chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Blood test, Body temperature, Chest X-ray
Clinical narrative: FAINT; NAUSEA; RIGHT SHOULDER BACK PAIN; LEFT CHEST PAIN; DIZZINESS; RIGHT HAND NUMBNESS; COULD NOT MOVE; WEAKNESS; FEVER 102-103 F; BODY ACHES; SLIGHT HEADACHE; FELT LIKE HAVING AN ALLERGIC REACTION/FELT LIKE HIT BY TRUCK; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's past medical history included pneumonia. 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: 041A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the patient had a slight headache. On 10-APR-2021, the patient got off at midnight and felt body aches and upon waking up she could not move. On the same day, she felt like hit by a truck and experienced dizziness, right hand numbness, fever of 102-103 Fahrenheit and weakness. The patient took Bayer aspirin (acetylsalicylic acid) and Tylenol (paracetamol). The patient's headaches were excruciating and came and went and some she had all day. The patient also felt like having an allergic reaction. On 12-APR-2021, the patient had left chest pain and right side of her up shoulder back pain upon taking a breath. On 15-APR-2021, the patient had nausea and visited emergency room and had blood test, chest X-ray and electrocardiogram and everything was normal. The patient was treated with unspecified anti-inflammatory medications, Toradol (ketorolac tromethamine) as intravenous, and they advised to visit a heart doctor. On 17-APR-2021, the patient was faint.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from left chest pain, fever 102-103 F, faint, right shoulder back pain, and right hand numbness, had not recovered from slight headache, weakness, nausea, and dizziness, and the outcome of body aches, could not move and felt like having an allergic reaction/felt like hit by truck was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: :20210436128 -covid-19 vaccine ad26.cov2.s -faint, bodyaches, left chest pain, dizziness, right hand numbness, could not move, right shoulder back pain. 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).  20210436128 -covid-19 vaccine ad26.cov2.s -weakness, fever 102- 103 F,  nausea, slight headache, allergic reaction. This event(s) is labeled per Agency and is therefore considered potentially related.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Electrocardiogram, Feeling abnormal, Headache
Clinical narrative: FAINT; NAUSEA; RIGHT SHOULDER BACK PAIN; LEFT CHEST PAIN; DIZZINESS; RIGHT HAND NUMBNESS; COULD NOT MOVE; WEAKNESS; FEVER 102-103 F; BODY ACHES; SLIGHT HEADACHE; FELT LIKE HAVING AN ALLERGIC REACTION/FELT LIKE HIT BY TRUCK; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's past medical history included pneumonia. 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: 041A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the patient had a slight headache. On 10-APR-2021, the patient got off at midnight and felt body aches and upon waking up she could not move. On the same day, she felt like hit by a truck and experienced dizziness, right hand numbness, fever of 102-103 Fahrenheit and weakness. The patient took Bayer aspirin (acetylsalicylic acid) and Tylenol (paracetamol). The patient's headaches were excruciating and came and went and some she had all day. The patient also felt like having an allergic reaction. On 12-APR-2021, the patient had left chest pain and right side of her up shoulder back pain upon taking a breath. On 15-APR-2021, the patient had nausea and visited emergency room and had blood test, chest X-ray and electrocardiogram and everything was normal. The patient was treated with unspecified anti-inflammatory medications, Toradol (ketorolac tromethamine) as intravenous, and they advised to visit a heart doctor. On 17-APR-2021, the patient was faint.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from left chest pain, fever 102-103 F, faint, right shoulder back pain, and right hand numbness, had not recovered from slight headache, weakness, nausea, and dizziness, and the outcome of body aches, could not move and felt like having an allergic reaction/felt like hit by truck was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: :20210436128 -covid-19 vaccine ad26.cov2.s -faint, bodyaches, left chest pain, dizziness, right hand numbness, could not move, right shoulder back pain. 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).  20210436128 -covid-19 vaccine ad26.cov2.s -weakness, fever 102- 103 F,  nausea, slight headache, allergic reaction. This event(s) is labeled per Agency and is therefore considered potentially related.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Mobility decreased, Nausea, Pain, Pyrexia
Clinical narrative: FAINT; NAUSEA; RIGHT SHOULDER BACK PAIN; LEFT CHEST PAIN; DIZZINESS; RIGHT HAND NUMBNESS; COULD NOT MOVE; WEAKNESS; FEVER 102-103 F; BODY ACHES; SLIGHT HEADACHE; FELT LIKE HAVING AN ALLERGIC REACTION/FELT LIKE HIT BY TRUCK; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's past medical history included pneumonia. 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: 041A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the patient had a slight headache. On 10-APR-2021, the patient got off at midnight and felt body aches and upon waking up she could not move. On the same day, she felt like hit by a truck and experienced dizziness, right hand numbness, fever of 102-103 Fahrenheit and weakness. The patient took Bayer aspirin (acetylsalicylic acid) and Tylenol (paracetamol). The patient's headaches were excruciating and came and went and some she had all day. The patient also felt like having an allergic reaction. On 12-APR-2021, the patient had left chest pain and right side of her up shoulder back pain upon taking a breath. On 15-APR-2021, the patient had nausea and visited emergency room and had blood test, chest X-ray and electrocardiogram and everything was normal. The patient was treated with unspecified anti-inflammatory medications, Toradol (ketorolac tromethamine) as intravenous, and they advised to visit a heart doctor. On 17-APR-2021, the patient was faint.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from left chest pain, fever 102-103 F, faint, right shoulder back pain, and right hand numbness, had not recovered from slight headache, weakness, nausea, and dizziness, and the outcome of body aches, could not move and felt like having an allergic reaction/felt like hit by truck was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: :20210436128 -covid-19 vaccine ad26.cov2.s -faint, bodyaches, left chest pain, dizziness, right hand numbness, could not move, right shoulder back pain. 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).  20210436128 -covid-19 vaccine ad26.cov2.s -weakness, fever 102- 103 F,  nausea, slight headache, allergic reaction. This event(s) is labeled per Agency and is therefore considered potentially related.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: FAINT; NAUSEA; RIGHT SHOULDER BACK PAIN; LEFT CHEST PAIN; DIZZINESS; RIGHT HAND NUMBNESS; COULD NOT MOVE; WEAKNESS; FEVER 102-103 F; BODY ACHES; SLIGHT HEADACHE; FELT LIKE HAVING AN ALLERGIC REACTION/FELT LIKE HIT BY TRUCK; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's past medical history included pneumonia. 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: 041A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the patient had a slight headache. On 10-APR-2021, the patient got off at midnight and felt body aches and upon waking up she could not move. On the same day, she felt like hit by a truck and experienced dizziness, right hand numbness, fever of 102-103 Fahrenheit and weakness. The patient took Bayer aspirin (acetylsalicylic acid) and Tylenol (paracetamol). The patient's headaches were excruciating and came and went and some she had all day. The patient also felt like having an allergic reaction. On 12-APR-2021, the patient had left chest pain and right side of her up shoulder back pain upon taking a breath. On 15-APR-2021, the patient had nausea and visited emergency room and had blood test, chest X-ray and electrocardiogram and everything was normal. The patient was treated with unspecified anti-inflammatory medications, Toradol (ketorolac tromethamine) as intravenous, and they advised to visit a heart doctor. On 17-APR-2021, the patient was faint.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from left chest pain, fever 102-103 F, faint, right shoulder back pain, and right hand numbness, had not recovered from slight headache, weakness, nausea, and dizziness, and the outcome of body aches, could not move and felt like having an allergic reaction/felt like hit by truck was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: :20210436128 -covid-19 vaccine ad26.cov2.s -faint, bodyaches, left chest pain, dizziness, right hand numbness, could not move, right shoulder back pain. 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).  20210436128 -covid-19 vaccine ad26.cov2.s -weakness, fever 102- 103 F,  nausea, slight headache, allergic reaction. This event(s) is labeled per Agency and is therefore considered potentially related.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Dizziness, Fatigue, Haemarthrosis, Headache
Clinical narrative: BURNING; SLEEPY; THROMBOSIS AND BURNING WENT AWAY; SORE ARM; FELT TIRED; WARM BANDANA LIKE HEADACHE; DIZZINESS; BLEEDING BY ANKLE; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's past medical history included thrombosis, burning on inner thighs and concurrent conditions included thick varicose vein. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 043A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 05-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in APR-2021, the patient experienced bleeding by ankle. On 05-APR-2021, the patient experienced dizziness, sore arm, felt tired and warm bandana like headache. On 05-APR-2021, after getting a shot the patient noticed thrombosis and burning went away. On 06-APR-2021, the patient experienced sleepy. On 16-APR-2021, the patient experienced burning The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning on APR-2021, dizziness, sleepy, felt tired, and warm bandana like headache on 06-APR-2021, and sore arm on 07-APR-2021, and the outcome of bleeding by ankle and thrombosis and burning went away was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0; 20210436178-covid-19 vaccine ad26.cov2. s-Bleeding by ankle. 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 events than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence, Therapeutic response unexpected
Clinical narrative: BURNING; SLEEPY; THROMBOSIS AND BURNING WENT AWAY; SORE ARM; FELT TIRED; WARM BANDANA LIKE HEADACHE; DIZZINESS; BLEEDING BY ANKLE; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's past medical history included thrombosis, burning on inner thighs and concurrent conditions included thick varicose vein. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 043A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 05-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in APR-2021, the patient experienced bleeding by ankle. On 05-APR-2021, the patient experienced dizziness, sore arm, felt tired and warm bandana like headache. On 05-APR-2021, after getting a shot the patient noticed thrombosis and burning went away. On 06-APR-2021, the patient experienced sleepy. On 16-APR-2021, the patient experienced burning The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning on APR-2021, dizziness, sleepy, felt tired, and warm bandana like headache on 06-APR-2021, and sore arm on 07-APR-2021, and the outcome of bleeding by ankle and thrombosis and burning went away was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0; 20210436178-covid-19 vaccine ad26.cov2. s-Bleeding by ankle. 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 events than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Fatigue, Feeling abnormal, Hypoaesthesia, Injection site pain
Clinical narrative: NUMBNESS ON THE TIPS OF FINGERS ON LEFT HAND; UNEASY; FLUTTERY CHEST; SORENESS AT INJECTION SITE; ANXIOUS/MILD ANXIETY; MIGRAINE; BODY ACHE; TIRED; This spontaneous report received from a patient concerned a 39 year old female. The patient's weight was 140 pounds, and height was 65 inches. The patient's past medical history included marijuana abuse, and concurrent conditions included no alcohol use, non smoker, and hypothyroidism, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with aminobenzoic acid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 21-JUN-2021) .5 ml, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included levothyroxine for hypothyroidism, escitalopram oxalate, and ethinylestradiol/etonogestrel. On 07-APR-2021, the subject experienced migraine. On 07-APR-2021, the subject experienced body ache. On 07-APR-2021, the subject experienced tired. On 07-APR-2021 06:00, treatment medications included: ibuprofen. On 08-APR-2021, the subject experienced anxious/mild anxiety. On 08-APR-2021, the subject experienced soreness at injection site. On 09-APR-2021, the subject experienced fluttery chest. On 16-APR-2021, the subject experienced uneasy. On 16-APR-2021 10:00, the subject experienced numbness on the tips of fingers on left hand. On 17-APR-2021, treatment medications included: caffeine/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache on 08-APR-2021, anxious/mild anxiety on 13-APR-2021, numbness on the tips of fingers on left hand on 16-APR-2021, fluttery chest on APR-2021, and soreness at injection site on 09-APR-2021, and had not recovered from migraine, tired, and uneasy. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pain, Palpitations
Clinical narrative: NUMBNESS ON THE TIPS OF FINGERS ON LEFT HAND; UNEASY; FLUTTERY CHEST; SORENESS AT INJECTION SITE; ANXIOUS/MILD ANXIETY; MIGRAINE; BODY ACHE; TIRED; This spontaneous report received from a patient concerned a 39 year old female. The patient's weight was 140 pounds, and height was 65 inches. The patient's past medical history included marijuana abuse, and concurrent conditions included no alcohol use, non smoker, and hypothyroidism, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with aminobenzoic acid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 21-JUN-2021) .5 ml, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included levothyroxine for hypothyroidism, escitalopram oxalate, and ethinylestradiol/etonogestrel. On 07-APR-2021, the subject experienced migraine. On 07-APR-2021, the subject experienced body ache. On 07-APR-2021, the subject experienced tired. On 07-APR-2021 06:00, treatment medications included: ibuprofen. On 08-APR-2021, the subject experienced anxious/mild anxiety. On 08-APR-2021, the subject experienced soreness at injection site. On 09-APR-2021, the subject experienced fluttery chest. On 16-APR-2021, the subject experienced uneasy. On 16-APR-2021 10:00, the subject experienced numbness on the tips of fingers on left hand. On 17-APR-2021, treatment medications included: caffeine/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache on 08-APR-2021, anxious/mild anxiety on 13-APR-2021, numbness on the tips of fingers on left hand on 16-APR-2021, fluttery chest on APR-2021, and soreness at injection site on 09-APR-2021, and had not recovered from migraine, tired, and uneasy. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Road traffic accident, Syncope
Clinical narrative: FAINTED; LOSS OF CONSCIOUSNESS; CRASHED VEHICLE; This spontaneous report received from a patient concerned an adult (In between 18 to 65 years) 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) 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 number. No concomitant medications were reported. On an unspecified date, the patient fainted while driving on the interstate after  vaccination. He crashed his vehicle (road traffic accident) and experienced loss of consciousness, Currently under the care of a neurologist. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fainted, loss of consciousness and crashed vehicle was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210436363.; Sender's Comments: -20210436318-Covid-19 vaccine ad26.cov2.s-Fainted, Loss of consciousness. 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: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness unilateral, Eye irritation, Vision blurred
Clinical narrative: 90% LOSS OF VISION IN ONE-EYE; BURNING EYE; FOGGY VISION; This spontaneous report received from a consumer (company representative) concerned a 43 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) 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 experienced 90% loss of vision in one-eye, burning eye, and foggy vision because of which patient visited his physician. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the burning eye, foggy vision and 90% loss of vision in one-eye was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210436318.; Sender's Comments: :20210436363-covid-19 vaccine ad26.cov2.s-90% loss of vision. 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: Antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1805031, expiry: 26-MAY-2021) frequency one total, dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  The consumer reported that on 25-MAR-2021, the patient did antibody test to find out if he/she was immunized and the antibodies were not created. The patient then did antibody test again on 16-APR-2021 and was informed through the result that the patient did not create antibodies for Covid 19. On 25-MAR-2021, Laboratory data included: Antibody test (NR: not provided) No antibodies created, On 16-APR-2021, Laboratory data included: Antibody test (NR: not provided) No antibodies created.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210435716.; Sender's Comments: V0: 20210436395-covid-19 vaccine ad26.cov2.s-Confirmed immunological 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
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Insomnia, Nausea, Oropharyngeal pain
Clinical narrative: SWELLING OF FACE, TONGUE, ARMS AND HANDS; VOMITING; NAUSEA; ABDOMINAL PAIN; SWELLING OF FEET; COULDN'T SLEEP; ITCHY RASH; DIARRHEA; PAIN ALL OVER; SORE THROAT; 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 pre-existing medical conditions included patient had no underlying medical conditions.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the patient experienced pain all over the body, sore throat. On 12-APR-2021, the patient experienced rash. On 13-APR-2021, the patient experienced diarrhea, itching. On 14-APR-2021, the patient experienced abdominal pain, swelling of feet, could not sleep. On 15-APR-2021, the patient experienced swelling of face, tongue, arms and hands, nausea and vomiting. She went to clinic to see a doctor and doctor told the patient to go to ER. In Emergency room, they gave her intravenous fluids and medicine for the nausea and vomiting. All her symptoms were improving but she was worried that she will still have swelling and rash with the itching. She only slept for about 4 hours at night. She did not have insurance and medical bills got expensive and was worried. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and nausea on 15-APR-2021, was recovering from abdominal pain, diarrhea, pain all over, sore throat, and couldn't sleep, and had not recovered from swelling of face, tongue, arms and hands, swelling of feet, and itchy rash. This report was serious (Other Medically Important Condition).  .; Sender's Comments: V0;-covid-19 vaccine ad26.cov2. s-swelling of face, tongue, arms, hands and abdominal pain. This events are considered unassessable. The events had a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Rash pruritic, Swelling, Vomiting
Clinical narrative: SWELLING OF FACE, TONGUE, ARMS AND HANDS; VOMITING; NAUSEA; ABDOMINAL PAIN; SWELLING OF FEET; COULDN'T SLEEP; ITCHY RASH; DIARRHEA; PAIN ALL OVER; SORE THROAT; 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 pre-existing medical conditions included patient had no underlying medical conditions.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the patient experienced pain all over the body, sore throat. On 12-APR-2021, the patient experienced rash. On 13-APR-2021, the patient experienced diarrhea, itching. On 14-APR-2021, the patient experienced abdominal pain, swelling of feet, could not sleep. On 15-APR-2021, the patient experienced swelling of face, tongue, arms and hands, nausea and vomiting. She went to clinic to see a doctor and doctor told the patient to go to ER. In Emergency room, they gave her intravenous fluids and medicine for the nausea and vomiting. All her symptoms were improving but she was worried that she will still have swelling and rash with the itching. She only slept for about 4 hours at night. She did not have insurance and medical bills got expensive and was worried. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and nausea on 15-APR-2021, was recovering from abdominal pain, diarrhea, pain all over, sore throat, and couldn't sleep, and had not recovered from swelling of face, tongue, arms and hands, swelling of feet, and itchy rash. This report was serious (Other Medically Important Condition).  .; Sender's Comments: V0;-covid-19 vaccine ad26.cov2. s-swelling of face, tongue, arms, hands and abdominal pain. This events are considered unassessable. The events had a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Sex: U
Vaccine: COVID19
Symptoms: Coagulation factor, Coagulation factor increased, Headache, Platelet count, Scan
Clinical narrative: ELEVATED BLOOD CLOTTING; LONG LASTING HEADACHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) frequency 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.   On MAR-2021, patient had been to GP (general practitioner) in hospital 3 times as she was experiencing long lasting headaches. On an unspecified date, the patient experienced elevated blood clotting, and was hospitalized. Patient was inquiring whether PF4 should be considered as a part of tests for people experiencing long lasting headaches. Patient had elevated bloods clotting but platelets were normal and scan clear.  Patient still had persistent headache 4 weeks on and had been referred to neuro. Laboratory data (dates unspecified) included: Coagulation factor (NR: not provided) Elevated, Platelet count (NR: not provided) normal, and Scan (NR: not provided) clear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from long lasting headaches, and the outcome of elevated blood clotting was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:  This patient of unspecified age and gender reported to have "elevated bloods clotting" and "long lasting headache" after an unspecified duration from receiving COVID-19 VACCINE AD26.COV2.S for the prevention of symptomatic SARS-CoV-2 virus infection.  The patient reported to "have been to GP, hospital 3 times" with "platelets normal and scan clear".  No other details reported. The information available precludes a complete and meaningful assessment.  However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.  Additional information was requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Feeling abnormal
Clinical narrative: RECURRENT NOSE BLEEDS; WEIRD SENSATION IN HEAD; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced recurrent nose bleeds. On 2021, the subject experienced weird sensation in head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from recurrent nose bleeds, and weird sensation in head. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as case assessed as non-serious.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: PAIN ON KNEES, PAIN ON THE SIDE AND INSIDE OF THE KNEES, MORE PAIN ON LEFT KNEE; This spontaneous report received from a patient concerned a 73 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non drinker, and non-smoker. The patient experienced drug allergy when treated with acetylsalicylic acid.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) .5 ml, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 14-MAR-2021, the subject experienced pain on knees, pain on the side and inside of the knees, more pain on left knee. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain on knees, pain on the side and inside of the knees, more pain on left knee. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; DIZZINESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 05-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  On 17-APR-2021, the patient experienced dizziness and suspected covid-19 infection (cough and difficulty breathing) and suspected clinical vaccination failure. On 19-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) as Positive (units unspecified). Patient was referred to HCP to discuss further. 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 and dizziness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: - 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
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had stroke. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210438125-covid-19 vaccine ad26.cov2.s-Stroke. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Computerised tomogram, Dizziness, Headache, Pain in extremity
Clinical narrative: DIZZY SPELLS; SHARP PAIN IN LEFT LEG; STOMACH PAIN; HEADACHE; This spontaneous report received from a patient concerned an 87 year old female. The patient's height, and weight were not reported. The patient's past medical history included brain bleed, and surgery, and concurrent conditions included iodine allergy, drug allergy, shellfish allergy, and heart problems. The patient experienced drug allergy when treated with amoxicillin, cefalexin, codeine, cortisone, ciclosporin, ibuprofen, gramicidin/neomycin sulfate/polymyxin b sulfate, and prednisone.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. Concomitant medications included alprazolam, iron, and meclozine hydrochloride.  On 13-APR-2021, the subject experienced headache. Treatment medications included: paracetamol. On 14-APR-2021, the subject experienced stomach pain. Laboratory data included: CAT scan (NR: not provided) unknown. On 15-APR-2021, the subject experienced sharp pain in left leg. Laboratory data included: CAT scan (NR: not provided) unknown. On 19-APR-2021, the subject experienced dizzy spells. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach pain on 15-APR-2021, and headache on 14-APR-2021, had not recovered from dizzy spells, and the outcome of sharp pain in left leg was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Migraine, Nausea, Pyrexia, Visual impairment
Clinical narrative: CHRONIC MIGRAINE; VISUAL DISTURBANCE/AFFECTED VISION; BAD NOSE BLEED; LOW FEVER; NAUSEA; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included stevens johnson syndrome from med. The patient was previously treated with macrogol 4000. 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 09-APR-2021 for prophylactic vaccination. The batch number was not reported an has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced low fever. On 10-APR-2021, the subject experienced nausea. On 17-APR-2021, the subject experienced bad nose bleed. On an unspecified date, the subject experienced chronic migraine, and visual disturbance/affected vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chronic migraine, low fever, nausea, bad nose bleed and visual disturbance/affected vision was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ADVERSE EVENT NOS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced adverse event nos. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse event nos was not reported. This report was non-serious. This case, from the same reporter is linked to 20210438321.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: UNCONTROLLABLE VAGINAL BLEEDING; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's past medical history included intestinal surgery, and concurrent conditions included severely overweight, stomach issues, and severe scarring. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported .The company was unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient was hospitalized with uncontrollable vaginal bleeding, that would not stop without surgical intervention. As of 16-APR-2021, the patient was still hospitalized. The current condition and whereabouts of the patient is unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of uncontrollable vaginal bleeding was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20210438280-covid-19 vaccine ad26.cov2.s-Vaginal bleeding. 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: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Blood glucose increased, Headache, Musculoskeletal chest pain, Pain
Clinical narrative: HEADACHE; BACK PAIN; RIB PAIN/THE LEFT SIDE OF THE RIBS UNDER THE ARM; SEVERE BODY PAIN; ITCHY RED SPOTS ON LEGS/SPOTS ON BOTH LEGS, UPPER LEG, LOWER PART ANKLE, AND ONE ON THE FEET, SMALL LIKE A DIME; BLOOD SUGAR FASTING RESULTS WAS 450 MG/D; This spontaneous report received from a patient concerned a 65 years male. The patient's weight was 175 pounds, and height was 68 inches. The patient's concurrent conditions included diabetes, and high blood pressure, and other pre-existing medical conditions included the patient had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 in left deltoid for prophylactic vaccination. No concomitant medications were reported.  Patient reported that, received the COVID-19 vaccine on 11-MAR-2021on the left arm. Patient's main reason for calling was the severe body pain on the right back and the left side of the ribs under the arm. Patient was taking Tylenol 500 mg 2 tablets in the morning for the past weeks to ease the pain, which was not normal for him, living on tablet for a couple of week. The pain on the ribs, come on hard, and it might stay like 10-15 mins then it cools off. Patient mentioned that he had headache too and had red spots on his legs that started out to be itchy. Patient had spots on both legs, upper leg 3, lower part ankle 2, and one on the feet, small like a dime. Lastly, patient said that his blood sugar fasting results is 450 mg/dL and that was not normal for him (his normal is 110/180-200mg/dL). However, Patient's blood pressure is under control.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood sugar fasting results was 450 mg/d, and had not recovered from headache, back pain, itchy red spots on legs/spots on both legs, upper leg, lower part ankle, and one on the feet, small like a dime, rib pain/the left side of the ribs under the arm, and severe body pain. This report was serious (Other Medically Important Condition). .; Sender's Comments: . 20210438296- Covid-19 vaccine ad26.cov2-blood sugar fasting results was 450 mg/d. 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: UNDERLYING DISEASE
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: HEADACHE; BACK PAIN; RIB PAIN/THE LEFT SIDE OF THE RIBS UNDER THE ARM; SEVERE BODY PAIN; ITCHY RED SPOTS ON LEGS/SPOTS ON BOTH LEGS, UPPER LEG, LOWER PART ANKLE, AND ONE ON THE FEET, SMALL LIKE A DIME; BLOOD SUGAR FASTING RESULTS WAS 450 MG/D; This spontaneous report received from a patient concerned a 65 years male. The patient's weight was 175 pounds, and height was 68 inches. The patient's concurrent conditions included diabetes, and high blood pressure, and other pre-existing medical conditions included the patient had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 in left deltoid for prophylactic vaccination. No concomitant medications were reported.  Patient reported that, received the COVID-19 vaccine on 11-MAR-2021on the left arm. Patient's main reason for calling was the severe body pain on the right back and the left side of the ribs under the arm. Patient was taking Tylenol 500 mg 2 tablets in the morning for the past weeks to ease the pain, which was not normal for him, living on tablet for a couple of week. The pain on the ribs, come on hard, and it might stay like 10-15 mins then it cools off. Patient mentioned that he had headache too and had red spots on his legs that started out to be itchy. Patient had spots on both legs, upper leg 3, lower part ankle 2, and one on the feet, small like a dime. Lastly, patient said that his blood sugar fasting results is 450 mg/dL and that was not normal for him (his normal is 110/180-200mg/dL). However, Patient's blood pressure is under control.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood sugar fasting results was 450 mg/d, and had not recovered from headache, back pain, itchy red spots on legs/spots on both legs, upper leg, lower part ankle, and one on the feet, small like a dime, rib pain/the left side of the ribs under the arm, and severe body pain. This report was serious (Other Medically Important Condition). .; Sender's Comments: . 20210438296- Covid-19 vaccine ad26.cov2-blood sugar fasting results was 450 mg/d. 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: UNDERLYING DISEASE