chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Headache, Nausea
Clinical narrative: DIZZINESS; FEELING "OFF" AND FEELING FOGGY; HEADACHE; NAUSEA; TIREDNESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for this case. Concomitant medications were reported.  On an unspecified date, the subject experienced dizziness, feeling "off" and feeling foggy, headache, nausea, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, and the outcome of headache, tiredness, dizziness and feeling "off" and feeling foggy was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Asthenia, Chills, Diarrhoea, Fatigue
Clinical narrative: WEAK; FATIGUED/ TIRED; VERTIGO; DIARRHEA; SWEAT(WATER) WAS DRIPPING FROM HER; VOMITING; LETHARGY; NAUSEA; CHILLS; FEVER; HEADACHE; 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, and thyroid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and batch number: 1808980 expiry: UNKNWON) dose was not reported, administered on 02-APR-2021 to Left Deltoid for prophylactic vaccination. Concomitant medications included carvedilol for high blood pressure, and levothyroxine for thyroid. On 03-APR-2021, the subject experienced chills. On 03-APR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced lethargy. On 06-APR-2021, the subject experienced nausea. On 07-APR-2021 21:00, the subject experienced vertigo. On 07-APR-2021 21:00, the subject experienced diarrhea. On 07-APR-2021 21:00, the subject experienced sweat (water) was dripping from her. On 07-APR-2021 21:00, the subject experienced vomiting. On 08-APR-2021, the subject experienced weak. On 08-APR-2021, the subject experienced fatigued/ tired. Treatment medications (dates unspecified) included: oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargy, vertigo, diarrhea, sweat(water) was dripping from her, vomiting, chills, fever, and nausea, and headache on 03-APR-2021, and had not recovered from weak, and fatigued/ tired. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Lethargy, Nausea, Pyrexia
Clinical narrative: WEAK; FATIGUED/ TIRED; VERTIGO; DIARRHEA; SWEAT(WATER) WAS DRIPPING FROM HER; VOMITING; LETHARGY; NAUSEA; CHILLS; FEVER; HEADACHE; 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, and thyroid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and batch number: 1808980 expiry: UNKNWON) dose was not reported, administered on 02-APR-2021 to Left Deltoid for prophylactic vaccination. Concomitant medications included carvedilol for high blood pressure, and levothyroxine for thyroid. On 03-APR-2021, the subject experienced chills. On 03-APR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced lethargy. On 06-APR-2021, the subject experienced nausea. On 07-APR-2021 21:00, the subject experienced vertigo. On 07-APR-2021 21:00, the subject experienced diarrhea. On 07-APR-2021 21:00, the subject experienced sweat (water) was dripping from her. On 07-APR-2021 21:00, the subject experienced vomiting. On 08-APR-2021, the subject experienced weak. On 08-APR-2021, the subject experienced fatigued/ tired. Treatment medications (dates unspecified) included: oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargy, vertigo, diarrhea, sweat(water) was dripping from her, vomiting, chills, fever, and nausea, and headache on 03-APR-2021, and had not recovered from weak, and fatigued/ tired. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo, Vomiting
Clinical narrative: WEAK; FATIGUED/ TIRED; VERTIGO; DIARRHEA; SWEAT(WATER) WAS DRIPPING FROM HER; VOMITING; LETHARGY; NAUSEA; CHILLS; FEVER; HEADACHE; 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, and thyroid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and batch number: 1808980 expiry: UNKNWON) dose was not reported, administered on 02-APR-2021 to Left Deltoid for prophylactic vaccination. Concomitant medications included carvedilol for high blood pressure, and levothyroxine for thyroid. On 03-APR-2021, the subject experienced chills. On 03-APR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced lethargy. On 06-APR-2021, the subject experienced nausea. On 07-APR-2021 21:00, the subject experienced vertigo. On 07-APR-2021 21:00, the subject experienced diarrhea. On 07-APR-2021 21:00, the subject experienced sweat (water) was dripping from her. On 07-APR-2021 21:00, the subject experienced vomiting. On 08-APR-2021, the subject experienced weak. On 08-APR-2021, the subject experienced fatigued/ tired. Treatment medications (dates unspecified) included: oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargy, vertigo, diarrhea, sweat(water) was dripping from her, vomiting, chills, fever, and nausea, and headache on 03-APR-2021, and had not recovered from weak, and fatigued/ tired. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Tremor
Clinical narrative: SHAKING; CHILLS; HEADACHE; NAUSEA; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The company is unable to perform follow-up to request batch/lot no. On an unspecified date, the subject experienced shaking, chills, headache, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shaking, chills, headache, and nausea. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: EXTREMELY HIGH FEVER; This spontaneous report received from a health care professional 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced extremely high fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of extremely high fever was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lethargy, Nausea, Pain, Pyrexia
Clinical narrative: BODY ACHES/SHOOTING PAIN FROM FRONT OF HEAD TO BACK OF EARS/PAIN IN HANDS AND FEET; LETHARGIC; FEVER; HEADACHE; NAUSEA; 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 past medical history included covid-19 infection. 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. No concomitant medications were reported. On an unspecified date, the subject experienced body aches/shooting pain from front of head to back of ears/pain in hands and feet, lethargic, fever, headache, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, body aches/shooting pain from front of head to back of ears/pain in hands and feet, headache, nausea and lethargic was not reported. This report was non-serious. This case, from the same reporter is linked to 20210417271.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Rash, Skin mass
Clinical narrative: NODULE ON RIGHT SIDE OF THE NECK UNDER JAW; MILD RASH ON FACE; RASH ON LEFT UPPER ARM AT VACCINATION SITE THAT SPREADS TO ELBOW; This spontaneous report received from a patient concerned a 43 year old female. The patient's weight was 179 pounds, and height was not reported. The patient's concurrent conditions included seafood allergies, alcohol user, and smoker, and other pre-existing medical conditions included the 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: 041A21A,expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced nodule on right side of the neck under jaw. On 06-APR-2021, the subject experienced mild rash on face. On 06-APR-2021, the subject experienced rash on left upper arm at vaccination site that spreads to elbow. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mild rash on face, nodule on right side of the neck under jaw, and rash on left upper arm at vaccination site that spreads to elbow. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Dizziness, Dry mouth, Erythema
Clinical narrative: DIZZY AND LIGHT HEADED; BAD HEADACHE; HURT IN NECK MUSCLES VERY BAD; FACE WAS RED; DRY MOUTH; FACE WAS HOT; BREAKING OUT IN A COLD SWEAT CLOTHES WERE SOAKED; LITERALLY ALMOST FAINTED; SHAKES; CHILLS; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included had surgery from the meds. 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 14:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced face was red. On 08-APR-2021, the subject experienced dry mouth. On 08-APR-2021, the subject experienced face was hot. On 08-APR-2021, the subject experienced breaking out in a cold sweat clothes were soaked. On 08-APR-2021, the subject experienced literally almost fainted. On 08-APR-2021, the subject experienced shakes. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced nausea. On 08-APR-2021 15:00, the subject experienced dizzy and light headed. On 08-APR-2021 15:00, the subject experienced bad headache. On 08-APR-2021 15:00, the subject experienced hurt in neck muscles very bad. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy and light headed, face was red, dry mouth, face was hot, breaking out in a cold sweat clothes were soaked, literally almost fainted, shakes, chills, nausea, bad headache, and hurt in neck muscles very bad on APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Myalgia, Nausea, Presyncope
Clinical narrative: DIZZY AND LIGHT HEADED; BAD HEADACHE; HURT IN NECK MUSCLES VERY BAD; FACE WAS RED; DRY MOUTH; FACE WAS HOT; BREAKING OUT IN A COLD SWEAT CLOTHES WERE SOAKED; LITERALLY ALMOST FAINTED; SHAKES; CHILLS; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included had surgery from the meds. 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 14:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced face was red. On 08-APR-2021, the subject experienced dry mouth. On 08-APR-2021, the subject experienced face was hot. On 08-APR-2021, the subject experienced breaking out in a cold sweat clothes were soaked. On 08-APR-2021, the subject experienced literally almost fainted. On 08-APR-2021, the subject experienced shakes. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced nausea. On 08-APR-2021 15:00, the subject experienced dizzy and light headed. On 08-APR-2021 15:00, the subject experienced bad headache. On 08-APR-2021 15:00, the subject experienced hurt in neck muscles very bad. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy and light headed, face was red, dry mouth, face was hot, breaking out in a cold sweat clothes were soaked, literally almost fainted, shakes, chills, nausea, bad headache, and hurt in neck muscles very bad on APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: DIZZY AND LIGHT HEADED; BAD HEADACHE; HURT IN NECK MUSCLES VERY BAD; FACE WAS RED; DRY MOUTH; FACE WAS HOT; BREAKING OUT IN A COLD SWEAT CLOTHES WERE SOAKED; LITERALLY ALMOST FAINTED; SHAKES; CHILLS; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included had surgery from the meds. 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 14:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced face was red. On 08-APR-2021, the subject experienced dry mouth. On 08-APR-2021, the subject experienced face was hot. On 08-APR-2021, the subject experienced breaking out in a cold sweat clothes were soaked. On 08-APR-2021, the subject experienced literally almost fainted. On 08-APR-2021, the subject experienced shakes. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced nausea. On 08-APR-2021 15:00, the subject experienced dizzy and light headed. On 08-APR-2021 15:00, the subject experienced bad headache. On 08-APR-2021 15:00, the subject experienced hurt in neck muscles very bad. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy and light headed, face was red, dry mouth, face was hot, breaking out in a cold sweat clothes were soaked, literally almost fainted, shakes, chills, nausea, bad headache, and hurt in neck muscles very bad on APR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea
Clinical narrative: DIAPHORESIS; NAUSEA; This spontaneous report received from a health care professional 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 and batch number: 1805031 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 diaphoresis. On 07-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diaphoresis, and nausea on 07-APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210417122, 20210417456, 20210417209, 20210417469, 20210417550, 20210417620 and 20210418457.
Sex: U
Vaccine: COVID19
Symptoms: Hypersomnia
Clinical narrative: SLEPT ALOT; 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 APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot no. No concomitant medications were reported. On APR-2021, the subject experienced slept alot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slept alot on APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Lethargy, Nausea, Pain, Pain in extremity
Clinical narrative: LETHARGY; NAUSEA; MINIMAL BODY ACHES/SHOOTING PAIN  FROM THE FRONT  OF  HEAD TO BACK OF EARS; FEVER; PAIN IN HANDS AND FEET; 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: 042A21A and  expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced pain in hands and feet. Laboratory data included: Body temperature (NR: not provided) 102. On 07-APR-2021 23:00, the subject experienced minimal body aches/shooting pain from the front of head to back of ears. On 07-APR-2021 23:00, the subject experienced fever. On 08-APR-2021, the subject experienced lethargy. On 08-APR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 101-102. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, minimal body aches/shooting pain from the front of head to back of ears, nausea, lethargy, and pain in hands and feet. This report was non-serious. This case, from the same reporter is linked to 20210417239.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: LETHARGY; NAUSEA; MINIMAL BODY ACHES/SHOOTING PAIN  FROM THE FRONT  OF  HEAD TO BACK OF EARS; FEVER; PAIN IN HANDS AND FEET; 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: 042A21A and  expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced pain in hands and feet. Laboratory data included: Body temperature (NR: not provided) 102. On 07-APR-2021 23:00, the subject experienced minimal body aches/shooting pain from the front of head to back of ears. On 07-APR-2021 23:00, the subject experienced fever. On 08-APR-2021, the subject experienced lethargy. On 08-APR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 101-102. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, minimal body aches/shooting pain from the front of head to back of ears, nausea, lethargy, and pain in hands and feet. This report was non-serious. This case, from the same reporter is linked to 20210417239.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: FATIGUE; This spontaneous report received from a patient concerned an 86 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, and batch number: WAG 50555 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 at left deltoid for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Somnolence
Clinical narrative: DROWSINESS; 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, and batch number: 202A21A 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 drowsiness. On 07-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and drowsiness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Headache, Nausea
Clinical narrative: ANXIETY; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, allergy to latex, allergy to potato, non alcoholic, and non smoker, and other pre-existing medical conditions included the patient did not have any drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced anxiety. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and had not recovered from nausea, and anxiety. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling hot, Hyperhidrosis, Influenza like illness
Clinical narrative: FEELING OF WARMTH; NASAL STUFFINESS; FLU LIKE SYMPTOMS; BODY ACHES; SWEATING; CHILLS; TIREDNESS; 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 cigarette smoker, asthma, allergies, and anxiety. 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 05-APR-2021 for prophylactic vaccination. Concomitant medications included Montelukast. On 06-APR-2021, the subject experienced tiredness. On 07-APR-2021, the subject experienced feeling of warmth. On 07-APR-2021, the subject experienced nasal stuffiness. On 07-APR-2021, the subject experienced flu like symptoms. On 07-APR-2021, the subject experienced body aches. On 07-APR-2021, the subject experienced sweating. On 07-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the tiredness, chills, feeling of warmth, nasal stuffiness, flu like symptoms, body aches and sweating was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pain
Clinical narrative: FEELING OF WARMTH; NASAL STUFFINESS; FLU LIKE SYMPTOMS; BODY ACHES; SWEATING; CHILLS; TIREDNESS; 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 cigarette smoker, asthma, allergies, and anxiety. 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 05-APR-2021 for prophylactic vaccination. Concomitant medications included Montelukast. On 06-APR-2021, the subject experienced tiredness. On 07-APR-2021, the subject experienced feeling of warmth. On 07-APR-2021, the subject experienced nasal stuffiness. On 07-APR-2021, the subject experienced flu like symptoms. On 07-APR-2021, the subject experienced body aches. On 07-APR-2021, the subject experienced sweating. On 07-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the tiredness, chills, feeling of warmth, nasal stuffiness, flu like symptoms, body aches and sweating was not reported. This report was non-serious.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hypophagia, Nausea
Clinical narrative: CHILLS; SEVERE HEADACHE; FEVER; NAUSEA; NO SLEEP; UNABLE TO EAT; ACHY; FATIGUE; This spontaneous report received from a patient concerned a 25 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, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced unable to eat. On APR-2021, the subject experienced achy. On APR-2021, the subject experienced fatigue. On 07-APR-2021, the subject experienced no sleep. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced severe headache. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from achy, had not recovered from severe headache, chills, fever, nausea, fatigue, and no sleep, and the outcome of unable to eat was not reported. This report was non-serious.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Sleep disorder
Clinical narrative: CHILLS; SEVERE HEADACHE; FEVER; NAUSEA; NO SLEEP; UNABLE TO EAT; ACHY; FATIGUE; This spontaneous report received from a patient concerned a 25 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, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced unable to eat. On APR-2021, the subject experienced achy. On APR-2021, the subject experienced fatigue. On 07-APR-2021, the subject experienced no sleep. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced severe headache. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from achy, had not recovered from severe headache, chills, fever, nausea, fatigue, and no sleep, and the outcome of unable to eat was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: BODYACHES; TIRED; CHILLS; This spontaneous report received from a patient concerned a 44 year old adult  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, intramuscular, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 in right arm for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced bodyaches. On 07-APR-2021, the subject experienced tired. On 07-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bodyaches, tired, and chills on 08-APR-2021. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: DIZZINESS; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and other pre-existing medical conditions included patient had on beta blocker. The patient experienced drug allergy when treated with acetylsalicylic acid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: not reported) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-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 dizziness. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Application site discolouration, Arthralgia, Headache, Malaise, Pain in extremity
Clinical narrative: OVER ALL BLECH FEELING; SORE ARM; GENERAL MALAISE; MINOR ACHES IN JOINTS; STUBBORN 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 was previously treated with for prophylactic vaccination. 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 13:00 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 over all blech feeling, sore arm, general malaise, minor aches in joints, and stubborn headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stubborn headache, general malaise, over all blech feeling, minor aches in joints, and sore arm. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: CHILLS; HEADACHE; TIREDNESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported. On 2021, the subject experienced chills. On 2021, the subject experienced headache. On 2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, chills and tiredness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Influenza, Pain
Clinical narrative: CHILLS; BODY ACHES; FLU-BLOWN FLU; 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: Unknown) dose was not reported, administered on 07-APR-2021 08:00 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The company is unable to perform follow-up to request batch/lot no. On 07-APR-2021 17:00, the subject experienced chills. On 07-APR-2021 17:00, the subject experienced body aches. On 07-APR-2021 17:00, the subject experienced flu-blown flu. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, body aches, and flu-blown flu. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a parent concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. It was not reported whether the patient had been pregnant before. 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 12-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced vaccine exposure during pregnancy. The date of the subject's last menstrual period was 06-MAR-2021. On 01-APR-2021, Laboratory data included: Pregnancy test (NR: not provided) Positive. The pregnancy was continuing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vaccine exposure during pregnancy. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate increased, Injection site pain, Pain
Clinical narrative: MINOR ACHES AND PAIN; ELEVATED RHR; INJECTION SITE IS A LITTLE SORE; 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. 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 minor aches and pain, elevated rhr, and injection site is a little sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the minor aches and pain, elevated rhr and injection site is a little sore was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Injection site pain, Pyrexia
Clinical narrative: CHILLS; FEVER; FATIGUE; WEAKNESS GENERALIZED; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and sulfa allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced weakness generalized. On 07-APR-2021, the subject experienced injection site pain. On 07-APR-2021, the subject experienced fatigue. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from injection site pain, and chills, and had not recovered from fever, weakness generalized, and fatigue. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: GENERAL BODY MALAISE; FEVER; This spontaneous report received from a patient via a company representative concerned an adult female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 07-APR-2021, the patient experienced fever. On 07-APR-2021, the patient experienced general body malaise. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and general body malaise on 08-APR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: CHILLS; HEADACHE; FEVER; MUSCLE ACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced chills, headache, fever, and muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, fever, chills, and muscle ache. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Injection site pain
Clinical narrative: SEVERE BACK PAIN; SORE ARM AT INJECTION SITE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) 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 severe back pain. On APR-2021, the subject experienced sore arm at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe back pain and sore arm at injection site was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Platelet count, Ultrasound Doppler
Clinical narrative: SEVERE BACK PAIN; SORE ARM AT INJECTION SITE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) 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 severe back pain. On APR-2021, the subject experienced sore arm at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe back pain and sore arm at injection site was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain in extremity
Clinical narrative: CHILLS; LEGS HURT; HEADACHE; TIRED; 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: Unk) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers No concomitant medications were reported. On 2021, the subject experienced chills. On 2021, the subject experienced legs hurt. On 2021, the subject experienced headache. On 2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, headache, tired, and legs hurt. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: STRANGE SIDE EFFECT IN LA SKIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 2021, the subject experienced strange side effect in la skin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of strange side effect in la skin was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: ARM SORENESS; LOW GRADE FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The company is unable to perform follow-up to request batch/lot no. On an unspecified date, the subject experienced arm soreness, and low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the low grade fever and arm soreness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling jittery, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: JITTERY; MULTIPLE KINDS OF PAIN IN INJECTION ARM; FEVERISH FEELING; MUSCLE ACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced jittery, multiple kinds of pain in injection arm, feverish feeling, and muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle ache, feverish feeling, multiple kinds of pain in injection arm and jittery was not reported. This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: BODY ACHES; EXTREME CHILLS ( ALMOST CONVULSANT AND SHAKES); NAUSEA; SEVERE HEADACHE; EXTREMELY HIGH FEVER; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient didn't took any medications.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 19:00 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced body aches. On 07-APR-2021, the subject experienced extreme chills ( almost convulsant and shakes). On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced severe headache. On 07-APR-2021, the subject experienced extremely high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, extreme chills ( almost convulsant and shakes), nausea, severe headache, and extremely high fever on 08-APR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; 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: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number is 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 sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: LIGHT HEADACHE; 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 non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies and did not had any 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: 201A21A, 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 light headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from light headache. This report was non-serious.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: FEVER; HEADACHE; ARM PAIN; This spontaneous report received from a patient via a company representative concerned a 25 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-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 arm pain. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm pain on APR-2021, and was recovering from fever, and headache. This report was non-serious.