chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Loss of personal independence in daily activities, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: DYING FROM PAIN; FEVER 99-100.8 F AS IF GOT THE SHOT AGAIN; CHILLS AGAIN; SEVERE PAIN IN THE LEFT LEG FROM HIP TO KNEE, THE WHOLE LEFT SIDE; FUNCTIONABLE DURING THE DAY  BUT NOT AT NIGHT; CAN NOT SLEEP AT NIGHT; BOTH LEGS HURT AT GROIN; CRIES FROM THE SEVER PAIN; INCREASE IN THE BLOOD PRESSURE; DEHYDRATION WHICH MADE HER VERY THIRSTY; FELT BURNING IN THE RIGHT ARM WHILE GETTING THE SHOT; SWOLLEN FACE; SEVER CHILLS; FELT EXHAUSTED; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's past medical history included hip implant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 09-JUN-2021) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: Blood pressure measurement (NR: not provided) increased, COVID-19 virus test (NR: not provided) negative, Hip X-ray (NR: not provided) normal, and Investigation (NR: not provided) Negative. On 31-MAR-2021, the subject experienced increase in the blood pressure. On 31-MAR-2021, the subject experienced dehydration which made her very thirsty. On 31-MAR-2021, the subject experienced felt burning in the right arm while getting the shot. On 31-MAR-2021, the subject experienced swollen face. On 31-MAR-2021, the subject experienced sever chills. On 31-MAR-2021, the subject experienced felt exhausted. On 14-APR-2021, the subject experienced functionable during the day but not at night. On 14-APR-2021, the subject experienced can not sleep at night. On 14-APR-2021, the subject experienced both legs hurt at groin. On 14-APR-2021, the subject experienced cries from the sever pain. On 14-APR-2021, the subject experienced severe pain in the left leg from hip to knee, the whole left side. On 16-MAY-2021, the subject experienced fever 99-100.8 f as if got the shot again. On 16-MAY-2021, the subject experienced chills again. On an unspecified date, the subject experienced dying from pain. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increase in the blood pressure, and dehydration which made her very thirsty on 05-APR-2021, felt burning in the right arm while getting the shot on 2021, swollen face, sever chills, and felt exhausted on 14-APR-2021, and fever 99-100.8 f as if got the shot again, and chills again on 21-MAY-2021, had not recovered from severe pain in the left leg from hip to knee, the whole left side, functionable during the day but not at night, can not sleep at night, and cries from the sever pain, and the outcome of both legs hurt at groin and dying from pain was not reported. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, X-ray of pelvis and hip
Clinical narrative: DYING FROM PAIN; FEVER 99-100.8 F AS IF GOT THE SHOT AGAIN; CHILLS AGAIN; SEVERE PAIN IN THE LEFT LEG FROM HIP TO KNEE, THE WHOLE LEFT SIDE; FUNCTIONABLE DURING THE DAY  BUT NOT AT NIGHT; CAN NOT SLEEP AT NIGHT; BOTH LEGS HURT AT GROIN; CRIES FROM THE SEVER PAIN; INCREASE IN THE BLOOD PRESSURE; DEHYDRATION WHICH MADE HER VERY THIRSTY; FELT BURNING IN THE RIGHT ARM WHILE GETTING THE SHOT; SWOLLEN FACE; SEVER CHILLS; FELT EXHAUSTED; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's past medical history included hip implant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 09-JUN-2021) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: Blood pressure measurement (NR: not provided) increased, COVID-19 virus test (NR: not provided) negative, Hip X-ray (NR: not provided) normal, and Investigation (NR: not provided) Negative. On 31-MAR-2021, the subject experienced increase in the blood pressure. On 31-MAR-2021, the subject experienced dehydration which made her very thirsty. On 31-MAR-2021, the subject experienced felt burning in the right arm while getting the shot. On 31-MAR-2021, the subject experienced swollen face. On 31-MAR-2021, the subject experienced sever chills. On 31-MAR-2021, the subject experienced felt exhausted. On 14-APR-2021, the subject experienced functionable during the day but not at night. On 14-APR-2021, the subject experienced can not sleep at night. On 14-APR-2021, the subject experienced both legs hurt at groin. On 14-APR-2021, the subject experienced cries from the sever pain. On 14-APR-2021, the subject experienced severe pain in the left leg from hip to knee, the whole left side. On 16-MAY-2021, the subject experienced fever 99-100.8 f as if got the shot again. On 16-MAY-2021, the subject experienced chills again. On an unspecified date, the subject experienced dying from pain. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increase in the blood pressure, and dehydration which made her very thirsty on 05-APR-2021, felt burning in the right arm while getting the shot on 2021, swollen face, sever chills, and felt exhausted on 14-APR-2021, and fever 99-100.8 f as if got the shot again, and chills again on 21-MAY-2021, had not recovered from severe pain in the left leg from hip to knee, the whole left side, functionable during the day but not at night, can not sleep at night, and cries from the sever pain, and the outcome of both legs hurt at groin and dying from pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Eating disorder, Malnutrition, Pain in extremity
Clinical narrative: MALNOURISHED; NOT ABLE TO EAT; SORE ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included pulmonary embolism, hepatitis c, and liver cirrhosis, and other 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: 182266, and expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-MAY-2021, the subject experienced sore arm. On 22-MAY-2021, the subject experienced malnourished. On 22-MAY-2021, the subject experienced not able to eat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 21-MAY-2021, and the outcome of malnourished and not able to eat was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT; This spontaneous report received from a consumer concerned a 24 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: Unknown) dose, therapy start date were not reported, with frequency 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in APR-2021, the patient experienced blood clot and was hospitalized (date unspecified) and it was reported caller said his brother would called to provide more information regarding the patient's case. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210552268-COVID-19 VACCINE AD26.COV2.S-BLOOD CLOT. 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: M
Vaccine: COVID19
Symptoms: Headache, Vomiting
Clinical narrative: This spontaneous report received from a parent concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 26-MAY-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 26-MAY-2021, the subject experienced vomiting. On 26-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vomiting and headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ADVERSE EVENT NOS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced 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.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Tension headache
Clinical narrative: FEELS LIKE A RUBBER BAND AROUND HEAD OR TENSE FEELING AROUND HEAD; ACHES; CHILLS; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 22-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 22-MAY-2021, the subject experienced aches. On 22-MAY-2021, the subject experienced chills. On 22-MAY-2021, the subject experienced nausea. On 24-MAY-2021, the subject experienced feels like a rubber band around head or tense feeling around head. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches, chills, and nausea on MAY-2021, and had not recovered from feels like a rubber band around head or tense feeling around head. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain, Chills, Headache, Pain in extremity
Clinical narrative: SEVERE ABDOMINAL PAIN; SEVERE BLOATING; LEG PAIN; CHILLS; MILD HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 18-MAY-2021, the subject experienced severe abdominal pain. On 18-MAY-2021, the subject experienced severe bloating. On 18-MAY-2021, the subject experienced leg pain. On 18-MAY-2021, the subject experienced chills. On 18-MAY-2021, the subject experienced mild headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 20-MAY-2021, and had not recovered from severe abdominal pain, severe bloating, mild headache, and leg pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; 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: 1805022 and expiry: 25-MAY-2021) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-MAY-2021, the subject experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Chills, Cough, Fatigue, Headache
Clinical narrative: LOSS OF TASTE; COUGH; BODY ACHES; CHILLS; FEVER; FATIGUE; HEADACHE; NAUSEA; MUSCLE ACHES; This spontaneous report received from a patient concerned an 81 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and non-alcohol use, and other pre-existing medical conditions included the patient had no known drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, and batch number: 1820095 expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAY-2021, the subject experienced loss of taste. On 20-MAY-2021, the subject experienced cough. On 20-MAY-2021, the subject experienced body aches. On 20-MAY-2021, the subject experienced chills. On 20-MAY-2021, the subject experienced fever. On 20-MAY-2021, the subject experienced fatigue. On 20-MAY-2021, the subject experienced headache. On 20-MAY-2021, the subject experienced nausea. On 20-MAY-2021, the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of taste on 25-MAY-2021, body aches, and muscle aches on 22-MAY-2021, chills on 24-MAY-2021, fever on 27-MAY-2021, and headache, and nausea on 26-MAY-2021, and was recovering from cough, and fatigue. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: LOSS OF TASTE; COUGH; BODY ACHES; CHILLS; FEVER; FATIGUE; HEADACHE; NAUSEA; MUSCLE ACHES; This spontaneous report received from a patient concerned an 81 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and non-alcohol use, and other pre-existing medical conditions included the patient had no known drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, and batch number: 1820095 expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAY-2021, the subject experienced loss of taste. On 20-MAY-2021, the subject experienced cough. On 20-MAY-2021, the subject experienced body aches. On 20-MAY-2021, the subject experienced chills. On 20-MAY-2021, the subject experienced fever. On 20-MAY-2021, the subject experienced fatigue. On 20-MAY-2021, the subject experienced headache. On 20-MAY-2021, the subject experienced nausea. On 20-MAY-2021, the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of taste on 25-MAY-2021, body aches, and muscle aches on 22-MAY-2021, chills on 24-MAY-2021, fever on 27-MAY-2021, and headache, and nausea on 26-MAY-2021, and was recovering from cough, and fatigue. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Hypertension, Illness, Nasopharyngitis, Pain
Clinical narrative: SICK; COLD SYMPTOMS; SEVERE BODY PAIN; BLOOD PRESSURE VERY HIGH; COUGHING; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure (hypertension).The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-APR-2021 15:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced sick. On 2021, the subject experienced cold symptoms. On 2021, the subject experienced severe body pain. On 2021, the subject experienced blood pressure very high. On 2021, the subject experienced coughing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood pressure very high, coughing, and cold symptoms, and the outcome of severe body pain and sick was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103.9 F, 102.3 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Breast pain, Hypokinesia, Muscle strain
Clinical narrative: UNABLE TO MOVE LEFT ARM NORMALLY; MILD TO SEVERE/ LOT OF PAIN IN SIDE LEFT BREAST; MILD TO SEVERE/ LOT OF PAIN IN ARMPIT; PAIN FEELS LIKE MUSCLE STRAIN; MILD TO SEVERE/ LOT OF PAIN IN ELBOW; MILD TO SEVERE/ LOT OF PAIN IN LEFT ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included ibuprofen for drug used for unknown indication.  On an unspecified date, the subject experienced unable to move left arm normally, mild to severe/ lot of pain in side left breast, mild to severe/ lot of pain in armpit, pain feels like muscle strain, mild to severe/ lot of pain in elbow, and mild to severe/ lot of pain in left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mild to severe/ lot of pain in left arm, unable to move left arm normally, mild to severe/ lot of pain in side left breast, pain feels like muscle strain, mild to severe/ lot of pain in elbow, and mild to severe/ lot of pain in armpit. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: UNABLE TO MOVE LEFT ARM NORMALLY; MILD TO SEVERE/ LOT OF PAIN IN SIDE LEFT BREAST; MILD TO SEVERE/ LOT OF PAIN IN ARMPIT; PAIN FEELS LIKE MUSCLE STRAIN; MILD TO SEVERE/ LOT OF PAIN IN ELBOW; MILD TO SEVERE/ LOT OF PAIN IN LEFT ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included ibuprofen for drug used for unknown indication.  On an unspecified date, the subject experienced unable to move left arm normally, mild to severe/ lot of pain in side left breast, mild to severe/ lot of pain in armpit, pain feels like muscle strain, mild to severe/ lot of pain in elbow, and mild to severe/ lot of pain in left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mild to severe/ lot of pain in left arm, unable to move left arm normally, mild to severe/ lot of pain in side left breast, pain feels like muscle strain, mild to severe/ lot of pain in elbow, and mild to severe/ lot of pain in armpit. This report was non-serious.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Chest X-ray, Dyspnoea, Echocardiogram, Inflammation
Clinical narrative: SWELLING OF WRISTS; HAND/FEET SWELLING/PERIPHERY SWELLING; UNEVALUABLE EVENT/LONG HAULERS SYNDROME; DYSPNOEA/WINDED WITH TALKING OR WALKING; INFLAMMATION; WRIST PAIN; PAIN OF EXTREMITIES/HAND AND FEET PAIN; SUSPECTED COVID 19; This spontaneous report received from a patient concerned a 60 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, intramuscular, 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. Non-company suspect drugs included: adalimumab (solution for infusion in pre-filled syringe, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On DEC-2020, the subject experienced suspected covid 19. On an unspecified date, the subject experienced swelling of wrists, hand/feet swelling/periphery swelling, unevaluable event/long haulers syndrome, dyspnoea/winded with talking or walking, inflammation, wrist pain, and pain of extremities/hand and feet pain. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) inflammation in long, Echocardiogram (NR: not provided) Normal, and Pulmonary function test (NR: not provided) Normal. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling of wrists, hand/feet swelling/periphery swelling, wrist pain, and unevaluable event/long haulers syndrome, and the outcome of suspected covid 19, pain of extremities/hand and feet pain, dyspnoea/winded with talking or walking and inflammation was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required per standard procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Joint swelling, Pain in extremity, Peripheral swelling, Pulmonary function test, Suspected COVID-19
Clinical narrative: SWELLING OF WRISTS; HAND/FEET SWELLING/PERIPHERY SWELLING; UNEVALUABLE EVENT/LONG HAULERS SYNDROME; DYSPNOEA/WINDED WITH TALKING OR WALKING; INFLAMMATION; WRIST PAIN; PAIN OF EXTREMITIES/HAND AND FEET PAIN; SUSPECTED COVID 19; This spontaneous report received from a patient concerned a 60 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, intramuscular, 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. Non-company suspect drugs included: adalimumab (solution for infusion in pre-filled syringe, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On DEC-2020, the subject experienced suspected covid 19. On an unspecified date, the subject experienced swelling of wrists, hand/feet swelling/periphery swelling, unevaluable event/long haulers syndrome, dyspnoea/winded with talking or walking, inflammation, wrist pain, and pain of extremities/hand and feet pain. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) inflammation in long, Echocardiogram (NR: not provided) Normal, and Pulmonary function test (NR: not provided) Normal. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling of wrists, hand/feet swelling/periphery swelling, wrist pain, and unevaluable event/long haulers syndrome, and the outcome of suspected covid 19, pain of extremities/hand and feet pain, dyspnoea/winded with talking or walking and inflammation was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required per standard procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Unevaluable event
Clinical narrative: SWELLING OF WRISTS; HAND/FEET SWELLING/PERIPHERY SWELLING; UNEVALUABLE EVENT/LONG HAULERS SYNDROME; DYSPNOEA/WINDED WITH TALKING OR WALKING; INFLAMMATION; WRIST PAIN; PAIN OF EXTREMITIES/HAND AND FEET PAIN; SUSPECTED COVID 19; This spontaneous report received from a patient concerned a 60 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, intramuscular, 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. Non-company suspect drugs included: adalimumab (solution for infusion in pre-filled syringe, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On DEC-2020, the subject experienced suspected covid 19. On an unspecified date, the subject experienced swelling of wrists, hand/feet swelling/periphery swelling, unevaluable event/long haulers syndrome, dyspnoea/winded with talking or walking, inflammation, wrist pain, and pain of extremities/hand and feet pain. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) inflammation in long, Echocardiogram (NR: not provided) Normal, and Pulmonary function test (NR: not provided) Normal. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling of wrists, hand/feet swelling/periphery swelling, wrist pain, and unevaluable event/long haulers syndrome, and the outcome of suspected covid 19, pain of extremities/hand and feet pain, dyspnoea/winded with talking or walking and inflammation was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required per standard procedure as the case assessed as non-serious.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Urticaria
Clinical narrative: HIVES ALL OVER BODY; ITCHY RASHES IN FACE AND NECK AREA; This spontaneous report received from a patient concerned a 30 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: 203A21A expiry: 23/JUN/2021) .5 ml, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 26-MAY-2021, the subject experienced hives all over body. On 26-MAY-2021, the subject experienced itchy rashes in face and neck area. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, loratadine, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from itchy rashes in face and neck area, and had not recovered from hives all over body. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis, Ultrasound Doppler, Ultrasound scan
Clinical narrative: BLOOD CLOT FROM GROIN AREA ALL THE WAY TO THE LEG; This spontaneous report received from a patient concerned a 63-year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included osteoporosis, osteoarthritis, bursitis, rheumatoid arthritis (RA), migraine headache, anxiety, and cholesterol, and other pre-existing medical conditions included patient had no history of blood clots and no prior heart conditions.  On 16-Mar-2021 around 09:00, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: Unknown) dose was not reported, frequency 1 total, administered on left arm for prophylactic vaccination. Concomitant medications included pantoprazole for acid reflux, citalopram for anxiety, simvastatin for cholesterol, and prn 1371 for migraine headache.  On an unspecified date in Feb-2021, the patient mentioned (heart doctor) had done some tests on veins making sure the patient's heart was open and does not have any blood clots. Laboratory data included: Diagnostic ultrasound (NR: not provided) Normal, and Doppler ultrasound (NR: not provided) No blood clots. 7 days later the patient was informed everything was fine and she got vaccinated on 16-Mar-2021. On 07-May-2021, the patient reported that her left leg started hurting. On 09-May-2021, the leg started swelling. On 11-May-2021, the patient was admitted to the hospital with a massive blood clot from groin area all the way to the leg. On 14-May-2021, she was discharged from hospital. The patient was hospitalized for 3 days. The patient stated her doctor will let her know if she can move around more next week, the patient is currently in lot of pain. Treatment medications (dates unspecified) included: apixaban, paracetamol, tramadol hydrochloride, gabapentin, and baclofen. The action taken with covid-19 vaccine ad26.cov2. s was not applicable. The patient had not recovered from blood clot from groin area all the way to the leg. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20210500586-COVID-19 VACCINE AD26.COV2.S-This case concerns with 63 year old female  blood clot from groin area all the way to the leg -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: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Dyspnoea, Insomnia, Product dose omission issue
Clinical narrative: DIFFICULTY BREATHING; LOSS OF APPETITE; DIFFICULTY SLEEPING; UNABLE TO TAKE KIDNEY MEDICATIONS; This spontaneous report received from a patient concerned a 63 year old male. The patient's weight was 180 pounds, and height was 75 inches.  The patient's concurrent conditions included kidney failure, dialysis, non smoker, and marijuana drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 882A286 expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced difficulty breathing. On MAY-2021, the subject experienced loss of appetite. On MAY-2021, the subject experienced difficulty sleeping. On MAY-2021, the subject experienced unable to take kidney medications. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the loss of appetite, difficulty breathing, difficulty sleeping and unable to take kidney medications was not reported. This report was non-serious.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Pyrexia
Clinical narrative: RAPID HEART BEAT; FEVER; This spontaneous report received from a consumer concerned a 42 year old male. The patient's weight was 270 pounds, and height was 77 inches. 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: 20621A expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  On 26-MAY-2021, the subject experienced rapid heart beat. On 26-MAY-2021, the subject experienced fever. On 27-MAY-2021, treatment medications included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from rapid heart beat, and fever. This report was non-serious.
Age: 23.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Medication error
Clinical narrative: ADMINISTRATION ERROR/ADMINISTERED THE DOSE AFTER 6 HOUR EXPIRATION TIME WINDOW.; MEDICATION ERROR; This spontaneous report received from a health care professional concerned a 23 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the subject experienced administration error/administered the dose after 6 hour expiration time window. On 27-MAY-2021, the subject experienced medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration error/administered the dose after 6 hour expiration time window. and medication error was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Off label use, Overdose
Clinical narrative: POSSIBLY GIVEN 1.5ML OF VACCINE; OVERDOSE; OFF LABEL USE; 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: 204A21A, and batch number: 204A21A expiry: 23/JUN/2021) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the subject experienced possibly given 1.5ml of vaccine. On 27-MAY-2021, the subject experienced overdose. On 27-MAY-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from possibly given 1.5ml of vaccine, and the outcome of overdose and off label use was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a 5 decade old white 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: Unknown) dose was not reported,1 total administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 24-MAY-2021,the patient had suspected covid-19 infection with lost of taste and smell and headache. On 27-MAY-2021, patient was diagnosed with Covid-19 virus and was not hospitalized. It was unsure whether the patient have taken any medication or not.  On 27-MAY-2021, Laboratory data included: COVID-19 virus test (NR: not provided) POSITIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000180990 This case, from the same reporter is linked to 20210554591.; Sender's Comments: V0: 20210554340- 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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Migraine, Vision blurred
Clinical narrative: SEVERE MIGRAINE; BLURRED VISION; DIZZINESS; FATIGUE; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included patient had no previous medical history, no known drug allergies, no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1821286, expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced severe migraine. On 25-MAY-2021, the subject experienced blurred vision. On 25-MAY-2021, the subject experienced dizziness. On 25-MAY-2021, the subject experienced fatigue. Treatment medications included: methocarbamol/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe migraine, blurred vision, fatigue, and dizziness. This report was non-serious. This case, involving the same patient is linked to 20210554732.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 64 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 22-JUN-2021) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the subject experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Feeling of body temperature change, Injection site pain, Malaise, Nasal congestion
Clinical narrative: HOT & COLD FEELING; HEAVY PAIN IN LEFT CALF WHEN TOUCHED IT; FEELING LIKE GETTING SICK/LAYING IN BED MOST OF THE TIME; PAIN IN ARM AT INJECTION SITE; SLIGHTLY STUFFED UP NOSE; CALF LITTLE HOT TO TOUCH; This spontaneous report received from a patient concerned a 37 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, and non-smoker, 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: 205A21A, and  expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced calf little hot to touch. On 25-MAY-2021, the subject experienced slightly stuffed up nose. On 25-MAY-2021, the subject experienced hot & cold feeling. On 25-MAY-2021, the subject experienced heavy pain in left calf when touched it. On 25-MAY-2021, the subject experienced feeling like getting sick/laying in bed most of the time. On 25-MAY-2021, the subject experienced pain in arm at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain in arm at injection site, had not recovered from heavy pain in left calf when touched it, feeling like getting sick/laying in bed most of the time, slightly stuffed up nose, and hot & cold feeling, and the outcome of calf little hot to touch was not reported. This report was non-serious.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: HOT & COLD FEELING; HEAVY PAIN IN LEFT CALF WHEN TOUCHED IT; FEELING LIKE GETTING SICK/LAYING IN BED MOST OF THE TIME; PAIN IN ARM AT INJECTION SITE; SLIGHTLY STUFFED UP NOSE; CALF LITTLE HOT TO TOUCH; This spontaneous report received from a patient concerned a 37 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, and non-smoker, 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: 205A21A, and  expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced calf little hot to touch. On 25-MAY-2021, the subject experienced slightly stuffed up nose. On 25-MAY-2021, the subject experienced hot & cold feeling. On 25-MAY-2021, the subject experienced heavy pain in left calf when touched it. On 25-MAY-2021, the subject experienced feeling like getting sick/laying in bed most of the time. On 25-MAY-2021, the subject experienced pain in arm at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain in arm at injection site, had not recovered from heavy pain in left calf when touched it, feeling like getting sick/laying in bed most of the time, slightly stuffed up nose, and hot & cold feeling, and the outcome of calf little hot to touch was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling
Clinical narrative: RIGHT ANKLE SWELLING; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 20-MAY-2021, the subject experienced right ankle swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right ankle swelling. This report was non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Dehydration, Diarrhoea, Dyspnoea, Fatigue
Clinical narrative: NOSE/HEAD CONGESTION; UNABLE TO BREATH; NIGHT SWEATS; CRAZY DREAMS; DIARRHEA; VOMITING; DEHYDRATION; DRY HEAVING; NAUSEA; SLUGGISH/TIRED; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's past medical history included flu, and concurrent conditions included overweight, and pcn (penicillin) allergy, and other pre-existing medical conditions included patient took a product (vaccine) as directed. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 23-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-MAY-2021, the subject experienced sluggish/tired. On 25-MAY-2021, the subject experienced diarrhea. On 25-MAY-2021, the subject experienced vomiting. On 25-MAY-2021, the subject experienced dehydration. On 25-MAY-2021, the subject experienced dry heaving. On 25-MAY-2021, the subject experienced nausea. On 26-MAY-2021, the subject experienced nose/head congestion. On 26-MAY-2021, the subject experienced unable to breath. On 26-MAY-2021, the subject experienced night sweats. On 26-MAY-2021, the subject experienced crazy dreams. Treatment medications included: bismuth subsalicylate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sluggish/tired, nausea, vomiting, diarrhea, nose/head congestion, dehydration, dry heaving, night sweats, unable to breath, and crazy dreams. This report was non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Night sweats, Retching, Sinus congestion, Vomiting
Clinical narrative: NOSE/HEAD CONGESTION; UNABLE TO BREATH; NIGHT SWEATS; CRAZY DREAMS; DIARRHEA; VOMITING; DEHYDRATION; DRY HEAVING; NAUSEA; SLUGGISH/TIRED; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's past medical history included flu, and concurrent conditions included overweight, and pcn (penicillin) allergy, and other pre-existing medical conditions included patient took a product (vaccine) as directed. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 23-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-MAY-2021, the subject experienced sluggish/tired. On 25-MAY-2021, the subject experienced diarrhea. On 25-MAY-2021, the subject experienced vomiting. On 25-MAY-2021, the subject experienced dehydration. On 25-MAY-2021, the subject experienced dry heaving. On 25-MAY-2021, the subject experienced nausea. On 26-MAY-2021, the subject experienced nose/head congestion. On 26-MAY-2021, the subject experienced unable to breath. On 26-MAY-2021, the subject experienced night sweats. On 26-MAY-2021, the subject experienced crazy dreams. Treatment medications included: bismuth subsalicylate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sluggish/tired, nausea, vomiting, diarrhea, nose/head congestion, dehydration, dry heaving, night sweats, unable to breath, and crazy dreams. This report was non-serious.