chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache
Clinical narrative: BRAIN FOG; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced brain fog, fatigue, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from brain fog, and fatigue, and was recovering from headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Eye pain, Feeling hot, Headache
Clinical narrative: SHIVERING; HEADACHE; FEVER; EYE PAIN; HOT EXTREMITIES; neck pain; everything aches; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 25-MAR-2021 for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On MAR-2021, the subject experienced eye pain. On MAR-2021, the subject experienced hot extremities. On MAR-2021, the subject experienced neck pain. On MAR-2021, the subject experienced everything aches. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced fever. On 26-MAR-2021 03:00, the subject experienced shivering. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) UNKNOWN. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, shivering, headache, eye pain, hot extremities, neck pain and everything aches was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Pyrexia
Clinical narrative: SHIVERING; HEADACHE; FEVER; EYE PAIN; HOT EXTREMITIES; neck pain; everything aches; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 25-MAR-2021 for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On MAR-2021, the subject experienced eye pain. On MAR-2021, the subject experienced hot extremities. On MAR-2021, the subject experienced neck pain. On MAR-2021, the subject experienced everything aches. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced fever. On 26-MAR-2021 03:00, the subject experienced shivering. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) UNKNOWN. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, shivering, headache, eye pain, hot extremities, neck pain and everything aches was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SEVERE ILLNESS NOS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient has an unspecified condition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 08-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 severe illness nos. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe illness nos was not reported. This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ARM PAIN; 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 fibromyalgia.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry date: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arm pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Headache, Insomnia, Pyrexia
Clinical narrative: COULDN'T SLEEP; HEADACHE; 101 DEGREE 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, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers No concomitant medications were reported. On an unspecified date, the subject experienced couldn't sleep, headache, and 101 degree fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101 degree. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from couldn't sleep, headache, and 101 degree fever. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Limb discomfort
Clinical narrative: HEAVY SHOULDER; BURNING IN THE INJECTION SITE; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic. 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 25-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow up to request batch number. No concomitant medications were reported. On 25-MAR-2021, the subject experienced heavy shoulder. On 25-MAR-2021, the subject experienced burning in the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the burning in the injection site and heavy shoulder was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Fatigue, Headache, Injection site bruising
Clinical narrative: DRY HEAVING; BUMP; BURNING SENSATION; BRUISE AT INJECTION SITE; CHILLS; SORE ARM ALL THE WAY DOWN TO MY ELBOW; HIGH FEVER; HEADACHE; TIREDNESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced dry heaving, bump, burning sensation, bruise at injection site, sore arm all the way down to my elbow, high fever, chills, headache, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from high fever, sore arm all the way down to my elbow, chills, and headache, and the outcome of burning sensation, bruise at injection site, bump, dry heaving and tiredness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site nodule, Pain in extremity, Pyrexia, Retching
Clinical narrative: DRY HEAVING; BUMP; BURNING SENSATION; BRUISE AT INJECTION SITE; CHILLS; SORE ARM ALL THE WAY DOWN TO MY ELBOW; HIGH FEVER; HEADACHE; TIREDNESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced dry heaving, bump, burning sensation, bruise at injection site, sore arm all the way down to my elbow, high fever, chills, headache, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from high fever, sore arm all the way down to my elbow, chills, and headache, and the outcome of burning sensation, bruise at injection site, bump, dry heaving and tiredness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Oral mucosal eruption
Clinical narrative: RASH AROUND MOUTH; This spontaneous report received from a patient concerned a 38 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: 0180153 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for preventive (covid vaccine). No concomitant medications were reported. On 19-MAR-2021, the subject experienced rash around mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rash around mouth was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass
Clinical narrative: LUMP AT INJECTION SITE; 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, once a total 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 lump at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lump at injection site. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: PATIENT RECEIVED ONLY A PARTIAL DOSE OF VACCINE DUE TO MALFUNCTIONING SYRINGE/NEEDLE.; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 25-MAR-2021, the subject experienced subject received only a partial dose of vaccine due to malfunctioning syringe/needle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of patient received only a partial dose of vaccine due to malfunctioning syringe/needle was not reported. This report was non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Malaise, Pain
Clinical narrative: FEEL SICK; SHIVERS; FEVER; HEADACHE; INJECTION SITE PAIN; BODY ACHE; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021, 09:00 at left arm for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced body ache. On 24-MAR-2021, the subject experienced shivers. On 24-MAR-2021, the subject experienced fever. On 24-MAR-2021, the subject experienced headache. On 24-MAR-2021, the subject experienced injection site pain. On 24-MAR-2021 15:00, the subject experienced feel sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, and shivers, had not recovered from fever, headache, and injection site pain, and the outcome of feel sick was not reported. This report was non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEEL SICK; SHIVERS; FEVER; HEADACHE; INJECTION SITE PAIN; BODY ACHE; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021, 09:00 at left arm for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced body ache. On 24-MAR-2021, the subject experienced shivers. On 24-MAR-2021, the subject experienced fever. On 24-MAR-2021, the subject experienced headache. On 24-MAR-2021, the subject experienced injection site pain. On 24-MAR-2021 15:00, the subject experienced feel sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, and shivers, had not recovered from fever, headache, and injection site pain, and the outcome of feel sick was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: HEADACHE; SOME MUSCLE ACHES; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, one total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported. On an unspecified date, the subject experienced headache, and some muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and some muscle aches was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypersomnia, Injection site pain, Pain in extremity
Clinical narrative: SLEPT MOST OF THE DAY AND NIGHT; ARM SORE; BURNED GOING IN; SEVERE FATIGUE; headache; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total, 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 slept most of the day and night, arm sore, burned going in, severe fatigue, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the burned going in, arm sore, severe fatigue, headache and slept most of the day and night was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: NEGATIVE FOR COVID 19 ANTIBODIES 2  WEEKS AFTER VACCINATION; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 09-MAR-2021 in the left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced negative for covid-19 antibodies 2 weeks after vaccination. Laboratory data included: Antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of negative for covid-19 antibodies 2 weeks after vaccination was not reported. This report was non-serious.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site haemorrhage, Injection site pain
Clinical narrative: BLACK AND BLUE MARK AT SITE OF INJECTION; SHE FELT PAIN DURING THE  INJECTION OF THE VACCINE; This spontaneous report received from a patient concerned a 94 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included deaf. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: unknown) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination on left arm. The batch number was not reported and has been requested. No concomitant medications were reported.  On 19-MAR-2021, the subject experienced black and blue mark at site of injection. On 19-MAR-2021, the subject experienced pain. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient had not recovered from black and blue mark at site of injection, and the outcome of pain was not reported. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Lethargy, Nausea, Pain
Clinical narrative: LETHARGY; OVERALL ACHES/SORENESS; NO ENERGY; NAUSEA; TIREDNESS; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's past medical history included anxiety/depression, and concurrent conditions included non alcohol user, non smoker, and dry cough, and other pre-existing medical conditions included patient had no known allergies and no drug abuse or illicit drug usage history. 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: 1805051, and batch number: 1805051 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced lethargy. On 27-MAR-2021, the subject experienced overall aches/soreness. On 27-MAR-2021, the subject experienced no energy. On 27-MAR-2021, the subject experienced nausea. On 27-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lethargy, and nausea, and the outcome of overall aches/soreness, tiredness and no energy was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Peripheral swelling
Clinical narrative: SWELLING ARM; RECURRENT INJECTION SITE PAIN; INJECTION SITE SWELLING; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced recurrent injection site pain. On 17-MAR-2021, the subject experienced injection site swelling. On an unspecified date, the subject experienced swelling arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the recurrent injection site pain, injection site swelling and swelling arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia, Nasopharyngitis, Pain in extremity
Clinical narrative: JOINT PAIN; HEADACHE; MUSCLE PAIN; FEELING LIKE COMING DOWN WITH  THE COLD-BUT NEVER CAME DOWN  WITH ANYTHING; SORE ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021  on left arm for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced feeling like coming down with the cold-but never came down with anything. On 05-MAR-2021, the subject experienced sore arm. On 06-MAR-2021, the subject experienced joint pain. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 05-MAR-2021, and had not recovered from feeling like coming down with the cold-but never came down with anything, joint pain, headache, and muscle pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pain, Palpitations
Clinical narrative: BODY ACHES; HEART RACING; HEADACHE; FEVER; TIRED; 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 not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced heart racing. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced tired. Laboratory data included: Body temperature (NR: not provided) 102.3 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, heart racing, headache, fever, and tired. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: BODY ACHES; HEART RACING; HEADACHE; FEVER; TIRED; 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 not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced heart racing. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced tired. Laboratory data included: Body temperature (NR: not provided) 102.3 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, heart racing, headache, fever, and tired. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: CHILLS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: 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 chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Injection site pain, Insomnia
Clinical narrative: LIGHTHEADEDNESS; WEAKNESS; SEVERE BODY ACHES; LACK OF SLEEP; CHILLS; INJECTION SITE SORENESS; 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 the patient had no loss of appetite. 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, one total, administered on 20-MAR-2021 in left deltoid for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced lightheadedness, weakness, severe body aches, lack of sleep, chills, and injection site soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe body aches, chills, and injection site soreness, had not recovered from lightheadedness, and weakness, and the outcome of lack of sleep was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: LIGHTHEADEDNESS; WEAKNESS; SEVERE BODY ACHES; LACK OF SLEEP; CHILLS; INJECTION SITE SORENESS; 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 the patient had no loss of appetite. 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, one total, administered on 20-MAR-2021 in left deltoid for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced lightheadedness, weakness, severe body aches, lack of sleep, chills, and injection site soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe body aches, chills, and injection site soreness, had not recovered from lightheadedness, and weakness, and the outcome of lack of sleep was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Nausea, Pyrexia
Clinical narrative: CHILLS; FEVER; NAUSEA; 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 not reported) dose was not reported, administered on 25-MAR-2021 13:10 on left arm for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 25-MAR-2021, the subject experienced chills. On 25-MAR-2021, the subject experienced fever. On 25-MAR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 101 (unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, chills, and nausea. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blood iron, Blood iron increased
Clinical narrative: Blood Iron Increased; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number not reported) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 22-MAR-2021, Laboratory data included: Blood iron (NR: not provided) High. On an unspecified date, the subject experienced blood iron increased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood iron increased was not reported. This report was non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: MUSCLE PAIN; This spontaneous report received from a parent concerned a 69 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: Unk) dose was not reported, administered on 17-MAR-2021  on left arm  for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of muscle pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: TIREDNESS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tiredness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hot flush, Hypoaesthesia, Pain in extremity
Clinical narrative: A LITTLE NUMBNESS IN WHOLE LEFT ARM; STARTED FEELING HOT DUE TO HOT FLASHES; ACHING A LITTLE BIT AROUND LEFT SHOULDER; ARM FEELS A LITTLE MORE SORE THAN USUAL; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and arthritis, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609) dose was not reported, administered on 24-MAR-2021 10:15 AM on Left Arm shoulder for prophylactic vaccination. Concomitant medications included lisinopril for hypertension, and diclofenac for pain, and arthritis. On 25-MAR-2021, the subject experienced numbness in whole left arm. On 25-MAR-2021, the subject experienced started feeling hot due to hot flashes. On 25-MAR-2021, the subject experienced aching a little bit around left shoulder. On 25-MAR-2021, the subject experienced arm feels a little more sore than usual. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from aching a little bit around left shoulder, numbness in whole left arm, and arm feels a little more sore than usual, and the outcome of started feeling hot due to hot flashes was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Illness, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION; SICK; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry: unknown) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination on left arm. The batch number was not reported and has been requested. No concomitant medications were reported.  On 18-MAR-2021, the subject experienced sick. On 24-MAR-2021, Laboratory data included: SARS-CoV-2 rapid POC test (NR: not provided) Positive. On an unspecified date, the subject experienced confirmed covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick, and the outcome of confirmed covid-19 infection was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: BAD BODY ACHES; CHILLS; 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: 1808609 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 26-MAR-2021, the subject experienced bad body aches. On 26-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, and bad body aches. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: SORE ARMS; CHILLS; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number 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 an unspecified date, the patient experienced sore arms, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arms and chills was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Product dispensing error
Clinical narrative: USING EXTRA DOSE OUT OF VIALS; This spontaneous report received from a pharmacist 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, expiry: UNKNOWN) dose, start therapy date and vaccination site were not reported for prophylactic vaccination. The batch number and expiry date were not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced using extra dose out of vials. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The outcome of using extra dose out of vials was not reported. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sensory disturbance
Clinical narrative: LEFT ARM KEEPS PULSATING; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to iodine, and smoker.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022,expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 08-SEP-2019, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative. On 14-MAR-2021, the subject experienced left arm keeps pulsating. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left arm keeps pulsating. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a patient concerned a 72 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 25-MAR-2021 15:00 on left arm for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.7 F. Treatment medications included: paracetamol. On 26-MAR-2021 12:45, Laboratory data included: Body temperature (NR: not provided) 102.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Chills, Dry mouth, Feeling abnormal, Hangover
Clinical narrative: COULDN'T SLEEP LAST NIGHT IN SO MUCH DISCOMFORT; DREAMING I WAS IN PAIN; FOGGY; SLIGHT COTTON MOUTH; HANG OVER; FLU; MY JOINTS FEEL LIKE I AM 80 YEARS OLD; CHILLS; POUNDING HEADACHE; FEVER; NAUSEATED; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On MAR-2021, the subject experienced difficulty sleeping. On MAR-2021, the subject experienced dreaming abnormal. On MAR-2021, the subject experienced foggy. On MAR-2021, the subject experienced slight cotton mouth. On MAR-2021, the subject experienced hang over. On MAR-2021, the subject experienced flu. On MAR-2021, the subject experienced my joints feel like i am 80 years old. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced pounding headache. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced nauseated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pounding headache, chills, fever, difficulty sleeping, dreaming abnormal, foggy, nauseated, slight cotton mouth, hang over, flu and my joints feel like i am 80 years old was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Influenza, Insomnia, Musculoskeletal discomfort, Nausea
Clinical narrative: COULDN'T SLEEP LAST NIGHT IN SO MUCH DISCOMFORT; DREAMING I WAS IN PAIN; FOGGY; SLIGHT COTTON MOUTH; HANG OVER; FLU; MY JOINTS FEEL LIKE I AM 80 YEARS OLD; CHILLS; POUNDING HEADACHE; FEVER; NAUSEATED; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On MAR-2021, the subject experienced difficulty sleeping. On MAR-2021, the subject experienced dreaming abnormal. On MAR-2021, the subject experienced foggy. On MAR-2021, the subject experienced slight cotton mouth. On MAR-2021, the subject experienced hang over. On MAR-2021, the subject experienced flu. On MAR-2021, the subject experienced my joints feel like i am 80 years old. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced pounding headache. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced nauseated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pounding headache, chills, fever, difficulty sleeping, dreaming abnormal, foggy, nauseated, slight cotton mouth, hang over, flu and my joints feel like i am 80 years old was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: COULDN'T SLEEP LAST NIGHT IN SO MUCH DISCOMFORT; DREAMING I WAS IN PAIN; FOGGY; SLIGHT COTTON MOUTH; HANG OVER; FLU; MY JOINTS FEEL LIKE I AM 80 YEARS OLD; CHILLS; POUNDING HEADACHE; FEVER; NAUSEATED; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On MAR-2021, the subject experienced difficulty sleeping. On MAR-2021, the subject experienced dreaming abnormal. On MAR-2021, the subject experienced foggy. On MAR-2021, the subject experienced slight cotton mouth. On MAR-2021, the subject experienced hang over. On MAR-2021, the subject experienced flu. On MAR-2021, the subject experienced my joints feel like i am 80 years old. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced pounding headache. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced nauseated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pounding headache, chills, fever, difficulty sleeping, dreaming abnormal, foggy, nauseated, slight cotton mouth, hang over, flu and my joints feel like i am 80 years old was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: HEADACHE; MUSCLE ACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age.  The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.No concomitant medications were reported. On an unspecified date, the subject experienced headache, and muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and muscle ache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210353137.
Sex: M
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: A LITTLE DISCOMFORT; 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced a little discomfort. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a little discomfort was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nasal discomfort, Pyrexia
Clinical narrative: NASAL BURNING; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination in left arm. No concomitant medications were reported. On 13-MAR-2021, the subject experienced fever. On 14-MAR-2021, the subject experienced nasal burning. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 13-MAR-2021, and had not recovered from nasal burning. This report was non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: ITCHINESS ON LOWER EXTREMITIES, UPPER EXTREMITIES AND EARS; HIVES ON LOWER EXTREMITIES, UPPER EXTREMITIES AND EARS; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included bee sting allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced itchiness on lower extremities, upper extremities and ears. On 22-MAR-2021, the subject experienced hives on lower extremities, upper extremities and ears. Treatment medications (dates unspecified) included: famotidine, diphenhydramine hydrochloride, and cetirizine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from itchiness on lower extremities, upper extremities and ears, and hives on lower extremities, upper extremities and ears. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: ACHE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced ache. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of ache was not reported. This report was non-serious.