chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test normal, Pain in extremity, Ultrasound scan
Clinical narrative: TINGLING; LIGHTHEADEDNESS; RANDOM SHARP PAINS AROUND CHEST ON BOTH SIDES PERSIST; NUMBNESS TO FACE; HEAVY FELLING; HEADACHE PERSISTS 2 WEEKS POST  VACCINE PULLING, ON LEFT AND  RIGHT SIDES; PAIN BEHIND LEFT THIGH; CHILLS ON HALF OF BODY; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, non smoker, and penicillin allergy, and other pre-existing medical conditions included the patient had no known medical history. the patient did not have any history of drug abuse or illicit drug use. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 08-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 pain behind left thigh. On APR-2021, the subject experienced chills on half of body. On 11-APR-2021, the subject experienced tingling. On 11-APR-2021, the subject experienced lightheadedness. On 11-APR-2021, the subject experienced random sharp pains around chest on both sides persist. On 11-APR-2021, the subject experienced numbness to face. On 11-APR-2021, the subject experienced heavy felling. On 11-APR-2021, the subject experienced headache persists 2 weeks post vaccine pulling, on left and right sides. Laboratory data included: Diagnostic ultrasound (NR: not provided) NEGATIVE. On 15-APR-2021, Laboratory data included: Blood pressure (NR: not provided) NOT REPORTED, and CT scan (NR: not provided) NEGATIVE. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache persists 2 weeks post vaccine pulling, on left and right sides, tingling, lightheadedness, random sharp pains around chest on both sides persist, numbness to face, and heavy felling, and the outcome of pain behind left thigh and chills on half of body was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Amnesia, Chest pain, Headache, Pain in extremity, Speech disorder
Clinical narrative: AMNESIA; CHEST PAIN; SPEECH DISABILITY; ARM PAIN; HEADACHE; 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 was not reported, administered on APR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On APR-2021, the subject experienced amnesia. On APR-2021, the subject experienced chest pain. On APR-2021, the subject experienced speech disability. On APR-2021, the subject experienced arm pain. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm pain, amnesia, chest pain, speech disability and headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Amnesia, Chest pain, Cognitive disorder, Confusional state, Dysarthria
Clinical narrative: AMNESIA; CHEST PAIN; SPEECH DISABILITY; ARM PAIN; HEADACHE; 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 was not reported, administered on APR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On APR-2021, the subject experienced amnesia. On APR-2021, the subject experienced chest pain. On APR-2021, the subject experienced speech disability. On APR-2021, the subject experienced arm pain. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm pain, amnesia, chest pain, speech disability and headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Feeling abnormal, Hallucination, Headache, Magnetic resonance imaging
Clinical narrative: AMNESIA; CHEST PAIN; SPEECH DISABILITY; ARM PAIN; HEADACHE; 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 was not reported, administered on APR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On APR-2021, the subject experienced amnesia. On APR-2021, the subject experienced chest pain. On APR-2021, the subject experienced speech disability. On APR-2021, the subject experienced arm pain. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm pain, amnesia, chest pain, speech disability and headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Memory impairment, Oxygen saturation decreased, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: AMNESIA; CHEST PAIN; SPEECH DISABILITY; ARM PAIN; HEADACHE; 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 was not reported, administered on APR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On APR-2021, the subject experienced amnesia. On APR-2021, the subject experienced chest pain. On APR-2021, the subject experienced speech disability. On APR-2021, the subject experienced arm pain. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm pain, amnesia, chest pain, speech disability and headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Respiratory tract congestion, Skin discolouration, Temperature regulation disorder, Thrombosis, Vision blurred
Clinical narrative: AMNESIA; CHEST PAIN; SPEECH DISABILITY; ARM PAIN; HEADACHE; 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 was not reported, administered on APR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On APR-2021, the subject experienced amnesia. On APR-2021, the subject experienced chest pain. On APR-2021, the subject experienced speech disability. On APR-2021, the subject experienced arm pain. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm pain, amnesia, chest pain, speech disability and headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Amnesia, Chills, Computerised tomogram, Dysarthria, Headache
Clinical narrative: AMNESIA; CHEST PAIN; SPEECH DISABILITY; ARM PAIN; HEADACHE; 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 was not reported, administered on APR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On APR-2021, the subject experienced amnesia. On APR-2021, the subject experienced chest pain. On APR-2021, the subject experienced speech disability. On APR-2021, the subject experienced arm pain. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm pain, amnesia, chest pain, speech disability and headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site pain, Magnetic resonance imaging, Motor dysfunction, Pain, Pyrexia
Clinical narrative: AMNESIA; CHEST PAIN; SPEECH DISABILITY; ARM PAIN; HEADACHE; 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 was not reported, administered on APR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On APR-2021, the subject experienced amnesia. On APR-2021, the subject experienced chest pain. On APR-2021, the subject experienced speech disability. On APR-2021, the subject experienced arm pain. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm pain, amnesia, chest pain, speech disability and headache was not reported. This report was non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Amnesia, Chest pain, Headache, Pain in extremity, Speech disorder
Clinical narrative: MEMORY LOSS; SLURRED SPEECH; LOSS OF MOTOR FUNCTIONS; BODY ACHES; CHILLS; FEVER; PAIN AT INJECTION SITE; SEVERE HEADACHE; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported.  The patient's pre-existing medical conditions included the patient had no medical conditions, no known allergies and was not on any other medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested.  No concomitant medications were reported.  On APR-2021, Laboratory data included: CT scan (NR: not provided) Unknown, and MRI (NR: not provided) Unknown. On 02-APR-2021, the subject experienced pain at injection site. On 02-APR-2021, the subject experienced severe headache. On 15-APR-2021, the subject experienced memory loss. On 15-APR-2021, the subject experienced slurred speech. On 15-APR-2021, the subject experienced loss of motor functions. On 15-APR-2021, the subject experienced body aches. On 15-APR-2021, the subject experienced chills. On 15-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain at injection site, severe headache, memory loss, slurred speech, loss of motor functions, fever, chills, and body aches. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Amnesia, Chest pain, Cognitive disorder, Confusional state, Dysarthria
Clinical narrative: MEMORY LOSS; SLURRED SPEECH; LOSS OF MOTOR FUNCTIONS; BODY ACHES; CHILLS; FEVER; PAIN AT INJECTION SITE; SEVERE HEADACHE; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported.  The patient's pre-existing medical conditions included the patient had no medical conditions, no known allergies and was not on any other medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested.  No concomitant medications were reported.  On APR-2021, Laboratory data included: CT scan (NR: not provided) Unknown, and MRI (NR: not provided) Unknown. On 02-APR-2021, the subject experienced pain at injection site. On 02-APR-2021, the subject experienced severe headache. On 15-APR-2021, the subject experienced memory loss. On 15-APR-2021, the subject experienced slurred speech. On 15-APR-2021, the subject experienced loss of motor functions. On 15-APR-2021, the subject experienced body aches. On 15-APR-2021, the subject experienced chills. On 15-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain at injection site, severe headache, memory loss, slurred speech, loss of motor functions, fever, chills, and body aches. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Feeling abnormal, Hallucination, Headache, Magnetic resonance imaging
Clinical narrative: MEMORY LOSS; SLURRED SPEECH; LOSS OF MOTOR FUNCTIONS; BODY ACHES; CHILLS; FEVER; PAIN AT INJECTION SITE; SEVERE HEADACHE; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported.  The patient's pre-existing medical conditions included the patient had no medical conditions, no known allergies and was not on any other medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested.  No concomitant medications were reported.  On APR-2021, Laboratory data included: CT scan (NR: not provided) Unknown, and MRI (NR: not provided) Unknown. On 02-APR-2021, the subject experienced pain at injection site. On 02-APR-2021, the subject experienced severe headache. On 15-APR-2021, the subject experienced memory loss. On 15-APR-2021, the subject experienced slurred speech. On 15-APR-2021, the subject experienced loss of motor functions. On 15-APR-2021, the subject experienced body aches. On 15-APR-2021, the subject experienced chills. On 15-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain at injection site, severe headache, memory loss, slurred speech, loss of motor functions, fever, chills, and body aches. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Memory impairment, Oxygen saturation decreased, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: MEMORY LOSS; SLURRED SPEECH; LOSS OF MOTOR FUNCTIONS; BODY ACHES; CHILLS; FEVER; PAIN AT INJECTION SITE; SEVERE HEADACHE; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported.  The patient's pre-existing medical conditions included the patient had no medical conditions, no known allergies and was not on any other medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested.  No concomitant medications were reported.  On APR-2021, Laboratory data included: CT scan (NR: not provided) Unknown, and MRI (NR: not provided) Unknown. On 02-APR-2021, the subject experienced pain at injection site. On 02-APR-2021, the subject experienced severe headache. On 15-APR-2021, the subject experienced memory loss. On 15-APR-2021, the subject experienced slurred speech. On 15-APR-2021, the subject experienced loss of motor functions. On 15-APR-2021, the subject experienced body aches. On 15-APR-2021, the subject experienced chills. On 15-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain at injection site, severe headache, memory loss, slurred speech, loss of motor functions, fever, chills, and body aches. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Respiratory tract congestion, Skin discolouration, Temperature regulation disorder, Thrombosis, Vision blurred
Clinical narrative: MEMORY LOSS; SLURRED SPEECH; LOSS OF MOTOR FUNCTIONS; BODY ACHES; CHILLS; FEVER; PAIN AT INJECTION SITE; SEVERE HEADACHE; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported.  The patient's pre-existing medical conditions included the patient had no medical conditions, no known allergies and was not on any other medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested.  No concomitant medications were reported.  On APR-2021, Laboratory data included: CT scan (NR: not provided) Unknown, and MRI (NR: not provided) Unknown. On 02-APR-2021, the subject experienced pain at injection site. On 02-APR-2021, the subject experienced severe headache. On 15-APR-2021, the subject experienced memory loss. On 15-APR-2021, the subject experienced slurred speech. On 15-APR-2021, the subject experienced loss of motor functions. On 15-APR-2021, the subject experienced body aches. On 15-APR-2021, the subject experienced chills. On 15-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain at injection site, severe headache, memory loss, slurred speech, loss of motor functions, fever, chills, and body aches. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Amnesia, Chills, Computerised tomogram, Dysarthria, Headache
Clinical narrative: MEMORY LOSS; SLURRED SPEECH; LOSS OF MOTOR FUNCTIONS; BODY ACHES; CHILLS; FEVER; PAIN AT INJECTION SITE; SEVERE HEADACHE; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported.  The patient's pre-existing medical conditions included the patient had no medical conditions, no known allergies and was not on any other medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested.  No concomitant medications were reported.  On APR-2021, Laboratory data included: CT scan (NR: not provided) Unknown, and MRI (NR: not provided) Unknown. On 02-APR-2021, the subject experienced pain at injection site. On 02-APR-2021, the subject experienced severe headache. On 15-APR-2021, the subject experienced memory loss. On 15-APR-2021, the subject experienced slurred speech. On 15-APR-2021, the subject experienced loss of motor functions. On 15-APR-2021, the subject experienced body aches. On 15-APR-2021, the subject experienced chills. On 15-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain at injection site, severe headache, memory loss, slurred speech, loss of motor functions, fever, chills, and body aches. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site pain, Magnetic resonance imaging, Motor dysfunction, Pain, Pyrexia
Clinical narrative: MEMORY LOSS; SLURRED SPEECH; LOSS OF MOTOR FUNCTIONS; BODY ACHES; CHILLS; FEVER; PAIN AT INJECTION SITE; SEVERE HEADACHE; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported.  The patient's pre-existing medical conditions included the patient had no medical conditions, no known allergies and was not on any other medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested.  No concomitant medications were reported.  On APR-2021, Laboratory data included: CT scan (NR: not provided) Unknown, and MRI (NR: not provided) Unknown. On 02-APR-2021, the subject experienced pain at injection site. On 02-APR-2021, the subject experienced severe headache. On 15-APR-2021, the subject experienced memory loss. On 15-APR-2021, the subject experienced slurred speech. On 15-APR-2021, the subject experienced loss of motor functions. On 15-APR-2021, the subject experienced body aches. On 15-APR-2021, the subject experienced chills. On 15-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain at injection site, severe headache, memory loss, slurred speech, loss of motor functions, fever, chills, and body aches. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Chills, Headache, Hyperhidrosis, Insomnia
Clinical narrative: SEVER ADVERSE EVENTS; SLEEPLESSNESS; SWEATING; MUSCLE CRAMP; CHILLS; MUSCLE PAIN; HEADACHE; NAUSEOUS; FEVER; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the subject experienced sever adverse events. On APR-2021, the subject experienced sleeplessness. On APR-2021, the subject experienced sweating. On APR-2021, the subject experienced muscle cramp. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced nauseous. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle cramp, chills, sweating, fever, headache, nauseous, sleeplessness, sever adverse events and muscle pain was not reported. This report was non-serious. This case, from the same reporter is linked to 20210430851.
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia, Nausea, Pyrexia
Clinical narrative: SEVER ADVERSE EVENTS; SLEEPLESSNESS; SWEATING; MUSCLE CRAMP; CHILLS; MUSCLE PAIN; HEADACHE; NAUSEOUS; FEVER; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the subject experienced sever adverse events. On APR-2021, the subject experienced sleeplessness. On APR-2021, the subject experienced sweating. On APR-2021, the subject experienced muscle cramp. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced nauseous. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle cramp, chills, sweating, fever, headache, nauseous, sleeplessness, sever adverse events and muscle pain was not reported. This report was non-serious. This case, from the same reporter is linked to 20210430851.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Feeling cold, Headache, Hypersomnia
Clinical narrative: PAIN AT INJECTION SITE; EXTENSIVE SLEEP; FEELING COLD; MALAISE; FEELING WEAK; HEADACHE; MUSCLE ACHES; This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included type ii diabetes, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 and expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination.  No concomitant medications were reported. On 25-MAR-2021, the subject experienced extensive sleep. On 25-MAR-2021, the subject experienced feeling cold. On 25-MAR-2021, the subject experienced malaise. On 25-MAR-2021, the subject experienced feeling weak. On 25-MAR-2021, the subject experienced headache. On 25-MAR-2021, the subject experienced muscle aches. On 27-MAR-2021, the subject experienced pain at injection site. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 94.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain at injection site, and had not recovered from malaise, feeling weak, headache, muscle aches, extensive sleep, and feeling cold. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Malaise, Myalgia
Clinical narrative: PAIN AT INJECTION SITE; EXTENSIVE SLEEP; FEELING COLD; MALAISE; FEELING WEAK; HEADACHE; MUSCLE ACHES; This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included type ii diabetes, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 and expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination.  No concomitant medications were reported. On 25-MAR-2021, the subject experienced extensive sleep. On 25-MAR-2021, the subject experienced feeling cold. On 25-MAR-2021, the subject experienced malaise. On 25-MAR-2021, the subject experienced feeling weak. On 25-MAR-2021, the subject experienced headache. On 25-MAR-2021, the subject experienced muscle aches. On 27-MAR-2021, the subject experienced pain at injection site. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 94.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain at injection site, and had not recovered from malaise, feeling weak, headache, muscle aches, extensive sleep, and feeling cold. This report was non-serious.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Lethargy, Myalgia, Retinal vein occlusion
Clinical narrative: DIAGNOSIS OF BRANCH RETINAL VEIN OCCLUSION VIA BLOOD CLOT; LETHARGIC; CHILLS; MUSCLE ACHE; HEADACHE; This spontaneous report received from a patient concerned a 41 year old male. The patient's weight was 210 pounds, and height was 72 inches. The patient's concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on left deltoid on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021,he reported blurred vision in left eye. Then he experienced lethargic, chills, muscle ache, headache. On 14-APR-2021, he experienced diagnosis of branch retinal vein occlusion via blood clot in the eye. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargic, chills, and muscle ache, and the outcome of diagnosis of branch retinal vein occlusion via blood clot and headache was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This is a report of a 41 year old male patient, who was noted to have branch retinal vein occlusion via blood clot in the eye 7 days after receiving the covid-19 vaccine ad26.cov.2.  Patient is 210 pounds and 72 inches. No pre existing medical conditions. No known allergies. Patient is a non smoker and did not have any drug abuse/illicit drug use. On the day of the vaccination, patient reported blurred vision on the left eye. He also experienced lethargy, chills, muscle ache and headache. Seven (7) days after receiving the vaccine, a blood clot was noted leading to branch retinal vein occlusion. The information provided precludes a meaningful medical assessment. Additional information requested.
Sex: U
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: GOUT; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. Per procedure, no follow-up will be requested for this case. On an unspecified date, the subject experienced gout. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of gout was not reported. This report was non-serious. This case, from the same reporter is linked. Sender's Comments: V0:As per standard protocol, comment is not required for non-serious case
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Induration, Myalgia
Clinical narrative: MUSCLE ACHES; HEADACHE; FELT FATIGUE; LOW GRADE FEVER; MENTAL FOGGINESS; HARD AREA; ARM PAIN; This spontaneous report received from a parent concerned a 30 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune issues. 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 24-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On 2021, the subject experienced mental fogginess. On 2021, the subject experienced hard area. On 2021, the subject experienced arm pain. On MAR-2021, the subject experienced muscle aches. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced felt fatigue. On MAR-2021, the subject experienced low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt fatigue, muscle aches, headache, arm pain, mental fogginess, low grade fever and hard area was not reported. This report was non-serious. This case, from the same reporter is linked to 20210422139.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case is assessed non serious
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: MUSCLE ACHES; HEADACHE; FELT FATIGUE; LOW GRADE FEVER; MENTAL FOGGINESS; HARD AREA; ARM PAIN; This spontaneous report received from a parent concerned a 30 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune issues. 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 24-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On 2021, the subject experienced mental fogginess. On 2021, the subject experienced hard area. On 2021, the subject experienced arm pain. On MAR-2021, the subject experienced muscle aches. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced felt fatigue. On MAR-2021, the subject experienced low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt fatigue, muscle aches, headache, arm pain, mental fogginess, low grade fever and hard area was not reported. This report was non-serious. This case, from the same reporter is linked to 20210422139.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case is assessed non serious
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Off label use, Wrong product administered
Clinical narrative: WRONG VACCINE ADMINISTERED; OFF LABEL USE; HEADACHE; MUSCLE ACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient was previously treated with covid-19 vaccine for prophylactic vaccination. 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 APR-2021 for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for  this case No concomitant medications were reported. On 07-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced muscle ache. On an unspecified date, the subject experienced wrong vaccine administered, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the wrong vaccine administered, headache, muscle ache and off label use was not reported. This report was non-serious.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Rash vesicular
Clinical narrative: RASH/2 BLISTERS ON CHIN UNDER LIP; This spontaneous report received from a patient concerned a 61 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: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-APR-2021, the subject experienced rash/2 blisters on chin under lip. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash/2 blisters on chin under lip. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: NO ADVERSE EVENT; This spontaneous report received from a patient concerned a 73 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: 042A21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced no adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of no adverse event was not reported. This report was non-serious.  This case, from the same reporter is linked to 20210440109.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Hypertension, Malaise
Clinical narrative: DIZZINESS; HIGH BLOOD PRESSURE; BODY ACHE; FEELING SICK; LACKING ENERGY; HEADACHE ON ONE SIDE OF HEAD; 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 05-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 subject experienced dizziness, high blood pressure, body ache, feeling sick, lacking energy, and headache on one side of head. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, feeling sick, and lacking energy, and had not recovered from headache on one side of head, dizziness, and high blood pressure. This report was non-serious. This case, from the same reporter is linked to 20210440783.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: DIZZINESS; HIGH BLOOD PRESSURE; BODY ACHE; FEELING SICK; LACKING ENERGY; HEADACHE ON ONE SIDE OF HEAD; 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 05-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 subject experienced dizziness, high blood pressure, body ache, feeling sick, lacking energy, and headache on one side of head. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, feeling sick, and lacking energy, and had not recovered from headache on one side of head, dizziness, and high blood pressure. This report was non-serious. This case, from the same reporter is linked to 20210440783.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Dyspnoea, Wheezing
Clinical narrative: Going on week two continued difficulty breathing. I have been doing breathing treatments and inhaler. Dry cough, some wheezing, some tightness in chest at times when breathing is harder.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Headache
Clinical narrative: heavy chills at 4 am followed by the temperature.  The temperature went down in 2-3 days, but the headaches continued for about a week.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstruation irregular
Clinical narrative: While on continuous birth control which halts menstruation I began cramping severely. Within 24 hours I began my period. Approximately two weeks later I had signs of possible but not confirmed ovulation.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Chronic lymphocytic leukaemia, Laboratory test, Lymphocyte count, Lymphoproliferative disorder, Vasodilatation
Clinical narrative: i TOOK A QUADRIVALENT FLU SHOT ON 10/14/19. TWO WEEKS LATER i NOTICED AWORM LIKE THING ON MY UPPER LEFT ARM. AFTER A MONTH AND A HALF THIS ORGANISM WENT INSIDE MY BODY AND CAUSED MY LEUKOCYTE TO MASS PROLIFERATION. THIS LED TO A DIAGNOSIS OF LYMPHOCYTE DISORDER AND CLL.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: White blood cell count increased
Clinical narrative: i TOOK A QUADRIVALENT FLU SHOT ON 10/14/19. TWO WEEKS LATER i NOTICED AWORM LIKE THING ON MY UPPER LEFT ARM. AFTER A MONTH AND A HALF THIS ORGANISM WENT INSIDE MY BODY AND CAUSED MY LEUKOCYTE TO MASS PROLIFERATION. THIS LED TO A DIAGNOSIS OF LYMPHOCYTE DISORDER AND CLL.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: CRAZY CHILLS; EXHAUSTED; A TERRIBLE HEADACHE; 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 crazy chills, exhausted, and a terrible headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from crazy chills, exhausted, and a terrible headache. This report was non-serious.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No Adverse Event occurred.  Minor at 16 years old received Moderna vaccine - Consent signed by both mother & father who are physicians and authorized vaccination of Moderna dose #1 and dose #2 to their son. Witnessed by the facilities  Medical Director.  NO ADVERSE EVENT OCCURRED
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Mobility decreased, Muscular weakness
Clinical narrative: Became very ill with chills and body ache then the next day I had extreme pain in my shoulder down my back and in to my right arm.  It got better after some stretching Ice and anti inflammatory I also noticed I could not press any weight over my head and my right scapula was winging then the pain came back about four days later. The pain was so bad I went to urgent care and was given muscle relaxers.  The pain went away after a couple days but after giving it several weeks to see if the winging and weakness in my arm went away.  When it didn't I contacted Orthopedics to have my arm looked at.  The PA and was seen by noticed the scapular winging and believes its due to damage of my long thoracic nerve.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Winged scapula, X-ray
Clinical narrative: Became very ill with chills and body ache then the next day I had extreme pain in my shoulder down my back and in to my right arm.  It got better after some stretching Ice and anti inflammatory I also noticed I could not press any weight over my head and my right scapula was winging then the pain came back about four days later. The pain was so bad I went to urgent care and was given muscle relaxers.  The pain went away after a couple days but after giving it several weeks to see if the winging and weakness in my arm went away.  When it didn't I contacted Orthopedics to have my arm looked at.  The PA and was seen by noticed the scapular winging and believes its due to damage of my long thoracic nerve.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anosmia, Fatigue, Oropharyngeal pain, Sinus headache
Clinical narrative: extreme severe sinus headaches, sore throat, for over 3 weeks, I have  loss of smell still & very  fatigue still.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Limb discomfort, Musculoskeletal discomfort, Musculoskeletal pain, Pain in extremity
Clinical narrative: 1.5 hours after vaccine -ongoing 1)Sunburn-like skin sensitivity/pain on right thigh and buttock. 2) Tight skin feeling on entire right leg . 3) Joint/ligament pain in right hip and knee.  Noticed 2 days after vaccine -ongoing 1) Raised,  painful rash on buttock. 2) Raised rash on right calf. I did have a massage after the vaccine.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular, Sensitive skin
Clinical narrative: 1.5 hours after vaccine -ongoing 1)Sunburn-like skin sensitivity/pain on right thigh and buttock. 2) Tight skin feeling on entire right leg . 3) Joint/ligament pain in right hip and knee.  Noticed 2 days after vaccine -ongoing 1) Raised,  painful rash on buttock. 2) Raised rash on right calf. I did have a massage after the vaccine.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Insomnia, Myalgia, Pain
Clinical narrative: hives, scattered over body itchy hands and feet headache fever chills all over body/muscle ache fatigued sleeplessness
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Urticaria
Clinical narrative: hives, scattered over body itchy hands and feet headache fever chills all over body/muscle ache fatigued sleeplessness
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding
Clinical narrative: Unexpected menstrual bleeding
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Vision blurred
Clinical narrative: Mild aches and headache, mild blurred vision for 2+ weeks
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Breast inflammation, Breast pain, Breast swelling, Erythema, Fatigue
Clinical narrative: LEFT-SIDED TORSO PAIN; FATIGUE; LEFT BREAST PAIN; RASH INFERIOR LEFT BREAST; LEFT BREAST REDNESS; LEFT BREAST INFLAMMATION; INJECTION SITE PAIN; SWELLING OF LEFT BREAST; This spontaneous report received from a patient concerned a 52 year old female. The patient's weight was 126 pounds, and height was 57 inches. The patient's concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known drug allergies. the patient did not have ant 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: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced swelling of left breast. On 09-APR-2021, the subject experienced injection site pain. On 17-APR-2021, the subject experienced left breast redness. On 17-APR-2021, the subject experienced left breast inflammation. On 17-APR-2021, the subject experienced left breast pain. On 17-APR-2021, the subject experienced rash inferior left breast. On 19-APR-2021, the subject experienced left-sided torso pain. On 19-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 16-APR-2021, had not recovered from left-sided torso pain, left breast redness, left breast inflammation, fatigue, left breast pain, and rash inferior left breast, and the outcome of swelling of left breast was not reported. This report was non-serious.