chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Antibody test abnormal
Clinical narrative: THEY GOT  NO ANTOBODIES AFTER RECEIVING  THEIR COVID 19 VACCINE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included multiple myeloma. The patient received daratumumab (form of admin, route of admin, and batch number were not reported) dose and frequency were not reported from 2019 for multiple myeloma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 did not get antibodies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with daratumumab was not reported. The outcome of did not get antibodies was not reported. 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: F
Vaccine: COVID19
Symptoms: Dysgeusia, Oral discomfort, Suspected COVID-19
Clinical narrative: BITTER TASTE; BURNING IN MOUTH; SUSPECTED COVID-19 INFECTION (TIRED, HEADACHE); This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included several allergies, anxiety, and other health conditions, and other pre-existing medical conditions included completed denture cleaning at dentist. 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 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 15-MAR-2021, the subject experienced suspected covid-19 infection. On 17-MAR-2021, the subject experienced bitter taste. On 17-MAR-2021, the subject experienced burning in mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, bitter taste, and burning in mouth. This report was non-serious.; Sender's Comments: MAC not required as per standard procedure as case was assessed as non-serious.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: BODY ACHES; EXCESSIVE FATIGUE/EXCEEDINGLY TIRED; FEVER; HEADACHES; PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 54 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: 1805022, and expiry: unknown) dose was not reported, administered on 07-MAR-2021 (vaccinated at left arm) for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced pain at injection site. On 08-MAR-2021, the subject experienced body aches. On 08-MAR-2021, the subject experienced excessive fatigue. On 08-MAR-2021, the subject experienced fever. On 08-MAR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and fever on 09-MAR-2021, pain at injection site on 10-MAR-2021, and headaches on 14-MAR-2021, and had not recovered from excessive fatigue. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SIDE EFFECTS; 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 administration not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Injection site pain, Pyrexia
Clinical narrative: SWEATING; CHILLS; FEVER; HEADACHE; SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 61 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: 1805025, and expiry: unknown) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced sweating. On 18-MAR-2021, the subject experienced chills. On 18-MAR-2021, the subject experienced fever. On 18-MAR-2021, the subject experienced headache. On 18-MAR-2021, the subject experienced soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, chills, and fever on MAR-2021, and had not recovered from headache, and soreness at injection site. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: BAD EFFECTS FOR DAYS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included lupus. 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 bad effects for days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad effects for days was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Pyrexia
Clinical narrative: FEELING WARM; CHILLS; RUNNING A 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) dose was not reported, administered on left arm on 20-MAR-2021 10:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-MAR-2021, the subject experienced feeling warm. On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced running a fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, running a fever and feeling warm was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dry mouth, Fatigue, Lethargy, Malaise
Clinical narrative: LETHARGY; FATIGUE; FEELING OUT OF ELEMENT; DRY MOUTH; LIGHT-HEADED; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included many co-morbidities. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 09-JUN-2021) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-MAR-2021 20:00, the subject experienced lethargy. On 19-MAR-2021 20:00, the subject experienced fatigue. On 19-MAR-2021 20:00, the subject experienced feeling out of element. On 19-MAR-2021 20:00, the subject experienced dry mouth. On 19-MAR-2021 20:00, the subject experienced light-headed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lethargy, fatigue, feeling out of element, dry mouth, and light-headed. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Myalgia, Pyrexia, Sensitive skin
Clinical narrative: SENSITIVE SKIN STOMACH AND BACK; FOGGY; MUSCLE PAIN; FEVER; FATIGUE; 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: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced sensitive skin stomach and back, foggy, muscle pain, fever, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and had not recovered from muscle pain, sensitive skin stomach and back, foggy, and fatigue. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Product administered to patient of inappropriate age, Pyrexia, Vomiting
Clinical narrative: VOMITING; FEVER; NAUSEA; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a parent concerned a child of unspecified 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 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced vomiting. On 19-MAR-2021, the subject experienced fever. On 19-MAR-2021, the subject experienced nausea. On 19-MAR-2021, the subject experienced product administered to subject of inappropriate age. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, nausea, vomiting and product administered to patient of inappropriate age was not reported. This report was non-serious. Version created to amend previously reported information on 20-MAR-2021. Upon review the following information was amended: The event as Product administered to patient of inappropriate age was added and relevant fields were updated.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: 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: 1085031, expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 09:00 am to left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and the outcome of headache was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: FATIGUE; This spontaneous report received from a vaccine facility 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 is 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 recovered from fatigue. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Oral mucosal eruption, Rash
Clinical narrative: RASH IN MOUTH; RASH IN NECK, TORSO; 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: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 20-MAR-2020, the subject experienced rash in mouth. On 20-MAR-2020, the subject experienced rash in neck, torso. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash in mouth and rash in neck, torso was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: EXTREME FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021   to left arm for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced extreme fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of extreme fatigue was not reported. This report was non-serious.    .
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Myalgia
Clinical narrative: CHILLS; RUNNY NOSE; LOSS OF APPETITE; NAUSEA; HEADACHE; FATIGUE; 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: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021, in the right arm, for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced loss of appetite. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced fatigue. On MAR-2021, the subject experienced muscle ache. On 20-MAR-2021, the subject experienced runny nose. On 20-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 runny nose, chills, loss of appetite, nausea, headache, fatigue, and muscle ache. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Rhinorrhoea
Clinical narrative: CHILLS; RUNNY NOSE; LOSS OF APPETITE; NAUSEA; HEADACHE; FATIGUE; 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: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021, in the right arm, for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced loss of appetite. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced fatigue. On MAR-2021, the subject experienced muscle ache. On 20-MAR-2021, the subject experienced runny nose. On 20-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 runny nose, chills, loss of appetite, nausea, headache, fatigue, and muscle ache. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: BODY ACHES; FEVER; EXHAUSTED; 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: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On an unspecified date, the subject experienced body aches, fever, and exhausted. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, body aches and exhausted was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Discomfort, Headache, Rhinorrhoea
Clinical narrative: STOMACH HURTS OFF AND ON; NASAL DISCHARGE AND SNIFFLING; BODY FEELS TOO HEAVY; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's 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: 1805025, expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 12:00 to right arm for prophylactic vaccination. Concomitant medications included methadone, mirtazapine, propranolol, and risperidone. On 20-MAR-2021, the subject experienced stomach hurts off and on. On 20-MAR-2021, the subject experienced nasal discharge and sniffling. On 20-MAR-2021, the subject experienced body feels too heavy. On 20-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, stomach hurts off and on, nasal discharge and sniffling, and body feels too heavy. This report was non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Mucosal disorder, Pain
Clinical narrative: BODY ACHES; MUCOUS; CHILLS; HEADACHE; FEELING NOT GOOD; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination at left arm. No concomitant medications were reported. On MAR-2021, the subject experienced feeling not good. On 19-MAR-2021, the subject experienced body aches. On 19-MAR-2021, the subject experienced mucous. On 19-MAR-2021, the subject experienced chills. On 19-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 chills, headache, mucous, body aches, and feeling not good. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dyspnoea, Fatigue, Oxygen saturation
Clinical narrative: SHAKY; DIARRHEA; difficulty breathing; ACHY SORE ARMS; CHILLS; TIRED; FEVER; This spontaneous report received from a patient concerned a 92 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, diabetes, and cholesterol, 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, intramuscular, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 11:00 to right arm for prophylactic vaccination. Concomitant medications included simvastatin for cholesterol. On 18-MAR-2021, the subject experienced achy sore arms. On 18-MAR-2021, the subject experienced chills. On 18-MAR-2021, the subject experienced tired. On 18-MAR-2021, the subject experienced fever. On 19-MAR-2021, the subject experienced diarrhea. On 19-MAR-2021, the subject experienced difficulty breathing. Laboratory data included: Fever (NR: not provided) 100.9. On 19-MAR-2021 07:00, Laboratory data included: Fever (NR: not provided) 101.7. On 20-MAR-2021, Laboratory data included: Fever (NR: not provided) Temp Fluctuated between 99 and 101.7. On 21-MAR-2021, Laboratory data included: Fever (NR: not provided) 97.2. On 21-MAR-2021 13:30, Laboratory data included: Fever (NR: not provided) 100.2. On an unspecified date, the subject experienced shaky. Laboratory data (dates unspecified) included: Pulse oximetry (NR: not provided) Unknown. Treatment medications (dates unspecified) included: paracetamol. The dose of covid-19 vaccine ad26.cov2.s was not changed. The patient recovered from diarrhea on 20-MAR-2021, and achy sore arms, and chills on 18-MAR-2021, was recovering from difficulty breathing, had not recovered from fever, and tired, and the outcome of shaky was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Tremor
Clinical narrative: SHAKY; DIARRHEA; difficulty breathing; ACHY SORE ARMS; CHILLS; TIRED; FEVER; This spontaneous report received from a patient concerned a 92 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, diabetes, and cholesterol, 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, intramuscular, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 11:00 to right arm for prophylactic vaccination. Concomitant medications included simvastatin for cholesterol. On 18-MAR-2021, the subject experienced achy sore arms. On 18-MAR-2021, the subject experienced chills. On 18-MAR-2021, the subject experienced tired. On 18-MAR-2021, the subject experienced fever. On 19-MAR-2021, the subject experienced diarrhea. On 19-MAR-2021, the subject experienced difficulty breathing. Laboratory data included: Fever (NR: not provided) 100.9. On 19-MAR-2021 07:00, Laboratory data included: Fever (NR: not provided) 101.7. On 20-MAR-2021, Laboratory data included: Fever (NR: not provided) Temp Fluctuated between 99 and 101.7. On 21-MAR-2021, Laboratory data included: Fever (NR: not provided) 97.2. On 21-MAR-2021 13:30, Laboratory data included: Fever (NR: not provided) 100.2. On an unspecified date, the subject experienced shaky. Laboratory data (dates unspecified) included: Pulse oximetry (NR: not provided) Unknown. Treatment medications (dates unspecified) included: paracetamol. The dose of covid-19 vaccine ad26.cov2.s was not changed. The patient recovered from diarrhea on 20-MAR-2021, and achy sore arms, and chills on 18-MAR-2021, was recovering from difficulty breathing, had not recovered from fever, and tired, and the outcome of shaky was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: HEADACHE; FEVER STARTED  24 HOURS LATER; COMPLAIN OF LEFT ARM PAIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and expiry: 25-MAR-2021) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced complain of left arm pain. On 19-MAR-2021, the subject experienced headache. On 19-MAR-2021, the subject experienced fever started 24 hours later. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and the outcome of fever started 24 hours later and complain of left arm pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: TWO RAISED BUMPS (RASH LIKE) ON BACK OF NECK; 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: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, 1 total, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced two raised bumps (rash like) on back of neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from two raised bumps (rash like) on back of neck. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a patient concerned a 25 year old female. The patient's height, and weight were not reported. The patient's past medical history included allergy to morphine, and concurrent conditions included acute migraines. The patient experienced drug allergy when treated with morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and batch number: 1808609 expiry: 09-JUN-2021) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: sumatriptan. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: LOWER PART OF LEFT LEG SWOLLEN; This spontaneous report received from a consumer concerned a 71 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: 1805029, expiry: UNKNOWN) dose was not reported, one total, in right arm administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced lower part of left leg swollen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lower part of left leg swollen. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Diarrhoea, Headache, Heart rate increased, Hypertension
Clinical narrative: JUMPING HEART; HIGH BLOOD PRESSURE; PROBLEM WITH WHITE BLOOD CELLS; DIARRHEA; NAUSEA; HEADACHE; SLEEPY; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's past medical history included hospitalization, and covid-19 infection, and concurrent conditions included immune variable disease. 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 on 15-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 jumping heart. On MAR-2021, the subject experienced high blood pressure. On MAR-2021, the subject experienced problem with white blood cells. On MAR-2021, the subject experienced diarrhea. On MAR-2021, the subject experienced nausea.  On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced sleepy. Laboratory data included: Blood pressure (NR: not provided) high, COVID-19 virus test (NR: not provided) Negative, and White blood cells (NR: not provided) problem. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the jumping heart, high blood pressure, problem with white blood cells, nausea, diarrhea, headache and sleepy was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
Sex: F
Vaccine: COVID19
Symptoms: Nausea, SARS-CoV-2 test, Somnolence, White blood cell count, White blood cell disorder
Clinical narrative: JUMPING HEART; HIGH BLOOD PRESSURE; PROBLEM WITH WHITE BLOOD CELLS; DIARRHEA; NAUSEA; HEADACHE; SLEEPY; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's past medical history included hospitalization, and covid-19 infection, and concurrent conditions included immune variable disease. 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 on 15-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 jumping heart. On MAR-2021, the subject experienced high blood pressure. On MAR-2021, the subject experienced problem with white blood cells. On MAR-2021, the subject experienced diarrhea. On MAR-2021, the subject experienced nausea.  On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced sleepy. Laboratory data included: Blood pressure (NR: not provided) high, COVID-19 virus test (NR: not provided) Negative, and White blood cells (NR: not provided) problem. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the jumping heart, high blood pressure, problem with white blood cells, nausea, diarrhea, headache and sleepy was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort, Nasopharyngitis, Pain
Clinical narrative: BODY ACHES; UNCOMFORTABLE; COLD; 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) dose was not reported, 1 total, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. Batch number was not reported. The company is unable to perform follow up to request batch/lot number. On 20-MAR-2021, the subject experienced body aches. On 20-MAR-2021, the subject experienced uncomfortable. On 20-MAR-2021, the subject experienced cold. On 20-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 body aches, chills, cold, and uncomfortable. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: BAD HEADACHE; MILD FEVER; 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, once a total administered on 15-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 bad headache. On 16-MAR-2021, the subject experienced mild fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from bad headache, and mild fever. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature abnormal, Dizziness, Flatulence, Pain
Clinical narrative: BODY ACHES; LIGHT HEADEDNESS; GAS; TEMPERATURE; 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: 1805025, expiry: 25-MAY-2021) dose was not reported, administered on 19-MAR-2021 14:00 in the left arm for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced body aches. On 20-MAR-2021, the subject experienced light headedness. On 20-MAR-2021, the subject experienced gas. On 20-MAR-2021, the subject experienced temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body aches, light headedness, gas, and temperature. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Myalgia
Clinical narrative: PAIN UNDER ARMS; CHILLS; MUSCLE ACHES; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced pain under arms. On 19-MAR-2021, the subject experienced chills. On 19-MAR-2021, the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, pain under arms, and muscle aches. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; HEADACHE; 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: Unknown) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination.  Batch no. is not reported. No concomitant medications were reported.  On 19-MAR-2021, the subject experienced body aches. On 19-MAR-2021, the subject experienced chills. On 19-MAR-2021, the subject experienced headache. On 19-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) Unknown. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, fever, chills and body aches was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: 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 11-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 18-MAR-2021, the subject experienced leg swelling. On 18-MAR-2021, the subject experienced ankle swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the leg swelling and ankle swelling was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: VERY SORE ARM; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose was not reported, administered on 19-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 19-MAR-2021, the subject experienced very sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of very sore arm was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Neck pain
Clinical narrative: LITTLE SORENESS IN NECK; LITTLE HEADACHE/HEADACHE WAS KIND OF SINUS HEADACHE; 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 past medical history included Covid, and concurrent conditions included neck soreness.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination on Left arm. No concomitant medications were reported.  On JUN-2020, the subject experienced little soreness in neck. On MAR-2021, the subject experienced little headache/headache is kind of sinus headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the little headache/headache is kind of sinus headache and little soreness in neck was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Nausea
Clinical narrative: CHILLS; MUSCLE ACHES; NAUSEA; This spontaneous report received from a vaccine facility concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 19-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 19-MAR-2021, the subject experienced chills. On 19-MAR-2021, the subject experienced muscle aches. On 19-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, and muscle aches, and the outcome of nausea was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Rash vesicular
Clinical narrative: BLISTERY RASH ON BACK (INCLUDE ITCHY AND SWELLING); 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, start therapy date were not reported for prophylactic vaccination. he batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced blistery rash on back (include itchy and swelling). Treatment medications (dates unspecified) included: camphor/diphenhydramine hydrochloride/zinc oxide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blistery rash on back (include itchy and swelling). This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: SEVERE HEADACHE; 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: JJ10802072, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: FATIGUE; This spontaneous report received from a vaccine facility via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose 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 fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on MAR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: WHOLE BODY MUSCLE ACHES; HEADACHE; 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: 1805020 expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination on left deltoid. No concomitant medications were reported. On 21-MAR-2021, the subject experienced whole body muscle aches. On 21-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 whole body muscle aches, and headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: VERY 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of very tired was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Injection site pain, Muscular weakness, Myalgia
Clinical narrative: DIZZINESS; MUSCLE WEAKNESS; HEADACHE; PAIN AT INJECTION SITE; MUSCLE ACHES; 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: 1805031, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination on right deltoid. No concomitant medications were reported. On 18-MAR-2021, the subject experienced pain at injection site. On 18-MAR-2021, the subject experienced muscle aches. On 19-MAR-2021, the subject experienced dizziness. On 19-MAR-2021, the subject experienced muscle weakness. On 19-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, muscle aches, muscle weakness, dizziness, and pain at injection site. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: FELT LIKE DEATH; 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported, the company unable to perform follow up to batch numbers. No concomitant medications were reported. On an unspecified date, the subject experienced felt like death. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt like death was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache
Clinical narrative: FELT A LITTLE COLD; SLIGHT HEADACHE; 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: 1805022 expiry: UNKNOWN) dose was not reported, administered on 07-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced felt a little cold. On 09-MAR-2021, the subject experienced slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt a little cold, and slight headache on 09-MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: VACCINE EXPOSURE VIA BREAST MILK; This spontaneous report received from a parent concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient's parent received covid-19 vaccine ad26.cov2.s (suspension for injection, Transmammary, batch number: Unk) dose was not reported, administered on 16-MAR-2021 for an unspecified indication. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced vaccine exposure via breast milk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine exposure via breast milk was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Rash
Clinical narrative: RASH; TIRED; 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 date: unknown) dose was not reported, administered on 17-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 17-MAR-2021, the subject experienced tired. On 19-MAR-2021, the subject experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired on 19-MAR-2021, and had not recovered from rash. This report was non-serious.