chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: NOT FEELING GOOD ON HER BODY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 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 not feeling good on her body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of not feeling good on her body was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: BAD CRAMPS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 15-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced cramps. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cramps. This report was non-serious.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Epistaxis, Hypertension, Limb discomfort, Musculoskeletal discomfort
Clinical narrative: DIARRHEA; FEELING PRESSURE ON BACK OF THE NECK; PRESSURE ON LEFT ARM; NOSE BLEEDS; ELEVATED BLOOD PRESSURE; This spontaneous report received from a patient concerned a 57 year old male. The patient's weight was 302 pounds, and height was 72 inches. The patient's past medical history included chronic obstructive pulmonary disease, dm type 2, and myasthenia gravis, and concurrent conditions included allergic to penicillin, non-alcoholic, and non-smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with clarithromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced elevated blood pressure. On 10-APR-2021, the subject experienced nose bleeds. On an unspecified date, the subject experienced diarrhea, feeling pressure on back of the neck, and pressure on left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from elevated blood pressure, had not recovered from nose bleeds, and the outcome of pressure on left arm, diarrhea and feeling pressure on back of the neck was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Pain in extremity, Pyrexia
Clinical narrative: FELT SUPER COLD; GOT A FEVER; MINOR HEADACHE; SORE ARM; 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 12-MAR-2021, the subject experienced sore arm. On an unspecified date, the subject experienced felt super cold, got a fever, and minor headache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt super cold, got a fever, and minor headache, and the outcome of sore arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Hyperhidrosis, Injection site nodule
Clinical narrative: HEADACHE; FEVER; SWEATING; KNOT AT INJECTION SITE; CHILLS; DIZZINESS; LIGHTHEADED; PAIN AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included corneal transplant, and penicillin allergy, and concurrent conditions included arthritis, hypertension, sinus problem, high cholesterol, asthma, and sleep apnea. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced dizziness. On 11-MAR-2021, the subject experienced lightheaded. On 11-MAR-2021, the subject experienced knot at injection site. On 11-MAR-2021, the subject experienced pain at the injection site. On 11-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced sweating. On 12-MAR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol, and isopropanol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, sweating, and fever on 14-MAR-2021, lightheaded, and chills on 13-MAR-2021, knot at injection site, and pain at the injection site on 21-MAR-2021, and headache on 11-APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pyrexia
Clinical narrative: HEADACHE; FEVER; SWEATING; KNOT AT INJECTION SITE; CHILLS; DIZZINESS; LIGHTHEADED; PAIN AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included corneal transplant, and penicillin allergy, and concurrent conditions included arthritis, hypertension, sinus problem, high cholesterol, asthma, and sleep apnea. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced dizziness. On 11-MAR-2021, the subject experienced lightheaded. On 11-MAR-2021, the subject experienced knot at injection site. On 11-MAR-2021, the subject experienced pain at the injection site. On 11-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced sweating. On 12-MAR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol, and isopropanol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, sweating, and fever on 14-MAR-2021, lightheaded, and chills on 13-MAR-2021, knot at injection site, and pain at the injection site on 21-MAR-2021, and headache on 11-APR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dehydration, Fatigue, Headache, Injection site erythema, Injection site reaction
Clinical narrative: DEHYDRATED; INJECTION SITE REACTION LIKE BUMP/ HEAT; FEVER; HEADACHE; FATIGUE; INJECTION SITE REDNESS; 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 dehydrated, injection site reaction like bump/ heat, fever, headache, fatigue, and injection site redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dehydrated, injection site reaction like bump/ heat, fever, fatigue, and injection site redness, and the outcome of headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: DEHYDRATED; INJECTION SITE REACTION LIKE BUMP/ HEAT; FEVER; HEADACHE; FATIGUE; INJECTION SITE REDNESS; 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 dehydrated, injection site reaction like bump/ heat, fever, headache, fatigue, and injection site redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dehydrated, injection site reaction like bump/ heat, fever, fatigue, and injection site redness, and the outcome of headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Somnolence
Clinical narrative: BODY ACHES; GOOFY SLEEP; 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Company is unable to perform follow-up to confirm batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, goofy sleep, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, goofy sleep, and fever. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: FATIGUE; 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, and batch number were not reported) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fatigue was not reported. This report was non-serious. This case, from the same reporter is linked to 20210432555.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Pyrexia
Clinical narrative: FEVER; MORE THAN 1 SHOT; This spontaneous report received from a parent concerned a 20 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included autism .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021 15:00, the subject experienced more than 1 shot. On 09-APR-2021 19:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 10-APR-2021, and the outcome of more than 1 shot was not reported. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Mobility decreased, Pain in extremity
Clinical narrative: DECREASE IN RANGE OF MOTION OF  RIGHT ARM; DIFFICULTY SLEEPING; ARM SORE / PAINFUL RIGHT ARM; This spontaneous report received from a patient concerned a 50 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: 1805031, expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced decrease in range of motion of right arm. On 20-MAR-2021, the subject experienced difficulty sleeping. On 20-MAR-2021, the subject experienced arm sore / painful right arm. On APR-2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm sore / painful right arm, decrease in range of motion of right arm, and difficulty sleeping. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Coordination abnormal, Dizziness, Dyspnoea, Euphoric mood
Clinical narrative: HEADACHE; DIZZINESS; BLURRED VISION; SHORTNESS OF BREATHE; CHEST TIGHTNESS; EUPHORIA; UNCOORDINATION; BODY ACHES AND BODY PAIN; FATIGUE AND FELT TRIED; NAUSEA; SEVERE MIGRAINE; SORES ON TONGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included clenching of the jaws.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 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced sores on tongue. On 01-APR-2021, the subject experienced severe migraine. On 01-APR-2021, the subject experienced euphoria. On 01-APR-2021, the subject experienced uncoordination. On 01-APR-2021, the subject experienced body aches and body pain. On 01-APR-2021, the subject experienced fatigue and felt tried. On 01-APR-2021, the subject experienced nausea. On 03-APR-2021, the subject experienced shortness of breathe. On 03-APR-2021, the subject experienced chest tightness. On 11-APR-2021, the subject experienced dizziness. On 11-APR-2021, the subject experienced blurred vision. On 15-APR-2021, Laboratory data included: MRI (NR: not provided) NEGATIVE. On an unspecified date, the subject experienced headache. Treatment medications (dates unspecified) included: meglumine gadoterate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breathe, and chest tightness on 04-APR-2021, euphoria, uncoordination, body aches and body pain, and nausea on 03-APR-2021, and dizziness, and blurred vision on APR-2021, had not recovered from severe migraine, fatigue and felt tried, and headache, and the outcome of sores on tongue was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Magnetic resonance imaging, Migraine, Nausea
Clinical narrative: HEADACHE; DIZZINESS; BLURRED VISION; SHORTNESS OF BREATHE; CHEST TIGHTNESS; EUPHORIA; UNCOORDINATION; BODY ACHES AND BODY PAIN; FATIGUE AND FELT TRIED; NAUSEA; SEVERE MIGRAINE; SORES ON TONGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included clenching of the jaws.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 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced sores on tongue. On 01-APR-2021, the subject experienced severe migraine. On 01-APR-2021, the subject experienced euphoria. On 01-APR-2021, the subject experienced uncoordination. On 01-APR-2021, the subject experienced body aches and body pain. On 01-APR-2021, the subject experienced fatigue and felt tried. On 01-APR-2021, the subject experienced nausea. On 03-APR-2021, the subject experienced shortness of breathe. On 03-APR-2021, the subject experienced chest tightness. On 11-APR-2021, the subject experienced dizziness. On 11-APR-2021, the subject experienced blurred vision. On 15-APR-2021, Laboratory data included: MRI (NR: not provided) NEGATIVE. On an unspecified date, the subject experienced headache. Treatment medications (dates unspecified) included: meglumine gadoterate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breathe, and chest tightness on 04-APR-2021, euphoria, uncoordination, body aches and body pain, and nausea on 03-APR-2021, and dizziness, and blurred vision on APR-2021, had not recovered from severe migraine, fatigue and felt tried, and headache, and the outcome of sores on tongue was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Tongue ulceration, Vision blurred
Clinical narrative: HEADACHE; DIZZINESS; BLURRED VISION; SHORTNESS OF BREATHE; CHEST TIGHTNESS; EUPHORIA; UNCOORDINATION; BODY ACHES AND BODY PAIN; FATIGUE AND FELT TRIED; NAUSEA; SEVERE MIGRAINE; SORES ON TONGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included clenching of the jaws.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 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced sores on tongue. On 01-APR-2021, the subject experienced severe migraine. On 01-APR-2021, the subject experienced euphoria. On 01-APR-2021, the subject experienced uncoordination. On 01-APR-2021, the subject experienced body aches and body pain. On 01-APR-2021, the subject experienced fatigue and felt tried. On 01-APR-2021, the subject experienced nausea. On 03-APR-2021, the subject experienced shortness of breathe. On 03-APR-2021, the subject experienced chest tightness. On 11-APR-2021, the subject experienced dizziness. On 11-APR-2021, the subject experienced blurred vision. On 15-APR-2021, Laboratory data included: MRI (NR: not provided) NEGATIVE. On an unspecified date, the subject experienced headache. Treatment medications (dates unspecified) included: meglumine gadoterate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breathe, and chest tightness on 04-APR-2021, euphoria, uncoordination, body aches and body pain, and nausea on 03-APR-2021, and dizziness, and blurred vision on APR-2021, had not recovered from severe migraine, fatigue and felt tried, and headache, and the outcome of sores on tongue was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia, Feeling hot, Headache, Hyperhidrosis
Clinical narrative: CANNOT SWALLOW PROPERLY; FEELING PAIN IN LEFT ARM; PAIN AT INJECTION SITE; NAUSEA; MUSCLE PAIN; HEADACHE; BLURRY VISION; HOT FEELING SENSATION; DIZZINESS; SWEATING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included heart test was performed. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported.  On 2021, Laboratory data included: X-ray (NR: not provided) Not reported. On 30-MAR-2021 16:30, the subject experienced hot feeling sensation. On 30-MAR-2021 16:30, the subject experienced dizziness. On 30-MAR-2021 16:30, the subject experienced sweating. On 31-MAR-2021, the subject experienced blurry vision. On 31-MAR-2021, the subject experienced feeling pain in left arm. On 31-MAR-2021, the subject experienced pain at injection site. On 31-MAR-2021, the subject experienced nausea. On 31-MAR-2021, the subject experienced muscle pain. On 31-MAR-2021, the subject experienced headache. On 04-APR-2021, the subject experienced cannot swallow properly. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot feeling sensation, and sweating on 31-MAR-2021, was recovering from pain at injection site, had not recovered from dizziness, nausea, muscle pain, headache, blurry vision, and cannot swallow properly, and the outcome of feeling pain in left arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia, Nausea, Pain in extremity, Vision blurred
Clinical narrative: CANNOT SWALLOW PROPERLY; FEELING PAIN IN LEFT ARM; PAIN AT INJECTION SITE; NAUSEA; MUSCLE PAIN; HEADACHE; BLURRY VISION; HOT FEELING SENSATION; DIZZINESS; SWEATING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included heart test was performed. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported.  On 2021, Laboratory data included: X-ray (NR: not provided) Not reported. On 30-MAR-2021 16:30, the subject experienced hot feeling sensation. On 30-MAR-2021 16:30, the subject experienced dizziness. On 30-MAR-2021 16:30, the subject experienced sweating. On 31-MAR-2021, the subject experienced blurry vision. On 31-MAR-2021, the subject experienced feeling pain in left arm. On 31-MAR-2021, the subject experienced pain at injection site. On 31-MAR-2021, the subject experienced nausea. On 31-MAR-2021, the subject experienced muscle pain. On 31-MAR-2021, the subject experienced headache. On 04-APR-2021, the subject experienced cannot swallow properly. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot feeling sensation, and sweating on 31-MAR-2021, was recovering from pain at injection site, had not recovered from dizziness, nausea, muscle pain, headache, blurry vision, and cannot swallow properly, and the outcome of feeling pain in left arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: CANNOT SWALLOW PROPERLY; FEELING PAIN IN LEFT ARM; PAIN AT INJECTION SITE; NAUSEA; MUSCLE PAIN; HEADACHE; BLURRY VISION; HOT FEELING SENSATION; DIZZINESS; SWEATING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included heart test was performed. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported.  On 2021, Laboratory data included: X-ray (NR: not provided) Not reported. On 30-MAR-2021 16:30, the subject experienced hot feeling sensation. On 30-MAR-2021 16:30, the subject experienced dizziness. On 30-MAR-2021 16:30, the subject experienced sweating. On 31-MAR-2021, the subject experienced blurry vision. On 31-MAR-2021, the subject experienced feeling pain in left arm. On 31-MAR-2021, the subject experienced pain at injection site. On 31-MAR-2021, the subject experienced nausea. On 31-MAR-2021, the subject experienced muscle pain. On 31-MAR-2021, the subject experienced headache. On 04-APR-2021, the subject experienced cannot swallow properly. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot feeling sensation, and sweating on 31-MAR-2021, was recovering from pain at injection site, had not recovered from dizziness, nausea, muscle pain, headache, blurry vision, and cannot swallow properly, and the outcome of feeling pain in left arm was not reported. This report was non-serious.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest discomfort, Chills, Dyspnoea, Pain in extremity
Clinical narrative: CHEST HEAVINESS; CHILLS; SORE ARM; FEVER OF 103F; DIFFICULTY BREATHING; This spontaneous report received from a patient concerned a 28 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: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced difficulty breathing. Treatment medications included: paracetamol. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced sore arm. On 06-APR-2021, the subject experienced fever of 103 F. Laboratory data included: Body temperature (NR: not provided) 103 F. On 11-APR-2021, the subject experienced chest heaviness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, sore arm, and fever of 103f on 08-APR-2021, had not recovered from chest heaviness, and the outcome of difficulty breathing was not reported. This report was non-serious.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: CHEST HEAVINESS; CHILLS; SORE ARM; FEVER OF 103F; DIFFICULTY BREATHING; This spontaneous report received from a patient concerned a 28 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: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced difficulty breathing. Treatment medications included: paracetamol. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced sore arm. On 06-APR-2021, the subject experienced fever of 103 F. Laboratory data included: Body temperature (NR: not provided) 103 F. On 11-APR-2021, the subject experienced chest heaviness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, sore arm, and fever of 103f on 08-APR-2021, had not recovered from chest heaviness, and the outcome of difficulty breathing was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Gait disturbance, Rash, Skin discolouration
Clinical narrative: MARKS ON WRIST THAT ARE BROWN; SEVERE DIARRHEA; BARELY WALK; RED SPOT ON LEFT KNEE; PAIN IN THE BACK OF BOTH KNEES; This spontaneous report received from a patient concerned an 85 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included varicose veins in legs, and other 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: 1808982 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 marks on wrist that are brown. On APR-2021, the subject experienced red spot on left knee. On APR-2021, the subject experienced severe diarrhea. On APR-2021, the subject experienced pain in the back of both knees. On APR-2021, the subject experienced barely walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from marks on wrist that are brown, and red spot on left knee, and the outcome of pain in the back of both knees, severe diarrhea and barely walk was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: DIARRHEA; SICK TO STOMACH; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history 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 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 diarrhea. On MAR-2021, the subject experienced sick to stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, and sick to stomach. This report was non-serious. This case, from the same reporter is linked to 20210436338.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cold agglutinins, Diarrhoea, Fatigue, Headache
Clinical narrative: ACHY; VOMITING; DIARRHEA; FATIGUE/EXHAUSTION; HEADACHE; NIGHTMARES; ICED COLD CHILLS; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported.  The patient's past medical history included cold agglutinin (clumping) of red blood cells, and flu episode, and concurrent conditions included non smoker, occasional red wine user, and sulfa allergy. The patient experienced drug allergy when treated with codeine, erythromycin, morphine, and doxycycline hydrochloride.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: 21-JUN-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced iced cold chills. On 10-APR-2021, the subject experienced nightmares. On 10-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced achy. On 11-APR-2021, the subject experienced vomiting. On 11-APR-2021, the subject experienced diarrhea. On 11-APR-2021, the subject experienced fatigue/exhaustion. On 16-APR-2021, Laboratory data included: Cold agglutinins (NR: not provided) Not present. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nightmares, was recovering from headache, and had not recovered from fatigue/exhaustion, iced cold chills, achy, vomiting, and diarrhea. This report was non-serious.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Nightmare, Pain, Vomiting
Clinical narrative: ACHY; VOMITING; DIARRHEA; FATIGUE/EXHAUSTION; HEADACHE; NIGHTMARES; ICED COLD CHILLS; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported.  The patient's past medical history included cold agglutinin (clumping) of red blood cells, and flu episode, and concurrent conditions included non smoker, occasional red wine user, and sulfa allergy. The patient experienced drug allergy when treated with codeine, erythromycin, morphine, and doxycycline hydrochloride.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: 21-JUN-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced iced cold chills. On 10-APR-2021, the subject experienced nightmares. On 10-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced achy. On 11-APR-2021, the subject experienced vomiting. On 11-APR-2021, the subject experienced diarrhea. On 11-APR-2021, the subject experienced fatigue/exhaustion. On 16-APR-2021, Laboratory data included: Cold agglutinins (NR: not provided) Not present. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nightmares, was recovering from headache, and had not recovered from fatigue/exhaustion, iced cold chills, achy, vomiting, and diarrhea. This report was non-serious.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Pain, Pain in extremity
Clinical narrative: POUNDING WHOLE BODY ACHES, SHOOTING IN HER LEGS AND BODY, STABBING PAINS; BONES HURT (KNEES, ARMS); UPPER ARM PAIN; This spontaneous report received from a patient concerned a 93 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) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced bones hurt (knees, arms). On APR-2021, the subject experienced upper arm pain. On 13-APR-2021, the subject experienced pounding whole body aches, shooting in her legs and body, stabbing pains. Treatment medications included: paracetamol. On 18-APR-2021, treatment medications included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from upper arm pain on APR-2021, and had not recovered from pounding whole body aches, shooting in her legs and body, stabbing pains, and bones hurt (knees, arms). This report was non-serious. This case, from the same reporter is linked to 20210436303.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hyperacusis, Pain in extremity
Clinical narrative: HYPERACUSIS; DIZZINESS; SORENESS IN ARM; TIREDNESS; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included hypothyroidism, tinnitus, nonsmoker, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, expiry: UNKNOWN) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-MAR-2021, the subject experienced hyperacusis. On 07-MAR-2021, the subject experienced dizziness. On 07-MAR-2021, the subject experienced soreness in arm. On 07-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hyperacusis, and dizziness on 07-MAR-2021, soreness in arm on 08-MAR-2021 17:00, and tiredness on 08-MAR-2021. This report was non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Feeling abnormal, Laziness, Myalgia, Pain
Clinical narrative: DRY COUGH; BODY HURTING /PAINFUL; PAINFUL MUSCLES; FEELING BAD; LITTLE BIT LAZY; This spontaneous report received from a patient concerned a 35 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced feeling bad. On 11-APR-2021, the subject experienced little bit lazy. On 16-APR-2021, the subject experienced dry cough. On 16-APR-2021, the subject experienced body hurting /painful. On 16-APR-2021, the subject experienced painful muscles. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling bad, and little bit lazy on 13-APR-2021, and had not recovered from body hurting /painful, painful muscles, and dry cough. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: FLU LIKE SYMPTOMS; This spontaneous report received from a patient via a company representative concerned a 40 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included 2 co-morbidities. 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. Batch number was not reported. The company was unable to follow-up request for batch number. 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 patient recovered from flu like symptoms. This report was non-serious.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Hypoaesthesia, Pyrexia
Clinical narrative: FOOT NUMBNESS; HEADACHE; FEVER; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 46 year old male. The patient's weight was 165 pounds, and height was 69 inches.  The patient's concurrent conditions included penicillin allergy, smoking, and abstain from alcohol, and other pre-existing medical conditions included no illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced shortness of breath. On 04-APR-2021, the subject experienced headache. On 15-APR-2021, the subject experienced foot numbness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, was recovering from headache, and had not recovered from foot numbness, and shortness of breath. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia
Clinical narrative: SLEEPY MOST OF THE DAY; FATIGUE; 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, 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 18-APR-2021, the subject experienced sleepy most of the day. On 18-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue and sleepy most of the day was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Hypotension, Pyrexia
Clinical narrative: LOW BLOOD PRESSURE; SLEEP; TIREDNESS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 34 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced low blood pressure, sleep, tiredness, fever, and headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.7 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, had not recovered from tiredness, low blood pressure, and sleep, and the outcome of headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: LOW BLOOD PRESSURE; SLEEP; TIREDNESS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 34 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced low blood pressure, sleep, tiredness, fever, and headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.7 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, had not recovered from tiredness, low blood pressure, and sleep, and the outcome of headache was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Testicular pain
Clinical narrative: SORE/TENDER/PAINFUL TESTICLES; HEADACHE; SORENESS AT ARM WHERE INJECTION ADMINISTERED; 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: 201A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced soreness at arm where injection administered. On 13-APR-2021, the subject experienced sore/tender/painful testicles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and soreness at arm where injection administered on APR-2021, and the outcome of sore/tender/painful testicles was not reported. This report was non-serious. This case, from the same reporter is linked to 20210430095 and 20210438566.
Sex: F
Vaccine: COVID19
Symptoms: Medication error, Product storage error
Clinical narrative: MEDICATION ERROR; TEMPERATURE EXCURSION EXPOSURE/ NO MORE TEMPERATURE WAS RECORDED FOR ABOUT 3 HOURS AND 20 MINUTES PAST THE LAST RECORDED WITHIN RANGE TEMPERATURE; This spontaneous report received from a pharmacist concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included augmentin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and batch number: 201A21A expiry: 23-JUN-2021) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced temperature excursion exposure/ no more temperature was recorded for about 3 hours and 20 minutes past the last recorded within range temperature. On an unspecified date, the subject experienced medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temperature excursion exposure/ no more temperature was recorded for about 3 hours and 20 minutes past the last recorded within range temperature and medication error was not reported. This report was non-serious.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Sensory disturbance
Clinical narrative: ACHE; BODY TIGHTNESS; This spontaneous report received from a patient concerned a 37 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included kidney stones, non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known drug allergies. the patient have socially drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 21-JUN-2021) 0.5 ml, administered on 09-APR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced body tightness. On 10-APR-2021, the subject experienced ache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ache on 16-APR-2021, and body tightness on 12-APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210436462.
Sex: U
Vaccine: COVID19
Symptoms: Disturbance in attention
Clinical narrative: CONCENTRATION IMPAIRED; 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 and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced concentration impaired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of concentration impaired was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Nausea
Clinical narrative: REDNESS AT SITE OF INJECTION; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-APR-2021, the subject experienced redness at site of injection. On 05-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 06-APR-2021, and was recovering from redness at site of injection. This report was non-serious. This case, from the same reporter is linked to 20210436344.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness, Malaise, Pyrexia
Clinical narrative: SICK; UNWELL; TIREDNESS; FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight 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 sick, unwell, tiredness, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick, unwell, tiredness, and fever. This report was non-serious. This case, from the same reporter is linked to 20210436316 and 20210436253.