chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: MINOR SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a 51 year old female. 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: Unk) dose was not reported, administered on 11-APR-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 APR-2021, the subject experienced minor side effects. The action taken with covid-19 vaccine  was not applicable. The patient recovered from minor side effects on APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Musculoskeletal stiffness
Clinical narrative: MUSCLE STIFFNESS IN LEGS; TIREDNESS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced muscle stiffness in legs, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle stiffness in legs, and tiredness. This report was non-serious.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Erythema, Pyrexia
Clinical narrative: RED HANDS; CHILLS; FEELING WEAK; FEVER OF 103; This spontaneous report received from a patient concerned an 18 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, and batch number: 043821A expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-APR-2021, the subject experienced red hands. On 30-APR-2021, the subject experienced chills. On 30-APR-2021, the subject experienced feeling weak. On 30-APR-2021, the subject experienced fever of 103. Laboratory data included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from red hands, chills, feeling weak, and fever of 103 on 02-MAY-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: POSSIBLE SORE ARM; HEADACHE; TIRED; 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, start therapy date were not reported for prophylactic vaccination. The batch 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 possible sore arm, headache, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from possible sore arm, headache, and tired. This report was non-serious. This case, from the same reporter is linked to.
Sex: U
Vaccine: COVID19
Symptoms: Electric shock sensation, Paraesthesia
Clinical narrative: TINGLING SENSATION; SHOCKLY SENSATION; 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced tingling sensation, and shockly sensation. The action taken with covid-19 vaccine  was not applicable. The outcome of the tingling sensation and shockly sensation was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: BODY ACHES; HEADACHE; EXTREME FATIGUE; This spontaneous report received from a consumer (company representative) concerned a 27 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: Unknown) dose was not reported, administered on 05-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 body aches. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced extreme fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, headache, and extreme fatigue on MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder, Chills, Dyspnoea, Hypertension, Pain
Clinical narrative: ACHED ALL OVER; SHORTNESS OF BREATH; HIGH BLOOD PRESSURE; BALANCE WAS OFF WHEN WALKING; CHILLS; 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 past medical history included brain stem stroke. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported.  On 2021, the subject experienced ached all over. On 2021, the subject experienced shortness of breath. On 2021, the subject experienced high blood pressure. On 2021, the subject experienced balance was off when walking. On 2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, ached all over, shortness of breath, high blood pressure, and balance was off when walking. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Emotional distress, Nausea, Vomiting
Clinical narrative: EXTREME ABDOMINAL PAIN; VOMIT SEVERAL TIMES; 12 HOURS OF DISTRESS; NAUSEA; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included menopause. 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-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 29-APR-2021, the subject experienced extreme abdominal pain. On 29-APR-2021, the subject experienced vomit several times. On 29-APR-2021, the subject experienced 12 hours of distress. On 29-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, extreme abdominal pain, vomit several times and 12 hours of distress was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Pain in extremity
Clinical narrative: WOOZY STOMACH; SORE ARM; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced woozy stomach, sore arm, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, woozy stomach and sore arm was not reported. This report was non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Medication error
Clinical narrative: VACCINE WAS ADMINISTERED PAST 6 HOURS FROM VIAL PUNCTURE; This spontaneous report received from a pharmacist concerned a 31 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 28-APR-2021 13:57 for prophylactic vaccination. No concomitant medications were reported.  On 28-APR-2021, the subject experienced vaccine was administered past 6 hours from puncture. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine was administered past 6 hours from puncture was not reported. This report was non-serious. This case, from the same reporter is linked to.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: ACHY; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's past medical history included asthma, and concurrent conditions included sulfonamide allergy, isocyanide allergy, non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. the patient had allergies of muscle and horseradish. The patient experienced drug allergy when treated with doxycycline.  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 02-MAY-2021 12:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 02-MAY-2021, the subject experienced achy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from achy. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: DIARRHEA; 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) dose was not reported, administered on 29-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 01-MAY-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: TIREDNESS; 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 08-APR-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 an unspecified date, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tiredness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pruritus, Pyrexia
Clinical narrative: 10 ITCHY RED DOT/MODERATE ITCHY FEELING; FEVER AT 37.9C; 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 30-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 01-MAY-2021, the subject experienced 10 itchy red dot/moderate itchy feeling. On 01-MAY-2021, the subject experienced fever at 37.9c.  Laboratory data included: Body temperature (NR: not provided) 37.9 C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever at 37.9c and 10 itchy red dot/moderate itchy feeling was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Illness, SARS-CoV-2 test
Clinical narrative: POSITIVE TO COVID; SICK; 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 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 2021, the subject experienced sick. On 09-APR-2021, the subject experienced positive to covid. Laboratory data included: COVID-19 virus test (NR: not provided) POSITIVE TO COVID. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sick and positive to covid was not reported. This report was non-serious.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: LEG FATIGUE/FATIGUE ELSEWHERE; This spontaneous report received from a patient concerned a 55 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-APR-2021, the subject experienced leg fatigue/fatigue elsewhere. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from leg fatigue/fatigue elsewhere. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction, Pain
Clinical narrative: SEVERE BODY ACHES; SEVERE SYMPTOMS; 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 severe body aches, and severe symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe body aches and severe symptoms was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ARM PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arm pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Feeling abnormal, Myalgia
Clinical narrative: DIZZY; FOG HEADDED; CHILLS; TIRED; MUSCLE PAIN IN NECK; LOW GRADE 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced dizzy, fog headded, chills, tired, muscle pain in neck, and low grade fever. Treatment medications (dates unspecified) included: acetylsalicylic acid, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tired, muscle pain in neck, low grade fever, chills, dizzy, and fog headded. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: DIZZY; FOG HEADDED; CHILLS; TIRED; MUSCLE PAIN IN NECK; LOW GRADE 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced dizzy, fog headded, chills, tired, muscle pain in neck, and low grade fever. Treatment medications (dates unspecified) included: acetylsalicylic acid, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tired, muscle pain in neck, low grade fever, chills, dizzy, and fog headded. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: NEARLY KILLED WITH COVID VACCINE; 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, 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 nearly killed with covid vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of nearly killed with covid vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Illness, Musculoskeletal stiffness, Pain
Clinical narrative: SICKNESS; MUSCLE STIFFNESS/NECK STIFFNESS; SHOOTING PAIN BESIDE THE NECK AND FACE; SORE ARM; FEVER; HEADACHE; TIREDNESS; 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 02-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-MAY-2021, the subject experienced sickness. On 02-MAY-2021, the subject experienced muscle stiffness/neck stiffness. On 02-MAY-2021, the subject experienced shooting pain beside the neck and face. On 02-MAY-2021, the subject experienced sore arm. On 02-MAY-2021, the subject experienced fever. On 02-MAY-2021, the subject experienced headache. On 02-MAY-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm, shooting pain beside the neck and face, fever, muscle stiffness/neck stiffness, headache, and sickness, and the outcome of tiredness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: SICKNESS; MUSCLE STIFFNESS/NECK STIFFNESS; SHOOTING PAIN BESIDE THE NECK AND FACE; SORE ARM; FEVER; HEADACHE; TIREDNESS; 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 02-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-MAY-2021, the subject experienced sickness. On 02-MAY-2021, the subject experienced muscle stiffness/neck stiffness. On 02-MAY-2021, the subject experienced shooting pain beside the neck and face. On 02-MAY-2021, the subject experienced sore arm. On 02-MAY-2021, the subject experienced fever. On 02-MAY-2021, the subject experienced headache. On 02-MAY-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm, shooting pain beside the neck and face, fever, muscle stiffness/neck stiffness, headache, and sickness, and the outcome of tiredness was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: SLIGHT TENDERNESS AT THE SITE OF INJECTION; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and hypertension. 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 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 2021, the subject experienced slight tenderness at the site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of slight tenderness at the site of injection was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: TIRED; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tired was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Discomfort, Hypoaesthesia, Limb discomfort, Pain in extremity
Clinical narrative: PRESSURE; ARM WAS A LITTLE NUMB; SORE AROUND ARM PIT; SORE ON LEFT ARM; FEEL LIKE BLOOD PRESSURE CUFF IN LEFT ARM; This spontaneous report received from a patient concerned a 54 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: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-MAY-2021, the subject experienced pressure. On 01-MAY-2021, the subject experienced arm was a little numb. On 01-MAY-2021, the subject experienced sore around arm pit. On 01-MAY-2021, the subject experienced sore on left arm. On 01-MAY-2021, the subject experienced feel like blood pressure cuff in left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feel like blood pressure cuff in left arm, pressure, sore on left arm, arm was a little numb, and sore around arm pit. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: TIRED; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 20-MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired on 21-MAR-2021. This report was non-serious. This case, from the same reporter is linked.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a parent concerned a 19 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included migraine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Bone pain, Headache, Muscle twitching, Neck pain
Clinical narrative: LEG TWITCHING IN CALF; BODY ACHE; VENOUS REFLUX (SWOLLEN AND PAINFUL CALF / FOOT PAIN); BACK PAIN; CLAVICLE PAIN; NECK PAIN; HEADACHE; TINGLING FEET; This spontaneous report received from a patient concerned a 61 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: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On APR-2021, the subject experienced tingling feet. On 22-APR-2021, the subject experienced leg twitching in calf. On 22-APR-2021, the subject experienced body ache. On 22-APR-2021, the subject experienced venous reflux (swollen and painful calf / foot pain). On 22-APR-2021, the subject experienced back pain. On 22-APR-2021, the subject experienced clavicle pain. On 22-APR-2021, the subject experienced neck pain. On 22-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from leg twitching in calf, headache, body ache, venous reflux (swollen and painful calf / foot pain), back pain, clavicle pain, and neck pain, and the outcome of tingling feet was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Peripheral venous disease
Clinical narrative: LEG TWITCHING IN CALF; BODY ACHE; VENOUS REFLUX (SWOLLEN AND PAINFUL CALF / FOOT PAIN); BACK PAIN; CLAVICLE PAIN; NECK PAIN; HEADACHE; TINGLING FEET; This spontaneous report received from a patient concerned a 61 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: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On APR-2021, the subject experienced tingling feet. On 22-APR-2021, the subject experienced leg twitching in calf. On 22-APR-2021, the subject experienced body ache. On 22-APR-2021, the subject experienced venous reflux (swollen and painful calf / foot pain). On 22-APR-2021, the subject experienced back pain. On 22-APR-2021, the subject experienced clavicle pain. On 22-APR-2021, the subject experienced neck pain. On 22-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from leg twitching in calf, headache, body ache, venous reflux (swollen and painful calf / foot pain), back pain, clavicle pain, and neck pain, and the outcome of tingling feet was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lethargy, Therapeutic response unexpected
Clinical narrative: UNEXPECTED BENEFICIAL EFFECT - REMISSION OF RHEUMATOID ARTHRITIS; LETHARGY; TIRED; This spontaneous report received from a patient concerned a 70 year old female. The patient's weight was 116 kilograms, and height was 60 inches. The patient's concurrent conditions included rheumatoid arthritis, Sjogren's disease, soreness, alcohol consumption, and smoker, and other pre-existing medical conditions included the patient had allergic to humira (drug-induced lupus-like reactions), remicade (total body rash), enbrel - others. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, expiry: 25-MAY-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included ibuprofen for rheumatoid arthritis. On 07-APR-2021, the subject experienced lethargy. On 07-APR-2021, the subject experienced tired. On 14-APR-2021, the subject experienced unexpected beneficial effect - remission of rheumatoid arthritis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargy, and tired on 08-APR-2021, and was recovering from unexpected beneficial effect - remission of rheumatoid arthritis. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICKNESS; 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 sickness. Treatment medications (dates unspecified) included: chlorphenamine maleate/paracetamol/phenylephrine hydrochloride, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sickness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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. No concomitant medications were reported. On an unspecified date, the subject experienced soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of soreness at injection site was not reported. This report was non-serious. This case, from the same reporter is linked to 20210504555.
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Headache
Clinical narrative: BONES HURT; HEADACHE; This spontaneous report received from a patient concerned a 23 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, and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced bones hurt. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and bones hurt was not reported. This report was non-serious. This case, from the same reporter is linked.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Fatigue, Headache, Malaise
Clinical narrative: FEELING VERY SICK; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: 23/JUN/2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included vitamins nos. On 11-APR-2021, the subject experienced fatigue. On 11-APR-2021, the subject experienced headache. On 15-APR-2021, the subject experienced feeling very sick. On 17-APR-2021, Laboratory data included: Blood test (NR: not provided) no infection, Chest X-ray (NR: not provided) no infection, and Urine analysis (NR: not provided) no infection. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, feeling very sick, and headache on 25-APR-2021. This report was non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: FEELING VERY SICK; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: 23/JUN/2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included vitamins nos. On 11-APR-2021, the subject experienced fatigue. On 11-APR-2021, the subject experienced headache. On 15-APR-2021, the subject experienced feeling very sick. On 17-APR-2021, Laboratory data included: Blood test (NR: not provided) no infection, Chest X-ray (NR: not provided) no infection, and Urine analysis (NR: not provided) no infection. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, feeling very sick, and headache on 25-APR-2021. This report was non-serious.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered
Clinical narrative: VACCINE STORED AT INAPPROPRIATE CONDITION BEFORE ADMINISTRATION; This spontaneous report received from a health care professional concerned a 37 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: 20321A, and batch number: 20321A expiry: 23-JUN-2021) dose was not reported, administered on 03-MAY-2021 11:17 for prophylactic vaccination. No concomitant medications were reported.  On 03-MAY-2021, the subject experienced vaccine stored at inappropriate condition before administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine stored at inappropriate condition before administration was not reported. This report was non-serious. This case, from the same reporter is linked to.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: VACCINE STORED AT INAPPROPRIATE CONDITION BEFORE ADMINISTRATION; This spontaneous report received from a health care professional concerned a 37 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: 20321A, and batch number: 20321A expiry: 23-JUN-2021) dose was not reported, administered on 03-MAY-2021 11:17 for prophylactic vaccination. No concomitant medications were reported.  On 03-MAY-2021, the subject experienced vaccine stored at inappropriate condition before administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine stored at inappropriate condition before administration was not reported. This report was non-serious. This case, from the same reporter is linked to.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity, SARS-CoV-2 test, Skin discolouration
Clinical narrative: RED SPOT UNDER SKIN; BODY ACHES; HEADACHE; PAIN IN ARM; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's past medical history included hematomas, and concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included patient had no known allergies and drug abuse and drug illicit use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative. On 30-APR-2021, the subject experienced pain in arm. On 01-MAY-2021, the subject experienced body aches. On 01-MAY-2021, the subject experienced headache. On 02-MAY-2021, the subject experienced red spot under skin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and headache on 02-MAY-2021, and pain in arm on 01-MAY-2021, and was recovering from red spot under skin. This report was non-serious.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity, Pyrexia, Sensory disturbance
Clinical narrative: PULSING AT INJECTION SITE; ARMS HURT; LEGS HURT; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 22 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, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, treatment medications included: paracetamol. On 08-APR-2021, the subject experienced arms hurt. On 08-APR-2021, the subject experienced legs hurt. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced headache. On 26-APR-2021, the subject experienced pulsing at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arms hurt, legs hurt, fever, and headache on 11-APR-2021, and chills on 09-APR-2021, and had not recovered from pulsing at injection site. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: TIRED; This spontaneous report received from a patient via a company representative concerned a 63 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: Unknown) dose was not reported, administered on 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 2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tired was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: CHILLS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,) 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 APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on APR-2021. This report was non-serious. This case, from the same reporter is linked to.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness
Clinical narrative: LIGHT HEADED; CHILLS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine  (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. As per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced light headed, and chills. The action taken with covid-19 vaccine  was not applicable. The patient recovered from light headed, and chills. This report was non-serious. This case, from the same reporter is linked to.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Induration, Nausea, Pain
Clinical narrative: One week after the vaccine I got the chills, nauseated  ,aches , exhausted. Then a very sore and red arm with a rash about 4 inches down  and  2 inches across. Very hard, red and swollen.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Rash, SARS-CoV-2 test negative
Clinical narrative: One week after the vaccine I got the chills, nauseated  ,aches , exhausted. Then a very sore and red arm with a rash about 4 inches down  and  2 inches across. Very hard, red and swollen.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 31 year old female. The patient's weight was 76.5 kilograms, and height was 168 centimeters. The patient's concurrent conditions included alcohol use 2 drinks per week, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies and had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 01-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-MAY-2021, the subject experienced chills. On 02-MAY-2021, the subject experienced fever. On 02-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and headache on 03-MAY-2021. This report was non-serious.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Blood test normal, Confusional state, Crying
Clinical narrative: Overall, wellbeing "off" and crying for no reason. brain fog and confusion. general weakness, easily winded walking upstairs, fatigue, severe muscle pain/soreness. originated underarms and back on 24th & 25th. ended in the left calf and occasionally entire left leg and sometimes right.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Feeling abnormal, Fibrin D dimer normal, Myalgia
Clinical narrative: Overall, wellbeing "off" and crying for no reason. brain fog and confusion. general weakness, easily winded walking upstairs, fatigue, severe muscle pain/soreness. originated underarms and back on 24th & 25th. ended in the left calf and occasionally entire left leg and sometimes right.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count normal
Clinical narrative: Overall, wellbeing "off" and crying for no reason. brain fog and confusion. general weakness, easily winded walking upstairs, fatigue, severe muscle pain/soreness. originated underarms and back on 24th & 25th. ended in the left calf and occasionally entire left leg and sometimes right.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Impaired work ability, Joint swelling, Muscle swelling
Clinical narrative: Muscles and joints swelling on both sides of the body.  Slow progression of pain until the pain was to much to work.  Muscles feel like the are torn and joints are swelling and painful like arthritis.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain
Clinical narrative: Muscles and joints swelling on both sides of the body.  Slow progression of pain until the pain was to much to work.  Muscles feel like the are torn and joints are swelling and painful like arthritis.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin warm
Clinical narrative: Circular rash, soreness, warm to the touch for 48 hours
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Lymph node pain, Lymphadenopathy, Rash erythematous
Clinical narrative: "Covid arm" - the evening of my vaccine  I developed a red rash & hard bump around injection site that was very tender;  the next day after my vaccine, my underarm lymph nodes in my left arm became slightly swollen & tender and remained so for about a week
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Malaise, Palpitations, Vertigo
Clinical narrative: Heavy Dizzy spells/vertigo lasting about 3 hours, starting 3 days after shot, accompanied by ?jelly legs? and heart palpitations.  On and off for 2 weeks.  Visited ER on 5/1 thinking of possible heart attack, all test came back normal. Sent home with not diagnostic ?might be side effects from vaccine?. Still feeling sick not taking second shot
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash and hives on and around neck and chest and under chin.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder, Tinnitus
Clinical narrative: Tinnitus got worse. I had very low level tinnitus before. The second night after the vaccine the tinnitus was quite bad, then the next day it settled down to be two or three times as noticeable as my baseline tinnitus was prior to the vaccine, at least. At this point, normally don't hear it, but when I'm going to sleep it's very noticeable. Ten weeks later, it's steady and hasn't gotten worse or better since  it steadied out on the third day.