chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: ACHEY; CHILLS; FEVER; NAUSEA; TIRED; WEAK; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 16-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 16-MAR-2021, the subject experienced fever. On 16-MAR-2021, the subject experienced nausea. On 16-MAR-2021, the subject experienced tired. On 16-MAR-2021, the subject experienced weak. On 16-MAR-2021, the subject experienced achey. On 16-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and had not recovered from fever, nausea, tired, weak, and achey. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: SWOLLEN AT THE SITE OF INJECTION; FEVER; PAIN AT THE SITE OF INJECTION; ITCHING; LITTLE DIZZY; FELT WEAK; REDNESS AT THE SITE OF INJECTION; FEELING SICK; This spontaneous report received from a patient concerned a 43 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-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 itching. On MAR-2021, the subject experienced little dizzy. On MAR-2021, the subject experienced felt weak. On MAR-2021, the subject experienced redness at the site of injection. On MAR-2021, the subject experienced feeling sick. On 06-MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced pain at the site of injection. On 09-MAR-2021, the subject experienced swollen at the site of injection. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itching, swollen at the site of injection, and redness at the site of injection, fever on 08-MAR-2021, and pain at the site of injection on 13-MAR-2021, had not recovered from little dizzy, and felt weak, and the outcome of feeling sick was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pruritus, Pyrexia
Clinical narrative: SWOLLEN AT THE SITE OF INJECTION; FEVER; PAIN AT THE SITE OF INJECTION; ITCHING; LITTLE DIZZY; FELT WEAK; REDNESS AT THE SITE OF INJECTION; FEELING SICK; This spontaneous report received from a patient concerned a 43 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-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 itching. On MAR-2021, the subject experienced little dizzy. On MAR-2021, the subject experienced felt weak. On MAR-2021, the subject experienced redness at the site of injection. On MAR-2021, the subject experienced feeling sick. On 06-MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced pain at the site of injection. On 09-MAR-2021, the subject experienced swollen at the site of injection. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itching, swollen at the site of injection, and redness at the site of injection, fever on 08-MAR-2021, and pain at the site of injection on 13-MAR-2021, had not recovered from little dizzy, and felt weak, and the outcome of feeling sick was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Off label use
Clinical narrative: INCOMPLETE DOSE ADMINISTERED; OFF LABEL USE; 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, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced incomplete dose administered, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incomplete dose administered and off label use was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Pyrexia
Clinical narrative: PATIENT WANT TO CRAWL UNDER A ROCK; HEADACHE; FEVER; CHILLS; 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, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced subject want to crawl under a rock, headache, fever, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the patient want to crawl under a rock, headache, fever and chills was not reported. This report was non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pain, Presyncope
Clinical narrative: ALMOST PASSED OUT; BODY ACHE; REALLY TIRED; CHILLS; FEVER; This spontaneous report received from a patient concerned a 35 year old female. The patient's weight was 145 pounds, and height was 157.48 centimeters. The patient's past medical history included back issue, and covid-19 infection, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced almost passed out. On 13-MAR-2021, the subject experienced body ache. On 13-MAR-2021, the subject experienced really tired. On 13-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 F. On 14-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101.7 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from almost passed out on 13-MAR-2021, body ache, and chills on 14-MAR-2021, and fever on MAR-2021, and had not recovered from really tired. This report was non-serious.  Additional information was received from patient on 24-03-2021 following information was updated and incorporated into case narrative: Patient demographic details (height, weight,  patient age and age group), pre-existing condition, event outcome and end date (fever), medical history added (covid-19 infection, back issues); Sender's Comments: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: ALMOST PASSED OUT; BODY ACHE; REALLY TIRED; CHILLS; FEVER; This spontaneous report received from a patient concerned a 35 year old female. The patient's weight was 145 pounds, and height was 157.48 centimeters. The patient's past medical history included back issue, and covid-19 infection, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced almost passed out. On 13-MAR-2021, the subject experienced body ache. On 13-MAR-2021, the subject experienced really tired. On 13-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 F. On 14-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101.7 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from almost passed out on 13-MAR-2021, body ache, and chills on 14-MAR-2021, and fever on MAR-2021, and had not recovered from really tired. This report was non-serious.  Additional information was received from patient on 24-03-2021 following information was updated and incorporated into case narrative: Patient demographic details (height, weight,  patient age and age group), pre-existing condition, event outcome and end date (fever), medical history added (covid-19 infection, back issues); Sender's Comments: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient concerned a 76 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 the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 at left Arm for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm. This report was non-serious.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: FATIGUE; This spontaneous report received from a patient via a company representative concerned a 78 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were 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 number. No concomitant medications were reported. On an unspecified date, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Pain in extremity, Paraesthesia, Swelling face
Clinical narrative: RIGHT SIDED FACIAL SWELLING (PUFFY); FACE FEELS NUMB; SLIGHT TINGLING; SLIGHT SORENESS TO ARM; LITTLE TIRED (SLIGHT FATIGUE); 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 pre-existing medical conditions included the patient had no medical history and no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and batch number: 1805020) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced slight soreness to arm. On 15-MAR-2021, the subject experienced little tired (slight fatigue). On 17-MAR-2021, the subject experienced right sided facial swelling (puffy). On 17-MAR-2021, the subject experienced face feels numb. On 17-MAR-2021, the subject experienced slight tingling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from slight soreness to arm, and had not recovered from little tired (slight fatigue), right sided facial swelling (puffy), slight tingling, and face feels numb. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Injection site pain, Insomnia
Clinical narrative: BRAIN FOG; INSOMNIA; INJECTION SITE TENDER / SORE ARM; TIRED; HEADACHE; SORE AND ACHEY; 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: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination on right arm. No concomitant medications were reported. On MAR-2021, the subject experienced sore and achey. On MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced insomnia. On 13-MAR-2021, the subject experienced injection site tender / sore arm. On 13-MAR-2021, the subject experienced tired. On 16-MAR-2021, the subject experienced brain fog. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired on 14-MAR-2021, was recovering from insomnia, and had not recovered from sore and achey, headache, brain fog, and injection site tender / sore arm. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: BRAIN FOG; INSOMNIA; INJECTION SITE TENDER / SORE ARM; TIRED; HEADACHE; SORE AND ACHEY; 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: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination on right arm. No concomitant medications were reported. On MAR-2021, the subject experienced sore and achey. On MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced insomnia. On 13-MAR-2021, the subject experienced injection site tender / sore arm. On 13-MAR-2021, the subject experienced tired. On 16-MAR-2021, the subject experienced brain fog. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired on 14-MAR-2021, was recovering from insomnia, and had not recovered from sore and achey, headache, brain fog, and injection site tender / sore arm. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: HEADACHE; FATIGUE; FEVER; MUSCLE ACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 16-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 an unspecified date, the subject experienced headache, fatigue, fever, and muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, fatigue, fever and muscle ache was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Nodule, Rash pruritic
Clinical narrative: BUMP ON BACK TOP PART OF THE HEAD; SWOLLEN EYES; ITCHING OF THE BUMPS; 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 not reported and is requested) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced swollen eyes. On 14-MAR-2021, the subject experienced itching of the bumps. On 15-MAR-2021, the subject experienced bump on back top part of the head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen eyes on MAR-2021, had not recovered from bump on back top part of the head, and the outcome of itching of the bumps was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: NAUSEA; FEVER; HEADACHE; TIREDNESS; 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: Unk) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On 17-MAR-2021, the subject experienced nausea. On 17-MAR-2021, the subject experienced fever. On 17-MAR-2021, the subject experienced headache. On 17-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, headache, nausea and tiredness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: MINOR ARM PAIN FROM THE INJECTION; 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, start therapy date were not reported for prophylactic vaccination. the batch number were not reported hence requested. No concomitant medications were reported. On an unspecified date, the subject experienced minor arm pain from the injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of minor arm pain from the injection was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Influenza like illness, Pain
Clinical narrative: BODY ACHES; TIRED AND FATIGUE; HEADACHE; FEVERISH; FLU-LIKE SYMPTOMS; COUGH; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included blood clotting disorder, and sulfa drug allergy, and other pre-existing medical conditions included patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced cough. On 14-MAR-2021, the subject experienced flu-like symptoms. On 14-MAR-2021, the subject experienced body aches. On 14-MAR-2021, the subject experienced tired and fatigue. On 14-MAR-2021, the subject experienced headache. On 14-MAR-2021, the subject experienced feverish. On 15-MAR-2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired and fatigue, headache, body aches, feverish, and flu-like symptoms, and the outcome of cough was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: BODY ACHES; TIRED AND FATIGUE; HEADACHE; FEVERISH; FLU-LIKE SYMPTOMS; COUGH; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included blood clotting disorder, and sulfa drug allergy, and other pre-existing medical conditions included patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced cough. On 14-MAR-2021, the subject experienced flu-like symptoms. On 14-MAR-2021, the subject experienced body aches. On 14-MAR-2021, the subject experienced tired and fatigue. On 14-MAR-2021, the subject experienced headache. On 14-MAR-2021, the subject experienced feverish. On 15-MAR-2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired and fatigue, headache, body aches, feverish, and flu-like symptoms, and the outcome of cough was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: SWELLING OF THE LYMPH NODE ON THE RIGHT SIDE OF NECK; 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 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 15-MAR-2021, the subject experienced swelling of the lymph node on the right side of neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling of the lymph node on the right side of neck. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Muscle mass, Pain in extremity, Pyrexia, Swelling
Clinical narrative: LUMP ON COLLARBONE THAT EXTENDS INTO NECK MUSCLE; SWELLING; SORE ARM; CHILLS; FEVER; 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 11-MAR-2021 08:40 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On MAR-2021, the subject experienced lump on collarbone that extends into neck muscle. On MAR-2021, the subject experienced swelling. On MAR-2021, the subject experienced sore arm. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on MAR-2021, had not recovered from sore arm, and the outcome of lump on collarbone that extends into neck muscle and swelling was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: SORENESS; EXTREME FATIGUE; FEVER; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, once a total administered, therapy start date was 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 soreness, extreme fatigue, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the extreme fatigue, fever and soreness was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: ACHES; 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 16-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 an unspecified date, the subject experienced aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of aches was not reported. This report was non-serious.  .
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: STOMACH CRAMPS; ON AND OFF FEVER; HEADACHE; DRY HEAVING; NAUSEA; VERY TIRED AND FATIGUE; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180508, and batch number: 180508 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced dry heaving. On 12-MAR-2021, the subject experienced nausea. On 12-MAR-2021, the subject experienced very tired and fatigue. On 13-MAR-2021, the subject experienced on and off fever. On 13-MAR-2021, the subject experienced headache. Treatment medications included: ibuprofen. On 15-MAR-2021, the subject experienced stomach cramps. Treatment medications included: bismuth subsalicylate, and dimenhydrinate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach cramps, dry heaving, nausea, and on and off fever on MAR-2021, and had not recovered from very tired and fatigue, and headache. This report was non-serious.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Retching
Clinical narrative: STOMACH CRAMPS; ON AND OFF FEVER; HEADACHE; DRY HEAVING; NAUSEA; VERY TIRED AND FATIGUE; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180508, and batch number: 180508 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced dry heaving. On 12-MAR-2021, the subject experienced nausea. On 12-MAR-2021, the subject experienced very tired and fatigue. On 13-MAR-2021, the subject experienced on and off fever. On 13-MAR-2021, the subject experienced headache. Treatment medications included: ibuprofen. On 15-MAR-2021, the subject experienced stomach cramps. Treatment medications included: bismuth subsalicylate, and dimenhydrinate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach cramps, dry heaving, nausea, and on and off fever on MAR-2021, and had not recovered from very tired and fatigue, and headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Oropharyngeal pain
Clinical narrative: DISCOMFORT (SICKNESS); fever; MASSIVE HEADACHE; fatigue; BODY ACHES; sore throat; chills; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 17-MAR-2021, the subject experienced body aches. On 17-MAR-2021, the subject experienced sore throat. On 17-MAR-2021, the subject experienced chills. On 17-MAR-2021, the subject experienced fever. On 17-MAR-2021, the subject experienced massive headache. On 17-MAR-2021, the subject experienced fatigue. On 17-MAR-2021 10:15, the subject experienced discomfort (sickness). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the discomfort (sickness), chills, fever, massive headache, body aches, sore throat and fatigue was not reported. This report was non-serious.  As per follow up information, the following information were updated on 22th March, 2021. Due Diligence scheduled/Address updated for the primary reporter/ Event and Labeling checked./The Event "Headache" replaced as "massive headache" and coded
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: DISCOMFORT (SICKNESS); fever; MASSIVE HEADACHE; fatigue; BODY ACHES; sore throat; chills; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 17-MAR-2021, the subject experienced body aches. On 17-MAR-2021, the subject experienced sore throat. On 17-MAR-2021, the subject experienced chills. On 17-MAR-2021, the subject experienced fever. On 17-MAR-2021, the subject experienced massive headache. On 17-MAR-2021, the subject experienced fatigue. On 17-MAR-2021 10:15, the subject experienced discomfort (sickness). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the discomfort (sickness), chills, fever, massive headache, body aches, sore throat and fatigue was not reported. This report was non-serious.  As per follow up information, the following information were updated on 22th March, 2021. Due Diligence scheduled/Address updated for the primary reporter/ Event and Labeling checked./The Event "Headache" replaced as "massive headache" and coded
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a health care professional concerned a 51 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included mrna 1273 for prophylactic vaccination.  On an unspecified date, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Urine odour abnormal
Clinical narrative: URINE HAS A STRANGE SMELL; This spontaneous report received from a patient via an unspecified 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. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced urine has a strange smell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of urine has a strange smell was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Oropharyngeal pain, Pain
Clinical narrative: BODY ACHES; DRY COUGH; CHILLS; SORE THROAT; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 in the left deltoid for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced sore throat. On 17-MAR-2021, the subject experienced body aches. On 17-MAR-2021, the subject experienced dry cough. On 17-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 sore throat, chills, body aches, and dry cough. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Fatigue, Headache, Pyrexia
Clinical narrative: SHORTNESS OF BREATH; CHEST PAIN; FEVER; HEADACHE; TIRED; This spontaneous report received from a vaccine facility 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,) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On 16-MAR-2021, the subject experienced shortness of breath. On 16-MAR-2021, the subject experienced chest pain. On 16-MAR-2021, the subject experienced fever. On 16-MAR-2021, the subject experienced headache. On 16-MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest pain, fever, headache, tired and shortness of breath was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Insomnia, Pyrexia, Somnolence
Clinical narrative: FEVER OF 99-101; Tired; GROGGY; COULD NOT SLEEP; 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, and batch number were not reported) dose was not reported, administered on 15-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 groggy. On MAR-2021, the subject experienced could not sleep. On MAR-2021, the subject experienced tired. On 16-MAR-2021, the subject experienced fever of 99-101. Body temperature (NR: not provided) 99-101 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever of 99-101, groggy, could not sleep and tired was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: UNKNOWN SIDE EFFECT; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced unknown side effect. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unknown side effect was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Head discomfort, Insomnia, Nausea, Somnolence
Clinical narrative: TROUBLE SLEEPING; TROUBLE GETTING UP; HEAVY HEAD; NAUSEA; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced trouble sleeping. On 2021, the subject experienced trouble getting up. On 2021, the subject experienced heavy head. On 2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the trouble sleeping, trouble getting up, nausea and heavy head was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness, Nausea, SARS-CoV-2 test, Vomiting
Clinical narrative: VOMITING; FLU LIKE SYMPTOMS; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-MAR-2021, the subject experienced vomiting. On 14-MAR-2021, the subject experienced flu like symptoms. On 14-MAR-2021, the subject experienced nausea. On 15-MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and nausea on MAR-2021, and had not recovered from flu like symptoms. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: CHILLS; This spontaneous report received from a consumer 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 and has been requested. No concomitant medications were reported. On 2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from chills on 17-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Illness
Clinical narrative: REALLY SICK; TWICE AS MANY SIDE EFFECTS; 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) 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 patient experienced really sick, and twice as many side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the really sick and twice as many side effects was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness
Clinical narrative: DIARRHEA; DIZZINESS; CHILLS; 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 was not reported, administered on 08-MAR-2021 to Left Arm for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported.  On 09-MAR-2021, the subject experienced diarrhea. On 09-MAR-2021, the subject experienced dizziness. On 09-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 diarrhea, dizziness, and chills. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Chills, Dizziness, Fatigue
Clinical narrative: STOMACH PAIN; CHILLS; FEVER; FATIGUE; HEART RATE INCREASED; DIZZINESS; TINGLING FEELING AT THE SITE OF INJECTION RADIATING UP TOWARD NECK; COLD; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-MAR-2021 19:15 at left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-MAR-2021, the subject experienced cold. On 08-MAR-2021, the subject experienced tingling feeling at the site of injection radiating up toward neck. On 09-MAR-2021, the subject experienced heart rate increased. On 09-MAR-2021, the subject experienced dizziness. On 09-MAR-2021, the subject experienced fatigue. Treatment medications included: ibuprofen. On 09-MAR-2021 01:00, the subject experienced chills. On 09-MAR-2021 01:00, the subject experienced fever. On 09-MAR-2021 04:55, Laboratory data included: Body temperature (NR: not provided) 101.3 F, and Heart rate (NR: not provided) 140 BPM. On 11-MAR-2021, the subject experienced stomach pain. Laboratory data included: Body temperature (NR: not provided) 101.4 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart rate increased, stomach pain, cold, dizziness, tingling feeling at the site of injection radiating up toward neck, chills, and fever on MAR-2021, and fatigue. 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: U
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Injection site paraesthesia, Nasopharyngitis, Pyrexia
Clinical narrative: STOMACH PAIN; CHILLS; FEVER; FATIGUE; HEART RATE INCREASED; DIZZINESS; TINGLING FEELING AT THE SITE OF INJECTION RADIATING UP TOWARD NECK; COLD; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-MAR-2021 19:15 at left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-MAR-2021, the subject experienced cold. On 08-MAR-2021, the subject experienced tingling feeling at the site of injection radiating up toward neck. On 09-MAR-2021, the subject experienced heart rate increased. On 09-MAR-2021, the subject experienced dizziness. On 09-MAR-2021, the subject experienced fatigue. Treatment medications included: ibuprofen. On 09-MAR-2021 01:00, the subject experienced chills. On 09-MAR-2021 01:00, the subject experienced fever. On 09-MAR-2021 04:55, Laboratory data included: Body temperature (NR: not provided) 101.3 F, and Heart rate (NR: not provided) 140 BPM. On 11-MAR-2021, the subject experienced stomach pain. Laboratory data included: Body temperature (NR: not provided) 101.4 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart rate increased, stomach pain, cold, dizziness, tingling feeling at the site of injection radiating up toward neck, chills, and fever on MAR-2021, and fatigue. 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, COVID19
Symptoms: Pruritus, Purpura, Urticaria
Clinical narrative: BLEEDING BUMPS/HIVES; TERRIBLE ITCHING; HIVES ALL OVER BODY; This spontaneous report received from a consumer 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 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 14:00 on right arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: diphenhydramine hydrochloride, hydrocortisone acetate, and paraffin, liquid/petrolatum/wool fat. On 13-MAR-2021, the subject experienced bleeding bumps/hives. On 13-MAR-2021, the subject experienced terrible itching. On 13-MAR-2021, the subject experienced hives all over body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hives all over body, terrible itching, and bleeding bumps/hives. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Crying, Pruritus, Rash, Urticaria
Clinical narrative: BLEEDING BUMPS/HIVES; TERRIBLE ITCHING; HIVES ALL OVER BODY; This spontaneous report received from a consumer 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 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 14:00 on right arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: diphenhydramine hydrochloride, hydrocortisone acetate, and paraffin, liquid/petrolatum/wool fat. On 13-MAR-2021, the subject experienced bleeding bumps/hives. On 13-MAR-2021, the subject experienced terrible itching. On 13-MAR-2021, the subject experienced hives all over body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hives all over body, terrible itching, and bleeding bumps/hives. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious