chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Headache, Pain
Clinical narrative: BODY ACHE; CHILLS; HEADACHE; FATIGUE; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included severe anaphylaxis with tree nuts, anaphylaxis with nsaids (angioedema), and anaphylaxis with fish. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, and batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 14:15 for prophylactic vaccination. Concomitant medications included epinephrine.  On 11-MAR-2021 approximately 8:45 p.m-9:45 p.m., the subject experienced shortness of breath. On an unspecified date, the subject experienced body ache, chills, headache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath on 11-MAR-2021, and the outcome of chills, headache, fatigue and body ache was not reported. The reporter causality and Company causality between JNJ-78436735 and shortness of breath, chills, headache, fatigue and body ache was possible.  This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: INJECTION SITE PAIN/SORE ARM; LUMP AT INJECTION SITE; REDNESS AT INJECTION SITE; This spontaneous report received from a parent 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 batch number: 1805022) dose was not reported, once a total administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced injection site pain/sore arm. On 06-MAR-2021, the subject experienced lump at injection site. On 06-MAR-2021, the subject experienced redness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain/sore arm, lump at injection site, and redness at injection site. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: RED LUMP AT THE SITE OF INJECTION; RED AT THE SITE OF INJECTION; HOT AT INJECTION SITE; SORE AT INJECTION SITE; ITCHY AT INJECTION SITE; FATIGUE; BODY ACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced body ache. On 09-MAR-2021, the subject experienced fatigue. On 10-MAR-2021, the subject experienced red lump at the site of injection. On 10-MAR-2021, the subject experienced red at the site of injection. On 10-MAR-2021, the subject experienced hot at injection site. On 10-MAR-2021, the subject experienced sore at injection site. On 10-MAR-2021, the subject experienced itchy at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, and fatigue on MAR-2021, and had not recovered from red lump at the site of injection, hot at injection site, sore at injection site, itchy at injection site, and red at the site of injection. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Pain
Clinical narrative: RED LUMP AT THE SITE OF INJECTION; RED AT THE SITE OF INJECTION; HOT AT INJECTION SITE; SORE AT INJECTION SITE; ITCHY AT INJECTION SITE; FATIGUE; BODY ACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced body ache. On 09-MAR-2021, the subject experienced fatigue. On 10-MAR-2021, the subject experienced red lump at the site of injection. On 10-MAR-2021, the subject experienced red at the site of injection. On 10-MAR-2021, the subject experienced hot at injection site. On 10-MAR-2021, the subject experienced sore at injection site. On 10-MAR-2021, the subject experienced itchy at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, and fatigue on MAR-2021, and had not recovered from red lump at the site of injection, hot at injection site, sore at injection site, itchy at injection site, and red at the site of injection. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain
Clinical narrative: EXCESSIVE PAIN; SEVERE HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. Initial information was processed along with additional information received on 18-MAR-2021. 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: 1805025, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced excessive pain. On 08-MAR-2021, the subject experienced severe headache. On 08-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe headache, excessive pain and nausea was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be voided (did not meet pqc criteria) based on the PQC evaluation/investigation performed.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Feeling cold, Pain
Clinical narrative: BODY HURT; FEELING COLD; SHAKING/CHILLS; JOINT SORE; 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, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-MAR-2021, the subject experienced body hurt. On 12-MAR-2021, the subject experienced feeling cold. On 12-MAR-2021, the subject experienced shaking/chills. On 12-MAR-2021, the subject experienced joint sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shaking/chills, and the outcome of body hurt, joint sore and feeling cold was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Migraine
Clinical narrative: MIGRAINE HEADACHE; DIARRHEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included cat hair allergy. The patient experienced drug allergy when treated with erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805016, and batch number: 1805016 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 12:30 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced migraine headache. On 13-MAR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 13-MAR-2021, and was recovering from migraine headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Hypertension
Clinical narrative: HIGH BLOOD PRESSURE; DIZZINESS; 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 hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced dizziness. On 08-MAR-2021, the subject experienced high blood pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, and high blood pressure. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain, Vomiting
Clinical narrative: SORENESS; VOMITING; TIREDNESS; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced soreness, vomiting, tiredness, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness, tiredness, nausea and vomiting was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: BODY ACHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch no. was not reported but it has been requested.  No concomitant medications were reported. On 13-MAR-2021, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of body aches was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain, Pyrexia
Clinical narrative: LOW GRADE FEVER; EXTREME EXHAUSTION; ACHE AND PAIN ALL OVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis. 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, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 16:15 to Right Arm for prophylactic vaccination. No concomitant medications were reported.  On 11-MAR-2021, the subject experienced low grade fever. On 11-MAR-2021, the subject experienced extreme exhaustion. On 11-MAR-2021, the subject experienced ache and pain all over. Laboratory data included: Body temperature (NR: not provided) 99 degrees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low grade fever, extreme exhaustion, and ache and pain all over on 12-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: TIREDNESS; SLIGHT HEADACHE; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient's past medical history included no medical history. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported on left arm, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-MAR-2021, the patient experienced tiredness. On 12-MAR-2021, the patient experienced slight headache. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tiredness, and slight headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: FATIGUE; HEADACHE; 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: Unk 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. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, headache and sore arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: HEADACHE; EXTREME NAUSEA; FATIGUE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced extreme nausea. On MAR-2021, the subject experienced fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, fatigue, and extreme nausea. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, COVID-19, Dysgeusia, Fatigue, Oropharyngeal pain
Clinical narrative: COVID 19 INFECTION; FATIGUE; BACK PAIN (WITH RADIATION); FEVER; BACK PAIN; SORE THROAT; DYSGEUSIA; 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 thyroid, and allergy. 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 10-MAR-2021 for prophylactic vaccination. Concomitant medications included bupropion hydrochloride. On 10-MAR-2021, the subject experienced dysgeusia. On 11-MAR-2021, the subject experienced back pain. On 11-MAR-2021, the subject experienced sore throat. On 11-MAR-2021, the subject experienced back pain (with radiation). On 11-MAR-2021, the subject experienced fever. On an unspecified date, the subject experienced covid 19 infection, and fatigue. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive, and Low grade fever (NR: not provided) low 99.4. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from back pain, dysgeusia, and fever on MAR-2021, had not recovered from sore throat, and the outcome of back pain (with radiation), covid 19 infection and fatigue was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: COVID 19 INFECTION; FATIGUE; BACK PAIN (WITH RADIATION); FEVER; BACK PAIN; SORE THROAT; DYSGEUSIA; 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 thyroid, and allergy. 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 10-MAR-2021 for prophylactic vaccination. Concomitant medications included bupropion hydrochloride. On 10-MAR-2021, the subject experienced dysgeusia. On 11-MAR-2021, the subject experienced back pain. On 11-MAR-2021, the subject experienced sore throat. On 11-MAR-2021, the subject experienced back pain (with radiation). On 11-MAR-2021, the subject experienced fever. On an unspecified date, the subject experienced covid 19 infection, and fatigue. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive, and Low grade fever (NR: not provided) low 99.4. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from back pain, dysgeusia, and fever on MAR-2021, had not recovered from sore throat, and the outcome of back pain (with radiation), covid 19 infection and fatigue was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Chills
Clinical narrative: OTHER SYMPTOMS EXPERIENCED; BODY CHILLS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced other symptoms experienced. On MAR-2021, the subject experienced body chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body chills and other symptoms experienced was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Injection site pain, Neck pain
Clinical narrative: NECK PAIN; LOWER BACK PAIN; ARM PAIN WHERE VACCINE WAS RECEIVED; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 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 neck pain. On MAR-2021, the subject experienced lower back pain. On MAR-2021, the subject experienced arm pain where vaccine was received. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the neck pain, lower back pain and arm pain where vaccine was received was not reported. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Pyrexia
Clinical narrative: BODY FELT HOT; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 46 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, intramuscular, batch number: Unknown) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced body felt hot. On 12-MAR-2021, the subject experienced headache. On 12-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, fever, and body felt hot. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Heart rate, Heart rate increased, Nasopharyngitis
Clinical narrative: FEVER; NAUSEA; COLD LIKE SYMPTOMS; WINDED; CANNOT STAY AWAKE; HEART RATE A LITTLE ACCELERATED; PULSE OXYGENATION AVERAGED ABOUT 90PP; VERY TIRED; 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, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 09-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 winded. On MAR-2021, the subject experienced cannot stay awake. On MAR-2021, the subject experienced heart rate a little accelerated. On MAR-2021, the subject experienced very tired. Laboratory data included: Body temperature (NR: not provided) Low, and Oxygen saturation decreased (NR: not provided) about 90. On 09-MAR-2021, the subject experienced cold like symptoms. On 11-MAR-2021, the subject experienced fever. On 11-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cold like symptoms, fever, nausea, winded, very tired, cannot stay awake and heart rate a little accelerated was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Oxygen saturation, Oxygen saturation decreased, Pyrexia, Somnolence
Clinical narrative: FEVER; NAUSEA; COLD LIKE SYMPTOMS; WINDED; CANNOT STAY AWAKE; HEART RATE A LITTLE ACCELERATED; PULSE OXYGENATION AVERAGED ABOUT 90PP; VERY TIRED; 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, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 09-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 winded. On MAR-2021, the subject experienced cannot stay awake. On MAR-2021, the subject experienced heart rate a little accelerated. On MAR-2021, the subject experienced very tired. Laboratory data included: Body temperature (NR: not provided) Low, and Oxygen saturation decreased (NR: not provided) about 90. On 09-MAR-2021, the subject experienced cold like symptoms. On 11-MAR-2021, the subject experienced fever. On 11-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cold like symptoms, fever, nausea, winded, very tired, cannot stay awake and heart rate a little accelerated was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Hiccups
Clinical narrative: HICCUPS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-MAR-2021, the subject experienced hiccups. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hiccups. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: CHILL; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-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 chill. On 12-MAR-2021, the subject experienced headache. On 12-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 headache, fatigue, and chill. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain
Clinical narrative: This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, 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 body aches, nausea, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body aches, nausea and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Sensory disturbance
Clinical narrative: STINGING; BURNING/ TINGLING IN ENTIRE ARM; COULD FEEL THE CIRCULATION; 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) dose was not reported, administered on 12-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 stinging. On 12-MAR-2021, the subject experienced burning/ tingling in entire arm. On 12-MAR-2021, the subject experienced could feel the circulation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stinging, burning/ tingling in entire arm and could feel the circulation was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: BURNING EYES; SORE THROAT; FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-MAR-2021, the subject experienced burning eyes. On 14-MAR-2021, the subject experienced sore throat. On 14-MAR-2021, the subject experienced fever. On 14-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, burning eyes, sore throat and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: SEVERE HEADACHES; 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 on right deltoid, batch number: 1805028, and expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. Concomitant medications included ibuprofen. On MAR-2021, the subject experienced severe headaches. On MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe headaches and chills was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: FAINT HEART PALPITATIONS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested  No concomitant medications were reported. On 14-MAR-2021, the subject experienced faint heart palpitations. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from faint heart palpitations. This report was non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: TIREDNESS; HIVES A COUPLE ON HER BACK AND ONE ON HER  CHEST AND ONE ON HER NECK; HOT - 99 CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 (vaccination at left deltoid) for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced hives a couple on her back and one on her chest and one on her neck. On 13-MAR-2021, the subject experienced hot - 99 chills. On 13-MAR-2021, the subject experienced fever. On 13-MAR-2021, the subject experienced headache. On 14-MAR-2021, the subject experienced tiredness. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hives a couple on her back and one on her chest and one on her neck, fever, hot - 99 chills, headache, and tiredness. This report was non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: TIREDNESS; HIVES A COUPLE ON HER BACK AND ONE ON HER  CHEST AND ONE ON HER NECK; HOT - 99 CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 (vaccination at left deltoid) for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced hives a couple on her back and one on her chest and one on her neck. On 13-MAR-2021, the subject experienced hot - 99 chills. On 13-MAR-2021, the subject experienced fever. On 13-MAR-2021, the subject experienced headache. On 14-MAR-2021, the subject experienced tiredness. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hives a couple on her back and one on her chest and one on her neck, fever, hot - 99 chills, headache, and tiredness. This report was non-serious.
Age: 47.0
Sex: U
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: ADMINISTED JANSSEN COVID-19 VACCINE AS SECOND DOSE  AFTER PFIZER COVID-19 VACCINE; This spontaneous report received from a pharmacist concerned a 47 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient was previously treated with covid-19 vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced administed janssen covid-19 vaccine as second dose after pfizer covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administed janssen covid-19 vaccine as second dose after pfizer covid-19 vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Discomfort, Muscle tightness, Myalgia
Clinical narrative: MUSCLE PAIN IN THE ABDOMINAL AREA; OVERALL DISCOMFORT; TIGHTENING OF THE MUSCLES IN THE MOUTH; STOMACHACHE; WEAKNESS IN WALKING FROM THE HOLDING AREA TO THE PARKING LOT; 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) dose was not reported, once a total administered on 12-MAR-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced overall discomfort. On 12-MAR-2021, the subject experienced tightening of the muscles in the mouth. On 12-MAR-2021, the subject experienced stomachache. On 12-MAR-2021, the subject experienced weakness in walking from the holding area to the parking lot. On an unspecified date, the subject experienced muscle pain in the abdominal area. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from overall discomfort, tightening of the muscles in the mouth, and weakness in walking from the holding area to the parking lot on 12-MAR-2021, and the outcome of stomachache and muscle pain in the abdominal area was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Pharyngeal erythema, Rhinorrhoea, Swelling
Clinical narrative: SWELLING UNDER BOTH ARMPITS; RUNNY NOSE; NASAL STUFFINESS; RED THROAT; This spontaneous report received from a parent concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included environmental allergies.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 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-MAR-2021, the subject experienced runny nose. On 10-MAR-2021, the subject experienced nasal stuffiness. On 10-MAR-2021, the subject experienced red throat. On 12-MAR-2021, the subject experienced swelling under both armpits. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling under both armpits, and runny nose, and the outcome of nasal stuffiness and red throat was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Muscle aches; 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, intramuscular, batch number was not reported) .5 ml, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced muscle aches. On 13-MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle aches and tired was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025) dose was not reported, administered on 09-MAR-2021 10:22 for prophylactic vaccination. No concomitant medications were reported.  On 09-MAR-2021, the subject experienced vaccine was used after the vial puncture past 6 hours mark in the fridge. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine was used after the vial puncture past 6 hours mark in the fridge was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 12-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Feeling hot, Nausea, Pain
Clinical narrative: MINOR ACHE IN SOME PART OF THE BODY AND WHOLE BODY ACHE; FEELING OF WARMTH; CHILLS; NAUSEA; WEAKNESS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 09:50 a.m. for prophylactic vaccination on left arm. No concomitant medications were reported. On 13-MAR-2021 17:00, the subject experienced minor ache in some part of the body and whole body ache. On 13-MAR-2021 17:00, the subject experienced feeling of warmth. On 13-MAR-2021 17:00, the subject experienced chills. On 13-MAR-2021 17:00, the subject experienced nausea. On 13-MAR-2021 17:00, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient recovered from chills on 13-MAR-2021, was recovering from minor ache in some part of the body and whole body ache, had not recovered from nausea, and feeling of warmth, and the outcome of weakness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Chest pain, Diarrhoea, Dyspnoea
Clinical narrative: ARM PAIN; SHORTNESS OF BREATH; DIARRHEA; CHEST PAIN; FATIGUE; STOMACH PAIN; JOINT PAIN; FEVER; HEADACHE; MUSCLE PAIN; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced stomach pain. On 06-MAR-2021, the subject experienced joint pain. On 06-MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced muscle pain. On 06-MAR-2021, the subject experienced nausea. On 07-MAR-2021, the subject experienced shortness of breath. On 07-MAR-2021, the subject experienced diarrhea. On 07-MAR-2021, the subject experienced chest pain. On 07-MAR-2021, the subject experienced fatigue. On 09-MAR-2021, the subject experienced arm pain. Laboratory data (dates unspecified) included: COVID-19 rapid POC test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, stomach pain, headache, muscle pain, nausea, chest pain, fatigue, shortness of breath, arm pain, and joint pain, and the outcome of diarrhea was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pain in extremity
Clinical narrative: ARM PAIN; SHORTNESS OF BREATH; DIARRHEA; CHEST PAIN; FATIGUE; STOMACH PAIN; JOINT PAIN; FEVER; HEADACHE; MUSCLE PAIN; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced stomach pain. On 06-MAR-2021, the subject experienced joint pain. On 06-MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced muscle pain. On 06-MAR-2021, the subject experienced nausea. On 07-MAR-2021, the subject experienced shortness of breath. On 07-MAR-2021, the subject experienced diarrhea. On 07-MAR-2021, the subject experienced chest pain. On 07-MAR-2021, the subject experienced fatigue. On 09-MAR-2021, the subject experienced arm pain. Laboratory data (dates unspecified) included: COVID-19 rapid POC test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, stomach pain, headache, muscle pain, nausea, chest pain, fatigue, shortness of breath, arm pain, and joint pain, and the outcome of diarrhea was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: ARM PAIN; SHORTNESS OF BREATH; DIARRHEA; CHEST PAIN; FATIGUE; STOMACH PAIN; JOINT PAIN; FEVER; HEADACHE; MUSCLE PAIN; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced stomach pain. On 06-MAR-2021, the subject experienced joint pain. On 06-MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced muscle pain. On 06-MAR-2021, the subject experienced nausea. On 07-MAR-2021, the subject experienced shortness of breath. On 07-MAR-2021, the subject experienced diarrhea. On 07-MAR-2021, the subject experienced chest pain. On 07-MAR-2021, the subject experienced fatigue. On 09-MAR-2021, the subject experienced arm pain. Laboratory data (dates unspecified) included: COVID-19 rapid POC test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, stomach pain, headache, muscle pain, nausea, chest pain, fatigue, shortness of breath, arm pain, and joint pain, and the outcome of diarrhea was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Pain, Pyrexia
Clinical narrative: CHILLS; DIZZY; FELT ACHY ALL DAY; LOW GRADE FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin unknown, batch number: unk) dose was not reported, administered on 09-MAR-2021 12:15 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced dizzy. On MAR-2021, the subject experienced felt achy all day. On MAR-2021, the subject experienced low grade fever. On 09-MAR-2021 20:30, the subject experienced chills. On 10-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99.7 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, dizzy, low grade fever and felt achy all day was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Fatigue, Insomnia, Lethargy, Myalgia
Clinical narrative: FATIGUE; ACHY BONES; ACHY MUSCLES; TROUBLE SLEEPING; LYING IN BED ALL THE DAY; This spontaneous report received from a patient concerned a 72 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, non smoker, unspecified antibiotic allergy, and no drug abuse. 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 12-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On 13-MAR-2021, the subject experienced fatigue. On 13-MAR-2021, the subject experienced achy bones. On 13-MAR-2021, the subject experienced achy muscles. On 13-MAR-2021, the subject experienced trouble sleeping. On 13-MAR-2021, the subject experienced lying in bed all the day. Laboratory data (dates unspecified) included: Ultrasound abdomen (NR: not provided) Fatty liver, gall bladder removed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, achy bones, achy muscles, and trouble sleeping, and the outcome of lying in bed all the day was not reported. This report was non-serious.