chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: ACHY; SUPER TIRED; STUBBORN THROBBING HEADACHE; MILD FEVER; 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. No concomitant medications were reported. The batch number was not reported. The company is unable to perform follow up to obtain batch/lot numbers. On an unspecified date, the subject experienced achy, super tired, stubborn throbbing headache, and mild fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy, super tired, stubborn throbbing headache, and mild fever. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasal congestion
Clinical narrative: STUFFY NOSE; COUGH; 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: 041A21A, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 12:30 to upper left arm for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced cough. On 06-APR-2021, the subject experienced stuffy nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cough, and stuffy nose. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Hypoaesthesia oral, Pain, Pyrexia
Clinical narrative: BODY ACHES; JOINT PAIN; NUMBNESS LIPS; CHILLS; FEVER; This spontaneous report received from a patient concerned a 26 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-APR-2021 at left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021, the subject experienced body aches. On 01-APR-2021, the subject experienced joint pain. On 01-APR-2021, the subject experienced numbness lips. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from numbness lips, and had not recovered from fever, body aches, chills, and joint pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: REALLY BAD SIDE EFFECT NOS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) once a total dose was not reported, administered on 07-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 2021, the subject experienced really bad side effect nos. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of really bad side effect nos was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Injection site pain
Clinical narrative: DIZZINESS; SORE BODY; JOINT PAIN; FEVER; HEADACHE; SORE INJECTION SITE; FEELING TIRED; This spontaneous report received from a patient concerned a 33 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A  expiry: UNKNOWN) dose was not reported, administered on 04-APR-2021 to left arm for prophylactic vaccination.  No concomitant medications were reported.  On 04-APR-2021, the subject experienced sore injection site. On 04-APR-2021, the subject experienced feeling tired. On 05-APR-2021, the subject experienced dizziness. On 05-APR-2021, the subject experienced sore body. On 05-APR-2021, the subject experienced joint pain. On 05-APR-2021, the subject experienced fever. On 05-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 06-APR-2021, was recovering from sore injection site, headache, sore body, and joint pain, and had not recovered from feeling tired, and dizziness. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: DIZZINESS; SORE BODY; JOINT PAIN; FEVER; HEADACHE; SORE INJECTION SITE; FEELING TIRED; This spontaneous report received from a patient concerned a 33 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A  expiry: UNKNOWN) dose was not reported, administered on 04-APR-2021 to left arm for prophylactic vaccination.  No concomitant medications were reported.  On 04-APR-2021, the subject experienced sore injection site. On 04-APR-2021, the subject experienced feeling tired. On 05-APR-2021, the subject experienced dizziness. On 05-APR-2021, the subject experienced sore body. On 05-APR-2021, the subject experienced joint pain. On 05-APR-2021, the subject experienced fever. On 05-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 06-APR-2021, was recovering from sore injection site, headache, sore body, and joint pain, and had not recovered from feeling tired, and dizziness. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: DOSE GIVEN FROM VIAL POSSIBLY  OUT OF ACCEPTED TEMPERATURE  RANGE; 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) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-APR-2021, the subject experienced dose given from vial possibly out of accepted temperature range. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dose given from vial possibly out of accepted temperature range was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Abnormal dreams, Anxiety, Influenza
Clinical narrative: ANXIETY; FRUSTRATION DREAMS; INTENSE MINI-FLU; 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 unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch number. No concomitant medications were reported.  On APR-2021, the subject experienced intense mini-flu. On 04-APR-2021, the subject experienced anxiety. On 04-APR-2021, the subject experienced frustration dreams. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from anxiety, and frustration dreams, and the outcome of intense mini-flu was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Pain
Clinical narrative: DIZZINESS; ACHY FEELING; NAUSEA; 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 high blood pressure, non alcohol, and non smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting, had no known allergies and no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, and batch number: 043A21A expiry: 21-JUN-2021) dose was not reported, administered on 05-APR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced dizziness. On 06-APR-2021, the subject experienced achy feeling. On 06-APR-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, achy feeling, and nausea on 06-APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Influenza, Pyrexia
Clinical narrative: FELT LIKE WAS GETTING FLU; CHILLS; JOINT PAIN; LOW GRADE FEVER; FELT TIRED; This spontaneous report received from a patient concerned a 78 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: 1802068, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced felt like was getting flu. On 24-MAR-2021, the subject experienced chills. On 24-MAR-2021, the subject experienced joint pain. On 24-MAR-2021, the subject experienced low grade fever. On 24-MAR-2021, the subject experienced felt tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, joint pain, low grade fever, and felt tired on 25-MAR-2021, and the outcome of felt like was getting flu was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Panic attack
Clinical narrative: PANIC ATTACK; This spontaneous report received from a patient concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. 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 panic attack. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of panic attack was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Nausea
Clinical narrative: SORE THROAT; CHILLS; JOINT PAIN; NAUSEA; FEVER; HEADACHE; MUSCLE PAIN; 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced sore throat, chills, joint pain, nausea, fever, headache, and muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore throat, nausea, fever, headache, muscle pain, joint pain and chills was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: SORE THROAT; CHILLS; JOINT PAIN; NAUSEA; FEVER; HEADACHE; MUSCLE PAIN; 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced sore throat, chills, joint pain, nausea, fever, headache, and muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore throat, nausea, fever, headache, muscle pain, joint pain and chills was not reported. This report was non-serious.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Joint stiffness, Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: STIFF MUSCLE; STIFF JOINTS; SORE BODY; FEVER; This spontaneous report received from a patient concerned a 31 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A,expiry: UNKNOWN) dose was not reported, in left arm administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. On 04-APR-2021, the subject experienced fever. On 04-APR-2021, the subject experienced stiff muscle. On 04-APR-2021, the subject experienced stiff joints. On 04-APR-2021, the subject experienced sore body. Treatment medications (dates unspecified) included: naproxen sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, stiff muscle, and stiff joints on 05-APR-2021, and sore body on 06-APR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: EXTREMELY FATIGUED; ARM AT INJECTION SITE HURTING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced arm at injection site hurting. On an unspecified date, the subject experienced extremely fatigued. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm at injection site hurting and extremely fatigued was not reported. This report was non-serious.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Exposure during pregnancy, Fatigue
Clinical narrative: DIZZINESS; BODY ACHE; MUSCLE STIFFNESS; JOINT PAIN; CHILLS; HEADACHE; FEVER; VACCINE EXPOSURE DURING PREGNANCY; SORE INJECTION SITE; FATIGUE; This spontaneous pregnancy report received from a patient concerned a 30 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 04-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 04-APR-2021, the subject experienced sore injection site. On 04-APR-2021, the subject experienced fatigue. On 04-APR-2021, the subject experienced vaccine exposure during pregnancy. The date of the subject's last menstrual period and expected delivery date were not reported. On 05-APR-2021, the subject experienced body ache. On 05-APR-2021, the subject experienced muscle stiffness. On 05-APR-2021, the subject experienced joint pain. On 05-APR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced headache. On 05-APR-2021, the subject experienced fever. On 06-APR-2021, the subject experienced dizziness. Treatment medications (dates unspecified) included: paracetamol. The pregnancy was continuing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 06-APR-2021, was recovering from sore injection site, headache, body ache, joint pain, and muscle stiffness, had not recovered from fatigue, and dizziness, and the outcome of vaccine exposure during pregnancy and fever was not reported. This report was non-serious.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: DIZZINESS; BODY ACHE; MUSCLE STIFFNESS; JOINT PAIN; CHILLS; HEADACHE; FEVER; VACCINE EXPOSURE DURING PREGNANCY; SORE INJECTION SITE; FATIGUE; This spontaneous pregnancy report received from a patient concerned a 30 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 04-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 04-APR-2021, the subject experienced sore injection site. On 04-APR-2021, the subject experienced fatigue. On 04-APR-2021, the subject experienced vaccine exposure during pregnancy. The date of the subject's last menstrual period and expected delivery date were not reported. On 05-APR-2021, the subject experienced body ache. On 05-APR-2021, the subject experienced muscle stiffness. On 05-APR-2021, the subject experienced joint pain. On 05-APR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced headache. On 05-APR-2021, the subject experienced fever. On 06-APR-2021, the subject experienced dizziness. Treatment medications (dates unspecified) included: paracetamol. The pregnancy was continuing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 06-APR-2021, was recovering from sore injection site, headache, body ache, joint pain, and muscle stiffness, had not recovered from fatigue, and dizziness, and the outcome of vaccine exposure during pregnancy and fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Diarrhoea, Myalgia, SARS-CoV-2 test, Vomiting
Clinical narrative: DIARRHEA; VOMITING; SEVERE BACK PAIN; MUSCLE ACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 15:45 to left arm for prophylactic vaccination. No concomitant medications were reported. On NOV-2020, Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. On 05-APR-2021, the subject experienced diarrhea. On 05-APR-2021, the subject experienced vomiting. On 05-APR-2021, the subject experienced severe back pain. On 05-APR-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, and vomiting on 06-APR-2021 08:30, and had not recovered from severe back pain, and muscle ache. This report was non-serious.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Muscle tightness
Clinical narrative: MUSCLE TENSION; HEADACHE; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's past medical history included headache.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 expiry: 23-JUN-2021) dose was not reported, administered on 05-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 05-APR-2021, the subject experienced muscle tension. On 05-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and the outcome of muscle tension was not reported. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Cough, Drainage, Fatigue
Clinical narrative: ACHINESS; CONGESTION; SINUS PRESSURE; ELEVATED BLOOD PRESSURE; COUGH; DRAINAGE; FATIGUE; SWEATING; NOT FEELING WELL; CHILLS; SLIGHT HEADACHE; SLIGHT NAUSEA; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies.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 27-MAR-2021 16:30 on right arm for prophylactic vaccination. Non-company suspect drugs included: ibuprofen ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for achiness. No concomitant medications were reported. On 27-MAR-2021 17:30, the subject experienced sweating. On 27-MAR-2021 17:30, the subject experienced not feeling well. On 27-MAR-2021 17:30, the subject experienced chills. On 27-MAR-2021 17:30, the subject experienced slight headache. On 27-MAR-2021 17:30, the subject experienced slight nausea. On 27-MAR-2021 17:30, the subject experienced low grade fever. On 28-MAR-2021, the subject experienced fatigue. On 29-MAR-2021, the subject experienced congestion. On 29-MAR-2021, the subject experienced sinus pressure. On 29-MAR-2021, the subject experienced elevated blood pressure. On 29-MAR-2021, the subject experienced cough. On 29-MAR-2021, the subject experienced drainage. Laboratory data included: Blood pressure (NR: not provided) 146/89 mmHg. On an unspecified date, the subject experienced achiness. Treatment medications (dates unspecified) included: amoxicillin, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with ibuprofen was not reported. The patient recovered from sweating on 01-APR-2021, slight headache, and slight nausea on 28-MAR-2021, and low grade fever on 29-MAR-2021, was recovering from not feeling well, fatigue, congestion, sinus pressure, cough, and drainage, and the outcome of elevated blood pressure, chills and achiness was not reported. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Hypertension, Malaise, Nausea
Clinical narrative: ACHINESS; CONGESTION; SINUS PRESSURE; ELEVATED BLOOD PRESSURE; COUGH; DRAINAGE; FATIGUE; SWEATING; NOT FEELING WELL; CHILLS; SLIGHT HEADACHE; SLIGHT NAUSEA; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies.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 27-MAR-2021 16:30 on right arm for prophylactic vaccination. Non-company suspect drugs included: ibuprofen ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for achiness. No concomitant medications were reported. On 27-MAR-2021 17:30, the subject experienced sweating. On 27-MAR-2021 17:30, the subject experienced not feeling well. On 27-MAR-2021 17:30, the subject experienced chills. On 27-MAR-2021 17:30, the subject experienced slight headache. On 27-MAR-2021 17:30, the subject experienced slight nausea. On 27-MAR-2021 17:30, the subject experienced low grade fever. On 28-MAR-2021, the subject experienced fatigue. On 29-MAR-2021, the subject experienced congestion. On 29-MAR-2021, the subject experienced sinus pressure. On 29-MAR-2021, the subject experienced elevated blood pressure. On 29-MAR-2021, the subject experienced cough. On 29-MAR-2021, the subject experienced drainage. Laboratory data included: Blood pressure (NR: not provided) 146/89 mmHg. On an unspecified date, the subject experienced achiness. Treatment medications (dates unspecified) included: amoxicillin, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with ibuprofen was not reported. The patient recovered from sweating on 01-APR-2021, slight headache, and slight nausea on 28-MAR-2021, and low grade fever on 29-MAR-2021, was recovering from not feeling well, fatigue, congestion, sinus pressure, cough, and drainage, and the outcome of elevated blood pressure, chills and achiness was not reported. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paranasal sinus discomfort, Pyrexia, Sinus congestion
Clinical narrative: ACHINESS; CONGESTION; SINUS PRESSURE; ELEVATED BLOOD PRESSURE; COUGH; DRAINAGE; FATIGUE; SWEATING; NOT FEELING WELL; CHILLS; SLIGHT HEADACHE; SLIGHT NAUSEA; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies.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 27-MAR-2021 16:30 on right arm for prophylactic vaccination. Non-company suspect drugs included: ibuprofen ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for achiness. No concomitant medications were reported. On 27-MAR-2021 17:30, the subject experienced sweating. On 27-MAR-2021 17:30, the subject experienced not feeling well. On 27-MAR-2021 17:30, the subject experienced chills. On 27-MAR-2021 17:30, the subject experienced slight headache. On 27-MAR-2021 17:30, the subject experienced slight nausea. On 27-MAR-2021 17:30, the subject experienced low grade fever. On 28-MAR-2021, the subject experienced fatigue. On 29-MAR-2021, the subject experienced congestion. On 29-MAR-2021, the subject experienced sinus pressure. On 29-MAR-2021, the subject experienced elevated blood pressure. On 29-MAR-2021, the subject experienced cough. On 29-MAR-2021, the subject experienced drainage. Laboratory data included: Blood pressure (NR: not provided) 146/89 mmHg. On an unspecified date, the subject experienced achiness. Treatment medications (dates unspecified) included: amoxicillin, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with ibuprofen was not reported. The patient recovered from sweating on 01-APR-2021, slight headache, and slight nausea on 28-MAR-2021, and low grade fever on 29-MAR-2021, was recovering from not feeling well, fatigue, congestion, sinus pressure, cough, and drainage, and the outcome of elevated blood pressure, chills and achiness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: LEG PAIN; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, 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 leg pain, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from leg pain, and fever. This report was non-serious.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Tinnitus
Clinical narrative: FELT WORSE WITH BLOCKING OF BOTH EARS AND SOME PRESSURE IN BOTH EARS; FELT WORSE WITH RINGING IN BOTH EARS; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and nonsmoker, 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: 1805029 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 at around 11:00 on right arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced felt worse with blocking of both ears and some pressure in both ears. On 02-APR-2021, the subject experienced felt worse with ringing in both ears. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt worse with blocking of both ears and some pressure in both ears, and felt worse with ringing in both ears. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no changes to diet or medication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180522, and expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 on right arm for prophylactic vaccination.  No concomitant medications were reported.  On 02-APR-2021, the subject experienced soreness at injection site. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness at injection site. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Heart rate, Hypertension, Oxygen saturation
Clinical narrative: HYPERTENSIVE WITH BLOOD PRESSURE OF 153/90; HIVES IN THE UPPER EXTREMITY AND CHEST; HEADACHE; This spontaneous report received from a physician concerned a 51 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 05-APR-2021 18:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, Laboratory data included: Blood pressure (NR: not provided) 148/80 mmHg, Heart rate (NR: not provided) 62 BPM (beats per minute), and Pulse oximetry (NR: not provided) 99 (not reported). On 05-APR-2021, Laboratory data included: Blood pressure (NR: not provided) 153/90 mmHg. On 05-APR-2021 21:30, the subject experienced hypertensive with blood pressure of 153/90. On 05-APR-2021 21:30, the subject experienced hives in the upper extremity and chest. On 05-APR-2021 21:30, the subject experienced headache. Treatment medications (dates unspecified) included: famotidine, diphenhydramine hydrochloride, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hypertensive with blood pressure of 153/90, hives in the upper extremity and chest, and headache on 06-APR-2021. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per the standard operating procedure as the case is assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: HYPERTENSIVE WITH BLOOD PRESSURE OF 153/90; HIVES IN THE UPPER EXTREMITY AND CHEST; HEADACHE; This spontaneous report received from a physician concerned a 51 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 05-APR-2021 18:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, Laboratory data included: Blood pressure (NR: not provided) 148/80 mmHg, Heart rate (NR: not provided) 62 BPM (beats per minute), and Pulse oximetry (NR: not provided) 99 (not reported). On 05-APR-2021, Laboratory data included: Blood pressure (NR: not provided) 153/90 mmHg. On 05-APR-2021 21:30, the subject experienced hypertensive with blood pressure of 153/90. On 05-APR-2021 21:30, the subject experienced hives in the upper extremity and chest. On 05-APR-2021 21:30, the subject experienced headache. Treatment medications (dates unspecified) included: famotidine, diphenhydramine hydrochloride, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hypertensive with blood pressure of 153/90, hives in the upper extremity and chest, and headache on 06-APR-2021. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per the standard operating procedure as the case is assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: HEART RATE GETTING FASTER; This spontaneous report received from a parent concerned a female of unspecified age. The patient's height, and weight were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch number. No concomitant medications were reported.  On 05-APR-2021, the subject experienced heart rate getting faster. Laboratory data included: Heart rate (NR: not provided) getting faster. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart rate getting faster. This report was non-serious.
Age: 45.0
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Incorrect route of product administration, Injection site reaction
Clinical narrative: PART OF THE DOSE MAY HAVE BEEN  ADMINISTERED SUBCUTANEOUSLY; PART OF THE DOSE MAY HAVE BEEN  ADMINISTERED; HARDNESS AT INJECTION AREA; This spontaneous report received from a pharmacist concerned a 45 year old of unspecified 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: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 in left deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced hardness at injection area. On an unspecified date, the subject experienced part of the dose may have been administered subcutaneously, and part of the dose may have been administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hardness at injection area, part of the dose may have been administered subcutaneously and part of the dose may have been administered was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dehydration, Fatigue, Headache, Nausea
Clinical narrative: DEHYDRATED; ACHY FEELING; HEADACHE; NAUSEA; TIREDNESS, FATIGUE; CHILLS; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included naproxen allergy, non-smoker, and non alcoholic, and other pre-existing medical conditions included the patient had no drug abuse or drug illicit use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced chills. On 04-APR-2021, the subject experienced dehydrated. On 04-APR-2021, the subject experienced achy feeling. On 04-APR-2021, the subject experienced headache. On 04-APR-2021, the subject experienced nausea. On 04-APR-2021, the subject experienced tiredness, fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dehydrated, achy feeling, chills, headache, and nausea on 05-APR-2021, and was recovering from tiredness, fatigue. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: DEHYDRATED; ACHY FEELING; HEADACHE; NAUSEA; TIREDNESS, FATIGUE; CHILLS; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included naproxen allergy, non-smoker, and non alcoholic, and other pre-existing medical conditions included the patient had no drug abuse or drug illicit use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced chills. On 04-APR-2021, the subject experienced dehydrated. On 04-APR-2021, the subject experienced achy feeling. On 04-APR-2021, the subject experienced headache. On 04-APR-2021, the subject experienced nausea. On 04-APR-2021, the subject experienced tiredness, fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dehydrated, achy feeling, chills, headache, and nausea on 05-APR-2021, and was recovering from tiredness, fatigue. This report was non-serious.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pruritus, Nausea
Clinical narrative: This spontaneous report received from a patient concerned a 26 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included anemia, alcohol user, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies and drug abuse illicit allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, and batch number: 043A21A expiry: 21-JUN-2021) dose was not reported, administered on 05-APR-2021 09:30 on left arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced throwing up. On 05-APR-2021, the subject experienced swollen arm. On 05-APR-2021, the subject experienced itchy at the injection site. On 05-APR-2021, the subject experienced arm pain. On 05-APR-2021, the subject experienced nausea. On 05-APR-2021, the subject experienced fatigue/ tired. On 05-APR-2021, the subject experienced red at the injection site. On 05-APR-2021 15:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, nausea, fatigue/ tired, arm pain, swollen arm, red at the injection site, and throwing up, and the outcome of itchy at the injection site was not reported. This report was non-serious.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Vomiting
Clinical narrative: This spontaneous report received from a patient concerned a 26 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included anemia, alcohol user, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies and drug abuse illicit allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, and batch number: 043A21A expiry: 21-JUN-2021) dose was not reported, administered on 05-APR-2021 09:30 on left arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced throwing up. On 05-APR-2021, the subject experienced swollen arm. On 05-APR-2021, the subject experienced itchy at the injection site. On 05-APR-2021, the subject experienced arm pain. On 05-APR-2021, the subject experienced nausea. On 05-APR-2021, the subject experienced fatigue/ tired. On 05-APR-2021, the subject experienced red at the injection site. On 05-APR-2021 15:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, nausea, fatigue/ tired, arm pain, swollen arm, red at the injection site, and throwing up, and the outcome of itchy at the injection site was not reported. This report was non-serious.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Fatigue, Nightmare, Poor quality sleep
Clinical narrative: NIGHTMARES; TALKING IN HIS SLEEP; RESTLESSNESS AND THRASHING ABOUT/ ASLEEP, HE THRASHES AROUND LIKE FISH OUT OF WATER; NO ENERGY; FEVER; FATIGUE; This spontaneous report received from a consumer concerned a 53 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 15:00 to right arm for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced nightmares. On 03-APR-2021, the subject experienced fatigue. On 03-APR-2021, the subject experienced talking in his sleep. On 03-APR-2021, the subject experienced restlessness and thrashing about/ asleep, he thrashes around like fish out of water. On 03-APR-2021, the subject experienced no energy. Laboratory data included: Body temperature (NR: not provided) 102 F. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, nightmares, fatigue, talking in his sleep, restlessness and thrashing about/ asleep, he thrashes around like fish out of water, and no energy. This report was non-serious.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Sleep talking
Clinical narrative: NIGHTMARES; TALKING IN HIS SLEEP; RESTLESSNESS AND THRASHING ABOUT/ ASLEEP, HE THRASHES AROUND LIKE FISH OUT OF WATER; NO ENERGY; FEVER; FATIGUE; This spontaneous report received from a consumer concerned a 53 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 15:00 to right arm for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced nightmares. On 03-APR-2021, the subject experienced fatigue. On 03-APR-2021, the subject experienced talking in his sleep. On 03-APR-2021, the subject experienced restlessness and thrashing about/ asleep, he thrashes around like fish out of water. On 03-APR-2021, the subject experienced no energy. Laboratory data included: Body temperature (NR: not provided) 102 F. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, nightmares, fatigue, talking in his sleep, restlessness and thrashing about/ asleep, he thrashes around like fish out of water, and no energy. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; 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: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Chills
Clinical narrative: Bells palsy; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Bells palsy) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037k20A and 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included VITAMIN 15 for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced CHILLS (Chills). On 08-Feb-2021, the patient experienced FACIAL PARALYSIS (Bells palsy) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (Bells palsy) had not resolved and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not Applicable.  Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.   This case was linked. Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.