chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain
Clinical narrative: HEADACHE; SORENESS AT SITE OF INJECTION; FATIGUE; This spontaneous report received from a patient concerned a 77 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: 043A21A, expiry: 21-JUN-2021) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced soreness at site of injection. On APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, soreness at site of injection and fatigue was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Heart rate increased, Influenza, Pain, Pyrexia
Clinical narrative: FAST HEART RATE; FLU; FEVER; BODYACHES; SLIGHT HEADACHE; This spontaneous report received from a parent concerned a 35 year old female. The patient's weight, height, and medical history were not reported. The patient was previously treated with influenza vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201AZ1A, expiry: not reported) dose was not reported, administered on 08-APR-2021 08:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced slight headache. Treatment medications included: paracetamol. On 08-APR-2021, the subject experienced bodyaches. On 08-APR-2021, the subject experienced flu. On 08-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced fast heart rate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bodyaches, and fever on APR-2021, and fast heart rate on 09-APR-2021, had not recovered from slight headache, and the outcome of flu was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Epicondylitis, Headache, Heart rate, Heart rate increased
Clinical narrative: FAST HEART RATE; FLU; FEVER; BODYACHES; SLIGHT HEADACHE; This spontaneous report received from a parent concerned a 35 year old female. The patient's weight, height, and medical history were not reported. The patient was previously treated with influenza vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201AZ1A, expiry: not reported) dose was not reported, administered on 08-APR-2021 08:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced slight headache. Treatment medications included: paracetamol. On 08-APR-2021, the subject experienced bodyaches. On 08-APR-2021, the subject experienced flu. On 08-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced fast heart rate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bodyaches, and fever on APR-2021, and fast heart rate on 09-APR-2021, had not recovered from slight headache, and the outcome of flu was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: FAST HEART RATE; FLU; FEVER; BODYACHES; SLIGHT HEADACHE; This spontaneous report received from a parent concerned a 35 year old female. The patient's weight, height, and medical history were not reported. The patient was previously treated with influenza vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201AZ1A, expiry: not reported) dose was not reported, administered on 08-APR-2021 08:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced slight headache. Treatment medications included: paracetamol. On 08-APR-2021, the subject experienced bodyaches. On 08-APR-2021, the subject experienced flu. On 08-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced fast heart rate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bodyaches, and fever on APR-2021, and fast heart rate on 09-APR-2021, had not recovered from slight headache, and the outcome of flu was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Asthenia, Chills, Fatigue, Nausea
Clinical narrative: LOSS OF SENSE OF TASTE; CHILLS; EXTREME FATIGUE; LOTS OF NAUSEA; NO ENERGY TO DO ANYTHING; This spontaneous report received from a patient concerned a 62 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 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced no energy to do anything. On 05-APR-2021, the subject experienced loss of sense of taste. On 05-APR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced extreme fatigue. On 05-APR-2021, the subject experienced lots of nausea. Treatment medications (dates unspecified) included: aluminium hydroxide gel, dried/magnesium hydroxide/simeticone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme fatigue, lots of nausea, loss of sense of taste, and chills, and the outcome of no energy to do anything was not reported. This report was non-serious.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Burning sensation, Headache, Insomnia, Pain
Clinical narrative: BURNING ALL OVER THE BODY; FEVER; HEADACHE; NOT BEEN ABLE TO SLEEP; BODY ACHE; This spontaneous report received from a patient. The patient's height, and weight were not reported. The patient's concurrent conditions included high cholesterol, high blood pressure, and sulfonamide allergy, and other pre-existing medical conditions included patient had not pregnant at the time of reporting. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced not been able to sleep. On 09-APR-2021, the subject experienced body ache. Laboratory data included: Body temperature (NR: not provided) just below 100 F. On 09-APR-2021 12:30, the subject experienced burning all over the body. On 09-APR-2021 12:30, the subject experienced fever. On 09-APR-2021 12:30, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from burning all over the body, and the outcome of fever, headache, not been able to sleep and body ache was not reported. This report was non-serious.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: BURNING ALL OVER THE BODY; FEVER; HEADACHE; NOT BEEN ABLE TO SLEEP; BODY ACHE; This spontaneous report received from a patient. The patient's height, and weight were not reported. The patient's concurrent conditions included high cholesterol, high blood pressure, and sulfonamide allergy, and other pre-existing medical conditions included patient had not pregnant at the time of reporting. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced not been able to sleep. On 09-APR-2021, the subject experienced body ache. Laboratory data included: Body temperature (NR: not provided) just below 100 F. On 09-APR-2021 12:30, the subject experienced burning all over the body. On 09-APR-2021 12:30, the subject experienced fever. On 09-APR-2021 12:30, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from burning all over the body, and the outcome of fever, headache, not been able to sleep and body ache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: CHILLS; FEVER; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced chills, fever, headache, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, headache and nausea was not reported. This report was non-serious.
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fall, Gait inability, Hyperhidrosis
Clinical narrative: COULDN'T WALK; FELL DOWN; LEGS, THIGH, CALF AND FOOT PAIN AND MUSCLE CRAMPS; SWEATING; BODY ACHES; COULDN'T PUT FOOT FLAT ON FLOOR; CHILLS; LEGS, THIGH MUSCLE CALF AND FOOT WEAKNESS/FEET STILL FEEL WEAK; ARM PAIN AT THE INJECTION SITE; FEVER OF 101; This spontaneous report received from a patient concerned a 51 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: 042A214 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 12:30 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced couldn't walk. On 09-APR-2021, the subject experienced fell down. On 09-APR-2021, the subject experienced legs, thigh, calf and foot pain and muscle cramps. On 09-APR-2021, the subject experienced sweating. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced couldn't put foot flat on floor. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced legs, thigh muscle calf and foot weakness/feet still feel weak. On 09-APR-2021, the subject experienced arm pain at the injection site. On 09-APR-2021, the subject experienced fever of 101. Laboratory data included: Body temperature (NR: not provided) 101. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, couldn't put foot flat on floor, chills, and fever of 101 on APR-2021, was recovering from legs, thigh, calf and foot pain and muscle cramps, and couldn't walk, had not recovered from arm pain at the injection site, body aches, and legs, thigh muscle calf and foot weakness/feet still feel weak, and the outcome of fell down was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard operating procedure as the case is assessed as non-serious
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain, Limb discomfort, Muscle spasms, Muscular weakness, Pain
Clinical narrative: COULDN'T WALK; FELL DOWN; LEGS, THIGH, CALF AND FOOT PAIN AND MUSCLE CRAMPS; SWEATING; BODY ACHES; COULDN'T PUT FOOT FLAT ON FLOOR; CHILLS; LEGS, THIGH MUSCLE CALF AND FOOT WEAKNESS/FEET STILL FEEL WEAK; ARM PAIN AT THE INJECTION SITE; FEVER OF 101; This spontaneous report received from a patient concerned a 51 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: 042A214 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 12:30 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced couldn't walk. On 09-APR-2021, the subject experienced fell down. On 09-APR-2021, the subject experienced legs, thigh, calf and foot pain and muscle cramps. On 09-APR-2021, the subject experienced sweating. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced couldn't put foot flat on floor. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced legs, thigh muscle calf and foot weakness/feet still feel weak. On 09-APR-2021, the subject experienced arm pain at the injection site. On 09-APR-2021, the subject experienced fever of 101. Laboratory data included: Body temperature (NR: not provided) 101. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, couldn't put foot flat on floor, chills, and fever of 101 on APR-2021, was recovering from legs, thigh, calf and foot pain and muscle cramps, and couldn't walk, had not recovered from arm pain at the injection site, body aches, and legs, thigh muscle calf and foot weakness/feet still feel weak, and the outcome of fell down was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard operating procedure as the case is assessed as non-serious
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: COULDN'T WALK; FELL DOWN; LEGS, THIGH, CALF AND FOOT PAIN AND MUSCLE CRAMPS; SWEATING; BODY ACHES; COULDN'T PUT FOOT FLAT ON FLOOR; CHILLS; LEGS, THIGH MUSCLE CALF AND FOOT WEAKNESS/FEET STILL FEEL WEAK; ARM PAIN AT THE INJECTION SITE; FEVER OF 101; This spontaneous report received from a patient concerned a 51 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: 042A214 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 12:30 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced couldn't walk. On 09-APR-2021, the subject experienced fell down. On 09-APR-2021, the subject experienced legs, thigh, calf and foot pain and muscle cramps. On 09-APR-2021, the subject experienced sweating. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced couldn't put foot flat on floor. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced legs, thigh muscle calf and foot weakness/feet still feel weak. On 09-APR-2021, the subject experienced arm pain at the injection site. On 09-APR-2021, the subject experienced fever of 101. Laboratory data included: Body temperature (NR: not provided) 101. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, couldn't put foot flat on floor, chills, and fever of 101 on APR-2021, was recovering from legs, thigh, calf and foot pain and muscle cramps, and couldn't walk, had not recovered from arm pain at the injection site, body aches, and legs, thigh muscle calf and foot weakness/feet still feel weak, and the outcome of fell down was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard operating procedure as the case is assessed as non-serious
Sex: U
Vaccine: COVID19
Symptoms: Headache, Illness, Nausea, Pyrexia
Clinical narrative: MODERATELY SICK; LOW GRADE FEVER; NAUSEA; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 09-APR-2021, the subject experienced moderately sick. On 09-APR-2021, the subject experienced low grade fever. On 09-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the moderately sick, low grade fever, nausea and headache was not reported. This report was non-serious.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Paraesthesia, Rash pruritic, Restlessness
Clinical narrative: FATIGUE; RESTLESSNESS; TINGLING IN HANDS AND FINGERS; ITCHY RASH ON BOTH ARMS; This spontaneous report received from a patient concerned an 88 year old female. The patient's height, and weight were not reported. The patient's past medical history included heart surgery, and concurrent conditions included hypertension, and other pre-existing medical conditions included statins allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180898, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced restlessness. On 09-APR-2021, the subject experienced tingling in hands and fingers. On 09-APR-2021, the subject experienced itchy rash on both arms. On 10-APR-2021, the subject experienced fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from restlessness, tingling in hands and fingers, and itchy rash on both arms on 10-APR-2021, and had not recovered from fatigue. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: 20 VIALS WAS MAINTAINED ON 18 DEGREES FAHRENHEIT; This spontaneous report received from a pharmacist 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 09-APR-2021 for prophylactic vaccination. Batch number was not reported. The company is unable to perform follow up for batch/lot number. No concomitant medications were reported.  On an unspecified date, the subject experienced 20 vials was maintained on 18 degrees fahrenheit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 20 vials was maintained on 18 degrees fahrenheit was not reported. This report was non-serious.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: VOMITING; ACHINESS; CHILLS; FEVER; HEADACHE/SEVERE PAIN IN TEMPLES; This spontaneous report received from a consumer concerned a 23 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: 40Z1AZ1A, and batch number: 40Z1AZ1A expiry: not reported) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced vomiting. On 06-APR-2021, the subject experienced achiness. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced fever. On 06-APR-2021, the subject experienced headache/severe pain in temples. Laboratory data included: Body temperature (NR: not provided) no fever. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, achiness, chills, fever, and headache/severe pain in temples on 06-APR-2021 13:00. This report was non-serious.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: VOMITING; ACHINESS; CHILLS; FEVER; HEADACHE/SEVERE PAIN IN TEMPLES; This spontaneous report received from a consumer concerned a 23 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: 40Z1AZ1A, and batch number: 40Z1AZ1A expiry: not reported) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced vomiting. On 06-APR-2021, the subject experienced achiness. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced fever. On 06-APR-2021, the subject experienced headache/severe pain in temples. Laboratory data included: Body temperature (NR: not provided) no fever. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, achiness, chills, fever, and headache/severe pain in temples on 06-APR-2021 13:00. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Hyperhidrosis
Clinical narrative: BODY ACHES; SWEATS; DIZZINESS; NECK PAIN; WRIST PAIN; ANKLE PAIN; FEVER; FATIGUE; HEADACHE; 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 concurrent conditions included type 1 diabetes.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 17:00 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021 02:00, the subject experienced body aches. On 08-APR-2021 02:00, the subject experienced sweats. On 08-APR-2021 02:00, the subject experienced dizziness. On 08-APR-2021 02:00, the subject experienced neck pain. On 08-APR-2021 02:00, the subject experienced wrist pain. On 08-APR-2021 02:00, the subject experienced ankle pain. On 08-APR-2021 02:00, the subject experienced fever. On 08-APR-2021 02:00, the subject experienced fatigue. On 08-APR-2021 02:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neck pain on APR-2021, and had not recovered from fever, body aches, sweats, dizziness, wrist pain, ankle pain, fatigue, and headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Neck pain, Pain, Pyrexia
Clinical narrative: BODY ACHES; SWEATS; DIZZINESS; NECK PAIN; WRIST PAIN; ANKLE PAIN; FEVER; FATIGUE; HEADACHE; 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 concurrent conditions included type 1 diabetes.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 17:00 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021 02:00, the subject experienced body aches. On 08-APR-2021 02:00, the subject experienced sweats. On 08-APR-2021 02:00, the subject experienced dizziness. On 08-APR-2021 02:00, the subject experienced neck pain. On 08-APR-2021 02:00, the subject experienced wrist pain. On 08-APR-2021 02:00, the subject experienced ankle pain. On 08-APR-2021 02:00, the subject experienced fever. On 08-APR-2021 02:00, the subject experienced fatigue. On 08-APR-2021 02:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neck pain on APR-2021, and had not recovered from fever, body aches, sweats, dizziness, wrist pain, ankle pain, fatigue, and headache. This report was non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: WARM TO TOUCH AT INJECTION SITE; LUMP AT THE INJECTION SITE; RED RAISED RASH AROUND THE INJECTION SITE THAT WAS VERY ITCHY; PAIN AT INJECTION SITE/TENDERNESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included obese, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced pain at injection site/tenderness at injection site. On 04-APR-2021, the subject experienced red raised rash around the injection site that was very itchy. On 05-APR-2021, the subject experienced warm to touch at injection site. On 05-APR-2021, the subject experienced lump at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from red raised rash around the injection site that was very itchy, and had not recovered from lump at the injection site, warm to touch at injection site, and pain at injection site/tenderness at injection site. This report was non-serious.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Inflammation, Injection site swelling, Joint swelling, Peripheral swelling
Clinical narrative: SWELLING FOREARM; RED AND BLUE ARM; SWELLING ELBOW; ITCHY ARM; INFLAMMATION IN ARM; BRUISED ARM; ARM SWELLING UP AROUND RIGHT SHOULDER WHERE GOT THE SHOT; This spontaneous report received from a consumer concerned a 71 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 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced swelling forearm. On APR-2021, the subject experienced red and blue arm. On APR-2021, the subject experienced swelling elbow. On APR-2021, the subject experienced itchy arm. On APR-2021, the subject experienced inflammation in arm. On APR-2021, the subject experienced bruised arm. On APR-2021, the subject experienced arm swelling up around right shoulder where got the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swelling forearm, red and blue arm, swelling elbow, itchy arm, inflammation in arm, bruised arm and arm swelling up around right shoulder where got the shot was not reported. This report was non-serious.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Skin discolouration
Clinical narrative: SWELLING FOREARM; RED AND BLUE ARM; SWELLING ELBOW; ITCHY ARM; INFLAMMATION IN ARM; BRUISED ARM; ARM SWELLING UP AROUND RIGHT SHOULDER WHERE GOT THE SHOT; This spontaneous report received from a consumer concerned a 71 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 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced swelling forearm. On APR-2021, the subject experienced red and blue arm. On APR-2021, the subject experienced swelling elbow. On APR-2021, the subject experienced itchy arm. On APR-2021, the subject experienced inflammation in arm. On APR-2021, the subject experienced bruised arm. On APR-2021, the subject experienced arm swelling up around right shoulder where got the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swelling forearm, red and blue arm, swelling elbow, itchy arm, inflammation in arm, bruised arm and arm swelling up around right shoulder where got the shot was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: FULL 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, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced full body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of full body aches was not reported. This report was non-serious.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Insomnia, Pain, Pyrexia
Clinical narrative: BODY ACHE; DIZZINESS; FEVER; HEADACHE; DIFFICULTY SLEEPING; This spontaneous report received from a parent concerned a 19 year old male. The patient's height, and weight were not reported. The patient's past medical history included premature baby, and concurrent conditions included asthma, and very thin.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 13:45 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced difficulty sleeping. On 11-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced body ache. On 11-APR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, fever, and body ache, and the outcome of dizziness and difficulty sleeping was not reported. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Fatigue, Pain, Pyrexia
Clinical narrative: BODY ACHES; LOSS OF APPETITE; FEVER; FATIGUE; This spontaneous report received from a consumer concerned a 52 year old female. The patient's weight was 54.5 kilograms, and height was not reported. The patient's concurrent conditions included alcohol use, and non smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting and had no illicit usage of drugs. The patient experienced drug allergy when treated with diazepam.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 11:30 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced fatigue. On 06-APR-2021, the subject experienced body aches. On 06-APR-2021, the subject experienced loss of appetite. On 06-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, body aches, fever and loss of appetite was not reported. This report was non-serious.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Fatigue, Headache
Clinical narrative: BACK PAIN; PAIN IN BILATERAL ARM; PAIN AT RIGHT KNEE; CHILLS; HEADACHE; PAIN AT INJECTION SITE; FEVERISH FEELING; FATIGUE; This spontaneous report received from a parent concerned a 27 year old female. The patient's height, and weight were not reported. The patient's past medical history included premature at birth, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced back pain. On 09-APR-2021, the subject experienced pain in bilateral arm. On 09-APR-2021, the subject experienced pain at right knee. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced pain at injection site. On 09-APR-2021, the subject experienced feverish feeling. On 09-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain at right knee, chills, and feverish feeling on 10-APR-2021, was recovering from pain in bilateral arm, back pain, and fatigue, and had not recovered from headache, and pain at injection site. This report was non-serious.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: BACK PAIN; PAIN IN BILATERAL ARM; PAIN AT RIGHT KNEE; CHILLS; HEADACHE; PAIN AT INJECTION SITE; FEVERISH FEELING; FATIGUE; This spontaneous report received from a parent concerned a 27 year old female. The patient's height, and weight were not reported. The patient's past medical history included premature at birth, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced back pain. On 09-APR-2021, the subject experienced pain in bilateral arm. On 09-APR-2021, the subject experienced pain at right knee. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced pain at injection site. On 09-APR-2021, the subject experienced feverish feeling. On 09-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain at right knee, chills, and feverish feeling on 10-APR-2021, was recovering from pain in bilateral arm, back pain, and fatigue, and had not recovered from headache, and pain at injection site. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Acarodermatitis, Fatigue, Pruritus, Rash, Scratch
Clinical narrative: SCRATCHING; SCABIES IN ARM, SHOULDER AND LOWER BACK; ITCHINESS; RASH BELOW LEFT ARM; TIREDNESS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included kidney problems, liver problems, and vision problems. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced rash below left arm. On APR-2021, the subject experienced tiredness. On 03-APR-2021, the subject experienced scabies in arm, shoulder and lower back. On 03-APR-2021, the subject experienced itchiness. On 04-APR-2021, the subject experienced scratching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from scabies in arm, shoulder and lower back, and itchiness, and the outcome of rash below left arm, tiredness and scratching was not reported. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Dizziness, Dry throat, Eructation
Clinical narrative: FEELS SPACEY; DIZZINESS; PAIN FROM HEAD TO TOE; NAUSEA; DRY THROAT; EYEBALLS WERE HURTING; FEELING HOT; FELT LIKE RUN OVER BY A MACK TRUCK; CHILLS; HEADACHE; HOT SWEATS; STOMACH ACHE / BELLY MUSCLE ACHE; INCREASED GAS; BURPING; SWOLLEN THROAT; THROAT IRRITATION; This spontaneous report received from a patient concerned a 62 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: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced increased gas. On 07-APR-2021, the subject experienced burping. On 07-APR-2021, the subject experienced swollen throat. On 07-APR-2021, the subject experienced throat irritation. On 08-APR-2021, the subject experienced stomach ache / belly muscle ache. On 08-APR-2021, the subject experienced hot sweats. On 08-APR-2021, the subject experienced dry throat. On 08-APR-2021, the subject experienced eyeballs were hurting. On 08-APR-2021, the subject experienced feeling hot. On 08-APR-2021, the subject experienced felt like run over by a mack truck. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced headache. On 08-APR-2021 03:00, the subject experienced dizziness. On 08-APR-2021 03:00, the subject experienced pain from head to toe. On 08-APR-2021 03:00, the subject experienced nausea. On 09-APR-2021, the subject experienced feels spacey. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stomach ache / belly muscle ache, increased gas, burping, headache, swollen throat, dizziness, nausea, pain from head to toe, chills, hot sweats, feels spacey, throat irritation, dry throat, eyeballs were hurting, feeling hot, and felt like run over by a mack truck. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Feeling abnormal, Feeling hot, Flatulence, Headache
Clinical narrative: FEELS SPACEY; DIZZINESS; PAIN FROM HEAD TO TOE; NAUSEA; DRY THROAT; EYEBALLS WERE HURTING; FEELING HOT; FELT LIKE RUN OVER BY A MACK TRUCK; CHILLS; HEADACHE; HOT SWEATS; STOMACH ACHE / BELLY MUSCLE ACHE; INCREASED GAS; BURPING; SWOLLEN THROAT; THROAT IRRITATION; This spontaneous report received from a patient concerned a 62 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: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced increased gas. On 07-APR-2021, the subject experienced burping. On 07-APR-2021, the subject experienced swollen throat. On 07-APR-2021, the subject experienced throat irritation. On 08-APR-2021, the subject experienced stomach ache / belly muscle ache. On 08-APR-2021, the subject experienced hot sweats. On 08-APR-2021, the subject experienced dry throat. On 08-APR-2021, the subject experienced eyeballs were hurting. On 08-APR-2021, the subject experienced feeling hot. On 08-APR-2021, the subject experienced felt like run over by a mack truck. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced headache. On 08-APR-2021 03:00, the subject experienced dizziness. On 08-APR-2021 03:00, the subject experienced pain from head to toe. On 08-APR-2021 03:00, the subject experienced nausea. On 09-APR-2021, the subject experienced feels spacey. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stomach ache / belly muscle ache, increased gas, burping, headache, swollen throat, dizziness, nausea, pain from head to toe, chills, hot sweats, feels spacey, throat irritation, dry throat, eyeballs were hurting, feeling hot, and felt like run over by a mack truck. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea, Pain, Pharyngeal swelling, Throat irritation
Clinical narrative: FEELS SPACEY; DIZZINESS; PAIN FROM HEAD TO TOE; NAUSEA; DRY THROAT; EYEBALLS WERE HURTING; FEELING HOT; FELT LIKE RUN OVER BY A MACK TRUCK; CHILLS; HEADACHE; HOT SWEATS; STOMACH ACHE / BELLY MUSCLE ACHE; INCREASED GAS; BURPING; SWOLLEN THROAT; THROAT IRRITATION; This spontaneous report received from a patient concerned a 62 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: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced increased gas. On 07-APR-2021, the subject experienced burping. On 07-APR-2021, the subject experienced swollen throat. On 07-APR-2021, the subject experienced throat irritation. On 08-APR-2021, the subject experienced stomach ache / belly muscle ache. On 08-APR-2021, the subject experienced hot sweats. On 08-APR-2021, the subject experienced dry throat. On 08-APR-2021, the subject experienced eyeballs were hurting. On 08-APR-2021, the subject experienced feeling hot. On 08-APR-2021, the subject experienced felt like run over by a mack truck. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced headache. On 08-APR-2021 03:00, the subject experienced dizziness. On 08-APR-2021 03:00, the subject experienced pain from head to toe. On 08-APR-2021 03:00, the subject experienced nausea. On 09-APR-2021, the subject experienced feels spacey. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stomach ache / belly muscle ache, increased gas, burping, headache, swollen throat, dizziness, nausea, pain from head to toe, chills, hot sweats, feels spacey, throat irritation, dry throat, eyeballs were hurting, feeling hot, and felt like run over by a mack truck. This report was non-serious.
Age: 24.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, Rhinorrhoea
Clinical narrative: RUNNY NOSE; SHIVERING/CHILLS; FEVER; FATIGUE; This spontaneous report received from a patient concerned a 24 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: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced runny nose. On 08-APR-2021, the subject experienced shivering/chills. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, shivering/chills, runny nose and fatigue was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: NOSE BLEEDS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced nose bleeds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nose bleeds. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea
Clinical narrative: CHILLS; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, nausea and chills was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. The company is unable to perform follow up to request batch number . On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain, Insomnia
Clinical narrative: DIFFICULTY SLEEPING; INJECTION SITE 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, and batch number were not reported) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced difficulty sleeping. On 2021, the subject experienced injection site pain. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection site pain and difficulty sleeping was not reported. This report was non-serious.