chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Dyspnoea, Myalgia, X-ray
Clinical narrative: MUSCLE PAIN TOOK HER BREATH AWAY WHEN SHE NEEDED TO LAY DOWN AND GET UP; BAD MUSCLE PAIN IN UPPER BACK; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included hypothyroidism, post-traumatic stress disorder, and high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203a21a, and expiry: 07-AUG-2021) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination.  Concomitant medications included hydrochlorothiazide/spironolactone for high blood pressure, levothyroxine for hypothyroidism, and sertraline hydrochloride for ptsd.  On JUN-2021,the subject experienced muscle pain took her breath away when she needed to lay down and get up. On JUN-2021, the subject experienced bad muscle pain in upper back.  Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not reported, CT scan (NR: not provided) Not reported, and X-ray (NR: not provided) Not reported. Treatment medications (dates unspecified) included: meloxicam, cyclobenzaprine, and tramadol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad muscle pain in upper back, and muscle pain took her breath away when she needed to lay down and get up. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Migraine, Pain
Clinical narrative: MIGRAINE FOR 3 DAYS; BODY ACHES ESPECIALLY IN LEGS; CHILLS; ACHES IN INJECTED ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced migraine for 3 days, body aches especially in legs, chills, and aches in injected arm. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from migraine for 3 days, body aches especially in legs, chills, and aches in injected arm. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Feeling of body temperature change, Middle insomnia, Pyrexia
Clinical narrative: SHAKING UNCONTROLLABLY; WOKE UP IN THE MIDDLE OF THE NIGHT; FEELING BOTH HOT AND COLD; AWFUL; TEETH CHATTERING; TERRIBLE FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced shaking uncontrollably, woke up in the middle of the night, feeling both hot and cold, awful, teeth chattering, and terrible fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shaking uncontrollably, woke up in the middle of the night, feeling both hot and cold, terrible fever, teeth chattering and awful was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: SHAKING UNCONTROLLABLY; WOKE UP IN THE MIDDLE OF THE NIGHT; FEELING BOTH HOT AND COLD; AWFUL; TEETH CHATTERING; TERRIBLE FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced shaking uncontrollably, woke up in the middle of the night, feeling both hot and cold, awful, teeth chattering, and terrible fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shaking uncontrollably, woke up in the middle of the night, feeling both hot and cold, terrible fever, teeth chattering and awful was not reported. This report was non-serious.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: LEFT ARM  SWOLLEN; LEFT ARM HURTS; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, diabetes mellitus, non-smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1865031 expiry: 20-MAR-2021) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced left arm swollen. On 13-MAR-2021, the subject experienced left arm hurts. 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 left arm swollen, and left arm hurts. This report was non-serious.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Paranasal sinus discomfort
Clinical narrative: SINUS PRESSURE; CHEST TIGHTNESS; CAN'T CATCH BREATH; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included migraine with aura. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 13-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-JUL-2021, the subject experienced sinus pressure. On 14-JUL-2021, the subject experienced chest tightness. On 14-JUL-2021, the subject experienced can't catch breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sinus pressure, chest tightness, and can't catch breath. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: PASSED AWAY DUE TO THE JOHNSON AND JOHNSON VACCINE; This spontaneous report received from a patient concerned a 4 decade old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown), 1 total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient passed away due to the Johnson and Johnson vaccine and cause of death was unknown. It was unspecified if autopsy performed. Reporter just got off the phone with her cousin it was her best friend who passed away. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210730562-covid-19 vaccine ad26.cov2.s-passed away due to the Johnson and Johnson vaccine. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: FEELS HORRIBLE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested. No concomitant medications were reported. On an unspecified date, the subject experienced feels horrible. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feels horrible was not reported. This report was non-serious.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: LOSING HAIR OF HAIR, ARMS AND LEGS; This spontaneous report received from a patient concerned a 72 year old male. The patient's weight was 165 pounds, and height was not reported. The patient's concurrent conditions included no smoking, and no alcohol use, and other pre-existing medical conditions included medical history none as per patient. stated taking prostate pills but denies any prostate issues. no known allergies and drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 20CA21A, and expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 20-JUN-2021, the subject experienced losing hair of hair, arms and legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from losing hair of hair, arms and legs. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cerebral thrombosis, Cerebral venous thrombosis, Platelet count, Platelet count decreased, Pulmonary thrombosis
Clinical narrative: BLOOD CLOT IN HEAD; BLOOD CLOT IN SINUS VEIN; BLOOD CLOT IN NECK; BLOOD CLOT IN LEFT AND RIGHT LUNGS; MINI STROKES; LOW PLATELETS; This spontaneous report received from a parent via a social media platform and concerned a female patient of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 16-APR-2021,10 days after the vaccination, the patient experienced a first blood clot in her head, then a second blood clot in the head, then several more in the left and right lungs, another in the neck and developed a blood clot in the sinus vein leading to the brain, and on unspecified dates in APR-2021, the patient also experienced mini strokes and low platelets.  The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The patient had not recovered from blood clot in head, mini strokes, blood clot in left and right lungs, blood clot in neck, low platelets and blood clot in sinus vein. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This spontaneous report received via social media concerns a female age, unspecified age, unknown ethnicity, who was noted to have multiple blood clots, clot in the sinus vein, mini strokes and low platelet 10 days after receiving the Janssen Covid-19 vaccine.  The patient experienced multiple clots - head, both lungs, neck, and in the sinus vein leading to the brain. She also experienced mini strokes and low platelets. Patient's height and weight were not reported. Patient's past medical/surgical history, concurrent conditions and concomitant medications were not reported. Information regarding past smoking history, illicit drug use and alcohol abuse were not provided. Information is limited in this case. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis, Transient ischaemic attack
Clinical narrative: BLOOD CLOT IN HEAD; BLOOD CLOT IN SINUS VEIN; BLOOD CLOT IN NECK; BLOOD CLOT IN LEFT AND RIGHT LUNGS; MINI STROKES; LOW PLATELETS; This spontaneous report received from a parent via a social media platform and concerned a female patient of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 16-APR-2021,10 days after the vaccination, the patient experienced a first blood clot in her head, then a second blood clot in the head, then several more in the left and right lungs, another in the neck and developed a blood clot in the sinus vein leading to the brain, and on unspecified dates in APR-2021, the patient also experienced mini strokes and low platelets.  The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The patient had not recovered from blood clot in head, mini strokes, blood clot in left and right lungs, blood clot in neck, low platelets and blood clot in sinus vein. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This spontaneous report received via social media concerns a female age, unspecified age, unknown ethnicity, who was noted to have multiple blood clots, clot in the sinus vein, mini strokes and low platelet 10 days after receiving the Janssen Covid-19 vaccine.  The patient experienced multiple clots - head, both lungs, neck, and in the sinus vein leading to the brain. She also experienced mini strokes and low platelets. Patient's height and weight were not reported. Patient's past medical/surgical history, concurrent conditions and concomitant medications were not reported. Information regarding past smoking history, illicit drug use and alcohol abuse were not provided. Information is limited in this case. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain, Poor quality sleep, Pyrexia
Clinical narrative: TIREDNESS; SLIGHT FEVER; KEPT ME AWAKE; CHILLS; SORE ARM WHERE SHE GOT VACCINE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 12-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On JUL-2021, the subject experienced sore arm where she got vaccine. On 12-JUL-2021, the subject experienced kept me awake. On 12-JUL-2021, the subject experienced chills. On 12-JUL-2021, the subject experienced slight fever. On 13-JUL-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from kept me awake, chills, sore arm where she got vaccine, slight fever, and tiredness on JUL-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Movement disorder, Nausea, Pain in extremity
Clinical narrative: FOUR INCH RED AND HOT LUMP AT INJECTION SITE; COULD NOT DO YOGA / TROUBLE WITH STAIRS; LEG HURTED; FOUR INCH RED AND HOT LUMP AT INJECTION SITE; QUEASY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient is needle phobic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced four inch red and hot lump at injection site, could not do yoga / trouble with stairs, leg hurted, four inch red and hot lump at injection site, and queasy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the four inch red and hot lump at injection site, queasy, leg hurted, four inch red and hot lump at injection site and could not do yoga / trouble with stairs was not reported. This report was non-serious.
Age: 32.0
Sex: U
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: 2 BIG BRUISES IN LEFT LEG; This spontaneous report received from a patient concerned a 32 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816077, and expiry: UNKNOWN) dose was not reported, administered on 08-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUL-2021, the subject experienced 2 big bruises in left leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from 2 big bruises in left leg. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: CHANGE IN MENSTRUAL CYCLE IT'S 4 DAYS LATE; 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 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 30-JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced change in menstrual cycle it's 4 days late. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of change in menstrual cycle it's 4 days late was not reported. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; JANSSEN COVID VACCINE DOSE GIVEN AFTER 6 HOUR; This spontaneous report received from a health care professional concerned a 49 year old female. The patient's weight was 133 pounds, and height was 64 inches. No past medical history or concurrent conditions were reported.  The patient experienced confusion and dizziness when treated with isoniazid for drug used for unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: 07-AUG-2021) dose was not reported, administered on 13-JUL-2021 03:45 for prophylactic vaccination. No concomitant medications were reported. On 13-JUL-2021, the subject experienced incorrect product storage. On 13-JUL-2021, the subject experienced janssen covid vaccine dose given after 6 hour. The outcome of the incorrect product storage and janssen covid vaccine dose given after 6 hour was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pulpitis dental, Tooth infection
Clinical narrative: INFLAMED TOOTH ROOT PRESSING AGAINST JAW BONE; TOOTH INFECTION; This spontaneous report received from a patient concerned a 42 year old male. The patient's weight was 190 pounds, and height was 70 inches.  The patient's past medical history included bridge for 9 years no issues, and concurrent conditions included cigarette smoker five cigarettes per day, and non-alcohol user, and other pre-existing medical conditions included the patient had no known allergies.  The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, and expiry: unknown) at a frequency one total, dose was not reported, administered on 26-JUN-2021 for prophylactic vaccination on left arm.  No concomitant medications were reported.  On 10-JUL-2021, the subject experienced tooth infection. On an unspecified date, the subject experienced inflamed tooth root pressing against jaw bone. Patient visited urgent care were received antibiotics and steroids for pain.  On 14-JUL-2021 patient had removal of bridges.  Patient oral surgeon had suggested surgery for inflammation. on 15-Jul-2021, Patient will have extraction of 2 teeth associated with the events.  As of 14-Jul-2021, the patient stated that the past 5 days of pain have been unbearable regardless of the medications received. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from inflamed tooth root pressing against jaw bone, and the outcome of tooth infection was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210730837 - Covid-19 vaccine ad26.cov2.s - Tooth infection. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY.
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain in extremity, X-ray
Clinical narrative: WEAK ARM; SORENESS ON INNER ASPECT OF ARM/TENDER ARM; This spontaneous report received from a patient concerned a 70 year old female. The patient's concurrent conditions included arthritis, non-alcohol user, non-smoker, rosacea, essential tremors at right side only, tendonitis/tennis elbow, and seasonal allergies, and other pre-existing medical conditions included the patient have no history of drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: T308612, expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. Concomitant medications included primidone for for essential tremors, and paracetamol. On 2021, treatment medications included: diclofenac, and paracetamol. On APR-2021, the subject experienced soreness on inner aspect of arm/tender arm. On an unspecified date, the subject experienced weak arm. Laboratory data (dates unspecified) included: X-ray (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness on inner aspect of arm/tender arm and weak arm was not reported. This report was non-serious.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Pain assessment, Paraesthesia
Clinical narrative: JOINT PAIN IN GREAT TOE AND 2 TOES NEXT OF RIGHT FOOT; NUMBNESS IN GREAT TOE AND 2 TOES NEXT OF RIGHT FOOT; TINGLING IN GREAT TOE AND 2 TOES NEXT OF RIGHT FOOT; This spontaneous report received from a patient concerned a 62 year old male. The patient's weight was 160 pounds, and height was 69 inches. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included patient had no known allergies and no drug abuse or illicit drug usage. patient was not taking any daily medications and did not have any medical conditions. 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 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced numbness in great toe and 2 toes next of right foot. On APR-2021, the subject experienced tingling in great toe and 2 toes next of right foot. On an unspecified date, the subject experienced joint pain in great toe and 2 toes next of right foot. Laboratory data (dates unspecified) included: Pain scale (NR: not provided) 5-6/10 pain scale level. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness in great toe and 2 toes next of right foot, tingling in great toe and 2 toes next of right foot, and joint pain in great toe and 2 toes next of right foot. This report was non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Neuralgia, Paraesthesia
Clinical narrative: TINGLING IN LEFT ARM FROM LEFT ELBOW TO LEFT HAND; WEAKNESS; DULL NERVE PAIN; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On JUN-2021, the subject experienced dull nerve pain. On 01-JUN-2021, the subject experienced tingling in left arm from left elbow to left hand. On 01-JUN-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weakness, and tingling in left arm from left elbow to left hand, and the outcome of dull nerve pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood
Clinical narrative: DOWN FOR A FEW DAYS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced down for a few days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of down for a few days was not reported. This report was non-serious. This case, from the same reporter is linked to 20210731626.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Feeling hot, Hypoaesthesia, Loss of consciousness
Clinical narrative: PASSED OUT; SURGES OF HEAT THROUGHOUT THE WHOLE BODY/HEAT ATTACKING THE HEART; PAIN IN THE BACK OF THE NECK UP TO THE SKULL; WHOLE BODY BURNING; LEFT ARM NUMB; LEFT ARM PAIN; PAIN ON THE LEFT SHOULDER BLADE; This spontaneous report received from a patient concerned a 26 year old female.  The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and other pre-existing medical conditions included the patient reported that the patient was healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: 23-JUN-2021) dose was not reported, 1 total, administered on 14-MAY-2021 to the left arm for prophylactic vaccination. No concomitant medications were reported.  On 18-MAY-2021, the patient experienced left arm completely numb and painful where she got the shot, pain on the left shoulder blade, her whole body was burning. The patient also experienced surges of heat throughout the whole body, the heat started attacking the heart of the patient. Then the patient started experiencing pain in the back of the neck up to the skull. On the same day, the patient passed out and went to the hospital however, they could not find anything and advised that it was basically from the shot. The patient was discharged from the hospital after five hours. All of those symptoms lasted for three weeks and then everything resolved. As of 14-Jul-2021, the patient still had random pain and numbness in the left arm.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out, surges of heat throughout the whole body/heat attacking the heart, pain in the back of the neck up to the skull, and whole body burning on JUN-2021, and had not recovered from left arm pain, pain on the left shoulder blade, and left arm numb. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210730970 - covid-19 vaccine ad26.cov2.s -Passed out- 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).
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity
Clinical narrative: PASSED OUT; SURGES OF HEAT THROUGHOUT THE WHOLE BODY/HEAT ATTACKING THE HEART; PAIN IN THE BACK OF THE NECK UP TO THE SKULL; WHOLE BODY BURNING; LEFT ARM NUMB; LEFT ARM PAIN; PAIN ON THE LEFT SHOULDER BLADE; This spontaneous report received from a patient concerned a 26 year old female.  The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and other pre-existing medical conditions included the patient reported that the patient was healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: 23-JUN-2021) dose was not reported, 1 total, administered on 14-MAY-2021 to the left arm for prophylactic vaccination. No concomitant medications were reported.  On 18-MAY-2021, the patient experienced left arm completely numb and painful where she got the shot, pain on the left shoulder blade, her whole body was burning. The patient also experienced surges of heat throughout the whole body, the heat started attacking the heart of the patient. Then the patient started experiencing pain in the back of the neck up to the skull. On the same day, the patient passed out and went to the hospital however, they could not find anything and advised that it was basically from the shot. The patient was discharged from the hospital after five hours. All of those symptoms lasted for three weeks and then everything resolved. As of 14-Jul-2021, the patient still had random pain and numbness in the left arm.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out, surges of heat throughout the whole body/heat attacking the heart, pain in the back of the neck up to the skull, and whole body burning on JUN-2021, and had not recovered from left arm pain, pain on the left shoulder blade, and left arm numb. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210730970 - covid-19 vaccine ad26.cov2.s -Passed out- 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).
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Epstein-Barr virus infection, Headache
Clinical narrative: EPSTEIN BARR INFECTION; HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot numbers. No concomitant medications were reported.  On APR-2021, Laboratory data included: Blood test (NR: not provided) Elevated epstein barr numbers, Covid-19 antibodies. On 07-APR-2021, the subject experienced epstein barr infection. On 07-APR-2021, the subject experienced headache. On 10-APR-2021, Laboratory data included: Body temperature (NR: not provided) 37.2 to 38.3 degree celsius or 99 and 101 degrees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 08-APR-2021, and had not recovered from epstein barr infection. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Computerised tomogram, Dyspnoea
Clinical narrative: CANNOT SIT AND LAY DOWN SOMETIMES; LINGERING PAIN; FELT HOT; CHILLS; SHOULDER TO SHOULDER PAIN ALL DAY ALL NIGHT; MIDDLE BACK PAIN; INABILITY TO CATCH BREATH; FEVER; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included radiculitis/radiculopathy, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 and expiry: 11-MAR-2021) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: oxycodone hydrochloride/paracetamol. On 11-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced middle back pain. On 12-MAR-2021, the subject experienced inability to catch breath. On 12-MAR-2021, the subject experienced shoulder to shoulder pain all day all night. On 13-MAR-2021, the subject experienced chills. On 19-MAR-2021, the subject experienced felt hot. On an unspecified date, the subject experienced cannot sit and lay down sometimes, and lingering pain. Laboratory data (dates unspecified) included: CT scan (NR: not provided) negative and no abnormalities. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 13-MAR-2021, and had not recovered from middle back pain, inability to catch breath, felt hot, shoulder to shoulder pain all day all night, cannot sit and lay down sometimes, and lingering pain. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hypokinesia, Pain, Pyrexia
Clinical narrative: CANNOT SIT AND LAY DOWN SOMETIMES; LINGERING PAIN; FELT HOT; CHILLS; SHOULDER TO SHOULDER PAIN ALL DAY ALL NIGHT; MIDDLE BACK PAIN; INABILITY TO CATCH BREATH; FEVER; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included radiculitis/radiculopathy, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 and expiry: 11-MAR-2021) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: oxycodone hydrochloride/paracetamol. On 11-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced middle back pain. On 12-MAR-2021, the subject experienced inability to catch breath. On 12-MAR-2021, the subject experienced shoulder to shoulder pain all day all night. On 13-MAR-2021, the subject experienced chills. On 19-MAR-2021, the subject experienced felt hot. On an unspecified date, the subject experienced cannot sit and lay down sometimes, and lingering pain. Laboratory data (dates unspecified) included: CT scan (NR: not provided) negative and no abnormalities. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 13-MAR-2021, and had not recovered from middle back pain, inability to catch breath, felt hot, shoulder to shoulder pain all day all night, cannot sit and lay down sometimes, and lingering pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 13-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-JUL-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Rash pruritic, Urticaria
Clinical narrative: SWEATING; CLUSTER OF RASHES ALL OVER BODY (SHOULDER BLADE, LEFT BICEP, RIGHT FOREARM IN LEFT BICEP, RIGHT FOREARM, UPPER THIGHS, ON TOP OF HEAD, INSIDE OF ARM AND ON BACK ALL OVER THE BODY) THEY ARE ITCHY WHEN SCRATCHED; HIVES ALL OVER THE BODY; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 and expiry: 21-MAY-2021) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced sweating, cluster of rashes all over body (shoulder blade, left bicep, right forearm in left bicep, right forearm, upper thighs, on top of head, inside of arm and on back all over the body) they are itchy when scratched, and hives all over the body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cluster of rashes all over body (shoulder blade, left bicep, right forearm in left bicep, right forearm, upper thighs, on top of head, inside of arm and on back all over the body) they are itchy when scratched, and the outcome of sweating and hives all over the body was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: FEVER OF 100.2F; This spontaneous report received from a consumer concerned a 21 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown) dose was not reported, administered on 13-JUL-2021 15:00 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 14-JUL-2021, the subject experienced fever of 100.2f. Laboratory data included: Body temperature (NR: not provided) 100.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever of 100.2f was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: IT FELT KIND OF LIKE THE FLU; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced it felt kind of like the flu. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from it felt kind of like the flu. This report was non-serious. This case, from the same reporter is linked to 20210730909.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICK FOR THREE MONTHS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced sick for three months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sick for three months was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: BODYACHES; HEADACHE; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported.  On 13-JUL-2021, the subject experienced bodyaches. On 13-JUL-2021, the subject experienced headache. On 13-JUL-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, fever and bodyaches was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: TEMPERATURE  EXCURSION OF 51.5 DEGREES FAHRENHEIT TO 52.4 DEGREES FAHRENHEIT FOR 2 DAYS (OUT OF ACCEPTABLE LIMIT); VACCINE WITH TEMPERATURE EXCURSION WAS ADMINISTERED TO PATIENTS (10 DOSES USED); This spontaneous report received from a pharmacist concerned multiple patients.  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: 043A21A, 203A21A and expiry: 05-AUG-2021) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced temperature excursion of 51.5 degrees fahrenheit to 52.4 degrees fahrenheit for 2 days (out of acceptable limit), and vaccine with temperature excursion was administered to subjects (10 doses used). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temperature excursion of 51.5 degrees fahrenheit to 52.4 degrees fahrenheit for 2 days (out of acceptable limit) and vaccine with temperature excursion was administered to patients (10 doses used) was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Hypoaesthesia
Clinical narrative: NUMBNESS OF TWO FINGERS AND THE RIBS OF THE PALM ON THE LEFT ARM; REDNESS HAS FORMED ON THE BEND OF THE ELBOW; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. 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: Unk) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-JUL-2021, the subject experienced numbness of two fingers and the ribs of the palm on the left arm. On 07-JUL-2021, the subject experienced redness has formed on the bend of the elbow. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness of two fingers and the ribs of the palm on the left arm, and had not recovered from redness has formed on the bend of the elbow. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: RED BLOTCHES (FIRST ON ARM AND THEN  SPREAD TO THE BODY); This spontaneous report received from a pharmacist concerned a female of unspecified age. The patient's height, and weight were not reported.  No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number:Unknown ,expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination.  The batch number was not reported and has been requested.  No concomitant medications were reported.  On an unspecified date, the subject experienced red blotches (first on arm and then spread to the body). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of red blotches (first on arm and then spread to the body) was not reported. This report was non-serious. This case, from the same reporter is linked to 20210730843.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain, Body temperature, Dyspnoea, Headache, Pain in extremity
Clinical narrative: SHORTNESS OF BREATH; ABDOMINAL PAIN; LEG PAIN; HIGH TEMPERATURE; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced shortness of breath, abdominal pain, leg pain, high temperature, and headache. Laboratory data (dates unspecified) included Body temperature (NR: not provided) high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high temperature, headache, abdominal pain, leg pain and shortness of breath was not reported. This report was non-serious.