chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Oropharyngeal pain, Pain in extremity, Pharyngeal swelling, Pyrexia
Clinical narrative: DIFFICULTY BREATHING; SORE THROAT; SWELLING OF THE  THROAT; FEVER; SORE ARM; This spontaneous report received from a parent concerned a 26 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, and expiry: Unknown) 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 22-MAR-2021, the subject experienced difficulty breathing. On 22-MAR-2021, the subject experienced sore throat. On 22-MAR-2021, the subject experienced swelling of the throat. On 22-MAR-2021, the subject experienced fever. On 22-MAR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore throat, swelling of the throat, fever, and sore arm, and the outcome of difficulty breathing was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per the standard procedure as the case is assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Injection site pain, Lethargy
Clinical narrative: LIGHTHEADEDNESS; PAINFUL INJECTION; DRAGGING HIS BUTT AROUND; NEEDLE HURT ON INJECTION; 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: 1808609 expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 at10:30 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced lightheadedness, painful injection, dragging his butt around, and needle hurt on injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lightheadedness, painful injection, dragging his butt around and needle hurt on injection was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: MODERATE ACHES AND PAIN; FATIGUE; This spontaneous report received from a consumer 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, expiry: 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 moderate aches and pain. On MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from moderate aches and pain, and fatigue on MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: NAUSEA; VOMITED; 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: 1805031, dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the Patient experienced nausea. On an unspecified date, the Patient  experienced vomited. after 4 days of vaccination she got nauseous and vomited. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, and the outcome of vomited was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue
Clinical narrative: JOINT PAIN; EXTREME FATIGUE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 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 joint pain, and extreme fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the extreme fatigue and joint pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced fever. The batch number was not reported and has been requested. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: FEVER; FATIGUE; SORENESS; This spontaneous report received from a consumer 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: Unk) 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 fever, fatigue, and soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, fatigue and soreness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: ITCHY RASH TO CHEST, BACK AND SHOULDERS/ RASH AND HIVES HAVE SPREAD TO  BOTH UPPER ARMS; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no previous medical history and no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 at approximately 15:00 hr on left arm for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021 18:00, the subject experienced itchy rash to chest, back and shoulders/ rash and hives have spread to both upper arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itchy rash to chest, back and shoulders/ rash and hives have spread to both upper arms. This report was non-serious.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache
Clinical narrative: MILD HEADACHE FROM SCALE 1-10 SEVERITY 3; This spontaneous report received from a patient concerned a 64 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sulpha allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and  expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 18:30 for prophylactic vaccination at left arm. No concomitant medications were reported. On 20-MAR-2021, the subject experienced mild headache from scale 1-10 severity 3. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mild headache from scale 1-10 severity 3. This report was non-serious.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 antibody test negative, Vaccine induced antibody absent
Clinical narrative: MILD HEADACHE FROM SCALE 1-10 SEVERITY 3; This spontaneous report received from a patient concerned a 64 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sulpha allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and  expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 18:30 for prophylactic vaccination at left arm. No concomitant medications were reported. On 20-MAR-2021, the subject experienced mild headache from scale 1-10 severity 3. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mild headache from scale 1-10 severity 3. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Nonspecific reaction
Clinical narrative: BAD REACTIONS; This spontaneous report received from a consumer via a company representative concerned 45,000 patients 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 21-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 bad reactions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad reactions was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: FLU LIKE SYMPTOMS; ARM SORENESS; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) 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 flu like symptoms, and arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The batch number was not reported and same has been requested. The outcome of the flu like symptoms and arm soreness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. The patient vaccinated on left arm. No concomitant medications were reported. On 22-MAR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 22-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Fatigue, Headache, Pain
Clinical narrative: DIZZINESS; FELL DOWN; EXHAUSTION; HEADACHE; BODY ACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on right arm on 21-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced body aches. On 22-MAR-2021, the subject experienced dizziness. On 22-MAR-2021, the subject experienced fell down. On 22-MAR-2021, the subject experienced exhaustion. On 22-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from exhaustion, dizziness, and headache, and the outcome of body aches and fell down was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: EXTREME TIREDNESS; HEADACHE; 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: 1805025, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced extreme tiredness. On 15-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme tiredness, and headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: CHILLS; SORE ARM; FEVER; 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: 1805031) dose was not reported, administered on 15-MAR-2021 on Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced chills. On 15-MAR-2021, the subject experienced sore arm. On 15-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and sore arm on 17-MAR-2021, and had not recovered from fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Illness
Clinical narrative: HIGH BLOOD PRESSURE; SICK; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension. 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 high blood pressure, and sick. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) high (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high blood pressure and sick was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: CHILLS; MUSCLE PAIN; FEVER; SEVERE HEADACHES; 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: 1805025, expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced chills, muscle pain, fever, and severe headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, muscle pain, fever and severe headaches was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Vomiting
Clinical narrative: BODY ACHES; VOMITING TWICE; BODY CHILLS; NAUSEA; 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 body aches, vomiting twice, body chills, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body chills, body aches, nausea and vomiting twice was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: SO SICK; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The company is unable to perform follow up to request batch number. On an unspecified date, the subject experienced so sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of so sick was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Lymphadenopathy, Myalgia
Clinical narrative: THROAT STARTING HURTING AT NIGHT/ LYMPH NODE ON LEFT START HURTING AND FELT INFLAMED/ HURTS WHEN SWALLOWING; JOINT PAIN; MUSCLE ACHES; FATIGUE; FEVER UP TO 100.1 DEGREE; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced joint pain. On 19-MAR-2021, the subject experienced muscle aches. On 19-MAR-2021, the subject experienced fatigue. On 19-MAR-2021, the subject experienced fever up to 100.1 degree. Laboratory data included: Body temperature (NR: not provided) 100.1 F. On 20-MAR-2021, the subject experienced throat starting hurting at night/ lymph node on left start hurting and felt inflamed/ hurts when swallowing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever up to 100.1 degree on 19-MAR-2021, was recovering from joint pain, and had not recovered from fatigue, muscle aches, and throat starting hurting at night/ lymph node on left start hurting and felt inflamed/ hurts when swallowing. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: THROAT STARTING HURTING AT NIGHT/ LYMPH NODE ON LEFT START HURTING AND FELT INFLAMED/ HURTS WHEN SWALLOWING; JOINT PAIN; MUSCLE ACHES; FATIGUE; FEVER UP TO 100.1 DEGREE; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced joint pain. On 19-MAR-2021, the subject experienced muscle aches. On 19-MAR-2021, the subject experienced fatigue. On 19-MAR-2021, the subject experienced fever up to 100.1 degree. Laboratory data included: Body temperature (NR: not provided) 100.1 F. On 20-MAR-2021, the subject experienced throat starting hurting at night/ lymph node on left start hurting and felt inflamed/ hurts when swallowing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever up to 100.1 degree on 19-MAR-2021, was recovering from joint pain, and had not recovered from fatigue, muscle aches, and throat starting hurting at night/ lymph node on left start hurting and felt inflamed/ hurts when swallowing. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: PAIN AT THE INJECTION; SWELLING AT THE INJECTION SITE; 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 glaucoma, and concurrent conditions included osteoporosis, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, once total, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced pain at the injection. On 12-MAR-2021, the subject experienced swelling at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swelling at the injection site, and had not recovered from pain at the injection. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Irritability, Testicular disorder
Clinical narrative: FEELING SLIGHTLY IRRITABLE; BEGINNING TO GROW A  THIRD TESTICLE; 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: UNKNOWN, expiry: 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 MAR-2021, the subject experienced feeling slightly irritable. On MAR-2021, the subject experienced beginning to grow a third testicle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling slightly irritable and beginning to grow a third testicle was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Asthenia, Chills, Fatigue, Headache, Pain
Clinical narrative: BODY ACHES; WEAKNESS; CHILLS; FATIGUE; FEVER; HEADACHES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. he 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 15-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Non-company suspect drugs included: amoxicillin sodium/clavulanate potassium ( batch number: UNKNOWN expiry: UNKNOWN, form of admin, route of admin were not reported) dose and frequency were not reported from 18-MAR-2021 for an unspecified indication. No concomitant medications were reported. On 19-MAR-2021, the subject experienced body aches. On 19-MAR-2021, the subject experienced weakness. On 19-MAR-2021, the subject experienced chills. On 19-MAR-2021, the subject experienced fatigue. On 19-MAR-2021, the subject experienced fever. On 19-MAR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with amoxicillin sodium/clavulanate potassium was not reported. The patient had not recovered from fever, chills, body aches, weakness, fatigue, and headaches. This report was non-serious.  Additional information was received from patient on 26-Mar-2021. The following information was updated and incorporated into the case narrative: Events (fever, chills, body aches, weakness, fatigue, headaches) added, event "side effects" removed. Upon review, the following information was amended: Drug "Amoxicillin-Clavulanate" updated as co-suspect.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Pyrexia
Clinical narrative: BODY ACHES; WEAKNESS; CHILLS; FATIGUE; FEVER; HEADACHES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. he 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 15-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Non-company suspect drugs included: amoxicillin sodium/clavulanate potassium ( batch number: UNKNOWN expiry: UNKNOWN, form of admin, route of admin were not reported) dose and frequency were not reported from 18-MAR-2021 for an unspecified indication. No concomitant medications were reported. On 19-MAR-2021, the subject experienced body aches. On 19-MAR-2021, the subject experienced weakness. On 19-MAR-2021, the subject experienced chills. On 19-MAR-2021, the subject experienced fatigue. On 19-MAR-2021, the subject experienced fever. On 19-MAR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with amoxicillin sodium/clavulanate potassium was not reported. The patient had not recovered from fever, chills, body aches, weakness, fatigue, and headaches. This report was non-serious.  Additional information was received from patient on 26-Mar-2021. The following information was updated and incorporated into the case narrative: Events (fever, chills, body aches, weakness, fatigue, headaches) added, event "side effects" removed. Upon review, the following information was amended: Drug "Amoxicillin-Clavulanate" updated as co-suspect.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Headache
Clinical narrative: BODILY DISCOMFORT; LITTLE TIRED; HEADACHE; 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 was not reported, administered on 10-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 bodily discomfort, little tired, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, little tired and bodily discomfort was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Cough, Lymphadenopathy
Clinical narrative: SWOLLEN LYMPH NODES IN THE NECK; COUGH; JOINTS INFLAMMATION; 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: 1802070, 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 joints inflammation. On 21-MAR-2021, the subject experienced swollen lymph nodes in the neck. On 21-MAR-2021, the subject experienced cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joints inflammation, swollen lymph nodes in the neck, and cough on MAR-2021. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per the standard procedure as the case is assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain in extremity, Somnolence
Clinical narrative: SLEEPY; ARM HURT; TIRED; LITTLE NAUSEOUS; 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: Unk) 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 sleepy. On MAR-2021, the subject experienced arm hurt. On MAR-2021, the subject experienced tired. On MAR-2021, the subject experienced little nauseous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tired, little nauseous, arm hurt and sleepy was not reported. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest discomfort, Chills, Dizziness, Oropharyngeal pain
Clinical narrative: BODY ACHES; CHILLS; SORE THROAT; DIZZINESS; TIGHTNESS OF CHEST; HIGH FEVER; 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 concurrent conditions included moderate asthma, allergies, and reactions to medication. 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 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced high fever, body aches, chills, sore throat, dizziness, and tightness of chest. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high fever, body aches, chills, sore throat, dizziness and tightness of chest was not reported. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; SORE THROAT; DIZZINESS; TIGHTNESS OF CHEST; HIGH FEVER; 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 concurrent conditions included moderate asthma, allergies, and reactions to medication. 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 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced high fever, body aches, chills, sore throat, dizziness, and tightness of chest. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high fever, body aches, chills, sore throat, dizziness and tightness of chest was not reported. This report was non-serious.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Chills, Cough, Fatigue
Clinical narrative: COUGH; DIFFICULTY SLEEPING/STRUGGLING TO SLEEP; LOSS OF ENERGY/ESPECIALLY NO ENERGY; SHIVERING; FATIGUE/FEELS  VERY TIRED; COLD SYMPTOMS; HEART RATE INCREASED/FAST HEART BEAT; VERTIGO; BRAIN FOG; CHEST PAIN; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. The patient's past medical history included pneumonia, and concurrent conditions included covid-19, 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: 1805029, expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 (vaccinated at left deltoid) for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced cold symptoms. On 19-MAR-2021, the subject experienced heart rate increased/fast heart beat. On 19-MAR-2021, the subject experienced vertigo. On 19-MAR-2021, the subject experienced brain fog. On 19-MAR-2021, the subject experienced chest pain. On 19-MAR-2021, the subject experienced difficulty sleeping/struggling to sleep. On 19-MAR-2021, the subject experienced loss of energy/especially no energy. On 19-MAR-2021, the subject experienced shivering. On 19-MAR-2021, the subject experienced fatigue/feels very tired. On 20-MAR-2021, the subject experienced cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold symptoms, and shivering on 20-MAR-2021, and was recovering from heart rate increased/fast heart beat, fatigue/feels very tired, vertigo, brain fog, chest pain, loss of energy/especially no energy, cough, and difficulty sleeping/struggling to sleep. This report was non-serious.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Heart rate increased, Insomnia, Nasopharyngitis, Vertigo
Clinical narrative: COUGH; DIFFICULTY SLEEPING/STRUGGLING TO SLEEP; LOSS OF ENERGY/ESPECIALLY NO ENERGY; SHIVERING; FATIGUE/FEELS  VERY TIRED; COLD SYMPTOMS; HEART RATE INCREASED/FAST HEART BEAT; VERTIGO; BRAIN FOG; CHEST PAIN; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. The patient's past medical history included pneumonia, and concurrent conditions included covid-19, 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: 1805029, expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 (vaccinated at left deltoid) for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced cold symptoms. On 19-MAR-2021, the subject experienced heart rate increased/fast heart beat. On 19-MAR-2021, the subject experienced vertigo. On 19-MAR-2021, the subject experienced brain fog. On 19-MAR-2021, the subject experienced chest pain. On 19-MAR-2021, the subject experienced difficulty sleeping/struggling to sleep. On 19-MAR-2021, the subject experienced loss of energy/especially no energy. On 19-MAR-2021, the subject experienced shivering. On 19-MAR-2021, the subject experienced fatigue/feels very tired. On 20-MAR-2021, the subject experienced cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold symptoms, and shivering on 20-MAR-2021, and was recovering from heart rate increased/fast heart beat, fatigue/feels very tired, vertigo, brain fog, chest pain, loss of energy/especially no energy, cough, and difficulty sleeping/struggling to sleep. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: ON AND OFF BRAIN FOG; 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 16-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 18-MAR-2021, the subject experienced on and off brain fog. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from on and off brain fog. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Nodule, Pain, Pruritus
Clinical narrative: This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, latex allergy, antibiotic allergy, non-alcoholic, and non-smoker, and other pre-existing medical conditions included patient had no drug abuse and illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The patient vaccinated at left arm. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced knot on arm. On 12-MAR-2021, the subject experienced rash and redness. On 12-MAR-2021, the subject experienced itchiness. On 12-MAR-2021, the subject experienced soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from knot on arm, rash and redness, and soreness, and the outcome of itchiness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Headache, Nausea
Clinical narrative: DIZZINESS; WEAKNESS; CHILLS; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 18-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 chills. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced nausea. On 21-MAR-2021, the subject experienced dizziness. On 21-MAR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, weakness, headache, chills and nausea was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Migraine, Pain in extremity
Clinical narrative: MIGRAINE; SORE ARM; HEADACHE; FATIGUE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: unknown) dose, one total, 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 migraine, sore arm, headache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, headache, migraine and fatigue was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION (WHICH WAS DESCRIBED AS MILD COUGH, BODY ACHES, DIARRHOEA, CHILLS AND LOW GRADE FEVER); This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination on left deltoid. No concomitant medications were reported. On MAR-2021, the subject experienced confirmed covid-19 infection (which was described as mild cough, body aches, diarrhoea, chills and low grade fever). On 18-MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection (which was described as mild cough, body aches, diarrhoea, chills and low grade fever). This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site pain, Injection site warmth
Clinical narrative: WARM AT SITE OF INJECTION; TENDER SORE ARM AT SITE OF INJECTION; BRUISE AT SITE OF INJECTION; 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 non smoker, and migraine, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on left arm on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced bruise at site of injection. On 10-MAR-2021, the subject experienced tender sore arm at site of injection. On 11-MAR-2021, the subject experienced warm at site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bruise at site of injection on MAR-2021, and had not recovered from warm at site of injection, and tender sore arm at site of injection. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Attention deficit hyperactivity disorder, Chills, Dizziness, Fatigue, Inflammation
Clinical narrative: HYPERACTIVITY (ADHD-LIKE); BURNING PAIN IN HAND AND UNDERARM; SWELLING IN ARM AND HAND; NERVE PAIN; INFLAMING NEUROPATHY; INFLAMMATION OF HANDS AND FINGERS; DIZZINESS; ARM PAIN; CHILLS BUT NO FEVER; NAUSEA; GENERAL TIRED; MUSCLE ACHE; 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: 1085031, expiry: UNKNOWN) dose was not reported, administered on left deltoid on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced hyperactivity (adhd-like). On MAR-2021, the subject experienced burning pain in hand and underarm. On MAR-2021, the subject experienced swelling in arm and hand. On MAR-2021, the subject experienced nerve pain. On MAR-2021, the subject experienced inflaming neuropathy. On MAR-2021, the subject experienced inflammation of hands and fingers. On MAR-2021, the subject experienced dizziness. On MAR-2021, the subject experienced arm pain. On MAR-2021, the subject experienced chills but no fever. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced general tired. On MAR-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm pain, hyperactivity (adhd-like), burning pain in hand and underarm, nausea, muscle ache, general tired, chills but no fever, swelling in arm and hand, nerve pain, inflammation of hands and fingers, inflaming neuropathy and dizziness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Nervous system disorder, Neuralgia, Pain
Clinical narrative: HYPERACTIVITY (ADHD-LIKE); BURNING PAIN IN HAND AND UNDERARM; SWELLING IN ARM AND HAND; NERVE PAIN; INFLAMING NEUROPATHY; INFLAMMATION OF HANDS AND FINGERS; DIZZINESS; ARM PAIN; CHILLS BUT NO FEVER; NAUSEA; GENERAL TIRED; MUSCLE ACHE; 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: 1085031, expiry: UNKNOWN) dose was not reported, administered on left deltoid on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced hyperactivity (adhd-like). On MAR-2021, the subject experienced burning pain in hand and underarm. On MAR-2021, the subject experienced swelling in arm and hand. On MAR-2021, the subject experienced nerve pain. On MAR-2021, the subject experienced inflaming neuropathy. On MAR-2021, the subject experienced inflammation of hands and fingers. On MAR-2021, the subject experienced dizziness. On MAR-2021, the subject experienced arm pain. On MAR-2021, the subject experienced chills but no fever. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced general tired. On MAR-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm pain, hyperactivity (adhd-like), burning pain in hand and underarm, nausea, muscle ache, general tired, chills but no fever, swelling in arm and hand, nerve pain, inflammation of hands and fingers, inflaming neuropathy and dizziness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: HYPERACTIVITY (ADHD-LIKE); BURNING PAIN IN HAND AND UNDERARM; SWELLING IN ARM AND HAND; NERVE PAIN; INFLAMING NEUROPATHY; INFLAMMATION OF HANDS AND FINGERS; DIZZINESS; ARM PAIN; CHILLS BUT NO FEVER; NAUSEA; GENERAL TIRED; MUSCLE ACHE; 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: 1085031, expiry: UNKNOWN) dose was not reported, administered on left deltoid on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced hyperactivity (adhd-like). On MAR-2021, the subject experienced burning pain in hand and underarm. On MAR-2021, the subject experienced swelling in arm and hand. On MAR-2021, the subject experienced nerve pain. On MAR-2021, the subject experienced inflaming neuropathy. On MAR-2021, the subject experienced inflammation of hands and fingers. On MAR-2021, the subject experienced dizziness. On MAR-2021, the subject experienced arm pain. On MAR-2021, the subject experienced chills but no fever. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced general tired. On MAR-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm pain, hyperactivity (adhd-like), burning pain in hand and underarm, nausea, muscle ache, general tired, chills but no fever, swelling in arm and hand, nerve pain, inflammation of hands and fingers, inflaming neuropathy and dizziness was not reported. This report was non-serious.