chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: SEVERE BODY ACHE; CHILLS; SEVERE HEADACHE; FEVER; FELT EXHAUSTED; FELT WEAK IN FIRST HOUR; HEAVY CONGESTION IN HER SINUSES; LIGHTHEADED IN FIRST HOUR; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 28-MAR-2021 to left deltoid for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 28-MAR-2021, the subject experienced heavy congestion in her sinuses. On 28-MAR-2021, the subject experienced lightheaded in first hour. On 28-MAR-2021, the subject experienced felt weak in first hour. On 28-MAR-2021, the subject experienced felt exhausted.  On 29-MAR-2021 01:00, the subject experienced severe body ache. On 29-MAR-2021 01:00, the subject experienced chills. On 29-MAR-2021 01:00, the subject experienced severe headache. On 29-MAR-2021 01:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, severe body ache, chills, fever, heavy congestion in her sinuses, lightheaded in first hour, and felt weak in first hour, and the outcome of felt exhausted was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comments not required as per standard procedure, as the case is assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Sinus congestion
Clinical narrative: SEVERE BODY ACHE; CHILLS; SEVERE HEADACHE; FEVER; FELT EXHAUSTED; FELT WEAK IN FIRST HOUR; HEAVY CONGESTION IN HER SINUSES; LIGHTHEADED IN FIRST HOUR; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 28-MAR-2021 to left deltoid for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 28-MAR-2021, the subject experienced heavy congestion in her sinuses. On 28-MAR-2021, the subject experienced lightheaded in first hour. On 28-MAR-2021, the subject experienced felt weak in first hour. On 28-MAR-2021, the subject experienced felt exhausted.  On 29-MAR-2021 01:00, the subject experienced severe body ache. On 29-MAR-2021 01:00, the subject experienced chills. On 29-MAR-2021 01:00, the subject experienced severe headache. On 29-MAR-2021 01:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, severe body ache, chills, fever, heavy congestion in her sinuses, lightheaded in first hour, and felt weak in first hour, and the outcome of felt exhausted was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comments not required as per standard procedure, as the case is assessed as non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Constipation, Decreased appetite, Gastrointestinal pain, Injection site pain
Clinical narrative: DID NOT FELT HUNGRY WHICH WAS DESCRIBED AS LOW  APPETITE; CHRONIC JOINT PAIN; TIREDNESS/LETHARGY; NAUSEA, INCONSISTENT; PAIN AT INJECTION SITE; ACHINESS IN GUT; CONSTIPATION; DELAY IN MENSTRUATION; PREMENSTRUAL SYNDROME; This spontaneous report received from a patient concerned a female. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic fatigue syndrome, chronic joint pain, post-traumatic stress disorder, wonky metabolism, and  lyme disease and other pre-existing medical conditions included patient Had a fever 2 nights before shot but had a fever for 1 day. The patient had no known drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, and batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. Vaccinated at Left  Deltoid . No concomitant medications were reported. On MAR-2021, the subject experienced achiness in gut. On MAR-2021, the subject experienced constipation. On MAR-2021, the subject experienced delay in menstruation. On MAR-2021, the subject experienced premenstrual syndrome. On 20-MAR-2021, the subject experienced pain at injection site. On 23-MAR-2021, the subject experienced nausea, inconsistent. On 24-MAR-2021, the subject experienced tiredness/lethargy. On 24-MAR-2021, the subject experienced chronic joint pain. On 26-MAR-2021, the subject experienced did not felt hungry which was described as low appetite. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain at injection site on MAR-2021, was recovering from nausea, inconsistent, had not recovered from tiredness/lethargy, did not felt hungry which was described as low appetite, chronic joint pain, achiness in gut, and constipation, and the outcome of delay in menstruation and premenstrual syndrome was not reported. This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Menstruation delayed, Nausea, Premenstrual syndrome
Clinical narrative: DID NOT FELT HUNGRY WHICH WAS DESCRIBED AS LOW  APPETITE; CHRONIC JOINT PAIN; TIREDNESS/LETHARGY; NAUSEA, INCONSISTENT; PAIN AT INJECTION SITE; ACHINESS IN GUT; CONSTIPATION; DELAY IN MENSTRUATION; PREMENSTRUAL SYNDROME; This spontaneous report received from a patient concerned a female. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic fatigue syndrome, chronic joint pain, post-traumatic stress disorder, wonky metabolism, and  lyme disease and other pre-existing medical conditions included patient Had a fever 2 nights before shot but had a fever for 1 day. The patient had no known drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, and batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. Vaccinated at Left  Deltoid . No concomitant medications were reported. On MAR-2021, the subject experienced achiness in gut. On MAR-2021, the subject experienced constipation. On MAR-2021, the subject experienced delay in menstruation. On MAR-2021, the subject experienced premenstrual syndrome. On 20-MAR-2021, the subject experienced pain at injection site. On 23-MAR-2021, the subject experienced nausea, inconsistent. On 24-MAR-2021, the subject experienced tiredness/lethargy. On 24-MAR-2021, the subject experienced chronic joint pain. On 26-MAR-2021, the subject experienced did not felt hungry which was described as low appetite. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain at injection site on MAR-2021, was recovering from nausea, inconsistent, had not recovered from tiredness/lethargy, did not felt hungry which was described as low appetite, chronic joint pain, achiness in gut, and constipation, and the outcome of delay in menstruation and premenstrual syndrome was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Tremor
Clinical narrative: WOBBLY/SHAKY LEGS; DIZZINESS; NAUSEA; This spontaneous report received from a patient concerned an 82 year old female. The patient's height, and weight were not reported. The patient's past medical history included knee replacement, hip replacement, dizziness and concurrent conditions included arthritis, heart problem, broken leg, allergic to vancomycine, allergic to penicillin, and allergic to sulfas. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: 25-MAY-2021) dose was not reported, administered on 23-MAR-2021 at right arm for prophylactic vaccination. Concomitant medications included vitamins nos for drug used for unknown indication and atenolol for heart problems.  On 24-MAR-2021, the subject experienced nausea. On 28-MAR-2021, the subject experienced wobbly/shaky legs. On 28-MAR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 24-MAR-2021, and had not recovered from wobbly/shaky legs, and dizziness. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: ADVERSE EVENT; 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, 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 adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse event was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Disorientation, Dizziness, Fatigue
Clinical narrative: WALKING WITH HELP OF CANE; OFF WORK X ONE WEEK; TIREDNESS WITH WALKING; DISORIENTATION; UNABLE TO DRIVE; NERVE PAIN TO LEFT SIDE; DIZZINESS; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's past medical history included throat problem, and concurrent conditions included multiple sclerosis, non smoker, non alcoholic, and cephalosporins allergies, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug use. The patient experienced drug allergy when treated with cefaclor for drug used for unknown indication, drug allergy when treated with amoxicillin, bupropion, and naproxen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Details not with caller) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. Non-company suspect drugs included: gabapentin (capsule, oral, batch number: UNKNOWN expiry: UNKOWN) 300 mg, 3 times every 1 day, from 18-MAR-2021 for multiple sclerosis. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAR-2021, the subject experienced nerve pain to left side. On 13-MAR-2021, the subject experienced dizziness. On 13-MAR-2021, the subject experienced unable to drive. On 14-MAR-2021, the subject experienced disorientation. On 14-MAR-2021, the subject experienced tiredness with walking. On 15-MAR-2021, the subject experienced off work x one week. On 16-MAR-2021, Laboratory data included: Chest X-ray (NR: not provided) NEGATIVE. On 16-MAR-2021 20:30, Laboratory data included: Blood test (NR: not provided) NEGATIVE, and MRI (NR: not provided) NEGATIVE. On an unspecified date, the subject experienced walking with help of cane. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of gabapentin was increased. The patient recovered from disorientation, and unable to drive on 18-MAR-2021, and off work x one week on 19-MAR-2021, and had not recovered from nerve pain to left side, dizziness, tiredness with walking, and walking with help of cane. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Impaired driving ability, Impaired work ability, Magnetic resonance imaging, Neuralgia
Clinical narrative: WALKING WITH HELP OF CANE; OFF WORK X ONE WEEK; TIREDNESS WITH WALKING; DISORIENTATION; UNABLE TO DRIVE; NERVE PAIN TO LEFT SIDE; DIZZINESS; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's past medical history included throat problem, and concurrent conditions included multiple sclerosis, non smoker, non alcoholic, and cephalosporins allergies, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug use. The patient experienced drug allergy when treated with cefaclor for drug used for unknown indication, drug allergy when treated with amoxicillin, bupropion, and naproxen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Details not with caller) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. Non-company suspect drugs included: gabapentin (capsule, oral, batch number: UNKNOWN expiry: UNKOWN) 300 mg, 3 times every 1 day, from 18-MAR-2021 for multiple sclerosis. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAR-2021, the subject experienced nerve pain to left side. On 13-MAR-2021, the subject experienced dizziness. On 13-MAR-2021, the subject experienced unable to drive. On 14-MAR-2021, the subject experienced disorientation. On 14-MAR-2021, the subject experienced tiredness with walking. On 15-MAR-2021, the subject experienced off work x one week. On 16-MAR-2021, Laboratory data included: Chest X-ray (NR: not provided) NEGATIVE. On 16-MAR-2021 20:30, Laboratory data included: Blood test (NR: not provided) NEGATIVE, and MRI (NR: not provided) NEGATIVE. On an unspecified date, the subject experienced walking with help of cane. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of gabapentin was increased. The patient recovered from disorientation, and unable to drive on 18-MAR-2021, and off work x one week on 19-MAR-2021, and had not recovered from nerve pain to left side, dizziness, tiredness with walking, and walking with help of cane. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Bedridden, Confusional state, Dizziness, Dysarthria
Clinical narrative: HYPERVENTILATING; FEELING LOOPY; DIZZINESS; COULDN'T WALK STRAIGHT; COULDN'T MAINTAIN BALANCE; STATE OF CONFUSION; TROUBLE BREATHING; SLURRING WORDS; BED RIDDEN; This spontaneous report received from a consumer concerned a 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, expiry: unknown) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced bed ridden. On 28-MAR-2021, the subject experienced hyperventilating. On 28-MAR-2021, the subject experienced feeling loopy. On 28-MAR-2021, the subject experienced dizziness. On 28-MAR-2021, the subject experienced couldn't walk straight. On 28-MAR-2021, the subject experienced couldn't maintain balance. On 28-MAR-2021, the subject experienced state of confusion. On 28-MAR-2021, the subject experienced trouble breathing. On 28-MAR-2021, the subject experienced slurring words. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bed ridden, feeling loopy, dizziness, couldn't walk straight, couldn't maintain balance, state of confusion, trouble breathing, hyperventilating and slurring words was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, Gait disturbance, Hyperventilation
Clinical narrative: HYPERVENTILATING; FEELING LOOPY; DIZZINESS; COULDN'T WALK STRAIGHT; COULDN'T MAINTAIN BALANCE; STATE OF CONFUSION; TROUBLE BREATHING; SLURRING WORDS; BED RIDDEN; This spontaneous report received from a consumer concerned a 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, expiry: unknown) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced bed ridden. On 28-MAR-2021, the subject experienced hyperventilating. On 28-MAR-2021, the subject experienced feeling loopy. On 28-MAR-2021, the subject experienced dizziness. On 28-MAR-2021, the subject experienced couldn't walk straight. On 28-MAR-2021, the subject experienced couldn't maintain balance. On 28-MAR-2021, the subject experienced state of confusion. On 28-MAR-2021, the subject experienced trouble breathing. On 28-MAR-2021, the subject experienced slurring words. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bed ridden, feeling loopy, dizziness, couldn't walk straight, couldn't maintain balance, state of confusion, trouble breathing, hyperventilating and slurring words was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: TIRED; FEVER; 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) one total, dose, start therapy date were not reported for prophylactic vaccination. The batch no was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced tired, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tired and fever was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: HEADACHE; BEING TIRED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced headache, and being tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and being tired was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Headache, Pain, Pyrexia
Clinical narrative: BODY ACHE; MILD STOMACH UPSET; CHILLS; LOW GRADE FEVER; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 28-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 body ache. On MAR-2021, the subject experienced mild stomach upset. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced low grade fever. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the low grade fever, chills, headache, body ache and mild stomach upset was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction, Illness
Clinical narrative: SICK FOR 24 HOURS; UNSPECIFIED SIDE EFFECTS; 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 25-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 MAR-2021, the subject experienced sick for 24 hours. On MAR-2021, the subject experienced unspecified side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick for 24 hours on Mar-2021, and the outcome of unspecified side effects was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: SWELLING; REDNESS; PAIN IN LEFT ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180518, and batch number: 180518 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. Vaccinated on Left Deltoid. No concomitant medications were reported. On an unspecified date, the subject experienced swelling, redness, and pain in left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swelling, redness and pain in left arm was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Cough, Diarrhoea, Headache, Pain
Clinical narrative: CHILLS; POUNDING HEADACHE; FEVER; VOMITING; DIARRHEA; FULL BODY ACHE; COUGHING; 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: 1808609) dose was not reported, administered on 26-MAR-2021 10:30 on Right Arm for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced vomiting. On 27-MAR-2021, the subject experienced diarrhea. On 27-MAR-2021, the subject experienced full body ache. On 27-MAR-2021, the subject experienced coughing. On 27-MAR-2021, the subject experienced pounding headache. On 27-MAR-2021, the subject experienced fever. On 29-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, chills, pounding headache, and fever on 29-MAR-2021, was recovering from full body ache, and coughing, and had not recovered from vomiting. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: CHILLS; POUNDING HEADACHE; FEVER; VOMITING; DIARRHEA; FULL BODY ACHE; COUGHING; 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: 1808609) dose was not reported, administered on 26-MAR-2021 10:30 on Right Arm for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced vomiting. On 27-MAR-2021, the subject experienced diarrhea. On 27-MAR-2021, the subject experienced full body ache. On 27-MAR-2021, the subject experienced coughing. On 27-MAR-2021, the subject experienced pounding headache. On 27-MAR-2021, the subject experienced fever. On 29-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, chills, pounding headache, and fever on 29-MAR-2021, was recovering from full body ache, and coughing, and had not recovered from vomiting. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Insomnia
Clinical narrative: BODY WEAKNESS; HEADACHE; DIFFICULTY SLEEPING; This spontaneous report received from a patient concerned a 19 year old male. The patient's weight was 155 pounds, and height was 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: 1808609, expiry: UNKNOWN) dose was not reported, administered to right deltoid on 28-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-MAR-2021, the subject experienced difficulty sleeping. On 29-MAR-2021, the subject experienced body weakness. On 29-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, difficulty sleeping, and body weakness. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: FEELING UNDER THE WEATHER; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced feeling under the weather. it was reported that most of reporter's coworkers experienced a couple of days of feeling under the weather. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feeling under the weather was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: MILD FEVER; SLIGHT HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 25-MAR-2021 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 MAR-2021, the subject experienced mild fever. On MAR-2021, the subject experienced slight headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mild fever and slight headache was not reported. This report was non-serious.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: FEVER; BODY ACHES; This spontaneous report received from a consumer concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included latex allergy. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808609,expiry: UNKNOWN) dose was not reported, administered to left deltoid on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-MAR-2021, the subject experienced body aches.  On 29-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine was not applicable. The patient recovered from fever on 29-MAR-2021, and had not recovered from body aches. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: SORE ARM; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 sore arm, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and sore arm was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Insomnia, Rash, Vomiting
Clinical narrative: RED SPOTS ON FACE LIKE ALLERGIES; WEAKNESS; DIDN'T SLEEP WHOLE NIGHT; THROWING UP; FELT BAD; This spontaneous report received from a patient concerned a 25 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 and batch number: 1805029 expiry: 05-MAY-2021) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination on Right Arm. No concomitant medications were reported. On 27-MAR-2021, the Patient experienced didn't sleep whole night. On 27-MAR-2021, the Patient experienced weak. On 27-MAR-2021, the Patient experienced throwing up. On 27-MAR-2021, the Patient experienced felt bad. On 28-MAR-2021, the Patient experienced red spots on face like allergies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from weak, throwing up, and felt bad on 27-MAR-2021, had not recovered from red spots on face like allergies, and the outcome of didn't sleep whole night was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Vomiting
Clinical narrative: MIGRAINE; VOMITING; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced migraine. On MAR-2021, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the migraine and vomiting was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Ocular discomfort, White blood cell count
Clinical narrative: FELT PRESSURE IN BOTH EYES / PRESSURE IN BACK OF EYES; LYMPH NODE SLIGHTLY RAISED; HEADACHE; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high cholesterol, platelet low, and white cell count low. The patient had no known drug allergy. 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, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced felt pressure in both eyes / pressure in back of eyes. On 27-MAR-2021, the subject experienced lymph node slightly raised. On 27-MAR-2021, the subject experienced headache. Laboratory data (dates unspecified) included: Platelet count (NR: not provided) 100000, and White blood cell count (NR: not provided) Low (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 27-MAR-2021, and was recovering from felt pressure in both eyes / pressure in back of eyes, and lymph node slightly raised. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Parosmia, Taste disorder
Clinical narrative: FLU LIKE SYMPTOMS; TASTE NOT AS USUAL; DECREASE IN SMELL; HEADACHE; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient was not pregnant at the time of event reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1008609, and batch number: 1008609 expiry: 09-JUN-2021) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. Vaccinated on Left arm. No concomitant medications were reported. On 28-MAR-2021, the subject experienced headache. On 29-MAR-2021, the subject experienced decrease in smell. On an unspecified date, the subject experienced flu like symptoms, and taste not as usual. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 29-MAR-2021, and had not recovered from flu like symptoms, taste not as usual, and decrease in smell. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Pain, Pyrexia
Clinical narrative: BODY ACHE; CHILLS; FEELING UNWELL/FEEL LIKE ABSOLUTE GARBAGE; FEVER; HEADACHE; 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: Unk) dose was not reported, administered on 26-MAR-2021, (noon) 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 26-MAR-2021, the subject experienced body ache. On 26-MAR-2021, the subject experienced chills. On 26-MAR-2021, the subject experienced feeling unwell/feel like absolute garbage. On 26-MAR-2021, the subject experienced fever. On 26-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever, body ache, headache and feeling unwell/feel like absolute garbage was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: SORE UNDERNEATH THE ARM; HEADACHE; EXTREMELY TIRED; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805029, expiry: not reported) dose was not reported, once a total administered on 21-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced sore underneath the arm. On 26-MAR-2021, the subject experienced headache. On 26-MAR-2021, the subject experienced extremely tired. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from headache, extremely tired, and sore underneath the arm. This report was non-serious.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Skin lesion, Tinea infection
Clinical narrative: PINL SKIN LESION; SKIN REDNESS ON THIGH AND UPPER BODY; RINGWORM; This spontaneous report received from a health care professional concerned a 3 decade 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, 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 pinl skin lesion, skin redness on thigh and upper body, and ringworm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pinl skin lesion, skin redness on thigh and upper body, and ringworm. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Haemoptysis, Malaise
Clinical narrative: SPITTING UP BLOOD; TIGHTNESS IN CHEST; NOT FEELING WELL; This spontaneous report received from a consumer 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, 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 spitting up blood, tightness in chest, and not feeling well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the spitting up blood, tightness in chest and not feeling well was not reported. This report was non-serious.; Sender's Comments: MAC not required as per standard procedure as case was assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Illness, Myalgia, Nausea
Clinical narrative: SICKNESS  2 HOURS  AFTER VACCINATION; BODY SHAKING; SEVERE CHILLS; EVERY MUSCLE IN MY BODY ACHED; SPIKED A TEMPERATURE; SEVERE HEADACHE FOR DAYS; NAUSEA; 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 past medical history included severe case of covid quite a while ago. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) once a total 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. No concomitant medications were reported. On MAR-2021, the subject experienced sickness 2 hours after vaccination. On MAR-2021, the subject experienced body shaking. On MAR-2021, the subject experienced severe chills. On MAR-2021, the subject experienced every muscle in my body ached. On MAR-2021, the subject experienced spiked a temperature. On MAR-2021, the subject experienced severe headache for days. On MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe chills, sickness 2 hours after vaccination, body shaking, every muscle in my body ached, spiked a temperature, severe headache for days and nausea was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: SICKNESS  2 HOURS  AFTER VACCINATION; BODY SHAKING; SEVERE CHILLS; EVERY MUSCLE IN MY BODY ACHED; SPIKED A TEMPERATURE; SEVERE HEADACHE FOR DAYS; NAUSEA; 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 past medical history included severe case of covid quite a while ago. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) once a total 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. No concomitant medications were reported. On MAR-2021, the subject experienced sickness 2 hours after vaccination. On MAR-2021, the subject experienced body shaking. On MAR-2021, the subject experienced severe chills. On MAR-2021, the subject experienced every muscle in my body ached. On MAR-2021, the subject experienced spiked a temperature. On MAR-2021, the subject experienced severe headache for days. On MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe chills, sickness 2 hours after vaccination, body shaking, every muscle in my body ached, spiked a temperature, severe headache for days and nausea was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Application site pain, Back pain, Injection site pain, Pyrexia
Clinical narrative: LOWER BACK PAIN; A BIT OF PAIN IN MY ARM; INJECTION SITE PAIN; LOW GRADE FEVER; 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 25-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 MAR-2021, the subject experienced lower back pain. On MAR-2021, the subject experienced a bit of pain in arm. On MAR-2021, the subject experienced injection site pain. On MAR-2021, the subject experienced low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from injection site pain, low grade fever, lower back pain, and a bit of pain in my arm. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: HEADACHES; NAUSEA; FATIGUE; CHEST TIGHTNESS; DIZZINESS; VERTIGO; This spontaneous report received from a patient concerned a 43 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: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered to the left arm, on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced chest tightness. On MAR-2021, the subject experienced dizziness. On MAR-2021, the subject experienced vertigo. On 16-MAR-2021, the subject experienced headaches. On 16-MAR-2021, the subject experienced nausea. On 16-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, and vertigo, and the outcome of chest tightness, dizziness, headaches and nausea was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: HEADACHES; NAUSEA; FATIGUE; CHEST TIGHTNESS; DIZZINESS; VERTIGO; This spontaneous report received from a patient concerned a 43 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: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered to the left arm, on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced chest tightness. On MAR-2021, the subject experienced dizziness. On MAR-2021, the subject experienced vertigo. On 16-MAR-2021, the subject experienced headaches. On 16-MAR-2021, the subject experienced nausea. On 16-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, and vertigo, and the outcome of chest tightness, dizziness, headaches and nausea was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Nausea, Pain in extremity
Clinical narrative: FINGERS AND TOES FREEZING; CHILLS; SORE ARM; FEVER; SUPER FATIGUE; SICK TO STOMACH; 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, one total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced fingers and toes freezing. On 2021, the subject experienced chills. On 2021, the subject experienced sore arm. On 2021, the subject experienced fever. On 2021, the subject experienced super fatigue. On 2021, the subject experienced sick to my stomach. Laboratory data included: Body temperature (NR: not provided) 100.0 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, fever, chills, super fatigue, fingers and toes freezing and sick to stomach was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness, Pyrexia
Clinical narrative: FINGERS AND TOES FREEZING; CHILLS; SORE ARM; FEVER; SUPER FATIGUE; SICK TO STOMACH; 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, one total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced fingers and toes freezing. On 2021, the subject experienced chills. On 2021, the subject experienced sore arm. On 2021, the subject experienced fever. On 2021, the subject experienced super fatigue. On 2021, the subject experienced sick to my stomach. Laboratory data included: Body temperature (NR: not provided) 100.0 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, fever, chills, super fatigue, fingers and toes freezing and sick to stomach was not reported. This report was non-serious.