chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pain in extremity
Clinical narrative: BRUISE; CALF PAIN; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.   On 12-APR-2021, the subject experienced bruise. On 12-APR-2021, the subject experienced calf pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from calf pain, and bruise. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Sinus headache
Clinical narrative: MILD HEADACHE/FELT LIKE A SINUS HEADACHE; FELT TIREDNESS; NAUSEA ON AND OFF; This spontaneous report received from a patient concerned a 49 year old. 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: 1808978, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced mild headache/felt like a sinus headache. On 13-APR-2021, the subject experienced felt tiredness. On 13-APR-2021, the subject experienced on and off. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mild headache/felt like a sinus headache, felt tiredness, and nausea on and off. This report was non-serious.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Blood test, Chest discomfort, Chills
Clinical narrative: FELT LIKE SOMETHING ON CHEST; SKIN HOT; LITTLE BIT OF COUGH; FEELING HOT; CAN'T SLEEP AT NIGHT; DIZZY; BARELY COULD STAND; COULD BARELY WALK; PAINS IN BACK ESPECIALLY BACK UP NECK; CHILLS; VERY WEAK; FELT VERY HOT FEVERISH; NIGHT SWEATS; TIRED; This spontaneous report received from a patient concerned a 58 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: 1808609 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced tired. Laboratory data included: Blood test (NR: not provided) everything was ok. On 24-MAR-2021, the subject experienced night sweats. On 24-MAR-2021, the subject experienced chills. On 24-MAR-2021, the subject experienced very weak. On 24-MAR-2021, the subject experienced felt very hot feverish. On 25-MAR-2021, the subject experienced dizzy. On 25-MAR-2021, the subject experienced barely could stand. On 25-MAR-2021, the subject experienced could barely walk. On 25-MAR-2021, the subject experienced pains in back especially back up neck. Treatment medications included: naproxen. On APR-2021, the subject experienced little bit of cough. On APR-2021, the subject experienced feeling hot. On APR-2021, the subject experienced can't sleep at night. On APR-2021, the subject experienced felt like something on chest. On APR-2021, the subject experienced skin hot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired on 2021, was recovering from pains in back especially back up neck, and felt very hot feverish, had not recovered from chills, and the outcome of night sweats, little bit of cough, dizzy, barely could stand, could barely walk, very weak, feeling hot, can't sleep at night, skin hot and felt like something on chest was not reported. This report was non-serious.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dizziness, Dysstasia, Fatigue, Feeling hot
Clinical narrative: FELT LIKE SOMETHING ON CHEST; SKIN HOT; LITTLE BIT OF COUGH; FEELING HOT; CAN'T SLEEP AT NIGHT; DIZZY; BARELY COULD STAND; COULD BARELY WALK; PAINS IN BACK ESPECIALLY BACK UP NECK; CHILLS; VERY WEAK; FELT VERY HOT FEVERISH; NIGHT SWEATS; TIRED; This spontaneous report received from a patient concerned a 58 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: 1808609 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced tired. Laboratory data included: Blood test (NR: not provided) everything was ok. On 24-MAR-2021, the subject experienced night sweats. On 24-MAR-2021, the subject experienced chills. On 24-MAR-2021, the subject experienced very weak. On 24-MAR-2021, the subject experienced felt very hot feverish. On 25-MAR-2021, the subject experienced dizzy. On 25-MAR-2021, the subject experienced barely could stand. On 25-MAR-2021, the subject experienced could barely walk. On 25-MAR-2021, the subject experienced pains in back especially back up neck. Treatment medications included: naproxen. On APR-2021, the subject experienced little bit of cough. On APR-2021, the subject experienced feeling hot. On APR-2021, the subject experienced can't sleep at night. On APR-2021, the subject experienced felt like something on chest. On APR-2021, the subject experienced skin hot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired on 2021, was recovering from pains in back especially back up neck, and felt very hot feverish, had not recovered from chills, and the outcome of night sweats, little bit of cough, dizzy, barely could stand, could barely walk, very weak, feeling hot, can't sleep at night, skin hot and felt like something on chest was not reported. This report was non-serious.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Insomnia, Night sweats, Pyrexia, Skin warm
Clinical narrative: FELT LIKE SOMETHING ON CHEST; SKIN HOT; LITTLE BIT OF COUGH; FEELING HOT; CAN'T SLEEP AT NIGHT; DIZZY; BARELY COULD STAND; COULD BARELY WALK; PAINS IN BACK ESPECIALLY BACK UP NECK; CHILLS; VERY WEAK; FELT VERY HOT FEVERISH; NIGHT SWEATS; TIRED; This spontaneous report received from a patient concerned a 58 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: 1808609 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced tired. Laboratory data included: Blood test (NR: not provided) everything was ok. On 24-MAR-2021, the subject experienced night sweats. On 24-MAR-2021, the subject experienced chills. On 24-MAR-2021, the subject experienced very weak. On 24-MAR-2021, the subject experienced felt very hot feverish. On 25-MAR-2021, the subject experienced dizzy. On 25-MAR-2021, the subject experienced barely could stand. On 25-MAR-2021, the subject experienced could barely walk. On 25-MAR-2021, the subject experienced pains in back especially back up neck. Treatment medications included: naproxen. On APR-2021, the subject experienced little bit of cough. On APR-2021, the subject experienced feeling hot. On APR-2021, the subject experienced can't sleep at night. On APR-2021, the subject experienced felt like something on chest. On APR-2021, the subject experienced skin hot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired on 2021, was recovering from pains in back especially back up neck, and felt very hot feverish, had not recovered from chills, and the outcome of night sweats, little bit of cough, dizzy, barely could stand, could barely walk, very weak, feeling hot, can't sleep at night, skin hot and felt like something on chest was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Paraesthesia
Clinical narrative: HEADACHE; TINGLING IN ARM; BODY ACHES; This spontaneous report received from a patient concerned a 37 year old female. The patient's weight was 118 pounds, and height was 60 inches. The patient's concurrent conditions included apples and nuts allergy, alcohol consumer, and non smoker, and other pre-existing medical conditions included patient had no drug abuse and illicit drug usage. 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 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced tingling in arm. On APR-2021, the subject experienced body aches. On 18-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body aches, and had not recovered from headache, and tingling in arm. This report was non-serious.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site irritation, Injection site pain
Clinical narrative: SPOTS OF IRRITATING IN ARM; FEELING TIRED FOR ABOUT A WEEK FOLLOWING ADMINISTRATION; PHANTOM PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: 13/JUN/2021) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced spots of irritating in arm. On 05-APR-2021, the subject experienced feeling tired for about a week following administration. On 05-APR-2021, the subject experienced phantom pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling tired for about a week following administration on 12-APR-2021, and had not recovered from phantom pain at injection site, and spots of irritating in arm. This report was non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Vision blurred
Clinical narrative: LOSS OF BALANCE; BLURRY CLOUDY VISION; DIZZINESS; This spontaneous report received from a patient concerned a 67 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: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced dizziness. On 13-APR-2021, the subject experienced blurry cloudy vision. On 15-APR-2021, the subject experienced loss of balance. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blurry cloudy vision, dizziness and loss of balance was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Chemotherapy, Fatigue, Headache, Nausea
Clinical narrative: LOW GRADE NAGGING HEADACHE ON AND OFF BUT NOW NOT LETTING GO; LIGHT NAUSEA ON AND OFF; DID NOT GET OUT OF BED; EXHAUSTED THAT COULD NOT  MOVE THE BLANKET; This spontaneous report received from a patient concerned a 79 year old female. The patient's height, and weight were not reported. The patient's past medical history included cancer. 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 07-APR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for headache.  On 07-APR-2021, the subject experienced did not get out of bed. On 07-APR-2021, the subject experienced exhausted that could not move the blanket. On 16-APR-2021, the subject experienced low grade nagging headache on and off but now not letting go. On 16-APR-2021, the subject experienced light nausea on and off.  Laboratory data (dates unspecified) included: Chemotherapy (NR: not provided) unknown, and Radiation therapy (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from did not get out of bed, and exhausted that could not move the blanket on 09-APR-2021, and had not recovered from low grade nagging headache on and off but now not letting go, and light nausea on and off. This report was non-serious
Sex: F
Vaccine: COVID19
Symptoms: Radiotherapy
Clinical narrative: LOW GRADE NAGGING HEADACHE ON AND OFF BUT NOW NOT LETTING GO; LIGHT NAUSEA ON AND OFF; DID NOT GET OUT OF BED; EXHAUSTED THAT COULD NOT  MOVE THE BLANKET; This spontaneous report received from a patient concerned a 79 year old female. The patient's height, and weight were not reported. The patient's past medical history included cancer. 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 07-APR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for headache.  On 07-APR-2021, the subject experienced did not get out of bed. On 07-APR-2021, the subject experienced exhausted that could not move the blanket. On 16-APR-2021, the subject experienced low grade nagging headache on and off but now not letting go. On 16-APR-2021, the subject experienced light nausea on and off.  Laboratory data (dates unspecified) included: Chemotherapy (NR: not provided) unknown, and Radiation therapy (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from did not get out of bed, and exhausted that could not move the blanket on 09-APR-2021, and had not recovered from low grade nagging headache on and off but now not letting go, and light nausea on and off. This report was non-serious
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling of body temperature change, Pain, Pain in extremity, Road traffic accident
Clinical narrative: HIT BY TRUCK; EYEBLUR; BODY ACHES; HOT AND COLD FLUSHES; DIZZINESS; SUPER SORE ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced hit by truck, eyeblur, body aches, hot and cold flushes, dizziness, and super sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from super sore arm, and the outcome of hit by truck, eyeblur, body aches, hot and cold flushes and dizziness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: HIT BY TRUCK; EYEBLUR; BODY ACHES; HOT AND COLD FLUSHES; DIZZINESS; SUPER SORE ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced hit by truck, eyeblur, body aches, hot and cold flushes, dizziness, and super sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from super sore arm, and the outcome of hit by truck, eyeblur, body aches, hot and cold flushes and dizziness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SLIGHT PAIN IN ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced slight pain in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of slight pain in arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20210428453.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain in extremity, Peripheral swelling, Rash pruritic, Swelling face
Clinical narrative: ITCHY RASH; SWELLING ON FACE; SWELLING ON LEGS; BURNING ON FACE ARM AND LEGS; SORE ARM; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, penicillin allergy, non-smoker, and abstains from alcohol, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 and expiry: UNKNOWN) dose was not reported, administered on 03-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-MAR-2021, the subject experienced sore arm. On 13-MAR-2021, the subject experienced itchy rash. On 13-MAR-2021, the subject experienced swelling on face. On 13-MAR-2021, the subject experienced swelling on legs. On 13-MAR-2021, the subject experienced burning on face arm and legs. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning on face arm and legs, and sore arm, and had not recovered from itchy rash, swelling on face, and swelling on legs. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Myalgia, Thyroid pain
Clinical narrative: PAIN IN UNILATERAL THYROID ON LEFT SIDE; MUSCLE PAIN; MILD SORENESS AT THE INJECTION SITE; FATIGUE; 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 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: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-APR-2021, the subject experienced fatigue. On 04-APR-2021, the subject experienced mild soreness at the injection site. On 05-APR-2021, the subject experienced muscle pain. On 14-APR-2021, the subject experienced pain in unilateral thyroid on left side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on 06-APR-2021, muscle pain on 08-APR-2021, and mild soreness at the injection site on APR-2021, and had not recovered from pain in unilateral thyroid on left side. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: BODY ACHE; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company has requested to follow-up for batch number.  No concomitant medications were reported. On an unspecified date, the subject experienced body ache, and fatigue. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue and body ache was not reported. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: LIGHT-HEADEDNESS; This spontaneous report received from a patient concerned a 47 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: 1808982, and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced light-headedness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from light-headedness. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Pain in extremity
Clinical narrative: PAIN IN ARM; UPSET STOMACH; This spontaneous report received from a patient concerned a 54 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: 1805025, expiry: 25/AUG/2021) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced pain in arm. On 19-MAR-2021, the subject experienced upset stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in arm on 21-MAR-2021, and upset stomach on 20-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site pain, Pyrexia
Clinical narrative: NUMBNESS IN RIGHT HAND / RIGHT FOOT /  LEFT ARM; INJECTION SITE PAIN; FEVER; This spontaneous report received from a patient concerned a 22 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: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced fever. On 15-APR-2021, the subject experienced numbness in right hand / right foot / left arm. On 15-APR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 13-APR-2021, was recovering from numbness in right hand / right foot / left arm, and had not recovered from injection site pain. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: HIGH FEVER; This spontaneous report received from a consumer concerned a 72 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19 illness. 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 high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high fever. This report was non-serious.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: SHIVERING; FEVER; This spontaneous report received from a consumer concerned a 33 year old female. The patient's height, and weight were not reported. The patient's 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: 180272, expiry: 25-MAY-2021) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced shivering. On 08-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shivering, and fever on 10-MAR-2021. This report was non-serious.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blood test, Electrocardiogram, Fatigue, Injection site pain
Clinical narrative: HEART PALPITATION; MUSCLES SPASM IN RIGHT ARM; BODY ACHE; INJECTION SITE ARM SORENESS; MILD FATIGUE; STOMACH UPSET; TWITCHING IN RIGHT ARM; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced stomach upset. On 20-MAR-2021, the subject experienced twitching in right arm. On 20-MAR-2021, the subject experienced muscles spasm in right arm. On 20-MAR-2021, the subject experienced body ache. On 20-MAR-2021, the subject experienced injection site arm soreness. On 20-MAR-2021, the subject experienced mild fatigue. On 03-APR-2021, the subject experienced heart palpitation. On 12-APR-2021, Laboratory data included: Blood test (NR: not provided) Normal, and Electrocardiogram (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach upset, body ache, injection site arm soreness, and mild fatigue on 23-MAR-2021, and was recovering from twitching in right arm, heart palpitation, and muscles spasm in right arm. This report was non-serious.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Muscle twitching, Pain, Palpitations
Clinical narrative: HEART PALPITATION; MUSCLES SPASM IN RIGHT ARM; BODY ACHE; INJECTION SITE ARM SORENESS; MILD FATIGUE; STOMACH UPSET; TWITCHING IN RIGHT ARM; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced stomach upset. On 20-MAR-2021, the subject experienced twitching in right arm. On 20-MAR-2021, the subject experienced muscles spasm in right arm. On 20-MAR-2021, the subject experienced body ache. On 20-MAR-2021, the subject experienced injection site arm soreness. On 20-MAR-2021, the subject experienced mild fatigue. On 03-APR-2021, the subject experienced heart palpitation. On 12-APR-2021, Laboratory data included: Blood test (NR: not provided) Normal, and Electrocardiogram (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach upset, body ache, injection site arm soreness, and mild fatigue on 23-MAR-2021, and was recovering from twitching in right arm, heart palpitation, and muscles spasm in right arm. This report was non-serious.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Pyrexia
Clinical narrative: RIGHT FOOT PAIN; FEVER; This spontaneous report received from a parent concerned a 24 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included scoliosis, non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known allergies. the patient have no history of drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 06-JUN-2021) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 F. On 15-APR-2021, the subject experienced right foot pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from fever on 12-APR-2021, and had not recovered from right foot pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding
Clinical narrative: DRUG EXPOSURE VIA  BREAST MILK; This spontaneous report received from a parent 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, transmammary, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced drug exposure via breast milk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of drug exposure via breast milk was not reported. This report was non-serious. This parent/child case is linked to 20210428439.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pulmonary embolism, Spleen disorder
Clinical narrative: BILATERAL PULMONARY EMBOLISM; UNSPECIFIED ISSUE WITH SPLEEN; DIZZINESS; HEADACHE; This spontaneous report received from a healthcare professional (nurse practitioner) via a company representative concerned a 54 year old female patient. The patient's height, weight were not reported and medical history was not known. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported,1 total administered (anatomical vaccination site unspecified) on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in MAR-2021, "about one week prior to admission", the subject experienced headaches and dizziness. On 03-APR-2021, the patient was admitted to hospital for bilateral pulmonary embolism and something with her spleen. The reporter believed that the patient had tests done on spleen (not further specified). Initially it was reported that the patient was out of hospital now and doing much better, but later it was clarified that patient has not yet been discharged from hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bilateral pulmonary embolism, unspecified issue with spleen, headache and dizziness was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This 54-year-old female patient experienced headache and dizziness unspecified days after receiving covid-19 vaccine ad26.cov2.s for prophylactic vaccination. The patient was hospitalized 1 week later for bilateral pulmonary embolism (PE) and unspecified issue with spleen.  Medical history and concomitant medications were reported. No other details of the events were reported. The patient had not yet been discharged from hospital. Based on a limited information, the events of bilateral PE, unspecified issue with spleen, headache and dizziness are assessed to have an indeterminate causal association to immunization, per the organization causality classification for adverse events following immunization.  Company causality is considered not related to covid-19 vaccine ad26.cov2.s. Additional information has been requested for further assessment.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia, Cold sweat, Fatigue, Feeling abnormal, Influenza like illness
Clinical narrative: SWEATY/FELT CLAMMY; HAIR FELL OUT; ITCHING; WHEEZING; HIVES ON CHEST; BLURRY; SUPER TIRED; ACHY ALL OVER; LITTLE WONKY/BLURRY BRAIN/FELT WONKY IN THE HEAD/BLURRY/THREW UP MY BREAKFAST; FLU LIKE SYMPTOMS; SHOT SITE SORE; 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 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced flu like symptoms. On 07-APR-2021, the subject experienced shot site sore. On 08-APR-2021, the subject experienced achy all over. On 08-APR-2021, the subject experienced little wonky/blurry brain/felt wonky in the head/blurry/threw up my breakfast. On 09-APR-2021, the subject experienced super tired. On 10-APR-2021, the subject experienced blurry. On 11-APR-2021, the subject experienced itching. On 11-APR-2021, the subject experienced wheezing. On 11-APR-2021, the subject experienced hives on chest. On 12-APR-2021, the subject experienced sweaty/felt clammy. On 12-APR-2021, the subject experienced hair fell out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu like symptoms, shot site sore, achy all over, little wonky/blurry brain/felt wonky in the head/blurry/threw up my breakfast, super tired, itching, hives on chest, wheezing, sweaty/felt clammy, hair fell out and blurry was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain, Pain, Pruritus, Urticaria, Vision blurred
Clinical narrative: SWEATY/FELT CLAMMY; HAIR FELL OUT; ITCHING; WHEEZING; HIVES ON CHEST; BLURRY; SUPER TIRED; ACHY ALL OVER; LITTLE WONKY/BLURRY BRAIN/FELT WONKY IN THE HEAD/BLURRY/THREW UP MY BREAKFAST; FLU LIKE SYMPTOMS; SHOT SITE SORE; 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 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced flu like symptoms. On 07-APR-2021, the subject experienced shot site sore. On 08-APR-2021, the subject experienced achy all over. On 08-APR-2021, the subject experienced little wonky/blurry brain/felt wonky in the head/blurry/threw up my breakfast. On 09-APR-2021, the subject experienced super tired. On 10-APR-2021, the subject experienced blurry. On 11-APR-2021, the subject experienced itching. On 11-APR-2021, the subject experienced wheezing. On 11-APR-2021, the subject experienced hives on chest. On 12-APR-2021, the subject experienced sweaty/felt clammy. On 12-APR-2021, the subject experienced hair fell out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu like symptoms, shot site sore, achy all over, little wonky/blurry brain/felt wonky in the head/blurry/threw up my breakfast, super tired, itching, hives on chest, wheezing, sweaty/felt clammy, hair fell out and blurry was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: SWEATY/FELT CLAMMY; HAIR FELL OUT; ITCHING; WHEEZING; HIVES ON CHEST; BLURRY; SUPER TIRED; ACHY ALL OVER; LITTLE WONKY/BLURRY BRAIN/FELT WONKY IN THE HEAD/BLURRY/THREW UP MY BREAKFAST; FLU LIKE SYMPTOMS; SHOT SITE SORE; 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 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced flu like symptoms. On 07-APR-2021, the subject experienced shot site sore. On 08-APR-2021, the subject experienced achy all over. On 08-APR-2021, the subject experienced little wonky/blurry brain/felt wonky in the head/blurry/threw up my breakfast. On 09-APR-2021, the subject experienced super tired. On 10-APR-2021, the subject experienced blurry. On 11-APR-2021, the subject experienced itching. On 11-APR-2021, the subject experienced wheezing. On 11-APR-2021, the subject experienced hives on chest. On 12-APR-2021, the subject experienced sweaty/felt clammy. On 12-APR-2021, the subject experienced hair fell out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu like symptoms, shot site sore, achy all over, little wonky/blurry brain/felt wonky in the head/blurry/threw up my breakfast, super tired, itching, hives on chest, wheezing, sweaty/felt clammy, hair fell out and blurry was not reported. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache
Clinical narrative: SEVERE HEADACHES; DIZZY; WEAKNESS; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non drinker, and non-smoker, and other pre-existing medical conditions included no known allergies and no illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070 and expiry: UNKNOWN) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-MAR-2021, the subject experienced weakness. On 08-MAR-2021, the subject experienced dizzy. On 10-MAR-2021, the subject experienced severe headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy, and weakness on 08-MAR-2021, and had not recovered from severe headaches. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: FLU LIKE SYMPTOM; This spontaneous report received from a patient via a company representative concerned an adult 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported.  The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain
Clinical narrative: FELT SORE THROAT; BODY ACHES; This spontaneous report received from a patient concerned a 52 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: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced felt sore throat. On 10-APR-2021, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt sore throat, and body aches. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: CHILLS; FEVER; MASSIVE HEADACHE; NAUSEA; 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,) 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 2021, the subject experienced chills. On 2021, the subject experienced fever. On 2021, the subject experienced headache. On 2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, headache, and nausea on 2021. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Bone pain, Confusional state, Granuloma annulare
Clinical narrative: WORSENING GRANULOMA ANNULAR; CONFUSION OF DAYS; JOINT PAIN; BACK PAIN; BODY PAIN; BONE PAIN; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 56 year old. The patient's weight was 213 pounds, and height was 69 inches. The patient's concurrent conditions included azithromycin allergy, tetracycline allergy, sulfa allergy, dye allergy, shell fish allergy, bee sting allergy, wasp sting allergy, non alcohol user, non smoker, and granuloma annular, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-APR-2021, the subject experienced nausea. On 02-APR-2021, the subject experienced bone pain. On 02-APR-2021, the subject experienced headache. On 03-APR-2021, the subject experienced back pain. On 03-APR-2021, the subject experienced body pain. On 03-APR-2021, the subject experienced confusion of days. On 03-APR-2021, the subject experienced joint pain. On 06-APR-2021, the subject experienced worsening granuloma annular. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from bone pain, nausea, headache, back pain, body pain, and joint pain, and had not recovered from worsening granuloma annular, and confusion of days. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain
Clinical narrative: WORSENING GRANULOMA ANNULAR; CONFUSION OF DAYS; JOINT PAIN; BACK PAIN; BODY PAIN; BONE PAIN; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 56 year old. The patient's weight was 213 pounds, and height was 69 inches. The patient's concurrent conditions included azithromycin allergy, tetracycline allergy, sulfa allergy, dye allergy, shell fish allergy, bee sting allergy, wasp sting allergy, non alcohol user, non smoker, and granuloma annular, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-APR-2021, the subject experienced nausea. On 02-APR-2021, the subject experienced bone pain. On 02-APR-2021, the subject experienced headache. On 03-APR-2021, the subject experienced back pain. On 03-APR-2021, the subject experienced body pain. On 03-APR-2021, the subject experienced confusion of days. On 03-APR-2021, the subject experienced joint pain. On 06-APR-2021, the subject experienced worsening granuloma annular. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from bone pain, nausea, headache, back pain, body pain, and joint pain, and had not recovered from worsening granuloma annular, and confusion of days. This report was non-serious.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot
Clinical narrative: WARM FEELING IN THE BELLY; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's past medical history included blood test (hba1c - 6.5%), and concurrent conditions included diabetes, sulfa allergy, cortisone allergy, non-smoker, epinephrine allergy, and dialkylthiolurea allergy. 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 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-MAR-2021, the subject experienced warm feeling in the belly. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from warm feeling in the belly on 11-MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Pain
Clinical narrative: LOSS OF APPETITE; BODY ACHES; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 13-MAR-2021 09:15 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAR-2021 17:00, the subject experienced loss of appetite. On 13-MAR-2021 17:00, the subject experienced body aches. On 13-MAR-2021 17:00, the subject experienced chills. On 13-MAR-2021 17:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of appetite, body aches, chills, and headache on 15-MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Medication error
Clinical narrative: DOSE ADMINISTERED PAST BEYOND USE TIME; 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 2021, the subject experienced dose administered past beyond use time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dose administered past beyond use time was not reported. This report was non-serious.