) dose was not reported, administered on 28-MAR-2021 11:00 to left deltoid for prophylactic vaccination. Concomitant medications included cetirizine hydrochloride, cyanocobalamin, famotidine, probiotics nos, and propranolol. On 28-MAR-2021, the subject experienced face got pretty red. On 28-MAR-2021, the subject experienced face started itching. On 28-MAR-2021, the subject experienced left ear aching. On 28-MAR-2021, the subject experienced sharp pain in left calf. On 28-MAR-2021, the subject experienced weakness. On 28-MAR-2021, the subject experienced fatigue. On 28-MAR-2021, the subject experienced pain at injection site. On 29-MAR-2021, the subject experienced neck aching. On 29-MAR-2021, the subject experienced all over body ache. On 29-MAR-2021, the subject experienced ears ringing. On 29-MAR-2021, the subject experienced insomnia. On 29-MAR-2021, the subject experienced back aching. On 29-MAR-2021, the subject experienced anxious. On an unspecified date, the subject experienced lower back pain. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, and oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from face started itching, and left ear aching on 28-MAR-2021, and sharp pain in left calf, weakness, and fatigue on 02-APR-2021, was recovering from face got pretty red, neck aching, all over body ache, ears ringing, insomnia, anxious, and pain at injection site, had not recovered from back aching, and the outcome of lower back pain was not reported. This report was non-serious.   The additional information received on 2-APR-2021 The following information was updated and incorporated into the case narrative: reporter address, patient details (age, birth date, sex, race, ethnic origin), medical history, events(lower back pain, weakness, fatigue, injection site pain) concomitant medication (famotidine, propranolol, Zyrtec, probiotics, vitamin), dose of drug used to treat AE.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Tinnitus
Clinical narrative: lower back pain; NECK ACHING; ALL OVER BODY ACHE; EARS RINGING; INSOMNIA; BACK ACHING; ANXIOUS; SHARP PAIN IN LEFT CALF; WEAKNESS; FATIGUE; PAIN AT INJECTION SITE; FACE GOT PRETTY RED; FACE STARTED ITCHING; LEFT EAR ACHING; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included uterus removed, ovaries removed, surgery for internal bleeding, and gall bladder removed, and concurrent conditions included sulfa allergy, latex allergy, paper tape allergy, pollen allergy, high blood pressure (temporary), fibromyalgia, and sleep apnea, and other pre-existing medical conditions included patient had allergies with medication which used to put under.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: 13-JUN-2021) dose was not reported, administered on 28-MAR-2021 11:00 to left deltoid for prophylactic vaccination. Concomitant medications included cetirizine hydrochloride, cyanocobalamin, famotidine, probiotics nos, and propranolol. On 28-MAR-2021, the subject experienced face got pretty red. On 28-MAR-2021, the subject experienced face started itching. On 28-MAR-2021, the subject experienced left ear aching. On 28-MAR-2021, the subject experienced sharp pain in left calf. On 28-MAR-2021, the subject experienced weakness. On 28-MAR-2021, the subject experienced fatigue. On 28-MAR-2021, the subject experienced pain at injection site. On 29-MAR-2021, the subject experienced neck aching. On 29-MAR-2021, the subject experienced all over body ache. On 29-MAR-2021, the subject experienced ears ringing. On 29-MAR-2021, the subject experienced insomnia. On 29-MAR-2021, the subject experienced back aching. On 29-MAR-2021, the subject experienced anxious. On an unspecified date, the subject experienced lower back pain. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, and oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from face started itching, and left ear aching on 28-MAR-2021, and sharp pain in left calf, weakness, and fatigue on 02-APR-2021, was recovering from face got pretty red, neck aching, all over body ache, ears ringing, insomnia, anxious, and pain at injection site, had not recovered from back aching, and the outcome of lower back pain was not reported. This report was non-serious.   The additional information received on 2-APR-2021 The following information was updated and incorporated into the case narrative: reporter address, patient details (age, birth date, sex, race, ethnic origin), medical history, events(lower back pain, weakness, fatigue, injection site pain) concomitant medication (famotidine, propranolol, Zyrtec, probiotics, vitamin), dose of drug used to treat AE.
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Chest discomfort, Dizziness, Fatigue, Headache
Clinical narrative: HEAVINESS IN THE CHEST; SINUS ISSUES; LOST SENSE OF SMELL; DIZZINESS; NAUSEA; MUSCLE PAIN MOSTLY IN THE BACK; FEELING VERY TIRED; HEADACHE; FACE WAS PUFFY; 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: 1808609, and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced headache. On 26-MAR-2021, the subject experienced muscle pain mostly in the back. On 26-MAR-2021, the subject experienced feeling very tired. On 26-MAR-2021, the subject experienced face was puffy. On 28-MAR-2021, the subject experienced dizziness. On 28-MAR-2021, the subject experienced nausea. On 29-MAR-2021, the subject experienced sinus issues. On 29-MAR-2021, the subject experienced lost sense of smell. On 30-MAR-2021, the subject experienced heaviness in the chest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from heaviness in the chest, and the outcome of headache, nausea, dizziness, muscle pain mostly in the back, sinus issues, lost sense of smell, feeling very tired and face was puffy was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Sinus disorder, Swelling face
Clinical narrative: HEAVINESS IN THE CHEST; SINUS ISSUES; LOST SENSE OF SMELL; DIZZINESS; NAUSEA; MUSCLE PAIN MOSTLY IN THE BACK; FEELING VERY TIRED; HEADACHE; FACE WAS PUFFY; 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: 1808609, and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced headache. On 26-MAR-2021, the subject experienced muscle pain mostly in the back. On 26-MAR-2021, the subject experienced feeling very tired. On 26-MAR-2021, the subject experienced face was puffy. On 28-MAR-2021, the subject experienced dizziness. On 28-MAR-2021, the subject experienced nausea. On 29-MAR-2021, the subject experienced sinus issues. On 29-MAR-2021, the subject experienced lost sense of smell. On 30-MAR-2021, the subject experienced heaviness in the chest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from heaviness in the chest, and the outcome of headache, nausea, dizziness, muscle pain mostly in the back, sinus issues, lost sense of smell, feeling very tired and face was puffy was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: BODY ACHES; CHILLS; FEVER; HEADACHE; 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 past medical history included mild covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: not reported) dose was not reported, once a total administered, start therapy date 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, fever, and headache. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, fever, and headache. This report was non-serious. This case, from the same reporter is linked to 20210358903.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: FATIGUE; HEADACHE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers .No concomitant medications were reported. On MAR-2021, the subject experienced fatigue. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, and headache on MAR-2021. This report was non-serious.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Nausea, Pain
Clinical narrative: BODY ACHES; NAUSEOUS; MUSCLE ACHES IN BOTH ARMS; TIRED; CHILLS; This spontaneous report received from a patient concerned a 71 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: 1805025 expiry: UNKNOWN) dose was not reported, 1 total, administered on 27-MAR-2021 13:00 on left arm for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced chills. On 28-MAR-2021, the subject experienced body aches. On 28-MAR-2021, the subject experienced nauseous. On 28-MAR-2021, the subject experienced muscle aches in both arms. On 28-MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and chills on MAR-2021, and nauseous on 29-MAR-2021, and had not recovered from muscle aches in both arms, and tired. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Gait disturbance, Nasopharyngitis, Nausea
Clinical narrative: COLD; TROUBLE WALKING; LEGS ARE SHAKING; FREEZING; CHILLS; NAUSEA; 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 31-MAR-2021 for prophylactic vaccination.The Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers.   No concomitant medications were reported. On an unspecified date, the subject experienced cold, difficulty in walking, legs are shaking, freezing, chills, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cold, difficulty in walking, legs are shaking, chills, freezing and nausea was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: COLD; TROUBLE WALKING; LEGS ARE SHAKING; FREEZING; CHILLS; NAUSEA; 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 31-MAR-2021 for prophylactic vaccination.The Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers.   No concomitant medications were reported. On an unspecified date, the subject experienced cold, difficulty in walking, legs are shaking, freezing, chills, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cold, difficulty in walking, legs are shaking, chills, freezing and nausea was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Sluggishness
Clinical narrative: FELT SLUGGISH; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested.   No concomitant medications were reported. On an unspecified date, the subject experienced felt sluggish. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt sluggish. This report was non-serious.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: RINGING ON THE LEFT EAR; This spontaneous report received from a patient concerned a 55 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: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced ringing on the left ear. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient was recovering from ringing on the left ear. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Joint swelling, Peripheral swelling
Clinical narrative: RIGHT WRIST SWELLING; WRIST PAIN; FOREARM SWELLING; SITE WAS PAINFUL TO HE TOUCH; 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 22-MAR-2021 on right deltoid for prophylactic vaccination. Batch number was not reported has been requested No concomitant medications were reported. On an unspecified date, the subject experienced right wrist swelling, wrist pain, forearm swelling, and site was painful to he touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from right wrist swelling, and wrist pain, and the outcome of forearm swelling and site was painful to he touch was not reported. This report was non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: HEADACHE; LIGHTHEADEDNESS; This spontaneous report received from a patient concerned a 35 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: 1805022, expiry: 25-MAY-2021) dose was not reported, administered on 24-MAR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced lightheadedness. On 31-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and had not recovered from lightheadedness. This report was non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Injection site haemorrhage, Rotator cuff syndrome
Clinical narrative: TORN ROTATOR CUFF; SHOULDER PAIN (FEEL COMING FROM ARMPIT, SHOULDER SOCKET AND SHOULDER NUMBNESS ON SKIN, PAIN GOING ALL THE WAY THROUGH SHOULDER JOINTS, PAIN RADIATING DOWN IN ARM AND IN WRIST AND HAND); BLED MORE THAN USUAL; 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 shoulder injury. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1802070, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced bled more than usual. On 16-MAR-2021, the subject experienced shoulder pain (feel coming from armpit, shoulder socket and shoulder numbness on skin, pain going all the way through shoulder joints, pain radiating down in arm and in wrist and hand). On an unspecified date, the subject experienced torn rotator cuff. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from shoulder pain (feel coming from armpit, shoulder socket and shoulder numbness on skin, pain going all the way through shoulder joints, pain radiating down in arm and in wrist and hand), and the outcome of torn rotator cuff and bled more than usual was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case assessed as non serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia, Thirst
Clinical narrative: BODY ACHE; INSATIABLE THIRST; FEVER; BAD HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN expiry; UNKNOWN) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced body ache. On MAR-2021, the subject experienced insatiable thirst. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, insatiable thirst, fever, and bad headache on 30-MAR-2021. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Pyrexia
Clinical narrative: GENERAL FLU LIKE SYMPTOMS; CHILLS; HIGH FEVER; BAD HEADACHE; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included cardiac problem, respiratory problem, non-smoker, and sulfa allergy. 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 left arm on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced general flu like symptoms. On 17-MAR-2021, the subject experienced chills. On 17-MAR-2021, the subject experienced high fever. On 17-MAR-2021, the subject experienced bad headache. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from general flu like symptoms, chills, high fever, and bad headache on 23-MAR-2021. This report was non-serious.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Acne, Fatigue, Headache, Injection site pain, Malaise
Clinical narrative: ARM SORE; RUN DOWN; INJECTION SITE PAIN; FATIGUE; LOW GRADE HEADACHE; ACNE ON FACE, BACK AND THIGH; This spontaneous report received from a patient concerned a 51 year old male. The patient's weight was 235 pounds, and height was 65 inches. The patient's past medical history included skin boils, and pimples, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 at right Arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced acne on face, back and thigh. On 21-MAR-2021, the subject experienced arm sore. On 21-MAR-2021, the subject experienced run down. On 21-MAR-2021, the subject experienced injection site pain. On 21-MAR-2021, the subject experienced fatigue. On 21-MAR-2021, the subject experienced low grade headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm sore, run down, injection site pain, fatigue, and low grade headache on 23-MAR-2021, and had not recovered from acne on face, back and thigh. This report was non-serious.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ARM SORE; RUN DOWN; INJECTION SITE PAIN; FATIGUE; LOW GRADE HEADACHE; ACNE ON FACE, BACK AND THIGH; This spontaneous report received from a patient concerned a 51 year old male. The patient's weight was 235 pounds, and height was 65 inches. The patient's past medical history included skin boils, and pimples, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 at right Arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced acne on face, back and thigh. On 21-MAR-2021, the subject experienced arm sore. On 21-MAR-2021, the subject experienced run down. On 21-MAR-2021, the subject experienced injection site pain. On 21-MAR-2021, the subject experienced fatigue. On 21-MAR-2021, the subject experienced low grade headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm sore, run down, injection site pain, fatigue, and low grade headache on 23-MAR-2021, and had not recovered from acne on face, back and thigh. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: LIGHTHEADED; ABDOMINAL PAIN; FELT AS THOUGH A BAD HANGOVER X 4 DAYS; TIREDNESS; 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 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 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 vaccinated on left arm for prophylactic vaccination. No concomitant medications were reported. On 28-MAR-2021, the subject experienced lightheaded. On 28-MAR-2021, the subject experienced abdominal pain. On 28-MAR-2021, the subject experienced felt as though a bad hangover x 4 days. On 28-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tiredness, and lightheaded, and the outcome of abdominal pain and felt as though a bad hangover x 4 days 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 assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Hypersensitivity, Pain in extremity
Clinical narrative: SORE ARM; MILD CHILLS; ALLERGIES ACTING UP; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced sore arm, mild chills, and allergies acting up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, mild chills and allergies acting up was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: FLU LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user drinks 2-3 every other day, and cigarette smoking 3-4 times per day, and other pre-existing medical conditions included the patient had no medical history, no known allergies and no history of drug abuse/ illicit drug use.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 27-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 29-MAR-2021, the subject experienced flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu like symptoms. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blood test, White blood cell count increased
Clinical narrative: ELEVATED JUVENILE WHITE BLOOD CELLS; 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: unknown) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported No concomitant medications were reported. On MAR-2021, the subject experienced elevated juvenile white blood cells. On 21-MAR-2021, Laboratory data included: Blood test (NR: not provided) unknown. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The outcome of elevated juvenile white blood cells was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case assessed as non serious.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Pustule
Clinical narrative: HUNDREDS OF PUSTULE ON THE UNDERSIDE OF MY WRISTS, THIGHS AND ARMS; PUSTULES ITCH; 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, 1 total, administered on 12-MAR-2021 on an unspecified anatomical site for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 23-MAR-2021, the subject experienced hundreds of pustule on the underside of my wrists, thighs and arms. On 23-MAR-2021, the subject experienced pustules itch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hundreds of pustule on the underside of my wrists, thighs and arms, and the outcome of pustules itch was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: ACHEY; MILD CHILLS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced achey, and mild chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from mild chills, and achey. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: TIREDNESS; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included leg pain. 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 30-MAR-2021 for prophylactic vaccination. Concomitant medications included meloxicam for leg pain. On 31-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tiredness. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: CHILLS; FATIGUE; FEVER; This spontaneous report received from a consumer 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) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced fatigue. On MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, chills and fever was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: SLEEPY; TIRED; 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 28-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 30-MAR-2021, the subject experienced sleepy. On 30-MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sleepy and tired was not reported. This report was non-serious. This report was associated with product quality complaint :90000174832.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Influenza
Clinical narrative: EXTREME FATIGUE/TIRED; HEADACHE; FELT LIKE FLU FOR 5 DAYS; COULD NOT GET UP OR WORK; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced felt like flu for 5 days. On MAR-2021, the subject experienced could not get up or work. On 24-MAR-2021, the subject experienced headache. On 25-MAR-2021, the subject experienced extreme fatigue/tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 28-MAR-2021, was recovering from extreme fatigue/tired, and the outcome of felt like flu for 5 days and could not get up or work was not reported. This report was non-serious.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia
Clinical narrative: FATIGUE; FEVER; This spontaneous report received from a patient concerned a 30 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) once a total dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F. On 27-MAR-2021, the subject experienced fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 27-MAR-2021, and fatigue on 29-MAR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19 INFECTION/LOSS OF SMELL AND TASTE/RUNNING NOSE/COUGHING/HEADACHE/BODY  ACHE; 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: 1805031, expiry: UNKNOWN) dose was not reported, vaccinated in right arm, administered on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced covid-19 infection/loss of smell and taste/running nose/coughing/headache/body ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from covid-19 infection/loss of smell and taste/running nose/coughing/headache/body ache. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case assessed as non serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 52 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported . The company is unable to perform follow-up to request batch/lot numbers . No concomitant medications were reported. On 26-MAR-2021, the subject experienced headache. On 27-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 27-MAR-2021, and fatigue on 29-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Influenza like illness, Oropharyngeal pain, Pruritus
Clinical narrative: SYMPTOMS LIKE FLU COLD /CHILLS; DIARRHEA; SORE THROAT; SLIGHT HEADACHES; ITCH; This spontaneous report received from a patient concerned an 85 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, diabetes, sciatic nerve pain, arthritis pain, and allergy (dust, cigarettes, environmental trees, grass).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 26-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced itch. On 26-MAR-2021, the subject experienced slight headaches. On 30-MAR-2021, the subject experienced symptoms like flu cold /chills. On 30-MAR-2021, the subject experienced diarrhea. On 30-MAR-2021, the subject experienced sore throat. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight headaches on 31-MAR-2021, was recovering from itch, diarrhea, and sore throat, and had not recovered from symptoms like flu cold /chills. This report was non-serious.