chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: White blood cell count
Clinical narrative: ORAL THRUSH; WHOLE BODY IS INFLAMED; EYE TWITCHING; LEG JERKING; PRESSURE UNDER HER RIB CAGE; HOT TO TOUCH; RASH ON UPPER ARM, CHEST, STOMACH; LEFT ARM SORE; UNEXPLAINED BLUE/PURPLE BRUISING ON FRONT AND BACK LEG; BAD TASTE; LOSING TASTE; BURNING IN THE MOUTH; SWOLLEN TONGUE; ITCHINESS ALL OVER THE BODY; SKIN FELT LIKE IT'S BURNING AND HOT TO TOUCH; LIPS NUMBING; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa allergy, abstain from alcohol, and non-smoker, and other pre-existing medical conditions included the patient had no known health condition and was taking supplements only. the patient never had allergy medications (never get seasonal allergies).The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: 21-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced skin felt like it's burning and hot to touch. On APR-2021, the subject experienced lips numbing. On 08-APR-2021, the subject experienced itchiness all over the body. On 20-APR-2021, the subject experienced burning in the mouth. On 20-APR-2021, the subject experienced swollen tongue. On 20-APR-2021, the subject experienced bad taste. On 20-APR-2021, the subject experienced losing taste. On MAY-2021, the subject experienced unexplained blue/purple bruising on front and back leg. On MAY-2021, the subject experienced left arm sore. On 03-MAY-2021, Laboratory data included: Blood test (NR: not provided) normal white blood cells and iron level low, Platelet count (NR: not provided) normal, Serum iron (NR: not provided) low, and White blood cells (NR: not provided) Normal. On an unspecified date, the subject experienced oral thrush, whole body is inflamed, eye twitching, leg jerking, pressure under her rib cage, hot to touch, and rash on upper arm, chest, stomach. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative. Treatment medications (dates unspecified) included: cetirizine hydrochloride, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine  was not applicable. The patient recovered from skin felt like it's burning and hot to touch, and rash on upper arm, chest, stomach, was recovering from pressure under her rib cage, had not recovered from swollen tongue, and burning in the mouth, and the outcome of itchiness all over the body, unexplained blue/purple bruising on front and back leg, eye twitching, leg jerking, left arm sore, whole body is inflamed, bad taste, losing taste, lips numbing, hot to touch and oral thrush was not reported. This report was non-serious. This case, from the same reporter is linked to 20210534998.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non serious.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Blepharospasm, Cold sweat, Contusion, Discomfort
Clinical narrative: ORAL THRUSH; WHOLE BODY IS INFLAMED; EYE TWITCHING; LEG JERKING; PRESSURE UNDER HER RIB CAGE; HOT TO TOUCH; RASH ON UPPER ARM, CHEST, STOMACH; LEFT ARM SORE; UNEXPLAINED BLUE/PURPLE BRUISING ON FRONT AND BACK LEG; BAD TASTE; LOSING TASTE; BURNING IN THE MOUTH; SWOLLEN TONGUE; ITCHINESS ALL OVER THE BODY; SKIN FELT LIKE IT'S BURNING AND HOT TO TOUCH; LIPS NUMBING; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa allergy, abstain from alcohol, and non-smoker, and other pre-existing medical conditions included the patient had no known health condition and was taking supplements only. the patient never had allergy medications (never get seasonal allergies).The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: 21-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced skin felt like it's burning and hot to touch. On APR-2021, the subject experienced lips numbing. On 08-APR-2021, the subject experienced itchiness all over the body. On 20-APR-2021, the subject experienced burning in the mouth. On 20-APR-2021, the subject experienced swollen tongue. On 20-APR-2021, the subject experienced bad taste. On 20-APR-2021, the subject experienced losing taste. On MAY-2021, the subject experienced unexplained blue/purple bruising on front and back leg. On MAY-2021, the subject experienced left arm sore. On 03-MAY-2021, Laboratory data included: Blood test (NR: not provided) normal white blood cells and iron level low, Platelet count (NR: not provided) normal, Serum iron (NR: not provided) low, and White blood cells (NR: not provided) Normal. On an unspecified date, the subject experienced oral thrush, whole body is inflamed, eye twitching, leg jerking, pressure under her rib cage, hot to touch, and rash on upper arm, chest, stomach. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative. Treatment medications (dates unspecified) included: cetirizine hydrochloride, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine  was not applicable. The patient recovered from skin felt like it's burning and hot to touch, and rash on upper arm, chest, stomach, was recovering from pressure under her rib cage, had not recovered from swollen tongue, and burning in the mouth, and the outcome of itchiness all over the body, unexplained blue/purple bruising on front and back leg, eye twitching, leg jerking, left arm sore, whole body is inflamed, bad taste, losing taste, lips numbing, hot to touch and oral thrush was not reported. This report was non-serious. This case, from the same reporter is linked to 20210534998.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non serious.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Full blood count normal, Mouth ulceration, Platelet count, Pruritus
Clinical narrative: ORAL THRUSH; WHOLE BODY IS INFLAMED; EYE TWITCHING; LEG JERKING; PRESSURE UNDER HER RIB CAGE; HOT TO TOUCH; RASH ON UPPER ARM, CHEST, STOMACH; LEFT ARM SORE; UNEXPLAINED BLUE/PURPLE BRUISING ON FRONT AND BACK LEG; BAD TASTE; LOSING TASTE; BURNING IN THE MOUTH; SWOLLEN TONGUE; ITCHINESS ALL OVER THE BODY; SKIN FELT LIKE IT'S BURNING AND HOT TO TOUCH; LIPS NUMBING; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa allergy, abstain from alcohol, and non-smoker, and other pre-existing medical conditions included the patient had no known health condition and was taking supplements only. the patient never had allergy medications (never get seasonal allergies).The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: 21-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced skin felt like it's burning and hot to touch. On APR-2021, the subject experienced lips numbing. On 08-APR-2021, the subject experienced itchiness all over the body. On 20-APR-2021, the subject experienced burning in the mouth. On 20-APR-2021, the subject experienced swollen tongue. On 20-APR-2021, the subject experienced bad taste. On 20-APR-2021, the subject experienced losing taste. On MAY-2021, the subject experienced unexplained blue/purple bruising on front and back leg. On MAY-2021, the subject experienced left arm sore. On 03-MAY-2021, Laboratory data included: Blood test (NR: not provided) normal white blood cells and iron level low, Platelet count (NR: not provided) normal, Serum iron (NR: not provided) low, and White blood cells (NR: not provided) Normal. On an unspecified date, the subject experienced oral thrush, whole body is inflamed, eye twitching, leg jerking, pressure under her rib cage, hot to touch, and rash on upper arm, chest, stomach. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative. Treatment medications (dates unspecified) included: cetirizine hydrochloride, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine  was not applicable. The patient recovered from skin felt like it's burning and hot to touch, and rash on upper arm, chest, stomach, was recovering from pressure under her rib cage, had not recovered from swollen tongue, and burning in the mouth, and the outcome of itchiness all over the body, unexplained blue/purple bruising on front and back leg, eye twitching, leg jerking, left arm sore, whole body is inflamed, bad taste, losing taste, lips numbing, hot to touch and oral thrush was not reported. This report was non-serious. This case, from the same reporter is linked to 20210534998.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non serious.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Swollen tongue, Tongue blistering, Tongue coated, Vasculitis
Clinical narrative: ORAL THRUSH; WHOLE BODY IS INFLAMED; EYE TWITCHING; LEG JERKING; PRESSURE UNDER HER RIB CAGE; HOT TO TOUCH; RASH ON UPPER ARM, CHEST, STOMACH; LEFT ARM SORE; UNEXPLAINED BLUE/PURPLE BRUISING ON FRONT AND BACK LEG; BAD TASTE; LOSING TASTE; BURNING IN THE MOUTH; SWOLLEN TONGUE; ITCHINESS ALL OVER THE BODY; SKIN FELT LIKE IT'S BURNING AND HOT TO TOUCH; LIPS NUMBING; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa allergy, abstain from alcohol, and non-smoker, and other pre-existing medical conditions included the patient had no known health condition and was taking supplements only. the patient never had allergy medications (never get seasonal allergies).The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: 21-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced skin felt like it's burning and hot to touch. On APR-2021, the subject experienced lips numbing. On 08-APR-2021, the subject experienced itchiness all over the body. On 20-APR-2021, the subject experienced burning in the mouth. On 20-APR-2021, the subject experienced swollen tongue. On 20-APR-2021, the subject experienced bad taste. On 20-APR-2021, the subject experienced losing taste. On MAY-2021, the subject experienced unexplained blue/purple bruising on front and back leg. On MAY-2021, the subject experienced left arm sore. On 03-MAY-2021, Laboratory data included: Blood test (NR: not provided) normal white blood cells and iron level low, Platelet count (NR: not provided) normal, Serum iron (NR: not provided) low, and White blood cells (NR: not provided) Normal. On an unspecified date, the subject experienced oral thrush, whole body is inflamed, eye twitching, leg jerking, pressure under her rib cage, hot to touch, and rash on upper arm, chest, stomach. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative. Treatment medications (dates unspecified) included: cetirizine hydrochloride, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine  was not applicable. The patient recovered from skin felt like it's burning and hot to touch, and rash on upper arm, chest, stomach, was recovering from pressure under her rib cage, had not recovered from swollen tongue, and burning in the mouth, and the outcome of itchiness all over the body, unexplained blue/purple bruising on front and back leg, eye twitching, leg jerking, left arm sore, whole body is inflamed, bad taste, losing taste, lips numbing, hot to touch and oral thrush was not reported. This report was non-serious. This case, from the same reporter is linked to 20210534998.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: SORE THROAT MORE ON THE LEFT SIDE OF THROAT; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1805018, expiry: 25-MAY-2021) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAY-2021, the subject experienced sore throat more on the left side of throat. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from sore throat more on the left side of throat. This report was non-serious.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Feeling cold, Injection site pain, Poor quality sleep
Clinical narrative: RESTLESS SLEEP; FELT COLD; INJECTION SITE SORENESS; TIRED; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 47 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced restless sleep. On 15-MAY-2021, the subject experienced felt cold. On 15-MAY-2021, the subject experienced injection site soreness. On 15-MAY-2021, the subject experienced tired. On 15-MAY-2021, the subject experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) 99.4 (unit unspecified). On 16-MAY-2021, Laboratory data included: Body temperature (NR: not provided) normal. The action taken with covid-19 vaccine  was not applicable. The patient recovered from restless sleep, felt cold, and low grade fever on 16-MAY-2021, injection site soreness on 19-MAY-2021, and tired on 17-MAY-2021. This report was non-serious.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: RESTLESS SLEEP; FELT COLD; INJECTION SITE SORENESS; TIRED; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 47 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced restless sleep. On 15-MAY-2021, the subject experienced felt cold. On 15-MAY-2021, the subject experienced injection site soreness. On 15-MAY-2021, the subject experienced tired. On 15-MAY-2021, the subject experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) 99.4 (unit unspecified). On 16-MAY-2021, Laboratory data included: Body temperature (NR: not provided) normal. The action taken with covid-19 vaccine  was not applicable. The patient recovered from restless sleep, felt cold, and low grade fever on 16-MAY-2021, injection site soreness on 19-MAY-2021, and tired on 17-MAY-2021. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site extravasation, Pain in extremity, Pruritus, Rash vesicular
Clinical narrative: ITCH IN LEGS AND ARM; LITTLE POLKA DOTS /FLUID-FILLED BLISTERS (RASH ON ARMS AND LEGS AND LITTLE BIT ON STOMACH); SHARP  PAINS FROM SHOULDER TO THE ELBOW/ SORE ARM; SHARP PAIN  DOWN TO WRIST/JOINT PAIN; FLUID LEAKING; 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 supraventricular tachycardia, low blood pressure, and osteoporosis, and other pre-existing medical conditions included the patient had taken a natural hormone medication from a compounding pharmacy and also osteonutrients and unspecified medication for osteoporosis. The patient experienced drug allergy when treated with cyclobenzaprine hydrochloride, and tetanus vaccine for drug used for unknown indication, drug allergy when treated with clarithromycin, diazepam, and hydrocodone bitartrate/paracetamol. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 23-JUN-2021) dose was not reported, administered on 13-MAY-2021 08:55 for prophylactic vaccination. Concomitant medications included atenolol for supraventricular tachycardia. On 13-MAY-2021, the subject experienced fluid leaking. On 13-MAY-2021, the subject experienced sharp pains from shoulder to the elbow/ sore arm. On 13-MAY-2021, the subject experienced sharp pain down to wrist/joint pain. On 14-MAY-2021, the subject experienced itch in legs and arm. On 14-MAY-2021, the subject experienced little polka dots /fluid-filled blisters (rash on arms and legs and little bit on stomach). Treatment medications (dates unspecified) included: calamine/glycerol/zinc oxide, ibuprofen, charcoal, activated, triamcinolone acetonide, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine was not applicable. The patient recovered from sharp pain down to wrist/joint pain on 14-MAY-2021, had not recovered from little polka dots /fluid-filled blisters (rash on arms and legs and little bit on stomach), and itch in legs and arm, and the outcome of fluid leaking and sharp pains from shoulder to the elbow/ sore arm was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: ACHES; This spontaneous report received from a patient via a company representative 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  (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 aches. The action taken with covid-19 vaccine  was not applicable. The outcome of aches was not reported. This report was non-serious. This case, from the same reporter is linked to 20210539064.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism, Suspected COVID-19, Thrombosis, Vaccination failure
Clinical narrative: MULTIPLE PULMONARY EMBOLISM; MULTIPLE BLOOD CLOTS; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a health care professional concerned a 55 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: Unknown, Expiry: Unknown) dose not reported, 1 total, on 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 patient developed multiple pulmonary embolism included multiple blood clots. On 19-MAY-2021, after 4 week of vaccination, the patient was diagnosed with suspected covid-19 infection (suspected clinical vaccination failure) and was not doing well. The patient got hospitalized. Number of hospitalization days was not reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, suspected clinical vaccination failure, multiple pulmonary embolism and multiple blood clots was not reported. This report was serious (Hospitalization Caused / Prolonged and Life Threatening). This report was associated with product quality complaint number: 90000180239. The suspected product quality complaint has been confirmed to be not voided based on the PQC evaluation/investigation performed.; Sender's Comments: V0:20210539965-covid-19 vaccine ad26.cov2.s - multiple pulmonary embolism,multiple blood clots,suspected covid 19 infection. 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). V0:20210539965 covid-19 vaccine ad26.cov2.s - suspected clinical vaccination failure 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:SPECIAL SITUATIONS
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site warmth, Rash
Clinical narrative: HOT SPOT SENSITIVE; ROUND BUMP RED CIRCLE ABOUT AN INCH ON ARM NEXT TO THE INJECTION SITE; FELT TIRED; MILD HEADACHE; 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 diabetes, fibromyalgia, non hodgkin's lymphoma, and sulfa allergy.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042172117 expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAY-2021, the subject experienced felt tired. On 18-MAY-2021, the subject experienced mild headache. On 19-MAY-2021, the subject experienced round bump red circle about an inch on arm next to the injection site. On an unspecified date, the subject experienced hot spot sensitive. The action taken with covid-19 vaccine  was not applicable. The patient recovered from mild headache on 18-MAY-2021, was recovering from felt tired, had not recovered from round bump red circle about an inch on arm next to the injection site, and the outcome of hot spot sensitive was not reported. This report was non-serious. This parent/child case is linked to 20210540029.
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Imaging procedure, Pulmonary embolism, Ultrasound scan
Clinical narrative: DEEP VEIN THROMBOSIS; PULMONARY EMBOLISM; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient had no family or personal history of clots and no provoking factors.  The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 05-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 18-MAY-2021, the patient presented to the emergency department with one week of leg swelling and pain. The patient work up was notable for deep vein thrombosis ultrasound positive for deep venous thrombosis in the left lower extremity in distal femoral and popliteal and PE study showing filling defect in the lobar and interlobar pulmonary arteries extending to segmental and subsegmental pulmonary arteries, right greater than left. On MAY-2021, the subject experienced deep vein thrombosis and pulmonary embolism. The action taken with covid-19 vaccine was not applicable. The outcome of deep vein thrombosis and pulmonary embolism was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: COVID-19 VACCINE deep vein thrombosis, pulmonary embolism. 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: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: UNSPECIFIED ADVERSE EVENT; 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 (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 unspecified adverse event. The action taken with covid-19 vaccine  was not applicable. The outcome of unspecified adverse event was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Expired product administered, Headache
Clinical narrative: CHILLS; HEADACHE; POSSIBLE EXPIRED VACCINE ADMINISTERED; 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  (suspension for injection, route of admin not reported, batch number: 042801A expiry: 01-FEB-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced possible expired vaccine administered. On 17-MAY-2021, the subject experienced chills. On 17-MAY-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from chills, had not recovered from headache, and the outcome of possible expired vaccine administered was not reported. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Fall, Head injury, Loss of personal independence in daily activities, Middle insomnia
Clinical narrative: FALL/SHE FELL OVER AGAIN; UPON DISCHARGE WENT HOME WITH WALKER/SENT HER HOME WITH A WALKER; HAVING TROUBLE WITH HER DAILY LIFE; RED POLKADOTS ON HANDS; DRY SKIN; SOMETHING IN THROAT/RASPY THROAT; LEGS  COLLAPSED; HER LEGS TURNED TO RUBBER; SAT DOWN HARD ON HER RIGHT ASS; HIT HEAD ON THE PAVEMENT; IT HURT; GOT UP DURING THE NIGHT; This spontaneous report received from a patient concerned a 68 year old other race female. The patient's height, and weight were not reported.  The patient's past medical history included has broken 3 bones in the top of the foot, stroke, and shattered her shoulders and arm, and concurrent conditions included seizure, hydrochlorothiazide allergy, and penicillin allergy. The patient taking blood pressure pills and pills for seizures (unspecified). The patient received Covid-19 (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) 1 total dose, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-MAR-2021, the patient hurts. Then the patient went home; and went to store for picked up some groceries. On the way back to car the patient's legs turned to rubber and she sat down. Her legs collapsed and sat on ass hit head on the pavement. On 25-MAR-2021 the patient got up during the night and same things happened again and she fell over again and spent the night on the floor and admitted to hospital (dates unspecified) for 4 days and the patient received blood thinner shots (unspecified) in her stomach. The patient discharged from hospital (dates unspecified) with walker. On an unspecified dates the patient had all kinds of tests and all came back normal. On an unknown date the patient having trouble with her daily life. The patient had a physical therapy and occupational therapy for a month. On 30-MAR-2021, the patient experienced dry skin and something in throat/raspy throat. On an unknown date the patient had red polkadots on hands.  The action taken with covid-19 vaccine was not applicable. On an unknown date the patient was recovered from fall/she fell over again, and not recovered from dry skin, and something in throat/raspy throat and the outcome for and the outcome of red polkadots on hands, her legs turned to rubber, sat down hard on her right ass, legs collapsed, hit head on the pavement, got up during the night, it hurt, upon discharge went home with walker/sent her home with a walker and having trouble with her daily life was not reported  This report was serious (Hospitalization Caused / Prolonged). FALL/SHE FELL OVER AGAIN. 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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Musculoskeletal pain, Pain, Rash, Sensory disturbance
Clinical narrative: FALL/SHE FELL OVER AGAIN; UPON DISCHARGE WENT HOME WITH WALKER/SENT HER HOME WITH A WALKER; HAVING TROUBLE WITH HER DAILY LIFE; RED POLKADOTS ON HANDS; DRY SKIN; SOMETHING IN THROAT/RASPY THROAT; LEGS  COLLAPSED; HER LEGS TURNED TO RUBBER; SAT DOWN HARD ON HER RIGHT ASS; HIT HEAD ON THE PAVEMENT; IT HURT; GOT UP DURING THE NIGHT; This spontaneous report received from a patient concerned a 68 year old other race female. The patient's height, and weight were not reported.  The patient's past medical history included has broken 3 bones in the top of the foot, stroke, and shattered her shoulders and arm, and concurrent conditions included seizure, hydrochlorothiazide allergy, and penicillin allergy. The patient taking blood pressure pills and pills for seizures (unspecified). The patient received Covid-19 (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) 1 total dose, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-MAR-2021, the patient hurts. Then the patient went home; and went to store for picked up some groceries. On the way back to car the patient's legs turned to rubber and she sat down. Her legs collapsed and sat on ass hit head on the pavement. On 25-MAR-2021 the patient got up during the night and same things happened again and she fell over again and spent the night on the floor and admitted to hospital (dates unspecified) for 4 days and the patient received blood thinner shots (unspecified) in her stomach. The patient discharged from hospital (dates unspecified) with walker. On an unspecified dates the patient had all kinds of tests and all came back normal. On an unknown date the patient having trouble with her daily life. The patient had a physical therapy and occupational therapy for a month. On 30-MAR-2021, the patient experienced dry skin and something in throat/raspy throat. On an unknown date the patient had red polkadots on hands.  The action taken with covid-19 vaccine was not applicable. On an unknown date the patient was recovered from fall/she fell over again, and not recovered from dry skin, and something in throat/raspy throat and the outcome for and the outcome of red polkadots on hands, her legs turned to rubber, sat down hard on her right ass, legs collapsed, hit head on the pavement, got up during the night, it hurt, upon discharge went home with walker/sent her home with a walker and having trouble with her daily life was not reported  This report was serious (Hospitalization Caused / Prolonged). FALL/SHE FELL OVER AGAIN. 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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Walking aid user
Clinical narrative: FALL/SHE FELL OVER AGAIN; UPON DISCHARGE WENT HOME WITH WALKER/SENT HER HOME WITH A WALKER; HAVING TROUBLE WITH HER DAILY LIFE; RED POLKADOTS ON HANDS; DRY SKIN; SOMETHING IN THROAT/RASPY THROAT; LEGS  COLLAPSED; HER LEGS TURNED TO RUBBER; SAT DOWN HARD ON HER RIGHT ASS; HIT HEAD ON THE PAVEMENT; IT HURT; GOT UP DURING THE NIGHT; This spontaneous report received from a patient concerned a 68 year old other race female. The patient's height, and weight were not reported.  The patient's past medical history included has broken 3 bones in the top of the foot, stroke, and shattered her shoulders and arm, and concurrent conditions included seizure, hydrochlorothiazide allergy, and penicillin allergy. The patient taking blood pressure pills and pills for seizures (unspecified). The patient received Covid-19 (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) 1 total dose, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-MAR-2021, the patient hurts. Then the patient went home; and went to store for picked up some groceries. On the way back to car the patient's legs turned to rubber and she sat down. Her legs collapsed and sat on ass hit head on the pavement. On 25-MAR-2021 the patient got up during the night and same things happened again and she fell over again and spent the night on the floor and admitted to hospital (dates unspecified) for 4 days and the patient received blood thinner shots (unspecified) in her stomach. The patient discharged from hospital (dates unspecified) with walker. On an unspecified dates the patient had all kinds of tests and all came back normal. On an unknown date the patient having trouble with her daily life. The patient had a physical therapy and occupational therapy for a month. On 30-MAR-2021, the patient experienced dry skin and something in throat/raspy throat. On an unknown date the patient had red polkadots on hands.  The action taken with covid-19 vaccine was not applicable. On an unknown date the patient was recovered from fall/she fell over again, and not recovered from dry skin, and something in throat/raspy throat and the outcome for and the outcome of red polkadots on hands, her legs turned to rubber, sat down hard on her right ass, legs collapsed, hit head on the pavement, got up during the night, it hurt, upon discharge went home with walker/sent her home with a walker and having trouble with her daily life was not reported  This report was serious (Hospitalization Caused / Prolonged). FALL/SHE FELL OVER AGAIN. 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: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test false positive, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; FALSE POSITIVE PCR TEST; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: 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 patient underwent to SARS-CoV-2 PCR test and diagnosed with the false positive result and had suspected clinical vaccination failure.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of false positive PCR test and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000180230, PQM001525200 and PQM001525259. The suspected product quality complaint has been confirmed to be this record indicates an adverse event. there is no product quality issue reported. Approval to void this record due to no PQC identified. based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210541182-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccine failure . This event(s) is considered not related. The event(s) has an unknown/unclear 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: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19, UNK
Symptoms: Malaise, Nasopharyngitis
Clinical narrative: Head cold; Feeling Sick; This spontaneous report received from a patient concerned a 67 year old female. The patient's weight was 72.7 kilograms, and height was not reported. The patient's concurrent conditions included primary pulmonary hypertension. The patient received macitentan (tablet, oral, batch number: ZE019B0101 expiry: 31-JUL-2024) dose, frequency, and therapy dates were not reported for an unspecified indication.  The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, and dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included tadalafil. On an unspecified date, the subject experienced head cold, and feeling sick. The action taken with covid-19 vaccine , and macitentan was not applicable. The outcome of the feeling sick and head cold was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: NECK PAIN; This spontaneous report received from a consumer received on 14-MAY-2021 and concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. Batch number was not reported and has been requested. The patient received covid-19 vaccine  (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced neck pain. The action taken with covid-19 vaccine  was not applicable. The outcome of neck pain was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Cough, Headache, Ocular discomfort
Clinical narrative: COUGH; SLIGHT ARM SORENESS; WEAKNESS/REALLY WEAK; HEADACHES EXCRUCIATING AFTER THE VACCINE; FEVER; SORE THROAT; COVID EYES; POST NASAL DRIP; This spontaneous report received from a consumer concerned a 64 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced post nasal drip. On 02-APR-2021, the subject experienced sore throat. On 02-APR-2021, the subject experienced covid eyes. On 02-APR-2021, the subject experienced cough. On 02-APR-2021, the subject experienced slight arm soreness. On 02-APR-2021, the subject experienced weakness/really weak. On 02-APR-2021, the subject experienced headaches excruciating after the vaccine. On 02-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine  was not applicable. The patient recovered from sore throat, covid eyes, cough, and fever on 06-APR-2021, and slight arm soreness on 04-APR-2021, was recovering from weakness/really weak, and headaches excruciating after the vaccine, and the outcome of post nasal drip was not reported. This report was non-serious. This case, from the same reporter is linked to 20210545446.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity, Pyrexia, Upper-airway cough syndrome
Clinical narrative: COUGH; SLIGHT ARM SORENESS; WEAKNESS/REALLY WEAK; HEADACHES EXCRUCIATING AFTER THE VACCINE; FEVER; SORE THROAT; COVID EYES; POST NASAL DRIP; This spontaneous report received from a consumer concerned a 64 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced post nasal drip. On 02-APR-2021, the subject experienced sore throat. On 02-APR-2021, the subject experienced covid eyes. On 02-APR-2021, the subject experienced cough. On 02-APR-2021, the subject experienced slight arm soreness. On 02-APR-2021, the subject experienced weakness/really weak. On 02-APR-2021, the subject experienced headaches excruciating after the vaccine. On 02-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine  was not applicable. The patient recovered from sore throat, covid eyes, cough, and fever on 06-APR-2021, and slight arm soreness on 04-APR-2021, was recovering from weakness/really weak, and headaches excruciating after the vaccine, and the outcome of post nasal drip was not reported. This report was non-serious. This case, from the same reporter is linked to 20210545446.
Sex: F
Vaccine: COVID19
Symptoms: Colonoscopy, Headache, Hemiparesis, Hypoaesthesia, Limb discomfort
Clinical narrative: WEAKNESS OF THE RIGHT SIDE OF THE BODY; NUMBNESS ON RIGHT SIDE OF THE BODY; PAIN ON THE RIGHT SIDE OF THE BODY; STIFFNESS OF BODY; FEELING OF HEAVINESS IN BODY; HEADACHE; MUSCLE PAIN THAT EXTENDS TO THE BONES; This spontaneous report received from a consumer concerned a 59 year old not Hispanic or Latino, Asian female. The patient's weight was 130 pounds, and height was 162 centimeters. The patient's past medical history included pain on the right side of the body but not similar to what she was experiencing now, and concurrent conditions included high blood pressure, no alcohol use, and non smoker, and other pre-existing medical conditions included patient had no known allergies and patient had no drug abuse or illicit drug usage. The patient was not pregnant at the time of report. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 1805029, expiry: unknown) frequency 1 total, dose was not reported, administered on 13-MAR-2021 at deltoid in left arm for prophylactic vaccination. No concomitant medications were reported. The reporter stated that on the 15-MAY-2021, his mother started to develop side effects of the vaccine such as headache, pain and numbness on her right side of the body which started from her head to her feet and weakness of the right side of the body. According to the reporter the pain scale varied from 6-10/10, she described the pain like a feeling of heaviness, stiffness and muscle pain that extends to her bones. The patient consulted her health care professional and Chiropractor 2 days before the date of report and they did not prescribe anything but recommended to do MRI which she will do moving forward. Patient was taking over the counter pain medication and had massage on the painful area but it only helped for a short period of time and according to her son it was really affecting her activity of daily living (subsumed under event weakness of the right side of the body) as the symptoms were getting worse. On an unspecified date in MAY-2021, Laboratory data included: Pain scale (NR: not provided) the pain scale varies from 6-10/10. On 01-MAY-2021, Laboratory data included: Colonoscopy (NR: not provided) Unknown.  The action taken with covid-19 vaccine was not applicable. The patient had not recovered from numbness on right side of the body, pain on the right side of the body, weakness of the right side of the body, headache, feeling of heaviness in body, stiffness of body, and muscle pain that extends to the bones. This report was serious (Other Medically Important Condition). covid-19 vaccine weakness of the right side of the body. 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: Musculoskeletal stiffness, Myalgia, Pain, Pain assessment
Clinical narrative: WEAKNESS OF THE RIGHT SIDE OF THE BODY; NUMBNESS ON RIGHT SIDE OF THE BODY; PAIN ON THE RIGHT SIDE OF THE BODY; STIFFNESS OF BODY; FEELING OF HEAVINESS IN BODY; HEADACHE; MUSCLE PAIN THAT EXTENDS TO THE BONES; This spontaneous report received from a consumer concerned a 59 year old not Hispanic or Latino, Asian female. The patient's weight was 130 pounds, and height was 162 centimeters. The patient's past medical history included pain on the right side of the body but not similar to what she was experiencing now, and concurrent conditions included high blood pressure, no alcohol use, and non smoker, and other pre-existing medical conditions included patient had no known allergies and patient had no drug abuse or illicit drug usage. The patient was not pregnant at the time of report. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 1805029, expiry: unknown) frequency 1 total, dose was not reported, administered on 13-MAR-2021 at deltoid in left arm for prophylactic vaccination. No concomitant medications were reported. The reporter stated that on the 15-MAY-2021, his mother started to develop side effects of the vaccine such as headache, pain and numbness on her right side of the body which started from her head to her feet and weakness of the right side of the body. According to the reporter the pain scale varied from 6-10/10, she described the pain like a feeling of heaviness, stiffness and muscle pain that extends to her bones. The patient consulted her health care professional and Chiropractor 2 days before the date of report and they did not prescribe anything but recommended to do MRI which she will do moving forward. Patient was taking over the counter pain medication and had massage on the painful area but it only helped for a short period of time and according to her son it was really affecting her activity of daily living (subsumed under event weakness of the right side of the body) as the symptoms were getting worse. On an unspecified date in MAY-2021, Laboratory data included: Pain scale (NR: not provided) the pain scale varies from 6-10/10. On 01-MAY-2021, Laboratory data included: Colonoscopy (NR: not provided) Unknown.  The action taken with covid-19 vaccine was not applicable. The patient had not recovered from numbness on right side of the body, pain on the right side of the body, weakness of the right side of the body, headache, feeling of heaviness in body, stiffness of body, and muscle pain that extends to the bones. This report was serious (Other Medically Important Condition). covid-19 vaccine weakness of the right side of the body. 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).