chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chest X-ray, Chest discomfort, Cough, Dyspnoea
Clinical narrative: NOT BEEN ABLE TO WEAR SHOES OR SANDAL; COUGH; SOB AT NIGHT AND COUGHS IF SHE LAYS DOWN,COULD NOT TAKE DEEP BREATH  UNLESS SHE COUGHS; CHEST HEAVINESS; BAKER'S CYST  IN THE BACK OF THE KNEE OF THE LEFT LEG; LEFT LEG IS BIGGER THAN THE RIGHT LEG, LEFT LEG DID NOT LOOK LIKE THE  RIGHT ONE; DOES NOT FEEL WELL; NO ENERGY; THE VEINS OF THE LEGS HAD BEEN LEAKING; BELLY  BUTTON AREA SWELLING; SWELLING OF BOTH LEGS; EXHAUSTION, CHRONIC FATIGUE.; RASH; SORE LEG AND VERY UNCOMFORTABLE, STANDING IS VERY PAINFUL; WORST HEADACHE, HEADACHE WAS HORRIBLE AND  TERRIFIC; FELT ACHY; 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 past medical history included: back surgery, and concurrent conditions included: hypothyroidism, polycystic ovary, and hashimoto. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the patient experienced felt achy. On 09-APR-2021, the patient experienced worst headache, headache was horrible and terrific. On 10-APR-2021, the patient experienced swelling of both legs. On 10-APR-2021, the patient experienced belly button area swelling. On 10-APR-2021, the patient experienced sore leg and very uncomfortable, standing is very painful. On 10-APR-2021, the patient experienced rash. On 10-APR-2021, the patient experienced exhaustion, chronic fatigue. Treatment medications included: ibuprofen. On JUL-2021, the patient experienced the veins of the legs had been leaking. On an unspecified date, the patient experienced not been able to wear shoes or sandal, cough, sob at night and coughs if she lays down, could not take deep breath unless she coughs, chest heaviness, baker's cyst in the back of the knee of the left leg, left leg is bigger than the right leg, left leg did not look like the right one, does not feel well, and no energy. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt achy, and worst headache, headache was horrible and terrific on 10-APR-2021, and rash on 30-APR-2021, had not recovered from swelling of both legs, the veins of the legs had been leaking, left leg is bigger than the right leg, left leg did not look like the right one, sore leg and very uncomfortable, standing is very painful, and belly button area swelling, and the outcome of not been able to wear shoes or sandal, cough, sob at night and coughs if she lays down, could not take deep breath unless she coughs, baker's cyst in the back of the knee of the left leg, no energy, exhaustion, chronic fatigue., does not feel well and chest heaviness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Loss of personal independence in daily activities, Lymphoedema, Malaise
Clinical narrative: NOT BEEN ABLE TO WEAR SHOES OR SANDAL; COUGH; SOB AT NIGHT AND COUGHS IF SHE LAYS DOWN,COULD NOT TAKE DEEP BREATH  UNLESS SHE COUGHS; CHEST HEAVINESS; BAKER'S CYST  IN THE BACK OF THE KNEE OF THE LEFT LEG; LEFT LEG IS BIGGER THAN THE RIGHT LEG, LEFT LEG DID NOT LOOK LIKE THE  RIGHT ONE; DOES NOT FEEL WELL; NO ENERGY; THE VEINS OF THE LEGS HAD BEEN LEAKING; BELLY  BUTTON AREA SWELLING; SWELLING OF BOTH LEGS; EXHAUSTION, CHRONIC FATIGUE.; RASH; SORE LEG AND VERY UNCOMFORTABLE, STANDING IS VERY PAINFUL; WORST HEADACHE, HEADACHE WAS HORRIBLE AND  TERRIFIC; FELT ACHY; 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 past medical history included: back surgery, and concurrent conditions included: hypothyroidism, polycystic ovary, and hashimoto. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the patient experienced felt achy. On 09-APR-2021, the patient experienced worst headache, headache was horrible and terrific. On 10-APR-2021, the patient experienced swelling of both legs. On 10-APR-2021, the patient experienced belly button area swelling. On 10-APR-2021, the patient experienced sore leg and very uncomfortable, standing is very painful. On 10-APR-2021, the patient experienced rash. On 10-APR-2021, the patient experienced exhaustion, chronic fatigue. Treatment medications included: ibuprofen. On JUL-2021, the patient experienced the veins of the legs had been leaking. On an unspecified date, the patient experienced not been able to wear shoes or sandal, cough, sob at night and coughs if she lays down, could not take deep breath unless she coughs, chest heaviness, baker's cyst in the back of the knee of the left leg, left leg is bigger than the right leg, left leg did not look like the right one, does not feel well, and no energy. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt achy, and worst headache, headache was horrible and terrific on 10-APR-2021, and rash on 30-APR-2021, had not recovered from swelling of both legs, the veins of the legs had been leaking, left leg is bigger than the right leg, left leg did not look like the right one, sore leg and very uncomfortable, standing is very painful, and belly button area swelling, and the outcome of not been able to wear shoes or sandal, cough, sob at night and coughs if she lays down, could not take deep breath unless she coughs, baker's cyst in the back of the knee of the left leg, no energy, exhaustion, chronic fatigue., does not feel well and chest heaviness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Peripheral swelling, Rash, Stasis dermatitis
Clinical narrative: NOT BEEN ABLE TO WEAR SHOES OR SANDAL; COUGH; SOB AT NIGHT AND COUGHS IF SHE LAYS DOWN,COULD NOT TAKE DEEP BREATH  UNLESS SHE COUGHS; CHEST HEAVINESS; BAKER'S CYST  IN THE BACK OF THE KNEE OF THE LEFT LEG; LEFT LEG IS BIGGER THAN THE RIGHT LEG, LEFT LEG DID NOT LOOK LIKE THE  RIGHT ONE; DOES NOT FEEL WELL; NO ENERGY; THE VEINS OF THE LEGS HAD BEEN LEAKING; BELLY  BUTTON AREA SWELLING; SWELLING OF BOTH LEGS; EXHAUSTION, CHRONIC FATIGUE.; RASH; SORE LEG AND VERY UNCOMFORTABLE, STANDING IS VERY PAINFUL; WORST HEADACHE, HEADACHE WAS HORRIBLE AND  TERRIFIC; FELT ACHY; 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 past medical history included: back surgery, and concurrent conditions included: hypothyroidism, polycystic ovary, and hashimoto. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the patient experienced felt achy. On 09-APR-2021, the patient experienced worst headache, headache was horrible and terrific. On 10-APR-2021, the patient experienced swelling of both legs. On 10-APR-2021, the patient experienced belly button area swelling. On 10-APR-2021, the patient experienced sore leg and very uncomfortable, standing is very painful. On 10-APR-2021, the patient experienced rash. On 10-APR-2021, the patient experienced exhaustion, chronic fatigue. Treatment medications included: ibuprofen. On JUL-2021, the patient experienced the veins of the legs had been leaking. On an unspecified date, the patient experienced not been able to wear shoes or sandal, cough, sob at night and coughs if she lays down, could not take deep breath unless she coughs, chest heaviness, baker's cyst in the back of the knee of the left leg, left leg is bigger than the right leg, left leg did not look like the right one, does not feel well, and no energy. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt achy, and worst headache, headache was horrible and terrific on 10-APR-2021, and rash on 30-APR-2021, had not recovered from swelling of both legs, the veins of the legs had been leaking, left leg is bigger than the right leg, left leg did not look like the right one, sore leg and very uncomfortable, standing is very painful, and belly button area swelling, and the outcome of not been able to wear shoes or sandal, cough, sob at night and coughs if she lays down, could not take deep breath unless she coughs, baker's cyst in the back of the knee of the left leg, no energy, exhaustion, chronic fatigue., does not feel well and chest heaviness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling, Synovial cyst
Clinical narrative: NOT BEEN ABLE TO WEAR SHOES OR SANDAL; COUGH; SOB AT NIGHT AND COUGHS IF SHE LAYS DOWN,COULD NOT TAKE DEEP BREATH  UNLESS SHE COUGHS; CHEST HEAVINESS; BAKER'S CYST  IN THE BACK OF THE KNEE OF THE LEFT LEG; LEFT LEG IS BIGGER THAN THE RIGHT LEG, LEFT LEG DID NOT LOOK LIKE THE  RIGHT ONE; DOES NOT FEEL WELL; NO ENERGY; THE VEINS OF THE LEGS HAD BEEN LEAKING; BELLY  BUTTON AREA SWELLING; SWELLING OF BOTH LEGS; EXHAUSTION, CHRONIC FATIGUE.; RASH; SORE LEG AND VERY UNCOMFORTABLE, STANDING IS VERY PAINFUL; WORST HEADACHE, HEADACHE WAS HORRIBLE AND  TERRIFIC; FELT ACHY; 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 past medical history included: back surgery, and concurrent conditions included: hypothyroidism, polycystic ovary, and hashimoto. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the patient experienced felt achy. On 09-APR-2021, the patient experienced worst headache, headache was horrible and terrific. On 10-APR-2021, the patient experienced swelling of both legs. On 10-APR-2021, the patient experienced belly button area swelling. On 10-APR-2021, the patient experienced sore leg and very uncomfortable, standing is very painful. On 10-APR-2021, the patient experienced rash. On 10-APR-2021, the patient experienced exhaustion, chronic fatigue. Treatment medications included: ibuprofen. On JUL-2021, the patient experienced the veins of the legs had been leaking. On an unspecified date, the patient experienced not been able to wear shoes or sandal, cough, sob at night and coughs if she lays down, could not take deep breath unless she coughs, chest heaviness, baker's cyst in the back of the knee of the left leg, left leg is bigger than the right leg, left leg did not look like the right one, does not feel well, and no energy. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt achy, and worst headache, headache was horrible and terrific on 10-APR-2021, and rash on 30-APR-2021, had not recovered from swelling of both legs, the veins of the legs had been leaking, left leg is bigger than the right leg, left leg did not look like the right one, sore leg and very uncomfortable, standing is very painful, and belly button area swelling, and the outcome of not been able to wear shoes or sandal, cough, sob at night and coughs if she lays down, could not take deep breath unless she coughs, baker's cyst in the back of the knee of the left leg, no energy, exhaustion, chronic fatigue., does not feel well and chest heaviness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Capillary fragility, Chest X-ray, Chest discomfort, Cough, Headache
Clinical narrative: NOT BEEN ABLE TO WEAR SHOES OR SANDAL; COUGH; SOB AT NIGHT AND COUGHS IF SHE LAYS DOWN,COULD NOT TAKE DEEP BREATH  UNLESS SHE COUGHS; CHEST HEAVINESS; BAKER'S CYST  IN THE BACK OF THE KNEE OF THE LEFT LEG; LEFT LEG IS BIGGER THAN THE RIGHT LEG, LEFT LEG DID NOT LOOK LIKE THE  RIGHT ONE; DOES NOT FEEL WELL; NO ENERGY; THE VEINS OF THE LEGS HAD BEEN LEAKING; BELLY  BUTTON AREA SWELLING; SWELLING OF BOTH LEGS; EXHAUSTION, CHRONIC FATIGUE.; RASH; SORE LEG AND VERY UNCOMFORTABLE, STANDING IS VERY PAINFUL; WORST HEADACHE, HEADACHE WAS HORRIBLE AND  TERRIFIC; FELT ACHY; 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 past medical history included: back surgery, and concurrent conditions included: hypothyroidism, polycystic ovary, and hashimoto. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the patient experienced felt achy. On 09-APR-2021, the patient experienced worst headache, headache was horrible and terrific. On 10-APR-2021, the patient experienced swelling of both legs. On 10-APR-2021, the patient experienced belly button area swelling. On 10-APR-2021, the patient experienced sore leg and very uncomfortable, standing is very painful. On 10-APR-2021, the patient experienced rash. On 10-APR-2021, the patient experienced exhaustion, chronic fatigue. Treatment medications included: ibuprofen. On JUL-2021, the patient experienced the veins of the legs had been leaking. On an unspecified date, the patient experienced not been able to wear shoes or sandal, cough, sob at night and coughs if she lays down, could not take deep breath unless she coughs, chest heaviness, baker's cyst in the back of the knee of the left leg, left leg is bigger than the right leg, left leg did not look like the right one, does not feel well, and no energy. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt achy, and worst headache, headache was horrible and terrific on 10-APR-2021, and rash on 30-APR-2021, had not recovered from swelling of both legs, the veins of the legs had been leaking, left leg is bigger than the right leg, left leg did not look like the right one, sore leg and very uncomfortable, standing is very painful, and belly button area swelling, and the outcome of not been able to wear shoes or sandal, cough, sob at night and coughs if she lays down, could not take deep breath unless she coughs, baker's cyst in the back of the knee of the left leg, no energy, exhaustion, chronic fatigue., does not feel well and chest heaviness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pain in extremity, Peripheral swelling, Rash, Ultrasound Doppler
Clinical narrative: NOT BEEN ABLE TO WEAR SHOES OR SANDAL; COUGH; SOB AT NIGHT AND COUGHS IF SHE LAYS DOWN,COULD NOT TAKE DEEP BREATH  UNLESS SHE COUGHS; CHEST HEAVINESS; BAKER'S CYST  IN THE BACK OF THE KNEE OF THE LEFT LEG; LEFT LEG IS BIGGER THAN THE RIGHT LEG, LEFT LEG DID NOT LOOK LIKE THE  RIGHT ONE; DOES NOT FEEL WELL; NO ENERGY; THE VEINS OF THE LEGS HAD BEEN LEAKING; BELLY  BUTTON AREA SWELLING; SWELLING OF BOTH LEGS; EXHAUSTION, CHRONIC FATIGUE.; RASH; SORE LEG AND VERY UNCOMFORTABLE, STANDING IS VERY PAINFUL; WORST HEADACHE, HEADACHE WAS HORRIBLE AND  TERRIFIC; FELT ACHY; 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 past medical history included: back surgery, and concurrent conditions included: hypothyroidism, polycystic ovary, and hashimoto. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the patient experienced felt achy. On 09-APR-2021, the patient experienced worst headache, headache was horrible and terrific. On 10-APR-2021, the patient experienced swelling of both legs. On 10-APR-2021, the patient experienced belly button area swelling. On 10-APR-2021, the patient experienced sore leg and very uncomfortable, standing is very painful. On 10-APR-2021, the patient experienced rash. On 10-APR-2021, the patient experienced exhaustion, chronic fatigue. Treatment medications included: ibuprofen. On JUL-2021, the patient experienced the veins of the legs had been leaking. On an unspecified date, the patient experienced not been able to wear shoes or sandal, cough, sob at night and coughs if she lays down, could not take deep breath unless she coughs, chest heaviness, baker's cyst in the back of the knee of the left leg, left leg is bigger than the right leg, left leg did not look like the right one, does not feel well, and no energy. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt achy, and worst headache, headache was horrible and terrific on 10-APR-2021, and rash on 30-APR-2021, had not recovered from swelling of both legs, the veins of the legs had been leaking, left leg is bigger than the right leg, left leg did not look like the right one, sore leg and very uncomfortable, standing is very painful, and belly button area swelling, and the outcome of not been able to wear shoes or sandal, cough, sob at night and coughs if she lays down, could not take deep breath unless she coughs, baker's cyst in the back of the knee of the left leg, no energy, exhaustion, chronic fatigue., does not feel well and chest heaviness was not reported. This report was non-serious.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Dizziness, Dyspnoea, Eczema, Fall
Clinical narrative: BRUISING; BLOOD IN URINE; HEAVY BREATHING; DIZZY AND LIGHT HEADED; FLARED ECZEMA ON SIDE OF THUMB, FORE FINGER AND MIDDLE FINGER OF RIGHT HAND; RASH LIKE MOSQUITO BITES; NEUROPATHY IN FEET,NECK AND HIP; FALL; This spontaneous report received from a patient concerned a 62 year old Aboriginal and African American male. The patient's height, and weight were not reported. The patient's concurrent conditions included smoker (2-3 cigarettes per day), marijuana abuse, street drugs abuse, diabetic, hypertension, memory issues, cirrhosis of liver, acid reflux, neuropathy, arthritis, and pain in ankle and legs and eczema.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: not reported) dose was not reported, 1 total, administered on 29-JUL-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 29-JUL-2021, after the vaccination patient laid down, half asleep and half awake and fell down. Patient nose, mouth, face, neck and shoulder hits on the floor. Patient experienced the neuropathy in feet. Patient reported that, he had the more pain in feet after the vaccination. On an unspecified date, patient experienced the bruising, rash like mosquito bite randomly on body, blood in urine, heavy breathing, dizzy and light headed. Patient had the asthma pump to use when he felt like short of breath. Patient reported that, he experienced the pain in left side of hip and not able to move. Patient did some stretching to lower the pain. He also experienced the neuropathy in hip, sharp pain in neck like sticking an ice pick and flared eczema on side of thumb, fore finger and middle finger of right hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood in urine, had not recovered from bruising, rash like mosquito bites, heavy breathing, dizzy and light headed, neuropathy in feet, neck and hip, and flared eczema on side of thumb, fore finger and middle finger of right hand, and the outcome of fall was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210808496-covid-19 vaccine ad26.cov2.s-Neuropathy.Peripheral 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
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Haematuria, Neuropathy peripheral, Rash
Clinical narrative: BRUISING; BLOOD IN URINE; HEAVY BREATHING; DIZZY AND LIGHT HEADED; FLARED ECZEMA ON SIDE OF THUMB, FORE FINGER AND MIDDLE FINGER OF RIGHT HAND; RASH LIKE MOSQUITO BITES; NEUROPATHY IN FEET,NECK AND HIP; FALL; This spontaneous report received from a patient concerned a 62 year old Aboriginal and African American male. The patient's height, and weight were not reported. The patient's concurrent conditions included smoker (2-3 cigarettes per day), marijuana abuse, street drugs abuse, diabetic, hypertension, memory issues, cirrhosis of liver, acid reflux, neuropathy, arthritis, and pain in ankle and legs and eczema.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: not reported) dose was not reported, 1 total, administered on 29-JUL-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 29-JUL-2021, after the vaccination patient laid down, half asleep and half awake and fell down. Patient nose, mouth, face, neck and shoulder hits on the floor. Patient experienced the neuropathy in feet. Patient reported that, he had the more pain in feet after the vaccination. On an unspecified date, patient experienced the bruising, rash like mosquito bite randomly on body, blood in urine, heavy breathing, dizzy and light headed. Patient had the asthma pump to use when he felt like short of breath. Patient reported that, he experienced the pain in left side of hip and not able to move. Patient did some stretching to lower the pain. He also experienced the neuropathy in hip, sharp pain in neck like sticking an ice pick and flared eczema on side of thumb, fore finger and middle finger of right hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood in urine, had not recovered from bruising, rash like mosquito bites, heavy breathing, dizzy and light headed, neuropathy in feet, neck and hip, and flared eczema on side of thumb, fore finger and middle finger of right hand, and the outcome of fall was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210808496-covid-19 vaccine ad26.cov2.s-Neuropathy.Peripheral 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: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; 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 was not reported, administered on 08-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 08-JUL-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 08-JUL-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: PERICARDITIS; This spontaneous report was received from literature: Myocarditis and Pericarditis After Vaccination for COVID-19. 2021 Aug 04. This report concerned multiple patients. 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, 1 total administered 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 patient experienced pericarditis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pericarditis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210809585-COVID-19 VACCINE AD26.COV2.S-pericarditis. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Gait inability, Incontinence, Oxygen saturation, SARS-CoV-2 test
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; CANNOT WALK; COVID-19 PNEUMONIA/BREAKTHROUGH INFECTION; INCONTINENT; This spontaneous report received from a consumer concerned an 83 year old female. The patient's weight was 190 pounds, and height was 62 centimeters. The patient's concurrent conditions included chronic obstructive pulmonary disease, diabetes, atrial fibrillation, non smoker, non alcohol user, and morphine allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and expiry: 25-MAY-2021) dose was not reported, one total administered on right deltoid on 17-MAR-2021 around 1 to 2 pm for prophylactic vaccination. No concomitant medications were reported.  On JUL-2021, Laboratory data included: Pulse oximetry (NR: not provided) 100 %. On 20-JUL-2021, the patient experienced covid-19 pneumonia/breakthrough infection, incontinent and on 22-JUL-2021 experienced cannot walk. On 23-JUL-2021, the patient had suspected clinical vaccination failure. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The patient was sent to the hospital by daughter on 23-JUL-2021 where diagnosed with pneumonia, the patient ended up in ICU (intensive care unit) from July 23 to 29, where the patient had 100 percent oxygen, then transferred to regular bed after 29-JUL-2021 and was discharged on 02-AUG-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from covid-19 pneumonia, suspected clinical vaccination failure, incontinent, cannot walk This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0. 20210810402-COVID-19 VACCINE AD26.COV2.S.-Suspected clinical vaccine failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS 20210810402-COVID-19 VACCINE AD26.COV2.S.-Covid-19 pneumonia/breakthrough infection, incontinent, cannot walk. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; CANNOT WALK; COVID-19 PNEUMONIA/BREAKTHROUGH INFECTION; INCONTINENT; This spontaneous report received from a consumer concerned an 83 year old female. The patient's weight was 190 pounds, and height was 62 centimeters. The patient's concurrent conditions included chronic obstructive pulmonary disease, diabetes, atrial fibrillation, non smoker, non alcohol user, and morphine allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and expiry: 25-MAY-2021) dose was not reported, one total administered on right deltoid on 17-MAR-2021 around 1 to 2 pm for prophylactic vaccination. No concomitant medications were reported.  On JUL-2021, Laboratory data included: Pulse oximetry (NR: not provided) 100 %. On 20-JUL-2021, the patient experienced covid-19 pneumonia/breakthrough infection, incontinent and on 22-JUL-2021 experienced cannot walk. On 23-JUL-2021, the patient had suspected clinical vaccination failure. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The patient was sent to the hospital by daughter on 23-JUL-2021 where diagnosed with pneumonia, the patient ended up in ICU (intensive care unit) from July 23 to 29, where the patient had 100 percent oxygen, then transferred to regular bed after 29-JUL-2021 and was discharged on 02-AUG-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from covid-19 pneumonia, suspected clinical vaccination failure, incontinent, cannot walk This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0. 20210810402-COVID-19 VACCINE AD26.COV2.S.-Suspected clinical vaccine failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS 20210810402-COVID-19 VACCINE AD26.COV2.S.-Covid-19 pneumonia/breakthrough infection, incontinent, cannot walk. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Headache, Injection site pain, Lymphadenopathy
Clinical narrative: RIGHT ARMPIT PAIN; ARMPIT SWELLING WHICH AFFECTS HER GLANDULAR AREA; CHILLS; HEADACHE; FEVER; INJECTION SITE TENDERNESS; This spontaneous report received from a patient concerned a 51 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: 205821A, expiry: UNKNOWN) dose was not reported, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, the patient experienced chills. On 02-AUG-2021, the patient experienced headache. On 02-AUG-2021, the patient experienced fever. On 02-AUG-2021, the patient experienced injection site tenderness. On 04-AUG-2021, the patient experienced right armpit pain. On 04-AUG-2021, the patient experienced armpit swelling which affects her glandular area. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, headache, fever, and injection site tenderness on 04-AUG-2021, and had not recovered from right armpit pain, and armpit swelling which affects her glandular area. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: RIGHT ARMPIT PAIN; ARMPIT SWELLING WHICH AFFECTS HER GLANDULAR AREA; CHILLS; HEADACHE; FEVER; INJECTION SITE TENDERNESS; This spontaneous report received from a patient concerned a 51 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: 205821A, expiry: UNKNOWN) dose was not reported, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, the patient experienced chills. On 02-AUG-2021, the patient experienced headache. On 02-AUG-2021, the patient experienced fever. On 02-AUG-2021, the patient experienced injection site tenderness. On 04-AUG-2021, the patient experienced right armpit pain. On 04-AUG-2021, the patient experienced armpit swelling which affects her glandular area. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, headache, fever, and injection site tenderness on 04-AUG-2021, and had not recovered from right armpit pain, and armpit swelling which affects her glandular area. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain, Paraesthesia
Clinical narrative: BURNING ON BACK OF HEAD; STINGING ON BACK OF HEAD; TINGLING ON BACK OF HEAD; This spontaneous report received from a patient concerned a 62 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: 202A21A expiry: 21-SEP-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the patient experienced burning on back of head. On 10-APR-2021, the patient experienced stinging on back of head. On 10-APR-2021, the patient experienced tingling on back of head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning on back of head, stinging on back of head, and tingling on back of head on APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210810364.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: POTENTIAL ADMINISTRATION ERROR; FREEZING EXCURSION OF 20 UNPUNCTURED VACCINE VIALS; This spontaneous report received from a health care professional 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, and batch number: 202A21A expiry: 21-SEP-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On 01-JUL-2021, the patient experienced freezing excursion of 20 unpunctured vaccine vials. On an unspecified date, the patient experienced potential administration error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the potential administration error and freezing excursion of 20 unpunctured vaccine vials was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Culture, Hypoaesthesia, Mental disorder, Muscular weakness, Rash
Clinical narrative: COLOR OF THE RASH CHANGED SOMETIMES PINK AND SOMETIMES BEET RED TO; LEGS HAD NO FEELING; LEGS STARTING TO GIVE OUT; SUSPECTED CLINICAL VACCINATION FAILURE; NO MENTAL CONTROL; SUSPECTED COVID-19 INFECTION; BODY RASH ON BOTH SIDES/KNEES/HANDS; This spontaneous report received from a patient concerned a 60year old White, not Hispanic or Latino female. The patient's weight was 200 pounds, and height was not reported. The patient's past medical history included weakness of lower extremities and no mental control, and concurrent conditions included anxiety around 16 years old, schizophrenia around 15 years of age, no-alcohol use, and non-smoker.  The patient had no known allergies. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: 25-MAY-2021) dose was not reported, 1 total administered to left deltoid on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the patient started having body rash and it was still present since march. On 15-JUL-2021, the patient experience loss of taste and smell. On 24-JUL-2021, the patient tested positive for covid 19 via nasal swab (suspected covid-19 infection). The incubation period of 28 days has been completed (suspected clinical vaccination failure). The patient then developed a rash on both side of the body on the same exact spot, behind knees and back of hands. The patient stated that it continued to get worse but it doesn't itch and hurt. The patient also stated that the size of body rash varied, some were pinpoint and some were clusters. The color of the rash changed during the day sometimes pink and sometimes beet red. The patient's legs started to give out and had no feeling. The patient also had no mental control. It also happened before the shot and it hasn't happened in couple of months and the patient was not sure whether it was due to the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected covid-19 infection, legs starting to give out, legs had no feeling, and no mental control, had not recovered from body rash on both sides/knees/hands, and color of the rash changed sometimes pink and sometimes beet red to, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint 90000188685.; Sender's Comments: V0: 20210810728-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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Suspected COVID-19, Vaccination failure
Clinical narrative: COLOR OF THE RASH CHANGED SOMETIMES PINK AND SOMETIMES BEET RED TO; LEGS HAD NO FEELING; LEGS STARTING TO GIVE OUT; SUSPECTED CLINICAL VACCINATION FAILURE; NO MENTAL CONTROL; SUSPECTED COVID-19 INFECTION; BODY RASH ON BOTH SIDES/KNEES/HANDS; This spontaneous report received from a patient concerned a 60year old White, not Hispanic or Latino female. The patient's weight was 200 pounds, and height was not reported. The patient's past medical history included weakness of lower extremities and no mental control, and concurrent conditions included anxiety around 16 years old, schizophrenia around 15 years of age, no-alcohol use, and non-smoker.  The patient had no known allergies. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: 25-MAY-2021) dose was not reported, 1 total administered to left deltoid on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the patient started having body rash and it was still present since march. On 15-JUL-2021, the patient experience loss of taste and smell. On 24-JUL-2021, the patient tested positive for covid 19 via nasal swab (suspected covid-19 infection). The incubation period of 28 days has been completed (suspected clinical vaccination failure). The patient then developed a rash on both side of the body on the same exact spot, behind knees and back of hands. The patient stated that it continued to get worse but it doesn't itch and hurt. The patient also stated that the size of body rash varied, some were pinpoint and some were clusters. The color of the rash changed during the day sometimes pink and sometimes beet red. The patient's legs started to give out and had no feeling. The patient also had no mental control. It also happened before the shot and it hasn't happened in couple of months and the patient was not sure whether it was due to the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected covid-19 infection, legs starting to give out, legs had no feeling, and no mental control, had not recovered from body rash on both sides/knees/hands, and color of the rash changed sometimes pink and sometimes beet red to, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint 90000188685.; Sender's Comments: V0: 20210810728-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: M
Vaccine: COVID19
Symptoms: Fluid retention, Musculoskeletal stiffness, Peripheral swelling, Skin disorder, Stomach mass
Clinical narrative: GAINED 50-60 POUNDS OF WATER COULDN'T FIT INTO PANTS CLOTHES; LEGS GOT STIFF AND HARD; SKIN BAD ON LEGS; LEG STILL HORRIBLE STILL SWELLED UP; IN STOMACH HAD SOMETHING SIZE OF SOFTBALL; This spontaneous report received from a patient concerned a 66 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 not reported, batch number: 1805025, and expiry: UNKNWON) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced gained 50-60 pounds of water couldn't fit into pants clothes, legs got stiff and hard, skin bad on legs, leg still horrible still swelled up, and in stomach had something size of softball. Treatment medications (dates unspecified) included: torasemide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from gained 50-60 pounds of water couldn't fit into pants clothes, legs got stiff and hard, skin bad on legs, leg still horrible still swelled up, and in stomach had something size of softball. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE USED; This spontaneous report received from a health care professional 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: 1808978, and expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination.  No concomitant medications were reported.  On an unspecified date, the patient experienced expired vaccine used. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine used was not reported. This report was non-serious.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Decreased appetite, Fatigue, Pain in jaw
Clinical narrative: BLURRED VISION; BURNING IN CHEST; JAW PAIN; BACK PAIN; LOSS OF APPETITE; FELT FATIGUE; This spontaneous report received from a patient concerned a 71 year old male. The patient's height, and weight were not reported. The patient had no known drug allergies, no known medical conditions and was not taking any medications at the time of vaccination. 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 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in JUL-2021, the patient experienced blurred vision, burning in chest, jaw pain, back pain, loss of appetite, and felt fatigue. On an unspecified date in JUL-2021, the patient was hospitalized for one night in one hospital and 3-4 nights in another hospital. Patient had been hospitalized twice within the past week of report. Physician stated that, they couldn't figure out what was wrong with patient and also stated that, there was not an issue with patient's heart, lungs and any of organs. On an unspecified date patient was discharged. Patient was hospitalized for 5 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt fatigue, blurred vision, burning in chest, jaw pain, back pain, and loss of appetite. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210811280-COVID-19 VACCINE AD26.COV2.S-blurred vision, burning in chest, jaw pain, back pain, loss of appetite. 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). 20210811280-COVID-19 VACCINE AD26.COV2.S-felt fatigue. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: BLURRED VISION; BURNING IN CHEST; JAW PAIN; BACK PAIN; LOSS OF APPETITE; FELT FATIGUE; This spontaneous report received from a patient concerned a 71 year old male. The patient's height, and weight were not reported. The patient had no known drug allergies, no known medical conditions and was not taking any medications at the time of vaccination. 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 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in JUL-2021, the patient experienced blurred vision, burning in chest, jaw pain, back pain, loss of appetite, and felt fatigue. On an unspecified date in JUL-2021, the patient was hospitalized for one night in one hospital and 3-4 nights in another hospital. Patient had been hospitalized twice within the past week of report. Physician stated that, they couldn't figure out what was wrong with patient and also stated that, there was not an issue with patient's heart, lungs and any of organs. On an unspecified date patient was discharged. Patient was hospitalized for 5 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt fatigue, blurred vision, burning in chest, jaw pain, back pain, and loss of appetite. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210811280-COVID-19 VACCINE AD26.COV2.S-blurred vision, burning in chest, jaw pain, back pain, loss of appetite. 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). 20210811280-COVID-19 VACCINE AD26.COV2.S-felt fatigue. This event(s) is labeled per RSI and is therefore considered potentially related.