chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Pyrexia
Clinical narrative: LUMP IN THE ARM AT INJECTION SITE; FEVER; REDNESS AT INJECTION SITE; 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 concurrent conditions included penicillin allergy, and latex allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced fever. On 11-MAR-2021, the subject experienced redness at injection site. On 12-MAR-2021, the subject experienced lump in the arm at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and redness at injection site on MAR-2021, and had not recovered from lump in the arm at injection site. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site urticaria
Clinical narrative: RAISED RED WELT AT INJECTION SITE; PAIN AT INJECTION SITE; REDNESS 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 and batch number: 1805031 expiry: 26-MAY-2021) dose was not reported, administered on 18-MAR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced redness at injection site. On 20-MAR-2021, the subject experienced raised red welt at injection site. On 20-MAR-2021, the subject experienced pain at injection site. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from redness at injection site, pain at injection site, and raised red welt at injection site. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction
Clinical narrative: 3 INCH SWOLLEN, RED BUMP ON LEFT ARM (SAME SIDE AS INJECTION), HOT TO TOUCH AND ITCHY; 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: 1805025 and expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced 3 inch swollen, red bump on left arm (same side as injection), hot to touch and itchy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from 3 inch swollen, red bump on left arm (same side as injection), hot to touch and itchy. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: FELT SICK; 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,) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 22-MAR-2021, the subject experienced felt sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt sick was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breast pain, Chest discomfort, Dyspnoea, Fatigue, Headache
Clinical narrative: PAIN MID TO RIGHT BREAST; SHORTNESS OF BREATH; TIGHT CHEST; DRENCHED BED SHEETS UPON  WAKING; PULSE 134 TO 143 WHILE SLEEPING; PRESSURE IN EYES; SHOOTING PAIN LEFT ARM TO HIP; VOMITING; SORE ARM; FATIGUE; NAUSEA; HEADACHE; FEVER; BODY 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: 108-5022, and batch number: 108-5022 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for in left arm prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Pulse rate (NR: not provided) 134-143 bpm. On 14-MAR-2021, the subject experienced drenched bed sheets upon waking. On 14-MAR-2021, the subject experienced pulse 134 to 143 while sleeping. On 14-MAR-2021, the subject experienced pressure in eyes. On 14-MAR-2021, the subject experienced shooting pain left arm to hip. On 14-MAR-2021, the subject experienced vomiting. On 14-MAR-2021, the subject experienced sore arm. On 14-MAR-2021, the subject experienced fatigue. On 14-MAR-2021, the subject experienced nausea. On 14-MAR-2021, the subject experienced headache. On 14-MAR-2021, the subject experienced fever. On 14-MAR-2021, the subject experienced body ache. On 18-MAR-2021, the subject experienced shortness of breath. On 18-MAR-2021, the subject experienced tight chest. On 19-MAR-2021, the subject experienced pain mid to right breast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from drenched bed sheets upon waking, pulse 134 to 143 while sleeping, pressure in eyes, shooting pain left arm to hip, vomiting, sore arm, fatigue, nausea, headache, fever, and body ache on MAR-2021, was recovering from tight chest, and shortness of breath, and had not recovered from pain mid to right breast. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate, Nausea, Night sweats, Ocular discomfort, Pain
Clinical narrative: PAIN MID TO RIGHT BREAST; SHORTNESS OF BREATH; TIGHT CHEST; DRENCHED BED SHEETS UPON  WAKING; PULSE 134 TO 143 WHILE SLEEPING; PRESSURE IN EYES; SHOOTING PAIN LEFT ARM TO HIP; VOMITING; SORE ARM; FATIGUE; NAUSEA; HEADACHE; FEVER; BODY 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: 108-5022, and batch number: 108-5022 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for in left arm prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Pulse rate (NR: not provided) 134-143 bpm. On 14-MAR-2021, the subject experienced drenched bed sheets upon waking. On 14-MAR-2021, the subject experienced pulse 134 to 143 while sleeping. On 14-MAR-2021, the subject experienced pressure in eyes. On 14-MAR-2021, the subject experienced shooting pain left arm to hip. On 14-MAR-2021, the subject experienced vomiting. On 14-MAR-2021, the subject experienced sore arm. On 14-MAR-2021, the subject experienced fatigue. On 14-MAR-2021, the subject experienced nausea. On 14-MAR-2021, the subject experienced headache. On 14-MAR-2021, the subject experienced fever. On 14-MAR-2021, the subject experienced body ache. On 18-MAR-2021, the subject experienced shortness of breath. On 18-MAR-2021, the subject experienced tight chest. On 19-MAR-2021, the subject experienced pain mid to right breast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from drenched bed sheets upon waking, pulse 134 to 143 while sleeping, pressure in eyes, shooting pain left arm to hip, vomiting, sore arm, fatigue, nausea, headache, fever, and body ache on MAR-2021, was recovering from tight chest, and shortness of breath, and had not recovered from pain mid to right breast. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia, Tachycardia, Vomiting
Clinical narrative: PAIN MID TO RIGHT BREAST; SHORTNESS OF BREATH; TIGHT CHEST; DRENCHED BED SHEETS UPON  WAKING; PULSE 134 TO 143 WHILE SLEEPING; PRESSURE IN EYES; SHOOTING PAIN LEFT ARM TO HIP; VOMITING; SORE ARM; FATIGUE; NAUSEA; HEADACHE; FEVER; BODY 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: 108-5022, and batch number: 108-5022 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for in left arm prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Pulse rate (NR: not provided) 134-143 bpm. On 14-MAR-2021, the subject experienced drenched bed sheets upon waking. On 14-MAR-2021, the subject experienced pulse 134 to 143 while sleeping. On 14-MAR-2021, the subject experienced pressure in eyes. On 14-MAR-2021, the subject experienced shooting pain left arm to hip. On 14-MAR-2021, the subject experienced vomiting. On 14-MAR-2021, the subject experienced sore arm. On 14-MAR-2021, the subject experienced fatigue. On 14-MAR-2021, the subject experienced nausea. On 14-MAR-2021, the subject experienced headache. On 14-MAR-2021, the subject experienced fever. On 14-MAR-2021, the subject experienced body ache. On 18-MAR-2021, the subject experienced shortness of breath. On 18-MAR-2021, the subject experienced tight chest. On 19-MAR-2021, the subject experienced pain mid to right breast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from drenched bed sheets upon waking, pulse 134 to 143 while sleeping, pressure in eyes, shooting pain left arm to hip, vomiting, sore arm, fatigue, nausea, headache, fever, and body ache on MAR-2021, was recovering from tight chest, and shortness of breath, and had not recovered from pain mid to right breast. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Breast pain, Chest pain, Chills
Clinical narrative: PAIN MID TO RIGHT BREAST; SHORTNESS OF BREATH; TIGHT CHEST; DRENCHED BED SHEETS UPON  WAKING; PULSE 134 TO 143 WHILE SLEEPING; PRESSURE IN EYES; SHOOTING PAIN LEFT ARM TO HIP; VOMITING; SORE ARM; FATIGUE; NAUSEA; HEADACHE; FEVER; BODY 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: 108-5022, and batch number: 108-5022 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for in left arm prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Pulse rate (NR: not provided) 134-143 bpm. On 14-MAR-2021, the subject experienced drenched bed sheets upon waking. On 14-MAR-2021, the subject experienced pulse 134 to 143 while sleeping. On 14-MAR-2021, the subject experienced pressure in eyes. On 14-MAR-2021, the subject experienced shooting pain left arm to hip. On 14-MAR-2021, the subject experienced vomiting. On 14-MAR-2021, the subject experienced sore arm. On 14-MAR-2021, the subject experienced fatigue. On 14-MAR-2021, the subject experienced nausea. On 14-MAR-2021, the subject experienced headache. On 14-MAR-2021, the subject experienced fever. On 14-MAR-2021, the subject experienced body ache. On 18-MAR-2021, the subject experienced shortness of breath. On 18-MAR-2021, the subject experienced tight chest. On 19-MAR-2021, the subject experienced pain mid to right breast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from drenched bed sheets upon waking, pulse 134 to 143 while sleeping, pressure in eyes, shooting pain left arm to hip, vomiting, sore arm, fatigue, nausea, headache, fever, and body ache on MAR-2021, was recovering from tight chest, and shortness of breath, and had not recovered from pain mid to right breast. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Electrocardiogram, Fatigue, Headache
Clinical narrative: PAIN MID TO RIGHT BREAST; SHORTNESS OF BREATH; TIGHT CHEST; DRENCHED BED SHEETS UPON  WAKING; PULSE 134 TO 143 WHILE SLEEPING; PRESSURE IN EYES; SHOOTING PAIN LEFT ARM TO HIP; VOMITING; SORE ARM; FATIGUE; NAUSEA; HEADACHE; FEVER; BODY 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: 108-5022, and batch number: 108-5022 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for in left arm prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Pulse rate (NR: not provided) 134-143 bpm. On 14-MAR-2021, the subject experienced drenched bed sheets upon waking. On 14-MAR-2021, the subject experienced pulse 134 to 143 while sleeping. On 14-MAR-2021, the subject experienced pressure in eyes. On 14-MAR-2021, the subject experienced shooting pain left arm to hip. On 14-MAR-2021, the subject experienced vomiting. On 14-MAR-2021, the subject experienced sore arm. On 14-MAR-2021, the subject experienced fatigue. On 14-MAR-2021, the subject experienced nausea. On 14-MAR-2021, the subject experienced headache. On 14-MAR-2021, the subject experienced fever. On 14-MAR-2021, the subject experienced body ache. On 18-MAR-2021, the subject experienced shortness of breath. On 18-MAR-2021, the subject experienced tight chest. On 19-MAR-2021, the subject experienced pain mid to right breast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from drenched bed sheets upon waking, pulse 134 to 143 while sleeping, pressure in eyes, shooting pain left arm to hip, vomiting, sore arm, fatigue, nausea, headache, fever, and body ache on MAR-2021, was recovering from tight chest, and shortness of breath, and had not recovered from pain mid to right breast. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Hyperhidrosis, Injection site pain, Migraine, Musculoskeletal chest pain
Clinical narrative: PAIN MID TO RIGHT BREAST; SHORTNESS OF BREATH; TIGHT CHEST; DRENCHED BED SHEETS UPON  WAKING; PULSE 134 TO 143 WHILE SLEEPING; PRESSURE IN EYES; SHOOTING PAIN LEFT ARM TO HIP; VOMITING; SORE ARM; FATIGUE; NAUSEA; HEADACHE; FEVER; BODY 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: 108-5022, and batch number: 108-5022 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for in left arm prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Pulse rate (NR: not provided) 134-143 bpm. On 14-MAR-2021, the subject experienced drenched bed sheets upon waking. On 14-MAR-2021, the subject experienced pulse 134 to 143 while sleeping. On 14-MAR-2021, the subject experienced pressure in eyes. On 14-MAR-2021, the subject experienced shooting pain left arm to hip. On 14-MAR-2021, the subject experienced vomiting. On 14-MAR-2021, the subject experienced sore arm. On 14-MAR-2021, the subject experienced fatigue. On 14-MAR-2021, the subject experienced nausea. On 14-MAR-2021, the subject experienced headache. On 14-MAR-2021, the subject experienced fever. On 14-MAR-2021, the subject experienced body ache. On 18-MAR-2021, the subject experienced shortness of breath. On 18-MAR-2021, the subject experienced tight chest. On 19-MAR-2021, the subject experienced pain mid to right breast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from drenched bed sheets upon waking, pulse 134 to 143 while sleeping, pressure in eyes, shooting pain left arm to hip, vomiting, sore arm, fatigue, nausea, headache, fever, and body ache on MAR-2021, was recovering from tight chest, and shortness of breath, and had not recovered from pain mid to right breast. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Oophorectomy bilateral, Ovarian disorder, Pain, Pelvic pain
Clinical narrative: PAIN MID TO RIGHT BREAST; SHORTNESS OF BREATH; TIGHT CHEST; DRENCHED BED SHEETS UPON  WAKING; PULSE 134 TO 143 WHILE SLEEPING; PRESSURE IN EYES; SHOOTING PAIN LEFT ARM TO HIP; VOMITING; SORE ARM; FATIGUE; NAUSEA; HEADACHE; FEVER; BODY 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: 108-5022, and batch number: 108-5022 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for in left arm prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Pulse rate (NR: not provided) 134-143 bpm. On 14-MAR-2021, the subject experienced drenched bed sheets upon waking. On 14-MAR-2021, the subject experienced pulse 134 to 143 while sleeping. On 14-MAR-2021, the subject experienced pressure in eyes. On 14-MAR-2021, the subject experienced shooting pain left arm to hip. On 14-MAR-2021, the subject experienced vomiting. On 14-MAR-2021, the subject experienced sore arm. On 14-MAR-2021, the subject experienced fatigue. On 14-MAR-2021, the subject experienced nausea. On 14-MAR-2021, the subject experienced headache. On 14-MAR-2021, the subject experienced fever. On 14-MAR-2021, the subject experienced body ache. On 18-MAR-2021, the subject experienced shortness of breath. On 18-MAR-2021, the subject experienced tight chest. On 19-MAR-2021, the subject experienced pain mid to right breast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from drenched bed sheets upon waking, pulse 134 to 143 while sleeping, pressure in eyes, shooting pain left arm to hip, vomiting, sore arm, fatigue, nausea, headache, fever, and body ache on MAR-2021, was recovering from tight chest, and shortness of breath, and had not recovered from pain mid to right breast. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting, X-ray
Clinical narrative: PAIN MID TO RIGHT BREAST; SHORTNESS OF BREATH; TIGHT CHEST; DRENCHED BED SHEETS UPON  WAKING; PULSE 134 TO 143 WHILE SLEEPING; PRESSURE IN EYES; SHOOTING PAIN LEFT ARM TO HIP; VOMITING; SORE ARM; FATIGUE; NAUSEA; HEADACHE; FEVER; BODY 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: 108-5022, and batch number: 108-5022 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for in left arm prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Pulse rate (NR: not provided) 134-143 bpm. On 14-MAR-2021, the subject experienced drenched bed sheets upon waking. On 14-MAR-2021, the subject experienced pulse 134 to 143 while sleeping. On 14-MAR-2021, the subject experienced pressure in eyes. On 14-MAR-2021, the subject experienced shooting pain left arm to hip. On 14-MAR-2021, the subject experienced vomiting. On 14-MAR-2021, the subject experienced sore arm. On 14-MAR-2021, the subject experienced fatigue. On 14-MAR-2021, the subject experienced nausea. On 14-MAR-2021, the subject experienced headache. On 14-MAR-2021, the subject experienced fever. On 14-MAR-2021, the subject experienced body ache. On 18-MAR-2021, the subject experienced shortness of breath. On 18-MAR-2021, the subject experienced tight chest. On 19-MAR-2021, the subject experienced pain mid to right breast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from drenched bed sheets upon waking, pulse 134 to 143 while sleeping, pressure in eyes, shooting pain left arm to hip, vomiting, sore arm, fatigue, nausea, headache, fever, and body ache on MAR-2021, was recovering from tight chest, and shortness of breath, and had not recovered from pain mid to right breast. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain
Clinical narrative: ACHYNESS; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 at 11:00 AM for prophylactic vaccination in left deltoid. No concomitant medications were reported.  On 23-MAR-2021, the subject experienced achyness. On 23-MAR-2021, the subject experienced headache. On 23-MAR-2021, the subject experienced nausea. Treatment medications included: hydrocodone. 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 achyness. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Feeling cold, Headache, Nausea
Clinical narrative: ITCHING OF LEGS; SWOLLEN FACE, LEFT ARM (INJ. SITE) AND BOTH LEGS, SWELLED UP AND COVERED FROM HEAD-TO-TOE; RASH; FREEZING; HEADACHE; TIRED; NAUSEA; FEVER (101F); This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included bowel obstruction, hernia, diabetes, non alcoholic, non-smoker, penicillin allergy, and levaquin allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 15:00 to left arm for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced freezing. On 17-MAR-2021, the subject experienced headache. On 17-MAR-2021, the subject experienced tired. On 17-MAR-2021, the subject experienced nausea. On 17-MAR-2021, the subject experienced fever (101f). On 20-MAR-2021, the subject experienced itching of legs. On 20-MAR-2021, the subject experienced swollen face, left arm (inj. site) and both legs, swelled up and covered from head-to-toe. On 20-MAR-2021, the subject experienced rash. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, tired, nausea, and fever (101f) on 18-MAR-2021, was recovering from freezing, and had not recovered from itching of legs, swollen face, left arm (inj. site) and both legs, swelled up and covered from head-to-toe, and rash. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash, Swelling
Clinical narrative: ITCHING OF LEGS; SWOLLEN FACE, LEFT ARM (INJ. SITE) AND BOTH LEGS, SWELLED UP AND COVERED FROM HEAD-TO-TOE; RASH; FREEZING; HEADACHE; TIRED; NAUSEA; FEVER (101F); This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included bowel obstruction, hernia, diabetes, non alcoholic, non-smoker, penicillin allergy, and levaquin allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 15:00 to left arm for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced freezing. On 17-MAR-2021, the subject experienced headache. On 17-MAR-2021, the subject experienced tired. On 17-MAR-2021, the subject experienced nausea. On 17-MAR-2021, the subject experienced fever (101f). On 20-MAR-2021, the subject experienced itching of legs. On 20-MAR-2021, the subject experienced swollen face, left arm (inj. site) and both legs, swelled up and covered from head-to-toe. On 20-MAR-2021, the subject experienced rash. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, tired, nausea, and fever (101f) on 18-MAR-2021, was recovering from freezing, and had not recovered from itching of legs, swollen face, left arm (inj. site) and both legs, swelled up and covered from head-to-toe, and rash. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ARM WAS 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: Unknown) dose was not reported, administered on MAR-2021 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 numbers.  On MAR-2021, the subject experienced arm was sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arm was sore was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Nausea
Clinical narrative: FEELS HORRIBLE; 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, batch number: Unknown, expiry: 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 feels horrible, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea and feels horrible was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Myalgia, Nausea, Pain in extremity
Clinical narrative: DIZZINESS; PAIN IN ARM; TIREDNESS; MUSCLE ACHES; NAUSEA; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 in right arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced dizziness. On MAR-2021, the subject experienced pain in arm. On MAR-2021, the subject experienced tiredness. On MAR-2021, the subject experienced muscle aches. On MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tiredness, pain in arm, muscle aches, nausea and dizziness was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: CHILLS; HEADACHE; This spontaneous report received from a health care professional 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) 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 chills, and headache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210345547.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Nasal congestion, Rhinorrhoea
Clinical narrative: HEADACHE; CONGESTION; RUNNY NOSE; 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: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced runny nose. On 17-MAR-2021, the subject experienced congestion. On 22-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, runny nose, and congestion. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Influenza like illness, Nasopharyngitis, Pain, SARS-CoV-2 test
Clinical narrative: COLD SYMPTOMS; FLU LIKE SYMPTOMS; ACHE; SWEATS; 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: 1805018 expiry: UNKNOWN) dose was not reported, 1 total, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: COVID-19 virus test (NR: not provided) NEGATIVE. On 16-MAR-2021, the subject experienced ache. On 16-MAR-2021, the subject experienced sweats. On 16-MAR-2021, the subject experienced flu like symptoms. On 22-MAR-2021, the subject experienced cold symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ache, and sweats on 21-MAR-2021, and was recovering from flu like symptoms, and cold symptoms. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Impaired driving ability, Impaired work ability
Clinical narrative: COULD NOT DRIVE; UNABLE TO GO TO WORK; SICK AT NIGHT/ ILL; This spontaneous report received from a vaccine facility concerned a 23 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the subject experienced sick at night/ ill. On 22-MAR-2021, the subject experienced could not drive. On 22-MAR-2021, the subject experienced unable to go to work. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sick at night/ ill, could not drive and unable to go to work was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea, Pain
Clinical narrative: VOMITING; VERY ACHY GETTING OUT OF BED; CHILLS; MUSCLE PAIN - LEFT LEG UP TO CENTER OF BACK; 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, batch number: 1808609 expiry: 09/JUN/2021) dose was not reported, administered on 22-MAR-2021 20:45 for prophylactic vaccination on left deltoid. No concomitant medications were reported. On 23-MAR-2021 00:30, the subject experienced vomiting. On 23-MAR-2021 00:30, the subject experienced very achy getting out of bed. On 23-MAR-2021 00:30, the subject experienced chills. On 23-MAR-2021 00:30, the subject experienced muscle pain - left leg up to center of back. On 23-MAR-2021 00:30, the subject experienced headache. On 23-MAR-2021 00:30, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nausea, and vomiting, and had not recovered from chills, muscle pain - left leg up to center of back, headache, and very achy getting out of bed. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: VOMITING; VERY ACHY GETTING OUT OF BED; CHILLS; MUSCLE PAIN - LEFT LEG UP TO CENTER OF BACK; 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, batch number: 1808609 expiry: 09/JUN/2021) dose was not reported, administered on 22-MAR-2021 20:45 for prophylactic vaccination on left deltoid. No concomitant medications were reported. On 23-MAR-2021 00:30, the subject experienced vomiting. On 23-MAR-2021 00:30, the subject experienced very achy getting out of bed. On 23-MAR-2021 00:30, the subject experienced chills. On 23-MAR-2021 00:30, the subject experienced muscle pain - left leg up to center of back. On 23-MAR-2021 00:30, the subject experienced headache. On 23-MAR-2021 00:30, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nausea, and vomiting, and had not recovered from chills, muscle pain - left leg up to center of back, headache, and very achy getting out of bed. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea
Clinical narrative: SHORTNESS OF BREATH; CHILLS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included copd (emphysema).The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,and batch number: 1808609 expiry: UNKNOWN) once a total dose was not reported, administered on 21-MAR-2021 on at left arm for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced shortness of breath. On 22-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath, and chills. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: BODY ACHE; CHILLS; FEVER 102.8; This spontaneous report received from a vaccine facility concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 21-MAR-2021 11:30 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested.  On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. On 22-MAR-2021, the subject experienced body ache. On 22-MAR-2021, the subject experienced chills. On 22-MAR-2021, the subject experienced fever 102.8. Laboratory data included: Body temperature (NR: not provided) 102.8 F. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever 102.8, chills and body ache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Limb discomfort
Clinical narrative: DIARRHEA; LEFT ARM DISCOMFORT; 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 concurrent conditions included diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: 25-MAY-2021) dose was not reported, administered at 13:00, in left arm on 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced left arm discomfort. On 23-MAR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 23-MAR-2021, and left arm discomfort on 22-MAR-2021. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Malaise, Nausea
Clinical narrative: NOT FEELING WELL; TRYING NOT TO VOMIT; This spontaneous report received from a patient concerned a 57 year old female. The patient's weight was 48.2 kilograms, and height was not reported. The patient's concurrent conditions included secondary pulmonary hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) and dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: macitentan (oral, batch number: ZE019B0101 expiry: 31-JUL-2024, form of admin was not reported) 10 mg, 1 time every 1 day, therapy dates were not reported for pulmonary hypertension secondary. Concomitant medications included sildenafil citrate. On MAR-2021, the subject experienced not feeling well. On MAR-2021, the subject experienced trying not to vomit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with macitentan was not reported. The outcome of the not feeling well and trying not to vomit was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: SEVERE BODY ACHES; FEVER; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAR-2021 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 MAR-2021, the subject experienced severe body aches. On MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and severe body aches was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: CHILLS; HEADACHE; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced chills, and headache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: CHILLS; SLIGHT 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: Unk) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced chills. On 22-MAR-2021, the subject experienced slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and slight headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Sleep disorder
Clinical narrative: SLEEP DISTURBANCE; BODY SORENESS; MILD NAUSEA; HEADACHE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 20-MAR-2021 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 MAR-2021, the subject experienced sleep disturbance. On MAR-2021, the subject experienced body soreness. On MAR-2021, the subject experienced mild nausea. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sleep disturbance, body soreness, mild nausea and headache was not reported. This report was non-serious.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Body mass index increased, Urticaria
Clinical narrative: HIVES; This spontaneous report received from a patient via a company representative concerned a 64 year old of unspecified sex. The patient's height, and weight were not reported. The patient's past medical history included facial redness, and covid-19, and other pre-existing medical conditions included patient was 10 pounds overweight and BMI was 27. The patient was previously treated with codeine.  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 20-MAR-2021 11:11 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-MAR-2021 03:00, the subject experienced hives. Laboratory data (dates unspecified) included: Body mass index high (NR: not provided) 27. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hives. This report was non-serious.; Sender's Comments: V0:Medical assessment comments not required as per standard procedure, as the case is assessed non serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Depressed mood, Headache, Pyrexia, Vomiting
Clinical narrative: VOMITING; SEVERE CHILLS (UNCONTROLLABLE SHAKING); FEVER; HEADACHE; DOWN FOR 24 HOURS; 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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced vomiting, down for 24 hours, severe chills (uncontrollable shaking), fever, and headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from down for 24 hours, fever, and headache, and the outcome of vomiting and severe chills (uncontrollable shaking) was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Headache, Pyrexia
Clinical narrative: LOSS OF APPETITE; HEADACHE; FEVER; 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, expiry: 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 loss of appetite, headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, fever and loss of appetite was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Therapeutic response unexpected
Clinical narrative: UNEXPECTED THERAPEUTIC BENEFIT; DULL 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 was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On MAR-2021, the subject experienced unexpected therapeutic benefit. On MAR-2021, the subject experienced dull ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dull ache on MAR-2021, and the outcome of unexpected therapeutic benefit was not reported. This report was non-serious.