chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Pain in extremity
Clinical narrative: TIRED; SORE ARM; FELT LIKE A BIG PIECE OF LEAD GOING IN WHEN VACCINE WAS INJECTED FOR ABOUT 15 MINUTES; This spontaneous report received from a patient concerned an 80 year old female patient. The patient's height, and weight were not reported. The patient's past medical history included previous diphtheria infection during childhood, and 2 episodes of potential mini-stroke, 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: 1803070,  expiry: UNKNOWN) 1 total dose, administered on 22-MAR-2021 at 13:30 in left arm for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced sore arm. On 22-MAR-2021, the subject experienced felt like a big piece of lead going in when vaccine was injected for about 15 minutes. On 23-MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and tired on 24-MAR-2021, and felt like a big piece of lead going in when vaccine was injected for about 15 minutes on 22-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Hypoacusis, Pyrexia
Clinical narrative: FEVER; CHILLS; HEADACHE; NASAL DRAINAGE; DECREASED HEARING; BLURRED VISION; LIGHT HEADED; This spontaneous report received from a parent concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and non-alcoholic, and other pre-existing medical conditions included patient have no known allergies and there was no 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: 1805031 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced nasal drainage. On MAR-2021, the subject experienced decreased hearing. On MAR-2021, the subject experienced blurred vision. On MAR-2021, the subject experienced light headed. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced headache. On 26-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, light headed, blurred vision, and decreased hearing, and had not recovered from fever, headache, and nasal drainage. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Sinus operation, Vision blurred
Clinical narrative: FEVER; CHILLS; HEADACHE; NASAL DRAINAGE; DECREASED HEARING; BLURRED VISION; LIGHT HEADED; This spontaneous report received from a parent concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and non-alcoholic, and other pre-existing medical conditions included patient have no known allergies and there was no 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: 1805031 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced nasal drainage. On MAR-2021, the subject experienced decreased hearing. On MAR-2021, the subject experienced blurred vision. On MAR-2021, the subject experienced light headed. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced headache. On 26-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, light headed, blurred vision, and decreased hearing, and had not recovered from fever, headache, and nasal drainage. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: 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: Unknown expiry date: unknown) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-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 headache. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Nausea, Pain, Pyrexia
Clinical narrative: ACHY; HEADACHE; NAUSEOUS; FEVER; 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, and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 15:00 for prophylactic vaccination on left arm. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-MAR-2021 01:00, the subject experienced achy. On 27-MAR-2021 01:00, the subject experienced headache. On 27-MAR-2021 01:00, the subject experienced nauseous. On 27-MAR-2021 01:00, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101, 99 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and had not recovered from headache, nauseous, and achy. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: A SORE THROAT; GLANDS ON HER NECK WERE MORE SWOLLEN; TIRED; SOME TENDERNESS ON THE SITE OF INJECTION FOR A COUPLE OF DAYS; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism, lupus, connective tissue disease, penicillin allergy, and sulfonamide allergy. The patient experienced drug allergy when treated with cefalexin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1005018, and batch number: 1005018 expiry: UNKNOWN) dose was not reported, 1 total, administered on 16-MAR-2021 for prophylactic vaccination. Concomitant medications included methotrexate. On 16-MAR-2021, the subject experienced some tenderness on the site of injection for a couple of days. On 20-MAR-2021, the subject experienced a sore throat. On 20-MAR-2021, the subject experienced glands on her neck were more swollen. 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 some tenderness on the site of injection for a couple of days on 18-MAR-2021, and had not recovered from a sore throat, glands on her neck were more swollen, and tired. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: CHILLS; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to ceftin, iodine allergy, allergy to dye, and allergy to bactrim. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered in left arm on 25-MAR-2021 12:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 25-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 25-MAR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: GENERAL FATIGUE; MUSCLES ACHES; 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: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 10:30 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 26-MAR-2021, the subject experienced general fatigue. On 26-MAR-2021, the subject experienced muscles aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from general fatigue, and muscles aches. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling abnormal, Impaired work ability, Insomnia
Clinical narrative: SENSITIVE SKIN; BODY ACHE; COLD; FELT THAT SHE WAS DYING FROM  WEDNESDAY-THURSDAY; FREEZE; LEG,ARM,BODY HURT; CHILLS; HIGH FEVER AND BURNING FROM INSIDE OUT; HAIR OF HER SKIN STAND; COULD NOT MAKE IT TO JOB; PRICKLY SKIN AND TOOTHPICKS POKING THE SKIN; COULD NOT SLEEP; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 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 24-MAR-2021 for prophylactic vaccination on right deltoid. 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 prickly skin. On MAR-2021, the subject experienced could not sleep. On MAR-2021, the subject experienced hair of her skin stand. On MAR-2021, the subject experienced toothpicks poking the skin and toothpicks poking the skin. On MAR-2021, the subject experienced could not make it to job. On 24-MAR-2021, the subject experienced body ache. On 24-MAR-2021,  at 4:30--5:15 PM the subject experienced leg, arm, body hurt. On 24-MAR-2021, the subject experienced cold. On 24-MAR-2021, the subject experienced felt that she was dying from Wednesday-Thursday. On 24-MAR-2021, the subject experienced freeze. On 24-MAR-2021, the subject experienced chills. On 24-MAR-2021, the subject experienced high fever and burning from inside out. Laboratory data included: Body temperature at around At 4:30--5:15 PM (NR: not provided) 101 F. On 25-MAR-2021, the subject experienced sensitive skin. Laboratory data included: Body temperature at night about 1 am (NR: not provided) 103.2 F, 101.9 (units unspecified). On 26-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100.8- 99.5 F Laboratory data included: Body temperature (NR: not provided) 100.8- 99.5 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from high fever and burning from inside out, sensitive skin, chills, and body ache, and the outcome of prickly skin and toothpicks poking the skin, could not sleep, leg,arm,body hurt, hair of her skin stand, toothpicks poking the skin, cold, felt that she was dying from Wednesday-Thursday, freeze and could not make it to job was not reported. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Nasopharyngitis, Pain, Paraesthesia, Piloerection
Clinical narrative: SENSITIVE SKIN; BODY ACHE; COLD; FELT THAT SHE WAS DYING FROM  WEDNESDAY-THURSDAY; FREEZE; LEG,ARM,BODY HURT; CHILLS; HIGH FEVER AND BURNING FROM INSIDE OUT; HAIR OF HER SKIN STAND; COULD NOT MAKE IT TO JOB; PRICKLY SKIN AND TOOTHPICKS POKING THE SKIN; COULD NOT SLEEP; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 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 24-MAR-2021 for prophylactic vaccination on right deltoid. 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 prickly skin. On MAR-2021, the subject experienced could not sleep. On MAR-2021, the subject experienced hair of her skin stand. On MAR-2021, the subject experienced toothpicks poking the skin and toothpicks poking the skin. On MAR-2021, the subject experienced could not make it to job. On 24-MAR-2021, the subject experienced body ache. On 24-MAR-2021,  at 4:30--5:15 PM the subject experienced leg, arm, body hurt. On 24-MAR-2021, the subject experienced cold. On 24-MAR-2021, the subject experienced felt that she was dying from Wednesday-Thursday. On 24-MAR-2021, the subject experienced freeze. On 24-MAR-2021, the subject experienced chills. On 24-MAR-2021, the subject experienced high fever and burning from inside out. Laboratory data included: Body temperature at around At 4:30--5:15 PM (NR: not provided) 101 F. On 25-MAR-2021, the subject experienced sensitive skin. Laboratory data included: Body temperature at night about 1 am (NR: not provided) 103.2 F, 101.9 (units unspecified). On 26-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100.8- 99.5 F Laboratory data included: Body temperature (NR: not provided) 100.8- 99.5 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from high fever and burning from inside out, sensitive skin, chills, and body ache, and the outcome of prickly skin and toothpicks poking the skin, could not sleep, leg,arm,body hurt, hair of her skin stand, toothpicks poking the skin, cold, felt that she was dying from Wednesday-Thursday, freeze and could not make it to job was not reported. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sensitive skin
Clinical narrative: SENSITIVE SKIN; BODY ACHE; COLD; FELT THAT SHE WAS DYING FROM  WEDNESDAY-THURSDAY; FREEZE; LEG,ARM,BODY HURT; CHILLS; HIGH FEVER AND BURNING FROM INSIDE OUT; HAIR OF HER SKIN STAND; COULD NOT MAKE IT TO JOB; PRICKLY SKIN AND TOOTHPICKS POKING THE SKIN; COULD NOT SLEEP; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 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 24-MAR-2021 for prophylactic vaccination on right deltoid. 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 prickly skin. On MAR-2021, the subject experienced could not sleep. On MAR-2021, the subject experienced hair of her skin stand. On MAR-2021, the subject experienced toothpicks poking the skin and toothpicks poking the skin. On MAR-2021, the subject experienced could not make it to job. On 24-MAR-2021, the subject experienced body ache. On 24-MAR-2021,  at 4:30--5:15 PM the subject experienced leg, arm, body hurt. On 24-MAR-2021, the subject experienced cold. On 24-MAR-2021, the subject experienced felt that she was dying from Wednesday-Thursday. On 24-MAR-2021, the subject experienced freeze. On 24-MAR-2021, the subject experienced chills. On 24-MAR-2021, the subject experienced high fever and burning from inside out. Laboratory data included: Body temperature at around At 4:30--5:15 PM (NR: not provided) 101 F. On 25-MAR-2021, the subject experienced sensitive skin. Laboratory data included: Body temperature at night about 1 am (NR: not provided) 103.2 F, 101.9 (units unspecified). On 26-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100.8- 99.5 F Laboratory data included: Body temperature (NR: not provided) 100.8- 99.5 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from high fever and burning from inside out, sensitive skin, chills, and body ache, and the outcome of prickly skin and toothpicks poking the skin, could not sleep, leg,arm,body hurt, hair of her skin stand, toothpicks poking the skin, cold, felt that she was dying from Wednesday-Thursday, freeze and could not make it to job was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: FLU LIKE SYMPTOMS; 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. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flu like symptoms was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: ALL SIDE EFFECTS; 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced all side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of all side effects was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Cardiac stress test, Chills, Decreased appetite, Dizziness
Clinical narrative: HEADACHE; CHILLS; NAUSEA; ON AND OFF TENSION HEADACHE; TIREDNESS/FEELING DRAINED; WARMNESS; FEVER; LIGHTHEADEDNESS; LITTLE SHORT OF BREATH BUT ABLE TO BREATH; BODY ACHES; BACK FELT ON FIRE; HEART RACING ON SECOND DAY; DIZZINESS; LITTLE NUMBNESS IN FINGERS; COULD NOT STAND; LACK OF APPETITE; FEELING DIFFERENT THINGS; WEAKNESS ON LIMB; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight was 170 pounds, and height was not reported. The patient's concurrent conditions included hypertension, penicillin allergy, non smoker, and no alcohol use, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on left arm on 25-MAR-2021 for prophylactic vaccination. Concomitant medications included amlodipine for hypertension, and lisinopril for hypertension. On MAR-2021, the subject experienced lightheadedness. On MAR-2021, the subject experienced little short of breath but able to breath. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced back felt on fire. On MAR-2021, the subject experienced heart racing on second day. On MAR-2021, the subject experienced dizziness. On MAR-2021, the subject experienced little numbness in fingers. On MAR-2021, the subject experienced could not stand. On MAR-2021, the subject experienced lack of appetite. On MAR-2021, the subject experienced feeling different things. On MAR-2021, the subject experienced weakness on limb. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced on and off tension headache. On MAR-2021, the subject experienced tiredness/feeling drained. On MAR-2021, the subject experienced warmness. On MAR-2021, the subject experienced fever. Laboratory data included: Stress test (NR: not provided) Unknown. On 01-MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 25-MAR-2021, the subject experienced chills. On 26-MAR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little numbness in fingers, could not stand, lack of appetite, chills, warmness, and fever on MAR-2021, was recovering from headache, tiredness/feeling drained, weakness on limb, heart racing on second day, dizziness, and nausea, had not recovered from lightheadedness, little short of breath but able to breath, body aches, back felt on fire, and on and off tension headache, and the outcome of feeling different things was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Dysstasia, Fatigue, Feeling abnormal, Feeling hot
Clinical narrative: HEADACHE; CHILLS; NAUSEA; ON AND OFF TENSION HEADACHE; TIREDNESS/FEELING DRAINED; WARMNESS; FEVER; LIGHTHEADEDNESS; LITTLE SHORT OF BREATH BUT ABLE TO BREATH; BODY ACHES; BACK FELT ON FIRE; HEART RACING ON SECOND DAY; DIZZINESS; LITTLE NUMBNESS IN FINGERS; COULD NOT STAND; LACK OF APPETITE; FEELING DIFFERENT THINGS; WEAKNESS ON LIMB; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight was 170 pounds, and height was not reported. The patient's concurrent conditions included hypertension, penicillin allergy, non smoker, and no alcohol use, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on left arm on 25-MAR-2021 for prophylactic vaccination. Concomitant medications included amlodipine for hypertension, and lisinopril for hypertension. On MAR-2021, the subject experienced lightheadedness. On MAR-2021, the subject experienced little short of breath but able to breath. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced back felt on fire. On MAR-2021, the subject experienced heart racing on second day. On MAR-2021, the subject experienced dizziness. On MAR-2021, the subject experienced little numbness in fingers. On MAR-2021, the subject experienced could not stand. On MAR-2021, the subject experienced lack of appetite. On MAR-2021, the subject experienced feeling different things. On MAR-2021, the subject experienced weakness on limb. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced on and off tension headache. On MAR-2021, the subject experienced tiredness/feeling drained. On MAR-2021, the subject experienced warmness. On MAR-2021, the subject experienced fever. Laboratory data included: Stress test (NR: not provided) Unknown. On 01-MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 25-MAR-2021, the subject experienced chills. On 26-MAR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little numbness in fingers, could not stand, lack of appetite, chills, warmness, and fever on MAR-2021, was recovering from headache, tiredness/feeling drained, weakness on limb, heart racing on second day, dizziness, and nausea, had not recovered from lightheadedness, little short of breath but able to breath, body aches, back felt on fire, and on and off tension headache, and the outcome of feeling different things was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Muscular weakness, Nausea, Pain
Clinical narrative: HEADACHE; CHILLS; NAUSEA; ON AND OFF TENSION HEADACHE; TIREDNESS/FEELING DRAINED; WARMNESS; FEVER; LIGHTHEADEDNESS; LITTLE SHORT OF BREATH BUT ABLE TO BREATH; BODY ACHES; BACK FELT ON FIRE; HEART RACING ON SECOND DAY; DIZZINESS; LITTLE NUMBNESS IN FINGERS; COULD NOT STAND; LACK OF APPETITE; FEELING DIFFERENT THINGS; WEAKNESS ON LIMB; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight was 170 pounds, and height was not reported. The patient's concurrent conditions included hypertension, penicillin allergy, non smoker, and no alcohol use, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on left arm on 25-MAR-2021 for prophylactic vaccination. Concomitant medications included amlodipine for hypertension, and lisinopril for hypertension. On MAR-2021, the subject experienced lightheadedness. On MAR-2021, the subject experienced little short of breath but able to breath. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced back felt on fire. On MAR-2021, the subject experienced heart racing on second day. On MAR-2021, the subject experienced dizziness. On MAR-2021, the subject experienced little numbness in fingers. On MAR-2021, the subject experienced could not stand. On MAR-2021, the subject experienced lack of appetite. On MAR-2021, the subject experienced feeling different things. On MAR-2021, the subject experienced weakness on limb. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced on and off tension headache. On MAR-2021, the subject experienced tiredness/feeling drained. On MAR-2021, the subject experienced warmness. On MAR-2021, the subject experienced fever. Laboratory data included: Stress test (NR: not provided) Unknown. On 01-MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 25-MAR-2021, the subject experienced chills. On 26-MAR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little numbness in fingers, could not stand, lack of appetite, chills, warmness, and fever on MAR-2021, was recovering from headache, tiredness/feeling drained, weakness on limb, heart racing on second day, dizziness, and nausea, had not recovered from lightheadedness, little short of breath but able to breath, body aches, back felt on fire, and on and off tension headache, and the outcome of feeling different things was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia, SARS-CoV-2 test, Tension headache
Clinical narrative: HEADACHE; CHILLS; NAUSEA; ON AND OFF TENSION HEADACHE; TIREDNESS/FEELING DRAINED; WARMNESS; FEVER; LIGHTHEADEDNESS; LITTLE SHORT OF BREATH BUT ABLE TO BREATH; BODY ACHES; BACK FELT ON FIRE; HEART RACING ON SECOND DAY; DIZZINESS; LITTLE NUMBNESS IN FINGERS; COULD NOT STAND; LACK OF APPETITE; FEELING DIFFERENT THINGS; WEAKNESS ON LIMB; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight was 170 pounds, and height was not reported. The patient's concurrent conditions included hypertension, penicillin allergy, non smoker, and no alcohol use, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on left arm on 25-MAR-2021 for prophylactic vaccination. Concomitant medications included amlodipine for hypertension, and lisinopril for hypertension. On MAR-2021, the subject experienced lightheadedness. On MAR-2021, the subject experienced little short of breath but able to breath. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced back felt on fire. On MAR-2021, the subject experienced heart racing on second day. On MAR-2021, the subject experienced dizziness. On MAR-2021, the subject experienced little numbness in fingers. On MAR-2021, the subject experienced could not stand. On MAR-2021, the subject experienced lack of appetite. On MAR-2021, the subject experienced feeling different things. On MAR-2021, the subject experienced weakness on limb. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced on and off tension headache. On MAR-2021, the subject experienced tiredness/feeling drained. On MAR-2021, the subject experienced warmness. On MAR-2021, the subject experienced fever. Laboratory data included: Stress test (NR: not provided) Unknown. On 01-MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 25-MAR-2021, the subject experienced chills. On 26-MAR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little numbness in fingers, could not stand, lack of appetite, chills, warmness, and fever on MAR-2021, was recovering from headache, tiredness/feeling drained, weakness on limb, heart racing on second day, dizziness, and nausea, had not recovered from lightheadedness, little short of breath but able to breath, body aches, back felt on fire, and on and off tension headache, and the outcome of feeling different things was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: CHILLS; 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, intramuscular, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered to the right arm, on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced chills. On 14-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99 degree F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 16-MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: POSSIBLE TEMPERATURE EXCURSION OF VACCINE AND ADMINISTRATION TO PATIENT AFTERWARDS; This spontaneous report received from a health care professional 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, 1 total, start therapy date were not reported for prophylactic vaccination. 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 possible temperature excursion of vaccine and administration to subject afterwards. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of possible temperature excursion of vaccine and administration to patient afterwards was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Lethargy, Muscular weakness
Clinical narrative: LOSS OF APPETITE; LETHARGIC; MUSCLE WEAKNESS; CHILLS; HEADACHE; This spontaneous report received from a patient concerned an 82 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included polycystic kidney disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unkown) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. The Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers.   No concomitant medications were reported. On 26-MAR-2021, the subject experienced headache. On 27-MAR-2021, the subject experienced loss of appetite. On 27-MAR-2021, the subject experienced lethargic. On 27-MAR-2021, the subject experienced muscle weakness. On 27-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of appetite on 27-MAR-2021, and chills, and had not recovered from headache, lethargic, and muscle weakness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: MUSCLE CRAMPS IN LEGS; 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 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 27-MAR-2021, the subject experienced muscle cramps in legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle cramps in legs. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Laboratory test, Paraesthesia oral
Clinical narrative: TINGLY ON THE RIGHT UPPER LIP; MILDEST ACHY JOINTS; NOT FEELING HUNGRY; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included latent TB, and concurrent conditions included diabetes, obese, and skin eczema, and other pre-existing medical conditions included patient had allergies to MRI dye. The patient was previously treated with immunoglobulin g human; and experienced allergy when treated with metronidazole.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown expiry date: unknown) dose was not reported, administered on 26-MAR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced not feeling hungry. On 27-MAR-2021, the subject experienced mildest achy joints. On 28-MAR-2021, the subject experienced tingly on the right upper lip. Laboratory data (dates unspecified) included: Lab test (NR: not provided) negative, 7 times tested. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingly on the right upper lip, and had not recovered from mildest achy joints, and not feeling hungry. This report was non-serious.      T
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Pain, Pain in extremity, Pyrexia
Clinical narrative: GENERALISED ACHING; SORE ARM; JOINTS HURTING; FEVER; 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  (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 generalised aching, sore arm, joints hurting, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.4 F. Treatment medications (dates unspecified) included: dextromethorphan hydrobromide/guaifenesin/paracetamol/phenylephrine hydrochloride. The action taken with covid-19 vaccine was not applicable. The patient recovered from generalised aching, joints hurting, and fever, and was recovering from sore arm. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: BODY ACHE; HEADACHE; FEVER; 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, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch no was not reported ,The company is unable to performed follow up to request batch /Lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced body ache, headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, fever and body ache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: CHILLS; SORE ARM; 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, 1 total, start therapy date were not reported for prophylactic vaccination. 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 chills, and sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and the outcome of sore arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: HEADACHE; FEVER; 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 headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210355508 and 20210355949.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: FEVER; HEADACHE; This spontaneous report received from a parent concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: unknown) dose was not reported, administered on 23-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 fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and headache. This report was non-serious. This case, from the same reporter is linked to 20210356558.   Additional information was received from parent on 29-MAR-2021 following information was updated and incorporated into the case narrative: Hospital/Organization details (name of the hospital, address and city) in vaccine facility tab was added and linked the case 20210356558.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SIDE EFFECTS; 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced side effects. The action taken with covid-19 vaccine was not applicable. The outcome of side effects was not reported. This report was non-serious.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pain
Clinical narrative: BODY ACHES; TIREDNESS; This spontaneous report received from a patient concerned a 79 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: 1805020 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced body aches. On 14-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and tiredness on MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210356833.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pain
Clinical narrative: BODY ACHES; TIREDNESS; This spontaneous report received from a patient concerned a 79 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: 1805020 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced body aches. On 14-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and tiredness on MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210356802.
Sex: U
Vaccine: COVID19
Symptoms: Product dispensing error
Clinical narrative: PATIENT GIVEN REPUNCTURED  VACCINE VIALS REFRIGERATED FOR  OVER 6 HOURS; This spontaneous report received from a physician 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 was not reported) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced subject given repunctured vaccine vials refrigerated for over 6 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of patient given repunctured vaccine vials refrigerated for over 6 hours was not reported. This report was non-serious.  Additional information was received on 29/Mar/2021. No new information received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Injection site pain
Clinical narrative: UNABLE TO USE ARM AS SHE DID IN THE PAST; ACHING RIGHT DELTOID MUSCLE/ACHING ARM AT THE SITE OF THE INJECTION; This spontaneous report received from a patient concerned a 62 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: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, 1 total, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced unable to use arm as she did in the past. On 06-MAR-2021, the subject experienced aching right deltoid muscle/aching arm at the site of the injection. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from aching right deltoid muscle/aching arm at the site of the injection, and unable to use arm as she did in the past. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Jaw disorder, Pyrexia, Sedation, Tooth disorder
Clinical narrative: TOOTH PROBLEM; JAW PROBLEM; FEVER; KNOCKED OUT; 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 26-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-MAR-2021, the subject experienced knocked out. On an unspecified date, the subject experienced tooth problem, jaw problem, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, knocked out, tooth problem and jaw problem was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: MILD HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 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 2021, the subject experienced mild headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild headache was not reported. This report was non-serious.