chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: ITCHINESS STARTED ON THE CHEST AND STOMACH AND THEN SPREAD THROUGHOUT THE BODY.; RASH THAT STARTED ON THE CHEST AND STOMACH AND THEN SPREAD THROUGHOUT THE BODY; CHILLS; FATIGUE; BODY ACHES; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included nickel, ore allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 at left deltoid for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced body aches. On 14-MAR-2021, the subject experienced chills. On 14-MAR-2021, the subject experienced fatigue. On 16-MAR-2021, the subject experienced itchiness started on the chest and stomach and then spread throughout the body. On 16-MAR-2021, the subject experienced rash that started on the chest and stomach and then spread throughout the body. Laboratory data (dates unspecified) included: Biopsy (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, and fatigue on 15-MAR-2021, and had not recovered from itchiness started on the chest and stomach and then spread throughout the body., and rash that started on the chest and stomach and then spread throughout the body. This report was non-serious.; Sender's Comments: MAC not required as per standard procedure as case was assessed as non-serious.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood urine present, Chills, Myalgia, Parosmia
Clinical narrative: SMELL OF COVID; TASTE WEIRD; HIP PAIN; MUSCLE ACHES; CHILLS; FEVER; BLOOD IN URINE; This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and hyperlipidemia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination in right arm. The batch number was not reported and has been requested.  No concomitant medications were reported. On JUL-2020, Laboratory data included: COVID-19 antigen test (NR: not provided) POSITIVE. On NOV-2020, Laboratory data included: COVID-19 PCR test (NR: not provided) NEGATIVE. On MAR-2021, the subject experienced blood in urine. On 22-MAR-2021, the subject experienced smell of covid. On 22-MAR-2021, the subject experienced taste weird. On 22-MAR-2021, the subject experienced hip pain. On 22-MAR-2021, the subject experienced muscle aches. On 22-MAR-2021, the subject experienced chills. On 22-MAR-2021, the subject experienced fever.  The patient was recovering from fever, muscle aches, smell of covid, taste weird, and hip pain, had not recovered from blood in urine, and the outcome of chills 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.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Taste disorder
Clinical narrative: SMELL OF COVID; TASTE WEIRD; HIP PAIN; MUSCLE ACHES; CHILLS; FEVER; BLOOD IN URINE; This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and hyperlipidemia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination in right arm. The batch number was not reported and has been requested.  No concomitant medications were reported. On JUL-2020, Laboratory data included: COVID-19 antigen test (NR: not provided) POSITIVE. On NOV-2020, Laboratory data included: COVID-19 PCR test (NR: not provided) NEGATIVE. On MAR-2021, the subject experienced blood in urine. On 22-MAR-2021, the subject experienced smell of covid. On 22-MAR-2021, the subject experienced taste weird. On 22-MAR-2021, the subject experienced hip pain. On 22-MAR-2021, the subject experienced muscle aches. On 22-MAR-2021, the subject experienced chills. On 22-MAR-2021, the subject experienced fever.  The patient was recovering from fever, muscle aches, smell of covid, taste weird, and hip pain, had not recovered from blood in urine, and the outcome of chills 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: Back pain, Mobility decreased, Nausea
Clinical narrative: SEVERE BACK PAIN; UNABLE TO MOVE; 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 the patient had no history of allergic reaction to vaccine, no other health condition, no neurological condition and no fever. 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 24-MAR-2021 10:10 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced severe back pain, unable to move, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, and the outcome of severe back pain and unable to move was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: DRUG EXPOSURE VIA BREAST MILK; This spontaneous report received from a consumer concerned a 3 week old patient of unspecified 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, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced drug exposure via breast milk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of drug exposure via breast milk was not reported. This report was non-serious. This parent/child case is linked to 20210347093.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Fatigue, Hypertension, Neck pain
Clinical narrative: NECK PAIN; ELBOW PAIN; HIGH BLOOD PRESSURE; LEFT ARM PAIN; SHOULDER PAIN; BODY ACHE; FATIGUE; This spontaneous report received from a patient 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, administered on 12-MAR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, Laboratory data included: Blood pressure (NR: not provided) High. On 12-MAR-2021, the subject experienced body ache. On 12-MAR-2021, the subject experienced fatigue. On 13-MAR-2021, the subject experienced shoulder pain. On 15-MAR-2021, the subject experienced left arm pain. On 16-MAR-2021, the subject experienced high blood pressure. On 27-MAR-2021, treatment medications included: paracetamol. On 01-APR-2021, the subject experienced elbow pain. On an unspecified date, the subject experienced neck pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, and fatigue on 14-MAR-2021, was recovering from high blood pressure, had not recovered from shoulder pain, and left arm pain, and the outcome of neck pain and elbow pain was not reported. This report was non-serious.; Sender's Comments: V1: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: NECK PAIN; ELBOW PAIN; HIGH BLOOD PRESSURE; LEFT ARM PAIN; SHOULDER PAIN; BODY ACHE; FATIGUE; This spontaneous report received from a patient 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, administered on 12-MAR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, Laboratory data included: Blood pressure (NR: not provided) High. On 12-MAR-2021, the subject experienced body ache. On 12-MAR-2021, the subject experienced fatigue. On 13-MAR-2021, the subject experienced shoulder pain. On 15-MAR-2021, the subject experienced left arm pain. On 16-MAR-2021, the subject experienced high blood pressure. On 27-MAR-2021, treatment medications included: paracetamol. On 01-APR-2021, the subject experienced elbow pain. On an unspecified date, the subject experienced neck pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, and fatigue on 14-MAR-2021, was recovering from high blood pressure, had not recovered from shoulder pain, and left arm pain, and the outcome of neck pain and elbow pain was not reported. This report was non-serious.; Sender's Comments: V1: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: UNSPECIFIED ADVERSE EVENT/ WIFE GOT YOUR SHOT AND ENDED  UP IN THE ER; 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 was not reported, once a total administered, start therapy date 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 unspecified adverse event/ wife got your shot and ended up in the er. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified adverse event/ wife got your shot and ended up in the er 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, COVID19
Symptoms: Depressed mood, Diarrhoea, Dizziness, Fatigue, Gastrointestinal disorder
Clinical narrative: VERY DEPRESSED; SLEEPING A LOT; MIGRAINE; SORED ARM, PAIN IN ARM; NAUSEA; WEIRD HEART BEAT; EXTREMELY TIRED; GI ISSUES; VOMIT; DIARRHEA; EXTREMELY DIZZY; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at time of reporting. the patient also stated that she had underlying condition.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 in left arm on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced weird heart beat. On 13-MAR-2021, the subject experienced extremely tired. On 13-MAR-2021, the subject experienced gi issues. On 13-MAR-2021, the subject experienced vomit. On 13-MAR-2021, the subject experienced diarrhea. On 13-MAR-2021, the subject experienced extremely dizzy. On 13-MAR-2021, the subject experienced migraine. On 13-MAR-2021, the subject experienced sored arm, pain in arm. On 13-MAR-2021, the subject experienced nausea. On 14-MAR-2021, the subject experienced very depressed. On 14-MAR-2021, the subject experienced sleeping a lot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from weird heart beat on 13-MAR-2021, and gi issues, vomit, extremely dizzy, and nausea, had not recovered from extremely tired, very depressed, sleeping a lot, migraine, and sored arm, pain in arm, 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 since case was assessed as non serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate irregular, Hypersomnia, Migraine, Nausea, Pain in extremity
Clinical narrative: VERY DEPRESSED; SLEEPING A LOT; MIGRAINE; SORED ARM, PAIN IN ARM; NAUSEA; WEIRD HEART BEAT; EXTREMELY TIRED; GI ISSUES; VOMIT; DIARRHEA; EXTREMELY DIZZY; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at time of reporting. the patient also stated that she had underlying condition.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 in left arm on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced weird heart beat. On 13-MAR-2021, the subject experienced extremely tired. On 13-MAR-2021, the subject experienced gi issues. On 13-MAR-2021, the subject experienced vomit. On 13-MAR-2021, the subject experienced diarrhea. On 13-MAR-2021, the subject experienced extremely dizzy. On 13-MAR-2021, the subject experienced migraine. On 13-MAR-2021, the subject experienced sored arm, pain in arm. On 13-MAR-2021, the subject experienced nausea. On 14-MAR-2021, the subject experienced very depressed. On 14-MAR-2021, the subject experienced sleeping a lot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from weird heart beat on 13-MAR-2021, and gi issues, vomit, extremely dizzy, and nausea, had not recovered from extremely tired, very depressed, sleeping a lot, migraine, and sored arm, pain in arm, 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 since case was assessed as non serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: VERY DEPRESSED; SLEEPING A LOT; MIGRAINE; SORED ARM, PAIN IN ARM; NAUSEA; WEIRD HEART BEAT; EXTREMELY TIRED; GI ISSUES; VOMIT; DIARRHEA; EXTREMELY DIZZY; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at time of reporting. the patient also stated that she had underlying condition.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 in left arm on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced weird heart beat. On 13-MAR-2021, the subject experienced extremely tired. On 13-MAR-2021, the subject experienced gi issues. On 13-MAR-2021, the subject experienced vomit. On 13-MAR-2021, the subject experienced diarrhea. On 13-MAR-2021, the subject experienced extremely dizzy. On 13-MAR-2021, the subject experienced migraine. On 13-MAR-2021, the subject experienced sored arm, pain in arm. On 13-MAR-2021, the subject experienced nausea. On 14-MAR-2021, the subject experienced very depressed. On 14-MAR-2021, the subject experienced sleeping a lot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from weird heart beat on 13-MAR-2021, and gi issues, vomit, extremely dizzy, and nausea, had not recovered from extremely tired, very depressed, sleeping a lot, migraine, and sored arm, pain in arm, 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 since case was assessed as non serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Decreased appetite, Depression, Dizziness, Fear
Clinical narrative: VERY DEPRESSED; SLEEPING A LOT; MIGRAINE; SORED ARM, PAIN IN ARM; NAUSEA; WEIRD HEART BEAT; EXTREMELY TIRED; GI ISSUES; VOMIT; DIARRHEA; EXTREMELY DIZZY; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at time of reporting. the patient also stated that she had underlying condition.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 in left arm on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced weird heart beat. On 13-MAR-2021, the subject experienced extremely tired. On 13-MAR-2021, the subject experienced gi issues. On 13-MAR-2021, the subject experienced vomit. On 13-MAR-2021, the subject experienced diarrhea. On 13-MAR-2021, the subject experienced extremely dizzy. On 13-MAR-2021, the subject experienced migraine. On 13-MAR-2021, the subject experienced sored arm, pain in arm. On 13-MAR-2021, the subject experienced nausea. On 14-MAR-2021, the subject experienced very depressed. On 14-MAR-2021, the subject experienced sleeping a lot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from weird heart beat on 13-MAR-2021, and gi issues, vomit, extremely dizzy, and nausea, had not recovered from extremely tired, very depressed, sleeping a lot, migraine, and sored arm, pain in arm, 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 since case was assessed as non serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Nausea, Palpitations, Social anxiety disorder, Suicidal behaviour
Clinical narrative: VERY DEPRESSED; SLEEPING A LOT; MIGRAINE; SORED ARM, PAIN IN ARM; NAUSEA; WEIRD HEART BEAT; EXTREMELY TIRED; GI ISSUES; VOMIT; DIARRHEA; EXTREMELY DIZZY; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at time of reporting. the patient also stated that she had underlying condition.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 in left arm on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced weird heart beat. On 13-MAR-2021, the subject experienced extremely tired. On 13-MAR-2021, the subject experienced gi issues. On 13-MAR-2021, the subject experienced vomit. On 13-MAR-2021, the subject experienced diarrhea. On 13-MAR-2021, the subject experienced extremely dizzy. On 13-MAR-2021, the subject experienced migraine. On 13-MAR-2021, the subject experienced sored arm, pain in arm. On 13-MAR-2021, the subject experienced nausea. On 14-MAR-2021, the subject experienced very depressed. On 14-MAR-2021, the subject experienced sleeping a lot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from weird heart beat on 13-MAR-2021, and gi issues, vomit, extremely dizzy, and nausea, had not recovered from extremely tired, very depressed, sleeping a lot, migraine, and sored arm, pain in arm, 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 since case was assessed as non serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting, Weight decreased
Clinical narrative: VERY DEPRESSED; SLEEPING A LOT; MIGRAINE; SORED ARM, PAIN IN ARM; NAUSEA; WEIRD HEART BEAT; EXTREMELY TIRED; GI ISSUES; VOMIT; DIARRHEA; EXTREMELY DIZZY; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at time of reporting. the patient also stated that she had underlying condition.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 in left arm on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced weird heart beat. On 13-MAR-2021, the subject experienced extremely tired. On 13-MAR-2021, the subject experienced gi issues. On 13-MAR-2021, the subject experienced vomit. On 13-MAR-2021, the subject experienced diarrhea. On 13-MAR-2021, the subject experienced extremely dizzy. On 13-MAR-2021, the subject experienced migraine. On 13-MAR-2021, the subject experienced sored arm, pain in arm. On 13-MAR-2021, the subject experienced nausea. On 14-MAR-2021, the subject experienced very depressed. On 14-MAR-2021, the subject experienced sleeping a lot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from weird heart beat on 13-MAR-2021, and gi issues, vomit, extremely dizzy, and nausea, had not recovered from extremely tired, very depressed, sleeping a lot, migraine, and sored arm, pain in arm, 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 since case was assessed as non serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Heart rate irregular, Injection site pain, Lethargy, Muscular weakness
Clinical narrative: AN IRREGULAR HEART BEAT; LETHARGY; ELEPHANT LEGS; PREMATURE ATRIAL CONTRACTIONS; PREMATURE VENTRICULAR CONTRACTIONS; MUSCLE WEAKNESS; INJECTION SITE PAIN; This spontaneous report received from a consumer concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included mild copd, and aortic aneurysm. The patient experienced drug allergy when treated with prednisone, and pseudoephedrine. 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 13-MAR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported. On 2020, Laboratory data included: Echocardiogram (NR: not provided) Unremarkable. On 16-MAR-2021, the subject experienced muscle weakness. On 16-MAR-2021, the subject experienced injection site pain. On 17-MAR-2021, the subject experienced premature atrial contractions. On 17-MAR-2021, the subject experienced premature ventricular contractions. On an unspecified date, the subject experienced elephant legs, an irregular heart beat, and lethargy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elephant legs, and lethargy, and muscle weakness on 22-MAR-2021, was recovering from injection site pain, and had not recovered from premature atrial contractions, premature ventricular contractions, and an irregular heart beat. This report was non-serious.; Sender's Comments: V1: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Supraventricular extrasystoles, Ventricular extrasystoles
Clinical narrative: AN IRREGULAR HEART BEAT; LETHARGY; ELEPHANT LEGS; PREMATURE ATRIAL CONTRACTIONS; PREMATURE VENTRICULAR CONTRACTIONS; MUSCLE WEAKNESS; INJECTION SITE PAIN; This spontaneous report received from a consumer concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included mild copd, and aortic aneurysm. The patient experienced drug allergy when treated with prednisone, and pseudoephedrine. 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 13-MAR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported. On 2020, Laboratory data included: Echocardiogram (NR: not provided) Unremarkable. On 16-MAR-2021, the subject experienced muscle weakness. On 16-MAR-2021, the subject experienced injection site pain. On 17-MAR-2021, the subject experienced premature atrial contractions. On 17-MAR-2021, the subject experienced premature ventricular contractions. On an unspecified date, the subject experienced elephant legs, an irregular heart beat, and lethargy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elephant legs, and lethargy, and muscle weakness on 22-MAR-2021, was recovering from injection site pain, and had not recovered from premature atrial contractions, premature ventricular contractions, and an irregular heart beat. This report was non-serious.; Sender's Comments: V1: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 POSITIVE; 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: 18022068, and expiry: unknown) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-MAR-2021, the subject experienced confirmed covid-19 positive. Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed covid-19 positive 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: Arthralgia, Body temperature, Bone pain, Chills, Headache
Clinical narrative: ARM PAIN; BODY ACHES; BONE PAIN (LEGS AND HIPS); RINGING IN EARS; CHILLS; JOINT PAIN (LEGS, BUTTOCKS AND  SHOULDER); FEVER; NAUSEA; HEADACHE; 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 past medical history included asthma, and concurrent conditions included antibiotic allergy, seasonal allergy, non smoker, and non alcoholic, and other pre-existing medical conditions included the patient had no drug abuse or illicit use.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 22-MAR-2021 09:30 in left arm for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced arm pain. On 22-MAR-2021, the subject experienced body aches. On 22-MAR-2021, the subject experienced bone pain (legs and hips). On 22-MAR-2021, the subject experienced ringing in ears. On 22-MAR-2021, the subject experienced chills. On 22-MAR-2021, the subject experienced joint pain (legs, buttocks and shoulder). On 22-MAR-2021, the subject experienced fever. On 22-MAR-2021, the subject experienced nausea. On 22-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and joint pain (legs, buttocks and shoulder), was recovering from fever, chills, and nausea, had not recovered from ringing in ears, headache, and arm pain, and the outcome of bone pain (legs and hips) was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia, Tinnitus
Clinical narrative: ARM PAIN; BODY ACHES; BONE PAIN (LEGS AND HIPS); RINGING IN EARS; CHILLS; JOINT PAIN (LEGS, BUTTOCKS AND  SHOULDER); FEVER; NAUSEA; HEADACHE; 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 past medical history included asthma, and concurrent conditions included antibiotic allergy, seasonal allergy, non smoker, and non alcoholic, and other pre-existing medical conditions included the patient had no drug abuse or illicit use.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 22-MAR-2021 09:30 in left arm for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced arm pain. On 22-MAR-2021, the subject experienced body aches. On 22-MAR-2021, the subject experienced bone pain (legs and hips). On 22-MAR-2021, the subject experienced ringing in ears. On 22-MAR-2021, the subject experienced chills. On 22-MAR-2021, the subject experienced joint pain (legs, buttocks and shoulder). On 22-MAR-2021, the subject experienced fever. On 22-MAR-2021, the subject experienced nausea. On 22-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and joint pain (legs, buttocks and shoulder), was recovering from fever, chills, and nausea, had not recovered from ringing in ears, headache, and arm pain, and the outcome of bone pain (legs and hips) was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as case was assessed as non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Fatigue, Myalgia, Respiratory tract congestion
Clinical narrative: COUGH; CHEST CONGESTION; TIRED; MUSCLE ACHES; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's past medical history included fall and concurrent conditions included high blood pressure, seasonal allergies and bleed on the brain. The patient experienced drug allergy when treated with ciprofloxacin. 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: 25-MAY-2021) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. Concomitant medications included metoprolol tartrate for blood pressure. On 13-MAR-2021, the subject experienced cough. On 13-MAR-2021, the subject experienced chest congestion. On 13-MAR-2021, the subject experienced tired. On 13-MAR-2021, the subject experienced muscle aches. On 25-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 97.2 Unit Not Reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cough, chest congestion, tired, and muscle aches. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Muscle tightness, Muscle twitching, Sinusitis
Clinical narrative: MUSCLE TIGHTNESS IN FOREARMS; FATIGUE; INVOLUNTARY TWITCHING IN CALVES AND IT MOVED TO THIGHS AND GOT WORSE AND TWITCHING OF THE EYELIDS; SINUSITIS; 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 immune suppressed. 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 10-MAR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced involuntary twitching in calves and it moved to thighs and got worse and twitching of the eyelids. On 13-MAR-2021, the subject experienced sinusitis. On 24-MAR-2021, the subject experienced muscle tightness in forearms. On 24-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sinusitis on 15-MAR-2021, had not recovered from involuntary twitching in calves and it moved to thighs and got worse and twitching of the eyelids, and fatigue, and the outcome of muscle tightness in forearms 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
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: HEADACHE; SORE ARM; This spontaneous report received from a consumer concerned a 33 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included developmentally challenged.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018,expiry: 25/MAY/2021) dose was not reported, administered in right arm on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced sore arm. On 24-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 23-MAR-2021, and had not recovered from headache. 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.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: REDNESS OF LEGS FROM KNEES DOWN; This spontaneous report received from a patient concerned a 71 year old male. The patient's height, and weight were not reported. The patient's past medical history included past history of cancer (15 years) that has recurred, and concurrent conditions included cancer.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 13:30 for prophylactic vaccination on Left arm. Concomitant medications included enzalutamide for cancer, gabapentin for cancer, rosuvastatin for cancer, ipratropium for drug used for unknown indication, leuprorelin acetate for drug used for unknown indication, loratadine for drug used for unknown indication, megestrol acetate for drug used for unknown indication, meloxicam, and metoprolol. On 24-MAR-2021, the subject experienced redness of legs from knees down. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from redness of legs from knees down. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza like illness, Pain
Clinical narrative: FLU-LIKE SYMPTOMS; BODY ACHES; CHILLS; 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: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 21-MAR-2021, the subject experienced flu-like symptoms. On 21-MAR-2021, the subject experienced body aches. On 21-MAR-2021, the subject experienced chills. On 21-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body aches, and had not recovered from flu-like symptoms, chills, and fatigue. This case is associated with PQC number 90000174263. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Myalgia, Pyrexia
Clinical narrative: MUSCLE ACHE; FEVER; HEADACHE; FEELING OUT OF IT; This spontaneous report received from a patient concerned a 59 year old female. The patient's weight, height, and medical history 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: 1808978 expiry date: unknown) dose was not reported, administered on 23-MAR-2021 in right arm for prophylactic vaccination. No concomitant medications were reported.  On 23-MAR-2021, the subject experienced feeling out of it. On 24-MAR-2021, the subject experienced fever. On 24-MAR-2021, the subject experienced headache. On 25-MAR-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and headache on 25-MAR-2021 and feeling out of it on 24-MAR-2021, and had not recovered from muscle ache. This report was non-serious.  Additional information was received from the patient on 25-Mar-2021. The following information was updated and incorporated into case narrative: Additional event added; outcome updated.
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: MISSED MENSTRUAL PERIOD; 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) dose was not reported, 1 total, administered on 11-MAR-2021 for prophylactic vaccination. 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 missed menstrual period. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of missed menstrual period was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: GOT THE VACCINE AND DIED 24 HOURS LATER; 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient died 24 hours later vaccination. Cause of death was not reported. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0:20210350465-covid-19 vaccine ad26.cov2.s-Got the vaccine and died 24 hours later. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s); Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Fatigue, Feeling abnormal, Head discomfort
Clinical narrative: DIZZINESS; BRAIN FOG; HIGH FEVER; FATIGUE; UNCLEAR  HEAD; LITTLE SORE IN THE ARM; 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 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: Unknown) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. Vaccinated on left deltoid. 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 20-MAR-2021, the subject experienced dizziness. On 20-MAR-2021, the subject experienced brain fog. On 20-MAR-2021, the subject experienced high fever. Laboratory data included: Body temperature (NR: not provided) 102 (unit not reported). On an unknown date in MAR/2021, the patient experienced 'little sore in the arm, unclear head.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from high fever, dizziness, and fatigue, had not recovered from brain fog, and the outcome of little sore in the arm and unclear head was not reported. This report was non-serious.  Additional information was received from a consumer on 25-MAR-2021 and following information was updated and incorporated into case narrative: On an unknown date in MAR/2021, the patient experienced 'little sore in the arm, unclear head. The patient had difficult time to find the words to say.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: DIZZINESS; BRAIN FOG; HIGH FEVER; FATIGUE; UNCLEAR  HEAD; LITTLE SORE IN THE ARM; 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 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: Unknown) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. Vaccinated on left deltoid. 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 20-MAR-2021, the subject experienced dizziness. On 20-MAR-2021, the subject experienced brain fog. On 20-MAR-2021, the subject experienced high fever. Laboratory data included: Body temperature (NR: not provided) 102 (unit not reported). On an unknown date in MAR/2021, the patient experienced 'little sore in the arm, unclear head.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from high fever, dizziness, and fatigue, had not recovered from brain fog, and the outcome of little sore in the arm and unclear head was not reported. This report was non-serious.  Additional information was received from a consumer on 25-MAR-2021 and following information was updated and incorporated into case narrative: On an unknown date in MAR/2021, the patient experienced 'little sore in the arm, unclear head. The patient had difficult time to find the words to say.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Needle issue
Clinical narrative: INCOMPLETE DOSE ADMINISTRATION; BROKEN NEEDLE; This spontaneous report received from a consumer concerned a 76 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included copd.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered to right arm on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced incomplete dose administration. On 07-MAR-2021, the subject experienced broken needle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incomplete dose administration and broken needle was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Muscle spasms, Pain, Pyrexia
Clinical narrative: LEG CRAMPS; LOT OF PAIN; FEVER; 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: 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 request for batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced leg cramps, lot of pain, fever, and very tired. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the leg cramps, lot of pain and fever was not reported. This report was non-serious.  Additional information was received on 28/Mar/2021.The following information was updated and incorporated into the case. Reporter full name and patient initials.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity
Clinical narrative: SORE ARM; CHILLS; 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm, chills, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, headache and chills was not reported. This report was non-serious.