chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia
Clinical narrative: MUSCLE ACHES; NO APPETITE; CHILLS/FREEZING; SEVERE HEADACHE; NAUSEA; INJECTION SITE PAIN; FEVERISH; HALLUCINATIONS; HEART PALPITATIONS; HOT/COLD SWEATS; BODY ACHES; UNABLE TO SLEEP; This spontaneous report received from a patient concerned an 18 year old white female. The patient's height, and weight were not reported. The patient's concurrent conditions included migraines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: unknown) dose was not reported, 1 total administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the patient experienced severe headache (described as beyond 10 positive), hallucination (feeling of being in a vivid dream but unable to sleep), heart palpitations, nausea, body aches, feverish, hot/cold sweats, and mild injection site pain approximately 9 hours post covid-19 vaccine ad26.cov2.s. As of 19:30 pm on 08-MAR-2021, approximately 21 hours from start symptoms, patient still had headache (5/10), mild injection site pain, minor muscle aches and no appetite. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hallucinations (feeling of being in a vivid dream), unable to sleep, heart palpitations, chills/freezing, and feverish on an unspecified date in APR-2021, was recovering from severe headache (described as beyond 10 positive), nausea, body aches, and mild injection site pain, and the outcome of hot/cold sweats, minor muscle aches and no appetite was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210417878-Covid-19 vaccine ad26.cov2.s-Hallucinations. This event is considered unassessable. The event 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.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Dyspnoea, Electrocardiogram, Feeling abnormal
Clinical narrative: HARD TIME BREATHING; SUSPECTED SINUS INFECTION; FELT BAD AND MISERABLE; LEFT ARM HURTS WHILE PRESSING INJECTION SITE; DIFFICULTY LIFTING LEFT ARM; MUSCLE ACHE; SEVERE INFLAMMATION ALL OVER THE BODY; PAIN EVERYWHERE; JOINT ACHE; TENDON ACHE; SLEPT FOR 6 HOURS THROUGHOUT THE DAY/SLEEPINESS; DRY COUGH; INJECTION SITE WAS RED; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergies, and other pre-existing medical conditions included patient has type-a blood group.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 25/MAY/2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced injection site was red. On 07-MAR-2021, the subject experienced severe inflammation all over the body. On 07-MAR-2021, the subject experienced pain everywhere. On 07-MAR-2021, the subject experienced tendon ache. On 07-MAR-2021, the subject experienced slept for 6 hours throughout the day/sleepiness. On 07-MAR-2021, the subject experienced dry cough. On 07-MAR-2021, the subject experienced joint ache. On 07-MAR-2021, the subject experienced muscle ache. On 07-APR-2021, the subject experienced difficulty lifting left arm. On 07-APR-2021, the subject experienced left arm hurts while pressing injection site. On an unspecified date, the subject experienced hard time breathing, suspected sinus infection, and felt bad and miserable. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Unknown, EKG (NR: not provided) Normal, Erythrocyte sedimentation rate (NR: not provided) indicated inflammation, and Fibrin D dimer (NR: not provided) indicated inflammation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slept for 6 hours throughout the day/sleepiness on 07-MAR-2021, had not recovered from severe inflammation all over the body, pain everywhere, joint ache, left arm hurts while pressing injection site, hard time breathing, dry cough, muscle ache, and tendon ache, and the outcome of difficulty lifting left arm, injection site was red, suspected sinus infection and felt bad and miserable 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.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer, Hypokinesia, Inflammation, Injection site erythema, Injection site pain
Clinical narrative: HARD TIME BREATHING; SUSPECTED SINUS INFECTION; FELT BAD AND MISERABLE; LEFT ARM HURTS WHILE PRESSING INJECTION SITE; DIFFICULTY LIFTING LEFT ARM; MUSCLE ACHE; SEVERE INFLAMMATION ALL OVER THE BODY; PAIN EVERYWHERE; JOINT ACHE; TENDON ACHE; SLEPT FOR 6 HOURS THROUGHOUT THE DAY/SLEEPINESS; DRY COUGH; INJECTION SITE WAS RED; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergies, and other pre-existing medical conditions included patient has type-a blood group.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 25/MAY/2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced injection site was red. On 07-MAR-2021, the subject experienced severe inflammation all over the body. On 07-MAR-2021, the subject experienced pain everywhere. On 07-MAR-2021, the subject experienced tendon ache. On 07-MAR-2021, the subject experienced slept for 6 hours throughout the day/sleepiness. On 07-MAR-2021, the subject experienced dry cough. On 07-MAR-2021, the subject experienced joint ache. On 07-MAR-2021, the subject experienced muscle ache. On 07-APR-2021, the subject experienced difficulty lifting left arm. On 07-APR-2021, the subject experienced left arm hurts while pressing injection site. On an unspecified date, the subject experienced hard time breathing, suspected sinus infection, and felt bad and miserable. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Unknown, EKG (NR: not provided) Normal, Erythrocyte sedimentation rate (NR: not provided) indicated inflammation, and Fibrin D dimer (NR: not provided) indicated inflammation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slept for 6 hours throughout the day/sleepiness on 07-MAR-2021, had not recovered from severe inflammation all over the body, pain everywhere, joint ache, left arm hurts while pressing injection site, hard time breathing, dry cough, muscle ache, and tendon ache, and the outcome of difficulty lifting left arm, injection site was red, suspected sinus infection and felt bad and miserable 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.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Red blood cell sedimentation rate, SARS-CoV-2 test, Sinusitis
Clinical narrative: HARD TIME BREATHING; SUSPECTED SINUS INFECTION; FELT BAD AND MISERABLE; LEFT ARM HURTS WHILE PRESSING INJECTION SITE; DIFFICULTY LIFTING LEFT ARM; MUSCLE ACHE; SEVERE INFLAMMATION ALL OVER THE BODY; PAIN EVERYWHERE; JOINT ACHE; TENDON ACHE; SLEPT FOR 6 HOURS THROUGHOUT THE DAY/SLEEPINESS; DRY COUGH; INJECTION SITE WAS RED; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergies, and other pre-existing medical conditions included patient has type-a blood group.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 25/MAY/2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced injection site was red. On 07-MAR-2021, the subject experienced severe inflammation all over the body. On 07-MAR-2021, the subject experienced pain everywhere. On 07-MAR-2021, the subject experienced tendon ache. On 07-MAR-2021, the subject experienced slept for 6 hours throughout the day/sleepiness. On 07-MAR-2021, the subject experienced dry cough. On 07-MAR-2021, the subject experienced joint ache. On 07-MAR-2021, the subject experienced muscle ache. On 07-APR-2021, the subject experienced difficulty lifting left arm. On 07-APR-2021, the subject experienced left arm hurts while pressing injection site. On an unspecified date, the subject experienced hard time breathing, suspected sinus infection, and felt bad and miserable. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Unknown, EKG (NR: not provided) Normal, Erythrocyte sedimentation rate (NR: not provided) indicated inflammation, and Fibrin D dimer (NR: not provided) indicated inflammation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slept for 6 hours throughout the day/sleepiness on 07-MAR-2021, had not recovered from severe inflammation all over the body, pain everywhere, joint ache, left arm hurts while pressing injection site, hard time breathing, dry cough, muscle ache, and tendon ache, and the outcome of difficulty lifting left arm, injection site was red, suspected sinus infection and felt bad and miserable 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.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Tendon pain
Clinical narrative: HARD TIME BREATHING; SUSPECTED SINUS INFECTION; FELT BAD AND MISERABLE; LEFT ARM HURTS WHILE PRESSING INJECTION SITE; DIFFICULTY LIFTING LEFT ARM; MUSCLE ACHE; SEVERE INFLAMMATION ALL OVER THE BODY; PAIN EVERYWHERE; JOINT ACHE; TENDON ACHE; SLEPT FOR 6 HOURS THROUGHOUT THE DAY/SLEEPINESS; DRY COUGH; INJECTION SITE WAS RED; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergies, and other pre-existing medical conditions included patient has type-a blood group.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 25/MAY/2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced injection site was red. On 07-MAR-2021, the subject experienced severe inflammation all over the body. On 07-MAR-2021, the subject experienced pain everywhere. On 07-MAR-2021, the subject experienced tendon ache. On 07-MAR-2021, the subject experienced slept for 6 hours throughout the day/sleepiness. On 07-MAR-2021, the subject experienced dry cough. On 07-MAR-2021, the subject experienced joint ache. On 07-MAR-2021, the subject experienced muscle ache. On 07-APR-2021, the subject experienced difficulty lifting left arm. On 07-APR-2021, the subject experienced left arm hurts while pressing injection site. On an unspecified date, the subject experienced hard time breathing, suspected sinus infection, and felt bad and miserable. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Unknown, EKG (NR: not provided) Normal, Erythrocyte sedimentation rate (NR: not provided) indicated inflammation, and Fibrin D dimer (NR: not provided) indicated inflammation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slept for 6 hours throughout the day/sleepiness on 07-MAR-2021, had not recovered from severe inflammation all over the body, pain everywhere, joint ache, left arm hurts while pressing injection site, hard time breathing, dry cough, muscle ache, and tendon ache, and the outcome of difficulty lifting left arm, injection site was red, suspected sinus infection and felt bad and miserable 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: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-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 08-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: J&J COVID-19 VACCINE ADMINISTERED 28 DAYS AFTER MODERNA COVID-19 VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned an 86 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: 042A21A expiry: unknown) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. Concomitant medications included MRNA 1273 for prophylactic vaccination. On an unspecified date, the subject experienced J&J covid-19 vaccine administered 28 days after Moderna covid-19 vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of J&J covid-19 vaccine administered 28 days after Moderna covid-19 vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210428348.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Chest discomfort, Palpitations, Tongue discomfort
Clinical narrative: BURNING SENSATION DOWN THE INSIDE OF ARM/ BURNING IN UPPER BODY; BURNING IN TONGUE; WEAKNESS IN CHEST; HEART PALPITATIONS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced burning sensation down the inside of arm/ burning in upper body, burning in tongue, weakness in chest, and heart palpitations. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the burning sensation down the inside of arm/ burning in upper body, weakness in chest, burning in tongue and heart palpitations was not reported. This report was non-serious.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Pain in extremity
Clinical narrative: BACK PAIN; FEELS LIKE PASSING OUT; LEG PAIN; This spontaneous report received from a consumer concerned a 25 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included lyme disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 08-APR-2021 15:30 for prophylactic vaccination. The batch no was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced back pain. On 08-APR-2021, the subject experienced leg pain. On 08-APR-2021, the subject experienced feels like passing out. 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 back pain, and leg pain, and the outcome of feels like passing out was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: HEAD BURNING; 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 and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced head burning. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of head burning was not reported. This report was non-serious.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Sinus headache
Clinical narrative: COVID 19 INFECTION; SINUS HEADACHE; This spontaneous report received from a patient concerned a 42 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, seasonal allergies, and high blood pressure, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced covid 19 infection. On 31-MAR-2021, the subject experienced sinus headache. On 04-APR-2021, Laboratory data included: Body temperature (NR: not provided) 99.5 F, and COVID-19 virus test (NR: not provided) Positive. Treatment medications (dates unspecified) included: dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol, fluticasone propionate, triamcinolone acetonide, and dextromethorphan hydrobromide/ethanol/guaifenesin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sinus headache, and had not recovered from covid 19 infection. 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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Influenza like illness, Myalgia, Pain
Clinical narrative: FEELING WEAK; MUSCLE ACHE; FEVER  (101.4 F); FLU-LIKE SYMPTOMS; ACHY BODY; PAIN IN ARM; This spontaneous report received from a patient concerned a 60 year old female. 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: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced flu-like symptoms. On 08-APR-2021, the subject experienced achy body. On 08-APR-2021, the subject experienced pain in arm. On 08-APR-2021, the subject experienced fever (101.4 f). Laboratory data included: Body temperature (NR: not provided) 101.4 F. On 09-APR-2021, the subject experienced feeling weak. On 09-APR-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever (101.4 f) on 09-APR-2021, had not recovered from pain in arm, flu-like symptoms, achy body, and feeling weak, and the outcome of muscle ache was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: FEELING WEAK; MUSCLE ACHE; FEVER  (101.4 F); FLU-LIKE SYMPTOMS; ACHY BODY; PAIN IN ARM; This spontaneous report received from a patient concerned a 60 year old female. 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: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced flu-like symptoms. On 08-APR-2021, the subject experienced achy body. On 08-APR-2021, the subject experienced pain in arm. On 08-APR-2021, the subject experienced fever (101.4 f). Laboratory data included: Body temperature (NR: not provided) 101.4 F. On 09-APR-2021, the subject experienced feeling weak. On 09-APR-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever (101.4 f) on 09-APR-2021, had not recovered from pain in arm, flu-like symptoms, achy body, and feeling weak, and the outcome of muscle ache was not reported. This report was non-serious.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Erection increased
Clinical narrative: PARTIAL ERECTION LASTING MORE THAN 4 HOURS; This spontaneous report received from a patient concerned a 20 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced partial erection lasting more than 4 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from partial erection lasting more than 4 hours. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Meningitis
Clinical narrative: MENINGITIS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total 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 after receiving COVID-19 vaccine, the patient developed meningitis.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of meningitis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210420512-covid-19 vaccine ad26.cov2. s-meningitis. This event is considered unassessable. The event 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.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: HIGH TEMPERATURE; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced high temperature. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103.4 to 103.1 F. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient was recovering from high temperature. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Chest X-ray, Chills, Echocardiogram
Clinical narrative: ANXIETY; INJECTION SITE PAIN; NAUSEA; JOINT PAIN; TACHYCARDIA; PALPITATION; MUSCLE ACHES; FEVER; CHILLS; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight was 133 pounds, and height was 62 inches. The patient's concurrent conditions included narcolepsy, hashimoto's disease, migraine headaches, non-alcohol user, non-smoker, amoxicillin and erythromycin allergy, dust mite allergy, and pollen allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A and expiry: 21-JUN-2021) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced fatigue. On 05-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced tachycardia. On 06-APR-2021, the subject experienced palpitation. On 06-APR-2021, the subject experienced joint pain. On 06-APR-2021, the subject experienced muscle aches. On 06-APR-2021, the subject experienced nausea. On 06-APR-2021, the subject experienced fever. Laboratory data included: Chest X-ray (NR: not provided) unknown, Echocardiogram (NR: not provided) Normal, and Urinalysis (NR: not provided) Urinalysis showed moderate blood. On an unspecified date, the subject experienced anxiety, and injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tachycardia, and palpitation on 08-APR-2021, chills, and fever on 07-APR-2021, and headache on 09-APR-2021, was recovering from nausea, fatigue, joint pain, and muscle aches, and the outcome of injection site pain and anxiety 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, Injection site pain, Myalgia, Nausea
Clinical narrative: ANXIETY; INJECTION SITE PAIN; NAUSEA; JOINT PAIN; TACHYCARDIA; PALPITATION; MUSCLE ACHES; FEVER; CHILLS; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight was 133 pounds, and height was 62 inches. The patient's concurrent conditions included narcolepsy, hashimoto's disease, migraine headaches, non-alcohol user, non-smoker, amoxicillin and erythromycin allergy, dust mite allergy, and pollen allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A and expiry: 21-JUN-2021) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced fatigue. On 05-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced tachycardia. On 06-APR-2021, the subject experienced palpitation. On 06-APR-2021, the subject experienced joint pain. On 06-APR-2021, the subject experienced muscle aches. On 06-APR-2021, the subject experienced nausea. On 06-APR-2021, the subject experienced fever. Laboratory data included: Chest X-ray (NR: not provided) unknown, Echocardiogram (NR: not provided) Normal, and Urinalysis (NR: not provided) Urinalysis showed moderate blood. On an unspecified date, the subject experienced anxiety, and injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tachycardia, and palpitation on 08-APR-2021, chills, and fever on 07-APR-2021, and headache on 09-APR-2021, was recovering from nausea, fatigue, joint pain, and muscle aches, and the outcome of injection site pain and anxiety 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: Palpitations, Pyrexia, Tachycardia, Urine analysis
Clinical narrative: ANXIETY; INJECTION SITE PAIN; NAUSEA; JOINT PAIN; TACHYCARDIA; PALPITATION; MUSCLE ACHES; FEVER; CHILLS; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight was 133 pounds, and height was 62 inches. The patient's concurrent conditions included narcolepsy, hashimoto's disease, migraine headaches, non-alcohol user, non-smoker, amoxicillin and erythromycin allergy, dust mite allergy, and pollen allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A and expiry: 21-JUN-2021) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced fatigue. On 05-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced tachycardia. On 06-APR-2021, the subject experienced palpitation. On 06-APR-2021, the subject experienced joint pain. On 06-APR-2021, the subject experienced muscle aches. On 06-APR-2021, the subject experienced nausea. On 06-APR-2021, the subject experienced fever. Laboratory data included: Chest X-ray (NR: not provided) unknown, Echocardiogram (NR: not provided) Normal, and Urinalysis (NR: not provided) Urinalysis showed moderate blood. On an unspecified date, the subject experienced anxiety, and injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tachycardia, and palpitation on 08-APR-2021, chills, and fever on 07-APR-2021, and headache on 09-APR-2021, was recovering from nausea, fatigue, joint pain, and muscle aches, and the outcome of injection site pain and anxiety 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: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pyrexia
Clinical narrative: COLD; HIGH FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 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 cold, and high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from high fever, and cold. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Nausea
Clinical narrative: INCREASED HEART RATE; NAUSEA; 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, intramuscular, batch number: Unknown) dose was not reported, administered on 09-APR-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 10-APR-2021, the subject experienced increased heart rate. On 10-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from increased heart rate, and nausea. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Headache, Joint swelling, Musculoskeletal stiffness
Clinical narrative: LEFT FOREARM SWELLING LIKE A RAISED KNOT; REDNESS IN RIGHT FOREARM; ANKLE SWELLING; LEFT AND RIGHT ANKLE JOINT PAIN/LEFT WRIST PAIN; PAIN MOVED TO HER NECK; NECK STIFFNESS; PAIN IN SHOULDER AND UNDERARM AREA OF THE LEFT ARM/PAIN IN RIGHT FOREARM AND FOREARM SORE/LEFT AND RIGHT FOOT PAIN/PAIN IN LEFT FOREARM; SEVERE HEADACHE; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included consume alcohol, and non-smoker, and other pre-existing medical conditions included patient had no known drug allergies and no drug abuse or illicit drug usage. Patient was not pregnant at the time of vaccination. Patient had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, and expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. Non-company suspect drugs included: paracetamol ( form of admin, route of admin, and batch number were not reported) dose and frequency were not reported from MAR-2021 for severe headache. No concomitant medications were reported. On 13-MAR-2021, the subject experienced severe headache. On 14-MAR-2021, the subject experienced pain in shoulder and underarm area of the left arm/pain in right forearm and forearm sore/left and right foot pain/pain in left forearm. On 15-MAR-2021, the subject experienced neck stiffness. On 15-MAR-2021, the subject experienced pain moved to her neck. On APR-2021, the subject experienced ankle swelling. On APR-2021, the subject experienced left and right ankle joint pain/left wrist pain. On 02-APR-2021, the subject experienced redness in right forearm. On 05-APR-2021, the subject experienced left forearm swelling like a raised knot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neck stiffness on 16-MAR-2021, redness in right forearm on APR-2021, and severe headache, and the outcome of pain in shoulder and underarm area of the left arm/pain in right forearm and forearm sore/left and right foot pain/pain in left forearm, ankle swelling, pain moved to her neck, left and right ankle joint pain/left wrist pain and left forearm swelling like a raised knot was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, Peripheral swelling
Clinical narrative: LEFT FOREARM SWELLING LIKE A RAISED KNOT; REDNESS IN RIGHT FOREARM; ANKLE SWELLING; LEFT AND RIGHT ANKLE JOINT PAIN/LEFT WRIST PAIN; PAIN MOVED TO HER NECK; NECK STIFFNESS; PAIN IN SHOULDER AND UNDERARM AREA OF THE LEFT ARM/PAIN IN RIGHT FOREARM AND FOREARM SORE/LEFT AND RIGHT FOOT PAIN/PAIN IN LEFT FOREARM; SEVERE HEADACHE; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included consume alcohol, and non-smoker, and other pre-existing medical conditions included patient had no known drug allergies and no drug abuse or illicit drug usage. Patient was not pregnant at the time of vaccination. Patient had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, and expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. Non-company suspect drugs included: paracetamol ( form of admin, route of admin, and batch number were not reported) dose and frequency were not reported from MAR-2021 for severe headache. No concomitant medications were reported. On 13-MAR-2021, the subject experienced severe headache. On 14-MAR-2021, the subject experienced pain in shoulder and underarm area of the left arm/pain in right forearm and forearm sore/left and right foot pain/pain in left forearm. On 15-MAR-2021, the subject experienced neck stiffness. On 15-MAR-2021, the subject experienced pain moved to her neck. On APR-2021, the subject experienced ankle swelling. On APR-2021, the subject experienced left and right ankle joint pain/left wrist pain. On 02-APR-2021, the subject experienced redness in right forearm. On 05-APR-2021, the subject experienced left forearm swelling like a raised knot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neck stiffness on 16-MAR-2021, redness in right forearm on APR-2021, and severe headache, and the outcome of pain in shoulder and underarm area of the left arm/pain in right forearm and forearm sore/left and right foot pain/pain in left forearm, ankle swelling, pain moved to her neck, left and right ankle joint pain/left wrist pain and left forearm swelling like a raised knot was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: COLD SORE; 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) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-APR-2021, the subject experienced cold sore. Treatment medications included: valaciclovir. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cold sore was not reported. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatinine, Blood glucose, Blood pressure measurement, Chest X-ray, Confusional state
Clinical narrative: CONFUSED FEELING; ELEVATED BLOOD PRESSURE 150/100; TACHYCARDIA/RACING HEART; DIARRHEA; WHOLE BODY ACHES; DIZZINESS/LIGHT HEADEDNESS/FELT FAINT; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 38 year old not Hispanic or Latino, White female. The patient's weight was 135 pounds, and height was 60 inches. The patient's concurrent conditions included thalassemia, no alcohol use, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies. patient had no drug abuse or illicit drug usage. 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: 1808609, expiry: 09-JUN-2021) dose was not reported, frequency once total administered on 05-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 05-APR-2021, the patient experienced dizziness/light headedness/felt faint,  whole body aches, fever, headache. On 07-APR-2021, the patient then experienced tachycardia/racing heart and diarrhea, called 911 and had elevated blood pressure 150/100 and referred to cardiologist. On 08-APR-2021, the patient experienced confused feeling. Laboratory data included: Blood pressure (NR: not provided) 150/100 mmHg, complete blood count (NR: not provided) autolymphocytes numer 0.91, WBC 4.59, red cell distribution width 17.4 me, Chest X-ray (NR: not provided) unknown, Creatinine (NR: not provided) 0.6, Electrocardiogram (NR: not provided) unknown, Echocardiogram (NR: not provided) unknown, Glucose (NR: not provided) 105, Hematocrit (NR: not provided) 34.9, Lymphocytes (NR: not provided) 19.8, Monocyte count (NR: not provided) 11.8, and Urinalysis (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from whole body aches, and fever on 06-APR-2021, was recovering from headache, and elevated blood pressure 150/100 , had not recovered from dizziness/light headedness/felt faint, diarrhea, and tachycardia/racing heart, and the outcome of  confused feeling was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210420710- Covid-19 vaccine ad26.cov2.s-Elevated blood pressure 150/100. This event is considered unassessable. The event 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.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Echocardiogram, Electrocardiogram, Full blood count
Clinical narrative: CONFUSED FEELING; ELEVATED BLOOD PRESSURE 150/100; TACHYCARDIA/RACING HEART; DIARRHEA; WHOLE BODY ACHES; DIZZINESS/LIGHT HEADEDNESS/FELT FAINT; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 38 year old not Hispanic or Latino, White female. The patient's weight was 135 pounds, and height was 60 inches. The patient's concurrent conditions included thalassemia, no alcohol use, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies. patient had no drug abuse or illicit drug usage. 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: 1808609, expiry: 09-JUN-2021) dose was not reported, frequency once total administered on 05-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 05-APR-2021, the patient experienced dizziness/light headedness/felt faint,  whole body aches, fever, headache. On 07-APR-2021, the patient then experienced tachycardia/racing heart and diarrhea, called 911 and had elevated blood pressure 150/100 and referred to cardiologist. On 08-APR-2021, the patient experienced confused feeling. Laboratory data included: Blood pressure (NR: not provided) 150/100 mmHg, complete blood count (NR: not provided) autolymphocytes numer 0.91, WBC 4.59, red cell distribution width 17.4 me, Chest X-ray (NR: not provided) unknown, Creatinine (NR: not provided) 0.6, Electrocardiogram (NR: not provided) unknown, Echocardiogram (NR: not provided) unknown, Glucose (NR: not provided) 105, Hematocrit (NR: not provided) 34.9, Lymphocytes (NR: not provided) 19.8, Monocyte count (NR: not provided) 11.8, and Urinalysis (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from whole body aches, and fever on 06-APR-2021, was recovering from headache, and elevated blood pressure 150/100 , had not recovered from dizziness/light headedness/felt faint, diarrhea, and tachycardia/racing heart, and the outcome of  confused feeling was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210420710- Covid-19 vaccine ad26.cov2.s-Elevated blood pressure 150/100. This event is considered unassessable. The event 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.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Haematocrit, Headache, Hypertension, Lymphocyte count, Monocyte count
Clinical narrative: CONFUSED FEELING; ELEVATED BLOOD PRESSURE 150/100; TACHYCARDIA/RACING HEART; DIARRHEA; WHOLE BODY ACHES; DIZZINESS/LIGHT HEADEDNESS/FELT FAINT; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 38 year old not Hispanic or Latino, White female. The patient's weight was 135 pounds, and height was 60 inches. The patient's concurrent conditions included thalassemia, no alcohol use, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies. patient had no drug abuse or illicit drug usage. 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: 1808609, expiry: 09-JUN-2021) dose was not reported, frequency once total administered on 05-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 05-APR-2021, the patient experienced dizziness/light headedness/felt faint,  whole body aches, fever, headache. On 07-APR-2021, the patient then experienced tachycardia/racing heart and diarrhea, called 911 and had elevated blood pressure 150/100 and referred to cardiologist. On 08-APR-2021, the patient experienced confused feeling. Laboratory data included: Blood pressure (NR: not provided) 150/100 mmHg, complete blood count (NR: not provided) autolymphocytes numer 0.91, WBC 4.59, red cell distribution width 17.4 me, Chest X-ray (NR: not provided) unknown, Creatinine (NR: not provided) 0.6, Electrocardiogram (NR: not provided) unknown, Echocardiogram (NR: not provided) unknown, Glucose (NR: not provided) 105, Hematocrit (NR: not provided) 34.9, Lymphocytes (NR: not provided) 19.8, Monocyte count (NR: not provided) 11.8, and Urinalysis (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from whole body aches, and fever on 06-APR-2021, was recovering from headache, and elevated blood pressure 150/100 , had not recovered from dizziness/light headedness/felt faint, diarrhea, and tachycardia/racing heart, and the outcome of  confused feeling was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210420710- Covid-19 vaccine ad26.cov2.s-Elevated blood pressure 150/100. This event is considered unassessable. The event 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.