chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Echocardiogram abnormal, Ejection fraction decreased, Left atrial dilatation, Left ventricular dysfunction
Clinical narrative: Per triage note of 4/7/2021:  "Chief Complaint: pt presents with Nausea & vomitting, ha,  body ache, unable to       sleep, swollen feet. Symptoms started 3/25 after he recieved his 1st covid       vaccine. has had to use a walker and gets SOB. pt had COVID 11/2020"  Assessment reveals mild CHF, positive troponin, myocarditis per physician's notes of 4/7/2021  Patient treated with Zofran 4 mg IV and given 500 ml NS IV then Lasix 40 mg IV.  Patient transferred to  Medical Center 4/7
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Left ventricular enlargement, Left ventricular failure, Mitral valve incompetence, Myocardial infarction, Nausea
Clinical narrative: Per triage note of 4/7/2021:  "Chief Complaint: pt presents with Nausea & vomitting, ha,  body ache, unable to       sleep, swollen feet. Symptoms started 3/25 after he recieved his 1st covid       vaccine. has had to use a walker and gets SOB. pt had COVID 11/2020"  Assessment reveals mild CHF, positive troponin, myocarditis per physician's notes of 4/7/2021  Patient treated with Zofran 4 mg IV and given 500 ml NS IV then Lasix 40 mg IV.  Patient transferred to  Medical Center 4/7
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Peripheral swelling, Tricuspid valve incompetence, Troponin increased, Vomiting
Clinical narrative: Per triage note of 4/7/2021:  "Chief Complaint: pt presents with Nausea & vomitting, ha,  body ache, unable to       sleep, swollen feet. Symptoms started 3/25 after he recieved his 1st covid       vaccine. has had to use a walker and gets SOB. pt had COVID 11/2020"  Assessment reveals mild CHF, positive troponin, myocarditis per physician's notes of 4/7/2021  Patient treated with Zofran 4 mg IV and given 500 ml NS IV then Lasix 40 mg IV.  Patient transferred to  Medical Center 4/7
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: right after injection given Patient tells me " I am going to faint" and she did faint into my arms without any injury while sitting upright . I lowered  her down to exam table and called for help placing her feet / legs up and she came around right away. When appropriate was able to sit up again and was able to drink a beverage then was guided to sit in a chair and stayed for 15 minutes and then was released to Home when feeling completely well per Patient self report.
Age: 61.0
Sex: F
Vaccine: DF
Symptoms: Blood glucose increased, Nausea
Clinical narrative: Nausea. Glucose 368 BP 143/86 HR 86
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: Pressure in chest since then, all day
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: BODY ACHES; TIREDNESS; This spontaneous report received from a patient concerned a 78 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: 1805020 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced body aches. On 14-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and tiredness on MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210358563.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: ACHES/PAIN; FEVER; NAUSEA; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination .The batch number was not reported and has been requested. No concomitant medications were reported. On 28-MAR-2021, the subject experienced aches/pain.  On 28-MAR-2021, the subject experienced fever. On 28-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, nausea and aches/pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Sensory disturbance
Clinical narrative: ARM COULD FALL OFF; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced arm could fall off. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arm could fall off was not reported. This report was non-serious.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: BODY ACHES; TIREDNESS; This spontaneous report received from a consumer concerned a 78 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: 1805020 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 14-MAR-2021, the subject experienced body aches. On 14-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and tiredness on MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210355363.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: HEADACHE; FEELING LETHARGIC; CONCENTRATING; HARD TIME WALKING FROM BED TO THE KITCHEN; PAIN WAS CONCENTRATED TO THE NECK; FEVER PERSISTED; MUSCLE PAIN AROUND NECK AND SHOULDER BLADE, EXPANDING TO THE BACK OR MUSCLE ACHES; NAUSEA; FEEL BADLY, FEEL LIKE PUNCHED; DIFFICULTY WALKING; CHILLS; ARM SORENESS AROUND THE SHOULDER; JOINT PAIN, SPECIFICALLY ON THE KNEES/JOINT PAIN; MUSCLE WEAKNESS; FELT PRESSURE ON THE FRONT OF THE FACE; COULD NOT SLEEP ON SIDE; COULD NOT EVEN HOLD UP PHONE; MIGRAINE; FLU LIKE ILLNESS; 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 overactive immune system. 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 26-MAR-2021 13:00 to the right arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced migraine. On MAR-2021, the subject experienced flu like illness. On 26-MAR-2021, the subject experienced feel badly, feel like punched. On 26-MAR-2021, the subject experienced difficulty walking. On 26-MAR-2021, the subject experienced felt pressure on the front of the face. On 26-MAR-2021, the subject experienced could not sleep on side. On 26-MAR-2021, the subject experienced could not even hold up phone. On 26-MAR-2021, the subject experienced chills. On 26-MAR-2021, the subject experienced arm soreness around the shoulder. On 26-MAR-2021, the subject experienced joint pain, specifically on the knees/joint pain. On 26-MAR-2021, the subject experienced muscle weakness. On 26-MAR-2021, the subject experienced muscle pain around neck and shoulder blade, expanding to the back or muscle aches. On 26-MAR-2021, the subject experienced nausea. On 27-MAR-2021, the subject experienced feeling lethargic. On 27-MAR-2021, the subject experienced concentrating. On 27-MAR-2021, the subject experienced hard time walking from bed to the kitchen. On 27-MAR-2021, the subject experienced pain was concentrated to the neck. On 27-MAR-2021, the subject experienced fever persisted. Treatment medications included: ibuprofen. On 28-MAR-2021, the subject experienced headache. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine, and chills on MAR-2021, was recovering from fever persisted, muscle pain around neck and shoulder blade, expanding to the back or muscle aches, feeling lethargic, nausea, muscle weakness, joint pain, specifically on the knees/joint pain, and flu like illness, and the outcome of feel badly, feel like punched, arm soreness around the shoulder, difficulty walking, headache, felt pressure on the front of the face, could not sleep on side, could not even hold up phone, concentrating, hard time walking from bed to the kitchen and pain was concentrated to the neck was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Feeling of body temperature change, Headache, Limb discomfort
Clinical narrative: BODY ACHES / BODY SORE; ARM HEAVY; FEELING OF GETTING A COLD; FEELING COLD AND WARM ALTERNATING; SORE ARM; SHIVERS; LIGHT HEADACHE; This spontaneous report received from a consumer concerned an adult female. The patient's height, and weight were not reported. The patient's past medical history included bronchitis, and concurrent conditions included cough. 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 29-MAR-2021 for prophylactic vaccination to the Right Deltoid. No concomitant medications were reported. On an unspecified date, the subject experienced body aches / body sore, arm heavy, feeling of getting a cold, feeling cold and warm alternating, sore arm, shivers, and light headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling cold and warm alternating, and had not recovered from body aches / body sore, shivers, arm heavy, feeling of getting a cold, light headache, and sore arm. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: BODY ACHES / BODY SORE; ARM HEAVY; FEELING OF GETTING A COLD; FEELING COLD AND WARM ALTERNATING; SORE ARM; SHIVERS; LIGHT HEADACHE; This spontaneous report received from a consumer concerned an adult female. The patient's height, and weight were not reported. The patient's past medical history included bronchitis, and concurrent conditions included cough. 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 29-MAR-2021 for prophylactic vaccination to the Right Deltoid. No concomitant medications were reported. On an unspecified date, the subject experienced body aches / body sore, arm heavy, feeling of getting a cold, feeling cold and warm alternating, sore arm, shivers, and light headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling cold and warm alternating, and had not recovered from body aches / body sore, shivers, arm heavy, feeling of getting a cold, light headache, and sore arm. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: MY ARM ONLY SORE WHEN I TOUCH  THE SITE; 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 (suspension for injection, route of admin not reported, batch number: Unknown) once a total 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 MAR-2021, the subject experienced arm only sore when i touch the site. The action taken with covid-19 vaccine was not applicable. The outcome of arm only sore when i touch the site was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hypersomnia, Injection site pain
Clinical narrative: SLEPT ALOT; CHILLS; SLIGHT HEADACHE; INJECTION SITE PAIN ON HER RIGHT ARM; FATIGUE; NAUSEA; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included multiple chemical syndrome, and many allergies to many different drugs. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808390 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 to right arm for prophylactic vaccination.  No concomitant medications were reported.  On 26-MAR-2021, the subject experienced slept a lot. On 26-MAR-2021, the subject experienced chills. On 26-MAR-2021, the subject experienced slight headache. On 26-MAR-2021, the subject experienced injection site pain on her right arm. On 26-MAR-2021, the subject experienced fatigue. On 26-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slept a lot, and chills, slight headache, injection site pain on her right arm, and fatigue on 29-MAR-2021, and was recovering from nausea. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: SLEPT ALOT; CHILLS; SLIGHT HEADACHE; INJECTION SITE PAIN ON HER RIGHT ARM; FATIGUE; NAUSEA; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included multiple chemical syndrome, and many allergies to many different drugs. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808390 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 to right arm for prophylactic vaccination.  No concomitant medications were reported.  On 26-MAR-2021, the subject experienced slept a lot. On 26-MAR-2021, the subject experienced chills. On 26-MAR-2021, the subject experienced slight headache. On 26-MAR-2021, the subject experienced injection site pain on her right arm. On 26-MAR-2021, the subject experienced fatigue. On 26-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slept a lot, and chills, slight headache, injection site pain on her right arm, and fatigue on 29-MAR-2021, and was recovering from nausea. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change
Clinical narrative: HOT AND COLD SENSATIONS ON BODY; 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 29-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 29-MAR-2021, the subject experienced hot and cold sensations on body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hot and cold sensations on body was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: BILATERAL SWOLLEN ARMPITS/BILATERAL LYMPH ADENOPATHY; This spontaneous report received from a physician 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: not reported) dose was not reported, once a total administered, start therapy date 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 bilateral swollen armpits/bilateral lymph adenopathy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bilateral swollen armpits/bilateral lymph adenopathy was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Myalgia
Clinical narrative: MUSCULAR PAIN; MILD BRAIN FOG; 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 (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. Per procedure no follow up will be requested for this case. No concomitant medications were reported. On 26-MAR-2021, the subject experienced mild brain fog. On 27-MAR-2021, the subject experienced muscular pain. The action taken with covid-19 vaccine was not applicable. The outcome of the mild brain fog and muscular pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, SARS-CoV-2 test
Clinical narrative: REKT ME; 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, 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 rekt me. 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 outcome of rekt me was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: FELT SICK; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the subject experienced felt sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt sick was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHEST HURT; FEVER; This spontaneous report received from a parent 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, 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 body aches, chest hurt, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and the outcome of body aches and chest hurt was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inflammation, Neck pain, Pain in extremity
Clinical narrative: INFLAMMATION BEHIND THE EAR - LEFT; TIREDNESS; LEFT ARM SORENESS; NECK PAIN; 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 sinus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced neck pain. On 12-MAR-2021, the subject experienced left arm soreness. On 23-MAR-2021, the subject experienced tiredness. On 29-MAR-2021, the subject experienced inflammation behind the ear - left. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from inflammation behind the ear - left, had not recovered from tiredness, and left arm soreness, and the outcome of neck pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity, Pyrexia
Clinical narrative: SORE ARM; FELT ILL; FEVERISH; This spontaneous report received from a patient concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case No concomitant medications were reported. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm, felt ill, and feverish. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and the outcome of feverish and felt ill was not reported. This report was non-serious.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Pain
Clinical narrative: CHILLS; SWEATING; ACHINESS; This spontaneous report received from a patient concerned a 70 year old male. The patient's height, and weight were not reported. The patient's past medical history included alcohol use, and concurrent conditions included asthma, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and patient had no drug abuse or illicit drug allergies.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 16-MAR-2021 16:00 at right deltoid for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included levofloxacin for asthma, and montelukast sodium for asthma. On 16-MAR-2021, the subject experienced chills. On 16-MAR-2021, the subject experienced sweating. On 16-MAR-2021, the subject experienced achiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, sweating, and achiness. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Pain
Clinical narrative: PAIN ALL OVER ARM AND MOST OF BODY; HEADACHE; HOT HEAD; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported. On an unspecified date, the subject experienced pain all over arm and most of body, headache, and hot head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain all over arm and most of body, headache and hot head was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: FEVER OF 101.6; 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 27-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 fever of 101.6. Laboratory data included: Body temperature (NR: not provided) 101.6 (unit not provided). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever of 101.6 was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included shellfish allergy, alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient experienced drug allergy when treated with lisinopril. 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 10-MAR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain at injection site. This report was non-serious.
Age: 47.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Pain
Clinical narrative: EXTREME/EXCRUCIATING PAIN; SLEEPING 20 HOURS A DAY; EXTREME TIREDNESS; This spontaneous report received from a patient concerned a 47 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included psoriatic arthritis, and spondylosis. 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 20-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced extreme/excruciating pain. On 20-MAR-2021, the subject experienced sleeping 20 hours a day. On 20-MAR-2021, the subject experienced extreme tiredness. Treatment medications (dates unspecified) included: alprazolam, and hydrocodone bitartrate/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme/excruciating pain on 20-MAR-2021, had not recovered from extreme tiredness, and the outcome of sleeping 20 hours a day was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included ulcerative colitis.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 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included vedolizumab for ulcerative colitis. On MAR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gastric disorder, Hypersensitivity, Pain, Pyrexia
Clinical narrative: ACHES/PAIN; STOMACH ISSUES; HIGH FEVER; EXHAUSTION; TURNED HER ALLERGY WORSE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced aches/pain, stomach issues, high fever, exhaustion, and turned her allergy worse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches/pain, stomach issues, high fever, exhaustion, and turned her allergy worse. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Chills, Myalgia, Pain in extremity
Clinical narrative: CHEST PAIN; CHILLS; ARM SORE; ACHY MUSCLES; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection. The patient received covid-19 vaccine  (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. Per procedure, no follow-up will be requested for this case No concomitant medications were reported. On MAR-2021, the subject experienced chest pain. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced arm sore. On MAR-2021, the subject experienced achy muscles. On MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102. The action taken with covid-19 vaccine was not applicable. The patient recovered from fever on 29-MAR-2021, and the outcome of achy muscles, chest pain, chills and arm sore was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: CHEST PAIN; CHILLS; ARM SORE; ACHY MUSCLES; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection. The patient received covid-19 vaccine  (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. Per procedure, no follow-up will be requested for this case No concomitant medications were reported. On MAR-2021, the subject experienced chest pain. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced arm sore. On MAR-2021, the subject experienced achy muscles. On MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102. The action taken with covid-19 vaccine was not applicable. The patient recovered from fever on 29-MAR-2021, and the outcome of achy muscles, chest pain, chills and arm sore was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Paraesthesia, Pyrexia
Clinical narrative: TINGLING IN LEFT AND RIGHT ARMS AND FINGERS; FEVER; PAIN AT INJECTION SITE; CHILLS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included surgery in left arm. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered to left arm on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced fever. On 24-MAR-2021, the subject experienced chills. On 24-MAR-2021, the subject experienced pain at injection site. On 27-MAR-2021, the subject experienced tingling in arms and fingers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, chills, and pain at injection site on 26-MAR-2021, and had not recovered from tingling in arms and fingers. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Insomnia, Palpitations, Paraesthesia
Clinical narrative: HEART RACING; FELT LIKE ADRENALINE RUSH; SKIN TINGLING; GOOSEBUMPS; TROUBLE SLEEPING; LOW ENERGY; 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: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021, vaccinated to left arm for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021 (Saturday), the patient experienced low energy. On 28-MAR-2021, the subject experienced heart racing and adrenaline was rush. On 28-MAR-2021, the patient also experienced tingling in her skin, goosebumps, trouble sleeping and heart racing. The patient still having these symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low energy on MAR-2021, and had not recovered from felt like adrenaline rush, skin tingling, goosebumps, trouble sleeping, and heart racing. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Piloerection
Clinical narrative: HEART RACING; FELT LIKE ADRENALINE RUSH; SKIN TINGLING; GOOSEBUMPS; TROUBLE SLEEPING; LOW ENERGY; 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: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021, vaccinated to left arm for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021 (Saturday), the patient experienced low energy. On 28-MAR-2021, the subject experienced heart racing and adrenaline was rush. On 28-MAR-2021, the patient also experienced tingling in her skin, goosebumps, trouble sleeping and heart racing. The patient still having these symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low energy on MAR-2021, and had not recovered from felt like adrenaline rush, skin tingling, goosebumps, trouble sleeping, and heart racing. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Feeling cold, Headache
Clinical narrative: MUSCLE ACHES; EXTREME COLD FEELING; FEVER OF 100 F; CHILLS; BODY ACHES; NAUSEA; EXTREME FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's past medical history included prediabetic but become better with diet and exercise .menopause, and other pre-existing medical conditions included does the patient have any allergies? :: no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 180 8069 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 body aches. On 26-MAR-2021, the subject experienced nausea. On 26-MAR-2021, the subject experienced extreme fatigue. On 26-MAR-2021, the subject experienced headache. On 27-MAR-2021, the subject experienced chills. On 27-MAR-2021, the subject experienced fever of 100 f. Laboratory data included: Body temperature (NR: not provided) 100 F. On 27-MAR-2021 03:00, the subject experienced extreme cold feeling. On an unspecified date, the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, muscle aches, and extreme fatigue on 28-MAR-2021, chills, nausea, headache, and fever of 100 f on 27-MAR-2021, and extreme cold feeling. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: MUSCLE ACHES; EXTREME COLD FEELING; FEVER OF 100 F; CHILLS; BODY ACHES; NAUSEA; EXTREME FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's past medical history included prediabetic but become better with diet and exercise .menopause, and other pre-existing medical conditions included does the patient have any allergies? :: no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 180 8069 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 body aches. On 26-MAR-2021, the subject experienced nausea. On 26-MAR-2021, the subject experienced extreme fatigue. On 26-MAR-2021, the subject experienced headache. On 27-MAR-2021, the subject experienced chills. On 27-MAR-2021, the subject experienced fever of 100 f. Laboratory data included: Body temperature (NR: not provided) 100 F. On 27-MAR-2021 03:00, the subject experienced extreme cold feeling. On an unspecified date, the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, muscle aches, and extreme fatigue on 28-MAR-2021, chills, nausea, headache, and fever of 100 f on 27-MAR-2021, and extreme cold feeling. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain
Clinical narrative: DULL HEADACHE; MUSCLE SORENESS AT INJECTION SITE; 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 muscle soreness at injection site. On 29-MAR-2021, the subject experienced dull headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from dull headache, and the outcome of muscle soreness at injection site was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: FLU LIKE SYMPTOMS FOR 3 DAYS; 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 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 flu like symptoms for 3 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms for 3 days on MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Pain, Swelling
Clinical narrative: SWELLING; BODY ACHES/PAIN; ARMPIT WAS VERY PAINFUL; 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) 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 swelling, body aches/pain, and armpit was very painful. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling, and body aches/pain, and the outcome of armpit was very painful was not reported. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dyspnoea, Glossodynia, Investigation, Joint swelling
Clinical narrative: BREATHING GOT WORST; ANKLES SWELLING; HANDS SWELLING; SORE THROAT; TONGUE SORE; FEVER; This spontaneous report received from a patient concerned an elderly female. The patient's height, and weight were not reported. The patient's past medical history included heart attack, and concurrent conditions included copd, bad heart, and pneumonia, and other pre-existing medical conditions included the patient had no history of allergy to vaccine, drug, or food and no past history of similar event.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 26-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 ankles swelling. On MAR-2021, the subject experienced hands swelling. On MAR-2021, the subject experienced sore throat. On MAR-2021, the subject experienced tongue sore. On MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F, and Investigation (NR: not provided) UNKNOWN. On 29-MAR-2021, the subject experienced breathing got worst. Laboratory data included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from breathing got worst, and the outcome of sore throat, ankles swelling, hands swelling, tongue sore and fever was not reported. This report was non-serious.; Sender's Comments: V1: Medical assessment comment not required as per the standard operating procedure as the case is assessed as non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Peripheral swelling, Pyrexia, SARS-CoV-2 test
Clinical narrative: BREATHING GOT WORST; ANKLES SWELLING; HANDS SWELLING; SORE THROAT; TONGUE SORE; FEVER; This spontaneous report received from a patient concerned an elderly female. The patient's height, and weight were not reported. The patient's past medical history included heart attack, and concurrent conditions included copd, bad heart, and pneumonia, and other pre-existing medical conditions included the patient had no history of allergy to vaccine, drug, or food and no past history of similar event.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 26-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 ankles swelling. On MAR-2021, the subject experienced hands swelling. On MAR-2021, the subject experienced sore throat. On MAR-2021, the subject experienced tongue sore. On MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F, and Investigation (NR: not provided) UNKNOWN. On 29-MAR-2021, the subject experienced breathing got worst. Laboratory data included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from breathing got worst, and the outcome of sore throat, ankles swelling, hands swelling, tongue sore and fever was not reported. This report was non-serious.; Sender's Comments: V1: Medical assessment comment not required as per the standard operating procedure as the case is assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Breast tenderness, Hot flush, Menopause, Nipple pain
Clinical narrative: BREAST TENDERNESS; NIPPLE TENDERNESS; HOT FLASHES; MENOPAUSE; This spontaneous report received from a patient concerned a 63 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, and expiry: not reported) dose was not reported, once a total administered on 12-MAR-2021 to left arm as prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced menopause. On 13-MAR-2021, the subject experienced hot flashes. On 25-MAR-2021, the subject experienced breast tenderness. On 25-MAR-2021, the subject experienced nipple tenderness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot flashes on 16-MAR-2021, had not recovered from breast tenderness, and nipple tenderness, and the outcome of menopause was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus
Clinical narrative: ITCHING; TINGLING IN SKIN; 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, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination on right arm. No concomitant medications were reported. On an unspecified date, the subject experienced itching, and tingling in skin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the itching and tingling in skin was not reported. This report was non-serious.