chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Product dispensing error, Product packaging quantity issue
Clinical narrative: SOME PATIENTS GOT ARM BIT PAIN; SOME VIALS DID NOT HAVE ENOUGH FOR 5 DOSES/ NOT ENOUGH VOLUME IN VIALS; USED 9 VIALS TO GET 40 SHOTS/ USED THE LEFT OVER QUANTITY FROM ONE VIAL WHICH WAS 0.2 OR 0.3 ML AND COMPLETE THE DOSE FROM THE NEXT VIAL; This spontaneous report received from a pharmacist concerned multiple patients (ages from 35 to 70 years). The patient's height, and weight were not reported. The patient's concurrent conditions included some patients have cancer and recover from cancer, diabetes type 1, diabetes type 2, and high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced some subjects got arm bit pain. On 06-MAR-2021, the subject experienced some vials did not have enough for 5 doses/ not enough volume in vials. On 06-MAR-2021, the subject experienced used 9 vials to get 40 shots/ used the left over quantity from one vial which was 0.2 or 0.3 ml and complete the dose from the next vial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from some patients got arm bit pain on 07-MAR-2021, and the outcome of some vials did not have enough for 5 doses/ not enough volume in vials and used 9 vials to get 40 shots/ used the left over quantity from one vial which was 0.2 or 0.3 ml and complete the dose from the next vial was not reported. This report was associated with product quality complaint: 90000172234 This report was non-serious.; Reporter's Comments: This report contains multiple patients
Sex: U
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Headache; BODY ACHES (SPECIFICALLY LOWER BACK); Chills; Sweating; Lack of appetite; Goosebumps; TIRED; SLEEPY; 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 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 21:00 for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced headache. On 07-MAR-2021, the subject experienced body aches (specifically lower back). On 07-MAR-2021, the subject experienced chills. On 07-MAR-2021, the subject experienced sweating. On 07-MAR-2021, the subject experienced lack of appetite. On 07-MAR-2021, the subject experienced goosebumps. On 07-MAR-2021, the subject experienced tired. On 07-MAR-2021, the subject experienced sleepy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 07-MAR-2021, and the outcome of body aches (specifically lower back), chills, sweating, lack of appetite, goosebumps, tired and sleepy was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Piloerection, Somnolence
Clinical narrative: Headache; BODY ACHES (SPECIFICALLY LOWER BACK); Chills; Sweating; Lack of appetite; Goosebumps; TIRED; SLEEPY; 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 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 21:00 for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced headache. On 07-MAR-2021, the subject experienced body aches (specifically lower back). On 07-MAR-2021, the subject experienced chills. On 07-MAR-2021, the subject experienced sweating. On 07-MAR-2021, the subject experienced lack of appetite. On 07-MAR-2021, the subject experienced goosebumps. On 07-MAR-2021, the subject experienced tired. On 07-MAR-2021, the subject experienced sleepy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 07-MAR-2021, and the outcome of body aches (specifically lower back), chills, sweating, lack of appetite, goosebumps, tired and sleepy was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH ALL OVER BODY; 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 no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802072, and batch number: 1802072 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the patient experienced rash all over body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from rash all over body. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Pyrexia
Clinical narrative: CHILLS; FEVER; MALAISE; HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, treatment medications included: paracetamol. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced malaise. On 06-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, fever, malaise, and headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Haematoma
Clinical narrative: HEMATOMA; 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, intramuscular, batch number: 1802070, and batch number: 1802070 expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced hematoma. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from hematoma. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: NAUSEA; FATIGUE; BODY ACHES; HEADACHE; DIZZINESS; LOST APPETITE; This spontaneous report received from a female patient of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included mild headache. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and  expiry: not reported) dose was not reported, administered on 04-MAR-2021 at 03:30 pm to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced nausea, fatigue, body aches, headache, dizziness, and lost appetite. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, fatigue, and body aches, had not recovered from headache, and the outcome of dizziness and lost appetite was not reported. This report was non-serious. This case, from the same reporter is linked to 20210314196.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: NAUSEA; FATIGUE; BODY ACHES; HEADACHE; DIZZINESS; LOST APPETITE; This spontaneous report received from a female patient of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included mild headache. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and  expiry: not reported) dose was not reported, administered on 04-MAR-2021 at 03:30 pm to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced nausea, fatigue, body aches, headache, dizziness, and lost appetite. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, fatigue, and body aches, had not recovered from headache, and the outcome of dizziness and lost appetite was not reported. This report was non-serious. This case, from the same reporter is linked to 20210314196.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Feeling of body temperature change, Headache, Nausea, Pain
Clinical narrative: HEADACHE; FEVER; AROUND 3:30 AM, THE PATIENT EXPERIENCED SHAKING; AROUND 3:30 AM, THE PATIENT EXPERIENCED COLD AND HOT FLASHES; VOMITING WHICH WAS CONSISTENT TILL 3 AM; NAUSEA WHICH WAS CONSISTENT TILL 3 AM; ACHE DESCRIBED AS ACHENESS; 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: 10005022, and batch number: 10005022 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 05:30 to left arm for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced ache described as acheness. On 06-MAR-2021 11:00, the subject experienced vomiting which was consistent till 3 am. On 06-MAR-2021 11:00, the subject experienced nausea which was consistent till 3 am. On 07-MAR-2021, the subject experienced around 3:30 am, the subject experienced shaking. On 07-MAR-2021, the subject experienced around 3:30 am, the subject experienced shaking cold and hot flashes. On 07-MAR-2021, the subject experienced headache. On 07-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting which was consistent till 3 am on 07-MAR-2021, was recovering from fever, had not recovered from around 3:30 am, the patient experienced shaking cold and hot flashes, and ache described as acheness, and the outcome of around 3:30 am, the patient experienced shaking, headache and nausea which was consistent till 3 am was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Tremor, Vomiting
Clinical narrative: HEADACHE; FEVER; AROUND 3:30 AM, THE PATIENT EXPERIENCED SHAKING; AROUND 3:30 AM, THE PATIENT EXPERIENCED COLD AND HOT FLASHES; VOMITING WHICH WAS CONSISTENT TILL 3 AM; NAUSEA WHICH WAS CONSISTENT TILL 3 AM; ACHE DESCRIBED AS ACHENESS; 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: 10005022, and batch number: 10005022 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 05:30 to left arm for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced ache described as acheness. On 06-MAR-2021 11:00, the subject experienced vomiting which was consistent till 3 am. On 06-MAR-2021 11:00, the subject experienced nausea which was consistent till 3 am. On 07-MAR-2021, the subject experienced around 3:30 am, the subject experienced shaking. On 07-MAR-2021, the subject experienced around 3:30 am, the subject experienced shaking cold and hot flashes. On 07-MAR-2021, the subject experienced headache. On 07-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting which was consistent till 3 am on 07-MAR-2021, was recovering from fever, had not recovered from around 3:30 am, the patient experienced shaking cold and hot flashes, and ache described as acheness, and the outcome of around 3:30 am, the patient experienced shaking, headache and nausea which was consistent till 3 am was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: RED RAISED ITCHY RASH ON STOMACH AND UPPER ABDOMEN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, 1 total, administered on 07-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 07-MAR-2021, the subject experienced red raised itchy rash on stomach and upper abdomen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from red raised itchy rash on stomach and upper abdomen. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: FEVER; HEADACHE; CHILLS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included surgery on her finger recently, and developed an infection after the surgery, and concurrent conditions included cholesterol, thyroid, no alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient was previously treated with cefalexin for developed an infection after the surgery. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020 expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced fever. On 08-MAR-2021, the subject experienced headache. Laboratory data included: Fever (NR: not provided) 101.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 08-MAR-2021, and had not recovered from fever, and headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: ACHY ALL OVER; ARM REALLY SORE; HEADACHE; TIRED; NAUSEOUS; MILD LOW GRADE 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: Unk) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-MAR-2021, the subject experienced achy all over. On 05-MAR-2021, the subject experienced arm really sore. On 05-MAR-2021, the subject experienced headache. On 05-MAR-2021, the subject experienced tired. On 05-MAR-2021, the subject experienced nauseous. On 05-MAR-2021, the subject experienced mild low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild low grade fever on 08-MAR-2021, and had not recovered from headache, tired, arm really sore, achy all over, and nauseous. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: ACHY ALL OVER; ARM REALLY SORE; HEADACHE; TIRED; NAUSEOUS; MILD LOW GRADE 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: Unk) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-MAR-2021, the subject experienced achy all over. On 05-MAR-2021, the subject experienced arm really sore. On 05-MAR-2021, the subject experienced headache. On 05-MAR-2021, the subject experienced tired. On 05-MAR-2021, the subject experienced nauseous. On 05-MAR-2021, the subject experienced mild low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild low grade fever on 08-MAR-2021, and had not recovered from headache, tired, arm really sore, achy all over, and nauseous. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: NAUSEA; FEVER; PAIN; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 10:00 to Right Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-MAR-2021, the subject experienced nausea. On 07-MAR-2021, the subject experienced fever. On 07-MAR-2021, the subject experienced pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, fever, and pain. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hangover, Headache, Hyperhidrosis, Insomnia
Clinical narrative: WOKE UP IN THE MIDDLE OF THE NIGHT WITH SEVERE SWEATING; COULDN'T SLEEP; FEELS HUNGOVER THIS MORNING; PRETTY SIGNIFICANT CHILLS; PRETTY SIGNIFICANT FEVER; BAD HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, once a total administered on 07-MAR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced woke up in the middle of the night with severe sweating. On 08-MAR-2021, the subject experienced couldn't sleep. On 08-MAR-2021, the subject experienced feels hungover this morning. On 08-MAR-2021, the subject experienced pretty significant chills. On 08-MAR-2021, the subject experienced pretty significant fever. On 08-MAR-2021, the subject experienced bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from woke up in the middle of the night with severe sweating, pretty significant chills, and pretty significant fever on 08-MAR-2021, had not recovered from bad headache, and feels hungover this morning, and the outcome of couldn't sleep was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: WOKE UP IN THE MIDDLE OF THE NIGHT WITH SEVERE SWEATING; COULDN'T SLEEP; FEELS HUNGOVER THIS MORNING; PRETTY SIGNIFICANT CHILLS; PRETTY SIGNIFICANT FEVER; BAD HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, once a total administered on 07-MAR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced woke up in the middle of the night with severe sweating. On 08-MAR-2021, the subject experienced couldn't sleep. On 08-MAR-2021, the subject experienced feels hungover this morning. On 08-MAR-2021, the subject experienced pretty significant chills. On 08-MAR-2021, the subject experienced pretty significant fever. On 08-MAR-2021, the subject experienced bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from woke up in the middle of the night with severe sweating, pretty significant chills, and pretty significant fever on 08-MAR-2021, had not recovered from bad headache, and feels hungover this morning, and the outcome of couldn't sleep was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Flushing, Headache, Lethargy, Pain in jaw
Clinical narrative: FLUSHNESS; FACIAL REDNESS; JAW SORENESS; LETHARGIC; SEVERE  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 experienced rash when treated with clopidogrel bisulfate, and swelling reaction when treated with benzylpenicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced flushness. On 07-MAR-2021, the subject experienced facial redness. On 07-MAR-2021, the subject experienced jaw soreness. On 07-MAR-2021, the subject experienced lethargic. On 07-MAR-2021, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from severe headache, flushness, facial redness, jaw soreness, and lethargic. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: SEVERE HEADACHE; This spontaneous report received from a female patient of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity
Clinical narrative: BODY ACHES IN LEGS; CHILLS; HEADACHE; 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 patient was not pregnant at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 01:30 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021 08:00, the subject experienced body aches in legs. On 06-MAR-2021 08:00, the subject experienced chills. On 06-MAR-2021 08:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches in legs, and chills on 07-MAR-2021, and had not recovered from headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Injection site pain
Clinical narrative: Pain at injection site lasted 24 hrs; MAJOR INSOMNIA NIGHT AFTER VACCINE COULD NOT FALL ASLEEP; Mild headache; Chills; Lack of appetite; Fatigue; This spontaneous report received from a physician concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) .5 ml, start therapy date was not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced pain at injection site lasted 24 hrs, major insomnia night after vaccine could not fall asleep, mild headache, chills, lack of appetite, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain at injection site lasted 24 hrs, major insomnia night after vaccine could not fall asleep, mild headache, chills, lack of appetite and fatigue was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Pain at injection site lasted 24 hrs; MAJOR INSOMNIA NIGHT AFTER VACCINE COULD NOT FALL ASLEEP; Mild headache; Chills; Lack of appetite; Fatigue; This spontaneous report received from a physician concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) .5 ml, start therapy date was not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced pain at injection site lasted 24 hrs, major insomnia night after vaccine could not fall asleep, mild headache, chills, lack of appetite, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain at injection site lasted 24 hrs, major insomnia night after vaccine could not fall asleep, mild headache, chills, lack of appetite and fatigue was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Pain, Pyrexia
Clinical narrative: FEVER; BODY ACHES; FLU LIKE SYMPTOMS; CHILLS; This spontaneous report received from a consumer concerned a patient of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced body aches. On 06-MAR-2021, the subject experienced flu like symptoms. On 06-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, body aches, flu like symptoms and chills was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Heart rate increased, Nausea, Pollakiuria
Clinical narrative: CHILLS; NAUSEA; VOMITING; EXCESSIVE URINATION; INCREASED HEART RATE; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-MAR-2021 16:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-MAR-2021, the subject experienced chills. On 07-MAR-2021, the subject experienced nausea. On 07-MAR-2021, the subject experienced vomiting. On 07-MAR-2021, the subject experienced excessive urination. On 07-MAR-2021, the subject experienced increased heart rate. On 07-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 07-MAR-2021, and nausea, vomiting, and excessive urination on 08-MAR-2021, and had not recovered from increased heart rate, and fatigue. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: CHILLS; NAUSEA; VOMITING; EXCESSIVE URINATION; INCREASED HEART RATE; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-MAR-2021 16:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-MAR-2021, the subject experienced chills. On 07-MAR-2021, the subject experienced nausea. On 07-MAR-2021, the subject experienced vomiting. On 07-MAR-2021, the subject experienced excessive urination. On 07-MAR-2021, the subject experienced increased heart rate. On 07-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 07-MAR-2021, and nausea, vomiting, and excessive urination on 08-MAR-2021, and had not recovered from increased heart rate, and fatigue. This report was non-serious.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: BODY ACHE; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 22 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, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 to Right Deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the subject experienced body ache. On 06-MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, and body ache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: HEADACHE; CHILLS; FEVER 100; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and expiry: not reported) dose was not reported, administered on 07-MAR-2021 04:00 to Right Deltoid for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced headache, chills, and fever 100. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100 (not reported). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, chills and fever 100 was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: SEVERE BODY ACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 to Right Arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced severe body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe body aches was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: HEADACHE; FEVER; CHILLS; ACHES; FATIGUE; 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, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced aches. On 06-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, fever, chills, aches and fatigue was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: CHILLS; HEADACHE; BODY ACHE; 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, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 03:00 to Left Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced headache. On 08-MAR-2021, the subject experienced body ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, headache and body ache was not reported. This report was non-serious.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: STING; This spontaneous report received from a patient concerned a 67 year old male. The patient's weight was 200 pounds, and height was 74 inches. The patient's concurrent conditions included type 2 diabetic, allergy to cats, no alcohol consumption, and no smoking, and other pre-existing medical conditions included patient had no drug abuse or illicit allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, once a total administered on 06-MAR-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the subject experienced sting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sting on 06-MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Nausea
Clinical narrative: NAUSEA; HEADACHE; FEVER; BODY SHAKING; CHILLS; FATIGUE; 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: 1802068, and batch number: 1802068 expiry: 25-MAY-2021) .5 ml, administered on 06-MAR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021 15:00, the subject experienced fatigue. On 06-MAR-2021 19:00, the subject experienced body shaking. On 06-MAR-2021 19:00, the subject experienced chills. On 07-MAR-2021, treatment medications included: butalbital/caffeine/paracetamol, ibuprofen, and ondansetron. On 07-MAR-2021 03:00, the subject experienced nausea. On 07-MAR-2021 03:00, the subject experienced headache. On 07-MAR-2021 03:00, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.7. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body shaking, chills, fatigue, nausea, and headache on 07-MAR-2021, and the outcome of fever was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000172187. The suspected product quality complaint has been confirmed to be no pqc was identified within the reported complaint case. based on the PQC evaluation/investigation performed.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: NAUSEA; HEADACHE; FEVER; BODY SHAKING; CHILLS; FATIGUE; 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: 1802068, and batch number: 1802068 expiry: 25-MAY-2021) .5 ml, administered on 06-MAR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021 15:00, the subject experienced fatigue. On 06-MAR-2021 19:00, the subject experienced body shaking. On 06-MAR-2021 19:00, the subject experienced chills. On 07-MAR-2021, treatment medications included: butalbital/caffeine/paracetamol, ibuprofen, and ondansetron. On 07-MAR-2021 03:00, the subject experienced nausea. On 07-MAR-2021 03:00, the subject experienced headache. On 07-MAR-2021 03:00, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.7. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body shaking, chills, fatigue, nausea, and headache on 07-MAR-2021, and the outcome of fever was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000172187. The suspected product quality complaint has been confirmed to be no pqc was identified within the reported complaint case. based on the PQC evaluation/investigation performed.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Somnolence
Clinical narrative: PLEASANT MILD DROWSINESS; TINY PAIN AT SITE OF INJECTION; This spontaneous report received from a patient concerned a 69 year old white,non Hispanic or latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol user, and non smoker, and other pre-existing medical conditions included no known drug allergies reported no drug abuse or illicit drug usage reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and expiry: not reported) dose was not reported, administered on 08-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the patient experienced pleasant mild drowsiness and tiny pain at site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pleasant mild drowsiness, and tiny pain at site of injection. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Hypoaesthesia oral, Lip pruritus, Nasal pruritus
Clinical narrative: ITCHY EYES; ITCHY NOSE; ITCHY LIPS; SLIGHT NUMB FEELING IN LIPS; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to penicillin, allergy to sulpha drugs, and sensitive to blood pressure medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 16:30 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, treatment medications included: diphenhydramine hydrochloride. On 08-MAR-2021 16:55, the subject experienced itchy eyes. On 08-MAR-2021 16:55, the subject experienced itchy nose. On 08-MAR-2021 16:55, the subject experienced itchy lips. On 08-MAR-2021 16:55, the subject experienced slight numb feeling in lips. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the itchy eyes, itchy nose, itchy lips and slight numb feeling in lips was not reported. This report was non-serious.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chapped lips, Chills, Dizziness, Fatigue, Feeling hot
Clinical narrative: SEVERE CHILLS; BEING INCREDIBLY HOT; GENERAL LIGHT HEADEDNESS; THIRSTY ALL NIGHT; URINATED (PEED) A LOT AT NIGHT; PAINFULLY CHAPPED LIPS; TIREDNESS; HORRIFIC HEADACHE; MAYBE SLEPT FOR 4 HOURS; This spontaneous report received from a patient concerned a 33 year old male. The patient's height, and weight were not reported. The patient's concurrent condition included obesity.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular) .5 ml, administered on 07-MAR-2021, around 11:30 am for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the patient experienced maybe slept for 4 hours. On 07-MAR-2021, the patient experienced severe chills. On 07-MAR-2021, the subject experienced being incredibly hot. On 07-MAR-2021, the subject experienced general light headedness. On 07-MAR-2021, the subject experienced thirsty all night. On 07-MAR-2021, the subject experienced urinated (reported as 'peed') a lot at night. On 07-MAR-2021, the subject experienced painfully chapped lips. On 07-MAR-2021, the subject experienced tiredness. On 07-MAR-2021, the subject experienced horrific headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tiredness, severe chills, horrific headache, general light headedness, and being incredibly hot, and the outcome of thirsty all night, painfully chapped lips, urinated (peed) a lot at night and maybe slept for 4 hours was not reported. This report was non-serious.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Insomnia, Pollakiuria, Thirst
Clinical narrative: SEVERE CHILLS; BEING INCREDIBLY HOT; GENERAL LIGHT HEADEDNESS; THIRSTY ALL NIGHT; URINATED (PEED) A LOT AT NIGHT; PAINFULLY CHAPPED LIPS; TIREDNESS; HORRIFIC HEADACHE; MAYBE SLEPT FOR 4 HOURS; This spontaneous report received from a patient concerned a 33 year old male. The patient's height, and weight were not reported. The patient's concurrent condition included obesity.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular) .5 ml, administered on 07-MAR-2021, around 11:30 am for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the patient experienced maybe slept for 4 hours. On 07-MAR-2021, the patient experienced severe chills. On 07-MAR-2021, the subject experienced being incredibly hot. On 07-MAR-2021, the subject experienced general light headedness. On 07-MAR-2021, the subject experienced thirsty all night. On 07-MAR-2021, the subject experienced urinated (reported as 'peed') a lot at night. On 07-MAR-2021, the subject experienced painfully chapped lips. On 07-MAR-2021, the subject experienced tiredness. On 07-MAR-2021, the subject experienced horrific headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tiredness, severe chills, horrific headache, general light headedness, and being incredibly hot, and the outcome of thirsty all night, painfully chapped lips, urinated (peed) a lot at night and maybe slept for 4 hours was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: BAD 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, intramuscular, batch number: 18020772, and batch number: 18020772 expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 11:00 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021 19:00, the subject experienced bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: MUSCLE ACHE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 06-MAR-2021 to Left Arm for prophylactic vaccination. Batch number was not reported has been requested. No concomitant medications were reported. On 07-MAR-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle ache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: FEVER; MUSCLE ACHES; 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, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 to Left Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and the outcome of muscle aches was not reported. This report was non-serious.